Clinical Outcomes Following a Switch from Remicade® to the Biosimilar CT-P13 in Inflammatory Bowel Disease Patients: A Prospective Observational Cohort Study.
OBJECTIVE
The biosimilar of Remicade®, CT-P13, recently entered the European market. Clinical data on switching from Remicade® to CT-P13 in inflammatory bowel disease [IBD] are scarce. We aimed to prospectively investigate efficacy, safety, pharmacokinetic profile, and immunogenicity following a switch from Remicade® to CT-P13 in IBD patients.


METHODS
Remicade®-treated IBD patients at the Radboud university medical centre who switched to CT-P13 were included in this prospective observational cohort study. Primary endpoint was change in Harvey-Bradshaw Index for Crohn's disease [CD] and Simple Clinical Colitis Activity Index for ulcerative colitis [UC] at week 16. We measured C-reactive protein [CRP], faecal calprotectin [FCP], infliximab trough level [TL] and anti-drug antibodies [ADAs] and documented adverse events.


RESULTS
Our cohort consisted of 83 patients (28 males, 57 CD, 24 UC, 2 IBD-unclassified [IBD-U]). The median age was 36 years, range 18-79. Median change in disease activity was 0 [range -23 to +7] for CD and 0 [range -3 to +6] for UC/IBD-U. Median CRP and FCP levels did not change significantly during follow-up. Median TL increased from 3.5 µg/ml [range 0-18] to 4.2 µg/ml [range 0-21] at week 16 [p = 0.010]. Two patients developed a new detectable ADA response during follow-up and five patients discontinued CT-P13. No serious adverse events occurred.


CONCLUSIONS
We demonstrated that switching from Remicade® to CT-P13 in a real-life cohort of IBD patients did not have a significant impact on short-term clinical outcomes. These results suggest that switching from Remicade® to CT-P13 for the treatment of IBD is feasible.
Inflammatory Bowel Disease Centre, Department of Gastroenterology and Hepatology, Radboud university medical centre, Nijmegen, The Netherlands.
Lisa J T
LJ
Smits
Inflammatory Bowel Disease Centre, Department of Gastroenterology and Hepatology, Radboud university medical centre, Nijmegen, The Netherlands.
Lauranne A A P
LA
Derikx
Inflammatory Bowel Disease Centre, Department of Gastroenterology and Hepatology, Radboud university medical centre, Nijmegen, The Netherlands.
Dirk J
DJ
de Jong
Sanquin Diagnostic Services, Biologics Laboratory, Amsterdam, The Netherlands.
Ronald S
RS
Boshuizen
Inflammatory Bowel Disease Centre, Department of Gastroenterology and Hepatology, Radboud university medical centre, Nijmegen, The Netherlands.
Aura A J
AA
van Esch
Inflammatory Bowel Disease Centre, Department of Gastroenterology and Hepatology, Radboud university medical centre, Nijmegen, The Netherlands.
Joost P H
JP
Drenth
Inflammatory Bowel Disease Centre, Department of Gastroenterology and Hepatology, Radboud university medical centre, Nijmegen, The Netherlands Frank.Hoentjen@radboudumc.nl.
Frank
F
Hoentjen
D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D002097:C-Reactive Protein / Q000032:analysis; D003093:Colitis, Ulcerative / Q000188:drug therapy; D003424:Crohn Disease / Q000188:drug therapy; D057915:Drug Substitution; D005243:Feces / Q000737:chemistry; D005260:Female; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D000069285:Infliximab / Q000627:therapeutic use*; D039841:Leukocyte L1 Antigen Complex / Q000032:analysis; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals; C000591237:CT-P13; D005765:Gastrointestinal Agents; D039841:Leukocyte L1 Antigen Complex; D002097:C-Reactive Protein; D000069285:Infliximab
Inflammatory bowel disease; biosimilar; switch