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News Capsules - April 2025

Impact of Human Papillomavirus Vaccination on Cervical Precancers

The Centers for Disease Control and Prevention has released an analysis of cervical precancer trends in the United States from 2008 to 2022, focusing on the effect of human papillomavirus (HPV) vaccination and changes in screening practices. The study used data from the Human Papillomavirus Vaccine Impact Monitoring Project (HPV-IMPACT), which tracks cervical intraepithelial neoplasia (CIN) cases in five U.S. sites.

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Inhaled Versus Intravenous Sedation for Acute Respiratory Distress Syndrome

Acute respiratory distress syndrome (ARDS) is a serious lung condition, requiring mechanical ventilation, and optimal sedation strategies are crucial for patient management. Propofol is commonly used in critically ill patients on ventilation; however, guidance for patients with moderate to severe ARDS is limited. A recent study investigated the effectiveness and safety of inhaled sevoflurane versus intravenous propofol for sedation in this patient population.

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Remibrutinib Improves Symptoms in Chronic Spontaneous Urticaria

Chronic spontaneous urticaria (CSU) is marked by itching, hives, and angioedema, which can last over 6 weeks and greatly reduces quality of life in those affected. Standard treatment is with second-generation H1-antihistamines, but only half of treated patients receive adequate relief. Two phase 3 clinical trials (REMIX-1 and REMIX-2) evaluated remibrutinib, a Bruton tyrosine kinase inhibitor, for CSU in patients whose symptoms were not well-controlled with second-generation H1-antihistamines.

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Tezepelumab for Chronic Rhinosinusitis with Nasal Polyps

A phase 3, multicenter, double-blind, randomized, controlled clinical trial (WAYPOINT) assessed the efficacy and safety of tezepelumab, a monoclonal antibody that targets thymic stromal lymphopoietin (TSLP), in treating severe, uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP). CRSwNP is a condition defined by epithelial barrier dysfunction and type 2 inflammation that leads to symptoms like nasal congestion, facial pain, and loss of smell, greatly impacting quality of life for patients.

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Drug News Abstracts Archive

News Capsules - April 2025
Impact of Human Papillomavirus Vaccination on Cervical PrecancersThe Centers for Disease Control and Prevention has released an analysis of cervical precancer trends in the United States from 2008 to 2022, focusing on the effect of human papillomavirus (HPV) vaccination and changes in screening practices. The study used data from the Human Papillomavirus Vaccine Impact Monitoring Project (HPV-IMPACT), which tracks cervical intraepithelial neoplasia (CIN) cases in five U.S. sites.READ MORE...The researchers analyzed trends in CIN2+ and CIN3+ incidence among screened women, adjusting for changes in frequency of screenings. They found substantial decreases in precancer occurrence in 2022 compared to 2008 among younger women (ages 20 to 24), particularly a substantial decline in cases for both CIN2+ (79.5% lower incidence) and CIN3+ (80.3% lower incidence), correlating with increased HPV vaccination in this age group.Conversely, older age groups (ages 25 to 64) initially showed an increased precancer incidence, likely due to longer gaps in screening and more sensitive HPV testing. However, recent data indicates that precancer incidence in the 25 to 29 age group has begun to decrease, particularly in CIN3+ cases, suggesting the delayed impact of HPV vaccination as those vaccinated at younger ages enter this demographic.Limitations of the study include potential inaccuracies in estimated screening rates, variations in screening and management, and the nature of the data, which doesn't directly establish causality. Despite these limitations, the trends strongly suggest that HPV vaccination and appropriate screening are crucial for preventing cervical cancer.Overall, the data demonstrates the importance of HPV vaccination on reducing cervical precancers, especially in younger women. It also shows a potential future reduction in precancer in older age groups as those vaccinated at younger ages progress. The study emphasizes the importance of continued HPV vaccination and adherence to cervical cancer screening guidelines. (Gargano, J. W., et al. [2025]. Trends in cervical precancers identified through population-based surveillance—Human Papillomavirus Vaccine Impact Monitoring Project, five sites, United States, 2008–2022. MMWR, 74[6], 96–101. Retrieved March 2025 from https://www.cdc.gov/mmwr/volumes/74/wr/mm7406a4.htm)Released: April 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Inhaled Versus Intravenous Sedation for Acute Respiratory Distress SyndromeAcute respiratory distress syndrome (ARDS) is a serious lung condition, requiring mechanical ventilation, and optimal sedation strategies are crucial for patient management. Propofol is commonly used in critically ill patients on ventilation; however, guidance for patients with moderate to severe ARDS is limited. A recent study investigated the effectiveness and safety of inhaled sevoflurane versus intravenous propofol for sedation in this patient population.READ MORE...The study was a multicenter, randomized, phase 3 trial which ran from May 2020 through October 2023 in 37 intensive care units in France, involving 687 adult patients with ARDS. Patients were randomized to receive either sevoflurane or propofol, with initial deep sedation and neuromuscular blockade followed by lighter sedation. The primary outcome was the number of ventilator-free days at 28 days, and secondary outcomes assessed 90-day survival and safety measures.The findings showed that patients receiving sevoflurane had fewer ventilator-free days (0.0 to 11.9 versus 0.0 to 18.7 with propofol) and a lower 90-day survival rate (47.1%) compared to those receiving propofol (55.7%). Additionally, the sevoflurane group experienced higher serum lactate levels, increased norepinephrine doses, and a higher incidence of acute kidney injury and nephrogenic diabetes insipidus.These results contradict previous studies suggesting potential advantages of inhaled volatile anesthetics in critically ill patients. The researchers' explanations for the adverse outcomes include possible hemodynamic instability and kidney injury associated with sevoflurane, as well as potential issues related to the delivery device impacting carbon dioxide levels.The study concluded that inhaled sevoflurane was associated with worse clinical outcomes than intravenous propofol in patients with moderate to severe ARDS. The findings suggest that propofol remains the preferred sedation agent in this patient population, and further research is needed to explore the effects of other volatile anesthetics and shorter durations of sevoflurane use. (Jabaudon, M., et al. [2025]. Inhaled sedation in acute respiratory distress syndrome: The SESAR randomized clinical trial. JAMA. Advance online publication. Retrieved March 2025 from https://jamanetwork.com/journals/jama/fullarticle/2831857)Released: April 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Remibrutinib Improves Symptoms in Chronic Spontaneous UrticariaChronic spontaneous urticaria (CSU) is marked by itching, hives, and angioedema, which can last over 6 weeks and greatly reduces quality of life in those affected. Standard treatment is with second-generation H1-antihistamines, but only half of treated patients receive adequate relief. Two phase 3 clinical trials (REMIX-1 and REMIX-2) evaluated remibrutinib, a Bruton tyrosine kinase inhibitor, for CSU in patients whose symptoms were not well-controlled with second-generation H1-antihistamines.READ MORE...The trials were randomized, double-blind, placebo-controlled studies where patients received either remibrutinib (25 mg twice daily) or a placebo for 24 weeks, in addition to their existing H1-antihistamine therapy. The primary endpoint was the change in the Urticaria Activity Score over 7 days (UAS7) from start to week 12. Key secondary endpoints were itch and hive severity scores, as well as the proportion of patients achieving well-controlled CSU (UAS7 score of 6 or less) and complete resolution of symptoms.Results showed remibrutinib substantially improved UAS7, itch severity, and hive severity compared to placebo at week 12, with improvements seen as early as week 1 and sustained through week 24. A greater percentage of patients on remibrutinib achieved well-controlled CSU over placebo (49.8% vs. 24.8% in REMIX-1; 46.8% vs. 19.6% in REMIX-2). Likewise, remibrutinib demonstrated better rates of complete symptom resolution (31.1% vs. 10.5% in REMIX-1; 27.9% vs. 6.5% in REMIX-2).Remibrutinib also demonstrated a favorable safety profile, with adverse events similar to placebo. Most events were mild or moderate, and serious adverse events were infrequent and unrelated to the study drug.These clinical trials support the efficacy and safety of remibrutinib as an add-on therapy for patients with CSU who don't respond adequately to H1-antihistamines, offering a potential new treatment option for this condition. (Metz, M., et al. [2025]. Remibrutinib in chronic spontaneous urticaria. NEJM, 392(10), 984–994. Retrieved March 2025 from https://www.nejm.org/doi/full/10.1056/NEJMoa2408792)Released: April 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Tezepelumab for Chronic Rhinosinusitis with Nasal PolypsA phase 3, multicenter, double-blind, randomized, controlled clinical trial (WAYPOINT) assessed the efficacy and safety of tezepelumab, a monoclonal antibody that targets thymic stromal lymphopoietin (TSLP), in treating severe, uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP). CRSwNP is a condition defined by epithelial barrier dysfunction and type 2 inflammation that leads to symptoms like nasal congestion, facial pain, and loss of smell, greatly impacting quality of life for patients.READ MORE...Current treatments, such as intranasal glucocorticoids and surgery, often provide limited relief. Biologic therapies targeting type 2 inflammatory pathways have emerged, but unmet needs remain for patients with inadequate responses. Tezepelumab, by blocking TSLP, an upstream inflammatory driver, offers a potential new approach, as elevated TSLP levels are found in nasal polyp tissue.The WAYPOINT trial, which ran from April 2021 through August 2023, involved 408 patients with severe CRSwNP, randomized to receive either tezepelumab (210 mg at week 0 and then every 4 weeks after) or placebo, alongside standard intranasal glucocorticoid therapy, over 52 weeks. The study measured changes in nasal polyp size, nasal congestion, loss of smell, sinus opacification, and the need for surgery or systemic glucocorticoids.Results showed significantly greater reductions in nasal polyp size (mean difference, −2.07) and nasal congestion (mean difference, −1.03) in the tezepelumab group compared to placebo. In addition, tezepelumab led to improvements in loss of smell, sinus opacification, and reduced the need for surgery or systemic glucocorticoids. The treatment was well-tolerated, with adverse events similar to placebo.The study concludes that tezepelumab is an effective and safe treatment option for severe, uncontrolled CRSwNP, offering symptom relief and reducing the need for invasive interventions. This suggests that targeting TSLP could be a promising therapeutic strategy for this challenging condition. (Lipworth, B. J., et al. [2025]. Tezepelumab in adults with severe chronic rhinosinusitis with nasal polyps. NEJM. Advance online publication. Retrieved March 2025 from https://www.nejm.org/doi/full/10.1056/NEJMoa2414482)Released: April 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.
