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Implications for sequencing of biologic therapy and choice of second anti-TNF in patients with inflammatory bowel disease: results from the IMmunogenicity to Second Anti-TNF therapy (IMSAT) therapeutic drug monitoring study

  • Neil Chanchlani*
  • , Simeng Lin
  • , IMSAT study investigators
  • , Marcus K. Auth
  • , Chai Leng Lee
  • , Helena Robbins
  • , Shi Looi
  • , Senthil V. Murugesan
  • , Tom Riley
  • , Cathryn Preston
  • , Sophie Stephenson
  • , Wendy Cardozo
  • , Sunil A. Sonwalkar
  • , Mohammed Allah-Ditta
  • , Lynne Mansfield
  • , Dharmaraj Durai
  • , Mark Baker
  • , Ian London
  • , Emily London
  • , Sanjay Gupta
  • Alex Di Mambro, Aisling Murphy, Edward Gaynor, Kelsey D.J. Jones, Andrew Claridge, Shaji Sebastian, Sankaranarayanan Ramachandran, Christian P. Selinger, Simon P. Borg-Bartolo, Paul Knight, Michael B. Sprakes, Julie Burton, Patricia Kane, Stephanie Lupton, Aimee Fletcher, Daniel R. Gaya, Roghan Colbert, John Paul Seenan, Jonathan MacDonald, Lucy Lynch, Iain McLachlan, Stephanie Shields, Richard Hansen, Lisa Gervais, Mwansa Jere, Muhammad Akhtar, Karen Black, Paul Henderson, Richard K. Russell, Charlie W. Lees, Lauranne A.A.P. Derikx, James R. Goodhand, Tariq Ahmad
*Corresponding author for this work
  • University of Exeter
  • Alder Hey Children's NHS Foundation Trust
  • Ashford and St Peter's Hospitals NHS Foundation Trust
  • Blackpool Teaching Hospitals NHS Foundation Trust
  • Bradford Teaching Hospitals NHS Foundation Trust
  • Calderdale and Huddersfield NHS Foundation Trust
  • Cardiff & Vale University Health Board
  • Countess of Chester Hospital NHS Foundation Trust
  • Croydon Health Services NHS Trust
  • Gloucestershire Hospitals NHS Foundation Trust
  • Great Ormond Street Hospital for Children NHS Foundation Trust
  • Great Western Hospitals NHS Foundation Trust
  • Hull University Teaching Hospitals NHS Trust
  • Leeds Teaching Hospitals NHS Trust
  • University Hospital of South Manchester
  • The Mid Yorkshire Hospitals NHS Trust
  • NHS Greater Glasgow and Clyde
  • NHS Lanarkshire
  • NHS Lothian
  • Western General Hospital (Edinburgh)
  • Royal Devon & Exeter NHS Foundation Trust

Research output: Contribution to journalArticleAcademicpeer-review

19 Citations (Scopus)

Abstract

Background: Anti-drug antibodies are associated with treatment failure to anti-TNF agents in patients with inflammatory bowel disease (IBD). Aim: To assess whether immunogenicity to a patient's first anti-TNF agent would be associated with immunogenicity to the second, irrespective of drug sequence. Methods: We conducted a UK-wide, multicentre, retrospective cohort study to report rates of immunogenicity and treatment failure of second anti-TNF therapies in 1058 patients with IBD who underwent therapeutic drug monitoring for both infliximab and adalimumab. The primary outcome was immunogenicity to the second anti-TNF agent, defined at any timepoint as an anti-TNF antibody concentration ≥9 AU/ml for infliximab and ≥6 AU/ml for adalimumab. Results: In patients treated with infliximab and then adalimumab, those who developed antibodies to infliximab were more likely to develop antibodies to adalimumab, than patients who did not develop antibodies to infliximab (OR 1.99, 95%CI 1.27–3.20, p = 0.002). Similarly, in patients treated with adalimumab and then infliximab, immunogenicity to adalimumab was associated with subsequent immunogenicity to infliximab (OR 2.63, 95%CI 1.46–4.80, p < 0.001). For each 10-fold increase in anti-infliximab and anti-adalimumab antibody concentration, the odds of subsequently developing antibodies to adalimumab and infliximab increased by 1.73 (95% CI 1.38–2.17, p < 0.001) and 1.99 (95%CI 1.34–2.99, p < 0.001), respectively. Patients who developed immunogenicity with undetectable drug levels to infliximab were more likely to develop immunogenicity with undetectable drug levels to adalimumab (OR 2.37, 95% CI 1.39–4.19, p < 0.001). Commencing an immunomodulator at the time of switching to the second anti-TNF was associated with improved drug persistence in patients with immunogenic, but not pharmacodynamic failure. Conclusion: Irrespective of drug sequence, immunogenicity to the first anti-TNF agent was associated with immunogenicity to the second, which was mitigated by the introduction of an immunomodulator in patients with immunogenic, but not pharmacodynamic treatment failure.

Original languageEnglish
Pages (from-to)1250-1263
Number of pages14
JournalAlimentary Pharmacology and Therapeutics
Volume56
Issue number8
DOIs
Publication statusPublished - Oct 2022
Externally publishedYes

Bibliographical note

Publisher Copyright: © 2022 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.

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