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Minerva Gastroenterologica e Dietologica 2017 December;63(4):313-8

DOI: 10.23736/S1121-421X.17.02402-3

Copyright © 2017 EDIZIONI MINERVA MEDICA

language: English

Effectiveness and safety of infliximab biosimilar CT-P13 in treating ulcerative colitis: a real‑life experience in IBD primary centers

Antonio TURSI 1 , Leonardo ALLEGRETTA 2, Stefania CHIRI 2, Nicola DELLA VALLE 3, Walter ELISEI 4, Giacomo FORTI 5, Roberto LORENZETTI 6, Giammarco MOCCI 7, Antonio PENNA 8, Giuseppe PRANZO 9, Cristina RICCIARDELLI 10, Marcello PICCHIO 11

1 Gastroenterology Service, ASL BAT, Andria, Italy; 2 Division of Gastroenterology, Santa Caterina Novella Hospital, Galatina, Lecce, Italy; 3 Division of Gastroenterology, A.O. Ospedali Riuniti, Foggia, Italy; 4 Division of Gastroenterology, ASL RM6, Albano Laziale, Rome, Italy; 5 Digestive Endoscopy Unit, Santa Maria Goretti Hospital, Latina, Italy; 6 Division of Gastroenterology, Nuovo Regina Margherita Hospital, Rome, Italy; 7 Division of Gastroenterology, Brotzu Hospital, Cagliari, Italy; 8 Division of Gastroenterology, S. Paolo Hospital, Bari, Italy; 9 IBD Clinic, Valle D’Itria Hospital, Martina Franca, Taranto, Italy; 10 Division of Gastroenterology, Veris Delli Ponti Hospital, Scorrano, Lecce, Italy; 11 Division of Surgery, P. Colombo Hospital, Velletri, Rome, Italy


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BACKGROUND: The aim of this study was to assess the efficacy and safety of infliximab biosimilar (IFX) IFX CT-P13 in inducing and maintaining remission in ulcerative colitis (UC) outpatients in Italian primary gastroenterology centers.
METHODS: Patients were prospectively assessed at entry, after 8, 12, 24, 36, and therefore 52 weeks. Clinical activity was rated as per the Mayo Score. The primary endpoint was reaching of clinical remission (Mayo Score ≤2). Several secondary endpoints were clinical response to treatment, reaching of mucosal healing (MH), safety of the drug.
RESULTS: Twenty-nine patients (16 males and 13 females, mean age 45 years, range 35-42 years) were enrolled. Eleven (37.9%) patients had previous exposure to other anti-TNF-α. Clinical remission was present in 78.5% at week 24, and in 100% at 12-month follow-up. Subgroup analysis did not reveal significant differences in clinical remission between IFX-naïve patients and patients switching from originator to IFX biosimilar. A clinical response was observed in 92.3% at week 8, in 50.0% at week 16, in 100% at week 36 and in 100% at 12-month follow-up. MH occurred in 85.7% at week 24, and in 100% at 12-month follow-up Reduction of steroids was achieved in 92.3% at week 8, and in 100% during follow-up. One patient underwent proctocolectomy 3 weeks after starting IFX CT-P13. The median C-reactive protein and calprotectin levels during follow-up were significantly reduced during follow-up. No adverse events were observed during follow-up.
CONCLUSIONS: IFX CT-P13 seems to be very effective and safe in real-life experience at primary IBD centers.


KEY WORDS: Biosimilar pharmaceuticals - CT-P13 - Infliximab - Ulcerative colitis

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