Abstract

Abstract Background/Aims Nail psoriasis (PsO) is a strong predictor for the development of psoriatic arthritis (PsA) and has been reported in 63-83% of patients with PsA. Psoriatic nails are linked to arthritis in the adjacent distal interphalangeal joint (DIP) of fingers or interphalangeal joint of thumbs, and both can lead to severe functional impairment. In the SPIRIT-H2H study of adults with PsA, 354 of 566 participants had nail PsO and adjacent joint disease in at least one digit at baseline. At the group level, SPIRIT-H2H patients treated with ixekizumab (IXE) achieved significantly greater improvements in nail PsO compared to those treated with adalimumab (ADA). This analysis aimed to assess the treatment effects of IXE and ADA at the individual digit level among patients with PsA, nail PsO, and adjacent joint disease. Methods This post hoc analysis included 354 patients from SPIRIT-H2H (NCT03151551) treated with either IXE (N = 186) or ADA (N = 168) who had nail PsO (Nail Psoriasis Severity Index (NAPSI) total score >0) and adjacent joint disease (tenderness and/or swelling) in at least one digit at baseline. Treatment effects were assessed for each individual finger unit displaying nail PsO and adjacent joint disease; here, finger unit defines the nail and adjacent joint of an individual digit; adjacent joint refers to the DIP of fingers or the interphalangeal joint of thumbs. Nail PsO was measured using NAPSI in the fingers only. Joint involvement was measured by tender/swollen joint count scores (TJC68/SJC66). Patients were evaluated for both nail and joint involvement at baseline and Weeks 12, 16, 24, 32, 40, and 52. Proportions of finger units with resolution of nail PsO, and proportions of finger units with resolution of adjacent joint disease were analyzed using Chi-square tests. Non-responder imputation was used to handle missing data. Results There were 1309 (IXE=639, ADA=670) finger units affected by nail and adjacent joint disease at baseline. Resolution of psoriatic nail disease and resolution of adjacent tenderness and/or swelling of the finger unit was significantly higher with IXE vs ADA at all post-baseline assessments over 52 weeks. Joint tenderness was resolved in a significantly larger proportion of IXE-treated finger units vs ADA at all post-baseline assessments over 52 weeks. Joint swelling was resolved in a larger proportion of IXE-treated finger units vs ADA, and these differences reached statistical significance at all visits except Week 16 and Week 40. The tenderness and/or swelling of the finger unit resolved more rapidly than the adjacent nail disease. Conclusion IXE treatment showed a significant advantage over ADA in resolving nail PsO, joint tenderness, and joint swelling among the finger units with nail and adjacent joint disease of patients with PsA. Disclosure D. McGonagle: Consultancies; D. McGonagle has received consulting fees and/or honoraria and/or research grants from: AbbVie and Eli Lilly and Company. A. Kavanaugh: Consultancies; A. Kavanaugh has received consulting fees and/or honoraria from: AbbVie, Eli Lilly and Company, Janssen, Novartis, Pfizer, UCB Pharma. I. McInnes: Corporate appointments; Vice Principle & Head of College for University of Glasgow, non-executive board member of NHS Greater Glasgow & Clyde, non-executive director of Evelo, and trustee of Versus Arthritis. Consultancies; AbbVie, Amgen, Bristol Myers Squibb, Cabaletta Bio, Causeway Therapeutics, Eli Lilly and Company, Gilead Sciences, Janssen, Novartis, Pfizer, Sanofi Regeneron, and UCB Pharma. L. Kristensen: Grants/research support; AbbVie, Amgen, Biogen, Bristol Myers Squibb, Eli Lilly and Company, Gilead Sciences, Janssen, Merck Sharpe & Dohme, Novartis, Pfizer, and UCB Pharma. J. Merola: Consultancies; AbbVie, Amgen, Biogen, Bristol Myers Squibb, Dermavant, Eli Lilly and Company, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi Regeneron, Sun Pharma, and UCB Pharma. B. Strober: Corporate appointments; Editor-in-Chief for the Journal of Psoriasis and Psoriatic Arthritis and scientific co-director and investigator for CorEvitas Psoriasis Registry. Consultancies; AbbVie, Alamar Biosciences, Almirall, Alumis, Amgen, Arcutis, Arena Pharmaceuticals, Aristea Therapeutics, Asana Biosciences, Boehringer Ingelheim, Bristol Myers Squibb, Connect Biopharma, Dermavant. Shareholder/stock ownership; Connect Biopharma and Mindera. Honoraria; Eli Lilly and Company, Evelo Biosciences, Immunic Therapeutics, Incyte Corporation, Janssen, Kangpu Pharmaceuticals, LEO Pharma, Maruho, Meiji Seika Pharma, Mindera, Nimbus Therapeutics, Novartis. Grants/research support; Pfizer, Protagonist Therapeutics, Regeneron, Sanofi Genzyme, Sun Pharma, UCB Pharma, Union Therapeutics, Ventyx Biosciences, and vTv Therapeutics. R. Bolce: Shareholder/stock ownership; R. Bolce is an employee and shareholder of Eli Lilly and Company. J.R. Lisse: Shareholder/stock ownership; J. Lisse is an employee and shareholder of Eli Lilly and Company. J. Pustizzi: Shareholder/stock ownership; J. Pustizzi is an employee and shareholder of: Eli Lilly and Company. C. Sapin: Shareholder/stock ownership; C. Sapin is an employee and shareholder of: Eli Lilly and Company. C. Ritchlin: Honoraria; AbbVie, Bristol Myers Squibb, Eli Lilly and Company, Janssen, Novartis, Pfizer, and UCB Pharma.

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