News Capsules - March 2025
Long-Term Outcomes of Deucravacitinib in Plaque PsoriasisPlaque psoriasis, a chronic inflammatory skin condition, impacts quality of life and can lead to disability. The enzyme tyrosine kinase 2 plays a central role in signaling inflammatory cytokines in psoriasis. Deucravacitinib has been used to treat plaque psoriasis by preventing this enzyme from becoming active.READ MORE...The efficacy and safety of deucravacitinib were previously evaluated in two global, 52-week, randomized phase 3 trials (POETYK PSO-110 and PSO-211), which demonstrated that the drug was better than placebo and apremilast in reducing moderate to severe plaque psoriasis severity. Patients who completed the initial trials had the option to enter in the long-term extension trial, which involved open-label treatment with deucravacitinib. This trial started in 2019 and provided ongoing data through 2022 to assess the long-term impact of treatment.Efficacy data from patients receiving continuous treatment revealed that clinical responses were maintained throughout the 3 years. Likewise, safety assessments throughout the 3-year period revealed that adverse events and discontinuations due to adverse events remained consistent with those seen during the first year. Serious infections, major cardiovascular events, and herpes zoster were also monitored, with most findings showing either decreased or similar incidence rates compared to the first year. Laboratory parameters, such as blood counts and lipid levels, also remained stable over time.This study suggests that deucravacitinib is a reliable and effective long-term treatment option for managing plaque psoriasis, offering patients consistent relief and a manageable safety profile over an extended treatment period. (Armstrong, A. W., et al. [2025]. Safety and efficacy of deucravacitinib in moderate to severe plaque psoriasis for up to 3 years: An open-label extension of randomized clinical trials. JAMA Dermatol, 161[1], 56–66. Retrieved February 2025 from https://jamanetwork.com/journals/jamadermatology/fullarticle/2827130)Released: March 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Finerenone Improves Long-Term Outcomes in Patients with Heart FailurePatients with heart failure with mildly reduced ejection fraction (HFmrEF) or preserved ejection fraction (HFpEF) face reduced life expectancy, often 15 years shorter than their age-matched peers. Until recently, treatment options were limited, focusing mainly on symptom management. Sodium-glucose cotransporter 2 (SGLT2) inhibitors and, more recently, the mineralocorticoid receptor antagonist, finerenone, have emerged as effective therapies, reducing cardiovascular events and improving patient outcomes.READ MORE...The phase 3, FINEARTS-HF trial, a large, global, randomized controlled trial, evaluated the long-term impact of finerenone on event-free survival in patients with HFmrEF or HFpEF. The trial enrolled 6,001 participants, age 40 and older, with evidence of heart disease and elevated natriuretic peptide levels. The patients were randomly assigned to receive either finerenone or a placebo. The primary endpoint of the study was cardiovascular death or worsening heart failure, while all-cause mortality was a secondary outcome. The study used actuarial methods to estimate the long-term benefits of finerenone, considering factors like patient age at randomization and adjusting for survival time free from the primary outcome.The analysis revealed notable long-term benefits with finerenone, with a 65-year-old patient gaining an estimated 2.0 years of event-free survival compared to those receiving placebo. The benefits were more pronounced in younger and middle-aged patients, who had longer life expectancies. Additionally, participants already on SGLT2 inhibitors at baseline also saw substantial benefits, suggesting that finerenone could complement current treatments.While finerenone was shown to extend event-free survival by up to 3 years in some patients, it didn't significantly improve overall survival. Despite this, the trial showed that finerenone provides meaningful long-term benefits for patients with HFmrEF or HFpEF, particularly for younger patients. The treatment has comparable benefits to SGLT2 inhibitors and offers an additional option for improving long-term outcomes in this challenging patient population. (Vaduganathan, M., et al. [2025]. Estimated long-term benefits of finerenone in heart failure: A prespecified secondary analysis of the FINEARTS-HF randomized clinical trial. JAMA Cardiol, 10[2], 176–181. Retrieved February 2025 from https://jamanetwork.com/journals/jamacardiology/fullarticle/2824342)Released: March 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Iptacopan Has Potential as Targeted Treatment for IgA NephropathyIgA nephropathy, a form of glomerulonephritis, is often associated with progressive kidney function loss, especially in individuals with high urinary protein levels, and is a major cause of kidney failure. Treatments for this immune disorder often rely on glucocorticoids, which have substantial side effects.READ MORE...Iptacopan, a proximal complement inhibitor, has shown promise in clinical trials for IgA nephropathy. It works by inhibiting factor B, preventing the formation of the membrane attack complex, which contributes to kidney damage. A current phase 3 trial, APPLAUSE-IgAN, is assessing iptacopan's effects on proteinuria and kidney function in patients at risk for progression. This reports on results of the interim analysis of that trial (data collected between January 2021 to August 2023), evaluating the impact on proteinuria specifically.In the study, patients were randomized to receive either iptacopan or a placebo, in addition to supportive care. Eligibility was based on having primary IgA nephropathy confirmed by biopsy and meeting certain criteria for proteinuria. The study examined the change in the 24-hour urinary protein-to-creatinine ratio at 9 months. Various measures of protein and albumin excretion were also assessed, as well as safety outcomes.At the interim analysis, results showed that iptacopan reduced the 24-hour urinary protein-to-creatinine ratio by 38.3% compared to placebo. Additionally, more patients in the iptacopan group had a protein-to-creatinine ratio of less than 1 at 9 months. Safety data also supported iptacopan, indicating that it was well-tolerated and reporting that most adverse events were mild to moderate. In addition, fewer patients in the iptacopan group discontinued the trial due to adverse events compared to the placebo group.The trial's interim results highlight iptacopan's potential as a targeted treatment for IgA nephropathy by blocking complement-mediated kidney injury. While the current trial focuses on proteinuria, future analysis of kidney function outcomes will provide a clearer understanding of its long-term effects on kidney health. (Perkovic, V., et al. [2025]. Alternative complement pathway inhibition with iptacopan in IgA nephropathy. NEJM, 392, 531–543. Retrieved February 2025 from https://www.nejm.org/doi/full/10.1056/NEJMoa2410316)Released: March 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Adding Obinutuzumab to Standard Therapy in Lupus NephritisA phase 3, randomized, double-blind, placebo-controlled trial aimed to assess whether obinutuzumab could enhance renal outcomes in lupus nephritis patients who were already receiving standard treatments, such as mycophenolate mofetil and glucocorticoids. Obinutuzumab has previously shown promise in other conditions, like chronic lymphocytic leukemia and follicular lymphoma.READ MORE...The trial included 271 patients with active class III or IV lupus nephritis. The patients were randomized to receive either obinutuzumab or a placebo, with both groups also receiving standard therapy. The primary endpoint was achieving a reduction in proteinuria and maintaining kidney function without treatment failure or major adverse events at week 76.Results showed that more participants in the obinutuzumab group (46.4%) attained a complete renal response at week 76 compared to the placebo group (33.1%). Additionally, the obinutuzumab group experienced fewer intercurrent events, such as treatment failure or the need for rescue therapy. Secondary endpoints also favored obinutuzumab, with a higher proportion of patients achieving reduced proteinuria and better preservation of kidney function.While obinutuzumab demonstrated superior efficacy, the trial also showed a higher incidence of serious adverse events. These included respiratory infections and complications related to coronavirus disease 2019 (COVID-19). However, after excluding COVID-19-related events, the rate of serious infections decreased.This phase 3 trial confirms that adding obinutuzumab to standard therapy improves renal outcomes for patients with lupus nephritis. However, the treatment comes with an increased risk of infections, especially in the context of COVID-19, and this must be balanced against its benefits. Overall, the study supports obinutuzumab as an encouraging option in treating lupus nephritis, although further investigation into long-term safety and efficacy is needed. (Furie, R. A., et al. [2025]. Efficacy and safety of obinutuzumab in active lupus nephritis. NEJM. Advance online publication. https://www.nejm.org/doi/full/10.1056/NEJMoa2410965)Released: March 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.
