TY - JOUR
T1 - Effect of Roflumilast Cream (ARQ-151) on Itch and Itch-Related Sleep Loss in Adults with Chronic Plaque Psoriasis
T2 - Patient-Reported Itch Outcomes of a Phase 2b Trial
AU - Stein Gold, Linda
AU - Alonso-Llamazares, Javier
AU - Draelos, Zoe D.
AU - Gooderham, Melinda J.
AU - Kempers, Steven E.
AU - Kircik, Leon H.
AU - Lebwohl, Mark G.
AU - Papp, Kim A.
AU - Pariser, David M.
AU - Toth, Darryl P.
AU - Yosipovitch, Gil
AU - Higham, Robert C.
AU - Feng, Amy
AU - Berk, David R.
N1 - Publisher Copyright:
© 2022, The Author(s).
PY - 2023/3
Y1 - 2023/3
N2 - Background: Itch is the most bothersome symptom reported by patients with psoriasis. Safe and effective treatments for psoriasis that also address itch are needed. Objectives: To report effects of roflumilast cream on itch-related outcomes from a Phase 2b trial. Methods: Adults with chronic plaque psoriasis were randomized to roflumilast 0.3%, roflumilast 0.15%, or vehicle once-daily for 12 weeks. Psoriasis severity was assessed via the Investigator Global Assessment (IGA; a 5-point scale assessing plaque thickening, scaling, and erythema ranging from 0 [clear] to 4 [severe]) and ≥ 2 on a modified Psoriasis Area and Severity Index (PASI-HD, which combines severity of lesions and area affected, ranging from 0 [no disease] to 72 [maximal disease], with the actual percentage of the anatomical area involved in those patients with < 10% of anatomical area involved [e.g., 0.1 for 1% to 0.9 for 9%]). Itch was evaluated via Worst Itch Numeric Rating Scale (WI-NRS), Psoriasis Symptom Diary (PSD) Items 1 (severity of itch) and 2 (bother of itch), and itch-related sleep loss NRS scores. Post hoc correlation analyses between WI-NRS and PASI, WI-NRS and itch-related sleep loss, and WI-NRS and DLQI were also performed. Results: Roflumilast-treated patients had significantly greater improvements than vehicle-treated patients in WI-NRS and PSD Items 1 and 2 beginning at Week 2 and in itch-related sleep loss Weeks 6 through 12. Among patients with baseline WI-NRS ≥ 6, significantly more patients achieved ≥ 4-point improvement with roflumilast than with vehicle as early as Week 2. Itch severity had low correlation with PASI while WI-NRS and IGA were not always aligned. Limitations: The first assessment was at 2 weeks, limiting the ability to assess early onset of itch response. Conclusion: Roflumilast cream improved itch and itch-related sleep loss associated with chronic plaque psoriasis. ClinicalTrials.gov identifier: NCT03638258.
AB - Background: Itch is the most bothersome symptom reported by patients with psoriasis. Safe and effective treatments for psoriasis that also address itch are needed. Objectives: To report effects of roflumilast cream on itch-related outcomes from a Phase 2b trial. Methods: Adults with chronic plaque psoriasis were randomized to roflumilast 0.3%, roflumilast 0.15%, or vehicle once-daily for 12 weeks. Psoriasis severity was assessed via the Investigator Global Assessment (IGA; a 5-point scale assessing plaque thickening, scaling, and erythema ranging from 0 [clear] to 4 [severe]) and ≥ 2 on a modified Psoriasis Area and Severity Index (PASI-HD, which combines severity of lesions and area affected, ranging from 0 [no disease] to 72 [maximal disease], with the actual percentage of the anatomical area involved in those patients with < 10% of anatomical area involved [e.g., 0.1 for 1% to 0.9 for 9%]). Itch was evaluated via Worst Itch Numeric Rating Scale (WI-NRS), Psoriasis Symptom Diary (PSD) Items 1 (severity of itch) and 2 (bother of itch), and itch-related sleep loss NRS scores. Post hoc correlation analyses between WI-NRS and PASI, WI-NRS and itch-related sleep loss, and WI-NRS and DLQI were also performed. Results: Roflumilast-treated patients had significantly greater improvements than vehicle-treated patients in WI-NRS and PSD Items 1 and 2 beginning at Week 2 and in itch-related sleep loss Weeks 6 through 12. Among patients with baseline WI-NRS ≥ 6, significantly more patients achieved ≥ 4-point improvement with roflumilast than with vehicle as early as Week 2. Itch severity had low correlation with PASI while WI-NRS and IGA were not always aligned. Limitations: The first assessment was at 2 weeks, limiting the ability to assess early onset of itch response. Conclusion: Roflumilast cream improved itch and itch-related sleep loss associated with chronic plaque psoriasis. ClinicalTrials.gov identifier: NCT03638258.
UR - https://www.scopus.com/pages/publications/85141683105
U2 - 10.1007/s40257-022-00739-3
DO - 10.1007/s40257-022-00739-3
M3 - Article
AN - SCOPUS:85141683105
SN - 1175-0561
VL - 24
SP - 305
EP - 313
JO - American Journal of Clinical Dermatology
JF - American Journal of Clinical Dermatology
IS - 2
ER -