BIMEKIZUMAB EFFICACY THROUGH 3 YEARS IN PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS: LONG-TERM POOLED ANALYSIS FROM BE BRIGHT

Background: A key factor of biologic discontinuation in patients with plaque psoriasis is loss of response over time; long-term treatment efficacy is therefore important. Objectives: To report 3-year efficacy of bimekizumab (BKZ) from a pooled analysis of patients with moderate to severe plaque psoriasis across three phase 3 clinical trials and their open-label extension (OLE). Methods: Data were pooled from the 52-week BE VIVID and 56-week BE SURE and BE READY phase 3 trials, and their common OLE BE BRIGHT. Included patients received BKZ 320 mg every 4 weeks (Q4W) then switched to Q4W or every 8 weeks (Q8W) maintenance dosing from Week 16 onwards, and entered the OLE; from OLE Week 48 or the next scheduled clinic visit, all patients received BKZ 320 mg Q8W. Proportions of patients achieving ≥90% improvement from baseline in Psoriasis Area and Severity Index (PASI 90), PASI 100, and Dermatology Life Quality Index (DLQI) 0/1 are reported through Year 3 using modified non-responder imputation: patients who discontinued treatment 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. Results: 771 patients received BKZ continuously in the feeder studies and entered the OLE. Among these, at Week 16, 90.9%, 65.8%, and 71.5% achieved PASI 90, PASI 100, and DLQI 0/1, respectively. At Year 1, 93.7%, 76.6%, and 83.1% of all BKZ-treated patients achieved PASI 90 (Week 52), PASI 100 (Week 52), and DLQI 0/1 (Week 48/52), respectively. Responses were durable to Year 3 (OLE Week 96): 91.0%, 70.3%, and 82.8% of all BKZ-treated patients achieved PASI 90, PASI 100, and DLQI 0/1, respectively. Similar trends were observed in the subset of patients that received BKZ Q4W/Q8W/Q8W (initial/maintenance/OLE). Conclusion: High and durable clinical and health-related quality of life responses were observed over 3 years of BKZ treatment across three phase 3 trials and their OLE. REFERENCES: [1] Warren RB et al. J Invest Dermatol 2015;135:2632–40. [2] Reich K et al. Lancet 2021;397:487–98, NCT03370133. [3] Warren RB et al. N Engl J Med 2021;385:130–41, NCT03412747. [4] Gordon KB et al. Lancet 2021;397:475–86, NCT03410992. [5] Strober B et al. Br J Dermatol 2023;188:749–59, NCT03598790. Acknowledgements: Funding: Studies funded by UCB Pharma. Medical writing support by Costello Medical. Disclosure of Interests: Georgios Kokolakis Received travel grants or honoraria, or has been a consultant member of advisory boards and speaker bureaus or has served as investigator for AbbVie, Actelion, Almirall, Amgen, Basilea, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Hexal-Sandoz, Janssen-Cilag, LEO Pharma, MSD, Novartis, Pfizer, Sanofi, Takeda, and UCB Pharma, Mark Lebwohl Employee of Mount Sinai, Consultant for Almirall, AltruBio Inc., AnaptysBio, Arcutis Inc., Arena Pharmaceuticals, Aristea Therapeutics, AstraZeneca, Avotres, BioMX, Boehringer Ingelheim, Brickell Biotech, Bristol-Myers Squibb, Castle Biosciences, Celltrion, CorEvitas, LLC, Dermavant Sciences, EPI, Evommune Inc., Facilitation of International Dermatology Education, Forte Biosciences, Foundation for Research and Education in Dermatology, Galderma, Genentech, Hexima Ltd, Incyte, LEO Pharma, Meiji Seika Pharma, Mindera, National Society of Cutaneous Medicine, New York College of Podiatric Medicine, Pfizer, Seanergy, Strata, SUN Pharma, Trevi, Verrica, and Vial, Receives research funds from: Abbvie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Cara Therapeutics, Dermavant Sciences, Eli Lilly and