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Oral roflumilast for plaque psoriasis: Results from a 24-week real-world study
By Ella Dixon
|
Psoriasis is associated with significant physical and psychological burden for patients, with frequent comorbidities such as obesity and cardiovascular disease. Current treatment options such as biologics, small molecules, and conventional systemic therapies are limited by safety and accessibility issues and the need for laboratory monitoring in some patients. The PDE-4 inhibitor roflumilast has shown efficacy in treating moderate to severe plaque psoriasis; however, real-world outcomes data are limited.1 A prospective cohort study was conducted at a single center in Portugal, evaluating the real-world effectiveness and safety of oral roflumilast (500 µg once daily) in 58 adults with moderate-to-severe plaque psoriasis. Results were published in the Journal of Dermatological Treatment by Lé et al.1 |
| Key learnings |
| Significant improvements in PASI score were observed at Week 24, with 63.0% of patients achieving PASI <5, 47.8% achieving PASI <3, and 21.7% reaching PASI <1. |
| Notably, 53.4% of patients experienced weight loss, with a mean reduction of 6 kg bodyweight (±4.3 kg), highlighting a potential benefit in patients with comorbid obesity. |
| Mild GI symptoms (diarrhea, nausea, dyspepsia) were common (44.8% of patients) but rarely led to discontinuation. No SAEs were reported. 24.1% of patients discontinued treatment due to lack of response. |
| The oral administration, lack of need for laboratory monitoring, and weight loss benefit make roflumilast a viable alternative to biologics and other systemic therapies, particularly for patients with comorbidities or limited access to biologics. |
Abbreviations: GI, gastrointestinal; PASI, Psoriasis Area and Severity Index; PDE-4, phosphodiesterase 4; SAE, serious adverse event.
- Lé AM, Yilmaz O, Luz M, et al. Oral roflumilast for psoriasis: a real-world 24-week prospective cohort study. J Dermatolog Treat. 2025;36(1):2464107. DOI: 1080/09546634.2025.2464107
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