Sargramostim (GM-CSF) for induction of remission in crohn's disease: A cochrane inflammatory bowel disease and functional bowel disorders systematic review of randomized trials

Inflammatory Bowel Diseases

Volumn 18, Issue 7, 2012, Pages 1333-1339

  Roth, Lee ^a   MacDonald, John K ^b   McDonald, John W D ^b   Chande, Nilesh ^c  

^a MCMASTER UNIVERSITY   (Canada)

^b ROBARTS RESEARCH INSTITUTE   (Canada)

^c LONDON HEALTH SCIENCES CENTRE   (Canada)

Author keywords

Crohn's disease; Meta analysis; Sargramostim

Indexed keywords

PLACEBO; RECOMBINANT GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR;

BONE PAIN; CAPILLARY LEAK SYNDROME; COCHRANE LIBRARY; CROHN DISEASE; DRUG EFFICACY; DYSPNEA; FEVER; HEART FAILURE; HUMAN; INJECTION SITE REACTION; LUNG EDEMA; MUSCULOSKELETAL PAIN; NEUROTOXICITY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REMISSION; REVIEW; STATISTICAL ANALYSIS; SYSTEMATIC REVIEW; THORAX PAIN; TREATMENT OUTCOME; TREATMENT RESPONSE;

CROHN DISEASE; GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR; HUMANS; IMMUNOLOGIC FACTORS; PROGNOSIS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECOMBINANT PROTEINS; REMISSION INDUCTION;

EID: 84862177873     PISSN: 10780998     EISSN: 15364844     Source Type: Journal    
DOI: 10.1002/ibd.22973     Document Type: Review

References (31)

1. Dalziel TK. Chronic interstitial enteritis. Br Med J. 1913;2:1068-1070.
2. Crohn BB, Ginzburg L, Oppenheimer GD. Regional ileitis: a pathologic and clinical entity. JAMA. 1932;99:1323-1329.
3. Loftus EV Jr, Schoenfeld P, Sandborn WJ. The epidemiology and natural history of Crohn's disease in population-based patient cohorts from North America: a systematic review. Aliment Pharmacol Ther. 2002;16:51-60. (Pubitemid 34123864)
4. Summers RW, Switz DM, Sessions JT Jr, et al. National cooperative Crohns disease study: results of drug treatment. Gastroenterology. 1979;77(4 Pt 2):847-869. (Pubitemid 9242048)
5. Lim WC, Hanauer S. Aminosalicylates for induction of remission or response in Crohn's disease. Cochrane Database Syst Rev.2010;12: CD008870.
6. Benchimol EI, Seow CH, Steinhart AH, et al. Traditional corticosteroids for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2008;2:CD006792.
7. Seow CH, Benchimol EI, Griffiths AM, et al. Budesonide for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2008;3:CD000296.
8. Prefontaine E, MacDonald JK, Sutherland LR. Azathioprine or 6-mercaptopurine for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2009;4:CD000545.
9. Alfadhli AAF, McDonald JWD, Feagan BG. Methotrexate for induction of remission in refractory Crohn's disease. Cochrane Database Syst Rev. 2004;4:CD003459.
10. Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002;359:1541-1549. (Pubitemid 34621118)
11. Hanauer SB, Sandborn WJ, Rutgeerts P, et al. Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: the CLASSIC-I trial. Gastroenterology. 2006; 130:323-333.
12. Akobeng AK, Zachos M. Tumor necrosis factor-alpha antibody for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2003;4:CD003574.
13. MacDonald JK, McDonald JWD. Natalizumab for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2007;1: CD006097.
14. Korzenik JR, Dieckgraefe BK. Is Crohn's disease an immunodeficiency? A hypothesis suggesting possible early events in the pathogenesis of Crohn's disease. Dig Dis Sci. 2000;45:1121-1129. (Pubitemid 30409456)
15. Vaughan D, Drumm B. Treatment of fistulas with granulocyte colony-stimulating factor in a patient with Crohn's disease. N Engl J Med. 1999;340:239-240. (Pubitemid 29063228)
16. Dieckgraefe BK, Korzenik JR. Treatment of active Crohn's disease with recombinant human granulocyte-macrophage colony-stimulating factor. Lancet. 2002;360:1478-1480. (Pubitemid 35356328)
17. Roth L, MacDonald JK, McDonald JWD, et al. Sargramostim (GMCSF) for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2011;11:CD008538.
18. Higgins JPT, Altman DG (eds.). Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Green S, eds. Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.0 [updated February 2008]. The Cochrane Collaboration, 2008. Available from www.cochrane-handbook.org
19. Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008;336:924.
20. Higgins JP, Thompson SG, Deeks JJ, et al. Measuring inconsistency in meta-analyses. BMJ. 2003;327:557-560. (Pubitemid 37088507)
21. Valentine JF, Fedorak RN, Feagan B, et al. Steroid-sparing properties of sargramostim in patients with corticosteroid-dependent Crohn's disease: a randomised, double-blind, placebo-controlled, phase 2 study. Gut. 2009;58:1354-1362.
22. Feagan BG, Anderson F, Radford-Smith GL, et al. Efficacy and safety of sargramostim in moderate to severe Crohn's disease: results of N.O.V.E.L. 4, a phase III multicenter study. Gastroenterology. 2007; 132(4 Suppl 2):A103.
23. Korzenik JR, Dieckgraefe BK, Valentine JF, et al. Sargramostim in Crohn's Disease Study Group. Sargramostim for active Crohn's disease. N Engl J Med. 2005;352:2193-2201.
24. Korzenik JR, Dieckgraefe BK. An open-labelled study of granulocyte colony-stimulating factor in the treatment of active Crohn's disease. Aliment Pharmacol Ther. 2005;21:391-400. (Pubitemid 40313941)
25. Moss AC, Farrell RJ. Adding fuel to the fire: GM-CSF for active Crohn's disease. Gastroenterology. 2005;129:2115-2117. (Pubitemid 41772990)
26. Sandborn WJ. How future tumor necrosis factor antagonists and other compounds will meet the remaining challenges in Crohn's disease. Rev Gastroenterol Disord. 2004;4(Suppl 3):S25-33. (Pubitemid 39600215)
27. Takazoe M, Matsui T, Motoya S, et al. Sargramostim in patients with Crohn's disease: results of a phase 1-2 study. J Gastroenterol. 2009; 44:535-543.
28. Tine F, Rossi F, Sferrazza A, et al. Meta-analysis: remission and response from control arms of randomized trials of biological therapies for active luminal Crohn's disease. Aliment Pharmacol Ther. 2008;27:1210-1223. (Pubitemid 351697273)
29. Pogue JM, Yusuf S. Cumulating evidence from randomized trials: utilizing sequential monitoring boundaries for cumulative meta-analysis. Control Clin Trials. 1997;18:580-593. (Pubitemid 27520846)
30. Targan SR, Hanauer SB, van Deventer SJ, et al. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn's disease. N Engl J Med. 1997;337:1029-1035.
31. Sandborn WJ, Feagan BG, Stoinov S, et al. Certolizumab pegol for the treatment of Crohn's disease. N Engl J Med. 2007;357: 228-238. (Pubitemid 47080387)