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.
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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