A Meta-Analysis of the Placebo Rates of Remission and Response in Clinical Trials of Active Crohn's Disease

Gastroenterology

Volumn 126, Issue 5, 2004, Pages 1257-1269

  Su, Chinyu ^a,c   Lichtenstein, Gary R ^a   Krok, Karen ^a   Brensinger, Colleen M ^b   Lewis, James D ^a,b  

^a HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c PENN PRESBYTERIAN MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA4 INTEGRIN ANTIBODY; ANTIBIOTIC AGENT; ANTIBODY; ANTISENSE OLIGONUCLEOTIDE; AZATHIOPRINE; BCG VACCINE; CORTICOSTEROID; INTERCELLULAR ADHESION MOLECULE 1; INTERLEUKIN 10; INTERLEUKIN 11; MESALAZINE; METHOTREXATE; PLACEBO; THROMBOXANE SYNTHASE INHIBITOR; TUMOR NECROSIS FACTOR ANTIBODY; UNCLASSIFIED DRUG;

CLINICAL TRIAL; CROHN DISEASE; DISEASE ACTIVITY; DISEASE SEVERITY; FOLLOW UP; HUMAN; IMMUNOMODULATION; META ANALYSIS; MULTIVARIATE ANALYSIS; PRIORITY JOURNAL; REMISSION; REVIEW; SCORING SYSTEM; TREATMENT INDICATION; TREATMENT OUTCOME;

EID: 2142755325     PISSN: 00165085     EISSN: None     Source Type: Journal    
DOI: 10.1053/j.gastro.2004.01.024     Document Type: Article

References (35)

