Therapies Approved for RR-MS

There are no Class I clinical trials by Goodhn criteria (Good-lin et al., 2002) comparing the approved therapies for RR-MS. The dials discussed in the following section are all post-marking trials of relatively short duration. Even so, valuable information can be found if their shortcomings are remembered. 

Published head to head trials of the FDA approved therapies for RR MS still involve relatively small numbers and relatively short time periods but they provide important information on efficacy and side effect profiles. The first such study was a retrospective review by Kahn that was followed by a prospective open label 18-month study comparing IFBp-la IM, IFNp-lb and glatiramer acetate (Khan et al., 2001a). The subcutaneous form of IFNp-la (Rebif) was not FDA approved at the time. At the end of the 18-month prospective trial, 122 of 156 participants remained on their original therapy (79%). Relapse rate was the primary outcome measure. Participants on Glatiramer acetate had a significant reduction in relapses (P 0.0001), as did those on IFNp-lb (p 0.001) compared to untreated patients. There was not a significant difference in the relapse rate for the control patients and those on IF[3-la IM. 

Almost three hundred patients enrolled in the Haas (2003) prospective head to head study of all four FDA approved therapies for RR-MS. All four therapies show a significant reduction in relapse rate (p 0.02 for the IFNs) with gladramer acetate showing the most significant reduction (p . 001). Discontinuation rates were also higher on the IFNps 20-30% by 6 months compared to 8% for those on glatiramer acetate by the end of the 2 year study. 

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