Bimekizumab 4-year Maintenance of Responses in Week 16 Responders with Moderate to Severe Plaque Psoriasis: Results from the BE BRIGHT Open-label Extension Phase 3 Trial
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Keywords
psoriasis, chronic disease, biologic therapies, long-term efficacy, bimekizumab, BKZ, moderate to severe plaque psoriasis, plaque psoriasis, skin clearance, BE BRIGHT, BE VIVID, BE SURE, BE READY, PASI90, PASI100, Psoriasis Area and Severity Index, phase 3, clinical trials, efficacy, clinical response
Abstract
Introduction: Psoriasis is a chronic disease where loss of response to biologic therapies over time is commonly observed; studying long-term efficacy of new treatments is important.1 Maintenance of high responses to bimekizumab (BKZ) has been reported through 3 years (yrs) in patients with moderate to severe plaque psoriasis.2 This study evaluates the maintenance of clinical responses over 4 years among patients with moderate to severe plaque psoriasis who achieved complete or near-complete skin clearance after 16 weeks (wks) of BKZ treatment and entered the BE BRIGHT open-label extension. Responses were compared over 4 years between all patients who were randomized to BKZ and continued to receive bimekizumab (320 mg every 4 wks [Q4W] or Q8W) in the open-label extension, and those who received the BKZ dosing regimen that is approved for most patients: BKZ 320 mg Q4W to Wk 16 followed by 320 mg Q8W.
Methods: Patients completing the 52-wk BE VIVID or 56-wk BE SURE/BE READY phase 3 trials could enter the BE BRIGHT open-label extension (OLE).2–5
Maintenance of PASI90/PASI100 (≥90%/100% improvements from baseline in Psoriasis Area and Severity Index) to Yr4 (OLE Wk144) was assessed in Wk16 responders. Analyzed patients were randomized to BKZ 320 mg Q4W to Wk16, received BKZ Q4W or Q8W until OLE entry, then BKZ Q4W or Q8W dependent on PASI response/prior dose (BKZ Total); the subset who received BKZ Q4W/Q8W/Q8W (initial/maintenance/OLE) were also analyzed. All received BKZ Q8W from OLE Wk48 or at their next scheduled visit.
Patients who discontinued due to lack of efficacy/treatment-related adverse events were considered non-responders; multiple imputation was used for all other missing data (modified non-responder imputation).
Results: Of 989 BKZ-randomized patients, 87.5% achieved PASI90 and 62.7% PASI100 at Wk16 (non-responder imputation). 693 Wk16 PASI90 and 503 PASI100 responders entered the OLE (BKZ Total); 186 and 147, respectively, received BKZ Q4W/Q8W/Q8W. 87.7%/73.3% of Wk16 PASI90/PASI100 responders maintained their responses to Yr4 (BKZ Total). In the Q4W/Q8W/Q8W subset, 89.0%/76.7% maintained their responses to Yr4.
Conclusions: Among Wk16 responders, high efficacy responses were sustained through 4 yrs of BKZ treatment, including patients who received the approved Q4W/Q8W/Q8W dosing regimen.
References
2. Strober B. et al. Br J Dermatol 2023;188:749–59, NCT03598790;
3. Reich K. et al. Lancet 2021;397:487–98, NCT03370133;
4. Warren B et al. N Engl J Med 2021;385:130–41, NCT03412747;
5. Gordon KB. et al. Lancet 2021;397:475–86, NCT03410992;
6. Food and Drugs Administration. Prescribing Information. 2023. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761151s000lbl.pdf [Accessed September 2024].
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