Long-Term Outcomes of Deucravacitinib in Plaque Psoriasis
Plaque 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.
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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 2025
Nursing 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 Failure
Patients 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.
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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 2025
Nursing Drug Handbook
© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.
Iptacopan Has Potential as Targeted Treatment for IgA Nephropathy
IgA 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.
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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 2025
Nursing Drug Handbook
© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.
Adding Obinutuzumab to Standard Therapy in Lupus Nephritis
A 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.
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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 2025
Nursing Drug Handbook
© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.