Phase III monotherapy study (JADE MONO-2) of PF 04965842 in atopic dermatitis published in JAMA Dermatol.- Pfizer Inc

Pfizer Inc. announced that JAMA Dermatology has published complete results from the second Phase III monotherapy pivotal study (JADE MONO-2) of PF 04965842 (abrocitinib), an investigational oral once-daily Janus kinase 1 (JAK1) inhibitor, in patients aged 12 and older with moderate to severe atopic dermatitis (AD). By Week 12, a greater proportion of patients on either dose of abrocitinib achieved the IGA, EASI-75, PP-NRS, and EASI-90 responses compared to those on placebo.

The proportion of patients achieving the IGA, EASI-75, PP-NRS, and EASI-90 responses were higher for abrocitinib treatment at each time point compared with placebo from Week 2 to Week 12, with responses seen as early as Week 2. Consistent with the first Phase III monotherapy study (JADE MONO-1), both doses of abrocitinib met all co-primary and key secondary endpoints and were generally well tolerated.

See: “Efficacy and Safety of Abrocitinib in Patients With Moderate-to-Severe Atopic DermatitisA Randomized Clinical Trial” Jonathan I. Silverberg et al. JAMA Dermatol. Published online June 3, 2020. doi:10.1001/jamadermatol.2020.1406