AVONEX (interferon beta-1a)

– an Injectable Beta-Interferon1

Indication

AVONEX is indicated for the treatment of

  • Patients diagnosed with relapsing multiple sclerosis (MS). In clinical trials, this was characterised by two or more acute exacerbations (relapses) in the previous three-years without evidence of continuous progression between relapses; AVONEX slows the progression of disability and decreases the frequency of relapses.
  • Patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis. 1

Posology

The recommend dosage for AVONEX is 30 μg administered by intramuscular injection once a week1 .

Efficacy

Results from a pivotal phase III study in patients with MS: AVONEX has demonstrated sustained efficacy across measures of annualised relapse rate (ARR) and disability progression compared with placebo.1,2

Significant results in all clinical endpoints in patients who completed 2 years of follow-up

The open-label ASSURANCE trial provided long-term data demonstrating the continued tolerability and efficacy of AVONEX over 15 years.3

Safety profile

AVONEX has an established and manageable tolerability and safety profile. The SmPC lists the following as ‘very common’ (>1/10 patient-years) adverse events: headache, flu-like symptoms, pyrexia, chills, sweating.1

 

See the SmPC (UK | ROI ) and PI for more information

Other

Almost 2.3 million patient-years of experience from 491,850 patients treated worldwide in the post-marketing setting.4

Study design: MSCRG was a 2-year, randomised, double-blind, placebo controlled, multicentre trial involving 301 patients with RRMS. The primary endpoint was the time to onset of sustained disability progression from baseline of at least 1.0 point on the EDSS persisting for > 6 months. Secondary endpoints included ARR and MRI outcomes.2

ASSURANCE was a multicentre, single-time-point, 15 year follow-up evaluation of patients who had completed 104 weeks in the MSCRG study. Patients were eligible regardless of current treatment or treatment assignment in the MSCRG study. The objective was to evaluate long-term tolerability of AVONEX and effects on disability and quality of life.3

Abbreviations: ARR: Annualised Relapse Rate; EDSS: expanded disability status scale; Gd+: Gadolinium Enhancing; RRMS: Relapsing Remitting Multiple Sclerosis

 

MSP-PAN-0010e Date of prep: September 2018