Company, Incyte, Inozyme, Janssen Research & Development, LLC, Novartis, Ortho Dermatologics, Regeneron, and UCB Pharma, Bruce Strober Speaker for AbbVie, Arcutis, Dermavant, Eli Lilly, Incyte, Janssen, Regeneron, and Sanofi Genzyme, Stock options from Connect Biopharma, Mindera Health, Consultant (honoraria): AbbVie, Acelyrin, Alamar, Almirall, Alumis, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim, Bristol-Myers-Squibb, Capital One, Celltrion, CorEvitas, Dermavant, Eli Lilly, Imagenebio, Janssen, Kangpu Pharmaceuticals, Leo, Maruho, Meiji Seika Pharma, Protagonist, Monte Carlo, Novartis, Pfizer, Rapt, Regeneron, Sanofi-Genzyme, SG Cowen, Sun Pharma, Takeda, UCB Pharma, Union Therapeutics, Ventyxbio, and vTv Therapeutics. Scientific Co-Director (consulting fee): CorEvitas Psoriasis Registry; investigator for CorEvitas Psoriasis Registry; editor-in-chief (honorarium): Journal of Psoriasis and Psoriatic Arthritis, Peter Foley Served as an investigator for AbbVie, Akaal, Amgen, Arcutis, Argenx, Aslan, AstraZeneca, Boehringer Ingelheim, Botanix, Bristol Myers Squibb, Celgene, Celtaxsys, CSL, Cutanea, Dermira, Eli Lilly, Evelo, Galderma, Geneseq, Genentech, GenesisCare, GSK, Hexima, Incite, Janssen, Kymab, LEO Pharma, MedImmune, Merck, Novartis, Pfizer, Regeneron, Reistone, Roche, Sanofi, Sun Pharma, Takeda, Teva, UCB Pharma, and Valeant, Served on advisory boards for AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Galderma, GSK, Janssen, LEO Pharma, Mayne Pharma, Merck, Novartis, Pfizer, Sanofi, Sun Pharma, UCB Pharma, and Valeant. Served as a speaker for or received honoraria from AbbVie, Amgen, Celgene, Eli Lilly, Galderma, GSK, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Roche, Sanofi, Sun Pharma, and Valeant, Served as a consultant for Aslan, Bristol Myers Squibb, Eli Lilly, Galderma, GenesisCare, Janssen, LEO Pharma, Mayne Pharma, MedImmune, Novartis, Pfizer, Roche, UCB Pharma, and Wintermute, Grant support from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Sanofi, and Sun Pharma. Received travel grants from AbbVie, Eli Lilly, Galderma, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Roche, Sun Pharma, and Sanofi, Richard G. Langley Principal investigator for AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, LEO Pharma, Merck, Novartis, Pfizer, and UCB Pharma, Served on scientific advisory boards for AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, LEO Pharma, Merck, Novartis, Pfizer, and UCB Pharma; provided lectures for AbbVie, Amgen, Celgene, Eli Lilly, LEO Pharma, Merck, Novartis, and Pfizer, Yayoi Tada Honoraria and/or grants from AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Eisai, Eli Lilly, Janssen, Kyowa Hakko Kirin, LEO Pharma, Maruho, Mitsubishi Tanabe Pharma, Sun Pharma, Taiho Pharmaceutical, Torii Pharmaceutical, and UCB Pharma, Philip Hampton Received educational grants and advisory board fees from AbbVie, Eli Lilly, LEO Pharma, and UCB Pharma; received unrestricted development grant for mobile medical app development from UCB Pharma, Leah Davis Shareholder of UCB Pharma, Employee of UCB Pharma, Susanne Wiegratz Shareholder of UCB Pharma, Employee of UCB Pharma, Bengt Hoepken Shareholder of UCB Pharma, Employee of UCB Pharma, Jérémy Lambert Shareholder of UCB Pharma, Employee of UCB Pharma. DOI: 10.1136/annrheumdis-2024-eular.5083 Keywords: Skin, Quality of life, Clinical Trial, Randomized controlled trial, Biological DMARD Citation: , volume 83, supplement 1, year 2024, page 1513Session: Psoriatic arthritis (Publication Only)

Skin, Quality of life, Clinical Trial, Randomized controlled trial, Biological DMARD