Published online Dec 14, 2018. doi: 10.3748/wjg.v24.i46.5288
Peer-review started: August 29, 2018
First decision: October 14, 2018
Revised: November 18, 2018
Accepted: December 7, 2018
Article in press: December 7, 2018
Published online: December 14, 2018
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.
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.
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.
98 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.
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.
Core tip: Although not strictly necessary, there are few studies comparing efficacy and safety of the switch from infliximab original (Remicade®) to infliximab biosimilar CT-P13 vs the maintenance of the original infliximab. For this reason, we presented a comparative study with the original infliximab. Our observational study demonstrates the real-life clinical results of efficacy and safety of infliximab original and the efficacy and safety after switching from original infliximab to infliximab biosimilar CT-P13 at the 12 mo follow-up. Our results demonstrate there is no statistical difference in remission rate, secondary loss of response or adverse events between both therapies.