AVONEX pivotal trials

AVONEX Study 11,2

MSCRG (Study 1) was a 2-year, randomized, double-blind, placebo-controlled study of 301 patients with relapsing MS in which 282 patients completed 1 year on study, and 172 (AVONEX, n=85; placebo, n=87) patients completed 2 years on study.

Randomization

AVONEX

n=158
AVONEX 30 mcg
by IM injection
once weekly

Placebo

n=143
Placebo
by IM injection
once weekly

Selected key inclusion criteria
  • Diagnosis of definite relapsing MS for at least 1 year
  • Baseline EDSS score of 1.0 to 3.5
Selected key exclusion criteria
  • Chronic progressive MS
Evaluations

Neurological evaluations
Performed at baseline and every 6 months

MRI evaluations
Performed at baseline, at year 1, and at year 2

AVONEX significantly reduced the risk of sustained disability progression at 2 years
(P=0.02)1,2,a

78% of patients taking AVONEX had no sustained disability progression compared with 65% of placebo-treated patients.

The percentage of patients progressing in disability was 22% in the AVONEX group and 35% in the placebo group.

Not all enrolled patients were assessed at 2 years.

AVONEX-treated patients were 37% less likely to have sustained disability progression at 2 years compared with placebo

AVONEX Study 21,3

CHAMPS (Study 2) was a randomized, double-blind, placebo-controlled study of 383 patients at high risk for developing clinically definite multiple sclerosis (CDMS)b who were followed for up to 3 yearsc or until they developed CDMS, defined as the occurrence of a second relapse in an anatomically distinct region of the central nervous system.

Randomization

AVONEX

n=193
AVONEX 30 mcg
by IM injection
once weekly

Placebo

n=190
Placebo
by IM injection
once weekly

Selected key inclusion criteria
  • Recently experienced an isolated demyelinating event involving the optic nerve, spinal cord, or brainstem/cerebellum
  • Lesions typical of MS on brain MRI
Selected key exclusion criteria
  • Prior neurologic or visual event consistent with the occurrence of demyelination that lasted longer than 48 hours
Evaluations1,2

Neurological evaluations
At baseline, at month 1 (and again at month 2, if the patient’s condition was not considered to be stable or improving at month 1), at month 6, and every 6 months thereafter

MRI evaluations
Performed at baseline and at months 6, 12, and 18

bWho had recently experienced an isolated demyelinating event involving the optic nerve, spinal cord, or brainstem/cerebellum, and who had lesions typical of MS on brain MRI.

cPatients were enrolled into the study over a 2-year period and followed for up to 3 years or until they developed a second relapse in an anatomically distinct region of the central nervous system.

Time to second relapse was significantly delayed in AVONEX-treated patients compared to placebo-treated patients at 2 years (P=0.002)1,3

79% of patients taking AVONEX were relapse free compared with 61% of placebo-treated patients.

The percentage of patients developing a second relapse was 21% in the AVONEX group and 39% in the placebo group.

The relative rate of developing a second relapse in the AVONEX group was 0.56 of the rate in the placebo group (95% CI, 0.38-0.81).

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AVONEX safety

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Abbreviations: IM, intramuscular; MSCRG, Multiple Sclerosis Collaborative Research Group; CHAMPS, Controlled High-Risk AVONEX Multiple Sclerosis Prevention Study.