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Neurology. 2014 Jul 1;83(1):78-86. doi: 10.1212/WNL.0000000000000541. Epub 2014 Jun 4.

Long-term safety and effectiveness of natalizumab redosing and treatment in the STRATA MS Study.

Author information

  • 1From the Department of Neurology (P.O.), St. Michael's Hospital, Toronto, Canada; Department of Neurology (A.G.), University of Rochester, NY; Departments of Neurology and Biomedicine (L.K.), University Hospital Basel, Switzerland; Corinne Goldsmith Dickinson Center for MS at The Icahn School of Medicine at Mount Sinai (F.L.), New York, NY; Department of Neurology (C.P.), VU Medical Centre, Amsterdam, the Netherlands; Mellen Center for Multiple Sclerosis Treatment and Research (R.A.R.), Cleveland Clinic Foundation, OH; Infusion Communications (K.H.), Haddam, CT; Departments of Safety and Benefit-Risk Management (L.M.C.) and Biostatistics (F.F.), Biogen Idec Inc., Cambridge; and Sarepta Therapeutics (P.D.), Cambridge, MA; P.D., a former employee of Biogen Idec Inc., was at the company during study conduct. OCONNORP@smh.toronto.on.ca.
  • 2From the Department of Neurology (P.O.), St. Michael's Hospital, Toronto, Canada; Department of Neurology (A.G.), University of Rochester, NY; Departments of Neurology and Biomedicine (L.K.), University Hospital Basel, Switzerland; Corinne Goldsmith Dickinson Center for MS at The Icahn School of Medicine at Mount Sinai (F.L.), New York, NY; Department of Neurology (C.P.), VU Medical Centre, Amsterdam, the Netherlands; Mellen Center for Multiple Sclerosis Treatment and Research (R.A.R.), Cleveland Clinic Foundation, OH; Infusion Communications (K.H.), Haddam, CT; Departments of Safety and Benefit-Risk Management (L.M.C.) and Biostatistics (F.F.), Biogen Idec Inc., Cambridge; and Sarepta Therapeutics (P.D.), Cambridge, MA; P.D., a former employee of Biogen Idec Inc., was at the company during study conduct.

Erratum in

  • Neurology. 2014 Aug 19;83(8):773.

Abstract

OBJECTIVES:

Report long-term safety and effectiveness of natalizumab over 240 weeks in the prospective, observational, open-label Safety of TYSABRI Re-dosing and Treatment (STRATA) Study.

METHODS:

Patients (N = 1,094) previously enrolled in natalizumab multiple sclerosis clinical trials received natalizumab 300 mg IV every 4 weeks, up to 240 weeks. Serious adverse events, Expanded Disability Status Scale (EDSS) scores, and annualized relapse rates were analyzed.

RESULTS:

At data cutoff (February 9, 2012), natalizumab exposure was 3,460 patient-years; a median of 56 (range 1-70) infusions were received. Serious adverse events, including progressive multifocal leukoencephalopathy, were consistent with natalizumab's known profile. Upon natalizumab re-exposure, rates of anti-natalizumab antibodies and hypersensitivity reactions were 3% and 5% overall, and 40% and 24% among patients with 1 to 2 prior natalizumab doses. Patients originally randomized to placebo/another disease-modifying therapy vs natalizumab in previous studies had significantly higher EDSS scores at STRATA baseline; this difference persisted over 240 weeks. EDSS scores generally remained stable. Patients initially randomized to natalizumab had lower annualized relapse rates over 240 weeks.

CONCLUSIONS:

Serious adverse events were consistent with natalizumab's known safety profile; short exposure with a gap before redosing was associated with higher incidences of anti-natalizumab antibodies and hypersensitivity reactions. Stability of EDSS scores and consistently low relapse rates over 5 years of natalizumab treatment are consistent with its known efficacy profile.

CLASSIFICATION OF EVIDENCE:

This study provides Class III evidence that in patients with relapsing-remitting multiple sclerosis, natalizumab stabilizes EDSS scores, decreases relapse rates, and is associated with an increased risk of progressive multifocal leukoencephalopathy.

© 2014 American Academy of Neurology.

PMID:
24898925
[PubMed - indexed for MEDLINE]
PMCID:
PMC4114173
Free PMC Article
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