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Adalimumab for Induction of Histological Remission in Moderately to Severely Active Ulcerative Colitis

Digestive Diseases and Sciences volume 63, pages 731–737 (2018)Cite this article

Abstract

Background

Histological remission represents a target distinct from endoscopic healing in ulcerative colitis (UC) and seems a better predictor of clinical outcomes.

Aims

The aim of this study was to assess the ability of adalimumab to achieve histological remission in UC patients.

Methods

Single-center, retrospective, open-label study of patients treated with adalimumab. Eligible patients were anti-TNF naïve adults with moderately to severely active UC. The Mayo score including endoscopy was performed at baseline and weeks 8 and 52. Histological activity was scored using the Geboes Index. The primary endpoint was histological remission, defined as a Geboes grade ≤ 3.0, at week 52.

Results

We included 34 patients. At week 8, 6 of 34 patients (17.6%) achieved histological remission. At week 52, 9 patients (26.5%, intention to treat; 31%, per protocol) had histological remission. Patients had a significant and progressive reduction in the most severe subgrades of Geboes Index from baseline at weeks 8 and 52. At weeks 8 and 52, 50 and 61.8% of patients achieved mucosal healing (Mayo endoscopic subscore 0–1). All patients who achieved histological remission also had mucosal healing. At week 8, 85.3 and 20.6% of patients achieved clinical response (decrease in Mayo score ≤ 3 points) or remission (Mayo score ≤ 2), respectively. At week 52, the corresponding values were 67.6 and 52.9%, respectively. At week 52, agreement between histological remission and mucosal healing was fair (kappa 0.293). Agreement between histological remission and Mayo endoscopic subscore 0 was good (kappa 0.71).

Conclusions

Adalimumab was able to achieve histological remission in anti-TNF naïve patients with moderately to severely active UC.

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Abbreviations

UC:

Ulcerative colitis

TNF:

Tumor necrosis factor

ITT:

Intention to treat

PP:

Per protocol

CI:

Confidence interval

SD:

Standard deviation

IQR:

Interquartile range

RR:

Risk ratio

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Acknowledgments

The authors would like to thank Dr. G. Morley for reviewing the English manuscript.

Funding

The article received no specific funding. Data were generated in routine clinical practice.

Author information

Affiliations

  1. Inflammatory Bowel Disease Unit, Hospital Universitario la Moncloa, Madrid, Spain

    J. Ignacio Fernández-Blanco, Guillermo Fernández-Díaz, Carlos Cara, María I. Vera & Carlos Taxonera

  2. Department of Gastroenterology, Hospital Puerta de Hierro, Madrid, Spain

    María I. Vera

  3. Inflammatory Bowel Disease Unit, Department of Gastroenterology, Hospital Clínico San Carlos, Instituto de Investigación del Hospital Clínico San Carlos (IdISSC), C/Profesor Martín Lagos s/n, 28040, Madrid, Spain

    David Olivares & Carlos Taxonera

Authors
  1. J. Ignacio Fernández-Blanco
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  2. Guillermo Fernández-Díaz
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  3. Carlos Cara
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  4. María I. Vera
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  5. David Olivares
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  6. Carlos Taxonera
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Corresponding author

Correspondence to Carlos Taxonera.

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Conflict of interest

MI.V. has served as a speaker, consultant, and advisory member for MSD, AbbVie, Takeda Pfizer, Ferring, and Shire Pharmaceuticals. C.T. has served as a speaker, a consultant, and advisory member for MSD, AbbVie, Takeda, Pfizer, Ferring, Faes Farma, Shire Pharmaceuticals, Dr. Falk Pharma, and Gebro Pharma. The remaining authors have no conflicts of interest to declare.

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Fernández-Blanco, J.I., Fernández-Díaz, G., Cara, C. et al. Adalimumab for Induction of Histological Remission in Moderately to Severely Active Ulcerative Colitis. Dig Dis Sci 63, 731–737 (2018). https://doi.org/10.1007/s10620-018-4935-5

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  • DOI: https://doi.org/10.1007/s10620-018-4935-5

Keywords

  • Ulcerative colitis
  • Adalimumab
  • Histological remission
  • Mucosal healing
  • GEBOES Index
  • Tumor necrosis factor antagonists