Real-World Insights Into First-Line Use of Topical Roflumilast Cream for Psoriasis

Abstract

Roflumilast cream 0.3% was approved for the treatment of plaque psoriasis in patients aged ≥12 years in July 2022 and for patients aged 6-11 years in October 2023. This real-world analysis was conducted to understand treatment patterns among patients who filled a roflumilast cream prescription for plaque psoriasis.

A retrospective administrative claims analysis of the IQVIA PharMetrics Plus database (2021–2024) was conducted to evaluate treatment patterns among patients initiating roflumilast cream 0.3% for plaque psoriasis. The index date was defined as the first claim for roflumilast cream 0.3%, with 6-month pre- and post-index periods to assess prior, subsequent, and/or concomitant therapies.

There were 1213 patients with a claim for roflumilast cream 0.3%, most (69%) treated with roflumilast monotherapy; 2 (<1%) initiated roflumilast cream in combination with a biologic agent. There were 303 patients (25%) with no psoriasis treatment in the 6-month pre-index period. Of these treatment-naive patients, 259 (83%) initiated topical roflumilast monotherapy. Among 44 patients who initiated roflumilast cream in a combination regimen, 39 (89.6%) used another topical agent, 2 (4.5%) an oral phosphodiesterase 4 inhibitor (PDE4), and 2 (4.5%) a biologic agent. Within the 6-month post-index period, 14/303 (4.6%) treatment-naive patients initiated a biologic agent.

In this real-world analysis, a substantial portion of patients used roflumilast cream 0.3% as first-line therapy for plaque psoriasis, the majority as monotherapy. Most treatment-naive patients who initiated topical roflumilast as monotherapy did not initiate a subsequent treatment during the 6-month follow-up period, and only a small portion escalated to biologic therapy or an oral PDE4 inhibitor. Among patients who initiated roflumilast cream, <1% (2/303) did so in combination with a biologic agent. These findings suggest that roflumilast cream 0.3% is frequently utilized as a monotherapy and an initial treatment option, suggesting topical roflumilast may help delay or reduce the need for oral and biologic therapy in routine clinical practice.

Sponsored by Arcutis Biotherapeutics, Inc.