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Regression of new gadolinium enhancing lesion activity in relapsing-remitting multiple sclerosis.
Neurology 2008; 70(13 Pt 2):1092-7Neur

Abstract

BACKGROUND

Contrast enhancing lesions (CEL) is a common endpoint in multiple sclerosis (MS) clinical trials. To minimize sample size or placebo exposure, a crossover design without a concurrent control group is attractive. Natural regression may confound this strategy. We assessed the degree of regression in monthly new gadolinium activity in relapsing-remitting (RR) placebo patients.

METHODS

A post hoc analysis was performed on 65 RRMS placebo patients in the Prevention of Relapses and disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis (PRISMS) trial. Patients were originally selected for relapses but not preselected for MRI activity. Eleven MRI scans were taken at screening, baseline, and months 1 through 9. Monthly new CEL rates were examined using a random effects Poisson model. Patients were analyzed as a single group and by screening CEL count level subgroups: no, low, and high (0, 1 to 3, >3 CEL).

RESULTS

A total of 32, 19, and 14 patients had no, low, and high CEL counts at screening. The monthly new CEL rates (95% CI) of all patients at baseline, months 1 to 3, 4 to 6, and 7 to 9 were 2.0 (1.3, 2.9), 1.8 (1.3, 2.5), 1.4 (1.0, 2.0), and 1.2 (0.8, 1.7). Compared to baseline, the rate decreased by 10%, 27%, and 39%. The monthly rate of the no subgroup remained stable. The rates for both the low and high subgroups decreased by 4%, 29%, and 48% at months 1 to 3, 4 to 6, and 7 to 9 compared to baseline.

CONCLUSIONS

Placebo relapsing-remitting multiple sclerosis patients experience a decline of new gadolinium activity over 9 months. A crossover design without a concurrent comparison group may overestimate the treatment effect.

Authors+Show Affiliations

Department of Medicine, University of British Columbia, Vancouver, BC, Canada. yinshan@interchange.ubc.caNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18003938

Citation

Zhao, Yinshan, et al. "Regression of New Gadolinium Enhancing Lesion Activity in Relapsing-remitting Multiple Sclerosis." Neurology, vol. 70, no. 13 Pt 2, 2008, pp. 1092-7.
Zhao Y, Traboulsee A, Petkau AJ, et al. Regression of new gadolinium enhancing lesion activity in relapsing-remitting multiple sclerosis. Neurology. 2008;70(13 Pt 2):1092-7.
Zhao, Y., Traboulsee, A., Petkau, A. J., & Li, D. (2008). Regression of new gadolinium enhancing lesion activity in relapsing-remitting multiple sclerosis. Neurology, 70(13 Pt 2), pp. 1092-7.
Zhao Y, et al. Regression of New Gadolinium Enhancing Lesion Activity in Relapsing-remitting Multiple Sclerosis. Neurology. 2008 Mar 25;70(13 Pt 2):1092-7. PubMed PMID: 18003938.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Regression of new gadolinium enhancing lesion activity in relapsing-remitting multiple sclerosis. AU - Zhao,Yinshan, AU - Traboulsee,Anthony, AU - Petkau,A John, AU - Li,David, Y1 - 2007/11/14/ PY - 2007/11/16/pubmed PY - 2008/6/20/medline PY - 2007/11/16/entrez SP - 1092 EP - 7 JF - Neurology JO - Neurology VL - 70 IS - 13 Pt 2 N2 - BACKGROUND: Contrast enhancing lesions (CEL) is a common endpoint in multiple sclerosis (MS) clinical trials. To minimize sample size or placebo exposure, a crossover design without a concurrent control group is attractive. Natural regression may confound this strategy. We assessed the degree of regression in monthly new gadolinium activity in relapsing-remitting (RR) placebo patients. METHODS: A post hoc analysis was performed on 65 RRMS placebo patients in the Prevention of Relapses and disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis (PRISMS) trial. Patients were originally selected for relapses but not preselected for MRI activity. Eleven MRI scans were taken at screening, baseline, and months 1 through 9. Monthly new CEL rates were examined using a random effects Poisson model. Patients were analyzed as a single group and by screening CEL count level subgroups: no, low, and high (0, 1 to 3, >3 CEL). RESULTS: A total of 32, 19, and 14 patients had no, low, and high CEL counts at screening. The monthly new CEL rates (95% CI) of all patients at baseline, months 1 to 3, 4 to 6, and 7 to 9 were 2.0 (1.3, 2.9), 1.8 (1.3, 2.5), 1.4 (1.0, 2.0), and 1.2 (0.8, 1.7). Compared to baseline, the rate decreased by 10%, 27%, and 39%. The monthly rate of the no subgroup remained stable. The rates for both the low and high subgroups decreased by 4%, 29%, and 48% at months 1 to 3, 4 to 6, and 7 to 9 compared to baseline. CONCLUSIONS: Placebo relapsing-remitting multiple sclerosis patients experience a decline of new gadolinium activity over 9 months. A crossover design without a concurrent comparison group may overestimate the treatment effect. SN - 1526-632X UR - https://www.unboundmedicine.com/medline/citation/18003938/Regression_of_new_gadolinium_enhancing_lesion_activity_in_relapsing_remitting_multiple_sclerosis_ L2 - http://www.neurology.org/cgi/pmidlookup?view=long&pmid=18003938 DB - PRIME DP - Unbound Medicine ER -