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

• Published in: Annals of the rheumatic diseases Vol. 77; no. Suppl 2; p. 999
• Main Authors: Deodhar, A., Miceli-Richard, C., Baraliakos, X., Marzo-Ortega, H., Gladman, D.D., Martin, R., Safi, J., Porter, B., Shete, A.
• Format: Journal Article
• Language: English
• Published: London BMJ Publishing Group LTD 01.06.2018
• Subjects: Ankylosing spondylitis; Arthritis; Clinical trials; Marketing; Monoclonal antibodies; Patients; Safety; Spondylitis; Stockholders; Uveitis
• ISSN: 0003-4967; 1468-2060
• DOI: 10.1136/annrheumdis-2018-eular.4474

BackgroundUveitis, 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.1 Uveitis occurs in 10%–50% of SpA pts.1 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).2–5 ObjectivesTo 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.MethodsAnalysis 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.ResultsIn 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.Abstract SAT0270 – Table 1Safety Analysis for Uveitis with Secukinumab in ASData from Clinical Studies Number of clinical studies/pts included3/794Uveitis cases reported, n (%)Total26 (3.3%)New onset cases14 (1.8%)Treatment discontinuation2 (0.3%)Treatment interruption1 (0.1%)EAIR (95% confidence interval) per 100 pt-yrsa1.4 (0.9–2.0)Post-Marketing DatabCumulative estimated market experience (pt-treatment yrs)c96 054Cumulative number of cases reported29Crude incidence rate per 100 pt-yrs0.03aRates are for uveitis MedDRA preferred termbData from the periodic safety update report (PSUR) dated 10th August 2017 – includes all indicationscEstimated based on cumulative worldwide sales volume and the average maintenance doseConclusions: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.References[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.Disclosure of InterestA. 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