BETAFERON is indicated for the treatment of patients with active SPMS as evidenced by relapses. Two controlled clinical trials with BETAFERON involving patients with SPMS and a baseline EDSS of 3 to 6.5 (patients who are able to walk) were performed:

  • The European BETAFERON SPMS study involving 718 patients across two arms (BETAFERON and placebo) [1]
  • BETAFERON North American SPMS study involving 939 patients across three arms (BETAFERON 250 µg, interferon beta-1b 160 µg/m2 body surface area and placebo) [2]


In the European BETAFERON study in SPMS (N=718), about 70% of patients had superimposed relapses during their progressive phase at study entrance [1]. The study observed significant positive results in favor of BETAFERON treatment across the spectrum of clinical and MRI outcomes [1] and led to the approval of BETAFERON as a treatment of SPMS with superimposed relapses in Europe [1,3].


Compared with placebo, patients who received BETAFERON in the European BETAFERON SPMS study experienced…

  • A 1.6 times lower probability of disability progression (odds ratio 0.63, 95% CI: 0.46-0.85) [1]
  • A 1.5 times lower probability of becoming wheelchair bound (odds ratio 0.66, 95% CI: 0.47-0.93) [1]
  • Approximately 33% fewer relapses (ARR 0.63 vs. 0.42; p<0.0001) [4]
  • Approximately 65-78% fewer newly active lesions (months 1-6 and 19-24, p<0.001) [1]



The North American SPMS study included patients in more advanced stages of SPMS [2,4]. They were older, had a longer duration of disease, had fewer relapses in the 2 years prior to study entry and fewer contrast enhancing lesions compared to those in the European study [2,4]. The North American study missed its primary outcome measure of time to confirmed disability progression. However, patients who had relapses or newly active MRI lesions benefited from treatment with BETAFERON [2,4] – a result later acknowledged in the 2018 AAN and the 2018 ECTRIMS therapeutic recommendations [5,6].



Return to 'Betaferon clinical studies'



AAN: American Academy of Neurology

CI: confidence interval

ECTRIMS: European Committee for Treatment and Research in Multiple Sclerosis


  • European Study Group on interferon b-1b in Secondary Progressive MS. Lancet 1998; 352: 1491-7. Return to content
  • The North American Study Group on Interferon beta-1b in Secondary Progressive MS. Neurology 2004; 63: 1788-95. Return to content
  • BETAFERON European Summary of Product Characteristics, October 2020. Available at: Return to content
  • Kappos L et al. Neurology 2004; 63: 1779-87. Return to content
  • Montalban X et al. Mult Scler 2018; 24(2): 96-120. Return to content
  • Rae-Grant A et al. Neurology 2018; 90(17): 777-88. Return to content
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