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Daclizumab HYP versus Interferon Beta-1a in Relapsing Multiple Sclerosis.

Ludwig Kappos1, Heinz Wiendl, Krzysztof Selmaj

  • 1From the Neurologic Clinic and Policlinic, the Departments of Medicine, Clinical Research, and Biomedicine and Biomedical Engineering, University Hospital, Basel, Switzerland (L.K.); the Department of Neurology, University of Münster, Münster, Germany (H.W.); the Department of Neurology, Medical University of Lodz, Lodz, Poland (K.S.); NeuroRx Research and Montreal Neurological Institute, McGill University - both in Montreal (D.L.A.); the Department of Neurology, First Faculty of Medicine, Charles University in Prague, Prague, Czech Republic (E.H.); the Department of Neurology and Neurosurgery, Russian National Research Medical University, and Moscow Multiple Sclerosis Center - both in Moscow (A.B.); Cole Neurological Institute, University of Tennessee, Knoxville (M.K.); the Department of Neurology and the Neurovirology Research Laboratory, University of Utah, and the Veterans Affairs Salt Lake City Health Care System - both in Salt Lake City (J.R.); AbbVie Biotherapeutics, Redwood City, CA (S.G.); and Biogen, Cambridge, MA (M.S., K.R., G.O., J.E.).

The New England Journal of Medicine
|October 8, 2015
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Summary

Daclizumab high-yield process (HYP) demonstrated superior efficacy in reducing relapses and MRI lesions in multiple sclerosis patients compared to interferon beta-1a. However, it did not significantly lower disability progression and had higher rates of infections and rash.

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Area of Science:

  • Immunology
  • Neurology
  • Pharmacology

Background:

  • Daclizumab high-yield process (HYP) targets CD25, modulating interleukin-2 signaling implicated in multiple sclerosis (MS) pathogenesis.
  • Interleukin-2 pathway dysregulation is a known factor in autoimmune disorders like MS.

Purpose of the Study:

  • To compare the efficacy and safety of daclizumab HYP versus interferon beta-1a in patients with relapsing-remitting multiple sclerosis (RRMS).
  • To evaluate the impact of daclizumab HYP on annualized relapse rate, MRI lesion activity, and disability progression.

Main Methods:

  • A Phase 3, randomized, double-blind, active-controlled study involving 1841 RRMS patients.
  • Daclizumab HYP (150 mg SC every 4 weeks) was compared with interferon beta-1a (30 μg IM weekly) for up to 144 weeks.
  • Primary endpoint: annualized relapse rate; secondary endpoints included MRI outcomes and disability progression.

Main Results:

  • Daclizumab HYP significantly reduced the annualized relapse rate by 45% (0.22 vs. 0.39; P<0.001) and new/enlarged MRI lesions by 54% (4.3 vs. 9.4; P<0.001) over 96 weeks.
  • No significant difference in 12-week confirmed disability progression (16% vs. 20%; P=0.16) between groups.
  • Higher incidence of serious adverse events (15% vs. 10%), infections (65% vs. 57%), cutaneous events (37% vs. 19%), and liver aminotransferase elevations (6% vs. 3%) with daclizumab HYP.

Conclusions:

  • Daclizumab HYP is more effective than interferon beta-1a in reducing relapses and MRI lesions in RRMS patients.
  • Daclizumab HYP did not demonstrate a significant benefit in preventing disability progression.
  • Increased risks of infections, rash, and liver enzyme elevations were observed with daclizumab HYP treatment.