Efficacy and effectiveness of biologic therapy in inflammatory bowel disease. EFIFECT study;Eficacia y efectividad de la terapia biológica en la Enfermedad Inflamatoria Intestinal. Estudio EFIFECT

Gastroenterologia y Hepatologia

Volumn 39, Issue 6, 2016, Pages 369-376

  Ginard, Daniel ^a   Khorrami, Sam ^a   Pérez Carazo, Leticia ^a   Tavío Hernández, Eduardo ^b   López Sanromán, Antonio ^b   García Alvarado, María ^c   Muñoz, Fernando ^c   Ibáñez Samaniego, Luis ^d   Marín Jiménez, Ignacio ^d   Guevara, Jorge ^e,f   Casellas, Francesc ^e,f  

^a HOSPITAL UNIVERSITARIO SON ESPASES   (Spain)

^b HOSPITAL RAMÓN Y CAJAL   (Spain)

^c HOSPITAL DE LEÓN   (Spain)

^d HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑÓN   (Spain)

^e HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^f INSTITUTO DE SALUD CARLOS III   (Spain)

Author keywords

Adalimumab; Effectiveness; Efficacy; Inflammatory bowel disease; Infliximab

Indexed keywords

BIOLOGICAL PRODUCT; TUMOR NECROSIS FACTOR INHIBITOR; ADALIMUMAB; BIOLOGICAL FACTOR; INFLIXIMAB;

ARTICLE; BIOLOGICAL THERAPY; CLINICAL PRACTICE; COHORT ANALYSIS; DRUG EFFICACY; DRUG SAFETY; FOLLOW UP; HUMAN; INFLAMMATORY BOWEL DISEASE; MAJOR CLINICAL STUDY; OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL (TOPIC); REMISSION; RETROSPECTIVE STUDY; TREATMENT RESPONSE; ADULT; CLINICAL TRIAL; EPIDEMIOLOGY; FEMALE; MALE; MIDDLE AGED; MULTICENTER STUDY; PATIENT SELECTION; TREATMENT OUTCOME; YOUNG ADULT;

ADALIMUMAB; ADULT; BIOLOGICAL FACTORS; FEMALE; FOLLOW-UP STUDIES; HUMANS; INFLAMMATORY BOWEL DISEASES; INFLIXIMAB; MALE; MIDDLE AGED; PATIENT SELECTION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RETROSPECTIVE STUDIES; SAMPLING STUDIES; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84961230832     PISSN: 02105705     EISSN: 15789519     Source Type: Journal    
DOI: 10.1016/j.gastrohep.2016.02.004     Document Type: Article

References (31)

