It’s called Daybreak, and it’s a large phase III clinical trial that involved more than two thousand patients with multiple sclerosis for over sixty months. And recently, on the occasion of the 9th Forum 2024 of the Americas Committee for Treatment and Research in Multiple Sclerosis (Actrims) in West Palm Beach, Florida, the new, very encouraging results were presented. The study concerns ozanimod, a drug already approved in Europe for the treatment of people with relapsing-remitting multiple sclerosis. In line with data from previous studies, those from Daybreak also confirmed that the drug is effective and safe in the long term. Specifically, the so-called annualized relapse rate (a parameter that measures the total number of relapses of all patients in the group, divided by the product of the number of years of treatment and the number of patients) was found to be 0.098, and the 84.8% of study participants had no disability progression at six months.
Multiple sclerosis: the first trials with Car-T therapies begin by Tiziana Moriconi 01 March 2024
Multiple sclerosis
Multiple sclerosis is a disabling disease for which there is currently no definitive cure. In people who suffer from multiple sclerosis, the immune system attacks the sheath that covers the neurons, interrupting communication between the brain and the rest of the body and irreversibly deteriorating the neurons. The active relapsing-remitting and secondary progressive forms of multiple sclerosis are characterized by episodes of worsening neurological function, called relapses, exacerbations or exacerbations, followed cyclically by periods of partial or complete recovery, called remissions.
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Previous studies and the Daybreak study
As already mentioned, the Daybreak results are in line with those of other studies of the same nature, however conducted on smaller samples. A phase II study, for example, had evaluated (positively) the effectiveness of the treatment on 258 people with relapsing multiple sclerosis; the Sunbeam (phase III, conducted on 1346 people) and Radiance (phase III, conducted on 1320 people) studies also reached the same conclusions. Daybreak participants were exposed to the drug for an average period of 60 months, and the results confirmed what had already emerged. “These Daybreak data – he commented Francesco Patti, head of the Multiple Sclerosis Center of the Aou Policlinico G. Rodolico San Marco in Catania – continue to validate the role of ozanimod in the long-term management of relapsing forms of multiple sclerosis, with two thirds of patients free of relapse six years after treatment . The therapy has demonstrated significant effectiveness in preventing the worsening of cognitive disorders, which is very frequent among patients. There is also a protective effect against brain loss and, therefore, prevention of disability. Finally, adverse events were detected in only a minimal percentage of patients, and just 4% had to discontinue treatment. Ozanimod – he concludes – is therefore confirmed as a very safe therapy with important protective capabilities”.
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