Bimekizumab Maintenance of Response at Every Visit Over 4 Years in Patients with Psoriasis Achieving Clear Skin at Week 16: Results from Four Phase 3 Trials
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Keywords
Psoriasis, Bimekizumab, Continuous Maintenance of Response
Abstract
Introduction: Achieving and maintaining skin clearance is key for patients with psoriasis.1,2 However, loss of disease control over time is often seen with biologics; therefore, evaluating whether high efficacy levels are maintained at every visit in the long term is important.3 Here, we assess whether bimekizumab (BKZ)-treated patients, who achieved complete skin clearance (PASI 100; 100% improvement in Psoriasis Area and Severity Index) after 16 weeks, maintained BSA (body surface area) ≤1% and PASI 90/75 (≥90/75% improvement in PASI) responses at every visit over 4 years.
Procedure/study: Data were pooled from the 52/56-week BE VIVID/BE SURE/BE READY trials and their 144-week open-label extension (OLE) BE BRIGHT.4–7 Included patients received BKZ 320 mg every 4 weeks (Q4W) to Week16, then Q4W or Q8W into the OLE; all received BKZ Q8W from Week100/104 or next scheduled visit. Dose groups were pooled for all analyses. Proportions of patients achieving PASI 100 at Week16 who maintained BSA ≤1%/PASI 90/PASI 75 at every subsequent study visit (29/30 further visits [study-dependent]) up to Year4 (Week196/200) are reported. Proportions who maintained their response at every visit except at most 1 and at most 2 are also reported. Patients discontinuing treatment due to lack of efficacy/treatment-related adverse events were considered non-responders at subsequent timepoints; last observation carried forward was used for other missing data (mNRI-LOCF).
Results: Of 989 BKZ-randomized patients, 62.7% achieved PASI 100 at Week16 (non-responder imputation). 503 Week16 PASI 100 responders received continuous BKZ and entered the OLE. Among these patients, BSA ≤1%, PASI 90, and PASI 75 responses were maintained at every study visit from Week16–Year4 by 69.4%, 80.9%, and 93.0% of patients, respectively (at every visit except at most 1: 79.5%, 87.5%, and 95.2%; at every visit except at most 2: 84.1%, 91.8%, and 96.8%).
Conclusion: High proportions of Week16 PASI 100 responders maintained BSA ≤1%/PASI 90/PASI 75 at every visit through 4 years. The vast majority maintained these responses at every visit except at most 2 visits through 4 years.
Funding: UCB. Medical writing support: Costello Medical.
References
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