Reich Kristian, Kristensen Lars Erik, Smith Saxon D, Rich Phoebe, Sapin Christophe, Leage Soyi Liu, McKenzie Robert, Schuster Christopher, Riedl Elisabeth, Gooderham Melinda
Center for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Musculoskeletal Statistics Unit, The Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
Dermatol Pract Concept. 2022 Apr 1;12(2):e2022104. doi: 10.5826/dpc.1202a104. eCollection 2022 May.
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.
This analysis investigated efficacy and safety of ixekizumab and adalimumab in the subgroup of patients with PsA and moderate-to-severe PsO through W52.
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.
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.
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.
随机、开放标签、评估者盲法、平行组SPIRIT-H2H试验（NCT03151551）表明，在初治的活动性银屑病关节炎（PsA）和斑块状银屑病（PsO）患者中，在第24周时，司库奇尤单抗在同时改善关节症状（美国风湿病学会[ACR]50）和皮肤清除率（银屑病面积和严重程度指数[PASI]100）方面优于阿达木单抗。司库奇尤单抗相对于阿达木单抗的更高疗效维持至第52周。
本分析研究了司库奇尤单抗和阿达木单抗在PsA和中度至重度PsO患者亚组中至第52周的疗效和安全性。
对PsA和中度至重度PsO（PASI≥12、体表面积≥10%、静态医生整体评估≥3）患者至第52周的疗效和安全性结果进行分析。分类和连续性结果分别使用逻辑回归模型和重复测量混合模型进行分析。
在第24周（40.8%对17.6%，P=0.015）和第52周（38.8%对17.6%，P=0.026），接受司库奇尤单抗治疗的患者比接受阿达木单抗治疗的患者更多地同时达到PASI100和ACR50。同样，在第52周，接受司库奇尤单抗治疗的患者比接受阿达木单抗治疗的患者更多地达到PASI100（59.2%对25.5%，P=0.001）和PASI90（81.6%对60.8%，P=0.028），以及在第24周时甲部PsO清除。两组之间关节症状改善情况相当。未报告新的安全性发现。
在PsA和中度至重度PsO患者中，司库奇尤单抗在第24周和第52周同时实现ACR50和PASI100方面比阿达木单抗疗效更高。接受司库奇尤单抗治疗的患者在第24周时甲部PsO清除率和报告对生活质量影响最小或无影响的反应率更高。
