Efficacy of Infliximab Biosimilar CT-P13 Induction Therapy on Mucosal Healing in Ulcerative Colitis
Jazyk angličtina Země Velká Británie, Anglie Médium print-electronic
Typ dokumentu klinické zkoušky, časopisecké články, multicentrická studie
PubMed
27106537
DOI
10.1093/ecco-jcc/jjw085
PII: jjw085
Knihovny.cz E-zdroje
- Klíčová slova
- CT-P13, Ulcerative colitis, biosimilar, infliximab, mucosal healing,
- MeSH
- biosimilární léčivé přípravky terapeutické užití MeSH
- dospělí MeSH
- gastrointestinální látky terapeutické užití MeSH
- infliximab terapeutické užití MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- monoklonální protilátky terapeutické užití MeSH
- prospektivní studie MeSH
- senioři MeSH
- střevní sliznice patologie MeSH
- ulcerózní kolitida farmakoterapie patologie MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- multicentrická studie MeSH
- Názvy látek
- biosimilární léčivé přípravky MeSH
- CT-P13 MeSH Prohlížeč
- gastrointestinální látky MeSH
- infliximab MeSH
- monoklonální protilátky MeSH
INTRODUCTION: CT-P13 is the first biosimilar to infliximab that has been approved for the same indications as its originator infliximab. No data are available on the effect of infliximab biosimilar on mucosal healing. The aim of this study was to evaluate the efficacy of CT-P13 induction therapy on mucosal healing in patients with ulcerative colitis [UC]. PATIENTS AND METHODS: UC patients, who received CT-P13 therapy from its local introduction at three Hungarian and one Czech inflammatory bowel disease centres, were prospectively enrolled. Sigmoidoscopy was performed after the end of the induction therapy at week 14. Mucosal healing was defined as Mayo endoscopic subscore 0 or 1. Complete mucosal healing was defined as Mayo endoscopic subscore 0. Trough level of CT-P13 was measured at week 14. RESULTS: Sixty-three UC patients who underwent CT-P13 induction therapy were enrolled in the study. Indication for the therapy was acute, severe flare up and chronic, refractory activity in 24 and 39 patients, respectively. Cumulative clinical response and steroid-free remission at week 14 were achieved in 82.5% and 47.6% of the patients, respectively. Sigmoidoscopy revealed steroid-free mucosal healing in 47.6% of the patients, and complete mucosal healing was present in 27%. Mayo endoscopic subscore decreased significantly at week 14 compared to baseline. Trough levels of infliximab correlated with mucosal healing. CONCLUSION: This is, to our knowledge, the first study examining the efficacy of CT-P13 induction therapy on mucosal healing in UC. The results indicate that mucosal healing is achieved in two-thirds of UC patients by the end of the induction treatment with CT-P13.
Department of Internal Medicine Military Hospital Charles University Prague Czech Republic
Department of Medical Physics and Informatics University of Szeged Szeged Hungary
Department of Medicine Semmelweis University Budapest Hungary
Department of Medicine University of Debrecen Debrecen Hungary
Department of Medicine University of Szeged Szeged Hungary
IBD Clinical and Research Centre Iscare a s Prague Czech Republic
Institute of Pharmacology 1 Medical Faculty Charles University Prague Czech Republic
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