Use of the noninvasive components of the mayo score to assess clinical response in Ulcerative Colitis§

Authors

  • James D. Lewis MD, MSCE,

    Corresponding author
    1. Division of Gastroenterology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
    2. Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
    3. Department of Medicine, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
    4. Department of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
    • University of Pennsylvania, Center for Clinical Epidemiology and Biostatistics, 7th Floor, Blockley Hall, 423 Guardian Dr., Philadelphia, PA 19104-6021
    Search for more papers by this author
  • Shaokun Chuai MS,

    1. Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
    2. Department of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
    Search for more papers by this author
  • Lisa Nessel MSS, MLSP,

    1. Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
    Search for more papers by this author
  • Gary R. Lichtenstein MD,

    1. Division of Gastroenterology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
    2. Department of Medicine, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
    Search for more papers by this author
  • Faten N. Aberra MD, MSCE,

    1. Division of Gastroenterology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
    2. Department of Medicine, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
    Search for more papers by this author
  • Jonas H. Ellenberg PhD

    1. Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
    2. Department of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
    Search for more papers by this author

  • Clinical trial registration: clinicaltrials.gov #NCT00065065.

  • Use of the Inflammatory Bowel Disease Questionnaire, authored by Dr. Jan Irvine, was made under license from McMaster University, Hamilton, Canada.

  • §

    The study was designed and conducted, the data were analyzed, and the article was written independently by the investigators.

  • The authors report no potential conflicts of interest related to this study.

Abstract

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.

(Inflamm Bowel Dis 2008)

Ancillary