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P661 Comparable clinical efficacy, safety and immunogenicity of infliximab biosimilar (CT-P13) after transition from reference infliximab (Remicade®) in children with established inflammatory bowel disease: a multi-centre prospective observational

Sladek M.*1, Vultaggio A.2, Ghione S.3, Nencini F.2, Matucci A.2, Pratesi S.2, Zanieri F.4, Maggi P.M.2, Paci M.5, Ponanta-Gawron K.1, Kulig K.6, Wasilewska A.1, Lionetti P.7

1Jagiellonian University Medical College, Department of Pediatrics, Gastroenterology and Nutrition, Krakόw, Poland 2University of Florence, Centre of Research DENOTHE and Department of Experimental and Clinical Medicine, Florence, Italy 3Univeristy of Florence, Florence, Italy 4University of Florence, Florence, Italy 5Meyer Children's Hospital, Florence, Italy 6Univeristy Hospital in Krakow, Krakow, Poland 7University of Florence, Department of Neuroscience, Psychology, Drug Research and Child Health, Meyer Children's Hospital, Florence, Italy

Background

CT-P13 is the first approved biosimilar infliximab (IFX) for all indications of the reference product (Remicade®). Similar-but-not-identical nature of CT-P13 compare to Remicade®, the concept of extrapolating data from one therapeutic indication to another, very limited clinical data on its use in inflammatory bowel disease (IBD) may be puzzling to physicians. In the present study we aimed to gain data on the efficacy, safety and immunogenicity of transition from Remicade to CT-P13 in a real-life IBD paediatric patients.

Methods

In this prospective, multi-centre study, all paediatric IBD patients treated with Remicade at two academic centres in Italy and Poland were electively transitioned to CT-P13. Registration was performed with a start time 2 months before transition, and for the each patient data on the efficacy, safety and immunogenicity were evaluated at the transition to CT-P13, at the second and fourth CT-P13 infusion with the follow up lasted for up to week 24–36. The primary end-point was the change in clinical disease activity and adverse reaction following transition. The secondary end-points included changes in inflammatory markers such as C-reactive protein (CRP), erythrocyte sedimentation (ESR), faecal calprotectin (FCP), infliximab trough level (TL) and development of anti-drug antibodies (ADAs).

Results

In total, 45 IBD children, 38 Crohn's disease (CD) and 7 ulcerative colitis (UC) were transitioned at the mean time elapsed between the beginning of Remicade therapy of 23.6±15.5 months for CD and 12.0±15.5 months for UC. At the time of the transition 33/38 CD and 4/7 UC patients presented with clinical remission. We did not observe any change in clinical disease activity, CRP, ESR, FCP, TL-IFX for both CD and UC. Of three patients having CT-P13 discontinued, only for one case the reason was an adverse reaction with high ADAs, presented even before the transition. One patients developed new detectable ADAs, while one patient with detectable ADAs before transition presented with undetectable level thereafter.

Conclusion

Our data indicate that clinical efficacy, safety and immunogenicity profile were highly comparable before and after the transition from Remicade® to CT-P13 in paediatric IBD patients.