References
- Rinaudo-Gaujous M, Paul S, Tedesco ED, et al. Review article: biosimilars are the next generation of drugs for liver and gastrointestinal diseases. Aliment Pharmacol Ther. 2013 Oct;38(8):914–924.
- 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 Feb;10(2):133–140.
- Gonczi L, Gecse KB, Vegh Z, et al. Long-term efficacy, safety, and immunogenicity of biosimilar infliximab after one year in a prospective nationwide cohort. Inflamm Bowel Dis. 2017 Nov;23(11):1908–1915.
- 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 Jul;65(7):1132–1138.
- Dave M, Loftus EVJ. Mucosal healing in inflammatory bowel disease – a true paradigm of success?. Gastroenterol Hepatol. 2012 Jan;8(1):29–38.
- Paine ER. Colonoscopic evaluation in ulcerative colitis. Gastroenterol Rep. 2014 Aug;2(3):161–168.
- Lopez-Palacios N, Mendoza JL, Taxonera C, et al. Mucosal healing for predicting clinical outcome in patients with ulcerative colitis using thiopurines in monotherapy. Eur J Intern Med. 2011 Dec;22(6):621–625.
- Frieri G, Galletti B, Di Ruscio M, et al. The prognostic value of histology in ulcerative colitis in clinical remission with mesalazine. Ther Adv Gastroenterol. 2017;Oct;10(10):749–759.
- Boal Carvalho P, Cotter J. Mucosal healing in ulcerative colitis: a comprehensive review. Drugs. 2017 Feb;77(2):159–173.
- Cholapranee A, Hazlewood GS, Kaplan GG, et al. Systematic review with meta-analysis: comparative efficacy of biologics for induction and maintenance of mucosal healing in Crohn’s disease and ulcerative colitis controlled trials. Aliment Pharmacol Ther. 2017 May;45(10):1291–1302.
- 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 Nov;10(11):1273–1278.
- Satsangi J, Silverberg MS, Vermeire S, et al. The Montreal classification of inflammatory bowel disease: controversies, consensus, and implications. Gut. 2006 Jun;55(6):749–753.
- 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. Internet. cited 2018 Feb 4. 141:4 1194–1201. Internet. .
- Yoo DH, Hrycaj P, Miranda P, et al. 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 Oct;72(10):1613–1620.
- 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 Oct;72(10):1605–1612.
- Danese S, Gomollon F. ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). J Crohns Colitis. 2013 Aug 7;7:586–589.
- 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(9):1257–1262.
- Gonczi L, Vegh Z, Golovics PA, et al. Prediction of short- and medium-term efficacy of biosimilar infliximab therapy. Do Trough Levels and Antidrug Antibody Levels or Clinical and Biochemical Markers Play the More Important Role? J Crohns Colitis. 2017 Jun 1;11(6):697–705.
- Balint A, Rutka M, Vegh Z, et al. Frequency and characteristics of infusion reactions during biosimilar infliximab treatment in inflammatory bowel diseases: results from Central European nationwide cohort. Expert Opin Drug Saf. 2017 Aug;16(8):885–890.
- 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 Dec;30(12):1705–1712.
- Tursi A, Allegretta L, Chiri S, et al. Effectiveness and safety of infliximab biosimilar CT-P13 in treating ulcerative colitis: a real‑life experience in IBD primary centers. Minerva Gastroenterol Dietol. 2017;63(4):313–318.
- Kolar M, Duricova D, Bortlik M, et al. Infliximab biosimilar (remsima) in therapy of inflammatory bowel diseases patients: experience from one tertiary inflammatory bowel diseases centre. Dig Dis Basel Switz. 2017;35(1–2):91–100.
- Fasanmade AA, Adedokun OJ, Olson A, et al. Serum albumin concentration: a predictive factor of infliximab pharmacokinetics and clinical response in patients with ulcerative colitis. Int J Clin Pharmacol Ther. 2010 May;48(5):297–308.
- Cano-Martinez D, Roman ID, Lobo T. MV, Pastor O, Moreno-Villena I, Paradela A, et al. Effect of Infliximab in Oxidised Serum Albumin Levels during Experimental Colitis. Biomark Biochem Indic Expo Response Susceptibility Chem.. 2014 Dec;19(8):693–701.
- Mooiweer E, Severs M, Schipper MEI, et al. Low fecal calprotectin predicts sustained clinical remission in inflammatory bowel disease patients: a plea for deep remission. J Crohns Colitis. 2015 Jan;9(1):50–55.
- Theede K, Holck S, Ibsen P, et al. Fecal calprotectin predicts relapse and histological mucosal healing in ulcerative colitis. Inflamm Bowel Dis. 2016 May;22(5):1042–1048.
- Voiosu T, Bengus A, Dinu R, et al. Rapid fecal calprotectin level assessment and the SIBDQ score can accurately detect active mucosal inflammation in IBD patients in clinical remission: a prospective study. J Gastrointest Liver Dis JGLD. 2014 Sep;23(3):273–278.
- Guidi L, Marzo M, Andrisani G, et al. Faecal calprotectin assay after induction with anti-Tumour Necrosis Factor alpha agents in inflammatory bowel disease: prediction of clinical response and mucosal healing at one year. Dig Liver Dis Off J Ital Soc Gastroenterol Ital Assoc Study Liver. 2014 Nov;46(11):974–979.
- Boal Carvalho P. Dias de Castro F, Rosa B, Moreira MJ, Cotter J. Mucosal Healing in Ulcerative Colitis – When Zero Is Better. J Crohns Colitis.. 2016 Jan;10(1):20–25.
- Froslie KF, Jahnsen J, Moum BA, et al. Mucosal healing in inflammatory bowel disease: results from a Norwegian population-based cohort. Gastroenterology. 2007 Aug;133(2):412–422.
- Jorgensen KK, Olsen IC, Goll GL, et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet Lond Engl. 2017 Jun 10;389(10086):2304–2316.
- Fiorino G, Manetti N, Armuzzi A, et al. The PROSIT-BIO cohort: a prospective observational study of patients with inflammatory bowel disease treated with infliximab biosimilar. Inflamm Bowel Dis. 2017 Feb;23(2):233–243.
- Thomas SS, Borazan N, Barroso N, et al. Comparative Immunogenicity of TNF Inhibitors: impact on clinical efficacy and tolerability in the management of autoimmune diseases. A Systematic Review and Meta-Analysis. BioDrugs Clin Immunother Biopharm Gene Ther. 2015 Aug;29(4):241–258.
- Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005;353:2462–2476.
- Kolář M, Ďuricová D, Bortlík M, et al. Biosimilar infliximab in anti-TNF-naïve IBD patients – 1-year clinical follow-up. Gastroent Hepatol. 2016;70(6):514–522.