RA: serious AEs with 4 mg baricitinib appear after 12 weeks in meta-analysis

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Takeaway

  • The Janus kinase inhibitor baricitinib (Olumiant) was approved by the FDA for moderate to severe rheumatoid arthritis (RA) in June 2018.
  • The FDA advisory committee reviewing the new drug application was concerned about serious adverse events with the 4-mg daily dose, not the 2-mg daily dose.
  • In this meta-analysis, serious adverse events (AEs) with the 4-mg daily dose were not observed until after 12 weeks of use.

Why this matters

  • Consider sticking with 2-mg daily dose until larger and longer trials are performed.

Study design

  • Meta-analysis of 4 randomized controlled trials (RCTs; n=959) that met eligibility criteria after search of Cochrane Library, MEDLINE, EMBASE, and ClinicalTrials.gov.
  • Funding: National Natural Science Foundation of China; Guangxi Natural Science Foundation.

Key results

  • At 12 weeks, no difference was seen between 4- and 2-mg daily doses in the following AEs:
    • serious AEs (P=.46),
    • any AE after the start of therapy (P=.13),
    • discontinuation because of AE (P=.60),
    • malignancy (P=.50),
    • major adverse cardiac event (P=.51),
    • herpes zoster infection (P=.99), and
    • serious infection (P=.69).
  • At 24 weeks, serious AEs were higher in the 4- than 2-mg dose (risk ratio, 1.84; P=.04), but no difference was seen between the 2 doses in any of the other AEs listed here.

Limitations

  • Small number of trials, subjects.