Correlation of Itch Response to Roflumilast Cream with Disease Severity and Patient-Reported Outcomes in Patients with Chronic Plaque Psoriasis

Document Type

Conference Proceeding

Publication Date

10-27-2021

Publication Title

J Cutan Med Surg

Abstract

Introduction: Roflumilast cream is a nonsteroidal, selective phosphodiesterase-4 inhibitor in development for plaque psoriasis (PsO). Methods, Results: A Phase 2b, double-blinded trial randomized adults with PsO (2-20% body surface area) to oncedaily roflumilast 0.3%, roflumilast 0.15%, or vehicle for 12 weeks (NCT03638258).1 Throughout the trial, itch and its impact were evaluated via patientreported outcomes (PROs): Worst Itch Numeric Rating Scale (WI-NRS), Itchrelated Sleep Loss (IRSL), and Dermatology Life Quality Index (DLQI). This posthoc analysis reports correlation of WI-NRS with other PROs and with disease severity. Overall, 331 patients were randomized (109 to roflumilast 0.3%, 113% to 0.15%, and 109 to vehicle). At baseline, the mean WI-NRS score was 5.87. Throughout the trial, both roflumilast doses showed similar improvements in WI-NRS starting at Week 2 and were significantly superior to vehicle (P ≤ 0.002). At baseline, Pearson correlation coefficients (PCCs) for WI-NRS and Psoriasis Area and Severity Index (PASI) were 0.189, 0.282, 0.205 for roflumilast 0.3%, roflumilast 0.15%, and vehicle, respectively (P ≤ 0.033 for all correlations); for WI-NRS and IRSL: 0.548, 0.646, 0.652 (P < 0.001); for WI-NRS and DLQI: 0.445, 0.617, 0.422 (P < 0.001). At Week 8, PCCs for WI-NRS and PASI were 0.420, 0.409, 0.365 (P < 0.001); for WI-NRS and IRSL: 0.673, 0.725, 0.696 (P < 0.001); for WI-NRS and DLQI: 0.607, 0.823, 0.529. Treatment with roflumilast resulted in rapid and robust improvement in the severity of itch associated with PsO. Conclusions: Itch response to roflumilast was independent of disease severity and positively correlated with patient-reported sleeploss and quality of life improvement. 1Lebwohl MG, et al. N Engl J Med. 2020;383(3):229-239. Learning Objective To understand the impact of itch and itch-related sleep loss on patients with psoriasis To understand the efficacy of once-daily roflumilast on the patientreported outcomes of Worst Itch Numeric Rating Scale, Itchrelated Sleep Loss, and Dermatology Life Quality Index. To understand the association between itch and other patient-reported outcomes with disease severity scores. Takeaway Message Treatment with roflumilast reduced severity of itch associated with psoriasis, which was independent of disease severity and positively correlated with patient-reported sleep loss and quality of life improvement.

Volume

25

Issue

1 SUPPL

First Page

77S

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