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  string(106) "Use of TNF antagonist therapies with or without steroids for induction in Crohn?s disease: A Meta-analysis"
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  string(661) "Biologic agents, such as TNF antagonists, and corticosteroids are highly effective for induction of remission in Crohn?s disease (CD) and ulcerative colitis (UC).  Examination of data from a recent randomized controlled trial of combination therapy in patients with active CD (COMMIT) suggests that the addition of corticosteroids to infliximab may result in higher remission rates.  However this possibility has not been evaluated by a dedicated RCT. Our objective is to perform a meta-analysis of existing induction trials of biologic therapies to assess whether adjunctive therapy with corticosteroids results in greater efficacy than biological monotherapy."
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      string(66) "CHU de Nancy, Department of Hepato-Gastroenterology, Nancy, France"
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      string(8) "Reinisch"
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      string(2) "MD"
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      string(70) "McMaster University, Department of Internal Medicine, Hamilton, Canada"
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      string(91) "University of California, San Diego, Division of Gastroenterology, San Diego, United States"
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      string(5) "Ruiqi"
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      string(5) "Huang"
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      string(39) "Icahn School of Medicine at Mount Sinai"
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    ["value"]=>
    string(68) "No external grants or funds are being used to support this research."
    ["label"]=>
    string(68) "No external grants or funds are being used to support this research."
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      string(232) "NCT00207662 - ACCENT I - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long-term Treatment of Patients With Moderately to Severely Active Crohn's Disease"
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      string(214) "NCT00207766 - ACCENT II - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long Term Treatment of Patients With Fistulizing CROHN'S Disease"
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  ["project_date_type"]=>
  string(91) "Individual Participant-Level Data, which includes Full CSR and all supporting documentation"
  ["property_scientific_abstract"]=>
  string(1606) "Background: Biologic agents, such as TNF antagonists, and corticosteroids are highly effective for induction of remission in Crohn?s disease (CD) and ulcerative colitis (UC).  Examination of data from a recent randomized controlled trial of combination therapy in patients with active CD (COMMIT) suggests that the addition of corticosteroids to infliximab may result in higher remission rates.  However this possibility has not been evaluated by a dedicated RCT.

Objective:  perform a meta-analysis of existing induction trials of biologic therapies to assess whether adjunctive therapy with corticosteroids results in greater efficacy than biological monotherapy. A secondary objective is to compare the safety of the two strategies.

Study Design: Meta-analysis of randomized control studies (RCTs) that fit search criteria

Participants: Study subjects in previously performed RCTs, age>18 years

Main Outcome Measure(s): The primary analysis will be a pooled summary estimate of clinical remission on anti-TNF therapy stratified by corticosteroid exposure at baseline. Secondary outcome to be measured are luminal response and safety of the two strategies.

Statistical Analysis:  Standard meta-analysis methods will be used.  The test of heterogeneity will be performed using the chi-squared test and the I2 test.  Stratified analyses and meta-regression will be performed to explore factors that may explain heterogeneity between studies.  This includes potential confounding factors such as disease severity (ex. Higher CDAI, CRP levels) or concurrent immunomodulator use."
  ["project_brief_bg"]=>
  string(732) "Biologic agents, such as TNF antagonists, and corticosteroids are highly effective for induction of remission in Crohn?s disease (CD) and ulcerative colitis (UC).  Examination of data from a recent randomized controlled trial of combination therapy in patients with active CD (COMMIT) suggests that the addition of corticosteroids to infliximab may result in higher remission rates.  However this possibility has not been evaluated by a dedicated RCT. Our objective is to perform a meta-analysis of existing induction trials of biologic therapies to assess whether adjunctive therapy with corticosteroids results in greater efficacy than biological monotherapy.  A secondary objective is to compare the safety of the two strategies."
  ["project_specific_aims"]=>
  string(497) "The primary aim of the project is to assess whether adjunctive therapy with corticosteroids results in greater efficacy than biological monotherapy.  We have performed a systematic literature review and will now perform a meta-analysis of relevant data. 

