Oral therapies – an update
The 2012 ECTRIMS meeting (European Committee for Treatment and Research in MS) recently concluded in Lyons, France, and provided some updates of recent clinical trials of oral MS drugs in development.
Two phase III studies, DEFINE and CONFIRM, have been published for BG-12 (Gold and colleagues. N Engl J Med 2012;367:1098-1107; Fox and colleagues. N Engl J Med 2012;367:1087-1097). A new analysis has combined the results of both studies (Gold and colleagues. ECTRIMS 2012; abstract 151). Overall, the annualized relapse rate (ARR; the number of relapses averaged over the two years of the study) was 0.19 with BG-12 taken either twice or three times a day. The ARR was 0.37 for the placebo group (i.e. no active treatment). This represented a 49% reduction in the number of relapses with the medication compared to placebo. The risk of disability progression (confirmed at 3 months) was reduced by about one-third. As might be expected, these results were very similar to the results previously published for the two studies individually (see Oral therapies: an overview of new meds, October 18, 2012).
More information is now available for the unpublished TOWER study of oral teriflunomide (Kappos and colleagues. ECTRIMS 2012; abstract 153). The phase III study compared two doses of teriflunomide (7 mg and 14 mg per day) with placebo in 1,169 people with MS. The ARR was reduced 36.3% with the higher dose and 31.5% with the lower dose of teriflunomide. The risk of disability (confirmed at 3 months) was reduced 31.5% with the 14-mg dose, but was no better than placebo with the 7-mg dose. Although the lower dose appears to less than fully effective, the FDA did accept both doses in its September 2012 approval of the drug (brand name Aubagio).
Side effects with Aubagio can include headaches, stomach upset (nausea, diarrhea), hair thinning, blood abnormalities and elevations in liver enzymes. The drug approval carries a black-box warning about the risk of severe liver injury (including death) during treatment. As a result, blood tests are needed every month for at least the first six months of treatment to ensure that any problems are detected early.
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