Published April 27, 2021
| Version v1
Publication
Long-term follow up after switching from original infliximab to an infliximab biosimilar: real-world data
Description
Background: Several studies have reported positive efficacy outcomes for patients with
inflammatory bowel disease treated with CT-P13, an infliximab biosimilar. Data from followup periods longer than 1 year are still scarce. Here, we assessed the long-term efficacy
data, loss of response and safety after switching from infliximab to CT-P13 in patients with
inflammatory bowel disease.
Methods: This was a prospective single-center observational study involving patients with
moderate-to-severe Crohn's disease and ulcerative colitis switched from infliximab to CT-P13
treatment and reviewed up to 24months. Efficacy and loss of response were measured using
the Harvey–Bradshaw (HB) index and partial Mayo score for patients with Crohn's disease and
ulcerative colitis respectively. C-reactive protein, infliximab drug levels, adverse events and
antidrug antibodies were also monitored throughout the study.
Results: A total of 64 patients with Crohn's disease and 36 patients with ulcerative colitis were
included. Most of them (72%) remained on CT-P13. Overall, 28% of patients discontinued the
therapy due to loss of response, adverse events or long-lasting clinical remission. Remission
at 18 and 24months occurred in 69.9% and 68.5% of patients, respectively. Dose increase was
performed in 22% of patients, with remission being reached in 60% of them. HB index, partial
Mayo score, C-reactive protein and infliximab drug levels did not show significant changes.
Serious adverse events were reported in 14% of patients. Overall, two patients developed low
levels of antidrug antibodies.
Conclusions: Most of the patients switching from original infliximab were maintained on CTP13 at 2years of follow up with a good profile of efficacy and safety.
Additional details
Identifiers
- URL
- https://idus.us.es/handle//11441/107965
- URN
- urn:oai:idus.us.es:11441/107965