Tumor necrosis factor‐alpha antibody for induction of remission in Crohn's disease

Anthony K Akobeng; Mary Zachos

doi:10.1002/14651858.CD003574.pub2

Anticuerpo inhibidor del factor de necrosis tumoral alfa para la inducción de la remisión en la enfermedad de Crohn

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Referencias

Referencias de los estudios incluidos en esta revisión

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estudios excluidos
otras referencias

Sandborn WJ, Feagan BG, Hanauer SB, Present DH, Sutherland LR, Kamm M, et al. An engineered human antibody to TNF (CDP571) for active Crohn's disease: A randomized double‐blind placebo‐controlled trial. Gastroenterology 2001;120:1330‐8.

Sandborn WJ, Hanauer SB, Katz S, Safdi M, Wolf DG, Baerg RD, et al. Etanercept for active Crohn's disease: A randomized double‐blind, placebo‐controlled trial. Gastroenterology 2001;121:1088‐94.

Stack WA, Mann SD, Roy AJ, Heath P, Sopwith M, Freeman J, et al. Randomised controlled trial of CDP571 antibody to tumour necrosis factor‐alpha in Crohn's disease. Lancet 1997;349:521‐4.

Targan SR, Hanauer SB, van Deventer SJH, 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. N Engl J Med 1997;337:1029‐35.

Referencias de los estudios excluidos de esta revisión

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estudios incluidos
otras referencias

Baldassano R, Braegger CP, Escher JC, DeWoody K, Hendricks DF, Keenan G, et al. Infliximab (REMICADE) therapy in the treatment of pediatric Crohn's disease. Am J Gastroenterol 2003;98:833‐8.

D'Haens G, van Deventer S, van Hogezand R, Chalmers D, Kothe C, Baert F, et al. Endoscopic and histologic healing with infliximab anti‐tumor Necrosis factor antibodies in Crohn's Disease: a European multicentre trial. Gastroenterology 1999;116:1029‐34.

Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, et al. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet 2002;359:1541‐9.

Present DH, Rutgeerts P, Targan S, Hanauer SB, Mayer L, van Hogezand RA, et al. Infliximab for the treatment of fistulas in patients with Crohn's disease. N Engl J Med 1999;340:1398‐405.

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.

Rutgeerts P, Lemmens L, Van Assche G, Noman M, Borghini‐Fuhrer I, Goedkoop R. Treatment of active Crohn's disease with onercept (recombinant human soluble p55 tumour necrosis factor receptor): results of a randomized, open label study. Aliment Pharmacol Ther 2003;17:185‐92.

Referencias adicionales

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estudios incluidos
estudios excluidos

Baert FJ, D'Haens GR, Peeters M, Hiele MI, Schaible TF, Shealy D, et al. Tumor necrosis factor alpha antibody (infliximab) therapy profoundly down‐regulates the inflammation in Crohn's ileocolitis. Gastroenterology 1999;116:22‐8.

Bauditz J, Haemling J, Ortner M, Lochs H, Raedler A, Schreiber S. Treatment with tumour necrosis factor inhibitor oxpentifylline does not improve corticosteroid dependent chronic active Crohn's disease. Gut 1997;40:470‐4.

Bell SJ, Kamm MA. Review article: the clinical role of anti‐TNF alpha antibody treatment in Crohn's disease. Aliment Pharmacol Ther 2000;14:501‐14.

Breese EJ, Michie CA, Nicholls SW, Murch SH, Williams CB, Domizio P, et al. Tumor necrosis factor ‐alpha producing cells in the intestinal musosa of children with inflammatory bowel disease. Gastroenterology 1994;106:1455‐66.

Brown SL, Greene MH, Gershon SK, Edwards ET, Braun MM. Tumor necrosis factor antagonist therapy and lymphoma development: twenty‐six cases reported to the Food and Drug Administration. Arthritis Rheum 2002;46:3151‐8.

Clarke M, Oxman AD, editors. Cochrane Reviewers' Handbook 4.1.4 [updated October 2001]. In: The Cochrane Library, Issue 4, 2001. Oxford : Update software. Updated quarterly.

Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJM, Gavaghan DJ, et al. Assessing the quality of reports of randomized clinical trials: Is blinding necessary?. Control Clin Trials 1996;17:1‐12.

Keane J, Gershon S, Wise RP, Mirabile‐Levens E, Kasznica J, Schwieterman WD, et al. Tuberculosis associated with infliximab, a tumor necrosis factor alpha‐neutralizing agent. N Engl J Med 2001;345:1098‐104.

MacDonald TT, Hutchings P, Choy MY, Murch S, Cooke A. Tumour necrosis factor‐alpha and interferon gamma production measured at the single cell level in normal and inflamed human intestine. Clin Exp Immunol 1990;81:301‐5.

Murch SH, Lamkin VA, Savage MO, Walker Smith JA, MacDonald TT. Serum concentrations of tumour necrosis factor‐alpha in childhood chronic inflammatory bowel disease. Gut 1991;32:913‐7.

Papadikas KA, Targan SR. Tumor necrosis factor: Biology and therapeutic inhibitors. Gastroenterolgy 2000;119:1148‐57.

Pitkin RM, Branagan MA, Burmeister LF. Accuracy of data in abstracts of published research articles. JAMA 1999;281:1110‐1.

Rampton DS. Management of Crohn's disease. BMJ 1999;319:1480‐5.

Reimund JM, Wittersheim C, Dumont S, Muller CD, Kenney JS, Baumann R, et al. Increased production of tumour necrosis factor‐a, interleukin 1b, and interleukin‐6 by morphologically normal intestinal biopsies from patients with Crohn's disease. Gut 1996;39:684‐9.

