Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: Final results from long-term extension study and integrated database

Annals of Rheumatic DiseasesTaylor PC, Takeuchi T, Burmester GR, et al. | October 28, 2021


A safety profile similar to earlier analyses was displayed by baricitinib (an oral selective Janus kinase inhibitor), without new safety signals, in this analysis of long-term data of baricitinib from 3,770 patients (median 4.6 years, up to 9.3 years) with active rheumatoid arthritis (RA).

  • Using an integrated database (9 phase III/II/Ib and 1 long-term extension), 3,770 patients with active RA who received baricitinib (14,744 patient-years of exposure) were analyzed.

  • Regarding treatment-emergent adverse events, 2.6, 3.0 and 0.5 were the estimated all-bari-RA (patients who received any baricitinib dose) incidence rates per 100 patient-years at risk, for serious infections, herpes zoster and major adverse cardiovascular events (MACE), respectively.

  • Baricitinib displayed a safety profile that was consistent with previous reports.

  • Rates of deaths, malignancies, MACE and deep vein thrombosis/pulmonary embolism (safety events of special interest) were stable through exposures up to 9.3 years and were generally similar between the 2 mg and 4 mg groups.

  • JAK inhibitors-associated potential risk of MACE, venous thromboembolic events and malignancy events warrants further characterization, including registries.

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