Inflammatory Myopathies Linked to Thrombi
Abstract
including acute liver failure and autoimmune hepatitis, has been reported rarely in patients receiving REMICADE (see WARNINGS, Hepatotoxicity). Reactivation of hepatitis B virus has occurred in patients receiving TNF-blocking agents, including REMICADE who are chronic carriers of this virus (see WARNINGS, Hepatitis B Virus Reactivation). In clinical trials in RA, CD, UC, AS, PsO and PsA, elevations of aminotransferases were observed (ALT more common than AST) in a greater proportion of patients receiving REMICADE than in controls, both when REMICADE was given as monotherapy and when it was used in combination with other immunosuppressive agents. In general, patients who developed ALT and AST elevations were asymptomatic, and the abnormalities decreased or resolved with either continuation or discontinuation of REMICADE, or modification of concomitant medications. In RA clinical trials (median follow-up 58 weeks), 34% of patients who received REMICADE + MTX experienced elevations in ALT at 1 to 3 times the upper limit of normal (ULN) compared to 24% of patients treated with placebo + MTX. ALT elevations 3 times ULN were observed in 4% of patients who received REMICADE + MTX compared with 3% of patients who received MTX alone. ALT elevations 5 times ULN were observed in 1% of patients in both REMICADE + MTX and MTX alone groups. In CD clinical trials (median follow up 54 weeks), 39% of patients receiving REMICADE-maintenance experienced elevations in ALT at 1 to 3 times the…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 1,129 participants or records.
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