News from the European Committee on Treatment and Research in MS (ECTRIMS)
Held in Prague, Czech Republic, October 2007
by Jack Burks, MD
Additional New MS Treatments May Prove to be Helpful
Several trials with potential new treatments were presented at the conference. For example, a small study found a trend toward effectiveness in treating relapsing forms of MS (relapsing-remitting MS, [RRMS], and secondary-progressive MS [SPMS] with relapses) with a common antidepressant, Prozac®. This drug appears to have an effect on modulating the immune system, which may help MS. More studies, however, are needed before a final determination is possible.
The Future Looks Good
One example of a promising new potential MS treatment is the drug, Campath®. Three years of data on Campath (a potent monoclonal antibody treatment being tested in MS) were presented at the prestigious Charcot Lecture by Professor Alistair Compston from England. He presented data that showed continued benefit at three years in patients treated with Campath, even though patients had received no new treatment for two years. Most were only treated at baseline and at one year. The data after three years from treatment onset continued to show substantial benefit over Rebif® (please note that Rebif also showed an effective response). Remarkably, with Campath, disability was actually less at three years compared to the beginning of the trial. In other words, people with MS on Campath improved with treatment. No new, toxic effects were detected in the last year of observation. However, in the first two years, thyroid problems, low platelets, and infections were detected. Toxicity will be carefully screened in the next trial, which is starting soon. Campath is not approved by the United States' Food and Drug Administration (FDA) for the treatment of MS. Other monoclonal antibody treatments, including Rituxan® and Zenapax®, are also showing encouraging efficacy results.
The New Rebif Formulation Data are being Evaluated by the FDA
The new, reformulated Rebif was associated with less injection-site reactions and pain, compared to data from a previous Rebif clinical trial. In addition, 30 percent fewer patients developed neutralizing antibodies with the new formulation. However, flu-like side effects occurred in 71 percent of patients, but 50 percent reported these side effects to be mild. The relapse rate per year (Annualized Relapse Rate) decreased from an average of 1.8 at the beginning of treatment to 0.7 after two years of treatment. A total of 53 percent of the treated patients were free of attacks during the two-year trial. The FDA has not yet approved the new formulation. Therefore, we await their decision.
Early Treatment Shows Reduction of Risk for MS Progression
Treating patients with Betaseron® after the initial attack of neurological damage (also referred to as a clinically isolated syndrome, or CIS), reduced the risk of disease progression at three years by 40 percent, compared to those who were treated after the second attack or at two years after the CIS. This was among the findings from the BENEFIT trial. Cognitive performance was also better in early-treatment patients. Neutralizing antibodies in treated patients were often transient and did not appear to have any negative effect on the clinical outcome, including disability progression. In another study of Betaseron, a short-term increase in disability appears to be related to long-term disability 16 years later. Therefore, the trend to treat MS patients as early as possible will likely increase, due to this demonstration of reduced disability with early treatment.
Class I Comparison Trials with Interferons and Copaxone
REGARD TRIAL: At ECTRIMS, a study comparing Rebif with Copaxone® found that no differences were noted in the primary clinical outcome, which was the time to first attack after beginning treatment. Furthermore, no differences were detected in relapse rates between the treatments. Some MRI outcomes favored Rebif. The best news for MS patients is that both treatments had very good results, which were even better than in previous trials. A low attack rate with both treatments may (or may not) have contributed to difficulty in detecting any differences in the treatments. In any event, in this group of patients, we can be pleased that these two drugs worked very well.
BEYOND TRIAL: Following the ECTRIMS meeting, Bayer HealthCare Pharmaceuticals released a statement announcing that the BEYOND comparison trial showed that a double dose of Betaseron had no clinical benefit over the regular dose of Betaseron. These results indicate that patients taking Betaseron are on the optimal dose, which is good news for these patients. Additionally, Betaseron and Copaxone were shown to be equally and robustly effective in the BEYOND comparison trial. Betaseron patients had fewer injection-site reactions, and the regular dose of Betaseron had the lowest drop-out rate of the three treatment groups, indicating it was well tolerated.
MESSAGE FROM THE TWO COMPARISON STUDIES: We are fortunate to have the interferons and Copaxone as first-line treatment options for MS. The two studies show very robust results in those three drugs' abilities to reduce disease activity in those with relapsing forms of MS. These results show that the message of starting treatment early and staying on the treatment are helpful in treating relapsing forms of MS. New drugs may be available in the future, but these three current treatments have all shown remarkable benefit in these two head-to-head comparison trials.
To reduce the effects of MS, using disease-modifying therapies at the earliest signs of MS, combined with a healthy lifestyle and a good mental attitude, are reasonable to consider. Unfortunately, not every patient is able to take advantage of these treatments, perhaps due to type of MS, lack of response to treatments, or financial challenges. The search is intensifying to find treatments and help for all MS patients.
A Total of 17,000 MS Patients on Tysabri®
Tysabri has now been started in 17,000 MS patients (10,500 in the United States). No new cases of progressive multifocal leukoencephalopathy (PML) have been reported since the original report of three patients who developed PML, two of whom died.
|Last Updated on Friday, 14 September 2012 13:25|