Use of Infliximab Biosimilar Versus Originator in a Paediatric United Kingdom Inflammatory Bowel Disease Induction Cohort

Objectives: To summarize short-term effectiveness, safety, and cost of using infliximab biosimilar (IFX-B) drugs, (Inflectra™ and Remsima™) compared to originator infliximab (IFX-O) (Remicade®) in biologic naive pediatric inflammatory bowel disease in the United Kingdom. Methods: Prospective audit of patients starting anti-TNF therapy. Disease severity, response to treatment, and remission rate was measured by Pediatric Crohn's Disease Activity Index (PCDAI) and/or Physician Global Assessment (PGA). Results: Between March 2015 and February 2016, 278 patients (175 IFX-O, 82 IFX-B, and 21 Adalimumab) were started on anti-TNF therapy. This was compared with collected data on 398 patients started on IFX-O from 2011–15. At initiation, median PCDAI was 36 (20,48) (n = 42) in the IFX-O group and 28 (20,40) (n = 29) in the IFX-B group, (p = 0.08). Immunosuppression rates were similar: 150/175 (86%) for IFX-O and 65/82 (79%) for IFX-B (p > 0.05). Post induction, median PCDAI score was 5 (0,11) (n = 19) and 0 (0,8) (n = 15) in the IFX-O and IFX-B groups respectively (p = 0.35). There was no difference in response to treatment using PGA 85% (n = 28) in IFX-O group and 86% (n = 19) in IFX-B group (p > 0.05). Adverse events (AE) at initiation and post induction were not different between both groups (p > 0.05). Using conservative calculations, £875,000 would have been saved over a one-year period with universal adoption of biosimilars in patients who were instead treated with IFX-O. Conclusions: IFX-B is likely as effective as IFX-O in treating IBD in comparable pediatric populations. Sites should adopt infliximab biosimilar for new starts due to cost reduction with no difference in other parameters. Address correspondence and reprint requests to Professor Richard K. Russell, Consultant Paediatric Gastroenterologist, Royal Hospital for Children, 1345 Govan Road, Glasgow, G51 4TF (e-mail: richardrussell@nhs.net). Received 16 January, 2018 Accepted 14 April, 2018 Supplemental digital content is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML text of this article on the journal's Web site (www.jpgn.org). Optional byline at editor's discretion: matched initial efficacy and safety, but with significant cost savings. Conflicts of interest RM has received consultation fees, research grants, or honorarium, from AbbVie, Janssen, Dr Falk, Tillott's pharma, 4D pharma, and Pfizer. MKHA declares that he received educational travel grants or consultation fees from Abbvie, MSD, Nutricia, and Dr Falk. JF is on the advisory board for Falk, scientific advisory board for Jansen, and has received support for travel and educational activity from Abbvie. AR has received consultation fees on advisory boards and educational/travel grants from Abbvie. SGM has received sponsorship for conferences from Abbvie. DCW has received consultancy fees from consultancy, lecture fees, and sponsorship to travel to meetings from Abbvie, consultancy fees from Takeda, and lecture fees from Falk. RKR has received consultation fees, research grants, or honorarium, from Nestlé, AbbVie, Takeda, Napp, Mead Johnson, Nutricia and Janssen. All other authors declare no conflicts of interest. © 2018 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,

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