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Clinical Drug Investigation
Published in: Clinical Drug Investigation 11/2020

Open Access 01-11-2020 | Mood Disorders | Original Research Article

Post-approval Safety Surveillance Study of Golimumab in the Treatment of Rheumatic Disease Using a United States Healthcare Claims Database

Authors: Najat J. Ziyadeh, Anja Geldhof, Wim Noël, Marijo Otero-Lobato, Suzan Esslinger, Soumya D. Chakravarty, Yiting Wang, John D. Seeger

Published in: Clinical Drug Investigation | Issue 11/2020

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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 non-biologic 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.
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Metadata
Title
Post-approval Safety Surveillance Study of Golimumab in the Treatment of Rheumatic Disease Using a United States Healthcare Claims Database
Authors
Najat J. Ziyadeh
Anja Geldhof
Wim Noël
Marijo Otero-Lobato
Suzan Esslinger
Soumya D. Chakravarty
Yiting Wang
John D. Seeger
Publication date
01-11-2020
Publisher
Springer International Publishing
Published in
Clinical Drug Investigation / Issue 11/2020
Print ISSN: 1173-2563
Electronic ISSN: 1179-1918
DOI
https://doi.org/10.1007/s40261-020-00959-7

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