Two new cases of the brain viral infection PML (progressive multifocal leukencephalopathy) have been reported on Tysabri treatment. One MS patient had been treated with Tysabri alone for 17 months without previous treatment with MS medications. This patient is still at home and walking. A second patient developed PML on Tysabri alone for 14 months, but had previous treatment with interferon and azathioprine. This second patient has cognitive problems and left-sided weakness and is currently hospitalized. If you are on Tysabri, contact your neurologist or healthcare provider to make a decision whether to continue therapy.
The Forte trial studied a double dose (40 mg) vs regular dose (20 mg) of Copaxone on relapses in 1155 relapsing-remitting MS patients over one year. The randomized, double-blind study was conducted at 136 centers in North America, Argentina, Europe and Israel.
The higher dose did not work better than the regular dose in reducing relapses. Patients on the regular 20 mg daily dose of Copaxone did well; 78% of patients remained relapse-free over the course of the year.
ATL/TV1102, a new anti-sense drug, significantly reduced MRI activity in patients with relapsing-remitting multiple sclerosis. Anti-sense drugs block disease-causing proteins from being made based on information in the genetic code. ATL/TV1102 may prevent white blood cells from entering sites of inflammation in the brain and spinal cord.
A randomized, double-blind, placebo-controlled Phase IIa study showed a 54.4% reduction (p=0.01) in cumulative number of new active MRI lesions in patients taking ATL/TV1102 for 8 weeks, compared to placebo. Seventy-seven patients received either ATL/TV1102 or placebo injections under the skin at a dose of 200 mg three times a week for the first week and twice weekly over additional 7 weeks. The patients received monthly MRI brain scans. Patients taking ATL/TV1102 experienced a 65% reduced cumulative number of T1 with contrast enhancing lesions (p=0.0053). Risks were injection site reactions and low platelet counts, which were reversible when the treatment was stopped.
A Phase II/III study of Rituxan® (rituximab) for primary-progressive multiple sclerosis (PPMS) did not slow the likelihood of disease progression during the 96-week treatment period. A total of 439 patients from approximately 60 sites in the U.S. and Canada were randomized 2:1 to receive either four treatment courses of Rituxan six months apart or placebo. Rituxan is an antibody that helps knock out a type of immune cell called B cells. A Phase II trial in relapsing-remitting MS showed a 58% reduction in relapses.
Primary progressive MS causes a slow, continuous progression of disability without relapses. Primary progressive disease affects 10 to 15 percent of people with MS. Unfortunately, no treatments have been proven to work in this type of MS. A large primary progressive study, Copaxone did not reduce the likelihood of disability progression overall. Analysis after the trial was over, showed a benefit of Copaxone in men that was statistically significant.
