SAT0270 Low incidence of both new-onset and flares of uveitis in secukinumab-treated patients with ankylosing spondylitis: clinical trial and post-marketing safety analysis
Authors: A. Deodhar, C. Miceli-Richard, X. Baraliakos, H. Marzo-Ortega, D.D. Gladman, R. Martin, J. Safi, B. Porter, A. Shete
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> Uveitis, a common extra-articular manifestation of SpA, has an estimated prevalence in patients (pts) with ankylosing spondylitis (AS) of 33.2%, which increases with disease duration and positive HLA-B27 status.<sup>1</sup> Uveitis occurs in 10%–50% of SpA pts.<sup>1</sup> The exposure-adjusted incidence rate [EAIR] of uveitis (combined new-onset and flares) reported in AS pts treated with TNF inhibitors is 2.6–3.5 per 100 patient-years (pt-yrs).<sup>2–5</sup> <h3>Objectives</h3> To assess the incidence of uveitis in secukinumab-treated AS pts in long-term pooled clinical data from three phase 3 trials (MEASURE 1–3 [NCT01358175, NCT01649375, NCT02008916]) and from post-marketing analyses. <h3>Methods</h3> Analysis included pooled pt-level data from all pts in MEASURE 1 who received any dose (≥1) of secukinumab up to the last pt attending Week 156 study visit, and up to visit Week 156 in MEASURE 2 and visit Week 104 in MEASURE 3 for each patient, respectively. Post-marketing data were from the most recent periodic safety surveillance report. Incidence of uveitis is reported as EAIR per 100 pt-yrs of secukinumab exposure. <h3>Results</h3> In the phase 3 AS clinical trials, 135 (17%) pts reported pre-existing (but not active or ongoing) uveitis at baseline and 589 (74.2%) pts were HLA-B27 positive. The EAIR for uveitis was 1.4 per 100 pt-yrs over the entire treatment period (n=794). Among all cases of uveitis (n=26), 14 (54%) were flares in pts with a history of uveitis at baseline (Table). The EAIR of uveitis in the post-marketing data (based on cumulative secukinumab exposure of 96 054 pt-yrs) was 0.03 per 100 pt-yrs. <h3>Conclusions:</h3> In secukinumab-treated pts with active AS, a low incidence of uveitis was observed, including new-onset cases and flares, in both clinical trials and post-marketing analyses. <h3>References</h3> [1] Zeboulon, et al. Ann Rheum Dis2008;67:955–59. [2] Wendling, et al. Curr Med Res Opin2014;30:2515–21. [3] Van der Heijde, et al. Rheumatology (Oxford)2017;56:1498–509. [4] Sieper, et al. Arthritis Rheum2014;66:S242. [5] Heldmann, et al. Clin Exp Rheumatol2011;29:672–80. <h3>Disclosure of Interest</h3> A. Deodhar Grant/research support from: AbbVie Inc., Eli Lilly, GSK, Janssen, Novartis, Pfizer Inc., UCB, Consultant for: AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, UCB, C. Miceli-Richard Grant/research support from: Pfizer, Roche, UCB, Wyeth, Merck, Consultant for: Abbott/AbbVie, Bristol-Myers Squibb, Novartis, Merck, Pfizer, Wyeth, Speakers bureau: Abbott, Bristol-Myers Squibb, Merck, Pfizer, Roche, Schering-Plough, Wyeth., X. Baraliakos Grant/research support from: AbbVie, BMS, Celgene, Chugai, MSD, Novartis, Pfizer, UCB, Consultant for: AbbVie, BMS, Celgene, Chugai, MSD, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, BMS, Celgene, Chugai, MSD, Novartis, Pfizer, UCB, H. Marzo-Ortega Grant/research support from: Janssen and Pfizer, Consultant for: AbbVie, Celgene, Janssen, Novartis and UCB, Speakers bureau: AbbVie, Celgene, Janssen and UCB, D. Gladman Grant/research support from: Amgen, AbbVie, BMS, Celgene, Eli Lilly, Janssen, Novartis, Pfizer and UCB., Consultant for: Amgen, AbbVie, BMS, Celgene, Eli Lilly, Janssen, Novartis, Pfizer and UCB., R. Martin Shareholder of: Novartis, Employee of: Novartis, J. Safi Jr Shareholder of: Novartis, Employee of: Novartis, B. Porter Shareholder of: Novartis, Employee of: Novartis, A. Shete Shareholder of: Novartis, Employee of: Novartis