- Il presente studio ha descritto gli effetti di roflumilast in crema sugli obiettivi correlati al prurito nei pazienti con psoriasi in un trial di fase 2b.
- I pazienti trattati con roflumilast hanno ottenuto miglioramenti significativamente maggiori rispetto a quelli trattati con il veicolo.
- La severità del prurito ha avuto una bassa correlazione con il PASI, mentre WI-NRS e IGA non sono risultati sempre allineati. Roflumilast in crema ha migliorato il prurito e i disturbi del sonno correlati al prurito nei pazienti con psoriasi cronica in placche.
Abstract
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.
Conclusions and perspectives
Roflumilast cream improved itch and itch-related sleep loss associated with chronic plaque psoriasis.