Effectiveness and Safety of Roflumilast in the Treatment of Psoriasis: A Systematic Review and Meta-Analysis.

Ali Mohammed Aleid; Salma Mohammed Alshreef; Mishari Tariq Alrubaiaan; Shahad Hamoud Alrowais; Mohammed Khalid Alghamdi; Shatha Saleh AlGhamdi; Laila Mohammed Alali; Houriah Yasir Nukaly; Mohammad A Alghamdi; Mahdi Al Dhafiri

doi:10.2174/0115748863406187251031101244

Effectiveness and Safety of Roflumilast in the Treatment of Psoriasis: A Systematic Review and Meta-Analysis.

Curr Drug Saf. 2026 Feb 10. doi: 10.2174/0115748863406187251031101244. Online ahead of print.

Affiliations

¹ King Faisal University (KFU) Dermatology Department, Ministry of Health Al-Hofuf Saudi Arabia.
² Umm Al-Qura University - Mecca Saudi Arabia.
³ King Saud Bin Abdulaziz University for Health Sciences College of Medicine Riyadh Saudi Arabia.
⁴ Princess Nourah Bint Abdulrahman University College of Medicine Riyadh Saudi Arabia.
⁵ University of Jeddah College of Medicine Jeddah Saudi Arabia.
⁶ King Abdulaziz University, College of Medicine College of Medicine Jeddah Saudi Arabia.
⁷ Jazan University College of Medicine Jizan Saudi Arabia.
⁸ Batterjee Medical College Medicine Program Jeddah Saudi Arabia.
⁹ Al-Baha University Internal Medicine Department, Division of Dermatology, Faculty of Medicine Al-Baha Saudi Arabia.
¹⁰ King Faisal University Division of Dermatology, College of Medicine, Al-Ahsa Saudi Arabia.

PMID: 41691689
DOI: 10.2174/0115748863406187251031101244

Abstract

Background: Psoriasis, a chronic autoimmune condition, can severely impact patients' well-being. It is characterized by erythema, thickening, and scaling of the skin. Plaque psoriasis, the most prevalent type, affects 80%-90% of psoriasis patients, ranging from localized to severe cases. Although corticosteroids are commonly used to treat psoriasis, prolonged use poses risks. Therefore, alternative therapies are needed. Roflumilast, a potent phosphodiesterase 4 inhibitor, is currently being considered as a treatment for plaque psoriasis.

Methods: We searched four electronic databases (Cochrane Central Register of Controlled Trials, PubMed, Scopus, and Web of Science) up to March 2024 for relevant articles evaluating the efficacy and tolerability of roflumilast in the management of psoriasis. The quality of evidence from trials was assessed using the Cochrane Risk of Bias tool (RoB1). Data from the included studies were extracted into a standardized online sheet and analyzed using RevMan 5.4.

Results: Roflumilast significantly increased the proportion of patients achieving an Investigator's Global Assessment score of 0 or 1 and a 2-point improvement score at both weeks 4 and 8 compared to placebo (RR = 3.48, 95% CI [2.04 to 5.92], P < 0.00001, and RR = 4.02, 95% CI [3.17 to 5.11], P < 0.00001, respectively). The pooled studies demonstrated homogeneity at both weeks 4 (P = 0.17, I² = 38%) and 8 (P = 0.38, I² = 5%). Regarding the results of the Psoriasis Area and Severity Index, 75% favored roflumilast over placebo (RR = 2.72, 95% CI [1.18 to 6.28], P < 0.00001, and RR = 3.41, 95% CI [2.19 to 5.32], P < 0.00001, at weeks 4 and 8, respectively). Subgroup analysis addressed the observed heterogeneity in the results.

Conclusion: This meta-analysis represents the first investigation into the efficacy and safety of roflumilast for treating psoriasis. Results suggest that roflumilast is both effective and well-tolerated in managing psoriasis. However, additional robust clinical trials are needed to validate these observations..

Keywords: Erythema; Th17 pathway; dermatological; phosphodiesterase inhibitors; psoriasis; roflumilast.

Publication types

Meta-Analysis