Incidence of Uveitis in Secukinumab‐treated Patients With Ankylosing Spondylitis: Pooled Data Analysis From Three Phase 3 Studies

Incidence of Uveitis in Secukinumab‐treated Patients With Ankylosing Spondylitis: Pooled Data Analysis From Three Phase 3 Studies

Objective The objective of this study was to report the incidence of uveitis in secukinumab‐treated patients with ankylosing spondylitis (AS) in a pooled analysis of three phase 3 trials (MEASURE 1‐3 [ClinicalTrials.gov identifiers NCT01358175, NCT01649375, NCT02008916]). Methods Analysis included p...

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Published in:ACR open rheumatology Vol. 2; no. 5; pp. 294 - 299
Main Authors: Deodhar, Atul A., Miceli‐Richard, Corine, Baraliakos, Xenofon, Marzo‐Ortega, Helena, Gladman, Dafna D., Blanco, Ricardo, Das Gupta, Ayan, Martin, Ruvie, Safi, Jorge, Porter, Brian, Shete, Abhijit, Rosenbaum, James T.
Format: Journal Article
Language:English
Published: United States John Wiley & Sons, Inc 01-05-2020
John Wiley and Sons Inc
Wiley
Subjects:
Antigens
Arthritis
Brief Report
Clinical trials
Inflammatory diseases
Patients
Psoriasis
Surveillance
Tumor necrosis factor-TNF
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Summary:Objective The objective of this study was to report the incidence of uveitis in secukinumab‐treated patients with ankylosing spondylitis (AS) in a pooled analysis of three phase 3 trials (MEASURE 1‐3 [ClinicalTrials.gov identifiers NCT01358175, NCT01649375, NCT02008916]). Methods Analysis included pooled patient‐level data from all patients (N = 794) who received any dose (one or more) of secukinumab up to the last patient attending the week 156 study visit in MEASURE 1 and up to the week 156 visit in MEASURE 2 and the week 104 visit in MEASURE 3 for each patient. Postmarketing data were from the periodic safety update report. Incidence of uveitis is reported as the exposure‐adjusted incidence rate (EAIR) per 100 patient‐years of secukinumab exposure. Results Overall, 135 (17%) patients reported preexisting (but not active or ongoing) uveitis at baseline, and 589 (74.2%) patients were HLA antigen B27 positive. The EAIR for uveitis was 1.4 per 100 patient‐years over the entire treatment period. Among all cases of uveitis (n = 26), 14 (54%) were flares. The exposure‐adjusted reporting rate of uveitis in the postmarketing data (which included patients across the three approved indications of psoriasis, psoriatic arthritis, and AS) was 0.03 per 100 patient‐years based on cumulative secukinumab exposure of 96 054 patient‐years. Conclusion The incidence rate of uveitis in secukinumab‐treated patients with active AS does not suggest an increased risk with secukinumab treatment.
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Atul A. Deodhar, MD: Oregon Health & Science University, Portland; 2Corine Miceli‐Richard, MD: Paris Descartes University, Hôpital Cochin, Assistance Publique–Hôpitaux de Paris, and European League Against Rheumatism Center of Excellence, Paris, France; 3Xenofon Baraliakos, MD: Ruhr‐University Bochum, Bochum, Germany; 4Helena Marzo‐Ortega, MD: Leeds Teaching Hospitals NHS Trust and University of Leeds, Leeds, UK; 5Dafna D. Gladman, MD: Toronto Western Hospital, Toronto, Canada; 6Ricardo Blanco, MD: Hospital Universitario Marqués de Valdecilla, Santander, Spain; 7Ayan Das Gupta, PhD: Novartis Healthcare Private Limited, Hyderabad, India; 8Ruvie Martin, PhD, Jorge Safi Jr, MD, Brian Porter, MD, PhD: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; 9Abhijit Shete, MD: Novartis Pharma AG, Basel, Switzerland; 10James T. Rosenbaum, MD: Oregon Health & Science University and Legacy Devers Eye Institute, Portland.
The clinical studies providing data and these analyses were funded by Novartis Pharma AG, Basel, Switzerland.
Dr. Deodhar has received consulting fees and/or honoraria more than 10,000 from Eli Lilly, Novartis, Pfizer and UCB, and less than 10,000 from AbbVie, Amgen, Boehringer Ingelheim, Bristol‐Myers Squibb, GlaxoSmithKlein and Janssen. Dr. Miceli‐Richard has served as a paid consultant for AbbVie, Bristol‐Myers Squibb, Novartis, Merck, Pfizer, Wyeth, and Gilead and has served on speakers bureaus for AbbVie, Bristol‐Myers Squibb, Merck, Pfizer, Novartis, Roche, and Eli Lilly. Dr. Baraliakos has served as a paid consultant and on speakers bureaus for AbbVie, Bristol‐Myers Squibb, Celgene, Chugai, Merck, Novartis, Pfizer, UCB, and Werfen. Dr. Marzo‐Ortega has served as a paid consultant for AbbVie, Celgene, Janssen, Novartis, and UCB and has served on speakers bureaus for AbbVie, Celgene, Janssen, and UCB. Dr. Gladman has served as a paid consultant for Amgen, AbbVie, Bristol‐Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, and UCB. Drs. Martin, Safi Jr, Porter, and Shete own stock or stock options in Novartis. Dr. Rosenbaum has served as a paid consultant for AbbVie, UCB, Gilead, Roche, Janssen, Santen, Novartis, Horizon, and Corvus and receives royalties from UpToDate. No other disclosures relevant to this article were reported.
ISSN:2578-5745
2578-5745
DOI:10.1002/acr2.11139