Multiple Sclerosis Patient Experiences Improved Vision on TYSABRI

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MISSISSAUGA, ON, Nov. 25 /CNW/ - Results recently presented from a study of multiple sclerosis (MS) patients taking TYSABRI® (natalizumab) are supported by a Canadian woman's improved vision since starting the therapy. A poster presentation entitled, Low-contrast letter acuity detects visual function improvement in a phase 3 trial of natalizumab monotherapy, recently showed TYSABRI was associated with sustained visual improvement in patients with MS¹. The poster, based on data from the AFFIRM phase III clinical trials, was presented during the 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Gothenburg, Sweden. ECTRIMS is the world's largest medical meeting dedicated to research and advances in MS.

"TYSABRI treatment changed my life. I've gained my vision back to the extent that I retired my guide dog," said Jennifer Bauder, a Windsor, Ontario woman living with MS. "This is the most hope I've had at any point since my diagnosis with MS. Getting to this point has made a huge difference in my life," she said.

"Frequently, visual problems are the first symptom of MS so for people newly diagnosed, the real possibility that vision may deteriorate creates anxiety about the practicalities of daily living and quality of life," said Dr. J.E. Rick Paulseth, Associate Clinical Professor, Medicine, McMaster University. "Jennifer has had great results while on natalizumab, including a reduction in relapses and improvement in vision."

Low-contrast letter acuity (LCA) testing can detect treatment effects for both visual loss and visual improvement. The capacity for LCA to demonstrate visual improvement has relevance for capturing treatment benefit, particularly in trials that examine axonal loss, neuroprotection, and repair.

Visual improvement was measured by the number of letters a patient identified correctly at each visit. Cumulative probability of visual function improvement sustained over 12 weeks was determined for increases in score by seven letters, as well as by five letters and 10 letters.

AFFIRM was a randomized, double-blind, placebo-controlled, phase 3 clinical study that evaluated the efficacy and safety of natalizumab monotherapy (n=627) compared with placebo (n=315) in patients with relapsing-remitting MS. These analysis of the AFFIRM trial demonstrated that TYSABRI was associated with the increased probability of sustained visual improvement as measured by low-contrast letter acuity. Vision impairment is one of the first symptoms experienced by many people with MS and can have a significant impact on daily life.

Results showed that visual improvement, defined as greater-than or equal to 7-letter score increase from baseline, sustained for 12 weeks, was greater for TYSABRI (n=627) vs. placebo (n=314). This result was observed for LCA, where improvement in visual function at the 2.5 percent and 1.25 percent contrast levels was 57 percent (21.1% vs. 13.4%; HR=1.6, p=0.012) and 39 percent (31.6% vs. 23.9%; HR=1.4, p=0.014, Cox proportional hazards models), respectively. There were no significant differences between the treatment groups at the five-letter and 10-letter thresholds or the High-Contrast Letter Acuity.

In the study, improved visual function was maintained during repeat study visits. Significantly greater proportions of patients in the TYSABRI group showed improvement from baseline in tests of LCA for the majority (at least 6 of 10) of study visits. There were also a greater proportion of patients with any improvement across all visits for LCA 2.5%, with a trend for LCA 1.25% contrast level. 

About TYSABRI
TYSABRI is approved in more than 45 countries. In Canada, it is approved as monotherapy for relapsing-remitting MS.

TYSABRI has advanced the treatment of MS patients with its established and powerful efficacy. It has been proven to reduce flare-ups and slow physical disability progression. Data from the Phase III AFFIRM trial, which was published in the New England Journal of Medicine, showed that after two years, TYSABRI treatment led to a 68 percent relative reduction (p<0.001) in the annualized relapse rate when compared with placebo and reduced the relative risk of disability progression by 42-54 percent (p<0.001). At the end of a separate two-year study, approximately seven out of 10 patients on TYSABRI had no flare-ups at all. In the same study, nearly 9 out of 10 TYSABRI patients were free from sustained disability progression.

TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. The risk of PML increases with longer treatment duration and in patients treated with an immunosuppressant prior to receiving TYSABRI; these risks appear to be independent of each other. Data beyond four years are limited. Other serious adverse events that have occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis) and infections, including opportunistic and other atypical infections. Clinically significant liver injury has also been reported in patients treated with TYSABRI in the post-marketing setting. Common adverse events reported in TYSABRI-treated MS patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain, and rash.

TYSABRI is co-marketed by Biogen Idec Inc. and Elan Corporation, plc. For more information about TYSABRI, please visit www.tysabri.com, www.biogenidec.com or www.elan.com, or call 1-800-456-2255.

^1. Low-contrast letter acuity detects visual function improvement in a phase 3 trial of natalizumab monotherapy L. Balceret. al

About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients worldwide benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.

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