SHE'S DONE AFTER WHAT SHE CALLED TRUMP WILL COST HER EVERYTHING!
Tysabri Preserves Upper-Limb Function in Secondary-Progressive MS
But overall disease progression was not slowed, according to the ASCEND study.
By Brian P. Dunleavy
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March 22, 2019
Natalizumab, marketed under the brand name Tysabri, is hardly a new drug in the treatment of multiple sclerosis (MS); it was first approved by the U.S. Food and Drug Administration in 2004.
But there is some new data concerning the injectable monoclonal antibody that may give cause for hope for at least some people with — a phase of MS that can follow relapsing-remitting MS and that is usually associated with symptom progression and increased disability.
In a study published online on March 12 by the journalThe Lancet Neurology, an international team of researchers working with SPMS patients in 17 countries found that Tysabri may have some positive effects — at least in terms of preserving upper-limb function.
The study failed to demonstrate that the drug is effective at slowing disease progression for those who have SPMS.
The study was funded by Biogen, which manufactures Tysabri, and the authors of the study did not respond to requests for comment.
Tysabri is among several disease-modifying treatments currently available for use in treating relapsing forms of MS, which can include SPMS. But although many of these drugs have shown promise in reducing the number and intensity of relapses, options for those whose MS has progressed to the point where they no longer have relapses but have “gradually accumulate(d)” permanent disability, to paraphrase the popular BartsMS Blog, have been limited.
Hence the interest in exploring the viability of drugs like Tysabri.
9-Hole Peg Test Performance Improves
For the recentLancet Neurologystudy, called ASCEND for short, the authors enrolled 889 adults between the ages of 18 and 58 to receive either monthly injections of 300 milligrams (mg) of Tysabri or a placebo for a period of two years. Among the 440 study participants who received Tysabri injections, 195 (44 percent) had confirmed disability progression at the end of study, as measured by commonly used assessments to measure function in those with MS, including the Expanded Disability Status Scale (EDSS) and the Timed 25-Foot Walk (T25FW). To compare, of the 449 patients who received the placebo, 214 (48 percent) had confirmed disability progression.
On the positive side, though, it seems Tysabri was effective at reducing upper-limb disability, based on the study participants’ performance in the 9-Hole Peg Test (9HPT), which is designed to assess hand and arm dexterity and function.
“This is a staggering result, as it shows that natalizumab has an impact on upper limb disability over a two year period without affecting lower limb disability,” the BartsMS Blog noted in a post about the study. “This result implies that people who have been labelled as having progressive disease can still derive benefit from natalizumab treatment.”
The Results Are Unlikely to Change Tysabri Prescribing
Not all MS experts were so enthusiastic, though.
“Overall, this study did not demonstrate robust evidence of benefit of natalizumab in slowing disability worsening in secondary-progressive MS,” said Jeffrey A. Cohen, MD, the Hazel Prior Hostetler Endowed Chair and Professor at the Cleveland Clinic Lerner College of Medicine and the director of experimental therapeutics at the Mellen Center for MS Treatment and Research at the Cleveland Clinic in Ohio. Dr. Cohen was not involved with the ASCEND trial.
“The results suggesting benefit on 9HPT are interesting, and a similar result has been seen in other trials in progressive MS, emphasiz[ing] the importance of including measures of other domains that contribute to disability besides walking,” he continued. “[However], I don’t think these results will change use of natalizumab substantially, although I suspect it already is used in some patients who technically have secondary-progressive MS but who’ve had a recent relapse.”
Serious Side Effects Temper Findings
The ASCEND findings may also be tempered by the fact that 90 of the study participants who received Tysabri experienced what the authors describe as “serious adverse events,” or side effects. Among 291 participants who continued Tysabri treatment for a second phase of the study, an additional 63 experienced serious adverse events.
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