Clinical data

 


 

The effects of MS therapies in mid-life or older patients are not well studied [1]. The average age of patients included in large phase 3 studies in relapsing-remitting MS was generally in the 30s, with patients around 10 years older in studies conducted in secondary progressive MS [1,2]. With Betaferon trials, for example, the average age of patients was 41 years in the European and 47 years in the North American secondary progressive studies [2-5]. Relapses in the European study were frequent; about 70% of patients had superimposed relapses during their progressive phase. This study achieved positive results in favor of Betaferon treatment across the spectrum of clinical and MRI outcomes [3] and led to the approval of Betaferon as a treatment for secondary progressive MS with superimposed relapses [3,4]. The North American study missed its primary outcome measure (the time to confirmed disability progression), but Betaferon had beneficial effects on relapse rate and MRI parameters in patients who had relapses or active new MRI lesions [4,5]. The latter findings were acknowledged in the 2018 AAN and the 2018 ECTRIMS therapeutic recommendations [2,7].

 

In the European Study of Betaferon in secondary progressive MS, patients on Betaferon compared with placebo had:

  • a 1.6 times lower probability of disability progression [3]
  • a 1.5 times lower probability of becoming wheelchair bound [3]
  • about 33% fewer relapses [5]
  • about 65-78% fewer newly active lesions (months 1-6 and 19-24) [3]

In the North American Study of Betaferon in secondary progressive MS missed its primary endpoint [5,6]. Still, patients on Betaferon versus those on placebo benefited from treatment with:

  • about 43% fewer relapses [5,6]
  • about 71% fewer newly active lesions [5]
  • about 83% fewer new Gd+ enhancing lesions (months 1-6) [6]

 

A post-hoc analysis of the phase 3 BEYOND study in relapsing-remitting MS compared efficacy and safety in older versus younger patients treated with Betaferon (n=897) [8]. The two cut-offs used were the ages of 50 and 40 years at baseline. Neither differences in adjusted relapse risks nor in adjusted time to confirmed EDSS progression were noted between age groups, indicating that Betaferon is as efficacious in patients below and above mid-life years. Likewise, its safety profile seems not to be altered. Differences in adverse event frequencies between the age groups were very minor.

 

Table: Older versus younger patients in the BEYOND study [8]

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References

  • Sanai SA et al. Mult Scler 2016; 22(6): 717-25. Return to content
  • Montalban X et al. Mult Scler 2018; 24(2): 96-120. Return to content
  • European Study Group. Lancet 1998; 352(9139): 1491-97. Return to content
  • BETAFERON® European Summary of Product Characteristics, October 2020. Available at: https://www.ema.europa.eu/en/documents/product-information/betaferon-epar-product-information_en.pdf. Return to content
  • Panitch H et al. Neurology 2004; 63(10): 1788-95. Return to content
  • Kappos L et al. Neurology 2004; 63(10): 1779-87. Return to content
  • Rae-Grant A et al. Neurology 2018; 90(17): 777-88. Return to content
  • Lampl C et al. J Neurol 2013; 260(7): 1838-45. Return to content
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