Pfizer’s PDE4 inhibitor shows early efficacy in psoriasis, atopic dermatitis

Key takeaways:

• Patients with atopic dermatitis or plaque psoriasis exhibited improved IGA scores with topical PF-07038124.
• PF-07038124 is a topical PDE4 inhibitor with immunomodulatory activity in T-cell-based assays.

Patients with atopic dermatitis and plaque psoriasis who were treated with a topical phosphodiesterase 4 inhibitor exhibited significant improvement, according to a study.

“Topical PF-07038124 is designed to be a potent, oxaborole-based [phosphodiesterase 4 (PDE4)] inhibitor with immunomodulatory activity in T-cell–based assays, contributing to inhibition of IL-4 and IL-13; thus, it could provide therapeutic benefit in the treatment of AD and plaque psoriasis, Lawrence F. Eichenfield, MD, of the department of dermatology at the University of California, San Diego School of Medicine, and colleagues wrote.

Researchers conducted a randomized, double-blind, vehicle-controlled, parallel-group, phase 2a basket study that included 104 patients with atopic dermatitis (n = 70) or psoriasis (n = 34). Of these, 60 in the AD group and 28 in the psoriasis group completed the study.

Patients were randomly assigned to receive topical PF-07038124 0.01% (Pfizer) or vehicle ointment once daily for 6 weeks.

Patients with AD treated with the study ointment had a statistically significant improvement in EASI scores, with 61.1% achieving EASI 75 from week 2 and maintaining that through week 6, compared with 20.6% of those in the vehicle group. Additionally, an IGA score of 0 or 1 was achieved by 44.4% of those in the PF-07038124 group compared with 8.8% of those in the vehicle group.

In patients with psoriasis, a significantly greater percentage of patients in the PF-07038124 group achieved EASI 75 compared with vehicle at 6 weeks (35.3% vs. 5.9%).

A PGA score of 0 or 1 with at least a 2-point reduction from baseline was achieved in 17.6% of the psoriasis treatment group compared with 0% of the vehicle group at week 4. At week 6, a numerically higher proportion of the treatment vs. vehicle group reached this goal, but it was not statistically significant.

Adverse events were recorded in 27 (26%) patients, including nine patients in the AD treatment group, nine patients in the AD vehicle group, three in the psoriasis treatment group and six in the vehicle psoriasis vehicle group, which the researchers called comparable.

Treatment-related adverse events were reported only in the vehicle groups.

“Treatment with PF-07038124 demonstrated superior efficacy, compared with vehicle, in patients with mild to moderate AD and plaque psoriasis. The study drug was well tolerated, with no treatment-related [adverse events] or application site reactions reported in the PF-07038124 group,” the authors wrote.