title: The PROSIT-BIO Cohort: A Prospective Observational Study of Patients with Inflammatory Bowel Disease Treated with Infliximab Biosimilar.
abstract: Few data are available on the safety and efficacy of infliximab biosimilar CT-P13 in patients with ulcerative colitis and Crohn's disease.
  
  
  
  A prospective, multicenter, cohort study using a structured database.
  
  
  
  Consecutive patients (313 Crohn's disease and 234 ulcerative colitis) were enrolled from 31 referral centers; 311 patients were naive to anti-tumor necrosis factor alpha, 139 had a previous exposure to biologics, and the remaining 97 were switched to CT-P13 after a mean of 18 ± 14 infusions of infliximab. The mean follow-up was 4.3 ± 2.8 months, and the total follow-up time was 195 patient-years. After 2061 infusions, 66 serious adverse events were reported (12.1%), 38 (6.9%) of them were infusion-related reactions. The biosimilar had to be stopped in 29 (5.3%) cases for severe infusion reactions (8 naive, 19 previous exposed, and 2 switch), and in further 16 patients (2.9%) for other serious adverse events. Infusion reactions were significantly more frequent in patients pre-exposed to infliximab than to other anti-tumor necrosis factor alpha (incidence rate ratio = 2.82, 95% CI: 1.05-7.9). The efficacy of the biosimilar was evaluated in 434 patients who received treatment for at least 8 weeks, using time-to-event methods for censored observations: 35 patients were primary failures (8.1%). After further 8, 16, and 24 weeks, the efficacy estimations were 95.7%, 86.4%, and 73.7% for naive, 97.2%, 85.2%, and 62.2% for pre-exposed, and 94.5%, 90.8%, and 78.9% for switch, respectively (log-rank P = 0.64).
  
  
  
  Although no direct comparison was performed, preliminary data on efficacy and safety of CT-P13 were in line with those of infliximab.
authors.affiliation: 1IBD Center, Department of Gastroenterology, Humanitas Research Hospital, Humanitas University, Rozzano, Italy; 2Department of Gastroenterology, AOU Careggi, Florence, Italy; 3IBD Unit, Complesso Integrato Columbus-Gemelli Hospital Catholic University Foundation, Rome, Italy; 4Department of Internal Medicine 2, IBD Unit, Riuniti Villa Sofia-Cervello Hospital, Palermo, Italy; 5Unit of Gastroenterology, Centro Malattie Retto-Intestinali, Sacro Cuore Don Calabria Hospital, Negrar, Italy; 6Gastroenterology Unit, IRCCS-CSS Hospital, San Giovanni Rotondo, Italy; 7Gastroenterology and IBD Unit, Luigi Sacco University Hospital, Milan, Italy; 8Unit of Gastroenterology, University of Padova, Padova, Italy; 9Department of Gastroenterology and Nutrition, Meyer Children's Hospital, Florence, Italy; 10Unit of Gastroenterology, S. Camillo-Forlanini Hospital, Rome, Italy; 11Clinical Unit for Chronic Bowel Disorders, University of Messina, Messina, Italy; 12Department of Gastroenterology, IRCCS Policlinico, San Donato Milanese-Milano, Italy; 13Unit of Gastroenterology, AOUP, Pisa, Italy; 14Department of Gastroenterology and Endoscopy, AO Hospital, Legnano, Italy; 15Department of Systems Medicine, Gastroenterology, University of Rome Tor Vergata, Roma, Italy; 16Unit of Gastroenterology, AOU di Circolo Fondazione Macchi, Varese, Italy; 17Department of Gastroenterology, Ospedale Valduce, Como, Italy; and 18Department of Gastroenterology, Fatebenefratelli-Oftalmico Hospital, Milano, Italy.
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authors.lastname: DʼIncà
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authors.forename: Laura
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authors.lastname: Annunziata
authors.forename: Francesco
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authors.forename: Maria M
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authors.forename: Sandro
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authors.lastname: Ardizzone
authors.forename: Silvio
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authors.forename: Luisa
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authors.lastname: Guidi
authors.forename: Giulia
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authors.lastname: Rizzuto
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authors.lastname: Massella
authors.forename: Angelo
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authors.lastname: Andriulli
authors.forename: Alessandro
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authors.lastname: Massari
authors.forename: Greta
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authors.lastname: Lorenzon
authors.forename: Silvia
authors.initials: S
authors.lastname: Ghione
authors.forename: Anna
authors.initials: A
authors.lastname: Kohn
authors.forename: Agostino
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authors.lastname: Ventra
authors.forename: Vito
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authors.lastname: Annese
mesh_terms: D000293:Adolescent; D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D003424:Crohn Disease / Q000188:drug therapy*; D016208:Databases, Factual; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage*; D006801:Humans; D000069285:Infliximab / Q000008:administration & dosage; D007262:Infusions, Intravenous; D008297:Male; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals; C000591237:CT-P13; D005765:Gastrointestinal Agents; D000069285:Infliximab