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Purpose <p>The aim of this study was to evaluate the clinico-radiological remission rate in patients with fistulizing anoperineal lesions of Crohn’s disease treated with CT-P13 SC, as well as pharmacokinetic data and treatment persistence rate.</p> Methods <p>We included all consecutive patients seen in the dedicated proctology outpatient clinic between June 1st and July 15th, 2024, for fistulizing anoperineal lesions and treated for at least 3&#xa0;months with CT-P13 SC. Clinical, radiological and pharmacokinetic data were collected.</p> Results <p>Data from 39 patients were analyzed. The median duration of treatment was 16.1&#xa0;months. Seventeen patients (43.6%) had initiated SC formulation upfront. The complete clinical remission rate was 74.4%, significantly higher in patients switched from IV to SC formulation. Among patients switched from IV to SC formulation, 86.5% maintained remission. In the overall study population, 89.7% were able to continue treatment, with intensified protocols in 61.5% of patients. The deep radiological remission rate was 61.5%. The median infliximab concentration was 22.7&#xa0;µg/mL. Only the intensified administration protocol was significantly associated with higher infliximab concentrations. Immunosuppressants had no impact. The median infliximab concentration was higher in patients in remission (35.9&#xa0;µg/mL vs 22.4&#xa0;µg/mL), but without any significant difference.</p> Conclusion <p>CT-P13 SC appears to be at least as effective as the IV formulation for fistulizing anoperineal lesions, and switching from IV to SC allows remission to be maintained in the vast majority of cases. Despite numerically higher infliximab concentrations in patients in remission, no significant difference could be identified.</p> <p><b>Trial registration number and date:</b> Registration with the ethics committee on 11/14/2023.</p>

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Clinical, Radiological and Pharmacokinetic Data of CT-P13 Subcutaneous in Individuals with Fistulizing Anoperineal Crohn’s Disease

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年7月25日

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  • N. Fathallah,
  • M. Draullette,
  • J. Kirchgesner,
  • S. Paul,
  • X. Roblin,
  • A. Bourrier,
  • M. A. Haouari,
  • E. Chambenois,
  • S. Morisset,
  • P. Seksik,
  • V. de Parades

摘要

Purpose

The aim of this study was to evaluate the clinico-radiological remission rate in patients with fistulizing anoperineal lesions of Crohn’s disease treated with CT-P13 SC, as well as pharmacokinetic data and treatment persistence rate.

Methods

We included all consecutive patients seen in the dedicated proctology outpatient clinic between June 1st and July 15th, 2024, for fistulizing anoperineal lesions and treated for at least 3 months with CT-P13 SC. Clinical, radiological and pharmacokinetic data were collected.

Results

Data from 39 patients were analyzed. The median duration of treatment was 16.1 months. Seventeen patients (43.6%) had initiated SC formulation upfront. The complete clinical remission rate was 74.4%, significantly higher in patients switched from IV to SC formulation. Among patients switched from IV to SC formulation, 86.5% maintained remission. In the overall study population, 89.7% were able to continue treatment, with intensified protocols in 61.5% of patients. The deep radiological remission rate was 61.5%. The median infliximab concentration was 22.7 µg/mL. Only the intensified administration protocol was significantly associated with higher infliximab concentrations. Immunosuppressants had no impact. The median infliximab concentration was higher in patients in remission (35.9 µg/mL vs 22.4 µg/mL), but without any significant difference.

Conclusion

CT-P13 SC appears to be at least as effective as the IV formulation for fistulizing anoperineal lesions, and switching from IV to SC allows remission to be maintained in the vast majority of cases. Despite numerically higher infliximab concentrations in patients in remission, no significant difference could be identified.

Trial registration number and date: Registration with the ethics committee on 11/14/2023.