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Journal article
Post-approval Safety Surveillance Study of Golimumab in the Treatment of Rheumatic Disease Using a United States Healthcare Claims Database
Clinical drug investigation, v 40(11), pp 1021-1040
01 Nov 2020
PMID: 32779120
Featured in Collection : UN Sustainable Development Goals @ Drexel
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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Details
- Title
- Post-approval Safety Surveillance Study of Golimumab in the Treatment of Rheumatic Disease Using a United States Healthcare Claims Database
- Creators
- Najat J. Ziyadeh - Optum Epidemiology, Boston, USAAnja Geldhof - JanssenWim Noel - JanssenMarijo Otero-Lobato - JanssenSuzan Esslinger - Janssen-CilagSoumya D. Chakravarty - Drexel UniversityYiting Wang - JanssenJohn D. Seeger - Optum Epidemiology, 1325 Boylston Street, 11th Floor, Boston, MA, 02215, USA.
- Publication Details
- Clinical drug investigation, v 40(11), pp 1021-1040
- Publisher
- Springer Nature
- Number of pages
- 20
- Grant note
- Optum Epidemiology Janssen Biologics B.V.
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Rheumatology
- Web of Science ID
- WOS:000558115900002
- Scopus ID
- 2-s2.0-85089289856
- Other Identifier
- 991019167458404721
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Pharmacology & Pharmacy