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P565. An experience of anti-TNF biosimilar, CT-P13 use: clinical efficacy, safety and interchangeability in inflammatory bowel disease; a pilot study

H.W. Kang, Y.J. Lim, J.H. Kim, Y.-S. Kang, Dongguk University Ilsan Hospital, Department of Internal Medicine, Goyang, Korea, Republic of

Background

CT-P13 is the world's first biosimilar monoclonal antibody to infliximab, which was approved in South Korea and Europe recently for all the six indications of infliximab. However, this biosimilar was tested only in rheumatoid arthritis and ankylosing spondylitis, which demonstrated it is equivalent to originator in efficacy, safety and PK profile. Therefore, the extrapolation of its efficacy and safety appears scientifically challenging. In addition, interchangeability with its originator is another interesting area. We aimed to decribe efficacy, safety and interchangeability of CT-P13 in inflammatory bowel disease at a tertiary center.

Methods

A total of 17 subjects, who were diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) and were administered CT-P13 from November 2012 to October 2013 at Dongguk University Ilsan Hospital, were retrospectively enrolled. We analyzed medical records including the patients' characteristics, previous history of anti-TNF administration, response and remission to this biosimilar, disease flare-up and adverse drug reaction (ADR).

Results

Male to female ratio was 1.8. Mean age was 35.4 years (range, 15 to 57). Patients with UC was 9 cases and those with CD was 8 cases. Mean number of CT-P13 administrations was 4.2±1.9. The induction treatments in 4 UC and 2 CD patients was done. Clinical response and remission at 8 week were achieved in 4 (3 UC, 1 CD) and 3 patients (3 UC). One UC patient experienced severe skin rash and was discontinued with CT-P13. One CD patent did not respond to CT-P13. Twelve patients in maintenance with originator, were interchanged with CT-P13. Eleven patients experienced no ADR or loss of response during study period. In one CD patient, disease flare-up was observed.

Conclusion

CT-P13 may have biosimilarity and interchangeability with its originator in IBD. Large, randomised, double-blind, prospective study about this issue is needed.