Important Safety Information
Do not take BETASERON® (interferon beta-1b) if you are allergic to interferon beta-1b, to another interferon beta, to human albumin, or mannitol. See additional Important Safety Information below.

5 Years of Safety and Efficacy Data
in the BENEFIT Study


BETASERON® (interferon beta-1b) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

BETASERON in Newly Emerging Multiple Sclerosis For Initial Treatment (BENEFIT)

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Primary endpoint

BETASERON Efficacy in the BENEFIT Study

2-year study:

  • The probability of reaching CDMS in the BETASERON group was significantly lower than in the placebo group (28% vs 45%, respectively; P<0.0001)1 Return to content
  • 5-year study:

  • 46% of patients in the early BETASERON treatment group reached CDMS at year 5 vs 57% of patients in the delayed treatment group2 Return to content
  • Probability of CDMS at Years 2 and 51,2,*

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    *By proportional hazards regression adjusted for age/gender/steroids/T2 lesions/Gd+ lesions.

    Safety Results in the BENEFIT Study

    Most common AEs, ≥10%4

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    To reduce the potential for flu-like symptoms in both studies, mitigation strategies were used, such as dose titration and/or premedication with NSAIDs.1,4

    Integrated analysis of 2- and 5-year studies.

    Incidence of SAEs* and Discontinuation Rates

    2-year study:

  • 7% (20/292) of patients in the BETASERON group experienced an SAE vs 7% (12/176) of those in the placebo group1 Return to content
  • 5-year study:

  • 21% (61/292) of patients in the BETASERON group experienced an SAE vs 24% (42/176) of those in the placebo group2 Return to content
  • No deaths were reported in the studies1,2 Return to content
  • Discontinuations

    2-year study:

  • The most frequently reported AEs resulting in discontinuation, dose adjustment, or need for concomitant medication were depression, flu-like symptom complex, injection site reactions, leukopenia, increased liver enzymes, asthenia, hypertonia, and myasthenia5 Return to content
  • 5-year study:

  • 2.1% (10/468) of patients who took BETASERON experienced SAEs4 Return to content
  • 7 patients discontinued treatment due to 8 SAEs, including depression, psychotic depression, and injection site necrosis/reaction4 Return to content
  • The most frequent AEs that led to discontinuation were local injection site reactions, flu syndrome, depression, headache, and MS relapse4 Return to content
  • AE, adverse event; CDMS, clinically definite multiple sclerosis; CIS, clinically isolated syndrome; Gd+, gadolinium enhancing; MRI, magnetic resonance imaging; MS, multiple sclerosis; NSAID, nonsteroidal anti-inflammatory drug; SAE, serious adverse event; SGOT, aspartate aminotransferase (AST); SGPT, alanine aminotransferase (ALT).

    *SAEs were classified as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.4

    References: 1. Kappos L, Polman CH, Freedman MS, et al. Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes. Neurology. 2006;67(7):1242-1249. 2. Kappos L, Freedman MS, Polman CH, et al. Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial. Lancet Neurol. 2009;8(11):987-997. 3. Kappos L, Freedman MS, Polman CH, et al. Effect of early versus delayed interferon beta-1b treatment on disability after a first clinical event suggestive of multiple sclerosis: a 3-year follow-up analysis of the BENEFIT study. Lancet. 2007;370(9585):389-397. 4. Data on file. BENEFIT study summary. Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ. 5. BETASERON [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; Rev. August 2019.