Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Jan;61(2):313-322.
doi: 10.1111/apt.18354. Epub 2024 Nov 18.

Subcutaneous Infliximab Concentration Thresholds for Mucosal and Transmural Healing in Patients With Crohn's Disease

Sung Noh Hong  1 , Joo Hye Song  1 , Sung Jin Kim  1 , Yoon Ha Park  1 , Chang Wan Choi  1 , Ji Eun Kim  1 , Eun Ran Kim  1 , Dong Kyung Chang  1 , Young-Ho Kim  1
Affiliations

Subcutaneous Infliximab Concentration Thresholds for Mucosal and Transmural Healing in Patients With Crohn's Disease

Sung Noh Hong et al. Aliment Pharmacol Ther. 2025 Jan.

Abstract

Background: Predose trough concentrations (Ctrough) of intravenous infliximab (IV-IFX) during maintenance therapy are associated with therapeutic outcomes in patients with Crohn's disease (CD). A subcutaneous formulation of infliximab (SC-IFX) has shown high Ctrough values due to its favourable pharmacokinetics.

Aims: To evaluate the association of Ctrough of SC-IFX with therapeutic outcomes and the threshold of SC-IFX Ctrough for achieving mucosal healing (MH) and transmural healing (TH) in patients with CD.

Methods: We performed this cross-sectional study in patients with CD who had received SC-IFX maintenance therapy for ≥ 6 months. We measured SC-IFX Ctrough immediately before SC-IFX injection. We performed ileocolonoscopy/single-balloon enteroscopy and/or magnetic resonance enterography within 3 months of SC-IFX Ctrough measurement. MH was defined as SES-CD-ulcerated surface subscore of 0. TH was defined as simplified MaRIA score of 0.

Results: We enrolled 124 patients with MH in 77.9% (74/95) and TH in 36.3% (37/102). SC-IFX Ctrough was significantly higher in patients with MH (24.1 vs.16.9 μg/mL; p = 0.001) and TH (26.0 vs. 20.5 μg/mL; p = 0.007) than in those without. ROC analysis identified that the threshold of SC-IFX Ctrough for MH and TH were 17.5 and 30.3 μg/mL, respectively. Multivariate logistic regression showed that SC-IFX Ctrough was significantly associated with MH (OR 1.16; 95% CI 1.05-1.27; p = 0.002) and TH (OR 1.08; 95% CI 1.02-1.14; p = 0.005).

Conclusions: SC-IFX Ctrough was positively associated with MH (≥ 18 μg/mL) and TH (≥ 30 μg/mL) in patients with CD, which may guide treatment decisions to optimise therapeutic response in the era of treat-to-target.

Keywords: Crohn's disease; mucosal healing; subcutaneous infliximab; transmural healing.

PubMed Disclaimer

References

    1. C. Steenholdt, J. Brynskov, O. Ø. Thomsen, et al., “Individualised Therapy Is More Cost‐Effective Than Dose Intensification in Patients With Crohn's Disease Who Lose Response to Anti‐TNF Treatment: A Randomised, Controlled Trial,” Gut 63 (2014): 919–927.
    1. B. G. Levesque, G. R. Greenberg, G. Zou, et al., “A Prospective Cohort Study to Determine the Relationship Between Serum Infliximab Concentration and Efficacy in Patients With Luminal Crohn's Disease,” Alimentary Pharmacology & Therapeutics 39 (2014): 1126–1135.
    1. K. Papamichael, S. Rakowsky, C. Rivera, A. S. Cheifetz, and M. T. Osterman, “Association Between Serum Infliximab Trough Concentrations During Maintenance Therapy and Biochemical, Endoscopic, and Histologic Remission in Crohn's Disease,” Inflammatory Bowel Diseases 24 (2018): 2266–2271.
    1. A. S. Cheifetz, M. T. Abreu, W. Afif, et al., “A Comprehensive Literature Review and Expert Consensus Statement on Therapeutic Drug Monitoring of Biologics in Inflammatory Bowel Disease,” American Journal of Gastroenterology 116 (2021): 2014–2025.
    1. K. Papamichael, A. S. Cheifetz, G. Y. Melmed, et al., “Appropriate Therapeutic Drug Monitoring of Biologic Agents for Patients With Inflammatory Bowel Diseases,” Clinical Gastroenterology and Hepatology 17 (2019): 1655–1668.

MeSH terms

LinkOut - more resources