Frontiers in pharmacology · 2026
Efficacy and safety of the JAK1 inhibitor abrocitinib for moderate-to-severe atopic dermatitis: a systematic review and meta-analysis.
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Ning Bobiao, Li Baohua, Luo Quan, Song Ping
Аннотация
BACKGROUND: Atopic dermatitis (AD) is a chronic inflammatory disease with substantial pruritic burden. Abrocitinib, an oral selective Janus kinase 1 (JAK1) inhibitor, targets cytokine pathways central to AD pathophysiology. This systematic review and meta-analysis evaluated its efficacy and safety in moderate-to-severe AD.
METHODS: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidance, PubMed, Embase, Web of Science, and the Cochrane Library were searched to 21 August 2025 for randomized controlled trials (RCTs) comparing abrocitinib with placebo. Two reviewers independently screened studies, extracted data, and assessed risk of bias (Cochrane RoB 2.0). Pooled risk ratios (RRs) with 95% confidence intervals (CIs) were calculated; model choice was based on heterogeneity.
RESULTS: Five double-blind placebo-controlled RCTs involving 1,927 patients were included. Abrocitinib significantly improved Investigator's Global Assessment response (RR = 2.97, 95% CI: 2.45-3.60), Eczema Area and Severity Index-75 response (RR = 2.56, 95% CI: 2.25-2.92), and ≥4-point Peak Pruritus Numerical Rating Scale improvement (RR = 2.64, 95% CI: 2.29-3.06), with greater efficacy observed for 200 mg than 100 mg. Treatment-emergent adverse events were increased (RR = 1.18, 95% CI: 1.10-1.27), mainly nausea (RR = 5.53, 95% CI: 3.41-9.34). Headache was also increased overall (RR = 1.64, 95% CI: 1.16-2.47), whereas skin allergy was reduced (RR = 0.58, 95% CI: 0.44-0.82).
CONCLUSION: Abrocitinib provides clinically meaningful short-term improvements in disease severity and pruritus in moderate-to-severe AD. The 200 mg dose offers greater efficacy but requires careful monitoring for tolerability, particularly nausea and headache.
METHODS: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidance, PubMed, Embase, Web of Science, and the Cochrane Library were searched to 21 August 2025 for randomized controlled trials (RCTs) comparing abrocitinib with placebo. Two reviewers independently screened studies, extracted data, and assessed risk of bias (Cochrane RoB 2.0). Pooled risk ratios (RRs) with 95% confidence intervals (CIs) were calculated; model choice was based on heterogeneity.
RESULTS: Five double-blind placebo-controlled RCTs involving 1,927 patients were included. Abrocitinib significantly improved Investigator's Global Assessment response (RR = 2.97, 95% CI: 2.45-3.60), Eczema Area and Severity Index-75 response (RR = 2.56, 95% CI: 2.25-2.92), and ≥4-point Peak Pruritus Numerical Rating Scale improvement (RR = 2.64, 95% CI: 2.29-3.06), with greater efficacy observed for 200 mg than 100 mg. Treatment-emergent adverse events were increased (RR = 1.18, 95% CI: 1.10-1.27), mainly nausea (RR = 5.53, 95% CI: 3.41-9.34). Headache was also increased overall (RR = 1.64, 95% CI: 1.16-2.47), whereas skin allergy was reduced (RR = 0.58, 95% CI: 0.44-0.82).
CONCLUSION: Abrocitinib provides clinically meaningful short-term improvements in disease severity and pruritus in moderate-to-severe AD. The 200 mg dose offers greater efficacy but requires careful monitoring for tolerability, particularly nausea and headache.