title: Effectiveness and safety of infliximab biosimilar CT-P13 in treating ulcerative colitis: a real‑life experience in IBD primary centers.
abstract: 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.
authors.affiliation: Gastroenterology Service, ASL BAT, Andria, Italy - antotursi@tiscali.it.
authors.forename: Antonio
authors.initials: A
authors.lastname: Tursi
authors.affiliation: Division of Gastroenterology, Santa Caterina Novella Hospital, Galatina, Lecce, Italy.
authors.forename: Leonardo
authors.initials: L
authors.lastname: Allegretta
authors.affiliation: Division of Gastroenterology, Santa Caterina Novella Hospital, Galatina, Lecce, Italy.
authors.forename: Stefania
authors.initials: S
authors.lastname: Chiri
authors.affiliation: Division of Gastroenterology, A.O. Ospedali Riuniti, Foggia, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Della Valle
authors.affiliation: Division of Gastroenterology, ASL RM6, Albano Laziale, Rome, Italy.
authors.forename: Walter
authors.initials: W
authors.lastname: Elisei
authors.affiliation: Digestive Endoscopy Unit, Santa Maria Goretti Hospital, Latina, Italy.
authors.forename: Giacomo
authors.initials: G
authors.lastname: Forti
authors.affiliation: Division of Gastroenterology, Nuovo Regina Margherita Hospital, Rome, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Lorenzetti
authors.affiliation: Division of Gastroenterology, Brotzu Hospital, Cagliari, Italy.
authors.forename: Giammarco
authors.initials: G
authors.lastname: Mocci
authors.affiliation: Division of Gastroenterology, S. Paolo Hospital, Bari, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Penna
authors.affiliation: IBD Clinic, Valle D'Itria Hospital, Martina Franca, Taranto, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Pranzo
authors.affiliation: Division of Gastroenterology, Veris Delli Ponti Hospital, Scorrano, Lecce, Italy.
authors.forename: Cristina
authors.initials: C
authors.lastname: Ricciardelli
authors.affiliation: Division of Surgery, P. Colombo Hospital, Velletri, Rome, Italy.
authors.forename: Marcello
authors.initials: M
authors.lastname: Picchio
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use; D002097:C-Reactive Protein / Q000187:drug effects / Q000378:metabolism; D003093:Colitis, Ulcerative / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D005762:Gastroenterology; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006785:Hospitals, University; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy; D000069285:Infliximab / Q000627:therapeutic use*; D007558:Italy; D039841:Leukocyte L1 Antigen Complex / Q000097:blood / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D015415:Biomarkers; D059451:Biosimilar Pharmaceuticals; C000591237:CT-P13; D005765:Gastrointestinal Agents; D039841:Leukocyte L1 Antigen Complex; D002097:C-Reactive Protein; D000069285:Infliximab