Daclizumab for relapsing remitting multiple sclerosis

  • Review
  • Intervention




The anti-CD25 treatment of daclizumab appears to be effective in patients with relapsing remitting multiple sclerosis (RRMS) as regards clinical and MRI outcomes. Moreover, there are no severe safety concerns arising from clinical testing so far.


To assess the efficacy and safety of daclizumab for patients with relapsing remitting multiple sclerosis.

Search methods

We searched the Cochrane Multiple Sclerosis Group trials register (September 2009), MEDLINE (January 1966 to September 2009), EMBASE (January 1985 to September 2009). At the same time, we handsearched the references quoted in the identified trials, reports (September 2009) from the most important neurological associations and MS Societies in Europe and America, contacted researchers who were participating in trials on daclizumab.

Selection criteria

All randomized controlled clinical trials (RCTs) evaluating daclizumab, alone or combined with other treatments versus placebo, or any other treatment for patients with RRMS. Both parallel group and cross-over designs were included.

Data collection and analysis

Two reviewers independently assessed references retrieved for possible inclusion. All disagreements were resolved by an independent party. Study authors were contacted for additional information. Adverse effects information was collected from the trials.

Main results

We found no study meeting our inclusion criteria.

Authors' conclusions

Although studies examining daclizumab for relapsing remitting multiple sclerosis were located, methodologic limitations resulted in the exclusion of all studies. Some of the studies were labelled as crossover trials, however they only compared the effect of different interventions for the same individual. The true randomized crossover trial should compare the effect of different groups, which receive the same intervention, only with the difference in sequence. In other words, the crossover comparison should be between the different groups, rather than on the individual between pretreatment and post treatment. At the same time, all the individuals should be randomly allocated to different groups. There was also a rigorous randomized controlled trial, but the follow-up was shorter than one year (only 44 weeks). In general, daclizumab is safe and well tolerated in combination of interferon treated multiple sclerosis population. Improvements in methodology in future studies are required for meaningful synthesis of data.

Plain language summary

Daclizumab (Zenapax) is an immunosuppressive drug, whose efficacy in patients with multiple sclerosis (MS) is worth of attention 

Monoclonal antibodies such as daclizumab could be a possible alternative to interferon beta treatment in MS. This review attempted to evaluate if daclizumab, alone or combined to other treatments, is generally effective and safe as a therapy for relapsing remitting MS. Among the pertinent literature, we find no study meeting our inclusion criteria. In genaral, daclizumab is safe and well tolerated in combination of interferon treated MS population. Rigorous research, using randomised controlled trials, is needed to evaluate if this therapy can improve clinical outcomes and magnetic resonance imaging in MS patients.