News Capsules - February 2025
Condoliase Offers Less Invasive Treatment for Patients With Lumbar Disc HerniationLumbar disc herniation (LDH) is a spinal condition that causes nerve root compression, leading to radicular leg pain and affecting quality of life. Although many cases resolve with conservative treatments, approximately 10% of patients require more intensive interventions. Consequently, alternative treatments like condoliase, are being explored.READ MORE...Condoliase is a glycosaminoglycan-degrading enzyme that reduces moisture retention and pressure within the intervertebral disc, alleviating nerve root compression, which is a key contributor to pain in LDH. A phase 3, multicenter, randomized, double-blind, sham-controlled trial focused on evaluating the safety and efficacy of condoliase in the United States.The study involved 352 participants ages 30 to 70 with radicular leg pain from LDH. Participants were randomized to receive either a single intradiscal injection (1.25 units) of condoliase or a sham injection. The primary endpoint was the change in worst leg pain score from baseline to Week 13, while secondary endpoints included changes in disability, herniation volume, and neurologic status. Results showed that the condoliase group had higher responder rates (50% or more reduction in pain) compared to the sham group. The condoliase group also showed improvements in disability and greater improvements in neurologic tests, such as the straight leg raise test, at Week 13.Although adverse events were reported more frequently in the condoliase group, including back pain and hypersensitivity reactions, no participants required discontinuation due to adverse events. Additionally, condoliase was associated with a lower rate of posttreatment surgery compared to the sham group, which is a promising result for patients looking for less invasive alternatives to surgery.This phase 3 trial supports condoliase as an effective treatment for radicular leg pain due to LDH, with improvements in pain relief and lower rates of surgery compared to sham treatment. Even though the drug was associated with some mild side effects, it provides a promising less-invasive option for patients who don't respond to conservative treatments. (Kim, K. D., et al. [2024]. A phase 3, randomized, double-blind, sham-controlled trial of SI-6603 [condoliase] in patients with radicular leg pain associated with lumbar disc herniation. The Spine Journal, 24[12], 2285–2296. Retrieved January 2025 from https://www.thespinejournalonline.com/article/S1529-9430(24)00936-7/fulltext)Released: February 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Promising Treatment Combination for Cystic FibrosisCystic fibrosis (CF) is a genetic disorder that's caused by mutations in the CFTR gene. The disease can manifest in early life, with symptoms such as pancreatic insufficiency and elevated chloride levels in sweat. Chronic respiratory infections and progressive lung damage are common, and poor nutrition exacerbates these issues, contributing to the overall decline in health.READ MORE...CFTR modulators are a therapeutic class designed to restore normal CFTR function, as individuals with healthy CFTR don't experience CF-related symptoms. Sweat chloride testing is a key diagnostic tool for CF, with elevated chloride levels indicating CFTR dysfunction. CFTR modulators, like vanzacaftor/tezacaftor/deutivacaftor, a new combination regimen, aim to normalize chloride transport and improve overall CFTR function.In a phase 3 trial for children ages 6 to 11 years, this combination was tested with 78 participants over a 24-week treatment period for safety, pharmacokinetics, and efficacy. In the trial, participants taking the combination therapy showed stable lung function, with no significant decline in forced expiratory volume in 1 second, a key measure of lung capacity. The treatment also led to a decrease in sweat chloride concentrations, with most children achieving sweat chloride levels below the 60 mmol/L threshold, a marker of improved CFTR function. Additionally, the Cystic Fibrosis Questionnaire-Revised respiratory domain scores improved, suggesting better respiratory health. As far as safety, the regimen was found to be well tolerated, with few serious adverse events.Overall, the 24-week trial demonstrated that vanzacaftor/tezacaftor/deutivacaftor treatment improves CFTR function in children ages 6 to 11, with a favorable safety profile. This next-generation CFTR modulator regimen offers hope for reducing the clinical burden of CF, potentially improving both quality of life and long-term health outcomes. (Hoppe, J. E., et al. [2025]. Vanzacaftor/tezacaftor/deutivacaftor for children aged 6–11 years with cystic fibrosis [RIDGELINE trial VX21-121-105]: An analysis from a single-arm, phase 3 trial. The Lancet Respiratory Medicine. Advance online publication. Retrieved January 2025 from https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(24)00407-7/fulltext)Released: February 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Updated Guidelines for Tuberculosis TreatmentUpdated guidelines from the American Thoracic Society, the Centers for Disease Control and Prevention, the European Respiratory Society, and the Infectious Diseases Society of America now recommend shorter, fully oral treatment regimens for tuberculosis (TB) in both adults and children.READ MORE...The push for shorter treatments comes after years of limited drug development. Recent studies have enabled the reduction of treatment durations to 4 months for drug-susceptible TB and 6 months for drug-resistant TB, providing a more efficient approach to managing the disease. However, not all patients qualify for these shortened regimens, and the existing recommendations for some patients from previous guidelines remain in place. The updated guidelines make the following suggestions:Children ages 3 months to 16 years old with nonsevere TB should receive a 4-month regimen of isoniazid, rifampin, pyrazinamide, and ethambutol for 2 months, followed by isoniazid and rifampin for the remaining 2 months.Patients age 12 and older with drug-susceptible TB should consider a 4-month regimen of isoniazid, rifapentine, moxifloxacin, and pyrazinamide.Patients age 14 and older with rifampin-resistant pulmonary TB and resistance to fluoroquinolones; and in cases of multidrug-resistant but fluoroquinolone-susceptible disease, a 6-month regimen of bedaquiline, pretomanid, linezolid, and moxifloxacin is recommended.Certain pediatric cases that don't meet the criteria for the shortened regimen should continue with the standard 6-month treatment, while children with severe TB forms may require alternative regimens. Some children may also be eligible for the 4-month rifapentine-moxifloxacin regimen. The guidelines stress that drug-susceptibility testing and close monitoring for safety and effectiveness remain essential, especially to prevent the emergence of drug resistance.The updated guidelines were largely adapted from the 2022 World Health Organization TB treatment recommendations, with a panel of 25 international experts contributing to the consensus. No new clinical trial data has emerged since the World Health Organization guidelines were published, and the U.S. guidelines align closely with the global recommendations. (Saukkonen, J. J., et al. [2025]. Updates on the treatment of drug-susceptible and drug-resistant tuberculosis: An official ATS/CDC/ERS/IDSA Clinical Practice Guideline. American Journal of Respiratory and Critical Care Medicine, 211[1], 15–33. Retrieved January 2025 from https://www.atsjournals.org/doi/full/10.1164/rccm.202410-2096ST)Released: February 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Combination Metronomic Capecitabine and Aromatase Inhibitor as First-Line Treatment for Hormone Receptor-Positive, HER2-Negative Breast CancerTreating hormone receptor-positive, HER2-negative metastatic breast cancer (MBC) is challenging, especially as resistance to endocrine therapy develops in most patients over time. Metronomic chemotherapy, which uses lower doses of chemotherapy agents at more frequent intervals, offers potential as a less toxic alternative to traditional chemotherapy.READ MORE...Capecitabine, an oral chemotherapy agent, is one such drug used in metronomic chemotherapy. The MECCA trial explored combining metronomic capecitabine with endocrine therapy, specifically an aromatase inhibitor (AI), as a first-line treatment for hormone receptor-positive, HER2-negative MBC. This phase 3 trial in China involved 254 patients and compared the combination of capecitabine and AI with AI alone in terms of progression-free survival (PFS) and other clinical outcomes.The primary endpoint was PFS, while secondary endpoints included overall survival (OS), objective response rate, disease control rate, and safety. Patients were randomly assigned to either the capecitabine (500 mg three times daily) plus AI group or the AI-only group. The study continued until disease progression, intolerable side effects, or patient withdrawal.After a median follow-up of 50.7 months, the combination group showed a meaningful improvement in PFS (20.9 months) compared to the AI-only group (11.9 months). The combination group also had an OS advantage, with a median OS not yet reached compared to 45.1 months in the AI-only group. The objective response and disease control rates were higher in the combination group as well, at 37.3% and 88.1%, respectively, compared to 25.0% and 75.8% for the AI-only group.In terms of safety, the combination therapy was generally well tolerated. Although adverse events like palmar-plantar erythrodysesthesia were more common in the capecitabine plus AI group, most side effects were mild to moderate.The MECCA trial supports metronomic capecitabine combined with AI as an effective first-line treatment for hormone receptor-positive, HER2-negative MBC, offering improvements in PFS and OS with manageable toxicity. Further research is needed to investigate its role alongside other therapies, including CDK4/6 inhibitors and targeted therapies. (Hong, R.-X., et al. [2025]. Metronomic capecitabine plus aromatase inhibitor as initial therapy in patients with hormone receptor–positive, human epidermal growth factor receptor 2–negative metastatic breast cancer. The phase III MECCA trial. Journal of Clinical Oncology. Advance online publication. Retrieved January 2025 from https://ascopubs.org/doi/10.1200/JCO.24.00938)Released: February 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.
