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Volumn 105, Issue 1, 2013, Pages 37-43

Joint statement of the Spanish society of digestive pathology and the Spanish society of pharmacology on treatment with biosimilars in inflammatory bowel disease;Posición conjunta de la sociedad Española de patología digestiva y de la sociedad Española de farmacología sobre el tratamiento con biosimilares en la enfermedad inflamatoria intestinal

Author keywords

Adalimumab; Biosimilars; Crohn's disease; Inflammatory bowel disease; Infliximab; Spanish Society of Gastroenterology; Ulcerative colitis

Indexed keywords

ADALIMUMAB; AZATHIOPRINE; BIOLOGICAL PRODUCT; BIOSIMILAR AGENT; CERTOLIZUMAB PEGOL; ERYTHROPOIETIN; ETANERCEPT; GOLIMUMAB; GRANULOCYTE COLONY STIMULATING FACTOR; GROWTH HORMONE; IMMUNOMODULATING AGENT; INFLIXIMAB; MONOCLONAL ANTIBODY; NATALIZUMAB; PLACEBO; RECOMBINANT DNA; TUMOR NECROSIS FACTOR ALPHA ANTIBODY; USTEKINUMAB; VEDOLIZUMAB;

EID: 84878532312     PISSN: 11300108     EISSN: None     Source Type: Journal    
DOI: 10.4321/s1130-01082013000100006     Document Type: Article
Times cited : (60)

