Rebif® (interferon beta-1a)
EMD Serono, Inc. and Pfizer Inc
- Administered by subcutaneous injection three times weekly; dosage is 22 or 44 mcg. The 44 mcg dose appears significantly more effective than 22 mcg, and is the dose most often used in the United States.
- Approved for relapsing types of MS.
- Rebif reduces the frequency of relapses and slows the progression of disability. It also has been shown to reduce MRI lesion area and activity compared to placebo.
- Interferons appear to reduce inflammation by modulating a favorable balance between cells that increase inflammation and cells that decrease it.
- The Rebif new formulation (RNF) is not yet approved by the FDA, but it is designed to be better tolerated and to minimize the development of neutralizing antibodies that may decrease the response to treatment. The completed IMPROVE trial documented the efficacy of RNF in RRMS, as measured by the number of active lesions on MRI at 16 weeks. Again, this formulation is not yet available in the United States.
- The ongoing STAR study has as its primary outcome measure the proportion of participants with injection-site reactions. Secondary measures include the occurrence of adverse events, the number and reason for missed injections, the proportion of relapse-free patients, and time to first relapse.
- A once-weekly dose of Rebif previously demonstrated an effect on delaying CDMS after CIS. An ongoing study is looking at the use of Rebif 44 mcg for CIS to confirm its effectiveness in delaying the conversion to CDMS.
- A 96-week trial of methylprednisolone as an add-on to Rebif is reported to significantly reduce the relapse rate in participants who showed clinical activity during interferon therapy. Half of the group received an MS treatment using interferon beta-1a plus 200 mg of oral methylprednisolone given in a "pulse therapy" fashion (200 mg on five consecutive days every four weeks), while the other half received interferon beta-1a plus a placebo treatment. The authors concluded that adding methylprednisolone led to a reduction in relapses. High dropout rate was a problem due to the side effects associated with steroids.
- The Phase IV SKORE study is evaluating cognition and fatigue in people with RRMS treated with Rebif. Its primary outcome measure is the percentage of patients with stable or altered cognition status; secondary outcome measures are the proportion of relapse-free subjects and the proportion with defined EDSS changes. The study has 300 participants; it was initiated in June 2009 and is scheduled for completion in November 2013.
- The ongoing Phase II RECYCLINE study combines Rebif with minocycline (an antibiotic that has immunomodulatory properties). The study, which has 320 participants, began in March 2006 and is estimated to be completed in February 2012. The primary outcome measure is the time to first relapse; secondary outcome measures include the average number of relapses per subject, the number of new or enlarging lesions on T2-weighted MRI; brain atrophy; and time to confirmed progression in disability. No data have as yet been published.
- The European COGIMUS study measured changes in depression, fatigue, quality of life, and social functioning in patients with RRMS treated with interferon beta-1a. It found that these parameters remained relatively stable over the three years of the study.