Session Information
Date: Monday, November 13, 2023
Title: (1412–1441) Spondyloarthritis Including Psoriatic Arthritis – Treatment Poster II: SpA
Session Type: Poster Session B
Session Time: 9:00AM-11:00AM
Background/Purpose: Clinical improvements through Week (Wk)96, with no unexpected safety findings, have previously been reported with bimekizumab (BKZ) in the BE RADIANT phase 3b trial in patients with moderate to severe plaque psoriasis.[1,2] Here, we evaluate the efficacy of BKZ, as measured by complete or near complete skin clearance using the Psoriasis Area and Severity Index (PASI), over 144 weeks, and assess long-term safety of BKZ treatment.
Methods: Patients with moderate to severe plaque psoriasis received BKZ (320mg every 4 wks [Q4W] through Wk16, then Q4W or Q8W) or secukinumab (SEC; 300mg weekly to Wk4, then Q4W) through Wk48, then BKZ (Q4W or Q8W; all received Q8W from Wk64/next scheduled visit). Wks48–144 (open-label extension [OLE]) overlapped with the COVID‑19 pandemic. Wk48–144 efficacy data are reported for patients treated with BKZ or SEC to Wk48 who entered the OLE, receiving BKZ Q4W or Q8W. Patients discontinuing due to lack of efficacy/treatment‑related adverse events (AEs) were considered non‑responders; multiple imputation was used for other missing data (modified non-responder imputation [mNRI]). Wk48–144 safety data (incidence/100 patient-years [PY]) are grouped for patients receiving ≥1 BKZ dose in this period.
Results: 336/373 BKZ-randomized and 318/370 SEC-randomized patients entered the OLE. Among these, 74.9% BKZ vs 52.8% SEC (Wk48) and 68.8% BKZ/BKZ vs 69.1% SEC/BKZ (Wk144) achieved PASI100 (100% improvement from baseline in PASI); 94.3% vs 83.9% (Wk48) and 89.8% vs 87.0% (Wk144) achieved PASI≤2. Wk48–144 serious AE rate with BKZ was low (5.4/100PY).Four deaths (two from coronavirus infection [unvaccinated patients]) occurred; none treatment-related. The most common AEs were: nasopharyngitis (8.4/100PY); oral candidiasis (7.1/100PY); coronavirus infection (5.1/100PY). Most (98.3%) oral candidiasis events were mild/moderate; three led to discontinuation.
Conclusion: Clinical improvements with BKZ were maintained through Wk144; outcomes improved for SEC-treated patients after switching to BKZ (Wk48–144). AEs were consistent with BKZ’s safety profile.[1–3]
Funding: This study was funded by UCB Pharma. Medical writing provided by Costello Medical and funded by UCB Pharma. References: 1. Strober B et al. Presented at AAD 2022, poster 34321; 2.Reich K et al. N Engl J Med 2021;
385(2):142–52, NCT03536884; 3.Gordon KB et al. JAMA Dermatol 2022;158(7):735–44.
Abstract previously submitted to AAD 2023.
To cite this abstract in AMA style:
Strober B, Puig L, Blauvelt A, Thaçi D, Elewski B, Wang M, Vanvoorden V, Deherder D, Staelens f, Wiegratz S, Merola J, Paul C. Bimekizumab Maintenance of Response and Safety in Patients with Moderate to Severe Plaque Psoriasis: Results from the Open-label Extension Period (Weeks 48–144) of the BE RADIANT Phase 3b Trial [abstract]. Arthritis Rheumatol. 2023; 75 (suppl 9). https://acrabstracts.org/abstract/bimekizumab-maintenance-of-response-and-safety-in-patients-with-moderate-to-severe-plaque-psoriasis-results-from-the-open-label-extension-period-weeks-48-144-of-the-be-radiant-phase-3b-tria/. Accessed .« Back to ACR Convergence 2023
ACR Meeting Abstracts - https://acrabstracts.org/abstract/bimekizumab-maintenance-of-response-and-safety-in-patients-with-moderate-to-severe-plaque-psoriasis-results-from-the-open-label-extension-period-weeks-48-144-of-the-be-radiant-phase-3b-tria/