References (50)
  • 1
    • 62949219864 scopus 로고    scopus 로고
    • Biological therapies for inflammatory bowel diseases
    • Rutgeerts P, Vermeire S, Van Assche G. Biological therapies for inflammatory bowel diseases. Gastroenterology 2009;136:1182-97.
    • (2009) Gastroenterology , vol.136 , pp. 1182-1197
    • Rutgeerts, P.1    Vermeire, S.2    van Assche, G.3
  • 2
    • 0030954732 scopus 로고    scopus 로고
    • A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn's disease. Crohn's disease cA2 Study Group
    • Targan SR, Hanauer SB, van Deventer SJ, Mayer L, Present DH, Braakman T, et al. 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;337:1029-35.
    • (1997) N Engl J Med , vol.337 , pp. 1029-1035
    • Targan, S.R.1    Hanauer, S.B.2    van Deventer, S.J.3    Mayer, L.4    Present, D.H.5    Braakman, T.6
  • 3
    • 33645958908 scopus 로고    scopus 로고
    • Groupe d'Etude Therapeutique des Affections Inflammatoires du Tube Digestif (GETAID). Infliximab plus azathioprine for steroiddependent Crohn's disease patients: A randomized placebo-controlled trial
    • Lémann M, Mary JY, Duclos B, Veyrac M, Dupas JL, Dlchier JC, et al; Groupe d'Etude Therapeutique des Affections Inflammatoires du Tube Digestif (GETAID). Infliximab plus azathioprine for steroiddependent Crohn's disease patients: a randomized placebo-controlled trial. Gastroenterology 2006;130:1054-61.
    • (2006) Gastroenterology , vol.130 , pp. 1054-1061
    • Lémann, M.1    Mary, J.Y.2    Duclos, B.3    Veyrac, M.4    Dupas, J.L.5    Dlchier, J.C.6
  • 5
    • 32044451548 scopus 로고    scopus 로고
    • Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: The CLASSIC-I trial
    • Hanauer SB, Sandborn WJ, Rutgeerts P, Fedorak RN, Lukas M, MacIntosh D, et al. Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: The CLASSIC-I trial. Gastroenterology 2006;130:323-33.
    • (2006) Gastroenterology , vol.130 , pp. 323-333
    • Hanauer, S.B.1    Sandborn, W.J.2    Rutgeerts, P.3    Fedorak, R.N.4    Lukas, M.5    Macintosh, D.6
  • 6
    • 34347402306 scopus 로고    scopus 로고
    • Adalimumab induction therapy for Crohn disease previously treated with infliximab: A randomized trial
    • Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Colombel JF, Panaccione R, et al. Adalimumab induction therapy for Crohn disease previously treated with infliximab: A randomized trial. Ann Intern Med 2007;146:829-38.
    • (2007) Ann Intern Med , vol.146 , pp. 829-838
    • Sandborn, W.J.1    Rutgeerts, P.2    Enns, R.3    Hanauer, S.B.4    Colombel, J.F.5    Panaccione, R.6
  • 7
    • 0032833517 scopus 로고    scopus 로고
    • Efficacy and safety of retreatment with anti-tumor necrosis factor antibody (infliximab) to maintain remission in Crohn's disease
    • Rutgeerts P, D'Haens G, Targan S, Vasiliauskas E, Hanauer SB, Present DH, et al. Efficacy and safety of retreatment with anti-tumor necrosis factor antibody (infliximab) to maintain remission in Crohn's disease. Gastroenterology 1999;117:761-9.
    • (1999) Gastroenterology , vol.117 , pp. 761-769
    • Rutgeerts, P.1    D'Haens, G.2    Targan, S.3    Vasiliauskas, E.4    Hanauer, S.B.5    Present, D.H.6
  • 9
    • 33846242958 scopus 로고    scopus 로고
    • Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: The CHARM trial
    • Colombel JF, Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Panaccione R, et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: The CHARM trial. Gastroenterology 2007;132:52-65.
    • (2007) Gastroenterology , vol.132 , pp. 52-65
    • Colombel, J.F.1    Sandborn, W.J.2    Rutgeerts, P.3    Enns, R.4    Hanauer, S.B.5    Panaccione, R.6
  • 15
    • 33746263856 scopus 로고    scopus 로고
    • New mediators of immunity and inflammation in inflammatory bowel disease
    • Monteleone G, Fina D, Caruso R, Pallone F. New mediators of immunity and inflammation in inflammatory bowel disease. Curr Opin Gastroenterol 2006;22:361-4.
    • (2006) Curr Opin Gastroenterol , vol.22 , pp. 361-364
    • Monteleone, G.1    Fina, D.2    Caruso, R.3    Pallone, F.4
  • 17
    • 0038460945 scopus 로고    scopus 로고
    • Infliximab in moderately severe glucocorticoid resistant ulcerative colitis: A randomised controlled trial
    • Probert CJ, Hearing SD, Schreiber S, Kühbacher T, Ghosh S, Arnott ID, et al. Infliximab in moderately severe glucocorticoid resistant ulcerative colitis: A randomised controlled trial. Gut 2003;52:998-1002.
    • (2003) Gut , vol.52 , pp. 998-1002
    • Probert, C.J.1    Hearing, S.D.2    Schreiber, S.3    Kühbacher, T.4    Ghosh, S.5    Arnott, I.D.6
  • 18
    • 20444479336 scopus 로고    scopus 로고
    • Infliximab as rescue therapy in severe to moderately severe ulcerative colitis: A randomized, placebo-controlled study
    • Jarnerot G, Hertervig E, Friis-Liby I, Blomquist L, Karlén P, Grännö C, et al. Infliximab as rescue therapy in severe to moderately severe ulcerative colitis: A randomized, placebo-controlled study. Gastroenterology 2005;128:1805-11.
