What is the safety and efficacy of high-dose interferon beta-1a (Rebif) in relapsing-remitting multiple sclerosis (MS) (RRMS)?

Updated: Oct 08, 2019
  • Author: Christopher Luzzio, MD; Chief Editor: Jasvinder Chawla, MD, MBA  more...
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In Europe and Canada, higher doses of subcutaneous interferon beta-1a (Rebif) were studied in the Prevention of Relapse and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis (PRISMS) Study. [90] The dose-comparison study of interferon beta-1a reported a 27% reduction in the relapse rate in patients receiving 66 µg/wk and a 33% reduction in those receiving 132 µg/wk. This study, of 560 patients with relapsing-remitting disease, also demonstrated a significant reduction in accrual of disability and MRI lesion burden with the higher dose. [90]

In 2002, the FDA approved interferon beta-1a (Rebif) in 22 µg and 44 µg formulations given 3 times per week.

In the Evidence of Interferon Dose-response: European North American Comparative Efficacy (EVIDENCE) trial, which compared 2 preparations of interferon beta-1a (Rebif and Avonex), relapse occurred less frequently with 44 µg 3 times weekly (Rebif) than with 30 µg once weekly (Avonex) (25% vs 37%). [91] In addition, the mean number of active unique MRI lesions per patient per scan was lower in the Rebif than in the Avonex group (0.17 vs 0.33). Patients on Rebif experienced fewer flulike symptoms, but more injection site reactions, hepatic function disorders, and white blood cell disorders. Rebif-treated patients had a higher incidence of neutralizing antibodies (Nabs). A reduced MRI effect was noted for Nab-positive patients on Rebif compared with Nab-negative patients on Rebif. However, Nab-positive Rebif patients had better clinical and comparable MRI results to Avonex patients. [91]

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