Roflumilast cream reduces psoriasis severity

Using a topical roflumilast cream to treat patients with chronic plaque psoriasis yields a significant improvement in disease severity, achieving a clear or almost clear IGA* status, based on a pooled analysis of the DERMIS-1** and DERMIS-2*** studies presented at AAD 2022.

These two identical, double-blind, multicentre, phase III studies involved 881 patients with plaque psoriasis, affecting 2–20 percent of body surface area, to assess the efficacy and safety of roflumilast in these patients. Participants were randomized to receive either roflumilast cream 0.3% (n=576) or vehicle cream (n=305) once daily for 8 weeks. [AAD 2022, abstract 31865]

At week 8, a significantly higher percentage of patients treated with roflumilast achieved an IGA success, defined as achieving an IGA score of clear or almost clear status with ≥2-grade improvement from baseline, compared with the vehicle treatment (39.9 percent vs 6.5 percent; p<0.0001).

In particular, significantly more roflumilast-treated patients had an IGA status of clear or almost clear compared with the vehicle-treated patients across all time points (10.1 percent vs 3.8 percent; p<0.01; 27.0 vs 6.6 percent; p<0.0001; 37.8 percent vs 7.7 percent; p<0.0001; and 48.0 percent vs 9.5 percent; p<0.0001 at weeks 2, 4, 6, and 8, respectively).

Among patients with intertriginous area involvement, a significantly higher percentage of patients on roflumilast achieved an intertriginous-IGA success than those treated with the vehicle cream at week 8 (69.7 percent vs 16.1 percent; p<0.01).

Significantly more patients treated with roflumilast also achieved a ≥4-point reduction in WI-NRS⁺ score (68.5 percent vs 31.3 percent) and a 75 percent reduction in PASI⁺⁺ score (40.3 percent vs 6.5 percent; p<0.0001) at week 8 than those treated with the vehicle cream.

The rates of treatment-emergent adverse events (TEAEs) and serious AEs were similar between the roflumilast and the vehicle treatment arms (25.5 percent vs 21.0 percent and 0.3 percent vs 0.7 percent, respectively). “The local tolerability profile as assessed by both patients and investigators was favourable [with roflumilast],” noted the researchers.

“Roflumilast cream 0.3% demonstrated statistically significant improvements on endpoints assessing disease severity, including intertriginous areas, and pruritus,” the researchers said.

“[As] no novel nonsteroidal topical therapies for plaque psoriasis have been approved in more than two decades, once-daily roflumilast cream 0.3% has the potential to address many of the shortcomings of existing topical treatments for plaque psoriasis,” the researchers noted.

*IGA: Investigator Global Assessment

**DERMIS-1: Trial of PDE4 inhibition with roflumilast for the management of plaque psoriasis

***DERMIS-2: Twin Trial of PDE4 inhibition with roflumilast for the management of plaque psoriasis

⁺WI-NRS: Worst Itch-Numeric Rating Scale

⁺⁺PASI: Psoriasis Area Severity Index