SHR0302 (ivarmacitinib 8 mg)
Trial question
What is the effect of ivarmacitinib in patients with moderate-to-severe atopic dermatitis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
36.0% female
64.0% male
N = 223
223 patients (81 female, 142 male).
Inclusion criteria: patients, aged 12-75 years, with moderate-to-severe atopic dermatitis.
Key exclusion criteria: thrombocytopenia, coagulopathy, or any use of systemic JAK inhibitors, corticosteroids, immunosuppressants, phosphodiesterase inhibitors, or phototherapy in the past 4 weeks; topical treatment for atopic dermatitis within 1 week; dupilumab within 6 weeks before the first dose of study treatment.
Interventions
N=112 ivarmacitinib (at a dose of 8 mg daily for 16 weeks).
N=111 placebo (matching placebo daily for 16 weeks).
Primary outcome
Percentage of patients achieving Investigator Global Assessment score of 0 or 1 by week 16
42%
9%
42.0 %
31.5 %
21.0 %
10.5 %
0.0 %
Ivarmacitinib
Placebo
Significant
increase ▲
NNT = 3
Significant increase in the percentage of patients achieving Investigator Global Assessment score of 0 or 1 by week 16 (42% vs. 9%; AD 32.1%, 95% CI 22.1 to 42.2).
Secondary outcomes
Significant increase in Eczema Area and Severity Index score improvement of 75% at week 16 (66.1% vs. 21.6%; AD 43.2%, 95% CI 32.6 to 53.8).
Significant increase in Worst Itch-NRS (40.2% vs. 12.6%; AD 26.6%, 95% CI 15.9 to 37.3).
Significant increase in Eczema Area and Severity Index score improvement of 50% at week 16 (77.7% vs. 48.6%; AD 28.8%, 95% CI 17.7 to 39.9).
Safety outcomes
No significant difference in treatment-emergent adverse and serious adverse events.
Conclusion
In patients, aged 12-75 years, with moderate-to-severe atopic dermatitis, ivarmacitinib was superior to placebo with respect to the percentage of patients achieving Investigator Global Assessment score of 0 or 1 by week 16.
Reference
Yan Zhao, Melinda Gooderham, Bin Yang et al. Ivarmacitinib for Moderate to Severe Atopic Dermatitis in Adults and Adolescents: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2025 Apr 30:e250982. Online ahead of print.
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