    • (2005) Gastroenterology , vol.128 , pp. 1805-1811
    • Jarnerot, G.1    Hertervig, E.2    Friis-Liby, I.3    Blomquist, L.4    Karlén, P.5    Grännö, C.6
  • 20
    • 70350446513 scopus 로고    scopus 로고
    • Adalimumab in ulcerative colitis: Two cases of mucosal healing and clinical response at two years
    • Barreiro-de Acosta M, Lorenzo A, Dominguez-Muñoz JE. Adalimumab in ulcerative colitis: Two cases of mucosal healing and clinical response at two years. World J Gastroenterol 2009;15:3814-6.
    • (2009) World J Gastroenterol , vol.15 , pp. 3814-3816
    • Barreiro-De, A.M.1    Lorenzo, A.2    Dominguez-Muñoz, J.E.3
  • 21
    • 52149104260 scopus 로고    scopus 로고
    • Long-term outcome of adalimumab therapy for ulcerative colitis with intolerance or lost response to infliximab: A single-centre experience
    • Oussalah A, Laclotte C, Chevaux JB, Bensenane M, Babouri A, Serre AA, et al. Long-term outcome of adalimumab therapy for ulcerative colitis with intolerance or lost response to infliximab: A single-centre experience. Aliment Pharmacol Ther 2008;28:966-72.
    • (2008) Aliment Pharmacol Ther , vol.28 , pp. 966-972
    • Oussalah, A.1    Laclotte, C.2    Chevaux, J.B.3    Bensenane, M.4    Babouri, A.5    Serre, A.A.6
  • 22
    • 79955859430 scopus 로고    scopus 로고
    • Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: Results of a randomised controlled trial
    • Reinisch W, Sandborn WJ, Hommes D, D'Haens G, Hanauer S, Schreiber S, et al. Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trial. Gut 2011;60:780-7.
    • (2011) Gut , vol.60 , pp. 780-787
    • Reinisch, W.1    Sandborn, W.J.2    Hommes, D.3    D'Haens, G.4    Hanauer, S.5    Schreiber, S.6
  • 23
    • 84881544049 scopus 로고    scopus 로고
    • The GETECCU clinical guideline for the treatment of ulcerative colitis: A guideline created using GRADE methodology
    • on behalf of GETECCU, Jan 8. pii: S0210-5705(12)00306-8
    • Gomollón F, García-López S, Sicilia B, Gisbert J, Hinojosa J, on behalf of GETECCU. The GETECCU clinical guideline for the treatment of ulcerative colitis: A guideline created using GRADE methodology. Gastroenterol Hepatol 2013 Jan 8. pii: S0210-5705(12)00306-8.
    • (2013) Gastroenterol Hepatol
    • Gomollón, F.1    García-López, S.2    Sicilia, B.3    Gisbert, J.4    Hinojosa, J.5
  • 25
    • 84856163835 scopus 로고    scopus 로고
    • Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis
    • Sandborn WJ, Van Assche G, Reinisch W, Colombel JF, D'Haens G, Wolf DC, et al. Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology 2012;142:257-65.
    • (2012) Gastroenterology , vol.142 , pp. 257-265
    • Sandborn, W.J.1    van Assche, G.2    Reinisch, W.3    Colombel, J.F.4    D'Haens, G.5    Wolf, D.C.6
  • 27
  • 30
    • 84863984524 scopus 로고    scopus 로고
    • Vedolizumab for the treatment of active ulcerative colitis: A randomized controlled phase 2 dose-ranging study
    • Parikh A, Leach T, Wyant T, Scholz C, Sankoh S, Mould DR, et al. Vedolizumab for the treatment of active ulcerative colitis: A randomized controlled phase 2 dose-ranging study. Inflamm Bowel Dis 2012;18:1470-9.
    • (2012) Inflamm Bowel Dis , vol.18 , pp. 1470-1479
    • Parikh, A.1    Leach, T.2    Wyant, T.3    Scholz, C.4    Sankoh, S.5    Mould, D.R.6
  • 31
    • 84878559875 scopus 로고    scopus 로고
    • ClinicalTrials.gov, (golimumab) in patients with moderately to severely active ulcerative colitis (CR014179). NCT00488631. [Consultado 20/01/2013]. Disponible en
    • ClinicalTrials.gov. A study of the safety and effectiveness of CNTO 148 (golimumab) in patients with moderately to severely active ulcerative colitis (CR014179). NCT00488631. [Consultado 20/01/2013]. Disponible en: http://clinicaltrials.gov/ct2/show/NCT00488631?term=NCT00488631&rank=1).
    • A Study of the Safety and Effectiveness of CNTO 148
  • 32
    • 84859059470 scopus 로고    scopus 로고
    • Changing Crohn's disease management: Need for new goals and indices to prevent disability and improve quality of life
    • Hommes D, Colombel J.F, Emery P, Greco M, Sandborn WJ. Changing Crohn's disease management: Need for new goals and indices to prevent disability and improve quality of life. J Crohn's Colitis 2012;6:S224-34.
    • (2012) J Crohn's Colitis , vol.6
    • Hommes, D.1    Colombel, J.F.2    Emery, P.3    Greco, M.4    Sandborn, W.J.5
  • 33
    • 84859070472 scopus 로고    scopus 로고
    • Implementing changes in clinical practice to improve the management of Crohn's disease
    • Panaccione R, Hibi T, Peyrin-Biroulet L, Schreiber S. Implementing changes in clinical practice to improve the management of Crohn's disease. J Crohn's Colitis 2012;6:S235-42.
    • (2012) J Crohn's Colitis , vol.6
    • Panaccione, R.1    Hibi, T.2    Peyrin-Biroulet, L.3    Schreiber, S.4
  • 35
    • 67650501700 scopus 로고    scopus 로고
    • The cholinergic antiinflammatory pathway: Towards innovative treatment of rheumatoid arthritis
