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Background <p>Therapeutic drug monitoring is important for optimizing anti-tumor necrosis factor-α (TNF-α) therapy in inflammatory bowel disease. However, the exposure–response relationship has never been assessed in pouchitis.</p> Aims <p>To explore associations between anti-TNF-α drug concentration and pouchitis disease activity in patients with a background of ulcerative colitis.</p> Methods <p>A retrospective, multicenter, cross-sectional study was conducted in adult patients with pouchitis requiring anti-TNF-α treatment. Rates of clinical and endoscopic remission were calculated, and drug concentrations during maintenance therapy were compared between remission and non-remission cohorts.</p> Results <p>Sixty-three patients were included: median age, 48&#xa0;years (IQR 36–59) and median time since pouchitis diagnosis, 7&#xa0;years (IQR 2–13). Patients received infliximab, <i>n</i> = 27 (43%), adalimumab, <i>n </i>= 29 (46%), or both <i>n</i> = 7&#xa0;(11%). Thirty-two (51%) patients received concomitant immunomodulation. Median infliximab trough concentrations (mg/ml) were similar between patients in clinical remission (<i>n</i> = 21) vs non-remission (<i>n</i> = 11), 5.3 vs. 4.4, <i>p</i> = 0.73. For adalimumab, median drug concentrations did not significantly differ between remission/non-remission groups based on clinical (<i>n</i> = 18/18), 11.4 vs 7.6, <i>p</i> = 0.32, or endoscopic assessment, (<i>n</i> = 7/29), 9.0 vs. 7.8, <i>p</i> = 0.78. Four patients had positive anti-drug antibodies with undetectable drug concentration.</p> Conclusion <p>In a cohort of patients with pouchitis, higher anti-TNF-α drug concentrations were not associated with more clinical or endoscopic remission.</p>

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Anti-tumor Necrosis Factor Drug Concentration Is Not Associated with Disease Outcomes in Pouchitis: A Retrospective, International Study

  • 期刊论文

  • 发表日期：

    2025年1月27日

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  • Sailish Honap,
  • Bénédicte Caron,
  • Jacob E. Ollech,
  • Maya Fischman,
  • Konstantinos Papamichael,
  • Djuna De Jong,
  • Krisztina B. Gecse,
  • Andrea Centritto,
  • Mark A. Samaan,
  • Peter M. Irving,
  • Miles P. Sparrow,
  • Konstantinos Karmiris,
  • Thomas Chateau,
  • Iris Dotan,
  • Laurent Peyrin-Biroulet

摘要

Background

Therapeutic drug monitoring is important for optimizing anti-tumor necrosis factor-α (TNF-α) therapy in inflammatory bowel disease. However, the exposure–response relationship has never been assessed in pouchitis.

Aims

To explore associations between anti-TNF-α drug concentration and pouchitis disease activity in patients with a background of ulcerative colitis.

Methods

A retrospective, multicenter, cross-sectional study was conducted in adult patients with pouchitis requiring anti-TNF-α treatment. Rates of clinical and endoscopic remission were calculated, and drug concentrations during maintenance therapy were compared between remission and non-remission cohorts.

Results

Sixty-three patients were included: median age, 48 years (IQR 36–59) and median time since pouchitis diagnosis, 7 years (IQR 2–13). Patients received infliximab, n = 27 (43%), adalimumab, n = 29 (46%), or both n = 7 (11%). Thirty-two (51%) patients received concomitant immunomodulation. Median infliximab trough concentrations (mg/ml) were similar between patients in clinical remission (n = 21) vs non-remission (n = 11), 5.3 vs. 4.4, p = 0.73. For adalimumab, median drug concentrations did not significantly differ between remission/non-remission groups based on clinical (n = 18/18), 11.4 vs 7.6, p = 0.32, or endoscopic assessment, (n = 7/29), 9.0 vs. 7.8, p = 0.78. Four patients had positive anti-drug antibodies with undetectable drug concentration.

Conclusion

In a cohort of patients with pouchitis, higher anti-TNF-α drug concentrations were not associated with more clinical or endoscopic remission.