- Lo studio randomizzato, in aperto, in cieco, a gruppi paralleli SPIRIT-H2H ha dimostrato la superiorità di ixekizumab su adalimumab nel raggiungimento simultaneo dei sintomi articolari (ACR50) e della clearance cutanea (PASI 100) in pazienti naïve ai biologici con artrite psoriasica attiva e psoriasi a placche alla settimana 24.
- Una maggiore efficacia di ixekizumab rispetto ad adalimumab è stata mantenuta fino alla settimana 52.
Abstract
Introduction
The randomized, open-label, assessor-blinded, parallel-group SPIRIT-H2H trial (NCT03151551) demonstrated superiority of ixekizumab over adalimumab in simultaneously achieving improvement in joint symptoms (American College of Rheumatology [ACR]50) and skin clearance (Psoriasis Area and Severity Index [PASI]100) in biologic-naïve patients with active psoriatic arthritis (PsA) and plaque psoriasis (PsO) at Week (W) 24. Higher efficacy of ixekizumab versus adalimumab was maintained through W52.
Objectives
This analysis investigated efficacy and safety of ixekizumab and adalimumab in the subgroup of patients with PsA and moderate-to-severe PsO through W52.
Methods
Efficacy and safety outcomes were analyzed in patients with PsA and moderate-to-severe PsO (PASI ≥12, Body Surface Area ≥10%, static Physician Global Assessment ≥3) through W52. Categorical and continuous outcomes were analyzed using logistic regression models and mixed model for repeated measures, respectively.
Results
More ixekizumab-versus adalimumab-treated patients simultaneously achieved PASI100 and ACR50 at W24 (40.8% versus 17.6%, p = 0.015) and W52 (38.8% versus 17.6%, p = 0.026). Likewise, more ixekizumab-versus adalimumab-treated patients achieved PASI100 (59.2% versus 25.5%, p = 0.001) and PASI90 (81.6% versus 60.8%, p = 0.028) through W52, and nail PsO clearance at W24. Joint symptom improvements were comparable between groups. No new safety findings were reported.
Conclusions
Ixekizumab had higher efficacy than adalimumab in simultaneous achievement of ACR50 and PASI100 at W24 and W52 in patients with PsA and moderate-to-severe PsO. Ixekizumab-treated patients showed higher response rates for nail PsO clearance and for reporting minimal or no impact on quality of life at W24.