Long-term safety and effectiveness of roflumilast cream 0.3% in adults with chronic plaque psoriasis: A 52-week, phase 2, open-label trial

• Published in: Journal of the American Academy of Dermatology Vol. 91; no. 2; pp. 273 - 280
• Main Authors: Stein Gold, Linda, Adam, David N., Albrecht, Lorne, Alonso-Llamazares, Javier, Ferris, Laura K., Gooderham, Melinda J., Hong, H. Chih-ho, Kempers, Steven E., Kircik, Leon H., Lebwohl, Mark, Loo, Wei Jing, Nahm, Walter K., Papp, Kim A., Stewart, Daniel, Toth, Darryl P., Zirwas, Matthew, Krupa, David, Snyder, Scott, Burnett, Patrick, Higham, Robert, Berk, David R.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-08-2024
• Subjects: Adult; Aged; Aminopyridines - administration & dosage; Aminopyridines - adverse effects; Benzamides - administration & dosage; Benzamides - adverse effects; Chronic Disease; Cyclopropanes - administration & dosage; Cyclopropanes - adverse effects; Cyclopropanes - therapeutic use; Drug Administration Schedule; durability of response; Female; Humans; local tolerability; long-term safety; Male; Middle Aged; Phosphodiesterase 4 Inhibitors - administration & dosage; Phosphodiesterase 4 Inhibitors - adverse effects; Plaque psoriasis; Psoriasis - drug therapy; roflumilast; Severity of Illness Index; Skin Cream - administration & dosage; Skin Cream - adverse effects; Time Factors; topical; Treatment Outcome; Young Adult; topical; roflumilast; FDA; IGA; PASI; AE; I-IGA; PDE4; local tolerability; BSA; TEAE; Plaque psoriasis; durability of response; long-term safety
• ISSN: 0190-9622; 1097-6787; 1097-6787
• DOI: 10.1016/j.jaad.2024.03.030

Efficacy and/or safety profiles limit topical psoriasis treatments.
Evaluate long-term effects of once-daily roflumilast cream 0.3% in patients with psoriasis.
In this open-label phase 2 trial, adult patients (N = 332) with psoriasis who completed the phase 2b parent trial or were newly enrolled applied roflumilast once-daily for 52 weeks. Safety and effectiveness were assessed.
Overall, 244 patients (73.5%) completed the trial; 13 patients (3.9%) discontinued due to adverse events (AEs) and 3 (0.9%) due to lack of efficacy. Twelve patients (3.6%) reported treatment-related AEs; none were serious. ≥97% of patients had no irritation. No tachyphylaxis was observed with 44.8% of the patients achieving Investigator Global Assessment (IGA) Clear or Almost Clear at Week 52.
Intertriginous-IGA and Psoriasis Area and Severity Index (PASI) were not evaluated in all patients.
In this long-term trial, once-daily roflumilast cream was well-tolerated and efficacious up to 64 weeks in patients in the earlier trial, suggesting it is suitable for chronic treatment, including the face and intertriginous areas.