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AB0744 EFFICACY OF IXEKIZUMAB IN ACTIVE PSORIATIC ARTHRITIS (PSA) PATIENTS WITH AXIAL PAIN STARTING BEFORE AGE 45: A SUBGROUP ANALYSIS OF SPIRIT-P1 AND SPIRIT-P2 PHASE 3 CLINICAL TRIALS
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  1. Atul Deodhar1,
  2. Alexis Ogdie2,
  3. Talia Muram3,
  4. David Sandoval3,
  5. Vladimir Geneus3,
  6. Peter Nash4
  1. 1Oregon Health and Science University, Portland, United States of america
  2. 2University of Pennsylvania, Philadelphia, United States of america
  3. 3Eli Lilly and Company, indianapolis, United States of america
  4. 4University of Queensland, Brisbane, australia

Abstract

Background The efficacy and safety of ixekizumab (IXE), an IL-17A antagonist, was investigated in patients with active psoriatic arthritis (PsA) in the SPIRIT-P1 and SPIRIT-P2 clinical trials.

Objectives To investigate the efficacy of ixekizumab on axial pain, fatigue, stiffness, and physical function in a subset of patients with PsA self-reporting axial pain starting before the age of 45 years at baseline.

Methods Patients with PsA in the intent-to-treat populations of SPIRIT-P1 (Biologic-naïve; NCT01695239) and SPIRIT-P2 (Inadequate responders or intolerant to 1 or 2 TNF inhibitors; NCT02349295) with baseline patient-reported axial pain (≥4 Bath ankylosing Spondylitis Disease activity index [BASDAI] question 2), high-sensitivity C-reactive protein (hsCRP) >5mg/L, and <45 years old were included in this post-hoc integrated analysis. SPIRIT-P1/P2 did not include axial imaging. Patients were treated with placebo (PBO) or ixekizumab 80-mg every 2 weeks (IXEQ2W) or 4 weeks (IXEQ4W) after a 160-mg starting dose for 24 weeks. The efficacy of ixekizumab on axial pain (BASDAI question 2), fatigue (BASDAI question 1), stiffness (mean of BASDAI questions 5/6), total BASDAI, Health assessment Questionnaire Disability index (HAQ-DI), and 36-Item Short form Health Survey Physical Component Summary (SF-36 PCS) was analyzed at Weeks 16 and 24 using mixed model for repeated measures with treatment, region, baseline conventional DMARD experience, visit, and treatment-by-visit interaction as fixed factors, and response value at baseline as a covariate.

Results Axial pain and stiffness significantly improved at Weeks 16 and 24 in patients with PsA treated with IXEQ4W or IXEQ2W versus PBO (p<.05; Table 1). Fatigue significantly improved at Week 16 in patients treated with IXEQ4W or IXEQ2W versus PBO and at Week 24 with IXEQ2W versus PBO (p<.05). Total BASDAI scores significantly improved at Weeks 16 and 24 in patients treated with IXEQ4W or IXEQ2W versus PBO (p<.01). Physical function significantly improved at Weeks 16 and 24 in patients treated with IXEQ4W or IXEQ2W versus PBO when assessed by HAQ-DI or SF-36 PCS (p<.05).

Conclusion Ixekizumab treatment yielded significantly higher improvements than placebo in axial pain, fatigue, stiffness, and physical function at Weeks 16 and 24 in the integrated PsA subpopulation self-reporting axial pain at baseline. These analyses were limited by a lack of baseline axial imaging.

Disclosure of interests atul Deodhar Grant/research support from: abbVie, amgen, Eli Lilly, GSK, Janssen, Novartis, Pfizer, and UCB, Consultant for: abbVie, amgen, BMS, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, alexis Ogdie Grant/research support from: (To my university) Novartis, Pfizer, Grant/research support from: Novartis, Pfizer, Grant/research support from: Novartis, Pfizer, Grant/research support from: Novartis, Pfizer, Consultant for: abbVie, Bristol-Myers Squibb, Celgene, Corrona, Eli Lilly and Company, Novartis, Pfizer, and Takeda, Consultant for: abbVie, amgen, Bristol-Myers Squibb, Celgene, Corrona, Eli Lilly, Novartis, Pfizer inc, Takeda, Consultant for: abbvie, amgen, BMS, Celgene, Corrona, Lilly, Novartis, Pfizer, Takeda, Consultant for: abbvie, amgen, BMS, Celgene, Corrona, Lilly, Novartis, Pfizer, Takeda, Talia Muram Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, David Sandoval Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Vladimir Geneus Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Peter Nash Grant/research support from: abbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer inc, Roche, Sanofi, UCB, Consultant for: abbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer inc, Roche, Sanofi, UCB, Speakers bureau: abbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer inc, Roche, Sanofi, UCB

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