Roflumilast Cream 0.3% Improves Patient-Reported Outcomes in Psoriasis: Analysis

A recent study suggested efficacy for roflumilast cream 0.3% for the topical treatment of plaque psoriasis.

Researchers for the study pooled data from two Phase 3 clinical trials (DERMIS-1 and DERMIS-2), which included patients aged ≥2 years with plaque psoriasis affecting between 2% and 20% of body surface area.

Previous research has shown that roflumilast-treated patients had significant improvements in IGA Success at week 8, with 39.9% achieving IGA Success vs. 6.5% of vehicle-treated patients (P<0.0001), and a positive safety profile. The current analysis focused on patient-reported outcomes using the Worst-Itch Numeric Rating Scale (WI-NRS), Psoriasis Symptom Diary (PSD), and Dermatology Life Quality Index (DLQI).

The study results showed roflumilast-treated patients experienced a greater reduction in pruritus by week 8 (WI-NRS Success: 68.5% vs. 31.3%; WI-NRS score 0/1: 55.4% vs. 19.4%; both P<0.0001), with notable differences observable at two weeks. The researchers also reported a significant reduction in DLQI total score in the roflumilast group vs. the vehicle group (−4.6 vs. −1.6; P<0.0001). Roflumilast-treated patients reported a substantial decrease in PSD total score (−69.2% vs. −26.0%; P<0.0001).

"Roflumilast cream 0.3% improved psoriasis across multiple patient-reported outcomes including pruritus and quality of life," the authors wrote. 

This abstract was published in the meeting supplement for the Society for Dermatology Physician Assistants (SDPA) Annual Summer Conference in San Diego.