Forecasting Phase 3 Dose-Response for Abrocitinib, an Oral Janus Kinase 1 Selective Inhibitor, Using Investigator’s Global Assessment and Eczema Area and Severity Index

The document summarized a study that forecasted the effectiveness of abrocitinib, an oral medication targeting Janus Kinase 1, in treating atopic dermatitis. The study analyzed data from 263 patients, using 245 Investigator's Global Assessment (IGA) and 2220 Eczema Area and Severity Index (EASI) records. It employed dose-response models to predict outcomes for a phase 3 trial. The models suggested that abrocitinib at doses of 100 mg and 200 mg daily would lead to significant improvements compared to placebo. Specifically, the predicted IGA response rates at week 12 were 6%, 26%, and 38%, and the EASI75 response rates were 21%, 50%, and 62% for placebo, 100 mg, and 200 mg doses, respectively. The study concluded that 100 mg and 200 mg doses of abrocitinib could provide meaningful benefits for patients aged 12 years and older with moderate-to-severe atopic dermatitis.