New TYSABRI® Data Show Earlier Treatment And Longer-Term Use Result In Significant Reductions In MS Disease Activity

Biogen Idec (NASDAQ: BIIB) today announced results from several new analyses of TYSABRI ® (natalizumab) data that demonstrate its effectiveness in reducing multiple sclerosis (MS) disease activity. This effect was particularly significant in people with relapsing MS who initiated treatment when they had lower Expanded Disability Status Scale (EDSS) scores as well as in those who have been treated for more than two years. These data will be presented at the 29 th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark from 2-5 October.

“These analyses build upon a growing body of evidence that demonstrates greater clinical benefits for people with MS when TYSABRI is initiated earlier in the course of the disease, as well as when TYSABRI is used for a longer duration in appropriate patients,” said Alfred Sandrock, M.D., Ph.D., group senior vice president, Development Sciences and Chief Medical Officer, Biogen Idec.

More Patients Demonstrated No Evidence of Clinical or MRI Disease Activity with Earlier TYSABRI Use

AFFIRM was a two-year, randomized, multi-center, placebo-controlled, double-blind study of 942 patients evaluating the effect of TYSABRI on the rate of clinical relapses and the progression of disability as measured by at least a one-point worsening in EDSS score sustained for three months.

A post-hoc analysis of AFFIRM was undertaken to determine which baseline characteristics were associated with patients showing no evidence of clinical or MRI disease activity (defined as no relapse, no 12 -week sustained EDSS progression, and no gadolinium -enhancing [Gd+] or new/enlarging T2-hyperintense lesions) at two years. A greater proportion of TYSABRI patients were found to have no evidence of clinical or MRI disease activity compared to those on placebo in all sub-groups analyzed with the beneficial effect being significantly greater in patients with an EDSS score of <3.0 versus ≥ 3.0 at baseline.

Fewer and Less-Severe Relapses with TYSABRI

An additional sub -analysis of AFFIRM assessed the effectiveness of TYSABRI on reducing relapse severity and recovery from relapse compared to placebo. Observations from this sub-analysis showed that patients treated with TYSABRI experienced less -severe relapses, as measured by EDSS score changes during the relapse and residual deficits following relapse.

These data will be presented in the poster session titled, “Immunomodulation/Immunosuppression,” on Friday, 4 October at 3:45 p.m. – 5:00 p.m. CET:
  • Effects of natalizumab treatment on freedom from disease activity by baseline characteristics in AFFIRM (poster 519)
  • Natalizumab reduces the disabling amplitude of multiple sclerosis relapses and improves post-relapse residual disability (poster 524)

Clinical Benefit of TYSABRI Improves Beyond Two Years of Treatment

An analysis of data from the TYSABRI Observational Program (TOP), an ongoing observational, open -label, 10 -year prospective study of relapsing -remitting MS (RRMS) patients, assessed patients who have been treated with TYSABRI for at least four years. The analysis found that patients with less disability at baseline (EDSS score of <3.0 at baseline) had a significantly greater reduction in 12 month sustained disability progression in months 25-48 compared with months 0-24. Additionally, annualized relapse rates (ARR) in patients treated with TYSABRI decreased from 2.03 at baseline to 0.19 during months 0-24 and 0.18 during months 25-48 (p<0.0001).

“TYSABRI has advanced the treatment of RRMS patients with its established efficacy,” Sandrock added. “This analysis is encouraging because it provides new insight into the use of TYSABRI beyond two years and suggests that effects of treatment are even better with longer use in appropriate patients.”

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