Monotherapy with the Janus kinase (JAK) inhibitor abrocitinib demonstrated remarkable efficacy: significant differences in skin clearance compared with placebo could be shown as early as 2 weeks in the phase 3 JADE MONO-1 trial .
After positive results in phase 2 trials , the 100 mg and 200 mg doses of abrocitinib were assessed in a phase 3 trial. Adolescents (> 12 years) and adults with moderate-to-severe atopic dermatitis (AD) were included and treated with the 2 dosages or placebo. The co-primary endpoints in JADE MONO-1 were achievement of an Investigator Global Assessment (IGA) score of 0 or 1 at week 12 and an EASI 75 response. “With a mean EASI score of about 30 at baseline, we treated a population quite impacted by the disease,” said Prof. Eric Simpson (Oregon Health & Science University, USA).
A clear-cut dose response was evident in the trial: the IGA response rates were 43.8% in the 200 mg dose group, 23.7% with 100 mg, and 7.9% with placebo. The EASI 75 response rates were 62.7%, 39.7%, and 11.8%, respectively, with a statistically significant separation from placebo already by week 2. Abrocitinib leads to a significant itch reduction: 57.2% in the high-dose group and 37.7% of patients in the low-dose group achieved an at least a 4-point improvement in itch on the Numeric Rating Scale (NRS) compared with 15.3% in the placebo group.
Abrocitinib showed an acceptable short-term safety profile. There were no cases of malignancy or major cardiovascular events. Laboratory evaluations revealed that there is a decrease in platelet count but without clinical sequelae. In addition, a dose-related ~10% increase in LDL-cholestrol and 20% decrease in HDL-cholesterol were observed.
1 Simpson E. Late-breaking abstract D3T01.1I, EADV 2019, 9-13 Oct, Madrid, Spain.
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