Inebilizumab Reduces Flares and Improves Remission Rates in IgG4-Related Disease
Immunoglobulin (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.
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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 2024
Nursing Drug Handbook
© 2024 Wolters Kluwer
Influenza Antiviral Treatment among Higher-Risk Children and Adolescents Declining
Each 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.
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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 2024
Nursing Drug Handbook
© 2024 Wolters Kluwer
Oral Semaglutide Reduces Risk of Cardiovascular Events in Patients with Type 2 Diabetes
Cardiovascular 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.
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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 2024
Nursing Drug Handbook
© 2024 Wolters Kluwer
Tirzepatide for Weight Loss and Diabetes Prevention in Patients with Obesity and Prediabetes
Obesity 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.
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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 2024
Nursing Drug Handbook
© 2024 Wolters Kluwer