The New England Journal of Medicine Publishes Results from Positive Phase 2b Trial of Arcutis’ ARQ-151 (Topical Roflumilast Cream) for the Treatment of Chronic Plaque Psoriasis - Seite 2

In the Phase 2b, double-blinded trial, a total of 331 adults with plaque psoriasis were randomly assigned in a 1:1:1 ratio to receive topical treatment with roflumilast cream 0.3%, 0.15%, or matching vehicle applied once daily for 12 weeks. 109 patients were treated with roflumilast cream 0.3%, 113 with 0.15% cream, and 109 with the vehicle. The primary efficacy outcome was Investigator Global Assessment (IGA, a 5-item scale assessing plaque thickening, scaling, and erythema, ranging from 0-clear to 4-severe) of clear or almost clear at week 6. Secondary outcomes included clear or almost clear plus a 2-grade improvement (IGA Success), IGA Success on an Intertriginous IGA, and change in Psoriasis Area and Severity Index (PASI).

The primary efficacy endpoint of an IGA score indicating clear or almost clear at Week 6 was 28 percent, 23 percent and 8 percent for roflumilast 0.3%, roflumilast 0.15% and vehicle (p<0.001 and p=0.004, vs vehicle for roflumilast 0.3% and 0.15%, respectively).  The secondary endpoint of an IGA score indicating clear or almost clear plus 2-grade improvement from baseline demonstrated that patients treated with both roflumilast doses showed separation from vehicle from Week 6 through Week 12, with Week 12 rates of 31% and 27% for roflumilast 0.3% and 0.15%, respectively, vs 14% for vehicle.  Among the approximately 15% of patients with baseline intertriginous psoriasis of at least mild severity, 14 of 15 (93%) patients treated with roflumilast 0.3% had an Intertriginous-IGA score of 0 (clear) at Week 12 compared with 3 of 17 (18%) patients in the vehicle group.  At Week 12, PASI-75 response rates (improvements in PASI from baseline of at least 75%) were 34% for roflumilast 0.3% vs 16% for vehicle. Application site reactions were less common in the roflumilast cream arms than the vehicle arm. Adverse events were reported in 39 percent, 27 percent and 30 percent of patients receiving roflumilast 0.3%, 0.15%, and vehicle, respectively. Ninety-seven percent of adverse events were rated mild or moderate in severity. In addition, 94 percent of patients completed the trial in the roflumilast 0.3% arm.

“The results from this Phase 2b study provide further evidence of the potential of roflumilast cream as a once-daily treatment for patients with plaque psoriasis who currently lack suitable treatment options,” said Frank Watanabe, Arcutis’ President and Chief Executive Officer. “We are pleased to share these results, which suggest topical roflumilast was well tolerated and efficacious, with the broader scientific community in such a prestigious journal.”