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. 2026 Jan;16(1):585-603.
doi: 10.1007/s13555-025-01595-9. Epub 2025 Dec 8.

Bimekizumab Impact on Patient-Reported Outcomes in Plaque Psoriasis: 4-Year Results from BE SURE, BE VIVID, BE READY, and BE BRIGHT

April Armstrong  1 , Kim A Papp  2   3 , Mark Lebwohl  4 , Laura J Savage  5 , Keiichi Yamanaka  6 , Diana Elena Vlase  7 , Rhys Warham  8   9 , Jérémy Lambert  10 , José M López Pinto  11 , Krista Wixted  12 , Diamant Thaçi  13
Affiliations

Bimekizumab Impact on Patient-Reported Outcomes in Plaque Psoriasis: 4-Year Results from BE SURE, BE VIVID, BE READY, and BE BRIGHT

April Armstrong et al. Dermatol Ther (Heidelb). 2026 Jan.

Abstract

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.

Plain language summary

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.

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Conflict of interest statement

Declarations. Conflict of Interest: April Armstrong: Research investigator and/or scientific advisor to AbbVie, Almirall, Arcutis, ASLAN, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Dermira, Eli Lilly, EPI, Incyte, Janssen, LEO Pharma, Nimbus, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sun Pharma, Sanofi, and UCB. Kim A. Papp: Received honoraria and/or grants from AbbVie, Acelyrin, Akros, Alumis, Amgen, Arcutis, Bausch Health/Valeant, Boehringer Ingelheim, Bristol Myers Squibb, Can-Fite Biopharma, Celltrion, Concert Pharmaceuticals, Dermavant, Dermira, DiCE Therapeutics, Eli Lilly, Evelo Biosciences, Forbion, Galderma, Horizon Therapeutics, Incyte, Johnson & Johnson, Kymab, Kyowa Hakko Kirin, LEO Pharma, Meiji Seika Pharma, Mitsubishi Pharma, Nimbus Therapeutics, Novartis, Pfizer, Reistone, Sanofi-Aventis/Genzyme, Sun Pharma, Takeda, Tarsus, UCB, and Zai Lab. Mark Lebwohl: Employee of Mount Sinai; receives research funds from Abbvie, Amgen, Arcutis, Avotres Therapeutics, Boehringer Ingelheim, Cara Therapeutics, Dermavant Sciences, Eli Lilly, Incyte, Inozyme, Janssen Research & Development, LLC, Ortho Dermatologics, Pfizer, Sanofi-Regeneron, and UCB; consultant for Almirall, AltruBio Inc., AnaptysBio, Apogee, Arcutis Inc., AstraZeneca, Atomwise, Avotres Therapeutics, Brickell Biotech, Boehringer Ingelheim, Bristol Myers Squibb, Castle Biosciences, Celltrion, CorEvitas, Dermavant Sciences, EPI, Evommune Inc., Facilitation of International Dermatology Education, Forte Biosciences, Foundation for Research and Education in Dermatology, Galderma, Genentech, Incyte, LEO Pharma, Meiji Seika Pharma, Mindera, Pfizer, Sanofi-Regeneron, Seanergy, Strata, Takeda, Trevi, and Verrica. Mark Lebwohl is an Editorial Board member of Dermatology and Therapy. Mark Lebwohl was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Laura J. Savage: Received grant/research support from Johnson and Johnson and Pfizer; consultant for AbbVie, Almirall, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Johnson and Johnson, LEO Pharma, Novartis, and UCB; speaker for AbbVie, Almirall, Amgen, Aspire Pharma, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Galderma, Johnson and Johnson, LEO Pharma, Novartis, Pfizer, Sanofi Genzyme, Takeda, and UCB. Keiichi Yamanaka: Grants from AbbVie, Bayer Yakuhin, Eisai, Eli Lilly, Kaken Pharmaceutical, Kyowa Kirin, Maruho, Maruho Takagi Dermatology Foundation, Nihon Pharmaceutical, Nippon Kayaku, Sasaki Chemical, Taiho Pharmaceutical, Torii Pharmaceutical, and Sun Pharma; speaker for AbbVie, Celgene, Daiichi Sankyo, Eisai, Eli Lilly, Janssen, Kaken Pharmaceutical, Kyowa Kirin, LEO Pharma, Maruho, Mitsubishi-Tanabe Pharmaceutical, Nippon Kayaku, Nobelpharma, Novartis, Sanofi, Sun Pharma, Taiho Pharmaceutical, Torii Pharmaceutical, and UCB. Diana Elena Vlase: Psoriasis Patient, Volunteer in National Patient Organization, Volunteer in European Group YASJC (Young Advocates with Chronic Skin and Joint Conditions), Workshop Participant (UCB). Rhys Warham: Veramed statistical consultant for UCB. Jérémy Lambert; José M. López Pinto; Krista Wixted: Employees and shareholders of UCB Pharma. Diamant Thaçi: Investigator and/or consultant/advisor for AbbVie, Almirall, Amgen, Bristol Myers Squibb, Boehringer Ingelheim, Celltrion, Eli Lilly, Galderma, Incyte, Johnson and Johnson, Kyowa Kirin, LEO Pharma, L’Oréal, New Bridge, Novartis, Pfizer, Regeneron, Samsung, Sanofi, Takeda, Target-RWE, UCB, and Vichy; received grants from AbbVie, LEO Pharma and Novartis. Ethical Approval: The BE SURE, BE VIVID, BE READY, and BE BRIGHT studies were conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonization Guidance for Good Clinical Practice. Ethical approvals were obtained from the relevant institutional review boards at participating sites. All patients provided written informed consent in accordance with local requirements. The authors thank the patients, the investigators and their teams who took part in these studies. All the results presented in this article are in aggregate form, and no personally identifiable information was used for these studies.