1. Best WR, Becktel JM, Singleton JW, Kern F Jr. Development of a Crohn's disease activity index. National Cooperative Crohn's Disease Study. Gastroenterology 1976;70:439-444.
2. Begg CB, Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics 1994;50:1088-1101.
3. Egger M, Davey SG, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997;315:629-634.
4. Rahban S, Sherman JH, Opelz G, Conley DR, Panish JF, Marks JW, Terasaki Pi, Schoenfield U. BCG treatment of Crohn's disease. Am J Gastroenterol 1979;71:196-201.
5. Summers RW, Switz DM, Sessions JT Jr, Becktel JM, Best WR, Kern F Jr, Singleton JW. National Cooperative Crohn's Disease Study: results of drug treatment. Gastroenterology 1979;77:847-869.
6. Malchow H, Ewe K, Brandes JW, Goebell H, Ehms H, Sommer H, Jesdinsky H. European Cooperative Crohn's Disease Study (ECCDS): results of drug treatment. Gastroenterology 1984;86: 249-266.
7. Brynskov J, Freund L, Norby RS, Lauritsen K, Schaffalitzky DM, Williams CN, MacDonald AS, Tanton R, Molina F, Campanini MC. Final report on a placebo-controlled, double-blind, randomized, multicentre trial of cyclosporin treatment in active chronic Crohn's disease. Scand J Gastroenterol 1991;26:689-695.
8. Sutherland L, Singleton J, Sessions J, Hanauer S, Krawitt E, Rankin G, Summers R, Mekhjian H, Greenberger N, Kelly M. Double blind, placebo controlled trial of metronidazole in Crohn's disease. Gut 1991;32:1071-1075.
9. Singleton JW, Hanauer SB, Gitnick GL, Peppercorn MA, Robinson MG, Wruble LD, Krawitt EL. Mesalamine capsules for the treatment of active Crohn's disease: results of a 16-week trial. Pentasa Crohn's Disease Study Group. Gastroenterology 1993;104: 1293-1301.
10. Greenberg GR, Feagan BG, Martin F, Sutherland LR, Thomson AB, Williams CN, Nilsson LG, Persson T. Oral budesonide for active Crohn's disease. Canadian Inflammatory Bowel Disease Study Group. N Engl J Med 1994;331:836-841.
11. Tremaine WJ, Schroeder KW, Harrison JM, Zinsmeister AR. A randomized, double-blind, placebo-controlled trial of the oral mesalamine (5-ASA) preparation, Asacol, in the treatment of symptomatic Crohn's colitis and ileocolitis. J Clin Gastroenterol 1994; 19:278-282.
12. Feagan BG, Rochon J, Fedorak RN, Irvine EJ, Wild G, Sutherland L, Steinhart AH, Greenberg GR, Gillies R, Hopkins M. Methotrexate for the treatment of Crohn's disease. The North American Crohn's Study Group Investigators. N Engl J Med 1995;332:292-297.
13. Stack WA, Mann SD, Roy AJ, Heath P, Sopwith M, Freeman J, Holmes G, Long R, Forbes A, Kamm MA. Randomised controlled trial of CDP571 antibody to tumour necrosis factor-alpha in Crohn's disease. Lancet 1997;349:521-524.
14. Targan SR, Hanauer SB, van Deventer SJ, Mayer L, Present DH, Braakman T, DeWoody KL, Schaible TF, Rutgeerts PJ. 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;337:1029-1035.
15. van Deventer SJ, Elson CO, Fedorak RN. Multiple doses of intravenous interleukin 10 in steroid-refractory Crohn's disease. Crohn's Disease Study Group. Gastroenterology 1997;113:383-389.
16. Yacyshyn BR, Bowen-Yacyshyn MB, Jewell L, Tami JA, Bennett CF, Kisner DL, Shanahan WR Jr. A placebo-controlled trial of ICAM-1 antisense oligonucleotide in the treatment of Crohn's disease. Gastroenterology 1998;114:1133-1142.
17. Sands BE, Bank S, Sninsky CA, Robinson M, Katz S, Singleton JW, Miner PB, Safdi MA, Galandiuk S, Hanauer SB, Varilek GW, Buchman AL, Rodgers VD, Salzberg B, Cai B, Loewy J, DeBruin MF, Rogge H, Shapiro M, Schwertschlag US. Preliminary evaluation of safety and activity of recombinant human interleukin 11 in patients with active Crohn's disease. Gastroenterology 1999; 117:58-64.
18. Fedorak RN, Gangl A, Elson CO, Rutgeerts P, Schreiber S, Wild G, Hanauer SB, Kilian A, Cohard M, LeBeaut A, Feagan B. Recombinant human interleukin 10 in the treatment of patients with mild to moderately active Crohn's disease. The Interleukin 10 Inflammatory Bowel Disease Cooperative Study Group. Gastroenterology 2000;119:1473-1482.
19. Schreiber S, Fedorak RN, Nielsen OH, Wild G, Williams CN, Nikolaus S, Jacyna M, Lashner BA, Gangl A, Rutgeerts P, Isaacs K, van Deventer SJ, Koningsberger JC, Cohard M, LeBeaut A, Hanauer SB. Safety and efficacy of recombinant human interleukin 10 in chronic active Crohn's disease. Crohn's Disease IL-10 Cooperative Study Group. Gastroenterology 2000;119:1461-1472.
20. Carty E, Rampton DS, Schneider H, Rutgeerts P, Wright JP. Lack of efficacy of ridogrel, a thromboxane synthase inhibitor, in a placebo-controlled, double-blind, multi-centre clinical trial in active Crohn's disease. Aliment Pharmacol Ther 2001;15:1323-1329.
21. Gordon FH, Lai CW, Hamilton MI, Allison MC, Srivastava ED, Fouweather MG, Donoghue S, Greenlees C, Subhani J, Amlot PL, Pounder RE. A randomized placebo-controlled trial of a humanized monoclonal antibody to alpha4 integrin in active Crohn's disease. Gastroenterology 2001;121:268-274.
22. Sandborn WJ, Feagan BG, Hanauer SB, Present DH, Sutherland LR, Kamm MA, Wolf DC, Baker JP, Hawkey C, Archambault A, Bernstein CN, Novak C, Heath PK, Targan SR. An engineered human antibody to TNF (CDP571) for active Crohn's disease: a randomized double-blind placebo-controlled trial. Gastroenterology 2001;120:1330-1338.
23. Sandborn WJ, Hanauer SB, Katz S, Safdi M, Wolf DG, Baerg RD, Tremaine WJ, Johnson T, Diehl NN, Zinsmeister AR. Etanercept for active Crohn's disease: a randomized, double-blind, placebo-controlled trial. Gastroenterology 2001;121:1088-1094.
24. Schreiber S, Nikolaus S, Malchow H, Kruis W, Lochs H, Raedler A, Hahn EG, Krummenerl T, Steinmann G. Absence of efficacy of subcutaneous antisense ICAM-1 treatment of chronic active Crohn's disease. Gastroenterology 2001;120:1339-1346.
25. Elliott PR, Bumham WR, Berghouse LM, Lennard-Jones JE, Langman MJ. Sulphadoxine-pyrimethamine therapy in Crohn's disease. Digestion 1982;23:132-134.
26. Griffiths A, Koletzko S, Sylvester F, Marcon M, Sherman P. Slow-release 5-aminosalicylic acid therapy in children with small intestinal Crohn's disease. J Pediatr Gastroenterol Nutr 1993;17: 186-192.
27. Hrobjartsson A, Gotzsche PC. Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. N Engl J Med 2001;344:1594-1602.
28. Barsky AJ, Saintfort R, Rogers MP, Borus JF. Nonspecific medication side effects and the nocebo phenomenon. JAMA 2002; 287:622-627.
29. Meyers S, Janowitz HD. "Natural history" of Crohn's disease. An analytic review of the placebo lesson. Gastroenterology 1984; 87:1189-1192.
30. Ilnyckyj A, Shanahan F, Anton PA, Cheang M, Bernstein CN. Quantification of the placebo response in ulcerative colitis. Gastroenterology 1997;112:1854-1858.
31. Sandborn WJ, Feagan B, Radford-Smith G, Kovacs A, Enns R, Patel J. A randomized, placebo-controlled trial of CDP571, a humanized monoclonal antibody to TNF-α, in patients with moderate to severe Crohn's disease (abstr). Gastroenterology 2004; 124:A61.
32. Schreiber S, Rutgeerts P, Fedorak R, Khaliq-Kareemi M, Kamm MA, Patel J. CDP870, a humanized anti-TNF antibody fragment, induces clinical response with remission in patients with active Crohn's disease (CD) (abstr). Gastroenterology 2004;124:A61.
33. Sandborn WJ, Feagan BG, Hanauer SB, Lochs H, Lofberg R, Modigliani R, Present DH, Rutgeerts P, Scholmerich J, Stange EF, Sutherland LR. A review of activity indices and efficacy endpoints for clinical trials of medical therapy in adults with Crohn's disease. Gastroenterology 2002;122:512-530.
34. Sands BE, Steinhart AH, Lewis JD, Hanauer SB, Persson T, Sandborn WJ. Optimal Crohn's Disease Activity Index (CDAI) response criteria is defined by decrease >100 points (abstr). Gastroenterology 2003;124:A206.
35. Berlin JA, Santanna J, Schmid CH, Szczech LA, Feldman HI. Individual patient-versus group-level data meta-regressions for the investigation of treatment effect modifiers: ecological bias rears its ugly head. Stat Med 2002;21:371-387.