Patient and clinician reported outcomes of calcipotriol/betamethasone dipropionate PAD-cream for the treatment of adult patients with scalp psoriasis under real-world conditions: results from the prospective, non-interventional, multicentre PRO-SCALP study.

Abstract

The novel cream formulation of calcipotriol and betamethasone dipropionate based on polyaphron dispersion technology (CAL/BDP PAD-cream), has shown promising results on psoriasis in phase 3 clinical trials. However, real-world data on scalp are limited. To assess clinician-reported outcomes (ClinROs) and patient-reported outcomes (PROs) of CAL/BDP PAD-cream in adults with mild-to-moderate scalp psoriasis under real-world conditions in Europe. PRO-SCALP is a prospective, non-interventional, multicentre, cohort study conducted between June 2023 and October 2024 in Germany, Spain and the United Kingdom. Data were collected at baseline and Week 8 (end of study, EOS). PROs included Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9), Scalpdex questionnaire, Worst Itch-Numerical Rating Scale (WI-NRS), sleep disturbances, Psychosocial Effects of Scalp Psoriasis Questionnaire and adherence. ClinROs included treatment satisfaction and physician global assessment of scalp (scalp-PGA) and scalp-modified Psoriasis Area and Severity Index (S-mPASI). 253 patients (mean age: 47.9 years; 65.2% females) had evaluable data. 59.9% of them reported high adherence (visual analogue scale score 80-100). At EOS, mean (standard deviation) global satisfaction (TSQM-9) was 76.0 (21.6) and 77.6% of patients achieved a scalp-PGA score of 0/1 (clear/almost clear). Moreover, 68.4% achieved scalp-PGA success (scores of 0/1 and ≥2-point improvement). WI-NRS, S-mPASI and Scalpdex scores improved significantly (p<0.0001) from baseline to EOS. Sleep patterns and psychosocial outcomes also improved. CAL/BDP PAD-cream is associated with high treatment satisfaction and improved clinical outcomes and quality of life in the real-world management of scalp psoriasis.