Phase 3 trial: TYSABRI improves vision in MS patients

Nov 25 2010

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 MS. 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>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>

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. 

Source: CNW SOCIAL MEDIA