Bimekizumab efficacy and safety in patients with moderate-to-severe plaque psoriasis who switched from adalimumab, ustekinumab or secukinumab: results from phase III/IIIb trials.

BACKGROUND

Discontinuation of biologics is common among patients with psoriasis due to treatment failure or adverse events. To achieve improvements in disease management, patients and clinicians may choose to switch biologics.

OBJECTIVES

To evaluate the efficacy and safety of switching to bimekizumab from adalimumab, ustekinumab and secukinumab.

METHODS

Data are reported for up to 80 weeks after patients switched to bimekizumab from adalimumab at week 24 in BE SURE, ustekinumab at week 52 in BE VIVID [upon entry into the BE BRIGHT open-label extension (OLE)] and secukinumab at week 48 in BE RADIANT (upon entry into the BE RADIANT OLE). Efficacy outcomes are reported by number of weeks after switching to bimekizumab and were split based on whether patients had achieved a ≥ 90% improvement from baseline in Psoriasis Area and Severity Index (PASI 90) at the time of switch. Treatment-emergent adverse events (TEAEs) are reported using exposure-adjusted incidence rates (EAIRs) per 100 patient-years. Trial registration: BE SURE (NCT03412747), BE VIVID (NCT03370133), BE BRIGHT (NCT03598790), BE RADIANT (NCT03536884).

RESULTS

Rapid and durable improvements in clinical responses and benefits in health-related quality of life were observed among PASI 90 nonresponders who switched to bimekizumab. Most PASI 90 nonresponders achieved PASI 90 4 weeks after switching to bimekizumab from adalimumab (67%), ustekinumab (79%) and secukinumab (53%). After 48 weeks of bimekizumab, 91%, 90% and 79% of PASI 90 nonresponders had achieved PASI 90 after switching from adalimumab, ustekinumab or secukinumab, respectively. Durable improvements were also observed for PASI 100, Investigator's Global Assessment score 0/1, body surface area affected by psoriasis ≤ 1%, absolute PASI ≤ 2, and Dermatology Life Quality Index 0/1. Among PASI 90 responders, existing treatment responses were maintained or improved after switching to bimekizumab. The majority of TEAEs were mild or moderate. EAIRs were generally similar between active-comparator treatment periods and after switching to bimekizumab. EAIRs typically decreased with a longer duration of bimekizumab exposure.

CONCLUSIONS

High proportions of patients who did not adequately respond to adalimumab, ustekinumab or secukinumab achieved high levels of skin clearance after switching to bimekizumab. Bimekizumab was well tolerated and there were no new safety findings.

Informations de copyright

© The Author(s) 2022. Published by Oxford University Press on behalf of British Association of Dermatologists.

Déclaration de conflit d'intérêts

Conflicts of interest G.K.: 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, Hexal-Sandoz, Janssen-Cilag, LEO Pharma, Eli Lilly, MSD, Novartis, Pfizer, Sanofi and UCB Pharma. R.B.W.: consulting fees from AbbVie, Almirall, Amgen, Arena, Astellas, Avillion, Biogen, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, 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. B.S.: ­consultant (honoraria) for AbbVie, Almirall, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim, Bristol Myers Squibb, Connect Biopharma, Dermavant, Eli Lilly, EPI Health, Evelo Biosciences, Immunic Therapeutics Janssen, LEO Pharma, Maruho, Meiji Seika Pharma, Mindera Health, Novartis, Ono, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, UCB Pharma, Union Therapeutics, Ventyxbio and vTv Therapeutics; stock options for Connect Biopharma and Minder Health; speaker for AbbVie, Eli Lilly, Incyte, Janssen, Regeneron and Sanofi Genzyme; scientific co-director (consulting fee) for CorEvitas (formerly Corrona) Psoriasis Registry; investigator for AbbVie, Cara, CorEvitas Psoriasis Registry, Dermavant, Dermira and Novartis; Editor-in-Chief (honoraria) for the Journal of Psoriasis and Psoriatic Arthritis. A.B.: has served as a speaker/received honoraria from AbbVie, Eli Lilly and Company and UCB; served as a scientific adviser/received honoraria from AbbVie, Abcentra, Affibody, Aligos, Almirall, Alumis, Amgen, Anaptysbio, Arcutis, Arena, Aslan, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Dermavant, EcoR1, Eli Lilly and Company, Escient, Evelo, Evommune, Forte, Galderma, HighlightII Pharma, Incyte, Janssen, Landos, LEO Pharma, Merck, Novartis, Pfizer, Rapt, Regeneron, Sanofi Genzyme, Spherix Global Insights, Sun Pharma, TLL Pharmaceutical, TrialSpark, UCB Pharma, Vibliome and Xencor; acted as a clinical study investigator/institution has received clinical study funds from AbbVie, Acelyrin, Amgen, Arcutis, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly and Company, Evelo, Galderma, Incyte, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Regeneron, Sun Pharma and UCB Pharma. L.P.: received consultancy/speaker’s honoraria from and/or participated in trials sponsored by AbbVie, Almirall, Amgen, Baxalta, Biogen, Boehringer Ingelheim, Celgene, Eli Lilly, Gebro, Janssen, JS BIOCAD, LEO Pharma, Merck-Serono, MSD, Mylan, Novartis, Pfizer, Regeneron, Roche, Samsung-Bioepis, Sandoz, Sanofi Genzyme and UCB Pharma. A.M.: received research grants, consulting fees and/or speaker’s fees from AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Eisai, Janssen, Kyowa Hakko Kirin, LEO Pharma, Maruho, Mitsubishi Tanabe Pharma, Nichi-Iko, Nippon Kayaku, Novartis, Pfizer, Sun Pharma, Taiho Pharma, Torii Pharma, Ushio and UCB Pharma. M.G.: investigator, speaker, consultant or advisory board member for AbbVie, Akros, Amgen, AnaptysBio, Arcutis, Aslan, Bausch Health, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Dermavant, Dermira, Eli Lilly, Galderma, GSK, Incyte, Janssen, Kyowa Kirin, MedImmune, Meiji, Merck, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma and UCB Pharma. A.K.: speaker (honoraria) or consulting fees from: AbbVie, Almirall, Beiersdorf, Biogen-Idec, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Hexal, Janssen-Cilag, LEO Pharma, Eli Lilly, MSD, Novartis, Pfizer, Sanofi and UCB Pharma. V.V., C.M., D.dC., M.W.: employees and shareholders of UCB Pharma. N.N.G.: former employee of UCB Pharma. M.L.: employee of Mount Sinai and receives research funds from AbbVie, Amgen, Arcutis, Avotres Therapeutics, Boehringer Ingelheim, Dermavant, Eli Lilly, Incyte, Janssen, LLC, Ortho Dermatologics, Regeneron and UCB Pharma; consultant for Aditum Bio, Almirall, AltruBio, AnaptysBio, Arcutis, Aristea Therapeutics, Arrive Technologies, Avotres Therapeutics, BiomX, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, Corrona, Dermavant Sciences, Dr. Reddy’s Laboratories, Evelo Biosciences, Evommune, Facilitation of International Dermatology Education, Forte Biosciences, Foundation for Research and Education in Dermatology, Helsinn Therapeutics, Hexima, LEO Pharma, Meiji Seika Pharma, Mindera, Pfizer, Seanergy and Verrica.