A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of Ivarmacitinib (SHR0302) in Adult Patients with Moderate to Severe Alopecia Areata.
J Am Acad Dermatol
; 2023 Apr 03.
Article
in English
| MEDLINE | ID: covidwho-2288918
ABSTRACT
BACKGROUND:
Alopecia areata (AA) is a CD8+ T cell mediated autoimmune disease characterized by non-scarring hair loss. Ivarmacitinib, a selective oral Janus kinase 1 (JAK1) inhibitor, may interrupt certain cytokine signaling implicated in the pathogenesis of AA.OBJECTIVE:
To evaluate the efficacy and safety of ivarmacitinib in adult AA patients who have ≥25% scalp hair loss.METHODS:
Eligible patients were randomized 1111 to receive ivarmacitinib 2 mg, 4 mg, or 8 mg QD or placebo for 24 weeks. The primary endpoint was percentage change from baseline in Severity of Alopecia Tool (SALT) score at week 24.RESULTS:
A total of 94 patients were randomized. At week 24, the least squares mean (LSM) difference in percentage change from baseline in SALT score for ivarmacitinib 2 mg,4 mg, 8 mg, and placebo groups were -30.51% (90% confidence interval [CI] -45.25, -15.76), -56.11% (90% CI -70.28, -41.95), -51.01% (90% CI -65.20, -36.82) and -19.87% (90% CI -33.99, -5.75), respectively. Two SAEs, follicular lymphoma, and COVID-19 pneumonia were reported.LIMITATIONS:
Small sample size limits the generalizability of the results.CONCLUSION:
Treatment with ivarmacitinib 4 mg and 8 mg doses in moderate and severe AA patients for 24 weeks was efficacious and generally tolerated.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Type of study:
Experimental Studies
/
Prognostic study
/
Randomized controlled trials
Language:
English
Year:
2023
Document Type:
Article
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