This study examined treatment-emergent (TE) herpetic infections in adult atopic dermatitis (AD) patients receiving ≥1 dose of baricitinib (Bari), an oral selective inhibitor of Janus kinase 1/2. Data were reported from 6 double-blinded, randomised, placebo-controlled (PC) trials and 2 long-term extension studies, within 3 analysis sets: PC, 2-mg–4-mg Bari extended, and All-Bari-AD. Frequency, incidence rate (IR)/ 100 person-years (PYs) and clinical characteristics of TE adverse events (AEs) of herpes simplex (HS) and herpes zoster (HZ) were reported. In the All-Bari-AD dataset (n=2531; 2247 PYs), HS was reported in 8.9% of patients (n=224; IR=10.3). Most HS infections were mild/moderate (93.3%) in severity, rarely lead to permanent discontinuation (2.2%) and presented mostly as oral/perioral HS (51.3%). The overall frequency of TE-eczema herpeticum (EH) was low (All-Bari-AD 1.7% n=43; IR=2.0) and mostly occurred as single events (88.4%). EH was reported in 0.5%, 0.2% and 1.4% of patients receiving placebo, 2-mg, or 4-mg Bari, respectively. Most events were investigator rated as mild/moderate (79.1%) with ≤2% body surface area involvement (n=23/31 with known BSA, 74.2%). Eleven serious AEs (All-Bari-AD IR=0.5) of EH occurred exclusively in patients with a vIGA-AD™ score 3 or 4 preceding the infection onset. TE-HZ was reported in 2.1% of Bari patients (n=53; IR=2.3), without a dose relationship during the PC period (1.0%; IR=2.7 and 0.0%; IR=0.0) or the extended dataset (2.8%; IR=3.8 and 1.6%; IR=1.8) for 2- or 4-mg Bari, respectively. TEAEs of HS were common, while occurrence of EH was uncommon. Most events of EH were rated mild or moderate, serious events of EH were linked to poor disease control. Events of HZ were uncommon and not dose dependent.

ESDR084 - Herpes virus infections amongst moderate to severe atopic dermatitis patients treated with baricitinib: an integrated analysis of phase 3 trials

50th Annual Meeting of the European Society for Dermatological Research. VIRTUAL MEETING