Efficacy and Safety of Ixekizumab Versus Adalimumab in Biologic-naïve Patients With Active Psoriatic Arthritis and Moderate-to-severe Psoriasis: 52-week Results From the Randomized SPIRIT-H2H Trial.

The randomized, open-label, assessor-blinded, parallel-group SPIRIT-H2H trial (NCT03151551) demonstrated superiority of ixekizumab over adalimumab in simultaneously achieving improvement in joint symptoms (American College of Rheumatology [ACR]50) and skin clearance (Psoriasis Area and Severity Index [PASI]100) in biologic-naïve patients with active psoriatic arthritis (PsA) and plaque psoriasis (PsO) at Week (W) 24. Higher efficacy of ixekizumab versus adalimumab was maintained through W52. This analysis investigated efficacy and safety of ixekizumab and adalimumab in the subgroup of patients with PsA and moderate-to-severe PsO through W52. Efficacy and safety outcomes were analyzed in patients with PsA and moderate-to-severe PsO (PASI ≥ 12, Body Surface Area ≥ 10%, static Physician Global Assessment ≥ 3) through W52. Categorical and continuous outcomes were analyzed using logistic regression models and mixed model for repeated measures, respectively. More ixekizumab-versus adalimumab-treated patients simultaneously achieved PASI100 and ACR50 at W24 (40.8% versus 17.6%, P = 0.015) and W52 (38.8% versus 17.6%, P = 0.026). Likewise, more ixekizumab-versus adalimumab-treated patients achieved PASI100 (59.2% versus 25.5%, P = 0.001) and PASI90 (81.6% versus 60.8%, P = 0.028) through W52, and nail PsO clearance at W24. Joint symptom improvements were comparable between groups. No new safety findings were reported. Ixekizumab had higher efficacy than adalimumab in simultaneous achievement of ACR50 and PASI100 at W24 and W52 in patients with PsA and moderate-to-severe PsO. Ixekizumab-treated patients showed higher response rates for nail PsO clearance and for reporting minimal or no impact on quality of life at W24.

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©2022 Reich et al.

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Competing interests: K. Reich reports conflicts of interest from Abbvie, Affibody, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, Forward Pharma, Janssen, Kyowa Kirin, Leo, and UCB. L.E. Kristensen reports conflicts of interest from AbbVie, Amgen, Biogen, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Forward Pharma, Janssen, Merck, and Co., Novartis, Pfizer, and UCB. S.D. Smith has been an advisor for and/or received speaking fees and/or served as an investigator in clinical trials for AbbVie, Amgen, Biogen, Bristol Myers Squibb, Eli Lilly and Company, Janssen Cilag, Leo Pharma, Novartis, Pfizer, Sanofi Genzyme, and UCB. P. Rich has been a principal investigator for AbbVie, Amgen, Arcutis, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dermavant, Eli Lilly and Company, Merck, Novartis, Pfizer and Sandoz, Sun Pharma, and UCB; a consultant for AbbVie, Novartis and Polichem; and an advisory board participant for AbbVie, Eli Lilly and Company, Leo, Novartis, and Sandoz. C. Sapin, S. Liu Leage, R. McKenzie, C. Schuster, and E. Riedl are employees and minor shareholders of Eli Lilly and Company. M. Gooderham has received grant/research support from: AbbVie, Actelion Pharmaceuticals, Akros Pharma, Amgen, Arcutis Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dermira, Dermavant, Eli Lilly and Company, Galderma SA, Incyte, Kyowa Kirin, Janssen, LEO Pharma, MedImmune, Merck and Co., Novartis, Pfizer, Regeneron Pharmaceuticals, Roche Laboratories, Sanofi Genzyme, UCB, and Bausch/Valeant Pharmaceuticals. Consultant for: Akros Pharma, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly and Company, Janssen, Novartis, Sanofi Genzyme, Valeant Pharmaceuticals. Speakers bureau for: AbbVie, Amgen, Arcutis, Boehringer Ingelheim International GmbH, Celgene, Eli Lilly and Company, Galderma SA, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Sanofi Genzyme, and UCB.