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Abrocitinib meets primary, secondary endpoints in atopic dermatitis

Abrocitinib, in both 100 mg and 200 mg doses, significantly improved Investigator Global Assessment and Eczema Area and Severity Index-75 scores in patients with moderate to severe atopic dermatitis compared with placebo, meeting all endpoints in the phase 3 JADE MONO-1 study, which was presented at the European Academy of Dermatology and Venereology Congress.

“There is a critical need for additional treatment options for patients living with moderate to severe atopic dermatitis,” Michael Corbo, PhD, chief development officer, inflammation and immunology, Pfizer Global Product Development, said in a press release.

Three hundred eighty-seven patients with atopic dermatitis underwent treatment with abrocitinib (Pfizer), an oral Janus kinase 1 selective inhibitor, or placebo; 156 patients received abrocitinib 100 mg, 154 patients received abrocitinib 200 mg and 77 received placebo.

By week 12 in the 100 mg group, 23.7% of patients had an IGA response, 39.7% reached EASI-75, 37.7% had a 4 point or more improvement in Numerical Rating Scale (NRS), and 18.6% reached EASI-90. By week 12 in the 200 mg group, 43.8% of patients had an IGA response, 62.7% met EASI-75, 57.2% had a 4 point or more improvement in NRS, and 38.6% met EASI-90.

In the placebo group, 7.9% of patients had an IGA response, 11.8% met EASI-75, 15.3% had a 4 point or more improvement in NRS, and 5.3% met EASI-90.

Eligible patients who completed the 12-week treatment period had the option to enter a long-term extension study.

“We are pleased by these findings, which together with the recently reported positive topline results from our second phase 3 trial, encourage us that, if approved, abrocitinib may provide the first oral, once-daily treatment option for these patients,” Corbo said.

The company previously announced positive topline results from the companion phase 3 JADE MONO-2 study, which suggests similar safety and efficacy, according to the release.

Additional data from the JADE program and abrocitinib will be released in 2020.