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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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Patient flow. †Two patients randomised to the ponesimod 20 mg group did not start treatment due to safety findings that were noted after randomisation (low heart rate and abnormal Holter ECG readings). ‡Respiratory system criteria. §One patient discontinued treatment due to pregnancy, one patient discontinued treatment due to respiratory system criteria.
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JNNP2013307282F2: Patient flow. †Two patients randomised to the ponesimod 20 mg group did not start treatment due to safety findings that were noted after randomisation (low heart rate and abnormal Holter ECG readings). ‡Respiratory system criteria. §One patient discontinued treatment due to pregnancy, one patient discontinued treatment due to respiratory system criteria.

Mentions: Of the 621 patients screened, 464 were randomised between October 2009 and November 2010 to receive ponesimod 10, 20 or 40 mg, or placebo. Patient disposition is summarised in figure 2. In the ponesimod 10, 20 and 40 mg groups, 16.7%, 13.2% and 21.0% of patients prematurely discontinued treatment, respectively, compared with 9.1% of patients receiving placebo. Demographic and baseline disease characteristics were generally similar across treatment groups (table 1).


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)

Patient flow. †Two patients randomised to the ponesimod 20 mg group did not start treatment due to safety findings that were noted after randomisation (low heart rate and abnormal Holter ECG readings). ‡Respiratory system criteria. §One patient discontinued treatment due to pregnancy, one patient discontinued treatment due to respiratory system criteria.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

JNNP2013307282F2: Patient flow. †Two patients randomised to the ponesimod 20 mg group did not start treatment due to safety findings that were noted after randomisation (low heart rate and abnormal Holter ECG readings). ‡Respiratory system criteria. §One patient discontinued treatment due to pregnancy, one patient discontinued treatment due to respiratory system criteria.
Mentions: Of the 621 patients screened, 464 were randomised between October 2009 and November 2010 to receive ponesimod 10, 20 or 40 mg, or placebo. Patient disposition is summarised in figure 2. In the ponesimod 10, 20 and 40 mg groups, 16.7%, 13.2% and 21.0% of patients prematurely discontinued treatment, respectively, compared with 9.1% of patients receiving placebo. Demographic and baseline disease characteristics were generally similar across treatment groups (table 1).

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