Use of the noninvasive components of the Mayo score to assess clinical response in ulcerative colitis.
BACKGROUND
The Mayo score and a noninvasive 9-point partial Mayo score are used as outcome measures for clinical trials assessing therapy for ulcerative colitis (UC). There are limited data assessing what defines a clinically relevant change in these indices. We sought to assess what constitutes a clinically meaningful change in these indices using data from a recently completed placebo-controlled clinical trial.


METHODS
In all, 105 patients were enrolled in a 12-week randomized, placebo-controlled trial assessing rosiglitazone for treatment of mild to moderate UC. We compared the change in the Mayo score, the partial Mayo score, and a 6-point score composed just of the stool frequency and bleeding components of the Mayo score to the patient's perception of disease activity at week 0 and week 12. Optimal cutpoints were calculated as the maximal product of sensitivity and specificity.


RESULTS
Each index was strongly correlated with the patient's rating of disease activity at week 12 (Spearman correlations 0.61-0.71, P < 0.0001 for all correlations). The maximal product of sensitivity and specificity to identify patient reported improvement of disease activity was achieved using cutpoints for change of 2.5 for the Mayo score (sensitivity 88%, specificity 80%), 2.5 for the partial Mayo score (sensitivity 88%, specificity 87%), and 1.5 for the 6-point score (sensitivity 88%, specificity 80%).


CONCLUSIONS
The partial Mayo score and the 6-point score composed solely of the stool frequency and bleeding components performed as well as the full Mayo score to identify patient perceived clinical response.
Lewis
James D
JD
Division of Gastroenterology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104-6021, USA. jlewis@cceb.med.upenn.edu
Chuai
Shaokun
S
Nessel
Lisa
L
Lichtenstein
Gary R
GR
Aberra
Faten N
FN
Ellenberg
Jonas H
JH
D003093:Colitis, Ulcerative / Q000145:classification / Q000188:drug therapy*; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D010919:Placebos; D012372:ROC Curve; D012074:Remission Induction; D000077154:Rosiglitazone; D012680:Sensitivity and Specificity; D045162:Thiazolidinediones / Q000627:therapeutic use*; D016896:Treatment Outcome
D005343:Fibrinolytic Agents; D007004:Hypoglycemic Agents; D010919:Placebos; D045162:Thiazolidinediones; D000077154:Rosiglitazone