Key clinical point: Baricitinib maintained a stable safety profile with no new safety signals even with long-term exposure of up to 9.3 years in patients with active rheumatoid arthritis (RA).
Major finding: Incidence rates (IRs) per 100 patient-years at risk for serious infections (incidence ratio [IR], 2.6; 95% CI, 2.33-2.86), herpes zoster (IR, 3.0; 95% CI, 2.70-3.28), major adverse cardiovascular events (IR, 0.5; 95% CI, 0.40-0.64), and malignancies excluding nonmelanoma skin cancer (IR, 0.9; 95% CI, 0.77-1.09) remained stable from previous report.
Study details: This was an integrated analysis of 9 randomized clinical trials and 1 long-term extension trial including 3,770 patients with RA who received any dose of baricitinib.
Disclosures: Eli Lilly and Company funded this research. W Deberdt, M Issa, JR Terres, and N Bello reported being employees and stockholders of Eli Lilly and Company. The other authors reported receiving grant/research assistance and consultancy/speakers’ fees from various companies including Eli Lilly.
Source: Taylor PC et al. Ann Rheum Dis. 2021 Oct 27. doi: 10.1136/annrheumdis-2021-221276 .