Spataru Teodora, Popescu Remus, State Monica, Pahomeanu Mihai, Mateescu Bogdan, Negreanu Lucian
Gastroenterology 1 Department, University Hospital, Carol Davila University, 020021 București, Romania.
Gastroenterology Department, Colentina Hospital, Carol Davila University, 020021 București, Romania.
Pharmaceuticals (Basel). 2024 Oct 2;17(10):1319. doi: 10.3390/ph17101319.
During the last two decades, an increased number of molecules with multiple mechanisms of action have been approved for the treatment of inflammatory bowel disease (IBD), with a substantial increase in the costs related to therapy, which has become a concern for payers, regulators, and healthcare professionals. Biosimilars are biologic medical products that are highly structurally similar to their reference products; have no clinically meaningful differences in terms of immunogenicity, safety, or effectiveness; and are available at a lower price. This was an observational prospective study conducted in two IBD centres in Bucharest and included 53 patients, 27 male (M) and 26 female (F), diagnosed with IBD according to standard clinical, endoscopic, radiological, and histological criteria, who were non-medically switched at the indication of the National Insurance House to a biosimilar of Adalimumab. The aim was to determine the rates of clinical remission, adverse effects, and treatment persistence at one year. No significant differences were found in terms of the faecal calprotectin (FC) and C-reactive protein (CRP) levels 6 and 12 months after changing from the originator biologic treatment to a biosimilar. Only one patient required a change in their biological treatment following the clinical and biological loss of response. The main adverse effect reported by the patients was pain at the injection site. Of the 53 patients, only 2 reported pain at the injection site, and 1 patient reported experiencing abdominal pain and rectal bleeding immediately after the switch, but no recurrence was observed clinically or endoscopically. : This observational study is the first to be carried out in Romania that shows that, after a non-medical switch, biosimilars of Adalimumab are as efficient and safe as the originator Adalimumab in the clinical treatment of patients with IBD.
在过去二十年中，越来越多具有多种作用机制的分子被批准用于治疗炎症性肠病（IBD），治疗相关成本大幅增加，这已成为支付方、监管机构和医疗保健专业人员关注的问题。生物类似药是在结构上与参照产品高度相似的生物医学产品；在免疫原性、安全性或有效性方面没有临床意义上的差异；且价格更低。这是一项在前瞻性观察研究，在布加勒斯特的两个IBD中心进行，纳入了53例患者，其中27例男性（M）和26例女性（F），根据标准的临床、内镜、放射学和组织学标准诊断为IBD，在国家保险公司的指示下非医疗性换用阿达木单抗生物类似药。目的是确定一年时的临床缓解率、不良反应率和治疗持续性。从原研生物制剂治疗换用生物类似药后6个月和12个月，粪便钙卫蛋白（FC）和C反应蛋白（CRP）水平方面未发现显著差异。仅1例患者在临床和生物学反应丧失后需要更换生物治疗。患者报告的主要不良反应是注射部位疼痛。在53例患者中，仅2例报告注射部位疼痛，1例患者在换药后立即报告出现腹痛和直肠出血，但临床和内镜检查均未观察到复发。：这项观察性研究是在罗马尼亚开展的首例研究，表明在非医疗性换药后，阿达木单抗生物类似药在IBD患者的临床治疗中与原研阿达木单抗一样有效且安全。
