Roflumilast Cream 0.3% in Patients With Chronic Plaque Psoriasis: Individual Patient PASI and PASI-HD Responses: Pooled DERMIS-1 and DERMIS-2 Phase 3 Trials

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James Del Rosso
H. Chih-ho Hong
Leon Kircik
Melinda Gooderham
Mark Lebwohl
Kim Papp
Linda Stein Gold
Adelaide Hebert
Melissa Seal
David Krupa
David Chu
Patrick Burnett
David Berk
Robert Higham


roflumilast cream, psoriasis, Psoriasis Area and Severity Index, PASI, individual response, safety, tolerability, Investigator Global Assessment


Background: Roflumilast cream 0.3% is a highly potent phosphodiesterase 4 inhibitor approved as a nonsteroidal, once-daily treatment for patients with plaque psoriasis. Pooled efficacy and safety results from two Phase 3 clinical trials (DERMIS-1 and DERMIS-2) have been presented previously. The Psoriasis Area and Severity Index (PASI) is used to assess the severity of plaque psoriasis in clinical trials; however, PASI is not precise when the area of involvement is <10% of a given anatomic region. A modified version of the PASI, the PASI-high discrimination (PASI-HD), allows more precise assessment of psoriasis in body regions where <10% area is affected. We present individual patient responses using PASI and PASI-HD.

Methods: Patients aged ≥2 years with at least mild plaque psoriasis involving 2-20% body surface area were randomized 2:1 to apply roflumilast cream 0.3% or vehicle cream once daily for 8 weeks. The primary efficacy endpoint was Investigator Global Assessment (IGA) Success (score of Clear or Almost Clear plus ≥2-grade improvement from baseline) at Week 8. PASI and PASI-HD were used to measure disease severity; individual patient PASI and PASI-HD responses were plotted graphically. Safety and tolerability were also evaluated and were reported previously.

Results: Roflumilast- and vehicle-treated patients had similar baseline demographic and disease characteristics. At Week 8, statistically significantly more roflumilast- than vehicle-treated patients achieved IGA Success (39.9% vs. 6.5%; P<0.0001). Statistically significant differences favoring roflumilast were observed at Week 8 for percentages of patients achieving a 50% reduction in PASI (72.1% vs. 25.5%; P<0.0001), 75% reduction (40.3% vs. 6.5%, P<0.0001), 90% reduction (19.7% vs 2.3%; P<0.0001), and 100% reduction (12.3% vs 0.8%; P<0.001). Likewise, statistically significant differences favoring roflumilast were observed at Week 8 for percentages of patients achieving 50% reduction in PASI-HD (79.4% vs. 33.1%; P<0.0001), 75% reduction (59.9% vs. 17.9%, P<0.0001), 90% reduction (39.9% vs 9.1%; P<0.0001), and 100% reduction (12.3% vs 0.8%; P<0.0001). Roflumilast cream demonstrated low rates of application-site adverse events (AEs), treatment-related AEs, and discontinuations due to AEs, comparable to vehicle. At the first application of roflumilast cream 0.3% (day 1), 96% of patients reported no or mild sensation, increasing to 99% of patients at Weeks 4 and 8.

Conclusions: Roflumilast cream 0.3% provided greater improvement in IGA Success, PASI, and PASI-HD versus vehicle with favorable safety and tolerability in patients with psoriasis in two Phase 3 trials. PASI-HD provided higher discrimination of effects of treatment in areas with <10% involvement than the traditional PASI. Identifiers: DERMIS-1: NCT04211363; DERMIS-2: NCT04211389

Financial Disclosures: Arcutis Biotherapeutics, Inc.


1. Fredriksson T, et al. Dermatologica 1978;157:238–244.

2. Papp KA, et al. Dermatol Ther (Heidelb) 2021;11:1079–1083.

3. Lebwohl MG, et al. Poster presented at: American Academy of Dermatology, March 25–29, 2022, Boston, MA, USA.

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