Background/Purpose: Nails are frequently involved in psoriasis and represent one of the most difficult to treat manifestations of the disease. This study evaluated the comparative efficacy of ixekizumab (IXE) and ustekinumab (UST) in the treatment of nail lesions during a head-to-head trial, IXORA-S.

Methods: In this Phase 3b, multicenter, randomized, double-blinded, parallel-group trial (IXORA-S, NCT02561806), patients with moderate-to-severe plaque psoriasis were randomized (1:1) to receive either IXE (160-mg starting dose, then 80 mg every 2 weeks for 12 weeks followed by 80 mg every 4 weeks; N=136) or UST (45 mg/90 mg weight-based dosing at Weeks 0, 4 and every 12 weeks thereafter per label; N=166). The primary endpoint was to determine if IXE was superior to UST, as measured by the proportion of patients achieving ≥ 90% improvement in Psoriasis Area and Severity Index (PASI 90) after 12 weeks of treatment. Nail Psoriasis Severity Index (NAPSI) was used to assess fingernail psoriasis for all patients presenting with nail involvement at baseline (NAPSI>0), and these patients were included in the present analysis. Each fingernail was scored for bed and matrix psoriasis, then scores were added to obtain total NAPSI fingernail scores ranging from 0 (no nail psoriasis) to 80 (severe nail psoriasis). Categorical data were assessed using logistic regression with weight and geographic region as factors at Weeks 12 and 24 and Fisher’s exact test at other time points. Missing data were imputed using non-responder imputation. Least squares (LS) means (95% CI) were calculated for NAPSI and treatment groups compared using covariance analysis with weight, geographic region, and baseline NAPSI score as factors.

Results: At week 12, a significantly higher proportion of patients treated with IXE achieved PASI 90 relative to UST (72.8% [n=99] vs 42.2% [n=70], p<0.001, respectively), thereby achieving the primary endpoint of IXORA-S.¹ At baseline, 84 IXE-treated (61.8%) and 105 UST-treated (63.3%) patients in IXORA-S had nail psoriasis. Mean NAPSI score at baseline was 28.3 (standard deviation [SD]: 19.9) for IXE-treated and 24.6 (SD: 20.1) for UST-treated patients. Statistically significant differences in percentage of patients achieving NAPSI=0 were first seen at Week 16, with 26 (31.0%) IXE-treated patients and 18 (17.1%) UST-treated patients reaching complete resolution of nail psoriasis (p=0.037). At Week 24, LS mean change from baseline NAPSI was -19.9 (-22.3, -17.5) and -13.2 (-15.4, -11.0) for patients treated with IXE and UST, respectively (p<0.001), and 41 (48.8%) patients treated with IXE achieved NAPSI=0 compared to 24 (22.9%) patients treated with UST (p=0.012).

Conclusion: Complete resolution of nail psoriasis was seen in significantly greater percentages of patients treated with IXE compared to UST at Week 24, even though improvement was observed in both groups over 24 weeks. Twenty-four weeks may be too early for full evaluation of nail psoriasis, and continued improvement can be expected through one year.

1. Reich et al. 2017 Comparison of ixekizumab with ustekinumab in moderate-to-severe psoriasis: 24-week results from IXORA-S, a Phase 3 study. Br J Dermatol. DOI: 10.1111/bjd.15666

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/comparison-of-ixekizumab-and-ustekinumab-efficacy-in-the-treatment-of-nail-lesions-of-patients-with-moderate-to-severe-plaque-psoriasis-24-week-data-from-a-phase-3-trial/