Roflumilast Cream Eases Psoriasis Burden

Once-daily roflumilast cream for psoriasis significantly improved patient burden and work productivity compared with placebo, according to results from a phase 2b randomized trial.

“Psoriasis can cause significant burden for patients, which can affect emotional health, sleep, and work performance,” wrote researchers. “Roflumilast is a selective and highly potent topical phosphodiesterase-4 inhibitor in development for treatment of several dermatologic diseases, including psoriasis.”

The study included 331 patients with chronic plaque psoriasis who were randomly assigned to once-daily roflumilast .3%, roflumilast .15%, or vehicle for 12 weeks.

The study’s primary endpoint of Investigator Global Assessment status of clear or almost clear at week 6 was met by 28% of patients on roflumilast .3%, 22.8% on roflumilast .15%, and 8.3% on vehicle, reported researchers.

A higher number of patients with baseline scores of 4 or higher on the Worst Itch Numeric Rating Scale treated with roflumilast .3% improved by 4 points or more as early as the second week of treatment. Differences between vehicle and roflumilast .15% were significant at weeks 6 and 12. Improvement in itch-related sleep loss was greater with roflumilast starting at week 6, according to study authors.

By week 12, Psoriasis Symptom Diary total scores improved an average -42.0 points with roflumilast .3%, -44.2 with roflumilast .15%, and -20.9 with vehicle. Work Productivity and Activity Impairment at week 12 also favored roflumilast, with greater improvement in presenteeism (roflumilast .3% -8.92, roflumilast .15% -7.63, and vehicle -.61) and general activity impairment outside of work (roflumilast .3% -11.31, roflumilast .15% -8.75, and vehicle -4.40).

Treatment-emergent adverse events tended to be mild to moderate in severity, wrote researchers, and application site pain with roflumilast was uncommon and similar to vehicle.

Reference:
Kircik L, Albrecht L, Ferris L, et al. Roflumilast cream significantly improves patient burden and work productivity in patients with psoriasis. J Manag Care Spec Pharm. 2022. 28(3-a Suppl):S1-S104. doi:10.18553/jmcp.2022.28.3-a.s1