Neil Chanchlani1, Kajal Mortier2, Linda J Williams3, Rafeeq Muhammed4, Marcus K H Auth5, Mike Cosgrove6,7, Andrew Fagbemi8, John Fell9, Sonny Chong10, Veena Zamvar11, Warren Hyer12, W Michael Bisset13, Mary-Anne Morris14, Astor Rodrigues15, Sally G Mitton16, Su Bunn17, R Mark Beattie18, Anne Willmott19, David C Wilson20, Richard K Russell21. 1. Homerton University Hospital NHS Foundation Trust. 2. UK IBD Audit, Royal College of Physicians, London. 3. Usher Institute of Population Health Sciences & Informatics, University of Edinburgh, Edinburgh. 4. Birmingham Children's Hospital, Birmingham, Birmingham Children's Hospital, Birmingham. 5. Alder Hey Children's Hospital and University of Liverpool, Liverpool. 6. Morriston Hospital, Abertawe Bro Morgannwg University Health Board, Wales. 7. Children's Hospital for Wales, Heath Park, Cardiff. 8. Royal Manchester Children's Hospital, Manchester. 9. Chelsea and Westminster Hospital, London. 10. Queen Mary's Hospital for Children (Epsom and St Helier University Hospitals), Sutton, Carshalton. 11. Clarendon Wing, Leeds General Infirmary, Leeds, West Yorkshire. 12. Northwick Park and St Mark's Hospital, Harrow, Middlesex. 13. NHS Grampian, Aberdeen Royal Infirmary, Foresterhill, Aberdeen. 14. Jenny Lind Children's Hospital, Norfolk and Norwich University Hospital, Norwich. 15. Children's Hospital, John Radcliffe Hospital, Headley Way, Oxford. 16. St George's Hospital, Tooting, London. 17. Great North Children's Hospital, Royal Victoria Infirmary, Newcastle upon Tyne. 18. Southampton Children's Hospital, Tremona Road, Southampton. 19. Leicester Royal Infirmary, Infirmary Square, Leicester. 20. Royal Hospital for Sick Children, Edinburgh. 21. Royal Hospital for Children, Glasgow, UK.
Abstract
OBJECTIVES: The aim of the study was to summarize short-term effectiveness, safety, and cost of using infliximab biosimilar (IFX-B) drugs, (Inflectra [Hospira] and Remsima [NAAP]) compared to originator infliximab (IFX-O) (Remicade [MSD]) in biologic naive pediatric inflammatory bowel disease in the United Kingdom. METHODS: Prospective audit of patients starting anti-tumour necrosis factor (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. 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 to 2015. 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 Physician Global Assessment 85% (n = 28) in IFX-O group and 86% (n = 19) in IFX-B group (P > 0.05). Adverse events at initiation and post induction were not different between both groups (P > 0.05). Using conservative calculations, £875,000 would have been saved for a 1-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.
OBJECTIVES: The aim of the study was to summarize short-term effectiveness, safety, and cost of using infliximab biosimilar (IFX-B) drugs, (Inflectra [Hospira] and Remsima [NAAP]) compared to originator infliximab (IFX-O) (Remicade [MSD]) in biologic naive pediatric inflammatory bowel disease in the United Kingdom. METHODS: Prospective audit of patients starting anti-tumour necrosis factor (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. 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 to 2015. 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 Physician Global Assessment 85% (n = 28) in IFX-O group and 86% (n = 19) in IFX-B group (P > 0.05). Adverse events at initiation and post induction were not different between both groups (P > 0.05). Using conservative calculations, £875,000 would have been saved for a 1-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.
Authors: Stanley B Cohen; Sebastiao C Radominski; Hideto Kameda; Alan J Kivitz; Michael Tee; Carol Cronenberger; Min Zhang; Sarah Hackley; Muhammad I Rehman; Oliver von Richter; Rieke Alten Journal: BioDrugs Date: 2020-04 Impact factor: 5.807