Loss of efficacy and safety of the switch from infliximab original to infliximab biosimilar(CT-P13)in patients with inflammatory bowel disease

BACKGROUND Infliximab original has changed the natural history of inflammatory bowel diseases(IBD) over the past two decades. However, the recent expiration of its patent has allowed the entry of the first Infliximab biosimilar into the European and Spanish markets. Currently switching drugs data in IBD are limited. AIM To compare the efficacy of infliximab biosimilar, CT-P13, against infliximab original, analyzing the loss of response of both at the 12 mo follow-up in patients with IBD.METHODS An observational study of two cohorts has been conducted. One retrospective cohort that included patients with IBD treated with Infliximab original, and a prospective cohort of patients who were switching from infliximab original to infliximab biosimilar(CT-P13). We had analyzed the overall efficacy and loss of efficacy in patients in remission at the end of one year after treatment with the original drug compared to the results of the year of treatment with the biosimilar.RESULTS98 patients(CD 67, CU 31) were included in both cohorts. The overall efficacy for infliximab original per year of treatment was 71% vs 68.2% for infliximab biosimilar(P = 0.80). The loss of overall efficacy at 12 mo for infliximab original was 6.6% vs 14.5% for infliximab biosimilar(P = 0.806). The loss of efficacy in patients who were in basal remission was 16.3% for infliximab original vs 27.1% for infliximab biosimilar. Adverse events were 9.2% for infliximab original vs 11.2% for infliximab biosimilar. CONCLUSION The overall efficacy and loss of treatment response with infliximab biosimilar(CT-P13) is similar to that observed with infliximab original in patients who were switching at the 12 mo follow-up. There is no difference in the rate of adverse events.

Real-world data on the infliximab biosimilar CT-P13 (Remsima®) in inflammatory bowel disease

BACKGROUND In recent years,biological therapies have revolutionized the management of inflammatory bowel disease(IBD);however,they are expensive.The development of biosimilar products has allowed us to reduce healthcare costs and improve patients’access to these treatments.Although various studies support the similarity between infliximab and its biosimilar CT-P13 in terms of efficacy and safety,there are unmet needs regarding research on these agents in the context of IBD.AIM To analyze clinical response rates to CT-P13 and adverse events in IBD patients treated in real-life practice.METHODS An observational,prospective,multicenter study of IBD patients treated with CTP13 in clinical practice who were naïve to biological treatments or failed to respond to other anti-tumor necrosis factor drugs or had switched from infliximab originator was carried out.No diagnostic or follow-up interventions were conducted on patients outside usual clinical practice.The primary endpoints were clinical response rates and number of adverse events.The primary efficacy variable was the proportion of patients who were in clinical remission and/or had a clinical response at 3,6,9,and 12 mo.RESULTS A total of 220 IBD patients treated with CT-P13(Remsima®)were included in the study:87(40%)with ulcerative colitis and 133(60%)with Crohn’s disease.Mean age of the patients was 41.47(SD 15.74)years,and 58%were female.Nineteen(9%)patients started treatment with CT-P13 after switching from infliximab.Of the remaining 201 patients,142(65%)were naïve to biologic agents.At baseline,68.6%(n=138/201)of patients presented with active disease.After 12 mo of treatment,14.8%(n=12/81)presented with active disease,and 64.2%(n=52/81)were in clinical remission without corticosteroids.After 3 mo,75.5%(n=115/152)had a clinical response or achieved clinical remission,which was sustained for 12 mo(85.2%;n=69/81).There was a decrease in specific IBD indices at 3,6,9,and 12 mo(P<0.001).A total of 34 adverse events were reported by 27(12.3%)patients,9(26.5%)of which were serious.CONCLUSION CT-P13 is an effective and safe infliximab biosimilar for the treatment of IBD in real-life practice and may be a valid and attractive alternative for the treatment of IBD.

生物仿制药治疗炎症性肠病的研究进展

生物仿制药是一种在质量、安全性和功效方面与已被授权使用的生物治疗产品相似的"生物治疗产品"。在过去20年中,英夫利西单抗等生物制剂的应用使炎症性肠病(IBD)的治疗策略发生了革命性变化,但生物制剂高昂的成本也给患者以及社会带来了沉重的经济负担,生物仿制药的研发与应用有望改善这一状况。该文就用于治疗IBD的生物仿制药的研发背景、研发过程、种类、安全性、免疫原性、药代动力学、与原生物制剂的互换性以及临床应用前景作一综述。