Key clinical point: The safety profile of baricitinib in patients with moderate-to-severe atopic dermatitis (AD) was similar to that reported in earlier analyses; major adverse cardiovascular event (MACE), pulmonary embolism (PE), and malignancy were within the background range.
Major finding: The adjusted incidence rate/100 patient-years at risk for any infection was 67.2 and that for herpes simplex, herpes zoster, opportunistic infections, serious adverse events, MACE, PE, and 14 malignancies excluding nonmelanoma skin cancer was 6.7, 2.8, 0.3, 5.2, 0.15, 0.06, and 0.3, respectively.
Study details: This updated integrated analysis of eight clinical trials included 2636 patients with moderate-to-severe AD treated with ≥1 baricitinib dose (1/2/4 mg) through 3.9 years (4628.4 patient-years of exposure).
Disclosures: Baricitinib is developed by Eli Lilly and Company, under license from Incyte Corporation. Some authors reported ties with various organizations, including Eli Lilly. Five authors declared being employees and stockholders of Eli Lilly.
Source: Bieber T et al. Safety of baricitinib for the treatment of atopic dermatitis over a median of 1.6 years and up to 3.9 years of treatment: An updated integrated analysis of eight clinical trials. J Dermatolog Treat. 2022 (Dec 22). Doi: 10.1080/09546634.2022.2161812