Real-world experience and long-term outcomes of a mandatory nonmedical switch of adalimumab originator to biosimilars in inflammatory bowel disease  

作　　者：Jeremy Liu Chen Kiow Thomas Hoang Harjot K Bedi Zhina Majdzadeh Ardekani Daniel Rosenfeld Marica Reise-Filteau Brian Bressler Yvette Leung Greg Rosenfeld 

机构地区：[1]Department of Medicine,Division of Gastroenterology,Montreal University Hospital Centre(CHUM),Montreal H2X 3E4,Quebec,Canada [2]Department of Gastroenterology,St.Paul’s Hospital,Vancouver V6Z 1Y6,British Columbia,Canada [3]Department of Medicine,University of British Columbia,Vancouver V6T 1Z4,British Columbia,Canada [4]Department of Gastroenterology,IBD Centre of BC,Vancouver V6Z 2L2,British Columbia,Canada [5]Department of Medicine,University of Western Ontario,London N6A 3K7,Ontario,Canada

出　　处：《World Journal of Gastroenterology》2024年第46期4904-4913,共10页世界胃肠病学杂志（英文）

摘　　要：BACKGROUND Over the last decade,the treatment options for inflammatory bowel disease(IBD)have significantly progressed with the emergence of new medications designed to target various immune pathways and mitigate inflammation.Adalimumab(ADA)is a tumor necrosis factor alpha antagonist and stands as an effective treatment for IBD.In April 2021,the province of British Columbia implemented a mandatory non-medical switch policy of the ADA originator Humira®to ADA biosimilars.Biosimilars offer a potential cost-effective,safe,and efficacious alternative to the originator,yet there remains limited real-world evidence on long-term outcomes of ADA non-medical switching in IBD.AIM To assess the long-term outcomes of non-medical switching from the ADA originator Humira®to an ADA biosimilar among IBD patients.METHODS A retrospective observational chart review study was conducted on IBD patients eligible for the provincially mandated non-medical switch to an ADA biosimilar.The primary outcome was treatment persistence at 30 months post-switch.Secondary outcomes included the proportion of and reasons for therapy alteration or ADA discontinuation,loss of response(LOR)rates,adverse events(AE),and clinical and biochemical remission status.Patients who remained on the originator throughout the switch period,through compassionate support or private pay,constituted the comparison group.RESULTS Patients in the originator(n=43)and biosimilar switch(n=228)groups displayed similar demographics and baseline disease characteristics.By the study endpoint of 30 months,there was no difference in the rate of treatment persistence in either group(n=36,83.7%originator group vs n=201,88.2%biosimilar group,P=0.451).Treatment persistence demonstrated similar rates of discontinuation between both study groups(log-rank P=0.543).There was a numerical but not statistically significant difference in rates of adverse outcomes between either group(39.5%originator vs 28.9%biosimilars,P=0.206).This included comparable rates of LOR(27.9%vs 17.5%)or AE(11.6

关 键 词：Inflammatory bowel disease Ulcerative colitis Crohn’s disease BIOLOGICS ADALIMUMAB Biosimilar switch 

分 类 号：R574[医药卫生—消化系统]