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

Kristian Reich; Lars Erik Kristensen; Saxon D Smith; Phoebe Rich; Christophe Sapin; Soyi Liu Leage; Robert McKenzie; Christopher Schuster; Elisabeth Riedl; Melinda Gooderham

doi:10.5826/dpc.1202a104

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

Dermatol Pract Concept. 2022 Apr 1;12(2):e2022104. doi: 10.5826/dpc.1202a104. eCollection 2022 May.

Authors

Affiliations

¹ Center for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
² Musculoskeletal Statistics Unit, The Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
³ The Dermatology and Skin Cancer Centre, St Leonards, and Discipline of Dermatology, Sydney Medical School, University of Sydney, Sydney, Australia.
⁴ Oregon Dermatology and Research, Portland, Oregon, USA.
⁵ Eli Lilly and Company, Indianapolis, Indiana, USA.
⁶ Department of Dermatology, Medical University of Vienna, Vienna, Austria.
⁷ SKiN Centre for Dermatology, Probity Medical Research and Queen's University, Peterborough, Ontario, Canada.

Abstract

Introduction: 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.

Objectives: This analysis investigated efficacy and safety of ixekizumab and adalimumab in the subgroup of patients with PsA and moderate-to-severe PsO through W52.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords: SPIRIT-H2H; adalimumab; ixekizumab; nail psoriasis; psoriasis.