News Capsules - January 2025
Blinatumomab Plus Chemotherapy Enhances Outcomes for Children with Newly Diagnosed B-Cell ALLOver the past five decades, the cure rates for acute lymphoblastic leukemia (ALL) have greatly improved, although further progress has slowed. Blinatumomab has appeared hopeful in treating children with relapsed B-cell ALL by redirecting T cells to attack these cancer cells. However, its effect on children with newly diagnosed disease remained unclear.READ MORE...AALL1731, an international, randomized, controlled, phase 3 trial conducted by the Children's Oncology Group, assessed whether adding two cycles of blinatumomab to standard chemotherapy would produce better results for children with standard-risk B-cell ALL. The study ran from June 2019 to June 2024 and enrolled 1,440 children ages 1 to 10 with standard-risk B-cell ALL and with an average or high risk for relapse. The patients were randomized into two groups: one received chemotherapy alone, while the other received chemotherapy along with two cycles of blinatumomab. The primary endpoint was disease-free survival (DFS), defined as the time from randomization to the first event of relapse, death, or a second malignancy.The results showed that adding blinatumomab improved DFS, with a 3-year DFS of 96% in the blinatumomab group versus 87.9% in the chemotherapy-only group. Additionally, blinatumomab was found to strengthen DFS across all subgroups, including those with varying minimal residual disease levels, race, and cytogenetic risk groups. Overall survival was also improved, particularly in patients with an average risk of relapse. Despite these positive results, patients in the blinatumomab group were more likely to experience severe infections, such as sepsis and catheter-related infections, although these events were relatively rare.The findings from this trial suggest that blinatumomab could produce better treatment outcomes for children with newly diagnosed standard-risk B-cell ALL, particularly those with higher relapse risks. Although further studies are needed to address the optimal number of blinatumomab cycles and the long-term effects of the treatment, the results from this trial could help refine the strategies used to treat childhood leukemia in the future. (Gupta, S., et al. [2024]. Blinatumomab in standard-risk B-cell acute lymphoblastic leukemia in children. NEJM. Advance online publication. Retrieved December 2024 from https://www.nejm.org/doi/full/10.1056/NEJMoa2411680?query=TOC&cid=DM2376567_Non_Subscriber&bid=-1601332578)Released: January 2025Nursing Drug Handbook© 2025 Wolters KluwerBrexpiprazole and Sertraline Combination a Promising Treatment for PTSDPosttraumatic stress disorder (PTSD) is a mental health condition marked by intrusive memories, avoidance of trauma-related stimuli, and negative mood shifts. It impacts quality of life and is linked to increased suicide risk. First-line treatment for PTSD is selective serotonin reuptake inhibitors (SSRIs), such as sertraline and paroxetine, though many patients don't respond to these medications.READ MORE...One promising alternative is brexpiprazole, an antipsychotic with a broad range of pharmacologic effects on neurotransmitter systems. A phase 3, multicenter, double-blind, randomized clinical study compared brexpiprazole plus sertraline with sertraline plus placebo in patients diagnosed with PTSD to assess its efficacy, safety, and tolerability. The study ran from October 2019 to August 2023 and enrolled 416 patients. Participants were randomized to either brexpiprazole (2 to 3 mg/day) with sertraline (150 mg/day) or sertraline (150 mg/day) with placebo and monitored over 11 weeks.The primary outcome of the study was the change in PTSD symptoms, as measured by the Clinician-Administered PTSD Scale (CAPS-5). Secondary outcomes included changes in global severity, psychosocial functioning, and anxiety and depression symptoms.The results of the trial indicated that the addition of brexpiprazole to sertraline led to greater improvements in PTSD symptoms compared to sertraline and placebo. This was evident from the CAPS-5 scores, where the combination treatment showed a mean improvement of 19.2 points by week 10, compared to 13.6 points for the placebo group. The brexpiprazole group also showed improvements in anxiety and depression, psychosocial functioning, and PTSD symptom clusters.The incidence of adverse events was similar between the two treatment arms, though the brexpiprazole group had slightly higher rates of weight gain, fatigue, and somnolence, primarily of mild to moderate severity. No serious adverse events were associated with the treatments.This study supports the brexpiprazole and sertraline combination as an effective treatment for PTSD, particularly in patients who don't respond to SSRIs. Future research should explore the treatment's applicability to a broader range of PTSD patients and examine its long-term effects. (Davis, L. L., et al. [2024]. Brexpiprazole and sertraline combination treatment in posttraumatic stress disorder: A phase 3 randomized clinical trial. JAMA Psychiatry. Advance online publication. Retrieved December 2024 from https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2827796)Released: January 2025Nursing Drug Handbook© 2025 Wolters KluwerImlunestrant Improves Progression-Free Survival for Patients with Breast CancerEstrogen receptor (ER)-positive, HER2-negative is the most common subtype of breast cancer and is typically treated with endocrine therapy. Despite improvements in outcomes through selective ER modulators and degraders, resistance can develop due to mutations in the ESR1 gene.READ MORE...Imlunestrant is an oral selective ER degrader, designed to target ESR1 mutations. The EMBER-3 trial tested imlunestrant both as monotherapy and in combination with abemaciclib in patients with ER-positive, HER2-negative advanced breast cancer. The phase 3, open-label trial ran from October 2021 through November 2023 and included 874 patients across 22 countries. Of the patients, 38.7% had ESR1 mutations, which were associated with a more challenging prognosis. Participants were randomized into three groups: imlunestrant alone, standard therapy (exemestane or fulvestrant), and imlunestrant plus abemaciclib. Progression-free survival (PFS) was the primary endpoint, with secondary endpoints including overall survival and adverse events.At the primary analysis, the median PFS for patients with ESR1 mutations was 5.5 months in the imlunestrant group versus 3.8 months in the standard therapy group, showing a statistically significant benefit for imlunestrant. However, the combination of imlunestrant and abemaciclib resulted in the most improved PFS results with a median of 9.4 months, emphasizing the broader benefit of combining these therapies.Adverse events with imlunestrant were similar to standard therapy, including fatigue, diarrhea, and nausea; but the imlunestrant–abemaciclib group produced a higher incidence of serious adverse events, particularly related to neutropenia and anemia.This study showed that although imlunestrant is effective for patients with ESR1 mutations, the combination of imlunestrant and abemaciclib provided a more pronounced benefit across a broader range of patients, including those without ESR1 mutations. This combination offers an encouraging approach to overcoming resistance and improving patient outcomes in ER-positive, HER2-negative breast cancer. (Jhaveri, K. L., et al. [2024]. Imlunestrant with or without abemaciclib in advanced breast cancer. NEJM. Advance online publication. Retrieved December 2024 from https://www.nejm.org/doi/full/10.1056/NEJMoa2410858) Released: December 2025Nursing Drug Handbook© 2025 Wolters KluwerUpdated Dosing Guidance for MenB VaccinationThe Advisory Committee on Immunization Practices (ACIP) recommends vaccination against serogroup B meningococcal (MenB) disease for adolescents and young adults as well as those age 10 and older who are at higher risk for severe disease. ACIP guidelines now include two licensed MenB vaccines: MenB-FHbp (Trumenba) and MenB-4C (Bexsero). This report provides updated dosing guidance for MenB-4C while maintaining other previous vaccination recommendations.READ MORE...The ACIP's Meningococcal Vaccines Work Group reviewed clinical trial data from several studies, evaluating MenB-4C's effectiveness and safety. The data indicated varying rates of immune response after different dosing schedules, with higher response rates after a three-dose series. The safety profile showed that common adverse reactions, such as pain at the injection site, headache, and fatigue, were similar across different dosing schedules. In addition, MenB vaccines from different manufacturers are not interchangeable, so it's important that all doses in a series are from the same brand.Based on this review, ACIP provides the following guidelines:MenB-4C should be delivered as two doses at 0 and 6 months for adolescents and young adults ages 16 to 23.For higher-risk individuals (age 10 and older with asplenia, complement deficiencies, complement inhibitor use, microbiologists exposed to Neisseria meningitidis, or those at heightened risk during an outbreak), a three-dose series at 0, 1 to 2, and 6 months is suggested.For individuals who start the MenB vaccine series within 6 months of a high-risk event (for example, college entry), the three-dose schedule is preferred to ensure rapid protection.Additional doses aren't recommended for those who have already received MenB-4C under previous dosing schedules, but booster doses should align with the original manufacturer. (Schillie, S., et al. [2024]. New dosing interval and schedule for the Bexsero MenB-4C vaccine: Updated recommendations of the Advisory Committee on Immunization Practices–United States, October 2024. MMWR, 73[49], 1124–1128. Retrieved December 2024 from https://www.cdc.gov/mmwr/volumes/73/wr/mm7349a3.htm?s_cid=mm7349a3_w)Released: January 2025Nursing Drug Handbook© 2025 Wolters Kluwer
News Capsules - December 2024
