Clinical monitoring: Infliximab biosimilar CT-P13 in the treatment of Crohn’s disease and ulcerative colitis

Scandinavian Journal of Gastroenterology

Volumn 51, Issue 9, 2016, Pages 1062-1068

  Keil, Radan ^a,b   Wasserbauer, Martin ^a,b   Zádorová, Zdena ^c   Hajer, Jan ^c   Drastich, Pavel ^d   Wohl, Pavel ^d   Beneš, Marek ^d   Bojková, Martina ^e   Svoboda, Pavel ^e   Konečný, Michal ^f   Falt, Přemysl ^g   Vaňásek, Tomáš ^h   Pešta, Martin ⁱ   Pešek, František ^j   Bouchner, Luděk ^j   Koželuhová, Jana ^a,k   Novotný, Aleš ^a,k   Bartůsková, Lucie ^l   Špičák, Julius ^d  

^a CHARLES UNIVERSITY   (Czech Republic)

^b UNIVERSITY HOSPITAL MOTOL   (Czech Republic)

^c CHARLES UNIVERSITY   (Czech Republic)

^d INSTITUTE FOR CLINICAL AND EXPERIMENTAL MEDICINE   (Czech Republic)

^e UNIVERSITY HOSPITAL OSTRAVA   (Czech Republic)

^f UNIVERSITY HOSPITAL OLOMOUC   (Czech Republic)

^g Vitkovicka nemocnice as   (Czech Republic)

^h UNIVERSITY HOSPITAL HRADEC KRALOVE   (Czech Republic)

ⁱ UNIVERSITY HOSPITAL BULOVKA   (Czech Republic)

^j CHARLES UNIVERSITY   (Czech Republic)

^k CHARLES UNIVERSITY   (Czech Republic)

^l UNIVERSITY OF ECONOMICS   (Czech Republic)

more..

Author keywords

Biosimilar; CT P13; inflammatory bowel disease; infliximab

Indexed keywords

AZATHIOPRINE; BIOSIMILAR AGENT; C REACTIVE PROTEIN; CORTICOSTEROID; CT P 13; INFLIXIMAB; MESALAZINE; UNCLASSIFIED DRUG; CT-P13; GASTROINTESTINAL AGENT; MONOCLONAL ANTIBODY;

ADULT; AGED; ANUS FISTULA; ARTICLE; CLINICAL EVALUATION; CONTROLLED STUDY; CORTICOSTEROID THERAPY; CROHN DISEASE; CROHN DISEASE ACTIVITY INDEX; CZECH REPUBLIC; DIARRHEA; DIGESTIVE SYSTEM DISEASE ASSESSMENT; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG MONITORING; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; HERPES LABIALIS; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; LEG THROMBOSIS; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MAYO SCORING SYSTEM; PNEUMONIA; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; REMISSION; SCORING SYSTEM; SYSTEMIC THERAPY; ULCERATIVE COLITIS; WEIGHT CHANGE; ADOLESCENT; CLINICAL TRIAL; COLITIS, ULCERATIVE; MIDDLE AGED; MULTICENTER STUDY; PROSPECTIVE STUDY; SEX DIFFERENCE; TREATMENT OUTCOME; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; ANTIBODIES, MONOCLONAL; BIOSIMILAR PHARMACEUTICALS; C-REACTIVE PROTEIN; COLITIS, ULCERATIVE; CROHN DISEASE; CZECH REPUBLIC; FEMALE; GASTROINTESTINAL AGENTS; HUMANS; INFLIXIMAB; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; REMISSION INDUCTION; SEX FACTORS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84961392267     PISSN: 00365521     EISSN: 15027708     Source Type: Journal    
DOI: 10.3109/00365521.2016.1149883     Document Type: Article

References (36)

