An experimental once-daily oral medication significantly improved symptoms in adolescents and adults with moderate to severe eczema, according to a randomized clinical trial involving 336 patients, in a phase 3 trial.
Ivarmacitinib, a selective Janus kinase 1 (JAK1) inhibitor, blocks immune signals that drive inflammation and itching in atopic dermatitis (AD). In a 16-week trial, participants received 4 mg or 8 mg of ivarmacitinib or a placebo.
By week 16, 42% of patients in the 8 mg group and 36.3% in the 4 mg group achieved clear or nearly clear skin, with at least a two-grade improvement on the Investigator Global Assessment (IGA) scale, compared with 9% in the placebo group, noted Yan Zhao, PhD, of the Department of Dermatology, Peking University People’s Hospital, Beijing, China
A 75% or greater improvement in Eczema Area and Severity Index (EASI-75) was seen in 66.1% of patients on 8 mg and 54% on 4 mg, versus 21.6% on placebo.
Itch reduction, defined as at least a 4-point drop in the Worst Itch Numeric Rating Scale, was reported by 40.2% of patients on 8 mg and 37.2% on 4 mg, compared with 12.6% in the placebo group. Symptom relief was observed as early as day 3 with 8 mg and day 8 with 4 mg.
The trial enrolled patients aged 12 to 75 years from 53 sites in China and Canada. All had moderate to severe AD for at least 1 year and were unresponsive or intolerant to prior topical treatments. The average body surface area affected by eczema was about 45%.
On the Dermatology Life Quality Index, scores decreased by 5.2 points in the 8 mg group and 4.4 in the 4 mg group compared to placebo, indicating fewer eczema-related disruptions.
Adverse events were reported in approximately two-thirds of patients in all groups. The most common were upper respiratory infections and elevated creatine phosphokinase levels. Two serious infections—sepsis and varicella—occurred in the 4 mg group; both patients recovered after stopping treatment. No deaths, thromboembolic events, major cardiac events, or malignancies were reported.
Laboratory changes in cholesterol, triglycerides, and white blood cell counts were noted but were generally mild and transient. Overall, safety findings were consistent with those of other approved JAK1 inhibitors.
Zhao and colleagues noted several study limitations. "First, the placebo-controlled period was limited to 16 weeks, and long-term data are needed to fully assess the efficacy and adverse events in patients with AD; these should be reported separately. Second, the predominance of Asian patients may limit the generalizability of the findings to other populations, although AD is more prevalent and severe in Asian patients compared to White patients."
Full disclosures are available in the published study.
Source: JAMA Dermatology