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Safety and immunogenicity of a new formulation of interferon β-1a (Rebif® New Formulation) in a Phase IIIb study in patients with relapsing multiple sclerosis: 96-week resultsInstitute of Cell and Molecular Science, Barts and the London School of Medicine and Dentistry, London, UK g.giovannoni{at}qmul.ac.uk
State Educational Institute of Higher Professional Education, Kemerovo State Medical Academy, Kemerovo, Russia
Merck Serono International S.A.*, Geneva, Switzerland
Department of Neurology, Royal Melbourne Hospital, Melbourne, Australia
Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada
MS Center of Oklahoma, Mercy NeuroScience Institute, Oklahoma City, Oklahoma, USA
Neurology Center of Fairfax, Hamaker Ct Ste 400, Fairfax, Virginia, USA
Department of Neurology, Danish MS Research Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
Merck Serono International S.A.*, Geneva, Switzerland on behalf of the Rebif® New Formulation Study Group Background A new formulation of subcutaneous (s.c.) interferon-β-1a has been developed (Rebif® New Formulation, RNF), produced without fetal bovine serum and without human serum albumin as an excipient, with the aim of improving injection tolerability, and reducing immunogenicity. Objectives This article reports 96-week analyses of a Phase IIIb, open-label study of the safety and immunogenicity of RNF compared with historical (EVIDENCE study) and recent (REGARD study) data on the original formulation. Methods Patients with relapsing multiple sclerosis (McDonald criteria) and an Expanded Disability Status Scale score < 6.0 received RNF, 44 µg s.c. three times weekly. Results
The proportion of neutralizing antibody-positive (NAb+) patients (serum NAb status Conclusions RNF has improved overall immunogenicity and safety profiles compared with the original formulation.
Key Words: immunogenicity • injection-site reactions • interferon-β-1a • multiple sclerosis • Rebif® New Formulation • safety
This version was published on February
1, 2009 Multiple Sclerosis, Vol. 15, No. 2,
219-228 (2009) |
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20 neutralizing units/mL) at week 96 (last observation carried forward; primary endpoint) was 17.4% (exact 95% confidence interval [CI]: 13.0–22.5), compared with 21.4% (95% CI: 17.2–26.2) in the EVIDENCE study, and 27.3% (95% CI: 22.8–32.1) in the REGARD study. The proportion of patients NAb+ at any time during the 96 weeks was 18.9% (95% CI: 14.4–24.2), compared with 27.1% (95% CI: 22.4–32.2) and 33.7% (95% CI: 28.9–38.7), respectively. Most pre-specified categories of adverse events were reported by patients in the RNF study at a similar or lower proportion than in the EVIDENCE and REGARD studies. Injection-site reactions were experienced by fewer patients than in the EVIDENCE and REGARD studies.