Roflumilast cream shows long-term efficacy, tolerability in chronic psoriasis
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Key takeaways:
- Patients with psoriasis, including in locations on the face and intertriginous areas, applied once-daily roflumilast for 52 weeks.
- By the end of the study, more than 97% of patients experienced no irritation.
Once-daily roflumilast cream 0.3% was well tolerated and efficacious in the long-term treatment of patients with plaque psoriasis, suggesting it is suitable for chronic treatment, according to a study.
“Patients with psoriasis need topical treatments that can be used long term and on multiple body sites, including areas sensitive to other treatments such as the face, genital and intertriginous areas,” Linda Stein Gold, MD, director of dermatology clinical research and division head of dermatology at Henry Ford Health, and colleagues wrote. “Phosphodiesterase 4 (PDE4) inhibition is an effective treatment for several inflammatory conditions including chronic obstructive pulmonary disease, psoriasis, atopic dermatitis and seborrheic dermatitis, and is well tolerated long-term.”
In an open-label phase 2 trial, researchers assessed the long-term effects of roflumilast cream 0.3%, a selective, highly potent PDE4 inhibitor, on patients with chronic plaque psoriasis.
Overall, 332 patients (mean age, 54.5 years; 54.8% men; 80.7% white) were enrolled in the study. The study included two cohorts: 164 patients that completed the earlier parent trial and the 168 treatment naïve patients. Each patient applied roflumilast to all psoriasis lesions once daily for 52 weeks, with the first cohort applying roflumilast for a total of 64 weeks altogether.
Results showed that 73.5% of patients competed the trial. The main reason for discontinuation was adverse events (3.9%) followed by a lack of efficacy (0.9%).
Overall, 49.4% of patients experienced a treatment-emergent adverse event; however, 94% of these events were mild or moderate in severity. Also, 97% of adverse events were considered not related or unlikely to be related to treatment. Of the 12 patients (3.6%) who reported a serious adverse event, none were considered related to treatment.
The most common adverse event was a viral/regular upper respiratory tract infection (6.6%) followed by nasopharyngitis (3.6%), urinary tract infection (3.3%) and sinusitis (2.4%).
Almost all patients ( 97%) did not experience any irritation from applying roflumilast. Additionally, the proportion of patients achieving an IGA score of clear or almost clear were consistent over time (44.8%) and without any evidence of tachyphylaxis.
“Long-term treatment with roflumilast cream extends the safety and tolerability profile found in earlier trials,” the authors said.