title: Clinical monitoring: infliximab biosimilar CT-P13 in the treatment of Crohn's disease and ulcerative colitis.
abstract: OBJECTIVE
  The infliximab biosimilar CT-P13 (Remsima(®), Inflectra(®)) was approved in Europe for the treatment of inflammatory bowel disease (IBD) based on extrapolation of data from patients with rheumatic disease. Because there are limited published reports on clinical outcomes for IBD patients treated with CT-P13, we monitored responses to induction treatment with this biosimilar in patients with Crohn's disease (CD) or ulcerative colitis (UC) in centres across the Czech Republic.
  
  
  METHODS
  Fifty-two patients with CD (n = 30) or UC (n = 22) were treated with 5 mg/kg CT-P13 for up to 14 weeks. Effectiveness of therapy was evaluated with the Crohn's Disease Activity Index (CDAI) or the Mayo Scoring System (MSS) in patients with CD or UC, respectively, before and after 14 weeks. Additional goals were to evaluate weight changes, serum C-reactive protein (CRP) levels, and complications/adverse events.
  
  
  RESULTS
  In patients with CD, remission (CDAI <150) was achieved in 50.0% of cases, and partial response (≥70-point decrease in CDAI score from baseline) in the remaining 50.0%. In patients with UC, remission (total score on partial Mayo index ≤2 points) was achieved in 40.9% of cases, partial response (≥2-point decrease in partial Mayo score from baseline) in 54.5%, and no response in 4.5%. There were statistically significant improvements in CDAI, MSS and CRP serum levels after 14 weeks of therapy, and body weight increased. Four adverse events were identified (n = 1 each): lower-extremity phlebothrombosis, herpes labialis, pneumonia and allergic reaction.
  
  
  CONCLUSIONS
  This prospective observational study provides evidence of the effectiveness of CT-P13 in IBD.
authors.affiliation: a Department of Internal Medicine, 2nd Faculty of Medicine , Charles University in Prague and Motol University Hospital , Prague , Czech Republic ;
authors.forename: Radan
authors.initials: R
authors.lastname: Keil
authors.affiliation: a Department of Internal Medicine, 2nd Faculty of Medicine , Charles University in Prague and Motol University Hospital , Prague , Czech Republic ;
authors.forename: Martin
authors.initials: M
authors.lastname: Wasserbauer
authors.affiliation: b 2nd Department of Internal Medicine, 3rd Faculty of Medicine , Charles University in Prague, FNKV , Prague , Czech Republic ;
authors.forename: Zdena
authors.initials: Z
authors.lastname: Zádorová
authors.affiliation: b 2nd Department of Internal Medicine, 3rd Faculty of Medicine , Charles University in Prague, FNKV , Prague , Czech Republic ;
authors.forename: Jan
authors.initials: J
authors.lastname: Hajer
authors.affiliation: c Department of Hepatogastroenterology , Institute for Clinical and Experimental Medicine , Prague , Czech Republic ;
authors.forename: Pavel
authors.initials: P
authors.lastname: Drastich
authors.affiliation: c Department of Hepatogastroenterology , Institute for Clinical and Experimental Medicine , Prague , Czech Republic ;
authors.forename: Pavel
authors.initials: P
authors.lastname: Wohl
authors.affiliation: c Department of Hepatogastroenterology , Institute for Clinical and Experimental Medicine , Prague , Czech Republic ;
authors.forename: Marek
authors.initials: M
authors.lastname: Beneš
authors.affiliation: d Clinic of Internal Medicine, University Hospital Ostrava , Ostrava , Czech Republic ;
authors.forename: Martina
authors.initials: M
authors.lastname: Bojková
authors.affiliation: d Clinic of Internal Medicine, University Hospital Ostrava , Ostrava , Czech Republic ;
authors.forename: Pavel
authors.initials: P
authors.lastname: Svoboda
authors.affiliation: e 2nd Department of Internal Medicine , University Hospital Olomouc , Olomouc , Czech Republic ;
authors.forename: Michal
authors.initials: M
authors.lastname: Konečný
authors.affiliation: f Digestive Diseases Center, Vítkovice Hospital , Ostrava , Czech Republic ;
authors.forename: Přemysl
authors.initials: P
authors.lastname: Falt
authors.affiliation: g 2nd Department of Internal Medicine-Gastroenterology , University Hospital Hradec Králové, Hradec Králové , Czech Republic ;
authors.forename: Tomáš
authors.initials: T
authors.lastname: Vaňásek
authors.affiliation: h Department of Internal Medicine , Hospital Na Bulovce , Prague , Czech Republic ;
authors.forename: Martin
authors.initials: M
authors.lastname: Pešta
authors.affiliation: i 2nd Department of Internal Medicine , University Hospital Plzeň-Bory , Plzeň, Czech Republic ;
authors.forename: František
authors.initials: F
authors.lastname: Pešek
authors.affiliation: i 2nd Department of Internal Medicine , University Hospital Plzeň-Bory , Plzeň, Czech Republic ;
authors.forename: Luděk
authors.initials: L
authors.lastname: Bouchner
authors.affiliation: j 4th Department of Internal Medicine - Clinic of Gastroenterology and Hepatology , The General University Hospital in Prague, 1st Medical Faculty, Charles University in Prague , Prague , Czech Republic ;
authors.forename: Jana
authors.initials: J
authors.lastname: Koželuhová
authors.affiliation: j 4th Department of Internal Medicine - Clinic of Gastroenterology and Hepatology , The General University Hospital in Prague, 1st Medical Faculty, Charles University in Prague , Prague , Czech Republic ;
authors.forename: Aleš
authors.initials: A
authors.lastname: Novotný
authors.affiliation: k Department of Economic and Social Policy , University of Economics , Prague , Czech Republic.
authors.forename: Lucie
authors.initials: L
authors.lastname: Bartůsková
authors.affiliation: c Department of Hepatogastroenterology , Institute for Clinical and Experimental Medicine , Prague , Czech Republic ;
authors.forename: Julius
authors.initials: J
authors.lastname: Špičák
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002097:C-Reactive Protein / Q000032:analysis; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D003424:Crohn Disease / Q000188:drug therapy*; D018153:Czech Republic; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D000069285:Infliximab / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012074:Remission Induction; D012737:Sex Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals; C000591237:CT-P13; D005765:Gastrointestinal Agents; D002097:C-Reactive Protein; D000069285:Infliximab
keywords: Biosimilar; CT-P13; inflammatory bowel disease; infliximab