Figures

Fig. 1
Fig. 1
Proportions of patients reporting P-SIM = 0 (no sign/symptom/impact) in each item over comparator-controlled periods (NRI) a BE SURE, b BE VIVID, c BE READY. Data are reported in all randomized patients. The mean average of daily scores for a given week was calculated to generate a weekly score in each item. To achieve a score of 0 for a given week, patients therefore needed to report a score of 0 on every day data were collected in that week. Weekly scores were considered missing if ≥ 4 daily scores were missing for that week. In BE SURE, P-SIM completion rates in BKZ Total/ADA patients were 85.0% (271/319)/78.6% (125/159) at baseline, 78.1% (249/319)/77.4% (123/159) at week 4, and 70.2% (224/319)/67.9% (108/159) at week 24, respectively. In BE VIVID, P-SIM completion rates in BKZ Q4W/UST/PBO patients were 81.0% (260/321)/76.1% (124/163)/80.7% (67/83) at baseline, 90.7% (291/321)/82.8% (135/163)/86.7% (72/83) at week 4, and 80.4% (258/321)/76.1% (124/163)/71.1% (59/83) at week 16, respectively. In BE READY, P-SIM completion rates in BKZ Q4W/PBO patients were 87.7% (306/349)/86.0% (74/86) at baseline, 90.3% (315/349)/86.0% (74/86) at week 4, and 78.8% (275/349)/74.4% (64/86) at week 16, respectively. ADA adalimumab, BKZ bimekizumab, NRI non-responder imputation, PBO placebo, P-SIM Psoriasis Symptoms and Impacts Measure, Q4W every 4 weeks, UST ustekinumab
Fig. 2
Fig. 2
Proportions of patients reporting DLQI = 0 in each item over comparator-controlled periods (NRI). a BE SURE, b BE VIVID, c BE READY. Data are reported in all randomized patients. ADA adalimumab, BKZ bimekizumab, DLQI Dermatology Life Quality Index, NRI non-responder imputation, PBO placebo, Q4W every 4 weeks, UST ustekinumab
Fig. 3
Fig. 3
Distribution of DLQI scores by severity category throughout comparator-controlled periods. a BE SURE, b BE VIVID, c BE READY. ADA adalimumab, BKZ bimekizumab, DLQI Dermatology Life Quality Index, N/A not applicable, PBO placebo, Q4W every 4 weeks, UST ustekinumab
Fig. 4
Fig. 4
Proportions of patients achieving concurrent PASI = 0 (complete skin clearance) and DLQI 0/1 (no effect on patient’s life) throughout comparator-controlled periods (NRI). a BE SURE. b BE VIVID. c BE READY. Data are reported in all randomized patients. PASI 100 data, indicating complete clearance of psoriasis, have been reported previously from BE SURE, BE VIVID, and BE READY.[9, 10, 15]. ADA adalimumab, BKZ bimekizumab, DLQI Dermatology Life Quality Index, NRI non-responder imputation, PASI Psoriasis Area and Severity Index, PASI 100 100% improvement from baseline in PASI, PBO placebo, Q4W every 4 weeks, UST ustekinumab
Fig. 5
Fig. 5
Pooled long-term proportions of patients reporting DLQI item scores of 0 through to year 4 (mNRI). BE VIVID lasted 52 weeks and BE SURE and BE READY lasted 56 weeks; to pool data across studies, week 56 data were not included. Week 52 corresponds to the week 48 assessment for BE SURE and BE READY, and week 52 for BE VIVID, owing to the lack of common visits at which DLQI was recorded in these studies. As a result of different feeder study lengths, week 196 corresponds to week 196 for patients from BE VIVID, and week 200 for patients in BE SURE and BE READY. aFor DLQI items 5, 7, 8, and 9, the Markov chain Monte Carlo step of the multiple imputation procedure failed to produce a monotone missing data pattern for the BKZ Q4W/Q8W treatment arm, as all observed values were identical at certain visits for these items. Consequently, the monotone regression step could not be performed, and no mNRI estimates are available for these items. OC data for the BKZ Total and BKZ Q4W/Q8W arms are presented in Fig. S4. BKZ bimekizumab, DLQI Dermatology Life Quality Index, mNRI Modified non-responder imputation, Q4W every 4 weeks, Q8W every 8 weeks
Fig. 6
Fig. 6
Pooled long-term proportions of patients achieving concurrent PASI = 0 (complete skin clearance) and DLQI 0/1 (no effect on patient’s life) through to year 4 (mNRI). BE VIVID lasted 52 weeks and BE SURE and BE READY lasted 56 weeks; to pool data across studies, week 56 data were not included. Week 52 corresponds to the week 48 assessment for BE SURE and BE READY, and week 52 for BE VIVID, owing to the lack of common visits at which DLQI was recorded in these studies. As a result of different feeder study lengths, week 196 corresponds to week 196 for patients from BE VIVID, and week 200 for patients in BE SURE and BE READY. PASI 100 data, indicating complete skin clearance, have been reported previously from BE BRIGHT [12]. BKZ bimekizumab, DLQI Dermatology Life Quality Index, mNRI modified non-responder imputation, OC observed case, PASI Psoriasis Area and Severity Index, PASI 100 100% improvement from baseline in PASI, Q4W every 4 weeks, Q8W every 8 weeks
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