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

Keywords

roflumilast, adult, body surface, clinical trial, conference abstract, controlled study, correlation coefficient, Dermatology Life Quality Index, disease severity assessment, double blind procedure, drug therapy, female, human, learning, major clinical study, male, numeric rating scale, outcome assessment, patient-reported outcome, phase 2 clinical trial, Psoriasis Area and Severity Index, psoriasis vulgaris, quality of life, randomized controlled trial, sleep

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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