Elford Alexander T, Heldt Rishni, Kamal Shahed, Christensen Britt, Segal Jonathan P
Faculty of Medicine, University of Melbourne.
Department of Gastroenterology, Royal Melbourne Hospital, Melbourne, Victoria, Australia.
Eur J Gastroenterol Hepatol. 2025 Jan 1;37(1):47-54. doi: 10.1097/MEG.0000000000002850. Epub 2024 Sep 12.
Biologic therapies are commonly used for inflammatory bowel disease (IBD) patients. Multiple biologic medicines can now be given both intravenously and subcutaneously. The different administration routes present provide different advantages regarding dose escalation, healthcare resource utilisation, pharmacokinetics, convenience and safety. Comparator effectiveness studies between intravenous and subcutaneous administration are lacking.
Our primary outcome was to compare the effectiveness between intravenous and subcutaneous biologics in rates of clinical remission.
We performed a systematic review and meta-analysis to include all relevant articles from MEDLINE ( Ovid ), EMBASE , PubMed and Cochrane Central Register of Controlled Trials from 1 January 2003 to 28 January 2024. Studies that compared intravenous and subcutaneous administration of the same biologic therapy in IBD patients and reported effectiveness outcomes were included. This study was registered on PROSPERO (CRD42023442675).
Twenty studies met the inclusion criteria for the systematic review. Nine vedolizumab cohort studies were meta-analysed for clinical remission and no difference was found in clinical remission rates between intravenous and subcutaneous administration (relative risk = 0.99; 95% confidence interval: 0.88, 1.11). Six infliximab cohort studies were meta-analysed for clinical remission and no difference was found in clinical remission rates between intravenous and subcutaneous administration (relative risk = 0.91; 95% confidence interval: 0.77, 1.08).
Our findings in the first meta-analysis comparing the effectiveness of intravenous and subcutaneous biologic therapies in IBD suggest there is no difference in the effectiveness between these two administration routes. However, further high-quality studies, particularly head-to-head studies are needed to confirm this finding.
生物疗法常用于炎症性肠病(IBD)患者。现在多种生物药物既可以静脉注射给药,也可以皮下注射给药。不同的给药途径在剂量递增、医疗资源利用、药代动力学、便利性和安全性方面具有不同优势。缺乏静脉注射和皮下注射给药之间的比较有效性研究。
我们的主要结局是比较静脉注射和皮下注射生物制剂在临床缓解率方面的有效性。
我们进行了一项系统评价和荟萃分析,纳入了2003年1月1日至2024年1月28日期间来自MEDLINE(Ovid)、EMBASE、PubMed和Cochrane对照试验中央注册库的所有相关文章。纳入比较IBD患者中相同生物疗法静脉注射和皮下注射给药并报告有效性结局的研究。本研究已在PROSPERO(CRD42023442675)注册。
20项研究符合系统评价的纳入标准。对9项维多珠单抗队列研究进行了临床缓解的荟萃分析,静脉注射和皮下注射给药的临床缓解率没有差异(相对风险=0.99;95%置信区间:0.88,1.11)。对6项英夫利昔单抗队列研究进行了临床缓解的荟萃分析,静脉注射和皮下注射给药的临床缓解率没有差异(相对风险=0.91;95%置信区间:0.77,1.08)。
我们在第一项比较IBD中静脉注射和皮下注射生物疗法有效性的荟萃分析中的发现表明,这两种给药途径在有效性方面没有差异。然而,需要进一步的高质量研究,尤其是头对头研究来证实这一发现。