1. M.Feldman, L.Friedman, L.Bramdt Sleisenger and Fordtran’s gastrointestinal and liver disease: pathophysiology, diagnosis, management. 9th ed. Philadelphia (PA): Elsevier; 2010. p. 1941–2013.
2. D.Baumgart Crohn’s disease and ulcerative colitis from epidemiology and immunobiology to a rational diagnostic and therapeutic approach. 1st ed. New York (NY): Springer; 2012. p. 3–74.
3. S.E.Plevy, C.J.Landers, J.Prehn,. A role for TNF-alpha and mucosal T helper-1 cytokines in the pathogenesis of Crohn’s disease. J Immunol. 1997;159:6276–6282.
4. P.Rutgeerts, G.Van Assche, S.Vermeire Review article: infliximab therapy for inflammatory bowel disease – seven years on. Aliment Pharmacol Ther. 2006;23:451–463.
5. G.Fiorino, S.Danese The biosimilar road in inflammatory bowel disease: the right way? Best Pract Res Clin Gastroenterol. 2014;28: 465–471.
6. H.Grabowski, R.Guha, M.Salgado Biosimilar competition: lessons from Europe. Nat Rev Drug Discov. 2014;13:99–100.
7. W.Park, P.Hrycaj, S.Jeka,. 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;72:1605–1612.
8. D.H.Yoo, P.Hrycaj, P.Miranda,. A randomised, double-blind, parallel-group 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;72:1613–1620.
9. S.R.Targan, S.B.Hanauer, S.J.van Deventer,. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn’s disease. Crohn’s Disease cA2 Study Group. N Engl J Med. 1997;337:1029–1035.
10. S.B.Hanauer, B.G.Feagan, G.R.Lichtenstein,. Maintenance infliximab for Crohn’s disease: the ACCENT I randomised trial. Lancet 2002;359:1541–1549.
11. D.H.Present, P.Rutgeerts, S.Targan,. Infliximab for the treatment of fistulas in patients with Crohn’s disease. N Engl J Med. 1999;340:1398–1405.
12. M.M.Lawson, A.G.Thomas, A.K.Akobeng Tumour necrosis factor alpha blocking agents for induction of remission in ulcerative colitis. Cochrane Database Syst Rev. 2006;19:CD005112.
13. P.Rutgeerts, W.J.Sandborn, B.G.Feagan,. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005;353:2462–2476.
14. G.Järnerot, E.Hertervig, I.Friis-Liby,. Infliximab as rescue therapy in severe to moderately severe ulcerative colitis: a randomized, placebo-controlled study. Gastroenterology. 2005;128: 1805–1811.
15. Y.S.Jung, D.I.Park, Y.H.Kim,. Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: a retrospective multicenter study. J Gastroenterol Hepatol. 2015;30:1705–1712.
16. Y.S.Kang, H.H.Moon, S.E.Lee,. 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;60:951–956.
17. K.Gecse, K.Farkas, B.Lovasz,. Biosimilar infliximab in inflammatory bowel diseases: first interim results from a prospective nationwide observational cohort. J Crohns Colitis. 2015;9: S234–S235.
18. D.Jarzebicka, A.Banaszkiewicz, A.Plocek,. Preliminary assessment of efficacy and safety of switching between originator and biosimilar infliximab in paediatric Crohn disease patients. J Crohns Colitis. 2015;9:S224–S225.
19. D.Jarzebicka, A.Plocek, J.Sieczkowska,. First observations of the use of biosimilar infliximab for treatment of ulcerative colitis in paediatric population. J Crohns Colitis. 2015; 9:S307–S308.
20. T.Molnar, K.Farkas, M.Rutka,. Efficacy of the new infliximab biomarker CT-P13 induction therapy on mucosal healing in ulcerative colitis patients. J Crohns Colitis. 2015;9:S382.
21. J.Sieczkowska, A.Banaszkiewicz, A.Plocek,. Assessment of safety and efficacy of biosimilar infliximab in children with Crohn disease: a preliminary report. J Crohns Colitis. 2015;9:S295.
22. K.B.Gecse, B.D.Lovász, K.Farkas,. Efficacy and safety of the biosimilar infliximab CT-P13 treatment in inflammatory bowel diseases: a prospective, multicentre, nationwide cohort. J Crohns Colitis. 2016;10:133–140.
23. F.Schnitzler, H.Fidder, M.Ferrante,. Long-term outcome of treatment with infliximab in 614 patients with Crohn’s disease: results from a single-centre cohort. Gut. 2009;58:492–500.
24. E.A.Fagan, R.F.Dyck, P.N.Maton,. Serum levels of C-reactive protein in Crohn’s disease and ulcerative colitis. Eur J Clin Invest. 1982;12:351–359.
25. S.Vermeire, G.Van Assche, P.Rutgeerts C-reactive protein as a marker for inflammatory bowel disease. Inflamm Bowel Dis. 2004;10:661–665.
26. A.Dignass, R.Eliakim, F.Magro,. Second European evidence-based consensus on the diagnosis and management of ulcerative colitis part 1: definitions and diagnosis. J Crohns Colitis. 2012;6:965–990.
27. G.Van Assche, A.Dignass, J.Panes,. The second European evidence-based consensus on the diagnosis and management of Crohn’s disease: definitions and diagnosis. J Crohns Colitis. 2010; 4:7–27.
28. D.C.Baumgart, W.J.Sandborn Inflammatory bowel disease: clinical aspects and established and evolving therapies. Lancet. 2007;369: 1641–1657.
29. J.Satsangi, L.R.Sutherland, editors. Inflammatory bowel diseases. London: Churchill Livingstone; 2003. p. 169–181.
30. D.Wiese, B.Lashner, D.Seidner Measurement of nutrition status in Crohn’s disease patients receiving infliximab therapy. Nutr Clin Pract. 2008;23:551–556.
31. R.Vadan, L.S.Gheorghe, A.Constantinescu,. The prevalence of malnutrition and the evolution of nutritional status in patients with moderate to severe forms of Crohn’s disease treated with infliximab. Clin Nutr. 2011;30:86–91.
32. J.Pichler, A.Hanslik, W.D.Huber,. Paediatric patients with inflammatory bowel disease who received infliximab experienced improved growth and bone health. Acta Paediatr. 2014;103: e69–e75.
33. J.H.Stone Tumor necrosis factor alpha inhibitors: an overview of adverse effects; 2014 [cited 2015 Jul 16]. Available from: http://www.uptodate.com/contents/tumor-necrosis-factor-alpha-inhibitors-an-overview-of-adverse-effects.
34. A.Cheifetz, M.Smedley, S.Martin,. The incidence and management of infusion reactions to infliximab: a large center experience. Am J Gastroenterol. 2003;98:1315–1324.
35. S.H.Park, Y.H.Kim, J.H.Lee,. Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea. Expert Rev Gastroenterol Hepatol. 2015;9:35–44.
36. A.Amiot, L.Peyrin-Biroulet Current, new and future biological agents on the horizon for the treatment of inflammatory bowel diseases. Therap Adv Gastroenterol. 2015;8:66–82.