Biosimilar infliximab CT-P13 treatment in patients with inflammatory bowel diseases – a one-year, single-centre retrospective study

Abstract

Background and Aims: CT-P13 is the first approved infliximab (IFX) biosimilar. It has proven equivalent to IFX treatment in several rheumatoid disorders; however, limited efficacy data is available for its use in inflammatory bowel disease (IBD). We evaluated clinical data from our first year using CT-P13 to assess its efficacy and safety in IBD patients. Methods: This retrospective cohort study included all consecutive Crohn’s disease (CD) or ulcerative colitis (UC) patients treated between March 2014 and April 2015. Clinical remission was evaluated for 14 weeks after the first induction treatment. Sustained clinical response during CT-P13 maintenance treatment was assessed every 8 weeks, both in CT-P13-induced patients and those switching from IFX. Results : The cohort included 25 IBD patients (19 CD, 6 UC). There was a median five CT-P13 administration per patient (range 2–9). There were 128 total infusions. Thirteen patients (9 CD, 4 UC) underwent CT-P13 induction, and 84% (7/9 CD, 4/4 UC) achieved clinical remission by week 14. Sustained clinical response was maintained in 85% (3/3 CD, 3/4 UC) at week 30. Twelve patients (10 CD, 2 UC) switched from IFX, and 100% had sustained clinical response at week 24, 87.5% (6/7 CD, 1/1 UC) at week 32, and 75% (5/7 CD, 1/1 UC) at week 48. Four CD patients discontinued CT-P13 therapy due to injection reactions, psoriasiform skin rash, or loss of response. Conclusion: Our data indicate that CT-P13 is comparable to IFX in terms of effectiveness and safety.