The following is a summary of “Efficacy and Safety of PF-07038124 in Patients With Atopic Dermatitis and Plaque Psoriasis,” published in the December 2023 issue of Dermatology by Eichenfield, et al.

Atopic dermatitis (AD) and plaque psoriasis represent inflammatory skin conditions with limited effective topical treatments and often lead to undesirable application site reactions. For a study, researchers sought to evaluate the efficacy and safety of PF-07038124, a topical phosphodiesterase 4 inhibitor, in patients with AD and plaque psoriasis.

The phase 2a, a double-blind clinical trial, was conducted across 34 sites in 4 countries from December 21, 2020, to August 18, 2021. Patients aged 18-70 years with mild to moderate AD (covering 5%-20% of body surface area) or plaque psoriasis (covering 5%-15% of body surface area) were eligible. Data were analyzed until December 15, 2021. Participants were randomized (1:1) to receive PF-07038124, 0.01%, topical ointment, or vehicle once daily for 6 weeks. The primary endpoint was the percent change from baseline (CFB) in the Eczema Area and Severity Index (EASI) total score for AD patients and in the Psoriasis Area and Severity Index (PASI) score for those with plaque psoriasis at week 6. Safety assessments included treatment-emergent adverse events and application site reactions.

Of the 104 randomized patients (mean age 43.0 years; 55 [52.9%] women), 70 had AD (41 women [58.6%]) with mean ages 41.4 years in the PF-07038124 group and 36.1 years in the vehicle group, and 34 had plaque psoriasis (20 men [58.8%]) with mean ages 51.8 years in the PF-07038124 group and 51.2 years in the vehicle group. Baseline characteristics were generally balanced. At week 6, PF-07038124 groups demonstrated significantly greater improvements in EASI and PASI scores compared to vehicle groups (EASI: least-squares mean CFB −74.9% vs −35.5%; PASI: CFB −4.8 vs 0.1; both P < .001). The incidence of treatment-emergent adverse events was similar between PF-07038124 and vehicle groups for both AD (PF-07038124, 9 [25.0%]; vehicle, 9 [26.5%]) and plaque psoriasis (PF-07038124, 3 [17.6%]; vehicle, 6 [35.3%]) patients. Notably, no application site reactions were observed with PF-07038124 treatment.

PF-07038124 exhibited favorable efficacy and safety profiles compared to vehicle in patients with mild to moderate AD and plaque psoriasis, indicating its potential as a promising topical treatment option.

Reference: jamanetwork.com/journals/jamadermatology/fullarticle/2812729