Secukinumab treatment leads to normalization of quality of life and disease symptoms in psoriasis patients with or without prior systemic psoriasis therapy: the PROSE study results

Abstract

Introduction Psoriatic disease is associated with considerable impairment of Quality of life (QoL). The PROSE study (NCT02752776) investigated the impact of secukinumab treatment on patient‐reported outcomes (PRO) in patients with moderate‐to‐severe psoriasis stratified by their treatment history. Methods PROSE was a prospective, non‐randomised, multicentre study. Patients were categorized at baseline according to treatment history as naïve (naïve to any systemic therapy [N=663]), conventional systemic (previously exposed to ≥1 conventional systemic (CS) therapy [N=673]), and biologics (previously exposed to ≥1 biologic therapy [N=324]). QoL PROs, efficacy and safety of secukinumab 300 mg were assessed for a period of 52 weeks. Results The primary objective was met with 70.8% patients achieving a Dermatology Life Quality Index (DLQI) 0/1 response at Week 16 (naϊve, 74.7%; CS, 71.3%; biologic, 61.7%), with effects sustained up to Week 52. Mean Family‐DLQI (FDLQI) score decreased from 11.5 at baseline (naϊve, 11.3; CS, 11.4; biologic, 12.1) to 2.5 at Week 16 (naϊve, 2.5; CS, 2.3; biologic: 3.5). Substantial improvements in EuroQoL 5‐Dimension Health Questionnaire, Numeric Rating Scale for pain, itching and scaling, Health Assessment Questionnaire‐Disability Index, Treatment Satisfaction Questionnaire for Medication, and Patient Benefit Index were also observed at Week 16. The QoL gains were associated with substantial improvements in Psoriasis Area and Severity Index and Investigator Global Assessment mod 2011 0/1 response. No meaningful difference was observed in the efficacy or QoL improvements across patient subpopulations. All QoL and efficacy parameter improvements were sustained up to Week 52. Secukinumab treatment was well‐tolerated, and no new safety signals were observed. Conclusion Secukinumab treatment resulted in complete normalization of QoL in a substantial proportion of psoriasis patients, and their families, regardless of their prior treatment history.