Inebilizumab Reduces Flares and Improves Remission Rates in IgG4-Related DiseaseImmunoglobulin (Ig) G4-related disease is a chronic, immune-mediated disorder characterized by inflammation and fibrosis across multiple organ systems, which can worsen over time and lead to organ failure. There are no approved therapies, and glucocorticoids, although effective for flare control, come with significant side effects.READ MORE...MITIGATE, a phase 3, multicenter, randomized, double-blind study showed that inebilizumab, a monoclonal antibody, is a promising treatment for IgG4-related disease. The trial involved 135 patients who received either inebilizumab (300 mg) or placebo, in addition to standard glucocorticoid therapy. The study evaluated inebilizumab's efficacy and safety in preventing disease flares and several secondary endpoints over 52-weeks of treatment.The results showed that disease flares were reduced by 87% in the inebilizumab group compared to placebo. Additionally, inebilizumab led to higher rates of flare-free, treatment-free (57%), and glucocorticoid-free (59%) complete remissions compared to placebo (22% for both). Participants treated with inebilizumab also required less glucocorticoid therapy to manage their disease —90% of the inebilizumab group discontinued glucocorticoids compared to 37% of the placebo group. Adverse events were similar between groups, but inebilizumab treatment led to more serious adverse events, including infection-related issues and lymphopenia, although no deaths occurred during the trial.The MITIGATE trial supports inebilizumab as an effective treatment for IgG4-related disease, demonstrating its ability to reduce flares and improve remission rates while reducing reliance on glucocorticoids. Further research, including long-term studies, will be needed to confirm these findings and establish the role of inebilizumab in the broader treatment landscape for IgG4-related disease. (Stone, J. H. [2024]. Inebilizumab for treatment of IgG4-related disease. NEJM. Advance online publication. Retrieved November 2024 from https://www.nejm.org/doi/pdf/10.1056/NEJMoa2409712)Released: December 2024Nursing Drug Handbook© 2024 Wolters KluwerInfluenza Antiviral Treatment among Higher-Risk Children and Adolescents DecliningEach year, tens of thousands of children and adolescents in the United States are hospitalized due to seasonal influenza, with the highest rates occurring in those under one year old. Antiviral treatment is critical to reduce the likelihood of severe illness, including intensive care unit admissions and death. The Centers for Disease Control and Prevention guidelines recommend antiviral therapy for hospitalized children with suspected influenza, even before laboratory confirmation. However, regardless of these recommendations, there has been a concerning decline in the percentage of children receiving antivirals.READ MORE...Reports from two U.S. surveillance networks: the Influenza Hospitalization Surveillance Network, which tracks hospitalizations for influenza, and the New Vaccine Surveillance Network, which monitors outpatient cases, highlight significant underuse of antiviral treatments. The data show that during the 2017 to 2018 flu season, 70% to 86% of children hospitalized with influenza received antivirals. However, this number declined in the 2023 to 2024 flu season, with just 52% to 59% of hospitalized children receiving antivirals, even though treatment has clear benefits in reducing severe outcomes.Demographic analysis revealed that children ages 2 to 4 were less likely to receive antiviral treatment compared to those under 6 months or older teens. Those with underlying conditions, such as asthma, were more likely to receive antiviral treatment, but even among this group, treatment was not universally administered. In outpatient settings, children under 6 months had the highest antiviral prescription rates (49%), while those ages 2 to 4 years had the lowest (21%).The findings point to the need for improved awareness and education among health care providers about the importance of early antiviral treatment for influenza in children and adolescents. Increasing access to timely care and addressing barriers in both hospital and outpatient settings could improve treatment adherence and outcomes for this vulnerable population. (Frutos, A. M., et al. [2024]. Underutilization of influenza antiviral treatment among children and adolescents at higher risk for influenza-associated complications—United States, 2023–2024. MMWR, 73(45), 1022–1029. Retrieved November 2024 from https://www.cdc.gov/mmwr/volumes/73/wr/mm7345a2.htm)Released: December 2024Nursing Drug Handbook© 2024 Wolters KluwerOral Semaglutide Reduces Risk of Cardiovascular Events in Patients with Type 2 DiabetesCardiovascular disease is a serious health concern for patients with type 2 diabetes, who are at higher risk for conditions like coronary artery disease, heart failure, and stroke. Studies focusing on the cardiovascular safety and efficacy of specific antihyperglycemic medications, namely glucagon-like peptide-1 (GLP-1) receptor agonists and sodium-glucose cotransporter-2 inhibitors, have shown that some of these drugs reduce this cardiovascular risk.READ MORE...SOUL, a phase 3, multicenter, randomized, double-blind trial, demonstrated that oral semaglutide, a GLP-1 receptor agonist, taken daily, is more effective at reducing the risk of adverse cardiovascular events in patients with diabetes and established cardiovascular disease or chronic kidney disease compared to traditional therapy alone.The trial enrolled 9,650 participants, most of whom were on metformin and had comorbidities like coronary artery disease, chronic kidney disease, and cerebrovascular disease. The participants were randomized to receive either oral semaglutide (14 mg/day) or placebo, both added to standard care. The trial found a 14% reduction in major adverse cardiovascular events for those treated with oral semaglutide. The primary endpoint of major cardiovascular events included cardiovascular death, MI, and nonfatal strokes, with all three contributing to the positive result.Oral semaglutide was well-tolerated, showing a safety profile consistent with previous trials. The trial's success supports the potential for semaglutide to be a valuable treatment for individuals with both type 2 diabetes and cardiovascular risk. (McKeown, L. A. [2024]. SOUL: Oral semaglutide cuts CV events in diabetic patients. TCTMD. Retrieved November 2024 from https://www.tctmd.com/news/soul-oral-semaglutide-cuts-cv-events-diabetic-patients; Novo Nordisk. [2024]. Novo Nordisk A/S: Oral semaglutide demonstrates a 14% reduction in risk of major adverse cardiovascular events in adults with type 2 diabetes in the SOUL trial. Retrieved November 2024 from https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=171480)Released: December 2024Nursing Drug Handbook© 2024 Wolters KluwerTirzepatide for Weight Loss and Diabetes Prevention in Patients with Obesity and PrediabetesObesity is recognized as a chronic neuroendocrine disease that increases a patient's risk of prediabetes, which can, in turn, raise the possibility of advancing to type 2 diabetes by up to 70%. Pharmacologic interventions that target obesity and dysglycemia, such as tirzepatide, have the potential to improve insulin sensitivity and pancreatic function, helping to manage obesity and prevent prediabetes from progressing.READ MORE...Tirzepatide has demonstrated major benefits in clinical trials, including SURMOUNT-1, a large, international, phase 3 study involving participants with obesity and prediabetes. In the trial, participants were randomly assigned to receive tirzepatide (5 mg, 10 mg, or 15 mg) or a placebo, with the treatment phase lasting up to 176 weeks. Outcomes of the trial included weight reduction, reversion to normoglycemia, and the incidence of type 2 diabetes. Participants in the tirzepatide group experienced substantial and sustained weight loss (average weight loss of over 20%), and those with prediabetes at baseline had lower rates of advancing to type 2 diabetes (1.3%) compared to the placebo group (13.3%).Safety data showed that tirzepatide was generally well tolerated, with mild to moderate GI side effects. Serious adverse events were rare and comparable to those observed in previous trials of similar drugs. Cardiometabolic improvements were also observed, with decreases in waist circumference, blood pressure, and lipid levels. Furthermore, quality of life scores in domains such as physical function and mental health were better in the tirzepatide group compared to the placebo group, pointing to the broader benefits of the treatment beyond metabolic health.The SURMOUNT-1 trial demonstrated that tirzepatide is an effective and safe treatment for individuals with obesity and prediabetes. It resulted in sustained weight loss, improved glycemic control, and reduced the risk of developing type 2 diabetes. The findings support the use of tirzepatide as a long-term treatment option for managing obesity and preventing the progression of prediabetes to diabetes. (Jastreboff, A. M., et al. [2024]. Tirzepatide for obesity treatment and diabetes prevention. NEJM. Advance online publication. Retrieved November 2024 from https://www.nejm.org/doi/full/10.1056/NEJMoa2410819?query=TOC&cid=DM2371552_Non_Subscriber&bid=-1652766108)Released: December 2024Nursing Drug Handbook© 2024 Wolters Kluwer
News Capsules - November 2024
Immunization Rates among Kindergarten StudentsVaccination coverage among kindergarten students in the United States for the measles, mumps, and rubella vaccine (MMR), as well as other essential vaccines, is declining. After maintaining near 95% coverage for a decade, rates dropped to approximately 93% during the 2020 to 2023 school years, prompting a summary of state and local immunization data reported to the Centers for Disease Control and Prevention (CDC) for the 2023 to 2024 school year.READ MORE...Parents are required to provide vaccination records or exemption documents to schools, which collaborate with health departments to assess compliance. The CDC utilizes data from 49 states and Washington, D.C. to estimate vaccination rates and exemptions among kindergarteners. For the 2023 to 2024 school year, the reported vaccination coverage reflects a significant drop compared to previous years, with only a few jurisdictions achieving the desired 95% coverage threshold.The analysis shows that national MMR coverage stands at 92.7%, with considerable variations among states. States with the lowest coverage reported figures below 80%, while some states exceeded 98%. Exemptions from vaccinations increased to 3.3%, primarily due to nonmedical reasons, which poses a risk for vaccine-preventable diseases and has implications for achieving public health targets.The findings underscore the need for immunization programs, health care providers, and schools to actively promote vaccination and counteract the rising exemption rates, which contribute to the potential for outbreaks of preventable diseases. Strategies, such as simplifying vaccination processes and improving access to vaccines, are essential for reversing the trends of declining coverage and increasing exemptions, ensuring the health and safety of children and communities. (Seither, R., et al. [2024]. Coverage with selected vaccines and exception rates among children in kindergarten United States, 2023—24 school year. MMWR Morb Mortal Wkly Rep, 73, 925—932. Retrieved October 2024 from https://www.cdc.gov/mmwr/volumes/73/wr/mm7341a3.htm)Released: November 2024Nursing Drug Handbook© 2024 Wolters KluwerNivolumab with AVD Enhances Progression-Free Survival in Classic Hodgkin LymphomaBrentuximab vedotin has been used to improve outcomes in patients with classic Hodgkin lymphoma, but toxic side effects and relapse rates remain a problem. The S1826 trial aimed to improve progression-free survival (PFS) while addressing the side effects common with current treatments. S1826 investigated the efficacy and safety of combining nivolumab (N) with doxorubicin, vinblastine, and dacarbazine (AVD) compared to brentuximab vedotin (BV) combined with AVD in patients with newly diagnosed advanced-stage classic Hodgkin lymphoma.READ MORE...The study enrolled 994 patients age 12 and older between July 2019 and October 2022. The participants were randomized with a focus on evaluating the time from randomization to disease progression or death. With a median follow-up of 12.1 months, results favored N+AVD with a 52% reduction in the risk of disease progression or death compared to BV+AVD. This trend continued with extended follow-up, showing a 92% PFS at 2 years for N+AVD compared to 83% for BV+AVD, further emphasizing the treatment's effectiveness. In addition, results demonstrated that N+AVD could reduce the need for consolidative radiation therapy, which has associated long-term risks, including secondary cancers.Adverse effects revealed a generally favorable safety profile for N+AVD compared to BV+AVD. Although neutropenia was more common in the N+AVD group, other significant adverse events, particularly those leading to treatment discontinuation, were more prevalent in the BV+AVD cohort.The S1826 