We hypothesize that patients with CD treated with anti-TNF agents will have a higher response rate if treated concomitantly with corticosteroids for induction of remission, without significant differences in  the risk of adverse events."
  ["project_study_design"]=>
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  ["project_purposes"]=>
  array(5) {
    [0]=>
    array(2) {
      ["value"]=>
      string(114) "New research question to examine treatment effectiveness on secondary endpoints and/or within subgroup populations"
      ["label"]=>
      string(114) "New research question to examine treatment effectiveness on secondary endpoints and/or within subgroup populations"
    }
    [1]=>
    array(2) {
      ["value"]=>
      string(49) "New research question to examine treatment safety"
      ["label"]=>
      string(49) "New research question to examine treatment safety"
    }
    [2]=>
    array(2) {
      ["value"]=>
      string(69) "Meta-analysis using data from the YODA Project and other data sources"
      ["label"]=>
      string(69) "Meta-analysis using data from the YODA Project and other data sources"
    }
    [3]=>
    array(2) {
      ["value"]=>
      string(36) "Participant-level data meta-analysis"
      ["label"]=>
      string(36) "Participant-level data meta-analysis"
    }
    [4]=>
    array(2) {
      ["value"]=>
      string(69) "Meta-analysis using data from the YODA Project and other data sources"
      ["label"]=>
      string(69) "Meta-analysis using data from the YODA Project and other data sources"
    }
  }
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  ["project_research_methods"]=>
  string(1021) "A systemic review was performed of Medline, Central and  Embase for all English language studies in adult patients with Crohn?s disease studying the efficacy of either adalimumab, certolizumab pegol, golimumab, and infliximab. Abstracts were included in the search in addition to a hand search to identify randomized controlled trials (manuscripts and abstracts). 

Inclusion criteria:

?	Randomized, placebo-controlled trials in which patient level data (case report forms) is obtainable and information regarding length and dosing of concurrent steroids

?	Adult patients with Crohn?s disease

?	Anti-TNF agent used includes any of Infliximab, adalimumab, certolizumab pegol, and golimumab

?	Duration of 4-12 weeks for induction

?	Data available for remission rates at a short time interval (i.e. between 4-12 weeks)

We have identified 16 full text articles that are eligible for our study.  In order to meet the aim of our study, non-published patient level data must be obtained."
  ["project_main_outcome_measure"]=>
  string(442) "The primary analysis will be a pooled summary estimate of clinical remission on anti-TNF therapy stratified by corticosteroid exposure at baseline.  Patients with high dose concurrent steroid use (as defined in the inclusion criteria) will be analyzed separately from those with low concurrent steroid use. In this main analysis, all anti-TNF agents will be combined and will be evaluated based on remission at induction (between 4-12 weeks)."
  ["project_main_predictor_indep"]=>
  string(321) "Many patients are treated with a weaning course of corticosteroids at the time of induction, so those patients who received the equivalent of >20mg daily of prednisone or equivalent during the first four weeks of induction treatment will be analyzed in the concomitant high-dose steroid therapy group.  Those treated with"
  ["project_other_variables_interest"]=>
  string(886) "A secondary outcome that will be evaluated is luminal response. Response is measured differently between studies, but most commonly for CD will be based on a decrease in the Crohn?s disease activity index (CDAI). Studies that report outcomes at weeks 4-12 will be combined irrespective of the duration of the induction period.  To account for differences in steroid use between studies (i.e forced tapering, fixed dose, etc), the average daily dose of steroids used during the first four weeks of induction will be used to classify patients.  An average daily dose of 20mg or more of prednisone will be considered high concurrent corticosteroid use.  An average dose of less than 20mg of prednisone per day will be considered low dose.  Safety will also be evaluated based on the same stratification and will include infusion/injection site reactions, malignancy, infections, and death."
  ["project_stat_analysis_plan"]=>
  string(3993) "Statistical analyses will be performed by a PhD biostatistician, Dr. Emilia Bagiella (Mount Sinai, NY).  The main analysis will be based on the intention-to-treat population from each study. The test of heterogeneity will be performed using the chi-squared test and the I2 test.  The I2 test describes the percentage of variability in effect estimates that is due to heterogeneity rather than chance, wherein an I2 test greater than 50% suggests significant heterogeneity.  A random effects model will be used assuming that heterogeneity will exist between studies; if the study data meet the criteria for homogeneity  then a fixed effects model  will be used. Stratified analyses and meta-regression will be performed to explore factors that may explain heterogeneity between studies.  This includes potential confounding factors such as disease severity (ex. Higher CDAI, CRP levels) or concurrent immunomodulator use.  Publication bias will be assessed using a funnel plot.

