Post-approval Safety Surveillance Study of Golimumab in the Treatment of Rheumatic Disease Using a United States Healthc
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ORIGINAL RESEARCH ARTICLE
Post‑approval Safety Surveillance Study of Golimumab in the Treatment of Rheumatic Disease Using a United States Healthcare Claims Database Najat J. Ziyadeh1 · Anja Geldhof2 · Wim Noël2 · Marijo Otero‑Lobato2 · Suzan Esslinger3 · Soumya D. Chakravarty4,5 · Yiting Wang6 · John D. Seeger1
© The Author(s) 2020
Abstract Background and Objective Golimumab is a fully human anti-tumor necrosis factor monoclonal antibody approved for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). This study estimated rates of prespecified outcomes in patients with RA, PsA or AS initiating golimumab versus matched patients initiating nonbiologic systemic (NBS) medications. Methods Patients enrolled in a US health plan with rheumatic disease who initiated a study medication were accrued between April 2009 and November 2014. Golimumab initiators were matched by propensity score to NBS initiators in a 1:4 ratio. Outcomes were identified through September 2015. As-treated, as-matched, and nested case–control (NCC) analyses were conducted in the matched cohorts. Sensitivity analyses evaluated the impact of residual confounding and nondifferential misclassification of exposure and outcomes. Results Risks of outcomes were similar between golimumab and NBS initiators. In the as-treated analysis, the rate ratio (RR) for depression was elevated during current golimumab use versus golimumab non-use in the NBS cohort [RR 1.45, 95% confidence interval (CI) 1.31–1.61]. This finding was not replicated in as-matched (RR 1.08, 95% CI 0.97–1.19) or NCC (odds ratio 1.01, 95% CI 0.78–1.31) analyses, which focused on incident cases. Sensitivity analyses suggest that depression was sensitive to misclassification, and the RR changed from greater than to less than one across a plausible range of specificity. Conclusions This study suggests that there is no association between exposure to golimumab and an increased risk of prespecified outcomes. Increased depression risk in the as-treated analysis was not replicated in other analyses and may be associated with residual imbalance in baseline history or severity of depression.
Key Points Electronic supplementary material The online version of this article (https://doi.org/10.1007/s40261-020-00959-7) contains supplementary material, which is available to authorized users. * Najat J. Ziyadeh [email protected] 1
Optum Epidemiology, 1325 Boylston Street, 11th Floor, Boston, MA 02215, USA
2
Janssen Biologics B.V., Leiden, The Netherlands
3
Janssen Cilag GmbH International, Zug, Switzerland
4
Janssen Scientific Affairs, LLC, Horsham, PA, USA
5
Drexel University School of Medicine, Philadelphia, PA, USA
6
Janssen Research and Development, LLC, Newark, NJ, USA
This study suggests that there is no association between exposure to golimumab and an increased risk of prespecified outcomes. The results of this study are consistent with golimumab’s overall safety profile and generally comparable with observat
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