Safety of Baricitinib for the Treatment of Atopic Dermatitis in Adults Over a Median of 1.6 and up to 4.6 Years Treatment: Final Integrated Analysis of Eight Clinical Trials

ABSTRACT Background Baricitinib is a selective Janus kinase (JAK)1/JAK2 inhibitor approved in more than 70 countries for the treatment of moderate‐to‐severe atopic dermatitis (AD) in adults, and in over 30 countries for adolescents and children from age 2 years with moderate‐to‐severe AD, who are candidates for systemic therapy. Objectives We report the final integrated safety profile of the AD clinical programme in adult patients up to 4.6 years of treatment. Methods The analysis includes three data sets from the integrated AD baricitinib clinical trial programme, described previously. All‐bari AD included patients that received at least one dose of baricitinib (1‐, 2‐, or 4‐mg). We report the proportion of patients with events and incidence rates (IRs)/100 patient‐years (PY) at risk. Results In total, 2637 patients received baricitinib for 5216.2 PY, with a median exposure duration of 594 days (1.6 years) and a maximum exposure of 1688 days (4.6 years). In All‐bari AD, the rate of discontinuation due to adverse events (AEs) was low (IR = 3.3). The IR for serious adverse events (SAEs) in All‐bari AD was 5.0. The most frequently reported SAEs were in the infections System Organ Class (IR = 1.7), and the IR for any infection was 64.0, whereas IRs for herpes simplex, herpes zoster and opportunistic infection were 6.2, 2.7 and 0.3, respectively. AEs of special interest in All‐bari AD included 10 positively adjudicated major adverse cardiovascular events (MACEs) (IR = 0.19), 3 of which were categorised as myocardial infarctions (IR = 0.06) and 6 stroke (IR = 0.11); 4 pulmonary embolisms (PEs; 1 patient experienced both a deep vein thrombosis [DVT] and PE) (IR = 0.07); 21 malignancies excluding nonmelanoma skin cancer (IR = 0.39), and 6 deaths (IR = 0.1). Conclusions In this final analysis, baricitinib continues to demonstrate a consistent and well‐established safety profile, with no new safety signals. Rates of serious infections, DVT/PE, MACE and malignancies were within ranges of background rates in patients with AD. Trial Registration NCT02576938 (JAHG), NCT03334396 (JAHL; BREEZE‐AD1), NCT03334422 (JAHM; BREEZE‐AD2), NCT03334435 (JAHN; BREEZE‐AD3), NCT03428100 (JAIN; BREEZE‐AD4), NCT03435081 (JAIW; BREEZE‐AD5), NCT03559270 (JAIX; BREEZE‐AD6) and NCT03733301 (JAIY; BREEZE‐AD7).