Sensitivity analyses (analyses to be run removing certain studies to see how it affects the results)

?	Other sensitivity analyses may be run if there are outlier studies with unique design characteristics that appear to have a strong influence on the results (standard according to the Cochrane Handbook, section 9.7)

Subgroup analyses

?	No concurrent immunomodulator versus immunomodulator-treated patients

?	Individual anti-TNF agents will be compared with or without steroids, but not against each other

In addition to the 4 studies requested from YODA, data from for the following 12 studies have been requested from  AbbVie, UCB, and Dr. Farrell.  Of note, IPD will not be pooled within the data sharing platform.  

1. Farrell, R. J., et al. (2003). "Intravenous hydrocortisone premedication reduces antibodies to infliximab in Crohn's disease: A randomized controlled trial." Gastroenterology 124(4): 917-924.

2. Colombel, J., et al. (2007). "Adalimumab for Maintenance of Clinical Response and Remission in Patients With Crohn's Disease: The CHARM Trial." Gastroenterology 132(1): 52-65.

3. Dewint, P., et al. (2014). "Adalimumab combined with ciprofloxacin is superior to adalimumab monotherapy in perianal fistula closure in Crohn's disease: A randomised, double-blind, placebo controlled trial (ADAFI)." Gut 63(2): 292-299.

4. Hanauer, S. B., et al. (2006). "Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: The CLASSIC-I trial." Gastroenterology 130(2): 323-332.

5. Rutgeerts, P., et al. (2012). "Adalimumab induces and maintains mucosal healing in patients with Crohn's Disease: Data from the EXTEND trial." Gastroenterology 142(5): 1102-1111.

6. Sandborn, W. J., et al. (2007). "Adalimumab induction therapy for Crohn disease previously treated with infliximab: a randomized trial.? Annals of internal medicine 146(12): 829-838.

7. Watanabe, M., et al. (2012). "Adalimumab for the induction and maintenance of clinical remission in Japanese patients with Crohn's disease." Journal of Crohn's & colitis 6(2): 160-173.

8. Sandborn, W. J., et al. (2007). "Certolizumab pegol for the treatment of Crohn's disease." New England journal of medicine 357(3): 228-238.

9. Sandborn, W. J., et al. (2010). "Certolizumab pegol in patients with moderate to severe Crohn's disease and secondary failure to infliximab." Clinical  Gastroenterology & Hepatology 8(8): 688-695.

10. Sandborn, W. J., et al. (2011). "Certolizumab Pegol for Active Crohn's Disease: A Placebo-Controlled, Randomized Trial." Clinical gastroenterology and hepatology 9(8): 670-678.

11. Schreiber, S., et al. (2005). ?A randomized, placebo-controlled trial of certolizumab pegol (CDP870) for treatment of Crohn's disease.? Gastroenterology 129, 807-818.

12. Schreiber, S., et al. (2007). ?Maintenance therapy with certolizumab pegol for Crohn's disease.? New England journal of medicine 357, 239-250."
  ["project_timeline"]=>
  string(454) "We have already performed a systematic literature review and have identified randomized control trials that fill our inclusion criteria.  We have extracted all relevant published data but much data is still missing.  Once access to study data is granted, we anticipate data extraction and analysis to take no longer than 2 months.  Manuscript drafting will take another 1 month.  Manuscript submission is aimed to take place no later than September 2016."
  ["project_dissemination_plan"]=>
  string(312) "The results of this meta-analysis is anticipated to be of great interest to all IBD clinicians.  A manuscript will be submitted about 3 months after data acquisition. As such, we plan to submit our manuscript to Gastroenterology, American Journal of Gastroenterology or  Clinical Gastroenterology and Hepatology."
  ["project_bibliography"]=>
  string(4987) "
Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, Lichtiger S, D’Haens G, Diamond RH, Broussard DL, Tang KL, van der Woude CJ, Rutgeerts P; SONIC Study Group. Infliximab, azathioprine, or combination therapy for Crohn’s disease. N Engl J Med. 2010 Apr 15;362(15):1383-95.

Colombel JF, Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Panaccione R, Schreiber S, Byczkowski D, Li J, Kent JD, Pollack PF. Adalimumab for maintenance of clinical response and remission in patients with Crohn’s disease: the CHARM trial. Gastroenterology. 2007 Jan;132(1):52-65.

