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Oral ponesimod in relapsing-remitting multiple sclerosis: a randomised phase II trial.

Olsson T, Boster A, Fernández Ó, Freedman MS, Pozzilli C, Bach D, Berkani O, Mueller MS, Sidorenko T, Radue EW, Melanson M - J. Neurol. Neurosurg. Psychiatr. (2014)

Bottom Line: The time to first confirmed relapse was increased with ponesimod compared with placebo.Once-daily treatment with ponesimod 10, 20 or 40 mg significantly reduced the number of new T1 Gd+ lesions and showed a beneficial effect on clinical endpoints.NCT01006265.

View Article: PubMed Central - PubMed

Affiliation: Department of Clinical Neurosciences, Karolinska Institute, Stockholm, Sweden.

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Related in: MedlinePlus

(A) Percentage change from baseline in lymphocyte counts up to week 24 (all-treated analysis set). (B) The group of patients who underwent safety follow-up (discontinued treatment prematurely or did not enter the extension study). FU1, follow-up visit 1 (end of treatment + 7 days); FU2, follow-up visit 2 (end of treatment+30 days).
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JNNP2013307282F5: (A) Percentage change from baseline in lymphocyte counts up to week 24 (all-treated analysis set). (B) The group of patients who underwent safety follow-up (discontinued treatment prematurely or did not enter the extension study). FU1, follow-up visit 1 (end of treatment + 7 days); FU2, follow-up visit 2 (end of treatment+30 days).

Mentions: Lymphocyte counts were rapidly reduced with ponesimod treatment in a dose-dependent manner (figure 5A). Following initial treatment (up-titration) with ponesimod 10 mg, the mean decrease from baseline to day 8 (predose) in lymphocyte count ranged from 43% to 45% in all ponesimod groups and was 1% in the placebo group. Following up-titration to 20 mg on day 8, the mean decrease from baseline to day 15 (predose) in lymphocyte count was 62% for both the ponesimod 20 and 40 mg groups. Following up-titration to 40 mg on day 15, the mean decrease from baseline to week 4 in lymphocyte count was 67% in the ponesimod 40 mg group. Mean reductions from baseline to week 24 were 50%, 65% and 69% for ponesimod 10, 20 and 40 mg, respectively, and 3% in the placebo group.


Oral ponesimod in relapsing-remitting multiple sclerosis: a randomised phase II trial.

Olsson T, Boster A, Fernández Ó, Freedman MS, Pozzilli C, Bach D, Berkani O, Mueller MS, Sidorenko T, Radue EW, Melanson M - J. Neurol. Neurosurg. Psychiatr. (2014)

(A) Percentage change from baseline in lymphocyte counts up to week 24 (all-treated analysis set). (B) The group of patients who underwent safety follow-up (discontinued treatment prematurely or did not enter the extension study). FU1, follow-up visit 1 (end of treatment + 7 days); FU2, follow-up visit 2 (end of treatment+30 days).
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4215282&req=5

JNNP2013307282F5: (A) Percentage change from baseline in lymphocyte counts up to week 24 (all-treated analysis set). (B) The group of patients who underwent safety follow-up (discontinued treatment prematurely or did not enter the extension study). FU1, follow-up visit 1 (end of treatment + 7 days); FU2, follow-up visit 2 (end of treatment+30 days).
Mentions: Lymphocyte counts were rapidly reduced with ponesimod treatment in a dose-dependent manner (figure 5A). Following initial treatment (up-titration) with ponesimod 10 mg, the mean decrease from baseline to day 8 (predose) in lymphocyte count ranged from 43% to 45% in all ponesimod groups and was 1% in the placebo group. Following up-titration to 20 mg on day 8, the mean decrease from baseline to day 15 (predose) in lymphocyte count was 62% for both the ponesimod 20 and 40 mg groups. Following up-titration to 40 mg on day 15, the mean decrease from baseline to week 4 in lymphocyte count was 67% in the ponesimod 40 mg group. Mean reductions from baseline to week 24 were 50%, 65% and 69% for ponesimod 10, 20 and 40 mg, respectively, and 3% in the placebo group.

Bottom Line: The time to first confirmed relapse was increased with ponesimod compared with placebo.Once-daily treatment with ponesimod 10, 20 or 40 mg significantly reduced the number of new T1 Gd+ lesions and showed a beneficial effect on clinical endpoints.NCT01006265.

View Article: PubMed Central - PubMed

Affiliation: Department of Clinical Neurosciences, Karolinska Institute, Stockholm, Sweden.

Show MeSH
Related in: MedlinePlus