trial presents compelling evidence supporting the use of N+AVD as a primary treatment for advanced-stage classic Hodgkin lymphoma, offering enhanced progression-free survival and a better side-effect profile. Given these promising results, N+AVD warrants consideration for integration into standard Hodgkin lymphoma treatment protocols. (Herrera, A. F., et al. [2024]. Nivolumab+AVD in advanced-stage classic Hodgkin's lymphoma. NEJM, 391[15], 1379—1389. Retrieved October 2024 from https://www.nejm.org/doi/full/10.1056/NEJMoa2405888)Released: November 2024Nursing Drug Handbook© 2024 Wolters KluwerRegorafenib for Patients with Advanced Gastric or Gastroesophageal Junction CancerPatients diagnosed with refractory advanced gastric or gastroesophageal junction cancer (AGOC) face a dire prognosis, where the overall survival (OS) is less than 6 months, and the 2-year OS rate is below 10%. New therapies, like trifluridine/tipiracil and immune checkpoint inhibitors are shifting the treatment standards for AGOC, and with the INTEGRATE IIa study, regorafenib has been added to this evolving landscape.READ MORE...The phase 3, randomized, controlled trial, conducted from October 2016 to September 2021, enrolled 251 patients with AGOC whose disease had progressed after two previous therapies. Patients were randomized to receive either regorafenib 160 mg on days 1 to 21 of a 28-day cycle, or placebo. The trial showed that regorafenib considerably extends OS (19%) for patients with refractory AGOC versus placebo (6%). It also demonstrated a 32% reduction in the risk of death when regorafenib was added to best supportive care.Additionally, patients receiving regorafenib experienced a longer time to deterioration in quality of life, as measured by the European Organisation for Research and Treatment of Cancer QLQ-C30 and STO22 modules (hazard ratio = 0.68). This suggests that regorafenib not only improves survival but also maintains a better quality of life for patients facing advanced cancer.These important findings of INTEGRATE IIa underscore the potential benefits of regorafenib as a treatment option in AGOC for a patient population with limited alternatives. (Pavlakis, N. [2024]. INTEGRATE IIa phase III study: Regorafenib for refractory advanced gastric cancer. Journal of Clinical Oncology. Advance online publication. Retrieved October 2024 from https://ascopubs.org/doi/10.1200/JCO.24.00055?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed; Stenger, M. [2024]. Regorafenib in refractory advanced gastric cancer. The ASCO Post. Retrieved October 2024 from https://ascopost.com/news/october-2024/regorafenib-in-refractory-advanced-gastric-cancer/)Released: November 2024Nursing Drug Handbook© 2024 Wolters KluwerTenecteplase Versus Alteplase for Stroke in Patients with Diabetes and Hyperglycemia on AdmissionDiabetes is prevalent among stroke patients and is associated with poorer neurologic outcomes, increased risk of symptomatic intracerebral hemorrhage (sICH), and generally unfavorable clinical results post-stroke. Although thrombolytic therapy can be beneficial, elevated admission glucose levels are common and complicate treatment, leading to worse outcomes and longer hospital stays.READ MORE...Alteplase is the only approved fibrinolytic for acute ischemic stroke (AIS), while tenecteplase, a modified variant of alteplase, has advantages like a longer half-life and faster administration. The TRACE-2 trial, a phase 3 multicenter study, which ran from June 2021 to May 2022, aimed to assess the efficacy and safety of tenecteplase against alteplase in AIS patients, especially considering their diabetic status and admission glucose levels.TRACE-2 included adult AIS patients eligible for thrombolysis but not for thrombectomy, enrolling participants with varying histories of diabetes and hyperglycemia. The study compared the functional outcomes at 90 days and the incidence of adverse events between patients receiving tenecteplase (0.25 mg/kg IV) and those receiving alteplase (0.9 mg/kg IV).Results indicated that although patients with a history of diabetes had significantly lower rates of excellent functional outcomes compared to those without diabetes, the efficacy of tenecteplase was comparable to alteplase in both diabetic and nondiabetic groups. The safety profiles were also similar, though patients with diabetes exhibited a higher incidence of sICH and other serious adverse events overall. Interestingly, tenecteplase was associated with shorter door-to-needle times in patients with diabetes, suggesting potential operational benefits.The study concluded that tenecteplase could be a viable alternative to alteplase for AIS patients, including those with diabetes and hyperglycemia, while also emphasizing the need for further research to confirm these findings across diverse patient groups. (Liu, H., et al. [2024]. Efficacy and safety of intravenous tenecteplase versus alteplase in treating acute ischemic stroke with diabetes and admission hyperglycemia. Journal of the American Heart Association, 13[20], Article e036393. Retrieved October 2024 from https://www.ahajournals.org/doi/full/10.1161/JAHA.124.036393)Released: November 2024Nursing Drug Handbook© 2024 Wolters Kluwer
News Capsules - October 2024
Ziresovir for Respiratory Syncytial Virus in Young ChildrenRespiratory syncytial virus (RSV) poses a serious health threat, particularly to young children, leading to millions of hospitalizations and significant mortality each year. Although some vaccines exist for adults and pregnant women, there is currently no approved vaccine for children.READ MORE...AIRFLO, a phase 3 trial, assessed the selective oral RSV F protein inhibitor, ziresovir, for its effictiveness and safety in children ages 1 to 24 months hospitalized with RSV. The study ran from September 2020 to January 2022 and was conducted across multiple centers in China. Participants, most age 6 months or younger, were randomly assigned to receive either ziresovir or placebo, focusing on clinically relevant cases of RSV infection.The trial comprised two parts: the first assessed safety and pharmacokinetics, while the second evaluated efficacy. Participants received doses of ziresovir every 12 hours for 5 days, tailored to their body weight. The primary efficacy endpoint was the Wang bronchiolitis clinical score, which measures the severity of respiratory symptoms, while secondary endpoints included viral load reductions and symptom-based assessments.Results showed that ziresovir improved clinical scores compared to placebo. Specifically, ziresovir produced notable reductions in the Wang score (−3.4 points versus −2.7 points for placebo), with reductions observed as early as 48 hours after treatment initiation. Furthermore, ziresovir achieved a decrease in RSV viral load, affirming its antiviral effectiveness. Improvements were consistent across various patient subgroups, including those at higher risk for severe outcomes.In terms of safety, adverse events were similar between the ziresovir and placebo groups and were predominantly mild to moderate in severity. Overall, the trial's encouraging clinical and virological results highlight the need for further international trials to explore ziresovir's potential as a treatment for RSV in young children worldwide. (Zhao, S., et al. (2024). Ziresovir in hospitalized infants with respiratory syncytial virus infection. NEJM, 391, 1096–1107. Retrieved September 2024 from https://www.nejm.org/doi/full/10.1056/NEJMoa2313551)Released: October 2024Nursing Drug Handbook© 2024 Wolters KluwerLiraglutide Effective for Weight Loss in Children with ObesityMany children with severe obesity struggle to achieve weight loss through standard lifestyle therapies alone, creating a need for more effective treatments. The SCALE Kids trial evaluated liraglutide for weight loss in children with obesity and found it an encouraging treatment option when paired with lifestyle changes. As there are currently no approved medications for obesity treatment in children under age 12, this trial is a potential breakthrough for addressing pediatric obesity.READ MORE...SCALE Kids, a phase 3 trial, involved 82 participants ages 6 to less than 12 with a BMI of 95% or higher, randomized to receive liraglutide or placebo, alongside lifestyle interventions. Results showed a major reduction in BMI and body weight for the liraglutide group. After 56 weeks, the liraglutide group had a BMI reduction of −5.8% compared to +1.6% in the placebo group, marking a substantial difference of −7.4% favoring liraglutide.Secondary endpoints, including blood pressure and glycated hemoglobin levels, also supported liraglutide. However, waist circumference changes were not significantly different between groups, and GI side effects were more common with the treatment. In addition, the study doesn't discuss how body composition changes with treatment and whether the weight loss comes from fat mass or lean mass.Although liraglutide shows promise for treating severe obesity in children who don't respond to lifestyle changes, it's important to consider a careful, individualized approach. The goal should not be to prescribe medication broadly for all children with elevated BMI but rather to identify those who truly need additional help because of severe obesity and related health complications. (Neale, T. (2024). Liraglutide helps shed weight in young children with obesity. TCTMD. Retrieved September 2024 from https://www.tctmd.com/news/liraglutide-helps-shed-weight-young-children-obesity; Fox, C. K., et al. (2024). Liraglutide for children 6 to < 12 years of age with obesity — a randomized trial. NEJM. Advance online publication. Retrieved September 2024 from https://www.nejm.org/doi/full/10.1056/NEJMoa2407379)Released: October 2024Nursing Drug Handbook© 2024 Wolters KluwerErenumab Provides Relief for Medication-Overuse Headache in Chronic MigraineMedication-overuse headache (MOH) is a concern for patients with chronic migraine, often resulting from the excessive use of headache medications, such as analgesics, triptans, and opioids. MOH is linked to increased health care utilization, psychiatric comorbidities, and a decline in quality of life, making effective management crucial.READ MORE...Management strategies emphasize the withdrawal of overused medications; however, this withdrawal process can lead to high relapse rates. Recent studies have focused instead on targeting the calcitonin gene-related peptide (CGRP) pathway, which is implicated in migraine pathogenesis. Erenumab, a monoclonal antibody that inhibits CGRP receptors, is a promising candidate for helping patients with MOH revert to nonmedication overuse status.A recent study investigated the efficacy and safety of erenumab in adults diagnosed with chronic migraine and concomitant MOH. The phase 4, randomized, controlled trial, which ran from October 2019 to November 2022, enrolled 584 participants who had a history of preventive treatment failure. Participants received either erenumab (140 mg or 70 mg) or placebo for 24 weeks, with a primary endpoint focused on the absence of MOH by month 6.Results indicated that a significant proportion of participants receiving erenumab achieved MOH remission (69.1% with 140-mg dose; 60.3% with 70-mg dose) compared to those on placebo (52.6%), with improvements in acute medication use and overall functionality. Additionally, participants reported a reduction in average monthly headache days and improvements in physical impairment and quality-of-life metrics, reinforcing the benefits of effective preventive therapies for managing MOH.These findings support the use of erenumab as an