Dewint P, Hansen BE, Verhey E, Oldenburg B, Hommes DW, Pierik M, Ponsioen CI, van Dullemen HM, Russel M, van Bodegraven AA, van der Woude CJ. Adalimumab combined with ciprofloxacin is superior to adalimumab monotherapy in perianal fistula closure in Crohn’s disease: a randomised, double-blind, placebo controlled trial (ADAFI). Gut. 2014 Feb;63(2):292-9.

Farrell RJ, Alsahli M, Jeen YT, Falchuk KR, Peppercorn MA, Michetti P. Intravenous hydrocortisone premedication reduces antibodies to infliximab in Crohn’s disease: a randomized controlled trial. Gastroenterology. 2003 Apr;124(4):917-24

Feagan BG, Coteur G, Tan S, Keininger DL, Schreiber S. Clinically meaningful improvement in health-related quality of life in a randomized controlled trial of certolizumab pegol maintenance therapy for Crohn’s disease. Am J Gastroenterol. 2009 Aug;104(8):1976-83.

Feagan BG, McDonald JW, Panaccione R, Enns RA, Bernstein CN, Ponich TP, Bourdages R, Macintosh DG, Dallaire C, Cohen A, Fedorak RN, Par P, Bitton A, Saibil F, Anderson F15, Donner A16, Wong CJ2, Zou G, Vandervoort MK, Hopkins M, Greenberg GR. Methotrexate in combination with infliximab is no more effective than infliximab alone in patients with Crohn’s disease.  Gastroenterology. 2014 Mar;146(3):681-688.

Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, Rachmilewitz D, Wolf DC, Olson A, Bao W, Rutgeerts P; ACCENT I Study Group. Maintenance infliximab for Crohn’s disease: the ACCENT I randomised trial. Lancet. 2002 May 4;359(9317):1541-9.

Hanauer SB, Sandborn WJ, Rutgeerts P, Fedorak RN, Lukas M, MacIntosh D, Panaccione R, Wolf D, Pollack P. Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn’s disease: the CLASSIC-I trial. Gastroenterology. 2006 Feb;130(2):323-33.

Present DH, Rutgeerts P, Targan S, Hanauer SB, Mayer L, van Hogezand RA, Podolsky DK, Sands BE, Braakman T, DeWoody KL, Schaible TF, van Deventer SJ.  Infliximab for the treatment of fistulas in patients with Crohn’s disease.  N Engl J Med. 1999 May 6;340(18):1398-405.

Rutgeerts P, Van Assche G, Sandborn WJ, Wolf DC, Geboes K, Colombel JF, Reinisch W; EXTEND Investigators, Kumar A, Lazar A, Camez A, Lomax KG, Pollack PF, D’Haens G. Adalimumab induces and maintains mucosal healing in patients with Crohn’s disease: data from the EXTEND trial. Gastroenterology. 2012 May;142(5):1102-1111.

Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Colombel JF, Panaccione R, D’Haens G, Li J, Rosenfeld MR, Kent JD, Pollack PF. Adalimumab induction therapy for Crohn disease previously treated with infliximab: a randomized trial. Ann Intern Med. 2007 Jun 19;146(12):829-38.

Sandborn WJ, Abreu MT, D’Haens G, Colombel JF, Vermeire S, Mitchev K, Jamoul C, Fedorak RN, Spehlmann ME, Wolf DC, Lee S, Rutgeerts P. Certolizumab pegol in patients with moderate to severe Crohn’s disease and secondary failure to infliximab. Clin Gastroenterol Hepatol. 2010 Aug;8(8):688-695.

Sandborn WJ, Feagan BG, Stoinov S, Honiball PJ, Rutgeerts P, Mason D, Bloomfield R, Schreiber S; PRECISE 1 Study Investigators  Certolizumab pegol for the treatment of Crohn’s disease.  N Engl J Med. 2007 Jul 19;357(3):228-38.

Sands BE, Blank MA, Patel K, van Deventer SJ; ACCENT II Study. Long-term treatment of rectovaginal fistulas in Crohn’s disease: response to infliximab in the ACCENT II Study. Clin Gastroenterol Hepatol. 2004 Oct;2(10):912-20.

Schreiber S, Khaliq-Kareemi M, Lawrance IC, Thomsen O, Hanauer SB, McColm J, Bloomfield R, Sandborn WJ; PRECISE 2 Study Investigators. Maintenance therapy with certolizumab pegol for Crohn’s disease. N Engl J Med. 2007 Jul 19;357(3):239-50.

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pi country
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}


pi affil
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products
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num of trials
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res
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}