Switch from Infliximab to Infliximab-dyyb for Rheumatology Indications

A. Spoto, Katie Pitcher, R. Hui, Aeris Lautchang
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Abstract

Introduction Multiple expert panels at Kaiser Permanente approved infliximab-dyyb (Inflectra®), a biosimilar to the reference product infliximab (Remicade®), to be the preferred infliximab agent for therapeutic substitution from infliximab for adult patients with dermatologic, rheumatologic, and/or gastroenterologic diagnoses. The objective of this study was to assess the safety and effectiveness of infliximab-dyyb for Kaiser Permanente Northern California patients with psoriatic and rheumatoid arthritis who switched from infliximab to infliximab-dyyb. Methods This was an observational, data-only, non-inferiority study assessing adult patients with a rheumatologic condition of psoriatic arthritis (PsA) or rheumatoid arthritis (RA) who were switched from infliximab to infliximab-dyyb or used infliximab continuously in the Northern California region of Kaiser Permanente from May 2017 through May 2018. Both groups were followed for 12 months. The primary effectiveness outcome was disease worsening requiring acute care defined as emergency room visit or hospitalization related to the rheumatologic condition or orthopedic surgery intervention. Non-inferiority was set at an upper limit of 4%. Results A total of 70 individuals were identified as continuing infliximab and 727 individuals were switched to infliximab-dyyb. There were 2 patients (2.9%) in the infliximab group and 22 patients (3.0%) in the infliximab-dyyb group who experienced disease worsening requiring acute care (P = 0.03 for non-inferiority). Conclusion There was no increased risk of disease worsening requiring acute care in patients with RA or PsA who switched from infliximab to infliximab-dyyb when compared to patients who remained on infliximab in this population.
从英夫利昔单抗切换到英夫利昔单抗-dyyb风湿病适应症
Kaiser Permanente的多个专家小组批准了英夫利昔单抗-dyyb (Inflectra®),一种参考产品英夫利昔单抗(Remicade®)的生物类似药,作为英夫利昔单抗治疗皮肤病、风湿病和/或胃肠病诊断的成人患者的首选替代药物。本研究的目的是评估英夫利昔单抗-dyyb对于从英夫利昔单抗转为英夫利昔单抗-dyyb的北加州Kaiser Permanente银屑病和类风湿关节炎患者的安全性和有效性。方法:这是一项观察性、仅限数据、非劣效性研究,评估了2017年5月至2018年5月在Kaiser Permanente北加州地区患有银屑病关节炎(PsA)或类风湿性关节炎(RA)的成人风湿病患者,这些患者从英夫利昔单抗切换到英夫利昔单抗-dyyb或连续使用英夫利昔单抗。两组随访12个月。主要疗效指标是疾病恶化,需要紧急护理,定义为风湿病或骨科手术干预相关的急诊室就诊或住院。非劣效性设定在4%的上限。结果共有70例患者被确定为英夫利昔单抗持续用药,727例患者改用英夫利昔单抗-dyyb。英夫利昔单抗组有2例患者(2.9%),英夫利昔单抗-dyyb组有22例患者(3.0%)出现疾病恶化需要急性护理(非劣效性P = 0.03)。结论:与继续使用英夫利昔单抗的患者相比,RA或PsA患者从英夫利昔单抗切换到英夫利昔单抗-dyyb的疾病恶化需要急性护理的风险没有增加。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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