BETAFERON clinical experience and safety


Accumulating data show that BETAFERON is particularly valuable when given early in MS, ideally at or shortly after the first neurological episode suggestive of MS [1-4]. This is in line with leading guidelines advocating that MS patients should begin treatment early in their disease course to maximize brain health [5,6]. It is widely agreed that a forward looking long-term treatment approach is important in MS, a disease not just of weeks to months but of years to decades.


BETAFERON is an established first-line MS therapy with a well-characterized benefit-risk profile [7]. As an interferon beta therapy, it maintains an important role in the treatment of relapsing MS [8], especially in patients with mild-to-moderate disease. An extensive body of evidence suggests long-term benefits of interferon beta treatment compared to no treatment or initial placebo including reduction of disability progression [9], reduced mortality [10,11] compared to no treatment or initial placebo and reassuring safety findings [12]. Confidence is further enhanced with ample outcomes data in first trimester interferon beta-exposed pregnancies [13] as well as the possibility of breastfeeding while taking interferon beta [13].


Importantly, BETAFERON has not been associated with impaired immune surveillance [14] and substantial datasets confirm its favorable benefit-risk profile over the long-term [12]. Moreover, the use of BETAFERON is supported by more than 30 years [15] and an estimated 1.7 million+ patient-years of clinical experience [16]. In general, the most frequently observed adverse reactions are a flu-like symptom complex (fever, chills, arthralgia, malaise, sweating, headache, or myalgia), which is mainly due to the pharmacological effects of the therapy, and injection site reactions [13].



Strategies to improve tolerability of BETAFERON

Betaferon prescribing information


  • Naismith RT. Mult Scler 2016; 22(11): 1400-1402. Return to content
  • Naismith RT. Neurol Clin Pract. 2011; 1(1): 69-72. Return to content
  • Kappos L et al. Neurology 2016; 87(10): 978-87. Return to content
  • Kappos L et al. American Academy of Neurology. Annual Meeting 2019, P3.2-080. 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
  • Kompetenznetz Multiple Sklerose: Qualitätshandbuch, 2022. Available at: (Accessed August 18, 2022). Return to content
  • Madsen C et al. Brain Behav 2017; 7: e00696. Return to content
  • Signori A et al. Mult Scler Rel Disord 2016; 6: 57-–63. Return to content
  • Goodin DS et al. Neurology 2012; 78: 1315-22. Return to content
  • Kingwell E et al. Brain 2019; 142(5): 1324-33. Return to content
  • Reder AT et al. Mult Scler Relat Disord 2014; 3(3): 294-302. Return to content
  • BETAFERON European Summary of Product Characteristics, October 2020. Available at: Return to content
  • Grebenciucova E and Pruitt A. Curr Neurol Neurosci Rep 2017; 17: 88. Return to content
  • The IFNB Multiple Sclerosis Study Group. Neurology 1993; 43(4): 655-61. Return to content
  • Calculated based on Bayer sales data from 1993 to 2020. Return to content
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