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Abstract
Introduction
The aim of this work is to evaluate baricitinib safety with respect to venous thromboembolism (VTE), major adverse cardiovascular events (MACE), and serious infection relative to tumor necrosis factor inhibitors (TNFi) in patients with rheumatoid arthritis (RA).
Methods
Patients with RA from 14 real-world data sources (three disease registries, eight commercial and three government health insurance claims databases) in the United States (n = 9), Europe (n = 3), and Japan (n = 2) were analyzed using a new user active comparator design. Propensity score matching (1:1) controlled for potential confounding. Meta-analysis of incidence rate ratios (IRR) and incidence rate differences (IRD) for each outcome, from each data source was executed using modified Poisson regression and Cochran–Mantel–Haenszel analysis.
Results
Of 9013 eligible baricitinib-treated patients, 7606 were propensity score-matched with TNFi-treated patients, contributing 5879 and 6512 person-years of baricitinib and TNFi exposure, respectively. Across data sources, 97 patients (56 baricitinib) experienced VTE during follow-up, 93 experienced MACE (54 baricitinib), and 321 experienced serious infection (176 baricitinib). Overall IRRs comparing baricitinib with TNFi treatment were 1.51 (95% CI 1.10, 2.08) for VTE, 1.54 (95% CI 0.93, 2.54) for MACE, and 1.36 (95% CI 0.86, 2.13) for serious infection. IRDs for VTE, MACE, and serious infection, respectively, were 0.26 (95% CI −0.04, 0.57), 0.22 (95% CI −0.07, 0.52), and 0.57 (95% CI −0.07, 1.21) per 100 person-years greater for baricitinib than TNFi.
Conclusions
Overall results suggest increased risk of VTE with baricitinib versus TNFi, with consistent point estimates from the two largest data sources. A numerically greater risk was observed for MACE and serious infection when comparing baricitinib versus TNFi, with different point estimates from the two largest data sources. Findings from this study and their impact on clinical practice should be considered in context of limitations and other evidence regarding the safety and efficacy of baricitinib and other Janus kinase inhibitors.
Trial registration:
EU PAS Register (http://encepp.eu), identifier #32271.
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Details
1 Eli Lilly and Company Corporate Center, Indianapolis, USA (GRID:grid.417540.3) (ISNI:0000 0000 2220 2544)
2 Aetion, New York, USA (GRID:grid.455208.e)
3 Karolinska Institutet, Clinical Epidemiology Division, Department of Medicine Solna, Stockholm, Sweden (GRID:grid.4714.6) (ISNI:0000 0004 1937 0626)
4 IQVIA, IQVIA, Epidemiology and Drug Safety, Durham, USA (GRID:grid.418848.9) (ISNI:0000 0004 0458 4007)
5 CorEvitas, Waltham, USA (GRID:grid.418848.9)
6 Sanno Medical Center, Rheumatology, Tokyo, Japan (GRID:grid.511745.3) (ISNI:0000 0004 4655 7437)
7 Kyorin University School of Medicine, Department of Nephrology and Rheumatology, Tokyo, Japan (GRID:grid.411205.3) (ISNI:0000 0000 9340 2869)
8 University of Occupational and Environmental Health, Japan, The First Department of Internal Medicine, Kitakyushu, Japan (GRID:grid.271052.3) (ISNI:0000 0004 0374 5913)
9 HealthCore Inc., Wilmington, USA (GRID:grid.467616.4) (ISNI:0000 0001 0698 1725)
10 Bordeaux PharmacoEpi, INSERM CIC-P 1401, Univ. Bordeaux, Bordeaux, France (GRID:grid.412041.2) (ISNI:0000 0001 2106 639X)