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

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

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.

Figures

Figure 1
Figure 1
Uveitis in pooled secukinumab ankylosing spondylitis (AS) clinical trials. Rates reported are n (%) for the entire treatment period (N = 794) for preferred terms by using the Medical Dictionary for Regulatory Activities. aIncludes two cases of treatment discontinuation and one case of treatment interruption.

References

    1. Rosenbaum JT, Dick AD. The eyes have it: a rheumatologist's view of uveitis. Arthritis Rheumatol 2018;70:1533–43.
    1. Cantini F, Nannini C, Cassara E, Kaloudi O, Niccoli L. Uveitis in spondyloarthritis: an overview. J Rheumatol Suppl 2015;93:27–9.
    1. Rosenbaum JT. Uveitis in spondyloarthritis including psoriatic arthritis, ankylosing spondylitis, and inflammatory bowel disease. Clin Rheumatol 2015;34:999–1002.
    1. Gran JT, Skomsvoll JF. The outcome of ankylosing spondylitis: a study of 100 patients. Br J Rheumatol 1997;36:766–71.
    1. Stolwijk C, van Tubergen A, Castillo‐Ortiz JD, Boonen A. Prevalence of extra‐articular manifestations in patients with ankylosing spondylitis: a systematic review and meta‐analysis. Ann Rheum Dis 2015;74:65–73.
    1. Letko E, Yeh S, Foster CS, Pleyer U, Brigell M, Grosskreutz CL. Efficacy and safety of intravenous secukinumab in noninfectious uveitis requiring steroid‐sparing immunosuppressive therapy. Ophthalmology 2015;122:939–48.
    1. Baeten D, Sieper J, Braun J, Baraliakos X, Dougados M, Emery P, et al. Secukinumab, an interleukin‐17A inhibitor, in ankylosing spondylitis. N Engl J Med 2015;373:2534–48.
    1. Sharma SM, Jackson D. Uveitis and spondyloarthropathies. Best Pract Res Clin Rheumatol 2017;31:846–62.
    1. Juanola X, Loza Santamaría E, Cordero‐Coma M, SENTINEL Working Group . Description and prevalence of spondyloarthritis in patients with anterior uveitis: the SENTINEL Interdisciplinary Collaborative Project. Ophthalmology 2016;123:1632–6.
    1. Heldmann F, Brandt J, van der Horst‐Bruinsma IE, Landewe R, Sieper J, Burmester GR, et al. The European Ankylosing Spondylitis Infliximab Cohort (EASIC): a European multicentre study of long term outcomes in patients with ankylosing spondylitis treated with infliximab. Clin Exp Rheumatol 2011;29:672–80.
    1. Sieper J, van der Heijde D, Varothai NA, Anderson JK. Comparison of baseline extra‐articular manifestations, comorbidities, and long‐term safety in patients treated with adalimumab for ankylosing spondylitis and non‐radiographic axial spondyloarthritis [abstract]. Arthritis Rheum 2014;66 Suppl 10:S242–3.
    1. Van Bentum RE, Heslinga SC, Nurmohamed MT, Gerards AH, Griep EN, Koehorst CB, et al. Reduced occurrence rate of acute anterior uveitis in ankylosing spondylitis treated with golimumab: the GO‐EASY study. J Rheumatol 2019;46:153–9.
    1. Van Der Heijde D, Dougados M, Landewe R, Sieper J, Maksymowych WP, Rudwaleit M, et al. Sustained efficacy, safety and patient‐reported outcomes of certolizumab pegol in axial spondyloarthritis: 4‐year outcomes from RAPID‐axSpA. Rheumatology (Oxford) 2017;56:1498–509.
    1. Wendling D, Joshi A, Reilly P, Jalundhwala YJ, Mittal M, Bao Y. Comparing the risk of developing uveitis in patients initiating anti‐tumor necrosis factor therapy for ankylosing spondylitis: an analysis of a large US claims database. Curr Med Res Opin 2014;30:2515–21.
    1. Deodhar A, Mease PJ, McInnes IB, Baraliakos X, Reich K, Blauvelt A, et al. Long‐term safety of secukinumab in patients with moderate‐to‐severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis: integrated pooled clinical trial and post‐marketing surveillance data. Arthritis Res Ther 2019;21:111.

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel