Abrocitinib versus Placebo or Dupilumab for Atopic Dermatitis
RCT (n=838) found that this oral JAK-1 inhibitor at dose of either 200mg or 100mg daily resulted in significantly greater reductions in signs and symptoms of moderate to severe disease (based on IGA and EASI-75 response) vs. placebo at week 12.
Source:
New England Journal of Medicine
SPS commentary:
The primary endpoints of Investigator’s Global Assessment (IGA) response at week 12 was observed in 48.4% of patients in the 200-mg abrocitinib group, 36.6% in the 100-mg abrocitinib group, 36.5% in the dupilumab group, and 14.0% in the placebo group (p<0.001 for both abrocitinib doses vs. placebo); an Eczema Area and Severity Index–75 (EASI-75) response at week 12 was observed in 70.3%, 58.7%, 58.1%, and 27.1%, respectively (p<0.001 for both abrocitinib doses vs. placebo). The trial was not formally designed to evaluate the superiority of abrocitinib over dupilumab with respect to the two primary end points. The 200-mg dose, but not the 100-mg dose, of abrocitinib was superior to dupilumab with respect to itch response at week 2 (secondary endpoint).
In Feb 2021, abrocitinib was granted Early Access to Medicines Scheme (EAMS) status in UK for treatment of adult and adolescent patients with severe atopic dermatitis who have not responded to approved treatments or who are ineligible or intolerant to approved treatments.