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Efficacy, Pharmacokinetics, and Immunogenicity is Not Affected by Switching From Infliximab Originator to a Biosimilar in Pediatric Patients With Inflammatory Bowel Disease

van Hoeve, Karen, MD*,†; Dreesen, Erwin, PharmD; Hoffman, Ilse, MD, PhD*; Van Assche, Gert, MD, PhD†,§; Ferrante, Marc, MD, PhD†,§; Gils, Ann, PharmD, PhD; Vermeire, Séverine, MD, PhD†,§

doi: 10.1097/FTD.0000000000000601
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Background: Rising evidence demonstrates that there are no differences in efficacy and safety between infliximab (IFX) originator and IFX biosimilar CT-P13 in the treatment of inflammatory bowel diseases (IBDs). However, most data are derived from adult patients, and data on pharmacokinetics are limited. The authors evaluated long-term IFX trough levels, immunogenicity, and remission rates in children with IBD who switched from IFX originator to biosimilar CT-P13.

Methods: In this single-center study, all children with Crohn disease and ulcerative colitis receiving maintenance IFX therapy were switched from originator to biosimilar CT-P13. Demographics, disease activity indices, and IFX drug levels were collected from 6 months before (baseline) till 6 months after switching to CT-P13. All data are presented as median (interquartile range).

Results: A total of 42 children (26 Crohn disease and 16 ulcerative colitis), with a median duration on IFX originator of 13.5 (6.8–35.5) months before switching to CT-P13, were included. No significant changes in IFX trough levels occurred after switching. The median baseline IFX trough level was 5.7 mcg/mL (3.8–9.3) versus 6.5 mcg/mL (3.9–8.6) at month 6 after switching (P = 0.900). Antibodies to IFX appeared in one patient after switching. The proportion of patients in clinical and/or biological remission did not significantly change after switching (all P > 0.05). No significant changes were observed in C-reactive protein, erythrocyte sedimentation rate, albumin, weight, and body mass index after the switch. Safety profile was also comparable.

Conclusions: Pediatric patients with IBD on IFX originator can be successfully switched during maintenance to biosimilar CT-P13 without affecting efficacy, pharmacokinetics, immunogenicity, or safety.

*Department of Pediatric Gastroenterology, Hepatology and Nutrition, University Hospitals Leuven, KU Leuven;

TARGID, Department of Chronic Diseases, Metabolism and Ageing (CHROMETA), KU Leuven;

Laboratory for Therapeutic and Diagnostic Antibodies, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven; and

§Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.

Correspondence: Séverine Vermeire, MD, PhD, Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Herestraat 49, 3000 Leuven, Belgium (e-mail: severine.vermeire@uzleuven.be).

K. van Hoeve reports having received research grant from Mundipharma Comm. VA and Celltrion Healthcare Co. G. Van Assche, M. Ferrante and S. Vermeire are senior clinical investigators of the Research Foundation-Flanders (FWO).

K. van Hoeve performed literature search, conducted acquisition of data, statistical analysis, data interpretation, drafted the initial manuscript, and reviewed and revised the manuscript. E. Dreesen assisted with analysis and interpretation of the data and reviewed the manuscript for important intellectual content. I. Hoffman, G. Van Acche, and M. Ferrante critically reviewed the manuscript for important intellectual content. A. Gils and S. Vermeire conceptualized and designed the study, supervised data interpretation, and reviewed and revised the manuscript. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

K. van Hoeve: Research grant: Mundipharma Comm. VA and Celltrion Healthcare Co. I. Hoffman: Lecture fees: Nutrica, nestlé, Mead Johnson, Abbvie; G. Van Acche: Research grant: Abbvie, Pfizer; Consultancy: Abbvie, MSD, Ferring, Takeda, Janssen, Pfizer Inc, Genentech/Roche; Speakers fee: AbbVie, Janssen, MSD, Takeda, Ferring, Dr. Falk Pharma, Pfizer; M. Ferrante: Research grant: Janssen, Takeda; Consultancy: AbbVie, Boehringer Ingelheim, Ferring, Janssen, Mitsubishi Tanabe, MSD, Pfizer; Speakers fee: AbbVie, Boehringer Ingelheim, Chiesi, Ferring, Janssen, Lamepro, Mitsubishi Tanabe, MSD, Pfizer, Tramedico, Tillotts, Zeria; A. Gils: Lecture fees: MSD, Janssen Biologicals, Pfizer, Takeda, Abbvie, Novartis; Advisory board: Takeda; Financial research support: Pfizer, MSD; license agreement: R-biopharm, apDia, Merck. S. Vermeire: Research grant: Takeda, MSD, Abbvie, Pfizer. Consultancy: Abbvie, MSD, Ferring, Takeda, Shire, Janssen, Pfizer Inc, Galapagos, Genentech/Roche, Celgene, Mundipharma, Eli Lilly, Second Genome, GSK; Speakers fee: AbbVie, MSD, Takeda, Ferring, Dr. Falk Pharma, Hospira, Pfizer Inc, and Tillotts. The remaining authors have no conflicts of interests to disclose.

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Received September 20, 2018

Accepted November 22, 2018

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