From the Ectrims site:

http://registration.akm.ch/einsicht....NMASKEN_ID=900


Oral teriflunomide is effective and well tolerated in multiple sclerosis with relapses: results of an open-label 144-week extension study

P. O'Connor, D. Li, M. Freedman, A. Bar-Or, G. Rice, C. Confavreux on behalf of the Teriflunomide Multiple Sclerosis Trial Group

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Background: Teriflunomide is an oral immunomodulator that reduced the number of combined unique active (CUA) lesions on MRI by more than 61% compared to placebo over 36 weeks of treatment in a phase II randomized, double-blind placebo-controlled trial (Neurology 2006; 66:894-900). This is a report of the 144-week open-label extension phase of that trial.

Methods: Patients originally enrolled in the phase II trial had clinically definite MS with age 18-65, baseline EDSS score less than 7, and two documented relapses in the previous 3 years. 147 patients who consented to participate entered the extension study. Placebo patients were randomized to either teriflunomide 7 or 14 mg per day and followed along with the original teriflunomide-treated patients

Adverse event(AE) and clinical efficacy assessments were performed every 12 weeks with brain MRI every 48 weeks.Safety and efficacy data after 144 weeks of extension study treatment were analyzed.

Results: At baseline the 4 groups consisted of placebo-7mg switch (N=29), placebo-14 mg switch(N=26); continuous 7 mg (N=52) and continuous 14 mg (N=40). The incidence of AEs, serious AEs and AEs leading to treatment withdrawal were similar in the 4 groups. Elevations in liver function tests beyond 3 times the upper limit of normal were uncommon and not dose related. The overall drop-out rate was less than 10% per year.

The annual relapse rate was similar between groups ( approximately 0.4/year) as was the proportion of relapse-free patients up to week 144 ( approximately 54%). Efficacy data in patients completing 144-weeks of treatment (n=114) were compared to the extension-study baseline. Placebo patients switched to 7 mg/day experienced a 65% decrease in MRI CUA lesions at week 144 (P=0.02) versus an 85% decrease for placebo-14 mg patients (P=0.02). The patients continuously on therapy throughout the study experienced no change in the number of CUA MRI lesions during the extension phase. There were no significant differences in clinical parameters between groups.

Conclusion: Teriflunomide was well tolerated with few drop-outs during this 144-week extension study. Patients switched from placebo to active treatment experienced a significant drop in the number of CUA MRI lesions, further supporting the results of the initial double-blind placebo-controlled phase of the study. There were no statistically significant changes in relapse rates or EDSS between groups during the extension study.