Baricitinib at a daily dose of 4 mg was associated with clinical improvement at 12 weeks, according to a study of 527 patients with rheumatoid arthritis and an inadequate response or unacceptable side effects associated with 1 or more biologic disease-modifying antirheumatic drugs (DMARDs). Researchers found:

• ACRO20 response at week 12 was 55% with 4-mg baricitinib vs 27% with placebo.

• Differences between the groups receiving 4-mg baricitinib and placebo were significant for the HAQ-DI score and the DAS28-CRP, but not for an SDAI score ≤3.3.

• Adverse event rates through 24 weeks were 71% with 2-mg baricitinib, 77% with 4-mg baricitinib, and 64% with placebo; infection rates were 44%, 40%, and 31%, and serious adverse event rates were 4%, 10%, and 7%, respectively.

• 2 nonmelanoma skin cancers and 2 major adverse cardiovascular events, including a fatal stroke, occurred in the higher dose group.

• Baricitinib was associated with a small reduction in neutrophil levels and increases in serum creatinine and low-density lipoprotein cholesterol levels.

Citation: Genovese MC, Kremer J, Zamani O, et al. Baricitinib in patients with refractory rheumatoid arthritis. N Engl J Med. 2016;374:1243-1252. doi:10.1056/NEJMoa1507247.