Introduction: While bimekizumab has demonstrated rapid, superior clinical efficacy versus adalimumab and ustekinumab, with sustained responses through 4 years, its comparative and long-term impact on patient-reported outcomes (PROs) remains underexplored. Here, we report PROs with bimekizumab versus adalimumab/ustekinumab/placebo in phase 3 controlled trials, and over 4 years with bimekizumab.
Methods: Data were analyzed from BE SURE, BE VIVID, BE READY (52/56 weeks), and their open-label extension (OLE), BE BRIGHT (144 weeks; 4 years' total treatment). Patients were randomized to bimekizumab/adalimumab/ustekinumab/placebo during comparator-controlled periods; all received bimekizumab during BE BRIGHT. Proportions of patients reporting Psoriasis Symptoms and Impacts Measure (P‑SIM) = 0 and Dermatology Life Quality Index (DLQI) = 0 (both at item-level) were assessed during comparator‑controlled periods using non-responder imputation (NRI). Over 4 years, PROs were analyzed using modified NRI in patients who received continuous bimekizumab from baseline into the OLE.
Results: BE SURE included 478 patients (bimekizumab, 319; adalimumab, 159); BE VIVID included 567 (bimekizumab, 321; ustekinumab, 163; placebo, 83); BE READY included 435 (bimekizumab, 349; placebo, 86). In total, 771 patients received continuous bimekizumab into the OLE. A larger proportion of bimekizumab-treated patients achieved P-SIM = 0 across key items versus adalimumab (week 24; itching, 30.7% vs. 18.9%; skin pain, 43.9% vs. 30.2%; scaling, 39.2% vs. 19.5%), ustekinumab (week 16; itching, 31.2% vs. 17.8%; skin pain, 51.7% vs. 27.6%; scaling, 43.6% vs. 17.2%), and placebo. Similar trends were seen for other P-SIM items and in proportions of bimekizumab-treated patients reporting DLQI = 0 across items versus comparators. The patient-reported benefits of bimekizumab were demonstrated throughout the OLE, with 65.5-94.8% of patients reporting DLQI = 0 across items at 4 years.
Conclusions: Bimekizumab provided greater improvements in PROs versus comparators, with durable effects over 4 years. These findings reinforce bimekizumab's role in effective psoriasis management, linking clinical efficacy with sustained patient-reported benefits.
Trial registration: NCT03412747, NCT03370133, NCT03410992, NCT03598790. A Graphical Abstract is available for this article.
Keywords: Bimekizumab; Biologic therapy; Health-related quality of life; IL-17A/F; Long-term treatment; Patient-reported outcomes; Phase 3 clinical trials; Plaque psoriasis.
Psoriasis is a long-lasting condition causing red, scaly skin patches that itch and hurt. As psoriasis symptoms affect daily life, finding treatments that work well and provide lasting improvements is important. While most studies report outcomes observed by physicians, we focused on patient-reported outcomes, exploring how psoriasis impacts were experienced and described by patients. Bimekizumab is an injection for psoriasis that works by lowering the activity of two proteins involved in causing inflammation. Several studies have been conducted to assess how well it controls psoriasis. The studies (BE SURE, BE VIVID, and BE READY) compared bimekizumab to other treatments (adalimumab and ustekinumab) and placebo over periods ranging from 16 to 52 weeks. These studies fed into a long-term study called BE BRIGHT, which followed patients for an additional 3 years to see if bimekizumab’s benefits lasted. In these studies, patients recorded how severe their psoriasis signs and symptoms were during the past day and how much psoriasis affected their lives over the past week, using two questionnaires. They completed these before their first injection and at different points throughout the studies. We examined the results to see how well bimekizumab worked, both versus other treatments, and over 4 years. The results showed that bimekizumab worked better than other treatments at reducing bothersome signs and symptoms like itching, pain, and scaling, and improving quality of life. Over 4 years, patients who took bimekizumab continued to experience a better quality of life. Overall, patients with psoriasis experienced strong, lasting benefits with bimekizumab.
© 2025. The Author(s).