Abstract：
UNASSIGNED: Infliximab (IFX) biosimilars are available to treat inflammatory bowel disease (IBD), offering cost reductions versus originator IFX in some jurisdictions. However, concerns remain regarding the efficacy and safety of originator-to-biosimilar switching. This systematic literature review evaluated safety and effectiveness of switching between IFX products in patients with IBD, including multiple switchers.
UNASSIGNED: Embase, PubMed, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials were searched to capture studies (2012-2022) including patients with IBD who switched between approved IFX products. Effectiveness outcomes: disease activity; disease severity; response to treatment; patient-reported outcomes (PROs). Safety outcomes: incidence and rate of adverse events (AEs); discontinuations due to AEs, failure rate; hospitalizations; surgeries. Immunogenicity outcomes (n, %): anti-drug antibodies; patients receiving concomitant immunomodulatory medication.
UNASSIGNED: Data from 85 publications (81 observational, two randomized controlled trials) were included. Clinical effectiveness outcomes were consistent with the known profile of originator IFX with no difference after switching. There were no unexpected/serious AEs after switching, and rates of AEs were generally consistent with the known profile of IFX.
UNASSIGNED: Most studies reported that clinical, PROs, and safety outcomes for originator-to-biosimilar switching were clinically equivalent to originator responses. Limited data are available regarding multiple switches.
UNASSIGNED: www.crd.york.ac.uk/prospero identifier is CRD42021289144.
UNASSIGNED: Embase, PubMed, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials were searched to capture studies (2012-2022) including patients with IBD who switched between approved IFX products. Effectiveness outcomes: disease activity; disease severity; response to treatment; patient-reported outcomes (PROs). Safety outcomes: incidence and rate of adverse events (AEs); discontinuations due to AEs, failure rate; hospitalizations; surgeries. Immunogenicity outcomes (n, %): anti-drug antibodies; patients receiving concomitant immunomodulatory medication.
UNASSIGNED: Data from 85 publications (81 observational, two randomized controlled trials) were included. Clinical effectiveness outcomes were consistent with the known profile of originator IFX with no difference after switching. There were no unexpected/serious AEs after switching, and rates of AEs were generally consistent with the known profile of IFX.
UNASSIGNED: Most studies reported that clinical, PROs, and safety outcomes for originator-to-biosimilar switching were clinically equivalent to originator responses. Limited data are available regarding multiple switches.
UNASSIGNED: www.crd.york.ac.uk/prospero identifier is CRD42021289144.
摘要：
■英夫利昔单抗（IFX）生物仿制药可用于治疗炎症性肠病（IBD），在某些司法管辖区提供与发起人IFX相比的成本降低。然而,对发起人转换为生物类似药的有效性和安全性仍然存在担忧。本系统文献综述评估了IBD患者在IFX产品之间切换的安全性和有效性。包括多个切换器。
■Embase,PubMed,Cochrane系统评价数据库，搜索Cochrane中央对照试验登记册以捕获研究（2012-2022年），其中包括IBD患者在批准的IFX产品之间切换。有效性结果：疾病活动；疾病严重程度；对治疗的反应；患者报告的结果（PRO）。安全性结果：不良事件（AE）的发生率和发生率；由于AE而导致的停药，失败率；住院；手术。免疫原性结果（n，%）：抗药物抗体；接受伴随免疫调节药物的患者。
■来自85种出版物的数据(81种观测数据，纳入两项随机对照试验)。临床有效性结果与初始IFX的已知概况一致,转换后无差异。切换后无意外/严重不良事件发生,AE的发生率通常与IFX的已知概况一致。
■大多数研究报告说，临床，PROs,并且,从始发者转换为生物类似药的安全性结果在临床上与始发者的反应相当.关于多个交换机的可用数据有限。
■www.crd.约克。AC.uk/prospro标识符为CRD42021289144。
■Embase,PubMed,Cochrane系统评价数据库，搜索Cochrane中央对照试验登记册以捕获研究（2012-2022年），其中包括IBD患者在批准的IFX产品之间切换。有效性结果：疾病活动；疾病严重程度；对治疗的反应；患者报告的结果（PRO）。安全性结果：不良事件（AE）的发生率和发生率；由于AE而导致的停药，失败率；住院；手术。免疫原性结果（n，%）：抗药物抗体；接受伴随免疫调节药物的患者。
■来自85种出版物的数据(81种观测数据，纳入两项随机对照试验)。临床有效性结果与初始IFX的已知概况一致,转换后无差异。切换后无意外/严重不良事件发生,AE的发生率通常与IFX的已知概况一致。
■大多数研究报告说，临床，PROs,并且,从始发者转换为生物类似药的安全性结果在临床上与始发者的反应相当.关于多个交换机的可用数据有限。
■www.crd.约克。AC.uk/prospro标识符为CRD42021289144。
