Regression to the mean and predictors of MRI disease activity in RRMS placebo cohorts - Is there a place for baseline-to-treatment studies in MS?

11Citations
Citations of this article
42Readers
Mendeley users who have this article in their library.

Abstract

Background Gadolinium-enhancing (GD+) lesions and T2 lesions are MRI outcomes for phase-2 treatment trials in relapsing-remitting Multiple Sclerosis (RRMS). Little is known about predictors of lesion development and regression-to-the-mean, which is an important aspect in early baseline-to-treatment trials. Objectives To quantify regression-to-the-mean and identify predictors of MRI lesion development in placebo cohorts. Methods 21 Phase-2 and Phase-3 trials were identified by a systematic literature research. Randomeffects meta-analyses were performed to estimate development of T2 and GD+ after 6 months (phase-2) or 2 years (phase-3). Predictors of lesion development were evaluated with mixed-effect meta-regression. Results The mean number of GD+-lesions per scan was similar after 6 months (1.19, 95%CI: 0.87- 1.51) and 2 years (1.19, 95%CI: 1.00-1.39). 39% of the patients were without new T2-lesion after 6 month and 19% after 2 years (95%CI: 12-25%). Mean number of baseline GD +-lesions was the best predictor for new lesions after 6 months.

Cite

CITATION STYLE

APA

Stellmann, J. P., Stürner, K. H., Young, K. L., Siemonsen, S., Friede, T., & Heesen, C. (2015). Regression to the mean and predictors of MRI disease activity in RRMS placebo cohorts - Is there a place for baseline-to-treatment studies in MS? PLoS ONE, 10(2). https://doi.org/10.1371/journal.pone.0116559

Register to see more suggestions

Mendeley helps you to discover research relevant for your work.

Already have an account?

Save time finding and organizing research with Mendeley

Sign up for free