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To the Editor:
We read with interest the Prevention of Relapse with Intravenous Immunoglobulin (PRIVIG) dose-finding trial in relapsing-remitting multiple sclerosis (RRMS) by Fazekas et al.1 The authors concluded that the trial “seriously questions the utility of IVIg for the treatment of relapsing-remitting MS” and that the “negative results of the PRIVIG trial therefore cannot be attributed to a problem of data quality.” However, the results of the PRIVIG trial should be carefully interpreted because of several methodologic limitations.
The rationale for choosing the two doses of IV immunoglobulin (IVIg) at 0.2 and 0.4 gm/kg is unclear, considering that higher doses of IVIg (2.0 gm/kg) have been used in previous studies. The authors did not present any immunologic rationale for choosing the two doses. It may have been interesting to examine higher doses, including the possibility of a third arm at doses >1.0 gm/kg.
It is also unclear why the primary endpoint of “proportion of relapse-free patients after only 48 weeks” was chosen. This endpoint has never been used as a primary outcome in any of the pivotal trials. Furthermore, the expectation of demonstrating an increase of 50% relapse-free patients in the active arm compared to placebo arm that was expected to have 50% relapse-free patients is also overly optimistic. This magnitude of effect in the proportion of relapse-free patients has not been demonstrated in several pivotal …
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