Despite the clear efficacy of baricitinib 4 mg, the primary issue of contention was safety and benefit-to-risk ratio. The primary safety concerns were serious infection from opportunistic pathogens, herpes zoster, various malignancies, arterial and venous thrombosis, and laboratory abnormalities including elevated platelet counts and liver test elevations.
Conference Coverage
FDA advisory committee recommends baricitinib 2 mg to treat rheumatoid arthritis
