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When Randomized Clinical Trials and Real-World Evidence Say the Same: Tocilizumab and its Cardiovascular Safety


Kim SC1,2, Schneeweiss S1. Arthritis Rheumatol. 2019 Aug 30. doi: 10.1002/art.41092. [Epub ahead of print]

Author Information

1 Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.

2 Division of Rheumatology, Immunology and Allergy, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.


In this issue of Arthritis and Rheumatology, Giles et al. report much awaited data from the ENTRACTE trial.(1) The United States Food and Drug Administration (FDA)-required this post-marketing randomized controlled trial (RCT) to study the risk of major adverse cardiovascular events (MACE) in patients with rheumatoid arthritis (RA) treated with monthly tocilizumab (TCZ) 8mg/kg intravenous infusions compared to the risk in those treated with weekly etanercept 50mg subcutaneous injections.(1)