When Randomized Clinical Trials and Real-World Evidence Say the Same: Tocilizumab and Its Cardiovascular Safety
- PMID: 31469243
- DOI: 10.1002/art.41092
When Randomized Clinical Trials and Real-World Evidence Say the Same: Tocilizumab and Its Cardiovascular Safety
Comment on
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Cardiovascular Safety of Tocilizumab Versus Etanercept in Rheumatoid Arthritis: A Randomized Controlled Trial.Arthritis Rheumatol. 2020 Jan;72(1):31-40. doi: 10.1002/art.41095. Arthritis Rheumatol. 2020. PMID: 31469238 Clinical Trial.
References
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- Giles JT, Sattar N, Gabriel S, Ridker PM, Gay S, Warne C, et al. Cardiovascular safety of tocilizumab versus etanercept in rheumatoid arthritis: a randomized controlled trial. Arthritis Rheumatol 2019;72:31-40.
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- US Food and Drug Administration. Framework for FDA's real-world evidence program. December 2018. URL: https://www.fda.gov/media/120060/download.
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- Kim SC, Solomon DH, Rogers JR, Gale S, Klearman M, Sarsour K, et al. Cardiovascular safety of tocilizumab versus tumor necrosis factor inhibitors in patients with rheumatoid arthritis: a multi-database cohort study. Arthritis Rheumatol 2017;69:1154-64.
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- Xie F, Yun H, Levitan EB, Muntner P, Curtis JR. Tocilizumab and the risk of cardiovascular disease: direct comparison among biologic disease-modifying antirheumatic drugs for rheumatoid arthritis patients. Arthritis Care Res (Hoboken) 2019;71:1004-18.
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- US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for industry: diabetes mellitus-evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. December 2008. URL: https://www.fda.gov/media/71297/download.
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