    • Van Maanen, MA, Vervoordeldonk MJ, Tak PP. The cholinergic antiinflammatory pathway: towards innovative treatment of rheumatoid arthritis. Nat Rev Rheumatol 2009;5:229-32.
    • (2009) Nat Rev Rheumatol , vol.5 , pp. 229-232
    • van Maanen, M.A.1    Vervoordeldonk, M.J.2    Tak, P.P.3
  • 36
    • 77950251400 scopus 로고    scopus 로고
    • A human gut microbial gene catalogue established by metagenomic sequencing
    • Qin J, Li R, Raes J, Arumugam M, Burgdorf KS, Manichanh C, et al. A human gut microbial gene catalogue established by metagenomic sequencing. Nature 2010;464:59-65.
    • (2010) Nature , vol.464 , pp. 59-65
    • Qin, J.1    Li, R.2    Raes, J.3    Arumugam, M.4    Burgdorf, K.S.5    Manichanh, C.6
  • 37
    • 35348857386 scopus 로고    scopus 로고
    • Molecular-phylogenetic characterization of microbial community imbalances in human inflammatory bowel diseases
    • Frank DN, St Amand AL, Feldman RA, Boedeker CE, Harpaz N, Pace NR. Molecular-phylogenetic characterization of microbial community imbalances in human inflammatory bowel diseases. Proc Natl Acad Sci USA 2007;104:13780-5.
    • (2007) Proc Natl Acad Sci USA , vol.104 , pp. 13780-13785
    • Frank, D.N.1    St Amand, A.L.2    Feldman, R.A.3    Boedeker, C.E.4    Harpaz, N.5    Pace, N.R.6
  • 38
    • 84867027990 scopus 로고    scopus 로고
    • Mucosal healing in inflammatory bowel diseases: A systematic review
    • Neurath MF, Travis SP. Mucosal healing in inflammatory bowel diseases: A systematic review. Gut 2012;61:1619-35.
    • (2012) Gut , vol.61 , pp. 1619-1635
    • Neurath, M.F.1    Travis, S.P.2
  • 39
    • 79251526548 scopus 로고    scopus 로고
    • Crohn's disease, feeling well or healthy?
    • Casellas F. Crohn's disease, feeling well or healthy? Rev Esp Enferm Dig 2010;102:621-3.
    • (2010) Rev Esp Enferm Dig , vol.102 , pp. 621-623
    • Casellas, F.1
  • 40
    • 84862231137 scopus 로고    scopus 로고
    • Mucosal healing restores normal health and quality of life in patients with inflammatory bowel disease
    • Casellas F, Barreiro de Acosta M, Iglesias M, Robles V, Nos P, Aguas M, et al. Mucosal healing restores normal health and quality of life in patients with inflammatory bowel disease. Eur J Gastroenterol Hepatol 2012;24:762-79.
    • (2012) Eur J Gastroenterol Hepatol , vol.24 , pp. 762-779
    • Casellas, F.1    de Acosta, M.B.2    Iglesias, M.3    Robles, V.4    Nos, P.5    Aguas, M.6
  • 41
    • 84878543978 scopus 로고
    • Biological products
    • Higgins CH. Biological products. Can Med Assoc J 1912;2:114-20.
    • (1912) Can Med Assoc J , vol.2 , pp. 114-120
    • Higgins, C.H.1
  • 42
  • 43
    • 84856710491 scopus 로고    scopus 로고
    • Biosimilars: Impact of biologic product life cycle and European experience on the regulatory trajectory in the United States
    • Ahmed I, Kaspar B, Sharma U. Biosimilars: Impact of biologic product life cycle and European experience on the regulatory trajectory in the United States. Clin Ther 2012;34:400-19.
    • (2012) Clin Ther , vol.34 , pp. 400-419
    • Ahmed, I.1    Kaspar, B.2    Sharma, U.3
  • 44
    • 8344224534 scopus 로고    scopus 로고
    • Characterizing biological products and assessing comparability following manufacturing changes
    • Chirino AJ, Mire-Sluis A. Characterizing biological products and assessing comparability following manufacturing changes. Nat Biotechnol 2004;22:1383-91.
    • (2004) Nat Biotechnol , vol.22 , pp. 1383-1391
    • Chirino, A.J.1    Mire-Sluis, A.2
  • 45
    • 37249013778 scopus 로고    scopus 로고
    • Similar biological medicinal products containing recombinant human growth hormone: European regulation
    • Pavlovic M, Girardin E, Kapetanovic L, Ho K, Trouvin JH. Similar biological medicinal products containing recombinant human growth hormone: European regulation. Horm Res 2008;69:14-21.
    • (2008) Horm Res , vol.69 , pp. 14-21
    • Pavlovic, M.1    Girardin, E.2    Kapetanovic, L.3    Ho, K.4    Trouvin, J.H.5
  • 48
    • 84860619510 scopus 로고    scopus 로고
    • Comparative pharmacokinetics of HD203, a biosimilar of etanercept, with marketed etanercept (Enbrel®): A double-blind, single-dose, crossover study in health volunteers
    • Yi S, Kim SE, Park MK, Yoon SH, Cho JY, Lim KS, et al. Comparative pharmacokinetics of HD203, a biosimilar of etanercept, with marketed etanercept (Enbrel®): a double-blind, single-dose, crossover study in health volunteers. BioDrugs 2012;26:177-84.
    • (2012) BioDrugs , vol.26 , pp. 177-184
    • Yi, S.1    Kim, S.E.2    Park, M.K.3    Yoon, S.H.4    Cho, J.Y.5    Lim, K.S.6
  • 49
    • 84878526388 scopus 로고    scopus 로고
    • American College of Rheumatology. [Consultado 20/01/2010] Disponible en
    • American College of Rheumatology. [Consultado 20/01/2010] Disponible en: http://www.rheumatology.org/practice/clinical/position/biosimilars.pdf.


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