BACKGROUND: CT-P13 is the first biosimilar monoclonal antibody to infliximab. However, the antibody was tested only in rheumatoid arthritis and ankylosing spondylitis, which demonstrated equivalence to the originator in efficacy, safety, and pharmacokinetic profile. Extrapolation of its efficacy and safety to other pathologies is tenuous. Interchangeability with its originator is another unclear area. AIM: We aimed to describe the experience of CT-P13 use in inflammatory bowel disease at a tertiary center. METHODS: Seventeen subjects diagnosed with Crohn's disease (CD, n = 8) or ulcerative colitis (UC, n = 9) who were administered CT-P13 from November 2012 to October 2013 at Dongguk University Ilsan Hospital were retrospectively enrolled. Medical records analyzed included patients' characteristics, previous history of anti-tumor necrosis factor administration, response and remission to this biosimilar antibody, disease flare-up, and adverse drug reaction. RESULTS: Male-female ratio was 1.8. Mean age was 35.4 years (range 15-57). Mean number of CT-P13 administrations was 4.2 ± 1.9. Induction treatments were done in five UC and three CD patients. Clinical response and remission at 8 weeks were achieved in seven patients (five UC and two CD). One CD patient did not respond to CT-P13. Nine patients in maintenance with the originator were interchanged with CT-P13 (four UC and five CD patients). One UC patient experienced arthralgia and CT-P13 was discontinued. One patient experienced loss of response during the study period. CONCLUSIONS: CT-P13 may have biosimilarity and interchangeability with its originator in inflammatory bowel disease. A large, randomized, double-blind, prospective study is needed.
BACKGROUND:CT-P13 is the first biosimilar monoclonal antibody to infliximab. However, the antibody was tested only in rheumatoid arthritis and ankylosing spondylitis, which demonstrated equivalence to the originator in efficacy, safety, and pharmacokinetic profile. Extrapolation of its efficacy and safety to other pathologies is tenuous. Interchangeability with its originator is another unclear area. AIM: We aimed to describe the experience of CT-P13 use in inflammatory bowel disease at a tertiary center. METHODS: Seventeen subjects diagnosed with Crohn's disease (CD, n = 8) or ulcerative colitis (UC, n = 9) who were administered CT-P13 from November 2012 to October 2013 at Dongguk University Ilsan Hospital were retrospectively enrolled. Medical records analyzed included patients' characteristics, previous history of anti-tumornecrosis factor administration, response and remission to this biosimilar antibody, disease flare-up, and adverse drug reaction. RESULTS: Male-female ratio was 1.8. Mean age was 35.4 years (range 15-57). Mean number of CT-P13 administrations was 4.2 ± 1.9. Induction treatments were done in five UC and three CDpatients. Clinical response and remission at 8 weeks were achieved in seven patients (five UC and two CD). One CDpatient did not respond to CT-P13. Nine patients in maintenance with the originator were interchanged with CT-P13 (four UC and five CDpatients). One UC patient experienced arthralgia and CT-P13 was discontinued. One patient experienced loss of response during the study period. CONCLUSIONS:CT-P13 may have biosimilarity and interchangeability with its originator in inflammatory bowel disease. A large, randomized, double-blind, prospective study is needed.
Authors: A Dignass; G Van Assche; J O Lindsay; M Lémann; J Söderholm; J F Colombel; S Danese; A D'Hoore; M Gassull; F Gomollón; D W Hommes; P Michetti; C O'Morain; T Oresland; A Windsor; E F Stange; S P L Travis Journal: J Crohns Colitis Date: 2010-01-15 Impact factor: 9.071
Authors: S R Targan; S B Hanauer; S J van Deventer; L Mayer; D H Present; T Braakman; K L DeWoody; T F Schaible; P J Rutgeerts Journal: N Engl J Med Date: 1997-10-09 Impact factor: 91.245
Authors: Michael Clark; Jean-Frederic Colombel; Brian C Feagan; Richard N Fedorak; Stephen B Hanauer; Michael A Kamm; Lloyd Mayer; Carol Regueiro; Paul Rutgeerts; William J Sandborn; Bruce E Sands; Stefan Schreiber; Stephan Targan; Simon Travis; Severine Vermeire Journal: Gastroenterology Date: 2007-07 Impact factor: 22.682
Authors: Stephen B Hanauer; Brian G Feagan; Gary R Lichtenstein; Lloyd F Mayer; S Schreiber; Jean Frederic Colombel; Daniel Rachmilewitz; Douglas C Wolf; Allan Olson; Weihang Bao; Paul Rutgeerts Journal: Lancet Date: 2002-05-04 Impact factor: 79.321