Abrocitinib induction, maintenance effective against atopic dermatitis
Induction with abrocitinib is effective against atopic dermatitis, and continuous treatment helps suppress flares, a new trial has shown. Similarly, rescue treatment with abrocitinib in combination with topical therapy is able to recapture response.
A total of 1,233 patients (median age 28.0 years) with moderate-to-severe atopic dermatitis were given 12 weeks of open-label 200-mg abrocitinib monotherapy as induction. Responders were randomized 1:1:1 to blinded abrocitinib at 200-mg or 100-mg doses, or to placebo. The trial lasted for 40 weeks. Those who experienced flares were given rescue doses of 200-mg abrocitinib with topical therapy.
After the 12-week open-label induction period, 798 (64.7 percent) reached protocol-defined treatment response and were subsequently randomized to receive maintenance treatment.
During the maintenance period, 16.5 percent and 39.6 percent of patients in the 200-mg and 100-mg abrocitinib arms experienced flares, as opposed to 77.5 percent of placebo participants. At the end of the maintenance period, the cumulative probability of flares in the respective arms were 18.9 percent, 42.6 percent, and 80.9 percent.
In terms of risks, the 200-mg abrocitinib dose led to the significant suppression of flare likelihood vs placebo (hazard ratio [HR], 0.10, 95 percent confidence interval [CI], 0.07–0.136; p<0.0001) and vs the 100-mg dose (HR, 0.36, 95 percent CI, 0.255–0.516; p<0.0001). Similarly, the 100-mg abrocitinib dose significantly lowered flare risk vs placebo (HR, 0.27, 95 percent CI, 0.211–0.341; p<0.0001).
“Additional real-world and clinical data will be needed to refine the optimal dosing regimen for individual patients with moderate-to-severe atopic dermatitis over time,” the researchers said.