Investigational drug scores big in mild-to-moderate AD, plaque psoriasis

The topical phosphodiesterase 4 inhibitor PF-07038124 is safe and helps lower disease activity in patients with mild-to-moderate atopic dermatitis (AD) and plaque psoriasis, according to the results of a phase IIa study.

The study included 104 adult patients (mean age 43.0 years, 52.9 percent women, 83.7 percent White) with mild-to-moderate AD (covering 5–20 percent body surface area; n=70) or plaque psoriasis (covering 5–15 percent body surface area; n=34).

The patients were randomly assigned to receive either PF-07038124 0.01% topical ointment (AD cohort: n=36; plaque psoriasis cohort: n=17) or vehicle (AD cohort: n=34; plaque psoriasis cohort: n=17). Treatment was applied daily and lasted for 6 weeks. Baseline characteristics were generally balanced.

The primary endpoint was the change from baseline in the Eczema Area and Severity Index (EASI) total score in the AD cohort and in the Psoriasis Area and Severity Index (PASI) score in the plaque psoriasis cohort at week 6.

Compared with the vehicle, PF-07038124 produced significantly greater improvements in the EASI (least-squares mean, −74.9 percent vs −35.5 percent; difference, −39.4 percent, 90 percent confidence interval [CI], −58.8 to −20.1; p<0.001) and PASI scores (least-squares mean, −4.8 vs 0.1; difference, −4.9, 90 percent CI, −7.0 to −2.8; p<0.001).

In terms of safety, the frequency of treatment-emergent adverse events did not significantly differ between the PF-07038124 and vehicle groups both in the AD cohort (25.0 percent vs 26.5 percent) and plaque psoriasis cohort (17.6 percent vs 35.3 percent). None of the PF-07038124-treated patients experienced application site reactions.