Longer-term safety and efficacy of baricitinib for atopic dermatitis in pediatric patients 2 to <18 years old: a randomized clinical trial of extended treatment to 3.6 years
Andreas Wollenberg, Masanori Ikeda, Chia‐Yu Chu, Lawrence F. Eichenfield, Marieke M.B. Seyger, Apurva Prakash, Robinette Angle, Danting Zhu, Marco Pontes, Amy S. Paller
Abstract
BACKGROUND: Baricitinib, an oral selective Janus kinase inhibitor, improved clinical signs and symptoms of moderate-to-severe atopic dermatitis (AD) at week 16 in the phase 3 pediatric study BREEZE-AD-PEDS. OBJECTIVE: To assess longer-term efficacy and safety of baricitinib in pediatric patients aged 2 to <18 years. METHODS: ] 0/1/2) at Week 16 remained on double-blind treatment to which they were randomized (placebo, baricitinib [1-mg equivalent, 2-mg equivalent, or 4-mg equivalent); non-responders (vIGA-AD 3 or 4) at Week 16 transitioned to open-label baricitinib 4-mg equivalent. Safety was summarized for all randomized patients who received ≥1 dose of study treatment. RESULTS: In total 467 patients received baricitinib for 750.7 patient-years. Proportion of responders/partial responders (at Week 16) who achieved vIGA-AD 0/1 at Week 52 was greater for baricitinib 4-mg equivalent (56.8%) versus all other treatment groups (42.2%, 47.7%, and 39.7% for 2-mg equivalent, 1-mg equivalent, and placebo, respectively). Most treatment-emergent adverse events were mild/moderate in severity. No deaths, pulmonary emboli, deep vein thromboses or arterial thrombotic events, major adverse cardiovascular events, malignancies, tuberculosis events, or gastrointestinal perforations were reported. CONCLUSIONS: Baricitinib demonstrated sustained long-term efficacy. No new safety signals were identified. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03952559.