effective treatment option for patients suffering from MOH due to chronic migraine. The study's outcomes support the importance of preventive treatment strategies that not only alleviate headache frequency but also enhance the overall quality of life for these patients. (Tepper, S. J., et al. (2024). Efficacy and safety of erenumab for nonopioid medication overuse headache in chronic migraine: A phase 4, randomized, placebo-controlled trial. JAMA Neurology. Advance online publication. Retrieved September 2024 from https://jamanetwork.com/journals/jamaneurology/fullarticle/2823594)Released: October 2024Nursing Drug Handbook© 2024 Wolters KluwerCabozantinib for Advanced Neuroendocrine TumorsNeuroendocrine tumors (NETs) are diverse malignancies primarily found in the GI tract, lungs, and pancreas. Treatment for advanced NETs depends on multiple factors, such as tumor location, differentiation grade, symptoms, and somatostatin-receptor expression. Options, including somatostatin analogues, everolimus, and sunitinib are available; however, most patients experience disease progression despite these treatments.READ MORE...In a phase 2 trial, cabozantinib, a tyrosine kinase inhibitor, showed potential in treating advanced NETs. This prompted the CABINET trial: a phase 3, double-blind, randomized, controlled study, designed to assess cabozantinib's efficacy in patients with previously treated, progressive extrapancreatic or pancreatic NETs. This trial was critical for evaluating new treatment avenues after standard therapies.The CABINET trial ran from October 2018 to August 2023 and enrolled 203 adults with extrapancreatic NETs and 95 with pancreatic NETs across multiple U.S. sites. It included patients with well- or moderately- differentiated NETs of grades 1 to 3. The study randomly assigned patients to receive either cabozantinib (60 mg) or a placebo. The primary endpoint was progression-free survival, defined as the time from randomization to disease progression or death.The results indicated a significant advantage for cabozantinib in delaying disease progression. In the extrapancreatic cohort, those receiving cabozantinib experienced a median progression-free survival of 8.4 months, compared to 3.9 months for placebo. Similarly, in the pancreatic cohort, cabozantinib led to a median progression-free survival of 13.8 months versus 4.4 months for placebo, demonstrating its potential as an effective treatment option.Although cabozantinib showed improved progression-free survival rates, overall survival results were not statistically significant, likely due to subsequent therapies received by patients. The trial did report adverse events consistent with the known safety profile of cabozantinib, with many patients requiring dose adjustments. Despite this, the CABINET trial supports cabozantinib as a promising therapy for advanced NETs. (Chan, J. A., et al. (2024). Phase 3 trial of cabozantinib to treat advanced neuroendocrine tumors. NEJM. Advance online publication. Retrieved September 2024 from https://www.nejm.org/doi/full/10.1056/NEJMoa2403991)Released: October 2024Nursing Drug Handbook© 2024 Wolters Kluwer
News Capsules - September 2024
New RSV Vaccination Recommendations for Older AdultsRespiratory syncytial virus (RSV) poses a major risk to older adults, especially during the fall and winter months. In response, the Advisory Committee on Immunization Practices (ACIP) initially recommended RSV vaccination for U.S. adults age 60 and older in June 2023. However, due to new evidence and postlicensure data, the ACIP updated its guidance on June 26, 2024. The revised recommendation advises a single dose of any FDA-approved RSV vaccine for all adults age 75 and older and for those ages 60 to 74 who are at higher risk for severe RSV disease. This update aims to improve vaccination coverage and target those who would benefit most.READ MORE...As of spring 2024, RSV vaccination uptake among adults 60 and older was about 20% to 25%. The updated recommendations were informed by new clinical trial data and postlicensure studies, including those for Moderna's mResvia, which showed an efficacy of about 78.7% initially, though it waned over time. Safety data indicated more severe reactions compared to placebo but didn't show a significant increase in serious adverse events. For other vaccines like GlaxoSmithKline's Arexvy and Pfizer's Abrysvo, effectiveness ranged from 75% to 82% in preventing RSV-related hospitalizations, with some safety concerns about Guillain-Barré syndrome, though not conclusively linked to the vaccines.The ACIP's updated recommendations aim to simplify vaccination guidelines based on age and risk. The committee will continue to assess and update recommendations as new evidence emerges and will consider the need for additional doses in the future. (Britton, A., et al. (2024). Use of respiratory syncytial virus vaccines in adults aged ≥60 years: Updated recommendations of the Advisory Committee on Immunization Practices: United States, 2024. MMWR Weekly, 73(32), 696–702. Retrieved August 2024 from https://www.cdc.gov/mmwr/volumes/73/wr/mm7332e1.htm?s_cid=mm7332e1_w)Released: September 2024Nursing Drug Handbook© 2024 Wolters KluwerOsimertinib Improves Progression-Free Survival in EGFR-Mutated NSCLCPatients with epidermal growth factor receptor (EGFR) mutations tend to experience shorter progression-free survival and higher incidence of distant metastases compared to those without mutations. For patients with unresectable stage III non-small-cell lung cancer (NSCLC) with EGFR mutations, the current standard treatment involves concurrent chemoradiotherapy followed by consolidation with durvalumab. However, targeted treatments are lacking, and previous studies suggest poorer outcomes for these patients.READ MORE...LAURA, an international, phase 3, double-blind, placebo-controlled trial, evaluated the efficacy and safety of osimertinib, an EGFR tyrosine-kinase inhibitor, in EGFR-mutated unresectable stage III NSCLC. The study ran from August 2018 through July 2022 and enrolled 216 patients. Eligible participants had completed chemoradiotherapy and showed no progression. They were randomized to receive either osimertinib (80 mg once per day) or placebo. The primary endpoint was progression-free survival.Results showed that osimertinib significantly improved progression-free survival compared to placebo, with a median of 39.1 months versus 5.6 months, respectively, and demonstrated a substantial reduction in the risk of disease progression or death (hazard ratio, 0.16). The treatment also showed lower rates of local progression, distant metastases, and new lesions, particularly brain lesions, compared to placebo.Adverse events with osimertinib included radiation pneumonitis and diarrhea. Although the incidence of interstitial lung disease was higher with osimertinib compared to placebo, most cases were mild. Despite the higher incidence of some adverse effects, osimertinib's overall safety profile was manageable.The results of the LAURA trial indicate that osimertinib may be a promising postchemoradiotherapy option for patients with unresectable stage III EGFR-mutated NSCLC compared to placebo, suggesting a shift in treatment strategies for this specific patient group. (Lu, S., et al. (2024). Osimertinib after chemoradiotherapy in stage III EGFR-mutated NSCLC. NEJM, 391, 585–597. Retrieved August 2024 from https://www.nejm.org/doi/10.1056/NEJMoa2402614?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed)Released: September 2024Nursing Drug Handbook© 2024 Wolters KluwerOlanzapine for Nausea and Vomiting in Moderately Emetogenic ChemotherapyChemotherapy-induced nausea and vomiting (CINV) remain significant challenges for cancer patients undergoing treatment, impacting their quality of life (QOL). Guidelines for antiemetic prophylaxis (AEP) have evolved to address these issues, but clinical studies indicate that breakthrough CINV remains a problem, prompting further research.READ MORE...Olanzapine, an atypical antipsychotic, has shown promise in controlling nausea and vomiting in highly emetogenic chemotherapy regimens. A recent phase 3 trial aimed to determine if incorporating olanzapine into standard AEP protocols could enhance complete response (CR) rates in patients receiving moderately emetogenic chemotherapy (MEC) regimens, including oxaliplatin, carboplatin, or irinotecan, and to assess its impact on patient-reported outcomes.Conducted from March 2019 to August 2023, this multicenter trial involved 560 chemotherapy-naïve patients receiving MEC regimens. Participants were randomized to receive either standard AEP or the same regimen with the addition of olanzapine. The study included randomization and blinding of medical professionals and statisticians to ensure accurate results. Patients recorded their symptoms and treatment responses, and QOL was measured using the Functional Living Index - Emesis questionnaire.The trial found that adding olanzapine significantly improved CR rates compared to standard AEP alone, with a notable benefit in the delayed phase of CINV. Specifically, 91% of patients in the olanzapine group achieved CR compared to 82% in the observation group, and this improvement was maintained during the later assessment period. The olanzapine group also experienced better nausea and CINV control and used fewer rescue medications.QOL assessments confirmed these results, with fewer patients in the olanzapine group experiencing deterioration in QOL related to CINV. Although the addition of olanzapine didn't significantly change nausea control compared to the observation group, it did improve overall control of nausea and vomiting combined.Study limitations include the absence of a placebo control and the lack of evaluation for lower doses of olanzapine. Also, the predominance of GI cancer patients receiving oxaliplatin could influence the findings. Nonetheless, the trial supports the incorporation of olanzapine into AEP protocols for MEC regimens, suggesting that it could become a standard part of antiemetic therapy. (Ostwal, V., et al. (2024). Olanzapine as antiemetic prophylaxis in moderately emetogenic chemotherapy: A phase 3 randomized clinical trial. JAMA Network Open, 7(8), Article e2426076. Retrieved August 2024 from https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2822027)Released: September 2024Nursing Drug Handbook© 2024 Wolters KluwerEnfortumab Vedotin Plus Pembrolizumab for Urothelial CancerEnfortumab vedotin, an antibody-drug conjugate targeting nectin-4, combined with pembrolizumab, a programmed death-1 inhibitor, has shown promise in treating advanced urothelial carcinoma. Based on positive phase 1b/2 trial results showing high response rates and durable outcomes, the FDA granted accelerated approval for this combination for patients who are ineligible for cisplatin-based chemotherapy.READ MORE...The EV-302 trial, a global phase 3 study, aimed to compare the effectiveness and safety of enfortumab vedotin plus pembrolizumab versus platinum-based chemotherapy in patients with previously untreated advanced urothelial carcinoma. The trial included 886 patients, median age 69 years, with a range of histologic types. Patients were randomly assigned to either the combination therapy or the chemotherapy group and treated accordingly.Results from the trial showed that enfortumab vedotin and pembrolizumab significantly improved progression-free survival compared to chemotherapy, with a median of 12.5 months versus 6.3 months, respectively. Overall survival was longer in the combination group as well, with a median of 31.5 months compared to 16.1 months in the chemotherapy group.Adverse events associated with enfortumab vedotin and pembrolizumab, such as skin reactions and peripheral neuropathy, were still present, but manageable. The combination therapy also resulted in fewer severe adverse events compared to chemotherapy, despite the longer duration of treatment.The EV-302 trial demonstrated that enfortumab vedotin and pembrolizumab offer significant benefits over platinum-based chemotherapy for untreated advanced or metastatic urothelial carcinoma. The improved survival and response rates make this combination a compelling alternative, potentially changing the standard treatment paradigm for this challenging cancer. (Levitan, D. (2024). Enfortumab vedotin plus pembrolizumab offer improved survival without detriment to quality of life. American Society of Clinical Oncology, Daily News. Retrieved August 2024 from https://dailynews.ascopubs.org/do/enfortumab-vedotin-plus-pembrolizumab-offer-improved-survival-without-detriment-quality; Powles, T., et al. (2024). Enfortumab vedotin and pembrolizumab in untreated advanced urothelial cancer. NEJM, 390, 875–888. Retrieved August 2024 from https://www.nejm.org/doi/full/10.1056/NEJMoa2312117)Released: September 2024Nursing Drug Handbook© 2024 Wolters Kluwer
