Roflumilast cream eases itch burden, severity in chronic plaque psoriasis

In patients with chronic plaque psoriasis, once-daily treatment with roflumilast improved severity and burden of itch compared with vehicle cream, according to results of the phase III DERMIS-1 and DERMIS-2 trials presented at EADV 2021.

Participants in the two identically designed, double-blind trials were patients aged ≥2 years with mild to severe chronic plaque psoriasis affecting 2–20 percent of their body surface area (n=439 and 442 in DERMIS-1 and DERMIS-2, respectively). They were randomized 2:1 to receive roflumilast cream 0.3% or vehicle cream once daily for 8 weeks. Baseline characteristics were generally similar between the two treatment groups and between the two trials. Mean Worst Itch–Numeric Rating Scale (WI–NRS)* scores at baseline were 5.7 and 5.9 in DERMIS-1 and DERMIS-2, respectively, >72 percent had an IGA** score of 3, and mean PASI** score was 6–7.

Patients who received roflumilast experienced greater improvements in WI–NRS score from baseline than those who received vehicle cream in both DERMIS-1 (least square [LS] mean change, -2.3 vs -1.0 [week 2], -2.9 vs -1.2 [week 4], -3.6 vs -1.4 [week 6], and -3.7 vs -1.4 [week 8]) and DERMIS-2 (LS mean change, -2.6 vs -1.2 [week 2], -3.0 vs -0.9 [week 4], -3.7 vs -1.7 [week 6], and -4.0 vs -1.7 [week 8]; p<0.0001 for all comparisons). [EADV 2021, abstract N°: 146]

Among patients with WI–NRS pruritus score ≥4 at baseline (n=333 and 345 in DERMIS-1 and DERMIS-2, respectively), more roflumilast than vehicle cream recipients experienced a ≥4-point improvement in WI–NRS score at weeks 4, 6, and 8 in DERMIS-1 (50.2 percent vs 18.0 percent, 57.8 percent vs 22.2 percent, and 67.5 percent vs 26.8 percent, respectively; p<0.0001 for all) and at weeks 2, 4, 6, and 8 in DERMIS-2 (41.9 percent vs 21.1 percent, 56.6 percent vs 21.9 percent, 62.0 percent vs 30.6 percent, and 69.4 percent vs 35.6 percent, respectively; p≤0.0026).

Change from baseline in severity of itch (Psoriasis Symptom Diary [PSD] item 1) was also greater with roflumilast than vehicle cream in DERMIS-1 (LS mean percentage change, -42.7 percent vs -11.1 percent [week 2], -55.2 percent vs -18.2 percent [week 4], -67.3 percent vs -18.8 percent [week 6], and -72.5 percent vs -21.5 percent [week 8]) and DERMIS-2 (LS mean percentage change, -48.9 percent vs -18.8 percent [week 2], -60.4 percent vs -13.9 percent [week 4], -65.0 percent vs -22.6 percent [week 6], and -70.5 percent vs -26.9 percent [week 8]; p<0.0001 for all).

Change from baseline in burden of itch (PSD item 2) was greater with roflumilast than vehicle cream in DERMIS-1 (LS mean percentage change, -42.8 percent vs -14.9 percent [week 2], -59.7 percent vs -12.5 percent [week 4], -70.1 percent vs -14.3 percent [week 6], and -71.6 percent vs -13.8 percent [week 8]) and DERMIS-2 (LS mean percentage change, -43.9 percent vs -15.5 percent [week 2], -63.6 percent vs -19.0 percent [week 4], -65.4 percent vs -22.6 percent [week 6], and -71.8 percent vs -28.7 percent [week 8]; p<0.0001 for all).

Overall quality of life (QoL), as per Dermatology Life Quality Index (DLQI) score, was also improved from baseline with roflumilast vs vehicle cream in DERMIS-1 (LS mean percentage change, -27.4 percent vs -2.4 percent [week 2], -51.2 percent vs -16.8 percent [week 4], and -65.2 percent vs -12.7 percent [week 8]) and DERMIS-2 (LS mean percentage change, -36.6 percent vs +15.0 percent [week 2], -46.8 percent vs -2.9 percent [week 4], and -69.4 percent vs -9.0 percent [week 8]; p≤0.0002 for all).

Treatment-related and application-site adverse event (AE) rates were low and comparable between treatment arms, as were AE-related discontinuations. There were no treatment-related serious AEs. The most common treatment-emergent AEs (>2 percent) were hypertension, headache, diarrhoea, psoriasis, and nasopharyngitis.

A new non-steroidal treatment for plaque psoriasis

“Itch is the most burdensome and frequently reported symptom of psoriasis,” remarked study author Dr Melinda Gooderham from the Skin Centre for Dermatology, Probity Medical Research and Queen’s University, Peterborough, Ontario, Canada.

“Once-daily treatment with roflumilast cream 0.3% provided significant, consistent, and sustained improvements in the severity and burden of itch and QoL in patients with chronic plaque psoriasis compared with vehicle cream, with early onset of action,” she continued.

“These studies support the potential use of roflumilast as an effective and well-tolerated non-steroidal topical therapy for improving patient burden and QoL in patients with chronic plaque psoriasis,” she concluded.