Infliximab Biosimilar (Remsima™) in Therapy of Inflammatory Bowel Diseases Patients: Experience from One Tertiary Inflammatory Bowel Diseases Centre

Digestive Diseases

Volumn 35, Issue 1-2, 2017, Pages 91-100

  Kolar, M ^a   Duricova, D ^a   Bortlik, M ^a   Hruba, V ^a   MacHkova, N ^a   Mitrova, K ^a,b   Malickova, K ^c   Lukas, M ^a   Lukas, Milan ^a,c  

^a CHARLES UNIVERSITY   (Czech Republic)

^b UNIVERSITY HOSPITAL MOTOL   (Czech Republic)

^c CHARLES UNIVERSITY   (Czech Republic)

Author keywords

Biosimilar; Inflammatory bowel diseases; Infliximab; Switching

Indexed keywords

C REACTIVE PROTEIN; CALGRANULIN; CORTICOSTEROID; DRUG ANTIBODY; INFLIXIMAB; TUMOR NECROSIS FACTOR ANTIBODY; BIOSIMILAR AGENT; GASTROINTESTINAL AGENT; MONOCLONAL ANTIBODY;

ABSCESS; ADOLESCENT; ADULT; AGED; ARTHRALGIA; ARTICLE; CONTROLLED STUDY; CORTICOSTEROID THERAPY; CROHN DISEASE; DISEASE ACTIVITY; DRUG EFFICACY; DRUG SAFETY; DYSPLASIA; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; HUMAN; IMMUNOGENICITY; IMMUNOSUPPRESSIVE TREATMENT; INFLAMMATORY BOWEL DISEASE; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; PUSTULOSIS PALMOPLANTARIS; RASH; ULCERATIVE COLITIS; CHEMISTRY; COLITIS, ULCERATIVE; DRUG EFFECTS; DRUG SUBSTITUTION; FECES; INFLAMMATORY BOWEL DISEASES; INTESTINE MUCOSA; MIDDLE AGED; REMISSION; RETROSPECTIVE STUDY; TREATMENT OUTCOME; YOUNG ADULT;

ADULT; ANTIBODIES, MONOCLONAL; BIOSIMILAR PHARMACEUTICALS; C-REACTIVE PROTEIN; COLITIS, ULCERATIVE; CROHN DISEASE; DRUG SUBSTITUTION; FECES; FEMALE; GASTROINTESTINAL AGENTS; HUMANS; INFLAMMATORY BOWEL DISEASES; INFLIXIMAB; INTESTINAL MUCOSA; LEUKOCYTE L1 ANTIGEN COMPLEX; MALE; MIDDLE AGED; REMISSION INDUCTION; RETROSPECTIVE STUDIES; TREATMENT OUTCOME; YOUNG ADULT;

EID: 85011715913     PISSN: 02572753     EISSN: 14219875     Source Type: Journal    
DOI: 10.1159/000453343     Document Type: Article

References (24)

1. Park W, Yoo DH, Jaworski J, et al: Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study. Arthritis Res Ther 2016; 18: 25.
2. Yoo DH, Racewicz A, Brzezicki J, et al: A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study. Arthritis Res Ther 2016; 18: 82.
3. Choe JY, Prodanovic N, Niebrzydowski J, et al: A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis 2015;pii:annrheum dis-2015-207764.
4. Keil R, Wasserbauer M, Zadorova Z, et al: Clinical monitoring: infliximab biosimilar CT-P13 in the treatment of Crohn's disease and ulcerative colitis. Scand J Gastroenterol 2016; 51: 1062-1068.
5. Gecse KB, Lovasz BD, Farkas K, et al: 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.
6. Farkas K, Rutka M, Golovics PA, et al: Efficacy of infliximab biosimilar CT-P13 induction therapy on mucosal healing in ulcerative colitis. J Crohns Colitis 2016; 10: 1273-1278.
7. 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: 1705-1712.
8. Jahnsen J, Detlie TE, Vatn S, et al: Biosimilar infliximab (CT-P13) in the treatment of inflammatory bowel disease: a Norwegian observational study. Expert Rev Gastroenterol Hepatol 2015; 9(suppl 1):45-52.
9. Regulation (EC): No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. OJ L 136, 2004.
10. Vande Casteele N, Khanna R, Levesque BG, et al: The relationship between infliximab concentrations, antibodies to infliximab and disease activity in Crohn's disease. Gut 2015; 64: 1539-1545.
11. 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 2016; 65: 1132-1138.
12. Gils A, Van Stappen T, Dreesen E, et al: Harmonization of infliximab and anti-infliximab assays facilitates the comparison between originators and biosimilars in clinical samples. Inflamm Bowel Dis 2016; 22: 969-975.
13. Maličkova K, Ďuricova 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: 33-36.
14. Vande Casteele N, Ferrante M, Van Assche G, et al: Trough concentrations of infliximab guide dosing for patients with inflammatory bowel disease. Gastroenterology 2015; 148: 1320-1329.e3.
15. Park W, Yoo DH, Miranda P, et al: Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study. Ann Rheum Dis 2016;pii:annrheumd is-2015-208783.
16. Yoo DH, Prodanovic N, Jaworski J, et al: Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study. Ann Rheum Dis 2016;pii:annrheumd is-2015-208786.
17. Nikiphorou E, Kautiainen H, Hannonen P, et al: Clinical effectiveness of CT-P13 (Infliximab biosimilar) used as a switch from Remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data. Expert Opin Biol Ther 2015; 15: 1677-1683.
18. Smits LJ, Derikx LA, de Jong DJ, et al: Clinical outcomes following a switch from Remicade ® to the biosimilar CT-P13 in inflammatory bowel disease patients: a Prospective Observational Cohort Study. J Crohns Colitis 2016; 10: 1287-1293.
19. Sieczkowska J, Jarzȩbicka D, Banaszkiewicz A, et al: Switching between infliximab originator and biosimilar in paediatric patients with inflammatory bowel disease. Preliminary observations. J Crohns Colitis 2016; 10: 127-132.
20. Park SH, Kim YH, Lee JH, et al: Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea. Expert Rev Gastroenterol Hepatol 2015; 9(suppl 1):35-44.
21. Egan LJ, et al: P452. Safety and efficacy of infliximab biosimilar (Remsima ©) in Crohn's disease patients in clinical practice: results after 6 months of treatment. J Crohns Colitis 2016; 10:S328-S329.
22. Egan LJ, et al: P600. Safety and efficacy of infliximab biosimilar (Remsima ©) in ulcerative colitis disease patients in clinical practice: results after 6-months treatment. J Crohns Colitis 2016; 10:S405.
23. Jha A, Upton A, Dunlop WC, et al: The budget impact of biosimilar infliximab (Remsima ®) for the treatment of autoimmune diseases in five European countries. Adv Ther 2015; 32: 742-756.
24. Brodszky V, Rencz F, Pentek M, et al: A budget impact model for biosimilar infliximab in Crohn's disease in Bulgaria, the Czech Republic, Hungary, Poland, Romania, and Slovakia. Expert Rev Pharmacoecon Outcomes Res 2016; 16: 119-225.