Efficacy of infliximab biosimilar CT-P13 induction therapy on mucosal healing in ulcerative colitis

Journal of Crohn's and Colitis

Volumn 10, Issue 11, 2016, Pages 1273-1278

  Farkas, Klaudia ^a   Rutka, Mariann ^a   Golovics, Petra A ^b   Végh, Zsuzsanna ^b   Lovász, Barbara D ^b   Nyári, Tibor ^a   Gecse, Krisztina B ^b   Kolar, Martin ^c,d   Bortlik, Martin ^c,d   Duricova, Dana ^c,d   Machkova, Nadezda ^c   Hruba, Veronika ^c   Lukas, Martin ^c   Mitrova, Katarina ^c,e   Malickova, Karin ^f   Bálint, Anita ^a   Nagy, Ferenc ^a   Bor, Renáta ^a   Milassin, Ágnes ^a   Szepes, Zoltán ^a   Palatka, Károly ^g   Lakatos, Péter L ^b   Lukas, Milan ^c,f   Molnár, Tamás ^a   more..

^a UNIVERSITY OF SZEGED   (Hungary)

^b SEMMELWEIS UNIVERSITY   (Hungary)

^c IBD centre   (Czech Republic)

^d CHARLES UNIVERSITY   (Czech Republic)

^e UNIVERSITY HOSPITAL MOTOL   (Czech Republic)

^f CHARLES UNIVERSITY   (Czech Republic)

^g UNIVERSITY OF DEBRECEN   (Hungary)

Author keywords

Biosimilar; CT P13; Infliximab; Mucosal healing; Ulcerative colitis

Indexed keywords

C REACTIVE PROTEIN; CORTICOSTEROID; CTP 13; INFLIXIMAB; SERUM ALBUMIN; UNCLASSIFIED DRUG; BIOSIMILAR AGENT; CT-P13; GASTROINTESTINAL AGENT; MONOCLONAL ANTIBODY;

ADOLESCENT; ADULT; AGED; ARTICLE; BIOLOGICAL THERAPY; CORTICOSTEROID THERAPY; DISEASE DURATION; DRUG EFFICACY; FEMALE; HEMATOCRIT; HUMAN; INTESTINE MUCOSA; LEUKOCYTE COUNT; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PRIORITY JOURNAL; PROSPECTIVE STUDY; REMISSION; SIGMOIDOSCOPY; SMOKING; THROMBOCYTE; ULCER HEALING; ULCERATIVE COLITIS; CLINICAL TRIAL; COLITIS, ULCERATIVE; MIDDLE AGED; PATHOLOGY; TREATMENT OUTCOME; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; ANTIBODIES, MONOCLONAL; BIOSIMILAR PHARMACEUTICALS; COLITIS, ULCERATIVE; FEMALE; GASTROINTESTINAL AGENTS; HUMANS; INFLIXIMAB; INTESTINAL MUCOSA; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; TREATMENT OUTCOME; YOUNG ADULT;

EID: 85012289049     PISSN: 18739946     EISSN: 18764479     Source Type: Journal    
DOI: 10.1093/ecco-jcc/jjw085     Document Type: Article

References (20)

1. Rinaudo-Gaujous M, Paul S, Tedesco ED, Genin C, Roblin X, Peyrin-Biroulet L. Review article: biosimilars are the next generation of drugs for liver and gastrointestinal diseases. Aliment Pharmacol Ther 2013;38:914-24.
2. Yoo DH, Hrycaj P, Miranda P, et al. A randomised, double-blind, parallelgroup study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis 2013;72:1613-20.
3. Park W, Hrycaj P, Jeka S, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis 2013;72:1605-12.
4. Feagan BG, Choquette D, Ghosh S, et al. The challenge of indication extrapolation for infliximab biosimilars. Biologicals 2014;42:177-83.
5. Jung YS, Park DI, Kim YH, et al. Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: A retrospective multicenter study. J Gastroenterol Hepatol 2015;30:1705-12.
6. Kang YS, Moon HH, Lee SE, Lim YJ, Kang HW. Clinical experience of the use of CT-P13, a biosimilar to infliximab in patients with inflammatory bowel disease: A case series. Dig Dis Sci 2015;60:951-6.
7. Farkas K, Rutka M, Balint A, et al. Efficacy of the new infliximab biosimilar CT-P13 induction therapy in Crohn's disease and ulcerative colitis-experiences from a single center. Expert Opin Biol Ther 2015;15: 1257-62.
8. Satsangi J, Silverberg MS, Vermeire S, Colombel JF. The Montreal classification of inflammatory bowel disease: controversies, consensus, and implications. Gut 2006;55:749-53.
9. Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. N Engl J Med 1987;317:1625-9.
10. Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med 2005;353: 2462-76.
11. Lee KM, Jeen YT, Cho JY, et al. Efficacy, safety, and predictors of response to infliximab therapy for ulcerative colitis: a Korean multicenter retrospective study. J Gastroenterol Hepatol 2013;28:1829-33.
12. Zhou YL, Xie S, Wang P, et al. Efficacy and safety of infliximab in treating patients with ulcerative colitis: experiences from a single medical center in southern China. J Dig Dis 2014;15:483-90.
13. Hyams J, Damaraju L, Blank M, et al. Induction and maintenance therapy with infliximab for children with moderate to severe ulcerative colitis. Clin Gastroenterol Hepatol 2012;10:391-9.e1.
14. Colombel JF, Rutgeerts P, Reinisch W, et al. Early mucosal healing with infliximab is associated with improved long-term clinical outcomes in ulcerative colitis. Gastroenterology 2011;141:1194-201.
15. Paul S, Del Tedesco E, Marotte H, et al. Therapeutic drug monitoring of infliximab and mucosal healing in inflammatory bowel disease: a prospective study. Inflamm Bowel Dis 2013;19:2568-76.
16. Ben-Horin S, Yavzori M, Benhar I, et al. Cross-immunogenicity: antibodies to infliximab in Remicade-treated patients with IBD similarly recognise the biosimilar Remsima. Gut 2015.
17. Malickova K, Duricova D, Bortlik M, et al. Serum trough infliximab levels: A comparison of three different immunoassays for the monitoring of CT-P13 (infliximab) treatment in patients with inflammatory bowel disease. Biologicals 2016;44:33-6.
18. Advances in IBD: Current developments in the treatment of inflammatory bowel diseases. Gastroenterol Hepatol (N Y) 2009;5:830-3.
19. Dai C, Liu WX, Jiang M, Sun MJ. Mucosal healing did not predict sustained clinical remission in patients with IBD after discontinuation of oneyear infliximab therapy. PLoS One 2014;9:e110797.
20. Farkas K, Lakatos PL, Szucs M, et al. Frequency and prognostic role of mucosal healing in patients with Crohn's disease and ulcerative colitis after one-year of biological therapy. World J Gastroenterol 2014;20:2995-3001.