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MINERVA GASTROENTEROLOGICA E DIETOLOGICA
A Journal on Gastroenterology, Nutrition and Dietetics
Indexed/Abstracted in: CAB, EMBASE, PubMed/MEDLINE, Scopus, Emerging Sources Citation Index
Minerva Gastroenterologica e Dietologica 2017 Mar 14
Copyright © 2017 EDIZIONI MINERVA MEDICA
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, Barletta, 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, PTP “Nuovo Regina Margherita”, Rome, Italy; 7 Division of Gastroenterology “Brotzu” Hospital, Cagliari, Italy; 8 Division of Gastroenterology, “S. Paolo” Hospital”, Bari, Italy; 9 Ambulatory of IBD, “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
BACKGROUND: To assess the efficacy and safety of biosimilar infliximab (IFX) IFX CT-P13 in inducing and maintain 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 scored according to 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-TNFα. Clinical remission was present in 50.0% at week 24, and in 100% at 12-month follow-up. Subgroup analysis did not reveal a significant difference in clinical remission between naïve patients to IFX and patients switching from originator to biosimilar IFX. Clinical response was present in 92.3% at week 8, in 81.8% 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 was submitted to proctocolectomy 3 weeks after starting IFX CT-P13. The median C-Reactive Protein and calprotectin level during follow-up was significantly reduced during follow-up. No adverse events were observed during follow-up.
CONCLUSIONS: IFX CT-P13 seems to be very effective and safe at real-life experience in primary IBD centers.
KEY WORDS: Biosimilar - CT-P13 - Infliximab - Ulcerative colitis