Multiple Sclerosis News

May 2005

http://www.msneighborhood.com/content/in_the_news/archive_2231.aspx

Copaxone Efficacy Confirmed in Relapsing MS

by John C. Martin

Article Date: 05-06-05

Doctors analyzing the effectiveness of Copaxone for people with relapsing-remitting multiple sclerosis say they've confirmed its ability to suppress the disease in a continuing retrospective trial. The trial's results were released at the American Academy of Neurology annual meeting last month.1

Relapsing MS is the most common form of the disease, affecting as much as 85 percent of the people who've been diagnosed. Contrasting with the primary-progressive and secondary-progressive forms, relapsing MS is characterized by clearly delineated flare-ups followed by episodes of acute worsening of neurologic function. These are followed by periods of complete or partial recovery.2

'Encouraging' Results for People with Severe MS

"Our significant findings are very encouraging for patients who have severe, active forms of relapsing-remitting MS," explained Michael Boggild, MD, of the Walton Centre in Liverpool, UK, who headed the trial.

Boggild, a consultant neurologist, and his fellow investigators recruited 27 patients with early active relapsing MS into the open-label study, in which, unlike a blinded trial, everyone knew the name of the drug being tested. Copaxone was given to each patient in combination with mitoxantrone (MX).

Copaxone (glatiramer acetate injection/Teva Pharmaceuticals) is currently approved as a medicine to reduce the frequency of relapses, or exacerbations, in people with relapsing multiple sclerosis. The drug has also been shown to reduce the number of brain lesions associated with MS.3 Mitoxantrone belongs to a class of medications known as antineoplastics (ann-tee-nee-oh-PLAS-tiks). Prescribed as a cancer therapy, mitoxantrone—marketed as Novantrone—is also indicated as an MS therapy. It's designed to extend the time between relapses in relapsing MS.

Limited Efficacy

Nonetheless, "the benefits of this agent [Novantrone] in reducing disease progression and relapse rate cannot be sustained in the long-term, as treatment is limited by the potential for cumulative cardiotoxicity [heart damage]," wrote Boggild and his research team.

So the researchers wanted to determine if another treatment protocol might be more effective. In the trial, each patient was treated with Novantone monotherapy initially, and then given the combination of Copaxone and Novantrone for up to 7 months, followed by Copaxone monotherapy for a total of 5 years. Each patient was then followed up over the course of several months after treatment ended. Measures of the number of relapses, as well as each patient's level of disability, were calculated in this follow-up period. In nine patients, magnetic resonance imaging (MRI) scans were begun to determine the medications' effect on brain lesions.

Positive Outcome

The researchers found that the combination treatment stabilized or improved disability, and significantly suppressed the number of brain lesions. No new brain lesions have been seen on MRI scans, as well, Boggild and his colleagues reported. While on Novantrone alone, the investigators discovered 6 relapses had occurred in the patients. But only two relapses happened several months after Copaxone monotherapy was started.

After an average of nearly 3 years on Copaxone monotherapy, there were no reports of relapses, and at the most recent follow-up exams, disability measures of each patient were either stable or had improved, the study team found.

Last year, initial trial results of the first 10 patients were unveiled at a meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Vienna, Austria. No relapses had been reported in any of these patients at an average of 30 months after starting treatment with Copaxone monotherapy. While the patients had disability severe enough to prevent them from taking part in full daily activities, they had only mild disability after 30 months on the medication, the investigators had reported.

A Therapeutic Synergy?

Thus, the latest study confirms the earlier findings. "The results may reflect a synergistic effect of this combination," Boggild said. "Mitoxantrone may be acting as a short-term immunosuppressant, further enhancing the effects of Copaxone in preventing inflammatory and neurodegenerative responses long-term."

The unique way this combination works" may make it a logical choice … for patients with particularly aggressive forms of the disease," he added.

Teva is sponsoring a future multicenter trial based on these findings. Enrollment of 40 patients in the trial was completed in December 2004. The trial is aimed at evaluating the safety of the combination, as well as confirming the findings of Boggild and his team.

"I’m encouraged that further ongoing studies may validate our results," he said.

1. Ramtahal, J, Jacob A, Das K, Boggild M. 5-year retrospective study of the use of mitoxantrone and glatiramer acetate combination in patients with very active relapsing remitting multiple sclerosis. American Academy of Neurology 57th Annual Meeting. 2005 Apr 9-16. Miami Beach, FL.

2. National Multiple Sclerosis Society. What is Multiple Sclerosis? Available at: http://www.nationalmssociety.org/What%20is%20MS.asp. Accessed April 29, 2005.

3. Teva Pharmaceutical Industries. About Copaxone. Available at: http://www.mswatch.com/therapy/section.aspx?SectionId=789eabf5-3a07-4dff-a7ee-0d4ad1381a6d. Accessed April 29, 2005.

John Martin is a long-time health journalist and an editor for Priority Healthcare. His credits include coverage of health news for the website of Fox Television's The Health Network, and articles for the New York Post and other consumer and trade publications.