1. 1 Baumgart, D., Sandborn, W., Crohn disease. Lancet 380 (2012), 1590–1605.
2. 2 Ordás, I., Eckmann, L., Talamini, M., Baumgart, D., Sandborn, W., Ulcerative colitis. Lancet 380 (2012), 1606–1619.
3. 3 Dignass, A., Van Assche, G., Lindsay, J.O., Lémann, M., Söderholm, J., Colombel, J.F., et al. The second European evidence-based consensus on the diagnosis and management of Crohn's disease: Current management. J Crohns Colitis 4 (2010), 28–62.
4. 4 Hanauer, S.B., Feagan, B.G., Lichtenstein, G.R., Mayer, L.L., Schreiber, S., Colombel, J.F., et al. Maintenance infliximab for Crohn's disease: The ACCENT I randomized trial. Lancet 359 (2002), 1541–1549.
5. 5 Colombel, J.F., Sandborn, W.J., Rutgeerts, P., Enns, R., Hanauer, S., Pannacione, R., et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: The CHARM trial. Gastroenterology 132 (2007), 52–65.
6. 6 Rutgeerts, P., Sandborn, W.J., Feagan, B.G., Reinish, W., Olson, A., Johanns, J., et al. Infliximab for Induction and Maintenance Therapy for Ulcerative Colitis. N Eng J Med 353 (2005), 2462–2476.
7. 7 Treweek, S.H., Zwarenstein, M., Making trials matter: Pragmatic and explanatory trials and the problem of applicability. Trials, 10, 2009, 37.
8. 8 Schnitzler, F., Fidder, H., Ferrante, M., Noman, M., Arijs, I., Van Assche, G., et al. Long-term outcome of treatment with infliximab in 614 patients with Crohn's disease: Results from a single-centre cohorte. Gut 58 (2009), 492–500.
9. 9 Teshima, C.H., Thomson, A., Dhanoa, L., Dieleman, L.A., Fedorak, R.N., Long term response rates to infliximab therapy for Crohn's disease in an outpatient cohort. Can J Gastroenterol 23 (2009), 348–352.
10. 10 Sands, B.E., Anderson, F.H., Bernstein, C.N., Chey, W., Feagan, B., Fedorak, R., et al. Infliximab maintenance therapy for fistulizing Crohn's disease (Accent 2). N Engl J Med 350 (2004), 876–885.
11. 11 Colombel, J., Sandborn, W., Reinisch, W., Mantzaris, G., Kornbluth, A., Rachmilewitz, D., et al. Infliximab, azathioprine, or combination therapy for Crohn's disease (Sonic). N Engl J Med 362 (2010), 1383–1395.
12. 12 Hanauer, S.B., Sandborn, W.J., Rutgeerts, P., Fedorak, R., Lukas, M., Macintosh, D., et al. Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: The CLASSIC I trial. Gastroenterology 130 (2006), 323–333.
13. 13 Harvey, R.F., Bradshaw, J.M., A simple index of Crohn's disease activity. Lancet, 1, 1980, 514.
14. 14 Van Spall, H.G., Toren, A., Kiss, A., Fowler, R., Eligibility criteria of randomized controlled trials published in high-impact general medical journals: A systematic sampling review. JAMA 297 (2007), 1233–1240.
15. 15 Ha, C., Ullman, T.H., Siegel, C., Siegel, C., Kornbluth, A., Patients enrolled in randomized controlled trials do not represent the inflammatory bowel disease patient population. Clin Gastro Hepatol 10 (2012), 1002–1007.
16. 16 Sokka, T., Pincus, T.H., Elegibility of patients in routine care for major clinical trials of anti tumor necrosis factor α agents in rheumatoid arthritis. Arthritis Rheum 48 (2003), 313–318.
17. 17 Herland, K., Akselsen, J.P., Skjonsberg, O.H., Bjermer, L., How representative are clinical study patients with asthma or COPD for a larger “real life” population of patients with obstructive lung disease. Respir Med 99 (2005), 11–19.
18. 18 Regueiro, M., Schraut, W., Baidoo, L., Kip, K.E., Sepulveda, A.R., Pesci, M., et al. Infliximab prevents Crohn's disease recurrence after ileal resection. Gastroenterology 136 (2009), 441–450.
19. 19 Järnerot, G., Hertervig, E., Friis-Liby, I., Bromquist, L., Karlen, P., Grännö, C., et al. Infliximab as rescue therapy in severe to moderately severe ulcerative colitis: A randomized, placebo-controlled study. Gastroenterology 128 (2005), 1805–1811.
20. 20 Lahaire, D., Bourreille, A., Branche, J., Allez, M., Bouhnik, Y., Filippi, J., et al. Cyclosporine versus infliximab in patients with severe ulcerative colitis refractory to intravenous steroids: A parallel, open label randomized controlled trial. Lancet 380 (2012), 1909–1915.
21. 21 Barreiro-de Acosta, M., García-Bosch, O., Souto, R., Mañosa, M., Miranda, J., García-Sanchez, V., et al. Efficacy of infliximab rescue therapy in patients with chronic refractory pouchitis: A multicenter study. Inflam Bowel Dis 18 (2012), 821–827.
22. 22 Cullen, G., Vaughn, B., Ahmed, A., Peppercorn, M.A., Smith, M.P., Moss, A.C., et al. Abdominal phlemons in Crohn's disease: Outcomes following antitumor necrosis factor therapy. Inflamm Bowel Dis 18 (2012), 691–696.
23. 23 Loras, C., Gisbert, J.P., Mínguez, M., Merino, O., Bujanda, L., Saro, C., et al. Liver dysfunction related to hepatitis B and C in patients with inflammatory bowel disease treated with immunosuppressive therapy. Gut 59 (2010), 1340–1346.
24. 24 Casanova, M.J., Chaparro, M., Domènech, E., Barreiro-de Acosta, M., Bermejo, F., Iglesias, E., et al. Safety of thiopurines and anti-TNF-α drugs during pregnancy in patients with inflammatory bowel disease. Am J Gastroenterol 108 (2013), 433–440.
25. 25 Sprakes, M., Ford, A., Warren, L., Greer, D., Hamlin, J., Efficacy, tolerability, and predictors of response to infliximab therapy for Crohn's disease: A large single centre experience. J Crohns Colitis 5 (2012), 143–153.
26. 26 Gonzalez Lama, Y., Fernandez Blanco, I., López SanRomán, A., Taxonera, C., Casis, B., Tabernero, S., et al. Open label infliximab therapy in ulcerative colitis: A multicenter survey of results and predictors of response. Hepatogastroenterology 55 (2008), 1609–1614.
27. 27 Lopez Palacios, N., Mendoza, J.L., Taxonera, C., Lana, R., Fuentes Ferrer, M., Diaz-Rubio, M., Adalimumab induction and maintenance therapy for Crohn's disease. An open label study. Rev Esp Enferm Dig 100 (2008), 676–681.
28. 28 Ginard, D., Khorrami, S., Vanrell, M., Efficacy and effectiveness of biological therapy in Inflammatory bowel disease: Comparative study between clinical practice and pivotal studies. J Crohns Colitis, 5, 2011, S128.
29. 29 Zwarenstein, M., Treweek, S.H., What kind of randomized trials do we need?. CMAJ 180 (2009), 998–1000.
30. 30 Vallvé, C., Revisión crítica del ensayo clínico pragmático. Med Clin (Barc) 121 (2003), 384–388.
31. 31 Mant, D., Can randomised trials inform clinical decisions about individual patients. Lancet 353 (1999), 743–746.