Ruth Ann Vleugels

Objective: To evaluate the long-term safety and efficacy of dazukibart, a novel antiinterferon β monoclonal antibody, in adults with moderate-to-severe dermatomyositis (DM). Methods: Participants from 2 cohorts of DM (skin-predominant [SP] and muscle-predominant [MP]) completing a 24-week phase II, double-blind study, were enrolled into a 52-week phase IIb, open-label extension (OLE) study, with a 16-week follow-up post treatment (combined study duration: 92 weeks). The pooled skin analysis set included all SP and MP DM participants with baseline Cutaneous Dermatomyositis Disease Area and Severity Index–Activity (CDASI-A) scores ≥ 14. The primary endpoint was incidence of treatment-emergent adverse events (TEAEs) from week 24 through week 92. Key secondary endpoints were change in CDASI-A and Total Improvement Score (TIS) from week 0 through week 92. Results: Participants who received ≥ 1 dose of dazukibart (600 mg) during the OLE study (comprising 9, 15, and 16 participants from the SP cohort, MP cohort, and pooled skin analysis set, respectively) were analyzed (median age 49.5 years, 83% female, 96% White). TEAEs were mild (55%), moderate (38%), or severe (7%), with no treatment-related serious AEs or treatment discontinuations. At week 76, CDASI-A scores improved, with a median change from baseline of −24.0 (range −33 to −12), −9.0 (range −32 to 1), and −23.5 (range −33 to −12) for participants from the SP cohort, MP cohort, and pooled skin analysis set, respectively. In the MP cohort, TIS (median 65.0, range 2.5-95.0) and associated core set measures, including patient-reported outcomes, improved at week 76. Overall, the observed improvements in outcomes, as indicated by the slight reduction in outcome measures, persisted during the 16-week posttreatment follow-up. Conclusion: The safety and efficacy profiles of dazukibart observed at 24 weeks were sustained through 92 weeks. ( ClinicalTrials.gov : NCT03181893 , NCT05192200 )

Introduction Clinical guidelines recommend against routine use of systemic corticosteroids in atopic dermatitis (AD) due to associated adverse effects. Real-world adherence to these guidelines is unclear. Methods This retrospective cohort study evaluated US healthcare claims using Optum’s Clinformatics Data Mart Database. We included two cohorts: exposure and diagnosis-based cohorts. Index was defined as the date of first systemic corticosteroid use post-AD diagnosis in the exposure cohort (AD diagnosis must have occurred within 6 months preceding index) or as the date of the first AD diagnosis in the diagnosis-based cohort. Follow-up began on index and continued until end of available data, health insurance discontinuation, death, or systemic corticosteroid discontinuation (exposure cohort) or initiation (diagnosis-based cohort). Patients were aged ≥ 12 years with diagnosed AD between 2017 and 2024 and had continuous health insurance enrollment ≥ 1 year before and after index. Patients were excluded if they had other immune-mediated inflammatory diseases within the 6 months preceding index or had history of malignancy, organ transplant, or HIV/AIDS. Systemic corticosteroid exposure duration was categorized as short term (≥ 1 day to < 30 days), medium term (> 1 month to ≤ 3 months), or long term (continuous/intermittent use for > 3 months). Categorization was informed by expert recommendations and observed prescription patterns. Exposure duration and treatment patterns were assessed in the exposure cohort. Prevalence of systemic corticosteroid use within 6 months post-AD diagnosis was evaluated in the diagnosis-based cohort. Results The exposure cohort included 29,994 patients; 67.7% had short-term use, 8.5% had medium-term use, and 23.9% had long-term use. Intramuscular systemic corticosteroids accounted for 20.0% of prescriptions; 80.0% received oral systemic corticosteroids. The diagnosis-based cohort included 80,647 patients; the prevalence of systemic corticosteroid use in AD was 20.0%. Conclusions In the USA, systemic corticosteroids remain widely prescribed. These findings highlight the critical need for broader adoption of effective corticosteroid-sparing therapies in patients with AD.

We describe radiological and symptomatic improvement in two patients with dermatomyositis with recalcitrant muscle disease following off-label treatment with anifrolumab, a monoclonal antibody targeting type I interferon receptor recently approved by the FDA and EMA for the treatment of systemic lupus erythematosus.

This case report describes a 14-year-old girl with juvenile dermatomyositis who presented with a 6-year history of a pruritic, photosensitive eruption involving her face, neck, trunk, and extremities and was successfully treated with anifrolumab.