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Clinical Trial
. 2023 Dec;89(6):1149-1158.
doi: 10.1016/j.jaad.2023.07.1024. Epub 2023 Aug 6.

Long-term safety and efficacy of risankizumab for the treatment of moderate-to-severe plaque psoriasis: Interim analysis of the LIMMitless open-label extension trial up to 5 years of follow-up

Kim A Papp  1 , Andrew Blauvelt  2 , Lluís Puig  3 , Mamitaro Ohtsuki  4 , Stefan Beissert  5 , Melinda Gooderham  6 , Ahmad Z Amin  7 , Jie Liu  8 , Tianshuang Wu  8 , Tofial Azam  8 , Vassilis Stakias  8 , Ramon Espaillat  8 , Ranjeeta Sinvhal  8 , Ahmed M Soliman  8 , Yinuo Pang  8 , Michael M Chen  8 , Mark G Lebwohl  9
Affiliations
Free article
Clinical Trial

Long-term safety and efficacy of risankizumab for the treatment of moderate-to-severe plaque psoriasis: Interim analysis of the LIMMitless open-label extension trial up to 5 years of follow-up

Kim A Papp et al. J Am Acad Dermatol. 2023 Dec.
Free article

Abstract

Background: Psoriasis is a chronic, inflammatory skin disease often requiring long-term therapy.

Objective: To evaluate the long-term safety and efficacy of risankizumab in patients with psoriasis.

Methods: LIMMitless is an ongoing phase 3, open-label extension study evaluating the long-term safety and efficacy of continuous risankizumab 150 mg every 12 weeks for adults with moderate-to-severe plaque psoriasis following multiple phase 2/3 base studies. This interim analysis assessed safety (ie, monitored treatment-emergent adverse events [TEAEs]) through 304 weeks. Efficacy assessments included determining the proportion of patients who achieved ≥90% or 100% improvement in Psoriasis Area and Severity Index (PASI 90/100), static Physician's Global Assessment of clear/almost clear (sPGA 0/1), and Dermatology Life Quality Index of no effect on patient's life (DLQI 0/1) through 256 weeks.

Results: Among 897 patients randomized to risankizumab in the base studies, 706 were still ongoing at data cutoff. Rates of TEAEs, TEAEs leading to discontinuation, and TEAEs of safety interest were low. At week 256, 85.1%/52.3% of patients achieved PASI 90/100, respectively, 85.8% achieved sPGA 0/1, and 76.4% achieved DLQI 0/1.

Limitations: Open-label study with no placebo or active-comparator group.

Conclusions: Long-term continuous risankizumab treatment for up to 5 years was well tolerated and demonstrated high and durable efficacy.

Keywords: interleukin 23; plaque psoriasis; psoriasis; risankizumab.

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Conflict of interest statement

Conflicts of interest Dr Papp has received research funds from or is a consultant and/or speaker for AbbVie, Amgen, Arcutis, Astellas, Bausch Health, Baxalta, Baxter, BI, Bristol Myers Squibb, Celgene, Coherus, Dermavant, Dermira, EMD Serono, Evelo, Galderma, Genentech, Gilead, Incyte, Janssen, LEO, Lilly, Meiji Seika Pharma, Merck, Mitsubishi Tanabe Pharma, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sandoz, Sanofi Genzyme, Stiefel, Sun Pharma, Takeda, and UCB. He is a committee member for PSOLAR and PURE registries. Dr Blauvelt has served as a speaker (received honoraria) for AbbVie, Bristol Myers Squibb, Lilly, Pfizer, Regeneron, and Sanofi, served as a scientific adviser (received honoraria) for AbbVie, Abcentra, Aclaris, Affibody, Aligos, Almirall, Alumis, Amgen, Anaptysbio, Arcutis, Arena, Aslan, Athenex, Bluefin Biomedicine, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Dermavant, EcoR1, Escient, Evelo, Evommune, Forte, Galderma, HighlightII Pharma, Incyte, InnoventBio, Janssen, Landos, Leo, Lilly, Merck, Novartis, Pfizer, Rani, Rapt, Regeneron, Sanofi Genzyme, Spherix Global Insights, Sun Pharma, TLL Pharmaceutical, TrialSpark, UCB, Union, Vibliome, and Xencor, and has acted as a clinical study investigator (institution has received clinical study funds) for AbbVie, Acelyrin, Almirall, Alumis, Amgen, Arcutis, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Concert, Dermavant, Evelo, Evommune, Galderma, Incyte, Janssen, LEO, Lilly, Merck, Novartis, Pfizer, Regeneron, Sun Pharma, and UCB. Dr Puig has received consultancy/speaker’s honoraria from and/or participated in clinical trials sponsored by AbbVie, Almirall, Amgen, Baxalta, Biogen, BI, Celgene, EMD Serono, Gebro, Janssen, LEO, Lilly, Merck, Mylan, Novartis, Pfizer, Regeneron, Roche, Samsung, Sandoz, Sanofi, and UCB. Dr Ohtsuki has received honoraria or fees for serving on advisory boards or speakers’ bureaus, fees for consulting, and grants for investigator activities from AbbVie, Amgen, BI, Bristol Myers Squibb, Celgene, Eisai, Janssen, Kyowa Kirin, LEO, Lilly, Maruho, Mitsubishi Tanabe Pharma, Novartis, Pfizer, Sun Pharma, Taiho, Torii, and UCB. Dr Beissert has received honoraria as an advisory board member and/or speaker for AbbVie, Actelion, Almirall, Amgen, Bristol Myers Squibb, Celgene, Galderma, GSK, Janssen, LEO, Lilly, Menlo Therapeutics, Merck, Novartis, Pfizer, Roche, Sandoz, Sanofi, and UCB. Dr Gooderham is or has been an investigator, adviser, and/or speaker for AbbVie, Akros, Amgen, AnaptysBio, Arcutis, Aristea, Bausch, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Coherus BioSciences, Dermira, Dermavant, Galderma, GlaxoSmithKline, Janssen, Kyowa Kirin, LEO, Lilly, Medimmune, Merck, Meiji, Moonlake, Nimbus, Novartis, Pfizer, Regeneron, Reistone, Roche, Sanofi Genzyme, Sun Pharma, UCB, and Ventyx. Dr Amin is a consultant and speaker for AbbVie, Amgen, Janssen, Lilly, Pfizer, Sanofi Genzyme, and UCB. Ms Liu, Dr Wu, Dr Azam, Dr Stakias, Dr Espaillat, Dr Sinvhal, Dr Soliman, Dr Pang, and Dr Chen are full-time employees of AbbVie Inc., and may hold AbbVie stock, stock options, and/or patents. Dr Lebwohl is an employee of Mount Sinai and receives research funds from AbbVie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Cara Therapeutics, Dermavant Sciences, Eli Lilly, Incyte, Janssen Research & Development LLC, Ortho Dermatologics, Regeneron, and UCB Inc., and is a consultant for Aditum Bio, Almirall, AltruBio Inc., AnaptysBio, Arcutis Inc., Aristea Therapeutics, Avotres Therapeutics, Brickell Biotech, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, Celltrion, Corevitas, Dermavant Sciences, Dr. Reddy, EPI, Evommune Inc., Facilitation of International Dermatology Education, Forte Biosciences, Foundation for Research and Education in Dermatology, Helsinn, Hexima Ltd., Incyte, LEO, Meiji Seika Pharma, Mindera, Pfizer, Seanergy, Strata, Trevi, and Verrica.

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