Original article—alimentary tractCorrelation Between the Crohn's Disease Activity and Harvey–Bradshaw Indices in Assessing Crohn's Disease Severity
Section snippets
Patients
Patients enrolled in PRECiSE 1 and PRECiSE 2 were aged ≥18 years and had moderate to severe active Crohn's disease (defined as a CDAI score of 220–450 points). To be eligible for enrollment, patients had to have been diagnosed with Crohn's disease at least 3 months before screening, based on radiologic, endoscopic, or histologic evidence. The protocals were approved by the institutional review board or ethics committee at each center. All patients gave written informed consent.
Study Procedures
In PRECiSE 1, 660
Correlation Between the CDAI and HBI
In the 2 studies, values for HBI ranged from 0 to 33, and CDAI values ranged from –16 to 661.7. In total, pairs of observations were available for 995 patients for the overall comparison of CDAI versus HBI scores, and 989 pairs of observations were available for the analysis of change from baseline in CDAI and HBI. The maximum number of patients for which paired data would have been available would have been 1088 as 240 patients in the PRECiSE 2 study did not respond to induction therapy and so
Discussion
These data from 1328 patients in the PRECiSE 1 and PRECiSE 2 studies represent by far the largest comparison and cross-validation of the HBI and CDAI published to date. The findings show that a decrease in CDAI score of 100 points corresponds with a decrease in HBI of 3.20 points, which is equivalent to a change of 31.25 points on the CDAI for 1 point on the HBI.
The findings of this analysis are in close agreement with the results from a previous comparison of these scales, which found a
Acknowledgments
Editorial assistance was provided by Dave Burton at Adelphi Communications Ltd, Cheshire, UK; and Lisa Thomas, at PAREXEL MMS, Worthing, UK, with funding from UCB Pharma, Brussels, Belgium.
References (28)
- et al.
A review of activity indices and efficacy endpoints for clinical trials of medical therapy in adults with Crohn's disease
Gastroenterology
(2002) - et al.
A simple index of Crohn's disease activity
Lancet
(1980) - et al.
A meta-analysis of the placebo rates of remission and response in clinical trials of active Crohn's disease
Gastroenterology
(2004) - et al.
A randomized, placebo-controlled trial of certolizumab pegol (CDP870) for treatment of Crohn's disease
Gastroenterology
(2005) - et al.
Development of a Crohn's disease activity indexNational Cooperative Crohn's Disease Study
Gastroenterology
(1976) - et al.
Methotrexate in Crohn's disease: long-term efficacy and toxicity
Am J Gastroenterol
(2000) - et al.
Update on the incidence and prevalence of Crohn's disease and ulcerative colitis in Olmsted County, Minnesota, 1940–2000
Inflamm Bowel Dis
(2007) - et al.
Incidence of inflammatory bowel disease across Europe: is there a difference between north and south? Results of the European Collaborative Study on Inflammatory Bowel Disease (EC-IBD)
Gut
(1996) - et al.
Increase in incidence and prevalence of inflammatory bowel disease in northern Denmark: a population-based study, 1978–2002
Eur J Gastroenterol Hepatol
(2006) Crohn's disease in Stockholm county during 1990–2001: an epidemiological update
World J Gastroenterol
(2006)
Inflammatory bowel disease: epidemiology and management in an English general practice population
Aliment Pharmacol Ther
Incidence and prevalence of inflammatory bowel disease in Gijon, Asturias, Spain
Gastroenterol Hepatol
How accurate are clinical activity indices for scoring of disease activity in inflammatory bowel disease (IBD)?
Clin Chem Lab Med
A survey of methodological variation in the Crohn's disease activity index
Inflamm Bowel Dis
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Conflicts of interest The authors disclose the following: William J. Sandborn received research support and consultant fees from UCB Pharma; Paul Rutgeerts received lecture fees, consultant fees, and research support from UCB Pharma. The remaining authors disclose no conflicts.
Funding The development of this manuscript was funded by UCB Pharma, Brussels, Belgium.