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
Authors: Atul Deodhar, Alexis Ogdie, Talia Muram, David Sandoval, Vladimir Geneus, Peter Nash
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> 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. <h3>Objectives</h3> 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. <h3>Methods</h3> 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) &gt;5mg/L, and &lt;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. <h3>Results</h3> Axial pain and stiffness significantly improved at Weeks 16 and 24 in patients with PsA treated with IXEQ4W or IXEQ2W versus PBO (p&lt;.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&lt;.05). Total BASDAI scores significantly improved at Weeks 16 and 24 in patients treated with IXEQ4W or IXEQ2W versus PBO (p&lt;.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&lt;.05). <h3>Conclusion</h3> 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. <h3>Disclosure of interests</h3> 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