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Original research
Comparison of subcutaneous and intravenous infliximab in patients with inflammatory bowel disease showed no differences in immunogenicity or treatment persistence at 1 year
  1. Sarah Hancox1,
  2. Francesco Morda2,
  3. Christopher J Black1,
  4. Christian Philipp Selinger1
  1. 1Leeds Gastroenterology Institute, Leeds Teaching Hospitals, Leeds, UK
  2. 2IRCCS Fondazione Policlinico San Matteo Internal Medicine, Pavia, Italy
  1. Correspondence to Dr Christian Philipp Selinger; christian.selinger{at}web.de

Abstract

Background Infliximab (IFX) effectiveness in inflammatory bowel disease (IBD) can be impaired by antidrug antibodies (ADA). Subcutaneous IFX has a different pharmacokinetic profile compared with intravenous administration, potentially affecting immunogenicity.

Methods Retrospective audit of adult patients starting IFX between January 2019 and June 2022. All participants received induction with three intravenous doses, followed by either maintenance subcutaneous IFX every 2 weeks (from 2021) or maintenance intravenous IFX (historic control). We compared ADA levels, IFX trough levels and treatment persistence between groups after 12 months of treatment.

Results 101 patients receiving maintenance subcutaneous IFX were compared with 108 patients with maintenance intravenous IFX. At 12 months, prevalence of ADA positivity was similar in both groups (48.1% subcutaneous vs 50.6% intravenous; p=0.775). There were no differences in detectable IFX trough levels and treatment persistence between both groups. Patients receiving combination therapy with IFX and immunomodulators (34.8%) had less often ADA (65.2%; OR 0.28 (95% CI 0.13 to 0.58); p=0.001) irrespective of route of IFX administration. Treatment persistence was higher in those receiving combination therapy compared with monotherapy at 12 months (73.3% vs 51.9%; p=0.004).

Conclusions There were no significant differences in ADA levels, IFX levels and treatment persistence between the subcutaneous and intravenous routes of IFX administration after 12 months. Concurrent use of immunomodulators was associated with reduced immunogenicity and better treatment persistence. Clinicians should advise patients on the benefits of immunomodulator combination therapy regardless of route of administration.

  • inflammatory bowel disease
  • ulcerative colitis
  • infliximab

Data availability statement

Data are available on reasonable request. Summary data are available on reasonable request. Owing to ethics/consent for this study, primary data are not available openly.

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Data availability statement

Data are available on reasonable request. Summary data are available on reasonable request. Owing to ethics/consent for this study, primary data are not available openly.

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Footnotes

  • SH and FM are joint first authors.

  • X @DrCJBlack

  • Correction notice This article has been corrected since it published Online First. The supplementary file has been replaced with the correct file.

  • Contributors CPS designed the study. SH, FM and CPS collected the data. FM performed the analysis. All authors interpreted the results. SH and FM wrote the draft manuscript. All authors critically reviewed the draft manuscript and approved the final manuscript. CPS is the guarantor of the article.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests CPS has received unrestricted research grants from Warner Chilcott, Janssen and AbbVie, has provided consultancy to Warner Chilcott, Dr Falk, AbbVie, Takeda, Fresenius Kabi, Galapagos, Ferring, Arena and Janssen and had speaker arrangements with Warner Chilcott, Dr Falk, AbbVie, MSD, Pfizer, Celltrion and Takeda. SH, FM and CJB declare that they have no competing interests

  • Provenance and peer review Not commissioned; internally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.