Results from a long-term pooled analysis presented at Maui Derm from five phase-3/3b trials indicate that bimekizumab (BKZ) is safe and well-tolerated at the 3-year mark in patients with moderate-to-severe plaque psoriasis.

In a poster presented at Maui Derm, 2024, results from a long-term pooled analysis from five phase-3/3b trials indicate that bimekizumab (BKZ) is safe and well-tolerated at the 3-year mark in patients with moderate-to-severe plaque psoriasis. The data is from pooled results from the BE SURE, BE VIVID, and BE READY phase 3 trails, as well as the open-label extension BE BRIGHT trial and the ongoing BE RADIANT phase 3b trial. Patients in the studies received BKZ 320 mg every 4 weeks or every 8 weeks, and all received BKZ 320 mg every 8 weeks from week 64 in the BE RADIANT study or week 100/104 in the BE BRIGHT study. The authors reported treatment-emergent adverse events over the course of 3 years using exposure-adjusted incidence rates per 100 patient-years (PY) for all patients who received one or more doses of BKZ (BKZ Total) and (BKZ Total), and separately for Years 1 (Week 0–52), 2 (Week >52–104), and 3 (Week >104–156) of BKZ exposure. The total BKZ exposure was 5,461 PY (n=2,186).

Exposure-adjusted incidence rates, according to the researchers, did not increase with longer exposure to BKZ, and the overall rates of treatment-emergent adverse events were lower in patients receiving BKZ every 8 weeks compared with those receiving it every 4 weeks. The most common reported treatment-emergent adverse events were nasopharyngitis (14.1/100 PY), oral candidiasis (10.0/100 PY) and upper respiratory tract infection (6.2/100 PY). Exposure-adjusted incidence rates of serious infections adjudicated inflammatory bowel disease, major adverse cardiac events, and suicidal ideation and behavior were low, the authors reported.

“Over 3 years of treatment, BKZ demonstrated a favorable safety profile, with no new safety signals observed,” the researchers reported. “Exposure-adjusted incidence rates or treatment-emergent adverse events did not increase with longer exposure to BKZ.”

Source: Lebwohl M, Strober B, Langley RG, et al. Bimekizumab 3-year safety and tolerability in moderate to severe plaque psoriasis: Long-term pooled analysis from five phase 3/3b trials. Abstract 12520. Presented at: Maui Derm, January 22-26, 2024.

Disclosures

Study funding was provided by UCB Pharma. Medical writing support was provided by Costello Medical.

ML: Employee of Mount Sinai and receives research funds from Abbvie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Cara Therapeutics, Dermavant Sciences, Eli Lilly and Company, Incyte, Inozyme, Janssen Research & Development, LLC, Ortho Dermatologics, Regeneron, and UCB Pharma; 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, 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.

BS: Consultant (honoraria) for AbbVie, Acelyrin, Alamar, Almirall, Alumis, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim, Bristol Myers Squibb, Capital One, Celltrion, CorEvitas, Dermavant, Eli Lilly and Company, Imagenebio, Janssen, Kangpu Pharmaceuticals, LEO Pharma, 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; stock options from Connect Biopharma, and Mindera Health; speaker for AbbVie, Arcutis, Dermavant, Eli Lilly and Company, Incyte, Janssen, Regeneron, and Sanofi Genzyme; Scientific Co-Director (consulting fee): CorEvitas Psoriasis Registry; investigator for CorEvitas Psoriasis Registry; editor-in-chief (honorarium): Journal of Psoriasis and Psoriatic Arthritis.

RGL: Principal investigator for AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly and Company, LEO Pharma, Merck, Novartis, Pfizer, and UCB Pharma; served on scientific advisory boards for AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly and Company, LEO Pharma, Merck, Novartis, Pfizer, and UCB Pharma; provided lectures for AbbVie, Amgen, Celgene, Eli Lilly and Company, LEO Pharma, Merck, Novartis, and Pfizer.

YO: Received research grants from Eisai, Maruho, Shiseido, and Torii Pharmaceutical; current consulting/advisory board agreements from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly and Company, Janssen, and Sun Pharma; speakers bureau from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eisai, Eli Lilly and Company, Janssen, Jimro, Kyowa Kirin, LEO Pharma, Maruho, Novartis, Pfizer, Sanofi, Sun Pharma, Taiho, Tanabe-Mitsubishi, Torii Pharmaceutical, and UCB Pharma; clinical trials sponsored by AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Janssen, LEO Pharma, Maruho, Pfizer, Sun Pharma, and UCB Pharma.

PF: Grant support from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Sanofi, and Sun Pharma; 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 and Company, Evelo, Galderma, Geneseq, Genentech, GenesisCare, GSK, Hexima, 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 and Company, Galderma, GSK, Janssen, LEO Pharma, Mayne Pharma, Merck, Novartis, Pfizer, Sanofi, Sun Pharma, UCB Pharma, and Valeant; served as a consultant for Aslan, Bristol Myers Squibb, Eli Lilly and Company, Galderma, GenesisCare, Janssen, LEO Pharma, Mayne Pharma, MedImmune, Novartis, Pfizer, Roche, UCB Pharma, and Wintermute; received travel grants from AbbVie, Eli Lilly and Company, Galderma, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Roche, Sun Pharma, and Sanofi; served as a speaker for, or received honoraria from AbbVie, Almirall, Amgen, Celgene, Eli Lilly and Company, Galderma, GSK, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Roche, Sanofi, Sun Pharma, UCB Pharma and Valeant.

RBW: Consulting fees from AbbVie, Almirall, Amgen, Arena, Astellas, Avillion, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly and Company, GSK, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi, and UCB Pharma; research grants to his institution from AbbVie, Almirall, Janssen, LEO Pharma, Novartis, and UCB Pharma; honoraria from Astellas, DiCE, GSK, and Union Therapeutics. LP, NC, SW, DD: Employee and shareholder of UCB Pharma.

DT: Served as an investigator and/or consultant/advisor for AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Eli Lilly and Company, Galapagos, Galderma, Janssen, Kyowa Kirin, LEO Pharma, Novartis, Pfizer, Regeneron, Samsung, Sandoz, Sanofi, Target-Solution, and UCB Pharma; received grants from AbbVie, LEO Pharma, and Novartis.