Topical Roflumilast 0.3% Demonstrates Significant Efficacy Across Psoriasis Severity Measures in Updated Meta-Analysis

An updated systematic review and meta-analysis of randomized controlled trials found that topical roflumilast 0.3% was associated with significant improvements in multiple clinician- and patient-reported psoriasis outcomes at 8 weeks compared with vehicle. The analysis, published in JEADV Clinical Practice, included five trials with 1 835 participants and evaluated plaque psoriasis across body, scalp, and intertriginous sites.

Researchers reported that roflumilast 0.3% improved Investigator’s Global Assessment (IGA) and Psoriasis Area and Severity Index (PASI) endpoints, reduced itch scores, and showed a favorable safety profile, although overall adverse events were slightly more frequent with roflumilast.

Significant Improvements in IGA and PASI Measures

Across trials, topical roflumilast 0.3% demonstrated statistically significant superiority to vehicle for multiple clinician-reported outcomes at 8 weeks:

• Body-IGA success: RR 4.19 (95% CI, 2.49–7.04; p < 0.00001); 40.6% vs 10.5%
• Scalp-IGA success: RR 3.37 (95% CI, 1.57–7.25; p = 0.002); 63.4% vs 21.2%
• Intertriginous-IGA success: RR 3.32 (95% CI, 2.11–5.22; p < 0.00001); 72.0% vs 20.5%

Topical roflumilast also improved PASI measures:

• PASI-50: RR 2.73 (95% CI, 2.27–3.29; p < 0.00001); 69.7% vs 25.0%
• PASI-75: RR 3.93 (95% CI, 2.46–6.28; p < 0.00001); 42.2% vs 10.7%
• PASI-90: RR 4.32 (95% CI, 2.37–7.89; p < 0.00001); 14.3% vs 3.2%

For scalp involvement, PSSI-75 success also favored roflumilast (RR 2.55; 95% CI, 1.92–3.38; p < 0.00001).

Patient-Reported Measures Also Favored Roflumilast

Itch and symptom severity demonstrated clinically meaningful improvement:

• Worst Itch-Numeric Rating Scale success: RR 2.12 (95% CI, 1.74–2.60; p < 0.00001); 66.9% vs 30.9%
• Psoriasis Symptoms Diary score: Mean difference –25.34 (95% CI, –31.77 to –18.92; p < 0.00001)

These improvements were consistent across available studies, with moderate heterogeneity noted for some endpoints.

Safety Profile Similar to Vehicle for Treatment-Related and Serious Adverse Events

Across 1831 participants, overall adverse events were more frequent in the roflumilast group:

• Any adverse event: RR 1.29 (95% CI, 1.08–1.54; p = 0.004); 26.6% vs 21.1%

However, key safety outcomes did not differ significantly:

• Treatment-related adverse events: RR 1.03 (95% CI, 0.59–1.78; p = 0.92)
• Serious adverse events: RR 0.73 (95% CI, 0.23–2.37; p = 0.60)
• Discontinuation due to adverse events: RR 0.92 (95% CI, 0.41–2.07; p = 0.83)

Across trials, application-site pain, hypertension, diarrhea, nasopharyngitis, headache, and psoriasis progression occurred at similar rates between groups.