英夫利昔单抗生物类似药SB2使用的真实世界证据：来自PERFUSE研究的数据。
Real-world evidence of the use of the infliximab biosimilar SB2: data from the PERFUSE study.
作者信息
Fautrel Bruno, Bouhnik Yoram, Dieude Philippe, Richette Pascal, Dougados Maxime, Freudensprung Ulrich, Brigui Amira, Addison Janet
机构信息
Rheumatology Department, Pitié-Salpêtrière Hospital, Sorbonne University, AP-HP, Paris, France.
Pierre Louis Institute for Epidemiology and Public Health, INSERM UMRS 1136, Paris, France.
出版信息
Rheumatol Adv Pract. 2023 Apr 17;7(2):rkad031. doi: 10.1093/rap/rkad031. eCollection 2023.
OBJECTIVE
PERFUSE is a non-interventional study of 1233 adult patients (rheumatology, =496; IBD, =737) receiving routine infliximab (IFX) biosimilar SB2 therapy. The aim of this report was to investigate the 12-month persistence, effectiveness and safety outcomes of routine SB2 treatment in patients with chronic inflammatory rheumatic disease.
METHODS
Patients with a diagnosis of RA, PsA or axial spondyloarthritis (axSpA) were assigned to one of three study cohorts according to whether SB2 treatment initiated after September 2017 had been the first IFX treatment (IFX naïve) or followed transition from reference IFX (IFX ref) or another IFX biosimilar (IFX bs). Outcomes to month 12 (±2) included persistence (primary outcome), SB2 dose, disease status, immunogenicity and safety.
RESULTS
At month 12, persistence on SB2 in IFX-naïve, IFX ref and IFX bs cohorts, respectively, [mean percentage (95% CI)] by indication was as follows: 59% (36.1, 76.2), 75% (57.5, 86.1) and 85% (69.6, 93.0) for RA ( = 98); 64% (34.3, 83.3), 87% (65.6, 95.7) and 83% (60.0, 93.1) for PsA ( = 62); and 56% (44.4, 66.5), 80% (70.8, 86.1) and 80% (72.5, 85.6) for axSpA ( = 336). Disease activity was comparable at baseline and month 12 within the IFX ref and bs subgroups of all cohorts by indication. No immunogenicity concerns or new safety signals were detected.
CONCLUSION
SB2 was safe and effective in IFX-naïve patients and in patients transitioned from prior IFX ref or bs.
TRIAL REGISTRATION
clinicaltrials.gov, NCT03662919.
目的
PERFUSE是一项针对1233例成年患者（风湿病患者496例；炎症性肠病患者737例）的非干预性研究，这些患者接受常规英夫利昔单抗（IFX）生物类似药SB2治疗。本报告旨在研究慢性炎症性风湿病患者常规SB2治疗的12个月持续率、有效性和安全性结果。
方法
根据2017年9月后开始的SB2治疗是否为首次IFX治疗（初治IFX）或是否由参照IFX（IFX ref）或另一种IFX生物类似药（IFX bs）转换而来，将诊断为类风湿关节炎（RA）、银屑病关节炎（PsA）或中轴型脊柱关节炎（axSpA）的患者分配到三个研究队列之一。至第12个月（±2）的结果包括持续率（主要结果）、SB2剂量、疾病状态、免疫原性和安全性。
结果
在第12个月时，初治IFX、IFX ref和IFX bs队列中，按适应症划分的SB2持续率[平均百分比（95%置信区间）]如下：RA患者（n = 98）分别为59%（36.1，76.2）、75%（57.5，86.1）和85%（69.6，93.0）；PsA患者（n = 62）分别为64%（34.3，83.3））、87%（65.6，95.7）和83%（60.0，93.1）；axSpA患者（n = 336）分别为56%（44.4，66.5）、80%（70.8，86.1）和80%（72.5，85.6）。在所有队列按适应症划分的IFX ref和bs亚组中，基线和第12个月时的疾病活动度相当。未检测到免疫原性问题或新的安全信号。
结论
SB2在初治IFX患者以及由先前IFX ref或bs转换而来的患者中安全有效。
试验注册
clinicaltrials.gov，NCT03662919。
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