Phase III JADE REGIMEN study of PF 04965842 meets endpoints in atopic dermatitis.- Pfizer

Pfizer Inc announced positive top-line results from the Phase III JADE REGIMEN study with PF 04965842 (abrocitinib) in moderate to severe atopic dermatitis (AD). This 52-week study investigated abrocitinib, an investigational oral once-daily Janus kinase 1 (JAK1) inhibitor, in patients 12 and older with moderate to severe AD following response to initial open label induction treatment with abrocitinib 200mg. Patients were randomized into one of three arms: 200mg, 100mg, or placebo. Both doses of abrocitinib met the primary endpoint, resulting in significantly fewer patients experiencing a loss of response requiring rescue treatment, or “flaring,” compared to those randomized to placebo. Both doses also met the key secondary endpoint of a larger percentage of patients maintaining an Investigator’s Global Assessment (IGA) response of clear or almost clear relative to placebo. The study met its primary and key secondary endpoints. After achieving clinical response in the induction period, patients who continued on the higher dose of abrocitinib, 200mg, or switched to the lower dose, 100mg, had a significantly higher probability of not experiencing a flare compared to those on placebo through week 52 (81.1%, 57.4%, and 19.1%, respectively; p<0.0001 for both doses versus placebo). in addition, patients who continued on the higher dose of abrocitinib were significantly less likely to flare than those on the lower dose (p><0.0001). patients on either dose of abrocitinib were significantly more likely to maintain an iga score of clear (zero) or almost clear (one) compared to placebo (p><0.0001 for both doses versus placebo). out of 1,233 subjects enrolled, 798 (64.7%) responded during the initial 12-week induction period with abrocitinib monotherapy (200mg, once daily), a higher than expected responder rate compared to the monotherapy studies jade mono-1 and jade mono-2. responder criteria was defined as achieving an iga score of clear (zero) or almost clear (one), a reduction from iga baseline of at least two points, and reaching an easi-75 response compared to baseline. no new safety signals were observed in the trial.>