The New England Journal of Medicine publishes positive phase IIb trial of topical roflumilast cream for chronic plaque psoriasis.- Arcutis Biotherapeutics.

Arcutis Biotherapeutics, Inc. ,announced that The New England Journal of Medicine has published positive results from a Phase IIb trial of its investigational drug topical roflumilast cream for the treatment of chronic plaque psoriasis . The article has been published in the July 16 issue of the journal.

These results demonstrate that ARQ 151 (roflumilast cream) administered once daily was superior to a matching vehicle in treating psoriasis, as measured by a rating of clear or almost clear at week six on the Investigator Global Assessment (IGA) scale.

Roflumilast cream (ARQ 151) is a once-daily, highly potent, selective phosphodiesterase-4 (PDE-4) inhibitor being developed for chronic plaque psoriasis. Arcutis is currently conducting a Phase III clinical program with topical roflumilast cream, including two ongoing Phase III clinical trials (DERMIS-1 and -2). The company anticipates topline data from the Phase III studies in the first half of 2021.

In the Phase IIb, 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.

See- “Trial of Roflumilast Cream for Chronic Plaque Psoriasis”- Mark G. Lebwohl, M.D., Kim A. Papp, M.D., Ph.D., Linda Stein Gold, M.D., Melinda J. Gooderham, M.D., Leon H. Kircik, M.D., , et al., for the ARQ-151 201 Study Investigators-July 16, 2020. N Engl J Med 2020; 383:229-239 DOI: 10.1056/NEJMoa2000073.