AD-REAL: A Prospective, Multinational, Observational Cohort Study of Clinical Effectiveness and Treatment Discontinuation of Oral Systemics for Moderate-to-Severe Atopic Dermatitis

INTRODUCTION: Clinical data surrounding treatment patterns and reasons for discontinuation of oral systemics (OS) for the treatment of adult patients with moderate-severe atopic dermatitis (AD) remain limited. AD-REAL descriptively reports the discontinuation rates and treatment responses at week (W) 24 for patients with AD initiating new OS treatments. METHODS: AD-REAL is a 12-month, multinational, observational cohort study of adult patients with moderate-to-severe AD commencing either conventional systemics (CS) or baricitinib. Other Janus kinase inhibitors (JAKis) were analyzed ad hoc. The primary objective reported the discontinuation rate of patients at W24 from baseline. Secondary objectives reported outcomes for Eczema Area and Severity index (EASI), Itch Numerical Rating Scale (NRS), and pain NRS. RESULTS: At baseline (N = 313), patients initiated CS (N = 113), baricitinib (N = 87), and other JAKi (N = 92), with a mean EASI of 19.8, 15.8, and 16.4, respectively. At W24, the Kaplan-Meier cumulative incidence of initial treatment discontinuation was 50.8% (95% confidence interval [95% CI] 40.9, 59.8) for CS, 29.0% (95% CI 19.8, 38.8) for baricitinib, and 18.8% (95% CI 11.5, 27.5) for other JAKi. The primary reason for discontinuation of baricitinib and other JAKi was primary lack of effectiveness, while CS discontinued owing to the addition of concomitant systemic treatment, adverse events, and patient/physician decisions. Of the baricitinib and other JAKi cohorts, 81.0% and 84.2% achieved an EASI ≤ 7 score, 38.1% and 38.2% improvement in pain, and 42.0% and 38.5% improvement in itch, while 63.1%, 16.7%, and 14.3% achieved these outcomes for CS, respectively. CONCLUSIONS: In this descriptive observational cohort study, patients treated with baricitinib and other JAKi reported numerically lower discontinuation rates and numerically improved clinical outcomes than patients treated with CS. Similar to early reports of baricitinib effectiveness in treating an itch-dominant subpopulation of patients with AD, patients receiving baricitinib in clinical practice reported improved outcomes for severe itch.