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Correlation between the Crohn's disease activity and Harvey-Bradshaw indices in assessing Crohn's disease severity
Severine Vermeire1, Stefan Schreiber, William J Sandborn
1Department of Gastroenterology, University Hospital Gasthuisberg, Leuven, Belgium. severine.vermeire@uz.kuleuven.ac.be
Insights
The Harvey-Bradshaw Index effectively assesses Crohn's disease activity, correlating well with the standard Crohn's Disease Activity Index. This simpler tool aids in long-term clinical trials for Crohn's disease management.
Area of Science:
- Gastroenterology
- Clinical Trials
- Biostatistics
Background:
- Crohn's disease clinical trials typically use the complex Crohn's Disease Activity Index (CDAI) for disease assessment.
- The Harvey-Bradshaw Index (HBI) offers a simpler alternative for evaluating disease severity.
Purpose of the Study:
- To investigate the correlation between the Harvey-Bradshaw Index and the Crohn's Disease Activity Index in assessing Crohn's disease activity.
- To determine if the HBI is an effective and practical tool for long-term clinical trials.
Main Methods:
- Data from two large multicenter trials (PRECiSE 1 and 2) involving certolizumab pegol were analyzed.
- Crohn's Disease Activity Index and Harvey-Bradshaw Index scores from nearly 1000 patient data pairs were compared.
- Spearman correlation coefficients were calculated to assess the relationship between the two indices.
Main Results:
- A strong positive correlation was observed between the CDAI and HBI scores (pooled Spearman correlation coefficient = 0.800).
- Specific HBI score changes corresponded to defined CDAI thresholds for clinical response and remission.
- A 3-point change in HBI correlated with a 100-point change in CDAI for clinical response.
Conclusions:
- The Harvey-Bradshaw Index demonstrates strong correlation with the Crohn's Disease Activity Index for assessing Crohn's disease activity.
- The HBI may serve as a simpler, more practical tool for disease assessment in long-term clinical trials.
- Utilizing the HBI can facilitate standardized disease activity measurements and enhance cross-center comparisons in Crohn's research.
Background & Aims:
Clinical trials of Crohn's disease generally use the Crohn's Disease Activity Index to assess disease activity; these calculations are complex, time-consuming, and impracticable. We investigated whether a simpler tool, the Harvey-Bradshaw Index, was equally effective in assessing disease severity.
Methods:
Crohn's Disease Activity and Harvey-Bradshaw Index scores were collected from 2 large multicenter Crohn's disease studies. The PEGylated antibody fragment evaluation in Crohn's disease: safety and efficacy (PRECiSE) 1 and 2 trials assessed efficacy and tolerability of certolizumab pegol (PEGylated, humanized, Fab' fragment of an antitumor necrosis factor alpha antibody). PRECiSE 1 and 2 data were analyzed to determine if results from the Crohn's Disease Activity Index correlated with those from the Harvey-Bradshaw Index criteria for defining response and remission.
Results:
Analysis of almost 1000 data pairs showed a positive correlation between scores. The correlation between the indices for pooled data from PRECiSE 1 and PRECiSE 2 was 0.800 (Spearman correlation coefficient). The correlations between indices for the PRECiSE 1 or PRECiSE 2 were 20.698 and 0.716, respectively (Kronecker product variance). A 3-point change in the Harvey-Bradshaw Index score corresponded to a 100-point change in the Crohn's Disease Activity Index (clinical response); scores < or =4 points corresponded to a Crohn's Disease Activity Index score < or =150 points (clinical remission).
Conclusions:
Results from the Crohn's Disease Activity Index correlate with those from the Harvey-Bradshaw Index; use of the Harvey-Bradshaw Index might permit simpler Crohn's disease activity assessment in long-term clinical trials, and facilitate standardized disease activity measurements and cross-center comparisons.
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