Pooled Analysis of Baricitinib Tolerability in Patients With Atopic Dermatitis in Relation to Acne, Headache, and Gastrointestinal Events From 8 Clinical Trials.

Background: Tolerability issues including acne, nausea, and headache have been reported with Janus kinase (JAK) inhibitors for moderate-to-severe atopic dermatitis (AD). Objectives: To report outcomes of tolerability adverse events (AEs) for baricitinib, a JAK1/JAK2 inhibitor, in patients with moderate-to-severe AD. Methods: Acne, headache, and gastrointestinal AEs are reported from placebo-controlled and long-term extensions of pooled data in the baricitinib AD clinical trial program. Proportions of patients with AEs, incidence rates (IRs)/100 patient-years at risk, and median time to onset/duration of AEs were calculated. Results: In 2531 patients treated with baricitinib, most AEs were mild to moderate in severity. Headache was the most common AE of tolerability (median of 14-26 days after first dose of baricitinib, lasting ≤3 days). IRs of acne were <5 in any group lasting up to a median of 90 days with no severe AEs. Diarrhea was the most common gastrointestinal AE, lasting a median of ≤7 days. There were few study drug interruptions (n = 6) and permanent discontinuations (n = 5) for tolerability AEs. Conclusions: For the AEs of tolerability analyzed, baricitinib appears to be well tolerated. Overall, the frequency of these AEs in patients being treated for moderate-to-severe AD was low with few leading to study drug interruption or permanent discontinuation. Clinical Trial Registration number: NCT02576938; NCT03334396; NCT03334422; NCT03428100; NCT03435081; NCT03733301; NCT03334435; NCT03559270.