Correlation between the Crohn's disease activity and Harvey-Bradshaw indices in assessing Crohn's disease severity.
OBJECTIVE
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.
Vermeire
Severine
S
Department of Gastroenterology, University Hospital Gasthuisberg, Leuven, Belgium. severine.vermeire@uz.kuleuven.ac.be
Schreiber
Stefan
S
Sandborn
William J
WJ
Dubois
Cécile
C
Rutgeerts
Paul
P
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D061067:Antibodies, Monoclonal, Humanized; D000068582:Certolizumab Pegol; D003424:Crohn Disease / Q000188:drug therapy / Q000473:pathology*; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000627:therapeutic use; D007155:Immunologic Factors / Q000627:therapeutic use; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000627:therapeutic use; D012720:Severity of Illness Index; D055815:Young Adult
D061067:Antibodies, Monoclonal, Humanized; D007140:Immunoglobulin Fab Fragments; D007155:Immunologic Factors; D011092:Polyethylene Glycols; D000068582:Certolizumab Pegol