PF-07038124 Shows Safety, Efficacy for AD and Plaque Psoriasis: Study

December 20, 2023

The topical phosphodiesterase 4 inhibitor also had a positive safety profile.

A novel topical phosphodiesterase 4 inhibitor (PF-07038124) has been shown to be efficacious and well-tolerated in patients with atopic dermatitis (AD) and plaque psoriasis, according to new study results. 

Researchers writing in JAMA Dermatologyconducted a phase 2a randomized, double-blind trial consisting of 104 patients (70 with mild to moderate AD and 34 with plaque psoriasis). Study participants were randomly assigned (1:1) to PF-07038124, 0.01%, topical ointment or vehicle given once daily for a period of 6 weeks. The primary study endpoint was the percent change from baseline in the Eczema Area and Severity Index (EASI) total score among patients with AD and in Psoriasis Area and Severity Index (PASI) score among patients with plaque psoriasis at week 6. 

The results indicated showed patients in the PF-07038124 group having significant improvement in EASI (least-squares mean CFB, −74.9% vs −35.5%; difference, −39.4% [90% CI, −58.8% to −20.1%]; P <0.001)and PASI (CFB, −4.8 vs 0.1; difference, −4.9 [90% CI, −7.0 to −2.8]; P < 0.001) when compared to the vehicle group. Adverse events were comparable between treatment groups, and there were no application site reactions in the treatment arm. 

"Treatment with PF-07038124 demonstrated superior efficacy, compared with vehicle, in patients with mild to moderate AD and plaque psoriasis," the authors wrote in their conclusion. "The study drug was well tolerated, with no treatment-related TEAEs or application site reactions reported in the PF-07038124 group. To confirm persistence of efficacy and the safety profile of PF-07038124, long-term data should be collected in larger studies."

Source: Eichenfield L, Tarabar S, Forman S, et al. JAMA Dermatol. Published online December 20, 2023. doi:10.1001/jamadermatol.2023.4990

Disclosures 

Dr. Eichenfield reported receiving personal fees from Pfizer Inc during the conduct of the study; grant funding from AbbVie, Arcutis Biotherapeutics, Bausch + Lomb, Castle Biosciences, Dermavant Sciences Inc, Galderma SA, Pfizer Inc, Regeneron, and Sanofi SA and consulting for ASLAN Pharmaceuticals, AbbVie, Almirall, SA, Arcutis Biotherapeutics, Arena Pharmaceuticals Inc, Dermavant Sciences Inc, Galderma SA, Incyte Corporation, LEO Pharma A/S, Eli Lilly and Company, Ortho Dermatologics, Pfizer Inc, Regeneron Pharmaceuticals Inc, Sanofi SA, and UCB outside the submitted work; and serving on the board of directors of Forté Pharma. Dr. Tarabar reported owning shares in Pfizer Inc outside the submitted work. Dr. Forman reported receiving grant funding and/or honoraria as a clinical trial investigator and/or consultant for AbbVie, Aclaris Therapeutics, Alumis Inc, Arcutis Biotherapeutics, Aristea Therapeutics, Asana BioSciences LLC, AstraZeneca, Athenex Inc, Bristol Myers Squibb, Celgene, Cutanea Life Sciences, Eli Lilly and Company, Incyte Corporation, Janssen Pharmaceuticals Inc, Pfizer Inc, Promius Pharma LLC, Q32 Bio Inc, RAPT Therapeutics Inc, Regeneron Pharmaceuticals Inc, UCB, Valeant Pharmaceuticals International Inc, and XBiotech; and serving as an advisory board member and/or speaker for AbbVie, Eli Lilly and Company, and Novartis AG. Dr. Feng reported owning shares in Pfizer Inc outside the submitted work. Dr. Fetterly reported owning shares in Pfizer Inc outside the submitted work. Dr. Mahling reported owning shares in Pfizer Inc outside the submitted work. Dr. Peeva reported owning shares in Pfizer Inc outside the submitted work. Dr. Vincent reported owning shares in Pfizer Inc outside the submitted work. Dr. Chandra reported owning shares in Pfizer Inc outside the submitted work. No other disclosures were reported. This study was supported by Pfizer Inc.

Facebook Comments

Register

We’re glad to see you’re enjoying PracticalDermatology…
but how about a more personalized experience?

Register for free