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

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.

journal_name

Clin Drug Investig

journal_title

Clinical drug investigation

authors

Ziyadeh NJ,Geldhof A,Noël W,Otero-Lobato M,Esslinger S,Chakravarty SD,Wang Y,Seeger JD

doi

10.1007/s40261-020-00959-7

subject

Has Abstract

pub_date

2020-11-01 00:00:00

pages

1021-1040

issue

eissn

1173-2563

issn

1179-1918

pii

10.1007/s40261-020-00959-7

journal_volume

pub_type

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