Guselkumab demonstrates long-term efficacy and maintenance of treatment response postwithdrawal in systemic treatment-naïve patients and nonresponders to fumaric acid esters: results from parts II and III of a randomized active-comparator-controlled phase IIIb trial (POLARIS)
- PMID: 38133615
- DOI: 10.1093/bjd/ljad523
Guselkumab demonstrates long-term efficacy and maintenance of treatment response postwithdrawal in systemic treatment-naïve patients and nonresponders to fumaric acid esters: results from parts II and III of a randomized active-comparator-controlled phase IIIb trial (POLARIS)
Abstract
Background: The anti-interleukin-23 antibody guselkumab (GUS) demonstrated favourable week 24 efficacy and safety over fumaric acid esters (FAE) in systemic treatment-naïve patients with moderate-to-severe plaque psoriasis (study part I).
Objectives: To compare, in study part II, the sustainability of treatment responses (weeks 24-32) in GUS- and FAE-treated patients and treatment responses (weeks 32-56) in patients treated with GUS and FAE and in FAE nonresponders switching to GUS; and, in part III, to investigate the maintenance of response through week 100 in patients withdrawn from GUS at week 56.
Methods: At week 0, systemic treatment-naïve patients were randomized 1 : 1 to GUS or FAE as per label. At week 32, patients with a Psoriasis Area and Severity Index (PASI) 75 (≥ 75% improvement in PASI score) response (r) continued assigned treatment (GUSr-GUS; FAEr-FAE), whereas nonresponders (nr) received GUS (FAEnr-GUS; GUSnr-GUS). GUS-treated patients with a week 56 PASI 90 response (≥ 90% improvement in PASI score) were withdrawn (w) and followed until loss of response or week 100.
Results: At week 32, 98% (n = 54/55) of GUS- and 41% (n = 14/34) of FAE-treated patients were PASI 75 responders. At week 56, 91%, 50% and 80% of GUSr-GUS, FAEr-FAE and FAEnr-GUS patients, respectively, achieved a PASI 90 response; 72%, 29% and 45%, respectively, achieved a Dermatology Life Quality Index score of 0/1. At week 100, 44 weeks postwithdrawal, 47% (n = 17/36) and 25% (n = 3/12) of GUS-GUSw and FAE-GUSw patients, respectively, maintained a PASI score ≤ 5. Overall, the adverse event and discontinuation rates were lower for GUS than FAE.
Conclusions: In these exploratory analyses, GUS, as a first-line systemic treatment or second-line systemic treatment in FAE nonresponders, was associated with long-term clinical efficacy up to week 100, including a withdrawal period.
© The Author(s) 2023. Published by Oxford University Press on behalf of British Association of Dermatologists.
Conflict of interest statement
Conflicts of interest D.T. has received investigator honoraria, honoraria for consultancy and/or has received speakers’ honoraria and/or research grants from AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Galapagos, Galderma, Janssen, LEO Pharma, Lilly, MSD, Novartis, Pfizer, Regeneron/Sanofi, Samsung and UCB. C.T. has received investigator honoraria and/or has received speakers’ honoraria and/or has received grants from and/or has been an advisor for the following companies: AbbVie, Allergopharma, Almirall, Janssen, LEO Pharma and UCB. A.P. has received investigator honoraria and/or has received speakers’ honoraria and/or has received grants from and/or has been an advisor for the following companies: AbbVie, Almirall-Hermal, Amgen, Biogen Idec, Boehringer Ingelheim, Celgene, Eli Lilly, Galderma, GSK, Hexal, Janssen, LEO Pharma, Medac, Merck Serono, Mitsubishi, MSD, Novartis, Pfizer, Regeneron, Roche, Sandoz Biopharmaceuticals, Schering-Plough, Tigercat Pharma and UCB Pharma. M. Sebastian has received investigator honoraria, has received grants from and/or has been an advisor/consultant for the following companies: AbbVie, Almirall, Boehringer Ingelheim, Celgene, Dr. Reddy, Galderma, GSK, Janssen, LEO Pharma, Lilly, MSD, Mundipharma, Novartis, Regeneron and UCB Pharma. M. Sticherling has received investigator and/or speaker honoraria, has received grants from and/or has participated in clinical studies for the following companies: AbbVie, Actelion, Almirall, Amgen, Boehringer Mannheim, Celgene, Galderma, GSK, Hexal, Janssen, LEO Pharma, Lilly, MSD, Mundipharma, Novartis, Pfizer, Sandoz, Sanofi and UCB Pharma. S.G. has been an advisor for and/or has received speakers’ honoraria and/or has received grants and/or has participated in clinical trials for the following companies: AbbVie, Affibody, Akari Therapeutics, Almirall-Hermal, Amgen, Argenx, Aristea Therapeutics, Biogen Idec, Bioskin, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Dermira, Eli Lilly, Galderma, Hexal, Incyte, Janssen-Cilag, Johnson & Johnson, Klinge Pharma, Kymab, LEO Pharma, Medac, MSD, Neubourg Skin Care, Novartis, Pfizer, Pierre Fabre, Principia Biopharma, Regeneron Pharmaceuticals, Sandoz Biopharmaceuticals, Sanofi-Aventis, Trevi Therapeutics and UCB Pharma. K.S. has received investigator and/or speaker honoraria, has received grants from and/or has participated in clinical studies for the following companies: AbbVie, Almirall, Boehringer Ingelheim, Celgene, Eli Lilly, Galderma, Janssen-Cilag, LEO Pharma, Novartis, Pfizer and UCB. S.W., S.K., C.R. and H.B. are employees of Janssen-Cilag, Germany. F.T. owns Taut Science and Service, a consultancy specialized in clinical development and medical affairs, and is receiving consultancy fees from the Janssen group. K.E. has received investigator honoraria and/or has received speakers’ honoraria from and/or received grants and/or has been an advisor for the following companies: AbbVie, BMS, Boehringer Ingelheim, Janssen, Lilly, LEO Pharma, Novartis, Pfizer, Sanofi and UCB.
Comment in
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Prior exposure to fumaric acid esters does not impact on subsequent treatment response to guselkumab.Br J Dermatol. 2024 Jun 20;191(1):5-6. doi: 10.1093/bjd/ljae036. Br J Dermatol. 2024. PMID: 38282352 No abstract available.
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