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Deodhar AA, Miceli-Richard C, Baraliakos X, et al. Incidence of Uveitis in Secukinumab-treated Patients With Ankylosing Spondylitis: Pooled Data Analysis From Three Phase 3 Studies. ACR Open Rheumatol. 2020;2(5):294-299doi: 10.1002/acr2.11139.
Deodhar, A. A., Miceli-Richard, C., Baraliakos, X., Marzo-Ortega, H., Gladman, D. D., Blanco, R., Das Gupta, A., Martin, R., Safi, J., Porter, B., Shete, A., & Rosenbaum, J. T. (2020). Incidence of Uveitis in Secukinumab-treated Patients With Ankylosing Spondylitis: Pooled Data Analysis From Three Phase 3 Studies. ACR open rheumatology, 2(5), 294-299. https://doi.org/10.1002/acr2.11139
Deodhar, Atul A, et al. "Incidence of Uveitis in Secukinumab-treated Patients With Ankylosing Spondylitis: Pooled Data Analysis From Three Phase 3 Studies." ACR open rheumatology vol. 2,5 (2020): 294-299. doi: https://doi.org/10.1002/acr2.11139
Deodhar AA, Miceli-Richard C, Baraliakos X, Marzo-Ortega H, Gladman DD, Blanco R, Das Gupta A, Martin R, Safi J, Porter B, Shete A, Rosenbaum JT. Incidence of Uveitis in Secukinumab-treated Patients With Ankylosing Spondylitis: Pooled Data Analysis From Three Phase 3 Studies. ACR Open Rheumatol. 2020 May;2(5):294-299. doi: 10.1002/acr2.11139. Epub 2020 Apr 30. PMID: 32352653; PMCID: PMC7231512.
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ACR Open Rheumatol. 2020 May;2(5):294-299. doi: 10.1002/acr2.11139. Epub 2020 Apr 30.

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

ACR open rheumatology

Atul A Deodhar, Corine Miceli-Richard, Xenofon Baraliakos, Helena Marzo-Ortega, Dafna D Gladman, Ricardo Blanco, Ayan Das Gupta, Ruvie Martin, Jorge Safi, Brian Porter, Abhijit Shete, James T Rosenbaum

Affiliations

  1. Oregon Health & Science University, Portland.
  2. Paris Descartes University, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, and European League Against Rheumatism Center of Excellence, Paris, France.
  3. Ruhr-University Bochum, Bochum, Germany.
  4. Leeds Teaching Hospitals NHS Trust and University of Leeds, Leeds, UK.
  5. Toronto Western Hospital, Toronto, Canada.
  6. Hospital Universitario Marqués de Valdecilla, Santander, Spain.
  7. Novartis Healthcare Private Limited, Hyderabad, India.
  8. Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
  9. Novartis Pharma AG, Basel, Switzerland.
  10. Oregon Health & Science University and Legacy Devers Eye Institute, Portland.

PMID: 32352653 PMCID: PMC7231512 DOI: 10.1002/acr2.11139

Abstract

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.

© 2020 The Authors. ACR Open Rheumatology published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology.

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