New MS treatment available soon
A new treatment, Mavenclad (cladribine), will soon become available in North America, providing another option for people with relapsing multiple sclerosis. The drug was recently approved in Europe, and is expected in Canada within the next year.
Mavenclad is a pill that is taken over the course of a week, with a second week of pills a month later. The regimen is then repeated one year after that. So an important advantage is convenience. The pills can be taken at home, and two weeks of pills a year won’t be very intrusive in a person’s daily life. The dosing of the drug varies according to the person’s body weight.
Mavenclad was initially studied for MS two decades ago, and it was set to become the first oral MS therapy (under the name Movectro) when it hit a series of roadblocks by regulatory authorities. The concern at that time was malignancies (cancers) in the pivotal clinical trial (called CLARITY; Giovannoni and colleagues. N Engl J Med 2010;362:416-426; a free pdf is available in the MSology Library). During the two-year study, about 1% of people taking the drug developed neoplasms (“new growths”, a category that includes benign and malignant tumours, cysts, etc.) compared to 0% in the placebo group. This difference from placebo raised a red flag, although the rate of neoplasms was in line with what has been seen in other trials of MS drugs.
The manufacturer of the drug, Merck Serono (which makes Rebif), set up a safety registry (called PREMIERE) to track people who were enrolled in the clinical trial program. At last report, the overall rate of neoplasms is unchanged, and is about the same as what’s seen in people in trials taking a placebo (1.14% compared to 1.01% with placebo) (Cook and colleagues. AAN 2017; abstract P5.394). Other analyses have since supported the idea that there’s no increased risk of malignancies with the drug (Pakpoor and colleagues. Neurol Neuroimmunol Neuroinflamm 2015;2:e158; free pdf at www.ncbi.nlm.nih.gov/pmc/articles/PMC4592538/pdf/NEURIMMINFL2015005454.pdf). This new evidence led to the drug’s approval in Europe.
How effective is Mavenclad? In the CLARITY trial, the drug significantly lowered the rate of MS relapses, and reduced the development of inflammatory lesions in the brain. It’s generally considered to be less potent than the big-gun infusion drugs (Tysabri, Lemtrada and Ocrevus), but more effective than the injectables (Copaxone and the interferons), Aubagio and Tecfidera. However, it’s important to note that head-to-head studies would be needed to rank the drugs, and such studies are generally not done.
The most common side effect in CLARITY was headache, which was reported in 24% of people taking Mavenclad (compared to 17% on a placebo). The overall rate of infections – always a potential concern with drugs that affect the immune response – was lower with Mavenclad compared to placebo. However, there was an increased risk of herpes infections (such as shingles) with treatment.
The safety of Mavenclad has also been studied in a long-term extension of the CLARITY trial, and results have recently been published (Giovannoni and colleagues. Mult Scler 2017; epublished August 1, 2017). People have been in the study for up to six and a half years. The most common side effects were upper respiratory tract infections, headache, back pain and influenza.
One group in the extension study received Mavenclad over a two-year period, and then went off drug for the next couple of years. About 75% remained free of MS relapses despite the fact that they were no longer taking the medication, suggesting that the benefits are long-lasting.
Additional information about Mavenclad and other MS therapies will be presented at the European and Americas Committee for Treatment and Research in MS (ECTRIMS-ACTRIMS) congress later this month. MSology will be providing on-the-spot coverage via Twitter, will follow-up stories on the latest in MS research on MSology. Subscribe now to get email advisories of news stories as they appear. Subscriptions to MSology are free.
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