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使用自动注射器给药司库奇尤单抗在52周内持续减轻斑块状银屑病的严重程度:随机对照JUNCTURE试验的结果

Secukinumab administration by autoinjector maintains reduction of plaque psoriasis severity over 52 weeks: results of the randomized controlled JUNCTURE trial.

作者信息

Lacour J-P, Paul C, Jazayeri S, Papanastasiou P, Xu C, Nyirady J, Fox T, Papavassilis C

机构信息

Department of Dermatology, University Hospital of Nice, Nice, France.

Department of Dermatology, Paul Sabatier University, Toulouse, France.

出版信息

J Eur Acad Dermatol Venereol. 2017 May;31(5):847-856. doi: 10.1111/jdv.14073. Epub 2017 Jan 23.

Abstract

BACKGROUND

User satisfaction is an important factor associated with treatment adherence in chronic diseases including moderate-to-severe psoriasis.

OBJECTIVE

To evaluate the efficacy, safety and patient acceptability of 300 and 150 mg secukinumab - a fully human anti-interleukin-17A monoclonal antibody that has demonstrated efficacy in the treatment of patients with moderate-to-severe plaque psoriasis - self-administered by autoinjection.

METHODS

Patients with moderate-to-severe plaque psoriasis were randomized to secukinumab 300 mg, secukinumab 150 mg or placebo self-administered by autoinjection at baseline, Weeks 1, 2 and 3 and then every 4 weeks from Week 4 to Week 48. Efficacy responses [≥75/90/100% improvement in Psoriasis Area and Severity Index (PASI 75/90/100) and clear/almost clear skin by Investigator's Global Assessment 2011 modified version (IGA mod 2011 0/1)] were measured at Week 52. Patient-reported usability of the autoinjector was evaluated by the self-injection assessment questionnaire to Week 48.

RESULTS

At Week 52 with secukinumab 300 mg, PASI 75/90/100 and IGA mod 2011 0/1 responses were achieved by 81.4/64.1/38.8% and 69.6% of patients, respectively, by multiple imputation. At Week 52 with secukinumab 150 mg, PASI 75/90/100 and IGA mod 2011 0/1 responses were achieved by 75.2/57.4/33.1% and 60.2% of patients, respectively, by multiple imputation. Patient-assessed acceptability of the autoinjector remained high to Week 48. The proportion of patients experiencing adverse events was greater with secukinumab 300 mg (88.6%) than with secukinumab 150 mg (78.7%).

CONCLUSION

Self-administration of secukinumab using an autoinjector was associated with robust and sustained efficacy, a good safety profile and high acceptability.

摘要

背景

患者满意度是包括中度至重度银屑病在内的慢性疾病治疗依从性的一个重要相关因素。

目的

评估300毫克和150毫克司库奇尤单抗(一种全人源抗白细胞介素-17A单克隆抗体,已证明对中度至重度斑块状银屑病患者的治疗有效)通过自动注射自我给药的疗效、安全性和患者可接受性。

方法

中度至重度斑块状银屑病患者在基线、第1、2和3周随机接受300毫克司库奇尤单抗、150毫克司库奇尤单抗或安慰剂自动注射自我给药,然后从第4周开始至第48周每4周给药一次。在第52周测量疗效反应[银屑病面积和严重程度指数(PASI 75/90/100)改善≥75/90/100%以及根据2011年改良版研究者整体评估(IGA mod 2011 0/1)皮肤清除/几乎清除]。通过自我注射评估问卷对自动注射器的患者报告可用性评估至第48周。

结果

在第52周,使用300毫克司库奇尤单抗时,通过多重填补法,分别有81.4/64.1/38.8%的患者达到PASI 75/90/100,69.6%的患者达到IGA mod 2011 0/1反应。在第52周,使用150毫克司库奇尤单抗时,通过多重填补法,分别有75.2/57.4/33.1%的患者达到PASI 75/90/100,60.2%的患者达到IGA mod 2011 0/1反应。至第48周,患者评估的自动注射器可接受性仍然很高。发生不良事件的患者比例在300毫克司库奇尤单抗组(88.6%)高于150毫克司库奇尤单抗组(78.7%)。

结论

使用自动注射器自我注射司库奇尤单抗具有强大且持续的疗效、良好的安全性和高可接受性。

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