Efficacy and safety of baricitinib versus azathioprine, both combined with topical corticosteroids, in patients with moderate-to-severe atopic dermatitis: a single-centre randomized open-label trial

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BACKGROUND: Atopic dermatitis (AD) is a chronic relapsing inflammatory skin disease that can be difficult to manage in moderate-to-severe cases. Baricitinib (a Janus kinase 1/2 inhibitor) and azathioprine (a traditional immunosuppressant) are both used in the systemic treatment of AD. OBJECTIVES: To compare the efficacy and safety of baricitinib vs. azathioprine, both combined with topical corticosteroids (TCS), in adults with moderate-to-severe AD. METHODS: In this single-centre open-label randomized head-to-head trial (NCT05969730), 40 adults with moderate-to-severe AD were randomly assigned 1 : 1 to receive baricitinib (4 mg daily) or azathioprine (1.52.5 mg kg-1 daily), both with TCS and urea 10% cream, for 12 weeks. The primary endpoint was the proportion of patients achieving ≥ 75% reduction in Eczema Area and Severity Index (EASI 75) at week 12. RESULTS: At week 12, 65% (n = 13/20) of patients in the baricitinib + TCS group achieved EASI 75 vs. 15% (n = 3/20) in the azathioprine + TCS group [difference 50%, 95% confidence interval (CI) 23.9-76.1; P = 0.002]. The baseline-adjusted post-treatment mean (SD) EASI scores were 5.60 (7.51) for baricitinib and 12.61 (7.51) for azathioprine (difference -7.01, 95% CI -11.86 to -2.17; P = 0.006), with a large effect size (Cohen's d = -0.93). A ≥ 75% decrease in SCORing Atopic Dermatitis score (SCORAD 75) was achieved by 55% (n = 11/20) in the baricitinib + TCS group vs. 15% (n = 3/20) in the azathioprine group (difference 40%, 95% CI 13.2-66.8; P = 0.01). Improvements in validated Investigator's Global Assessment for AD, Itch Numeric Rating Scale (NRS), Skin Pain NRS, Patient-Oriented Eczema Measure, Dermatology Life Quality Index and Hospital Anxiety and Depression Scale scores were found in both groups, with a trend favouring baricitinib, although the differences between groups were not statistically significant. Both treatments were well tolerated, with no serious adverse events or discontinuations recorded. CONCLUSIONS: Baricitinib + TCS demonstrated superior efficacy to azathioprine + TCS in adults with moderate-to-severe AD, both with a well-tolerated safety profile at 12 weeks.