Long-Term Clinical Outcomes After Switching from Remicade® to Biosimilar CT-P13 in Inflammatory Bowel Disease

Abstract

BackgroundLimited data are available on long-term clinical outcomes regarding the switch from Remicade® to the infliximab biosimilar CT-P13 in inflammatory bowel disease (IBD) patients.AimsTo investigate long-term efficacy, safety, pharmacokinetic profile, and immunogenicity.MethodsWe performed a single-center prospective observational cohort study following an elective switch from Remicade® to CT-P13 in IBD patients.ResultsEighty-three patients were included (57 Crohn’s disease, 24 ulcerative colitis, and 2 IBD unclassified), and 68 patients completed one-year follow-up. Disease activity (Harvey–Bradshaw Index and Simple Clinical Colitis Activity Index) as well as inflammatory markers (CRP, fecal calprotectin) did not change significantly during the 1-year follow-up. In total, 7 out of 83 patients (8%) demonstrated detectable antidrug antibodies during follow-up, and 5 out of 7 antidrug antibody titers were already detectable at baseline prior to switching. Six patients (7%) discontinued CT-P13 due to adverse events.ConclusionsFollowing a switch from Remicade® to CT-P13, 82% of IBD patients continued treatment through 1 year. Disease activity scores and inflammatory markers remained unchanged during follow-up, and no CT-P13-related serious adverse events occurred. These 1-year data suggest that switching to CT-P13 in Remicade®-treated IBD patients is safe and feasible.

Long‐term efficacy and safety of CT‐P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: A retrospective multicenter study

“…Another prospective study by Smits et al . including 83 IBD patients who switched from infliximab to CT‐P13, also documented that 82% continued CT‐P13 therapy through 1‐year follow‐up without serious adverse events or significant changes in disease activity . Additionally, a prospective study from Spain reported that 83.9% (47/56) of CD and 91.3% (21/23) of UC patients who were in remission at the time of the switch to CT‐P13 from reference infliximab maintained remission at month 6 of therapy .…”

“…32 Another prospective study by Smits et al including 83 IBD patients who switched from infliximab to CT-P13, also documented that 82% continued CT-P13 therapy through 1-year follow-up without serious adverse events or significant changes in disease activity. 33 Additionally, a prospective study from Spain reported that 83.9% (47/56) of CD and 91.3% (21/23) of UC patients who were in remission at the time of the switch to CT-P13 from reference infliximab maintained remission at month 6 of therapy. 18 In line with the results of previous studies, our study showed that a fairly large proportion (44.8% of CD and 42.5% of UC patients) who switched to CT-P13 from its originator continued CT-P13 therapy without disease worsening until the end of follow-up, with a median follow-up of 45 months (IQR 27.0-54.5).…”

The effectiveness and safety of infliximab compared with biosimilar CT‐P13, in 3112 patients with ulcerative colitis

“…Other prospective studies of CT‐P13 in inflammatory bowel disease patients have been published and provide reassuring results. However, none of these studies, except for a subgroup of one study, directly compared CT‐P13 and RP. In the light of these results, larger and longer‐term studies are needed.…”

“…However, none of these studies, [6][7][8][9][10][11] except for a subgroup of one study, 12 directly compared CT-P13 and RP. In the light of these results, larger and longer-term studies are needed.…”

Biosimilar Drugs for Inflammatory Bowel Disease: Is Similar Good Enough?

“…In from branded IFX (originator) to the IFX biosimilar CT-P13, after which they were followed for 1 year [5]. Both the disease activity, evaluated by Harvey-Bradshaw Index (HBI) for CD and Simple Clinical Colitis Activity Index (SCCAI) for UC and IBD-U, and the inflammatory biomarkers, including C-reactive protein (C-RP) and fecal calprotectin (FCP) did not change during the follow-up year.…”