Scallon BJ, Moore MA, Trinh H, Knight DM, Ghrayeb J. Chimeric anti TNF‐ alpha monoclonal antibody Ca2 binds recombinant trasmembrane TNF‐ alpha and activates immune effector functions. Cytokine 1995;7:251‐9.

Shanahan F. Inflammatory bowel disease: immunodiagnostics, immunotherapeutics and ecotherapeutics. Gastroenterology 2001;120:622‐35.

Siegel SA, Shealy DJ, Nakada MT, Le J, Woulfe DS, Probert L, et al. The mouse/human chimeric monoclonal antibody cA2 neutralizes in vitro and protects transgenic mice from cachexia and TNF‐ lethality in vivo. Cytokine 1995;7:15‐25.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

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estudios excluidos

Sandborn 2001a

Methods	Randomised, double‐blind placebo controlled study. Primary outcome measurement: Clinical response at 2 weeks
Participants	169 adults; 86 males, 83 females
Interventions	111 received CDP571 and 58 received placebo
Outcomes	Clinical response defined as a decrease in CDAI of 70 or more at 2 weeks.
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate

Sandborn 2001b

Methods	Randomised, double‐blind placebo‐controlled trial. Outcome measures: Clinical response and clinical remission
Participants	43 adults; 26 males and 17 females
Interventions	23 received etanercept and 20 received placebo
Outcomes	Clinical response defined as a decrease in CDAI of at least 70. Remission defined as CDAI <150.
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate

Stack 1997

Methods	Randomized, placebo‐controlled trial. Primary outcome assessment: Remission at 2 weeks.
Participants	31 adults; 14 males and 16 females
Interventions	21 patients received CDP571 and 10 received placebo
Outcomes	Remission defined as CDAI<150 after 2 weeks.
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate

Targan 1997

Methods	Randomized, double‐blind, placebo controlled study. Outcome assessments: Clinical response and remission at 2 weeks and 4 weeks
Participants	108 adults; 55 males, 53 females
Interventions	83 received infliximab and 25 received placebo
Outcomes	Clinical response defined as a decrease in CDAI of 70 or more. Remission defined as CDAI <150.
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate

Characteristics of excluded studies [ordered by study ID]

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estudios incluidos

Study	Reason for exclusion
Baldassano 2003	Did not compare TNF‐a blocking agents with either placebo or another treatment but rather only compared different doses of infliximab.
D'Haens 1999	A subgroup analysis from the Targan 1997 study.
Hanauer 2002	Described the use of TNF‐a agents for maintenance of remission rather than induction of remission.
Present 1999	Only described the use of infliximab for treatment of fistulas.
Rutgeerts 1999	Described the use of TNF‐a agents for maintenance of remission rather than induction of remission.
Rutgeerts 2003	Compared different doses of recombinant human soluble p55 TNF receptor (onercept) rather than comparing a TNF‐a blocking agent with either placebo or another treatment.

Data and analyses

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Comparison 1. Infliximab versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Remission rate Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 1.1 Comparison 1 Infliximab versus placebo, Outcome 1 Remission rate.
2 Clinical Response Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 1.2 Comparison 1 Infliximab versus placebo, Outcome 2 Clinical Response.

Open in table viewer

Comparison 2. CDP571 versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Remission rate Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 2.1 Comparison 2 CDP571 versus placebo, Outcome 1 Remission rate.
2 Clinical Response Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 2.2 Comparison 2 CDP571 versus placebo, Outcome 2 Clinical Response.

Open in table viewer

Comparison 3. Etanercept versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Remission rate Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 3.1 Comparison 3 Etanercept versus placebo, Outcome 1 Remission rate.
2 Clinical response Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 3.2 Comparison 3 Etanercept versus placebo, Outcome 2 Clinical response.

Analysis 1.1

Comparison 1 Infliximab versus placebo, Outcome 1 Remission rate.

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Analysis 1.2

Comparison 1 Infliximab versus placebo, Outcome 2 Clinical Response.

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Analysis 2.1

Comparison 2 CDP571 versus placebo, Outcome 1 Remission rate.

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Analysis 2.2

Comparison 2 CDP571 versus placebo, Outcome 2 Clinical Response.

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Analysis 3.1

Comparison 3 Etanercept versus placebo, Outcome 1 Remission rate.

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Analysis 3.2

Comparison 3 Etanercept versus placebo, Outcome 2 Clinical response.

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Comparison 1. Infliximab versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Remission rate Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2 Clinical Response Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 1. Infliximab versus placebo

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Comparison 2. CDP571 versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Remission rate Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2 Clinical Response Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 2. CDP571 versus placebo

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Comparison 3. Etanercept versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Remission rate Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2 Clinical response Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 3. Etanercept versus placebo

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Referencias

Referencias de los estudios incluidos en esta revisión

Sandborn 2001a {published data only}

Sandborn 2001b {published data only}

Stack 1997 {published data only}

Targan 1997 {published data only}

Referencias de los estudios excluidos de esta revisión

Baldassano 2003 {published data only}

D'Haens 1999 {published data only}

Hanauer 2002 {published data only}

Present 1999 {published data only}

Rutgeerts 1999 {published data only}

Rutgeerts 2003 {published data only}

Referencias adicionales

Baert 1999

Bauditz 1997

Bell 2000

Breese 1994

Brown 2002

Clarke 2001

Jadad 1996

Keane 2001

MacDonald 1990

Murch 1991

Papadikas 2000

Pitkin 1999

Rampton 1999

Reimund 1996

Scallon 1995

Shanahan 2001

Siegel 1995

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Characteristics of excluded studies [ordered by study ID]

Data and analyses

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