Low Incidence of Both New-Onset and Flares of Uveitis in Secukinumab-Treated Patients with Ankylosing Spondylitis: Clinical Trial and Post-Marketing Safety Analysis

Atul A. Deodhar¹, Corinne Miceli-Richard², Xenofon Baraliakos³, Helena Marzo-Ortega⁴, Dafna D Gladman⁵, Ruvie Martin⁶, Jorge Safi⁷, Brian Porter⁷ and Abhijit Shete⁸, ¹Oregon Health & Science University, Portland, OR, ²Rheumatology Department, Paris Descartes University, Paris, France, ³Ruhr-University Bochum, Herne, Germany, ⁴NIHR LBRC, LTHT and LIRMM, University of Leeds, Leeds, United Kingdom, ⁵Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada, ⁶Novartis Pharmaceuticals Corporation, East Hanover, NJ, ⁷Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, East Hanover, NJ, ⁸Novartis Pharma AG, Basel, Switzerland, Basel, Switzerland

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: Ankylosing spondylitis (AS), Biologics, interleukins (IL), safety and uveitis

Session Information

Date: Tuesday, October 23, 2018

Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster III: Treatment

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: Uveitis, a common extra-articular manifestation of spondyloarthritis (SpA), has an estimated prevalence of 33.2% in patients with ankylosing spondylitis (AS), which increases with duration of disease and positive HLA-B27 status.¹ The exposure-adjusted incidence rates (EAIR) of uveitis (combined new-onset and flares) reported in AS patients treated with TNF inhibitors is 2.6–3.5 per 100 patient-years.^2–5 Here we report the incidence of uveitis in secukinumab-treated AS patients in long-term pooled clinical data from three Phase 3 trials (MEASURE 1–3 [NCT01358175, NCT01649375, NCT02008916]) and from post-marketing analyses.

Methods: Analysis included pooled patient-level data from all patients (N=794) who received any dose (≥1) of secukinumab up to the last patient attending Week 156 study visit in MEASURE 1, 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 patient-years of secukinumab exposure.

Results: In the three Phase 3 clinical trials of AS patients, 135 (17%) reported pre-existing (but not active or ongoing) uveitis at baseline and 589 (74.2%) were HLA-B27 positive. The EAIR for uveitis was 1.4 per 100 patient-years over the entire treatment period (N=794; Table). Among all cases of uveitis (n=26), 14 (54%) were flares in patients with a history of uveitis at baseline. The EAIR of uveitis in the post-marketing data (based on cumulative secukinumab exposure of 96,054 patient-years) was 0.03 per 100 patient-years.

Conclusion: In secukinumab-treated patients 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 Dis. 2008;67:955–59; 2. Wendling, et al. Curr Med Res Opin. 2014;30:2515–21; 3. Van der Heijde, et al. Rheumatology (Oxford) 2017;56:1498–509; 4. Sieper, et al. Arthritis Rheum. 2014;66:S242; 5. Heldmann, et al. Clin Exp Rheumatol. 2011;29:672–80.

Table. Safety Analysis for Uveitis with Secukinumab in AS

Data from Clinical Studies
Number of clinical studies/patients included	3/794
Uveitis cases reported, n (%)
Total	26 (3.3%)
New onset cases	12 (1.5%)
Treatment discontinuation	2 (0.3%)
Treatment interruption	1 (0.1%)
EAIR (95% confidence interval) per 100 patient-years^a	1.4 (0.9, 2.0)
Post-Marketing Data^b
Cumulative estimated market experience (patient-treatment years)^c	96,054
Cumulative number of cases reported	29
Crude incidence rate per 100 patient-years	0.03
^aRates for uveitis using the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms (PT) ^bData from the periodic safety update report (PSUR) dated 10^th August 2017-includes all indications ^cEstimated based on cumulative worldwide sales volume and the average maintenance dose

Disclosure: A. A. Deodhar, AbbVie Inc., Eli Lilly, GSK, Janssen, Novartis, Pfizer Inc., and UCB, 2,AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, 5; C. Miceli-Richard, Pfizer, Roche, UCB, Wyeth, and Merck, 2,Abbott/AbbVie, Bristol-Myers Squibb, Novartis, Merck, Pfizer, and Wyeth, 5,Abbott, Bristol-Myers Squibb, Merck, Pfizer, Roche, Schering-Plough, and Wyeth, 8; X. Baraliakos, AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB, and Werfen, 2,AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB, and Werfen, 5,AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB, and Werfen, 8; H. Marzo-Ortega, Janssen and Pfizer, 2,Abbvie, Celgene, Janssen and UCB, 8,Abbvie, Celgene, Janssen, Novartis and UCB, 5; D. D. Gladman, Amgen, AbbVie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer and UCB, 2,Amgen, AbbVie, BMS, Celgene, Eli Lilly, Janssen, Novartis, Pfizer and UCB, 5; R. Martin, Novartis, 1, 3; J. Safi, Novartis, 1,Novartis, 3; B. Porter, Novartis, 1, 3; A. Shete, Novartis, 1, 3.

To cite this abstract in AMA style:

Deodhar AA, Miceli-Richard C, Baraliakos X, Marzo-Ortega H, Gladman DD, Martin R, Safi J, Porter B, Shete A. Low Incidence of Both New-Onset and Flares of Uveitis in Secukinumab-Treated Patients with Ankylosing Spondylitis: Clinical Trial and Post-Marketing Safety Analysis [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/low-incidence-of-both-new-onset-and-flares-of-uveitis-in-secukinumab-treated-patients-with-ankylosing-spondylitis-clinical-trial-and-post-marketing-safety-analysis/. Accessed .

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