Bimekizumab 3-year Maintenance of Response in Week 16 Responders with Moderate to Severe Plaque Psoriasis: Results from Five Phase 3/3b Trials
Year: 2024
Type: article
Abstract: Bimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, 1 has demonstrated rapid and superior efficacy in the treatment of patients with moderate to severe plaque psoriasis in head-to-head studies versus ustekinumab, adalimumab, and secukinumab, with established long-term durability of response.2-6 • As psoriasis is a chronic disease and loss of response to therapies can occur over time, studying long-term efficacy of new treatments is important.7 • Maintenance of responses through 3 years of BKZ 320 mg treatment, in psoriasis patients who achieved disease control after 16 weeks, has been shown previously in patients from four phase 3 trials.6 • Here, we report maintenance of response from the largest available data pool through 3 years, with patients included across five phase 3/3b trials. ObjectiveTo report maintenance of response over 3 years in patients who achieved complete or near-complete skin clearance after 16 weeks of BKZ treatment from five phase 3/3b trials. Methods• Data were pooled from the 52-week BE VIVID, 56-week BE READY, and 56-week BE SURE phase 3 trials, their ongoing open-label extension (OLE), BE BRIGHT, as well as the BE RADIANT phase 3b trial (48-week double-blinded period, 96-week OLE; Figure 1).2-6 • Included patients were randomized to BKZ 320 mg every 4 weeks (Q4W) at baseline to Week 16.Patients then received either BKZ Q4W or every 8 weeks (Q8W) through the maintenance and OLE periods.-All patients still receiving BKZ Q4W were re-assigned to BKZ Q8W at OLE Week 16/48 (BE RADIANT/BE BRIGHT) or next scheduled visit, via protocol amendment.• Maintenance of ≥90/100% improvement from baseline in Psoriasis Area and Severity Index (PASI 90/100), and Investigator's Global Assessment (IGA) 0/1 responses through Year 3 (Week 144/OLE Week 96) are reported in Week 16 PASI 90, PASI 100, and IGA 0/1 responders, respectively.• Dermatology Life Quality Index (DLQI) 0/1 responses (indicating no impact of skin disease on patient's life) 8 are also reported in Week 16 PASI 100 responders.• Data are reported for the combined BKZ dosing groups (BKZ Total) and for the subset of patients who received BKZ Q4W/Q8W/Q8W (initial/maintenance/OLE) dosing.• Data are reported using modified non-responder imputation (mNRI): patients who discontinued due to lack of efficacy or treatment-related adverse events were considered non-responders at subsequent timepoints; multiple imputation was used for all other missing data (NRI/observed case [OC] data in Table 2 only).
Language: English
Subfield: Immunology
Field: Immunology and Microbiology
Domain: Life Sciences
Open Access status: diamond
OpenAlex ID: W4390904849