News Capsules - August 2024
Comparing Safety and Efficacy of Chemotherapy Regimens for Hodgkin LymphomaSurvival outcomes for advanced-stage classical Hodgkin lymphoma were poor before the advent of modern chemotherapy. The high-intensity regimen, eBEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone), has been standard but is associated with serious toxicities. BrECADD, which incorporates the antibody-drug conjugate brentuximab vedotin, was developed to potentially offer comparable effectiveness with fewer toxic side effects. A study comparing the two chemotherapy regimens aimed to balance treatment efficacy with reduced toxicity, particularly focusing on long-term health impacts like organ dysfunction and infertility in young adults with Hodgkin lymphoma.READ MORE...The phase 3 randomized, multicenter, parallel, intergroup clinical trial was conducted between July 2016 and August 2020, and enrolled 1,500 patients (age 60 and younger) across multiple countries. Patients received cycles of either eBEACOPP or BrECADD (both initiated at full-dose level 4) administered in 21-day intervals. Positron emission tomography (PET) guided treatment adaptation to tailor therapy based on early response assessment.Researchers sought to compare treatment-related morbidity and progression-free survival between the two regimens. BrECADD demonstrated significantly lower treatment-related morbidity rates, with 42% of patients experiencing at least one treatment-morbidity event compared to 59% of patients receiving eBEACOPP. Both groups achieved similar rates of complete remission post-chemotherapy, with a substantial proportion of patients benefiting from PET-guided treatment adjustments.Regarding efficacy, BrECADD showed noninferiority and, in a subsequent analysis, superiority in progression-free survival compared to eBEACOPP (4-year progression-free survival for BrECADD was 94.3% versus 90.9% for eBEACOPP). Safety assessments included resolution of toxicities within a year posttreatment, showing generally manageable long-term impacts on patients' health. Additionally, BrECADD was associated with better preservation of gonadal function and fewer second primary malignancies compared to eBEACOPP.Overall, the study supports BrECADD as a promising alternative to eBEACOPP for treating advanced-stage Hodgkin lymphoma, offering comparable efficacy with significantly reduced treatment-related toxicity. These findings are likely to influence future treatment guidelines and improve outcomes for young adults facing this challenging cancer diagnosis. (Borchmann, P., et al. (2024). Assessing the efficacy and tolerability of PET-guided BrECADD versus eBEACOPP in advanced-stage, classical Hodgkin lymphoma (HD21): A randomised, multicentre, parallel, open-label, phase 3 trial. The Lancet. Advance online publication. Retrieved July 2024 from https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)01315-1/fulltext)Released: August 2024Nursing Drug Handbook© 2024 Wolters KluwerCendakimab Improves Skin Symptoms in Severe Atopic DermatitisAtopic dermatitis, a chronic inflammatory skin condition, causes substantial patient burden including severe itching, sleep disturbances, and impacts on daily activities. When topical treatments are inadequate for moderate to severe atopic dermatitis, systemic therapies like biologics become necessary. Biologics approved for atopic dermatitis target interleukin (IL)-4 or IL-13 pathways due to their involvement in atopic dermatitis pathogenesis.READ MORE...Cendakimab, a monoclonal antibody targeting IL-13, was evaluated in a phase 2 randomized, double-blind, placebo-controlled clinical trial for its efficacy and safety in adults with moderate to severe atopic dermatitis. The study, which ran from May 2021 to November 2022, randomized 221 patients to receive varying doses of cendakimab (720 mg, once weekly; 720 mg, every 2 weeks; or 360 mg, every 2 weeks) or placebo for 16 weeks. Primary endpoints included improvement in Eczema Area and Severity Index (EASI) scores, with secondary endpoints focusing on skin clearance and pruritus reduction.Overall, a larger proportion of cendakimab patients achieved a 75% or greater reduction in EASI (720 mg, once weekly: 50.0%; 720 mg, every 2 weeks: 48.2%; 360 mg, every 2 weeks: 52.7%) compared to placebo (26.3%). There was also a noticeable improvement in skin clearance in patients receiving 720-mg weekly cendakimab, with 33.3% of patients achieving a score of 0 (clear) or 1 (almost clear) than with placebo (9.4%). Safety assessments indicated manageable adverse events, with conjunctivitis being the most notable, consistent with other IL-13 inhibitors.This study supports cendakimab as a potential therapeutic option for treating moderate to severe atopic dermatitis, particularly in reducing inflammation and improving skin symptoms. Further research could explore its long-term efficacy and broader applicability in diverse patient populations. (Blauvelt, A., et al. (2024). Cendakimab in patients with moderate to severe atopic dermatitis: A randomized clinical trial. JAMA Dermatology. Published online. Retrieved July 2024 from https://jamanetwork.com/journals/jamadermatology/fullarticle/2821285)Released: August 2024Nursing Drug Handbook© 2024 Wolters KluwerEfanesoctocog Alfa Manages Bleeding in Children with Severe Hemophilia AHemophilia A is characterized by deficiency in factor VIII, leading to recurrent bleeding episodes, particularly into joints, despite current therapies. Standard treatments require frequent injections due to their limited duration of action, which poses challenges for adherence, especially in children. XTEND-Kids, a phase 3 open-label, international, single-group study, evaluated efanesoctocog alfa, a new factor VIII replacement therapy, in previously treated children with severe hemophilia A. Efanesoctocog alfa is designed to extend factor VIII half-life, which allows for weekly dosing, potentially improving treatment adherence.READ MORE...The study enrolled 74 patients (younger than age 12) who received prophylactic intravenous efanesoctocog alfa (50 IU/kg) once per week for 52 weeks. For bleeding episodes, one dose of efanesoctocog alfa (50 IU/kg) was given, with additional 30 or 50 IU/kg doses every 2 or 3 days, as needed. The primary endpoint was the development of inhibitors to factor VIII, which did not occur in any patient. Adverse events were mostly nonserious, and no treatment discontinuations due to adverse effects were reported.Efanesoctocog provided effective bleeding prevention, with a median annualized bleeding rate of 0.00 and a mean rate of 0.89. Bleeding episodes were likewise managed efficiently, with most resolved using a single injection. Joint health showed overall improvement, indicating potential long-term benefits in joint preservation. In addition, sustained factor VIII levels above therapeutic thresholds were observed for up to 7 days, supporting the weekly prophylactic dosing.Demonstrating promising safety and efficacy profiles in children with severe hemophilia A, efanesoctocog alpha offers a convenient weekly prophylactic option that may enhance treatment outcomes and patient quality of life compared to current therapies. Future studies will further explore its long-term safety and efficacy, including for previously untreated patients and different age groups. (Malec, L., et al. (2024). Efanesoctocog alfa prophylaxis for children with severe hemophilia A. N Engl J Med, 391, 235—246. Retrieved July 2024 from https://www.nejm.org/doi/abs/10.1056/NEJMoa2312611)Released: August 2024Nursing Drug Handbook© 2024 Wolters KluwerLowering LDL Cholesterol with Lerodalcibep in Patients with or at Risk for Cardiovascular DiseaseRecent updates to lipid guidelines suggest more aggressive treatment for lowering LDL cholesterol to prevent cardiovascular (CV) events, advocating for additional medications and stricter targets if statins alone are insufficient. However, lerodalcibep, a third-generation PCSK9 inhibitor, appears effective in achieving these lower targets.READ MORE...Lerodalcibep works by blocking proprotein convertase subtilisin/kexin type 9 (PCSK9) from binding to LDL cholesterol, thereby enhancing cholesterol clearance without significant safety concerns. The drug combines adnectin, an anti-PCSK9 binding protein, with human serum albumin, allowing for a smaller injection volume compared to existing monoclonal antibodies.The phase 3 LIBerate-HR study aimed to evaluate the effectiveness of lerodalcibep in lowering LDL cholesterol in patients at risk for CV disease. The study included 922 patients, with or at high risk for CV disease, randomized to receive monthly subcutaneous injections of lerodalcibep (300 mg) or placebo for 52 weeks. Results showed that lerodalcibep achieved a profound reduction in LDL cholesterol, with 94% of treated patients achieving at least a 50% reduction compared to placebo (19%). The drug also lowered non-HDL cholesterol (−47.3%), apolipoprotein B (−43%), lipoprotein(a) (−33.4%), and triglycerides (−16.5%) while increasing HDL cholesterol by 6.5%. Safety profiles were similar to placebo, with manageable injection-site reactions and no immunogenicity issues reported.Lerodalcibep may be a versatile option for patients needing PCSK9 inhibitors, with the advantage of monthly injections over bi-weekly injections required by current monoclonal antibodies. However, concerns remain regarding long-term safety and immunogenicity, given past issues with other PCSK9 inhibitors like bococizumab.Results of this study show lerodalcibep to be an effective and well-tolerated PCSK9 inhibitor, potentially enhancing treatment options for patients with or at high risk for CV disease, pending further regulatory and safety evaluations. (Maxwell, Y. L. (2024). LIBerate-HR: Lerodalcibep lowers LDL more sharply than placebo over 1 year. TCTMD. Retrieved July 2024 from https://www.tctmd.com/news/now-published-liberate-hr-lerodalcibep-lowers-ldl-more-sharply-placebo-over-1-year; Klug, E. Q., et al. (2024). Efficacy and safety of lerodalcibep in patients with or at high risk of cardiovascular disease: A randomized clinical trial. JAMA Cardiol. Advance online publication. Retrieved July 2024 from https://jamanetwork.com/journals/jamacardiology/article-abstract/2820248)Released: August 2024Nursing Drug Handbook© 2024 Wolters Kluwer
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