预填充注射器自行注射司库奇尤单抗在52周内维持斑块状银屑病严重程度的减轻：FEATURE试验结果
Secukinumab Self-Administration by Prefilled Syringe Maintains Reduction of Plaque Psoriasis Severity Over 52 Weeks: Results of the FEATURE Trial.
作者信息
Gottlieb Alice B, Blauvelt Andrew, Prinz Jörg C, Papanastasiou Philemon, Pathan Rashidkhan, Nyirady Judit, Fox Todd, Papavassilis Charis
出版信息
J Drugs Dermatol. 2016 Oct 1;15(10):1226-1234.
BACKGROUND
Secukinumab, a human monoclonal antibody that selectively targets interleukin-17A, is highly efficacious in the treatment of moderate-to-severe psoriasis, starting at early time points, with a sustained effect and a favorable safety profile.
METHODS
Patients with moderate-to-severe plaque psoriasis were randomized to secukinumab 300 mg, secukinumab 150 mg, or placebo self-administered by prefilled syringe at baseline, weeks 1, 2, and 3, and then every four weeks from week 4 to 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 to week 52. Patient-reported usability of the prefilled syringe was evaluated by the Self-Injection Assessment Questionnaire to week 48.
RESULTS
The efficacy of secukinumab increased to week 16 and was maintained to week 52. With secukinumab 300 mg at week 52, PASI 75/90/100 and IGA mod 2011 0/1 responses were achieved by 83.5%/68.0%/47.5% and 71.5% of patients when analyzed by multiple imputation, respectively, and by 75.9%/62.1%/43.1% and 63.8% of patients when analyzed by nonresponder imputation, respectively. With secukinumab 150 mg at week 52, PASI 75/90/100 and IGA mod 2011 0/1 responses were achieved by 63.5%/50.3%/31.1% and 43.6% of patients when analyzed by multiple imputation, respectively, and by 61.0%/49.2%/30.5% and 42.4% of patients when analyzed by nonresponder imputation, respectively. Self-reported acceptability of the prefilled syringe was high throughout the study. The incidence of adverse events (AE) was well balanced between groups, with AEs reported in 74.4% of patients receiving secukinumab 300 mg and 77.3% of patients receiving secukinumab 150 mg. Nasopharyngitis was the most common AE across both secukinumab groups.
CONCLUSION
Self-administration of secukinumab by prefilled syringe was associated with robust and sustained efficacy and a favorable safety profile up to week 52.
J Drugs Dermatol. 2016;15(10):1226-1234.
背景
司库奇尤单抗是一种选择性靶向白细胞介素-17A的人源单克隆抗体，在治疗中度至重度银屑病方面疗效显著，起效早，疗效持久，安全性良好。
方法
中度至重度斑块状银屑病患者被随机分为三组，分别接受300mg司库奇尤单抗、150mg司库奇尤单抗或安慰剂治疗，通过预填充注射器在基线、第1、2和3周自行给药，然后从第4周开始至第48周每四周给药一次。测量至第52周时的疗效反应（银屑病面积和严重程度指数改善≥75/90/100%[PASI 75/90/100]以及根据2011年改良版研究者整体评估[IGA mod 2011 0/1]达到皮肤清除/几乎清除）。通过自我注射评估问卷评估预填充注射器在患者报告中的易用性，直至第48周。
结果
司库奇尤单抗的疗效在第16周时升高，并维持至第52周。在第52周时，采用多重填补法分析，接受300mg司库奇尤单抗治疗的患者中，分别有83.5%/68.0%/47.5%和71.5%达到PASI 75/90/100以及IGA mod 2011 0/1反应；采用无反应者填补法分析，分别有75.9%/62.1%/43.1%和63.8%的患者达到上述反应。在第52周时，采用多重填补法分析，接受150mg司库奇尤单抗治疗的患者中，分别有63.5%/50.3%/31.1%和43.6%达到PASI 75/90/100以及IGA mod 2011 0/1反应；采用无反应者填补法分析，分别有61.0%/49.2%/30.5%和42.4%的患者达到上述反应。在整个研究过程中，预填充注射器的自我报告可接受性较高。各组不良事件（AE）的发生率均衡，接受300mg司库奇尤单抗治疗的患者中74.4%报告发生AE，接受150mg司库奇尤单抗治疗的患者中77.3%报告发生AE。鼻咽炎是两个司库奇尤单抗组中最常见的AE。
结论
通过预填充注射器自行注射司库奇尤单抗，在至第52周时具有强大且持续的疗效以及良好的安全性。
《皮肤药物学杂志》2016年；15(10):1226 - 1234。
Zotero 插件