New Studies Cast Fresh Light on MS Drugs

Jun 30, 2006 at 04:08 pm by steve

Dr. Omar Khan, Wayne State University

Researchers typically focus on the value of new drugs that are being pushed through the pipeline. But a pair of new studies on a 10-year-old therapy for multiple sclerosis is underscoring some hidden long-term gains for patients. Dr. Omar Khan, an associate professor of neurology at Detroit's Wayne State University and a prominent MS expert, has concluded that a new study of Copaxone® (glatiramer acetate injection) shows that the drug — made by Israel's Teva Pharmaceutical Industries — continues to help protect patients after they fail to respond to Avonex®. Biogen Idec's Avonex is one of the leading MS drugs on the market. That study closely followed a report in the June issue of Multiple Sclerosis, which concluded that patients who continued taking Copaxone over 10 years had a lower rate of disability compared to patients who had stopped taking the drug. On average, patients experienced only one relapse every five years compared to an average of 1.18 attacks a year before entering the 10-year study. Additionally, 92 percent of patients in the study who remained on Copaxone were still walking without assistance despite an average disease duration of more than 15 years. Dr. Khan and his associates concluded that Copaxone reduced the annual relapse rate of patients by 57 percent compared to Avonex while neurological disability did not worsen for 86 percent of patients. For the makers of Copaxone, the study helps secure the drug as a leading therapy for an intractable disease. "It's one of the four approved drugs currently for relapsing remitting MS," says Arney Rosenblat, a spokesperson for the National Multiple Sclerosis Society. "Physicians in general tend to prescribe it quite a bit. It's pretty much up there, challenging Avonex for the most prescribed drugs." Some 250,000 to 350,000 sufferers of MS in the United States have to deal with a progressively debilitating disease characterized by blurred vision, weakness, and a loss of cognitive function as their nerves lose their protective sheaths. Glatiramer acetate (Copaxone) is a synthetic compound made up of four amino acids found in myelin and is currently the only non-interferon agent available for MS. While researchers are not positive how the drug works, it is believed to help stimulate T cells in the body's immune system to lesson inflammation at lesion sites. The recent study at Wayne State included 85 patients who had been taking Avonex for at least a year and a half before relapsing or being forced to stop taking the medicine due to toxicity. "Our results corroborated another, larger prospective open-label study by Dr. Howard Zwibel, medical director of HealthSouth Doctors' Hospital Multiple Sclerosis Center, which demonstrated reductions in relapse rates in patients who switched from Betaseron® to Copaxone, and suggested that clinical observations including relapse rates, patient tolerability and toxicities assessed by serum laboratory parameters are valuable criteria for determining when a switch in therapy is warranted," says Khan. The long-term study of Copaxone was undertaken by Dr. Corey C. Ford, an associate professor of neurology and co-director at the MIND Imaging Center at the University of New Mexico Health Sciences Center in Albuquerque. Dr. Ford and his colleagues studied 232 MS patients who were started on Copaxone and kept on it for 10 years. Fifty patients were taken off the drug for the study, and all were monitored every six months. Of the patients who continued to take Copaxone, 62 percent stayed stable or showed improved symptoms, compared to 28 percent of the control group who were taken off the therapy. There has been a long-running debate among MS specialists over just when a patient should begin therapy. The National MS Society's position is that patients should be prescribed one of the leading therapies as soon as possible after a diagnosis of MS on a relapsing course. Evidence exists that patients early on experience damage to nerve endings that can hasten the debilitating effects of the disease. Some physicians disagree, however, saying that patients would be better served by waiting for awhile to see how the disease develops. Dr. Sean J. Pittock of the Mayo Clinic has argued that MS can run a "favorable" course that can be hard to distinguish when patients are treated over a prolonged period. Both pros and cons to early treatment are reviewed in the April issue of Archives of Neurology. For Teva, the most recent data underscores the high stakes involved when a drug company pushes a new therapy to approval. Copaxone was Teva's first approved drug, and it has been racking up steadily higher sales on the world market. In the first quarter of this year, global sales of Copaxone shot up 29 percent to $329 million. The bulk of those sales were in the United States. This new data may well help accelerate sales of Copaxone, solidifying its position at the top of a market for what is still an incurable disease.



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