Switching From Originator Adalimumab to the Biosimilar SB5 in Patients With Inflammatory Bowel Disease: Short-term Experience From a Single Tertiary Clinical Centre
Switching From Originator Adalimumab to the Biosimilar SB5 in Patients With Inflammatory Bowel Disease: Short-term Experience From a Single Tertiary Clinical Centre
复制标题
DOI：
10.1093/ecco-jcc/jjaa001
复制
发表时间：
2020-07-01
影响因子：
8
通讯作者：
Lukas, Milan
中科院分区：
文献类型：
--
作者：
Lukas, Martin;Malickova, K.;Lukas, Milan
背景和目的：患者从原始单抗转向生物相似单抗后的观点还有待评估。我们评估了炎症性肠病[IBD]患者从始发者转向生物相似化合物[SB5]的疗效。方法：对在IBD Center ISCARE中从始发者转向生物相似的ADA单抗[SB5]的IBD患者的数据进行分析。使用标准临床指数(克罗恩病的Harvey-Bradshaw指数[Hbi]和溃疡性结肠炎的部分Mayo评分[UC])和实验室参数(C-反应蛋白[CRP]和粪便钙保护蛋白[FC])来评估疾病活动性。测定谷值和抗药物抗体。结果：共有93名患者改用生物相似的阿达单抗[CD86%]，在年龄、性别、诊断和疾病活动性方面与93名对照组相匹配。在0周和10周之间，转换组和发起组的疾病活动性没有差异。同样，在两个预先指定的时间点，队列之间也没有发现差异。此外，在W0和W10之间，无论是在交换组还是在始发队列中，都没有看到CRP或Fc浓度的显著差异[p>；0.05]。阿达利单抗血清谷值在转换后保持稳定。没有检测到新的安全信号。结论：我们的研究证实，将IBD患者从最初的阿达利单抗改为生物相似的化合物[SB5]不会影响治疗效果。
Background and Aims: Patients' perspectives after switching from originator to biosimilar adalimumab have yet to be assessed. We evaluated the efficacy of switching from the originator adalimumab to a biosimilar compound [SB5] in patients with inflammatory bowel disease [IBD].Methods: Data on IBD patients who were switched from the originator to biosimilar adalimumab [SB5] at IBD Center ISCARE were analysed. Disease activity was assessed using standard clinical indices (Harvey-Bradshaw index [HBI] for Crohn's disease [CD] and partial Mayo score for ulcerative colitis [UC]), and laboratory parameters (C-reactive protein [CRP] and faecal calprotectin [FC]). Trough levels and anti-drug antibodies were measured. Patients were evaluated 10 weeks [W10] after the switch, and results were compared with the control group of patients on originator compound.Results: A total of 93 patients switched to biosimilar adalimumab were included [CD 86%] and were matched to 93 controls for age, gender, diagnosis, and disease activity. There was no difference in the disease activity in either SWITCH or ORIGINATOR cohorts between Weeks 0 and 10. Similarly, no difference was found between cohorts at both prespecified time points. Moreover, no significant differences in CRP or FC concentrations were seen between W0 and W10 either in the SWITCH, or in the ORIGINATOR cohort [p>0.05]. Adalimumab serum trough levels remained stable after the switch. No new safety signals were detected.Conclusions: Our study confirmed that switching IBD patients from the originator adalimumab to a biosimilar compound [SB5] does not affect treatment efficacy.