司库奇尤单抗与瑞莎珠单抗治疗中度至重度斑块状银屑病患者的疗效与安全性比较（IMMerge）：一项III期随机开放标签、疗效评估者设盲临床试验的结果
Efficacy and safety of risankizumab vs. secukinumab in patients with moderate-to-severe plaque psoriasis (IMMerge): results from a phase III, randomized, open-label, efficacy-assessor-blinded clinical trial.
作者信息
Warren R B, Blauvelt A, Poulin Y, Beeck S, Kelly M, Wu T, Geng Z, Paul C
机构信息
The Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, Manchester, UK.
Oregon Medical Research Centre, Portland, OR, USA.
出版信息
Br J Dermatol. 2021 Jan;184(1):50-59. doi: 10.1111/bjd.19341. Epub 2020 Sep 6.
BACKGROUND
Patients with plaque psoriasis treated with biologic therapies need more efficacious, safe and convenient treatments to improve quality of life. Risankizumab and secukinumab inhibit interleukin-23 and interleukin-17A, respectively, and are effective in adult patients with moderate-to-severe plaque psoriasis but have different dosing regimens.
OBJECTIVES
To compare directly the efficacy and safety of risankizumab vs. secukinumab over 52 weeks.
METHODS
IMMerge was an international, phase III, multicentre, open-label, efficacy-assessor-blinded, active-comparator study, in which adult patients with chronic, moderate-to-severe plaque psoriasis were randomized in a 1 : 1 ratio to treatment with risankizumab 150 mg or secukinumab 300 mg. Primary efficacy endpoints were the proportions of patients achieving ≥ 90% improvement from baseline in Psoriasis Area and Severity Index (PASI 90) at week 16 (noninferiority comparison with margin of 12%) and week 52 (superiority comparison).
RESULTS
In total 327 patients from nine countries were treated with risankizumab (n = 164) or secukinumab (n = 163). Risankizumab was noninferior to secukinumab in the proportion of patients achieving PASI 90 at week 16 [73·8% vs. 65·6%; difference of 8·2%, 96·25% confidence interval (CI)-2·2 to 18·6; within the 12% noninferiority margin] and superior to secukinumab at week 52 (86·6% vs. 57·1%; difference of 29·8%, 95% CI 20·8-38·8; P < 0·001), thus meeting both primary endpoints. All secondary endpoints (PASI 100, static Physician's Global Assessment 0 or 1, and PASI 75) at week 52 demonstrated superiority for risankizumab vs. secukinumab (P < 0·001). No new safety concerns were identified.
CONCLUSIONS
At week 52, risankizumab demonstrated superior efficacy and similar safety with less frequent dosing compared with secukinumab.
背景
接受生物疗法治疗的斑块状银屑病患者需要更有效、安全且便捷的治疗方法来改善生活质量。瑞莎珠单抗和司库奇尤单抗分别抑制白细胞介素-23和白细胞介素-17A，对中度至重度斑块状银屑病成年患者有效，但给药方案不同。
目的
直接比较瑞莎珠单抗与司库奇尤单抗在52周内的疗效和安全性。
方法
IMMerge是一项国际、III期、多中心、开放标签、疗效评估者设盲、活性对照研究，将慢性中度至重度斑块状银屑病成年患者按1:1比例随机分为接受150mg瑞莎珠单抗或300mg司库奇尤单抗治疗。主要疗效终点为在第16周（非劣效性比较，界值为12%）和第52周（优效性比较）达到银屑病面积和严重程度指数（PASI）较基线改善≥90%（PASI 90）的患者比例。
结果
来自9个国家的327例患者接受了瑞莎珠单抗（n = 164）或司库奇尤单抗（n = 163）治疗。在第16周达到PASI 90的患者比例方面，瑞莎珠单抗不劣于司库奇尤单抗[73.8%对65.6%；差异为8.2%，96.25%置信区间（CI）-2.2至18.6；在12%的非劣效性界值内]，且在第52周优于司库奇尤单抗（86.6%对57.1%；差异为29.8%，95%CI 20.8 - 38.8；P < 0.001），因此达到了两个主要终点。第52周时所有次要终点（PASI 100、静态医师整体评估为0或1、PASI 75）均显示瑞莎珠单抗优于司库奇尤单抗（P < 0.001）。未发现新的安全问题。
结论
在第52周时，与司库奇尤单抗相比，瑞莎珠单抗疗效更优、安全性相似且给药频率更低。
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