In the 2-year AFFIRM pivotal trial:

Relapsing MS patients received 300 mg TYSABRI IV every 28 days (n=627) or placebo (n=315). Patients with PPMS, SPMS, and PRMS were excluded.

83% of patients taking TYSABRI had no sustained physical disability progression for 12 weeks vs 71% with placebo (primary endpoint: 17% vs 29%; p<0.001)1,2

TYSABRI demonstrated 67% relative reduction in ARR vs placebo (secondary endpoint: 0.22 vs 0.67; p<0.001)1,2

ARR=annualized relapse rate.

EXPLORE THE ONSET OF EFFICACY OF TYSABRI

In a post hoc analysis of the AFFIRM trial:

Rapid and sustained reductions in disease activity with TYSABRI3

Onset of efficacy as early as 2 months and maintained over 2 years

Study description: A post hoc analysis of the AFFIRM pivotal trial was performed to look at time to onset of clinical effects following initiation of TYSABRI. ARR was measured at 3-month intervals.3,a-c

aAnnualized relapse rates per 3-month interval were calculated as the total number of relapses divided by total person-years observed within the interval.
bRelapses were defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted ≥24 hours and were accompanied by new neurologic signs found by the examining neurologist.

Study limitations:

  • Because this post hoc analysis is retrospective in nature, there are no prospectively defined endpoints
  • Post hoc analyses are performed after study completion and cannot be used to demonstrate statistically significant differences between treatment groups

CUMULATIVE PROBABILITY OF RELAPSE OVER 2 YEARS FOR ALL PATIENTSa

Copyright © 2013 Kappos L, et al; licensee Springer Nature is adapted under CC by 4.0.

Rapid onset of efficacy first observed after the second infusiona

Difference in risk of relapse between TYSABRI and placebo at:

  • Day 42 in patients overall (5.4% vs 9.3% [HR: 0.56, 95% CI 0.34-0.93; p=0.0238])a
  • Day 45 in patients with highly active disease (6.8% vs 16.6% [HR: 0.35, 95% CI 0.14-0.87; p=0.0243)]c

Efficacy maintained over 2 years

Reduced risk of relapse was sustained over 2 years

  • By 58% in the overall population (28.7% vs 55.7% [HR: 0.42, 95% CI 0.34-0.52; p<0.0001])
  • By 75% in patients with highly active disease (29.3% vs 76.0% [HR: 0.25, 95% CI 0.17-0.39; p<0.0001])c

ARR OVER 2 YEARS FOR ALL PATIENTS

Copyright © 2013 Kappos L, et al; licensee Springer Nature is adapted under CC by 4.0.

Rapid onset of efficacy demonstrated by 3-month ARRc

TYSABRI reduced ARR within 3 months vs placebo:

  • By 58% in the overall population (0.3 [95% CI 0.23-0.4] vs 0.71 [95% CI 0.55-0.91]; p<0.0001)d
  • By 68% in patients with highly active disease (0.3 [95% CI 0.17-0.53] vs 0.94 [95% CI 0.55-1.63]; p=0.0039)b,e

Efficacy maintained over 2 years

Reductions in ARR were sustained to 2 years:

  • By 69% in the overall population (TYSABRI ARR was 0.31 RR of placebo, 95% CI 0.19-0.5; p<0.0001)
  • By 80% in patients with highly active disease (TYSABRI ARR was 0.20 RR of placebo, 95% CI 0.09-0.46; p<0.001)b

Corresponding placebo groups also showed sizable reductions.

RR=rate ratio.

cPost hoc subgroup analysis of data from AFFIRM defined highly active disease as ≥2 relapses in the year before study entry and ≥1 T1 Gd+ MRI lesion at study entry. A total of 209 patients (148 TYSABRI and 61 placebo) in AFFIRM met the criteria for highly active MS.

Gd+=gadolinium-enhancing.

This study was funded by Biogen.