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Original Article

Efficacy and safety of ixekizumab versus adalimumab in patients with active psoriatic arthritis and moderate-to-severe psoriasis: 52-week results from the randomised SPIRIT-H2H trial

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Abstract

Introduction: The randomised, 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 clearance of skin lesions (Psoriasis Area and Severity Index [PASI]100) in biologic-naïve patients with active psoriatic arthritis (PsA) and plaque psoriasis (PsO) at Week 24. Additionally, this higher efficacy of ixekizumab versus adalimumab was maintained through Week 52.


Objectives: This analysis aimed to investigate the 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 analysed 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 analysed 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 treatment 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 also showed higher response rates for nail PsO clearance and for reporting minimal or no impact on quality of life at Week 24.

Keywords : ixekizumab, adalimumab, SPIRIT-H2H, nail psoriasis, psoriasis

References

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