Trial of Roflumilast Cream for Chronic Plaque Psoriasis

Area of Science:

• Dermatology
• Pharmacology

Background:

• Systemic oral phosphodiesterase type 4 (PDE-4) inhibitors are established treatments for psoriasis.
• Roflumilast cream, a topical PDE-4 inhibitor, is under investigation for psoriasis treatment.

Purpose of the Study:

• To evaluate the efficacy and safety of roflumilast cream for plaque psoriasis in a phase 2b trial.

Main Methods:

• A phase 2b, double-blind trial randomized 331 adults with plaque psoriasis to roflumilast 0.3% cream, 0.15% cream, or vehicle cream once daily for 12 weeks.
• Primary outcome: Investigator's Global Assessment (IGA) of clear or almost clear at week 6.
• Secondary outcomes included intertriginous area response and Psoriasis Area and Severity Index (PASI) change.

Main Results:

• At week 6, 28% of patients on 0.3% roflumilast and 23% on 0.15% achieved IGA clear/almost clear, versus 8% for vehicle (P<0.001 and P=0.004).
• In patients with intertriginous psoriasis, 73% (0.3% roflumilast) and 44% (0.15% roflumilast) achieved IGA clear/almost clear plus 2-grade improvement, versus 29% for vehicle.
• Mean PASI score changes at week 6 were -50.0% (0.3% roflumilast), -49.0% (0.15% roflumilast), and -17.8% (vehicle).
• Application-site reactions were similar across groups.

Conclusions:

• Roflumilast cream was superior to vehicle cream in achieving clear or almost clear psoriasis at 6 weeks.
• Larger, longer trials are necessary to assess the durability and safety of roflumilast cream for psoriasis.