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BOSTON—Siponimod reduces the risk of three-month and six-month confirmed disability progression in patients with secondary progressive multiple sclerosis (MS), according to research described at the 69th Annual Meeting of the American Academy of Neurology. The treatment also appears to reduce relapse rate and the number of new lesions. The study is “the largest controlled double-blind study in secondary progressive MS,” according to Ludwig Kappos, MD, Chair of Neurology at University Hospital Basel in Switzerland. 
Siponimod is a selective sphingosine 1-phosphate receptor-1 and -5 modulator with effects on the CNS and the peripheral nervous system. The treatment may have effects related to remyelination and neuroprotection, according to Dr. Kappos. He and his colleagues conducted a randomized, double-blind, placebo-controlled, phase III study to compare the effects of siponimod and placebo in patients with secondary progressive MS. The investigators randomized patients 2:1 to once-daily siponimod (2 mg) or placebo. Patients were treated for as long as three years in the double-blind phase of the study. In a subsequent extension study, participants were treated for as long as seven years.
The event- and exposure-driven study's primary end point was time to three-month confirmed disability progression, as assessed by the Expanded Disability Status Scale (EDSS). Key secondary end points included time to confirmed worsening of 20% or more from baseline in the Timed 25-Foot Walk test (T25FW) and T2 lesion volume change from baseline. Other secondary end points included six-month confirmed disability progression, annualized relapse rate, 12-item MS Walking Scale (MSWS-12), number of T1 gadolinium-enhancing and T2 lesions, and percent brain volume change.
The investigators randomized 1,651 patients. The population's mean age was 50, and mean EDSS score was 5.5. The sample was typical of the population of patients with secondary progressive MS.
Siponimod reduced the risk of three-month confirmed disability progression by 21% versus placebo. Dr. Kappos and colleagues consistently observed point estimates in favor of siponimod across predefined subgroups, including patients with no relapses in the two years before study initiation and patients without gadolinium-enhancing lesions at baseline.
The risk reduction observed for the T25FW was 6.2%, but was not statistically significant. Siponimod reduced the risk of six-month confirmed disability progression by 26%. In addition, siponimod reduced the annualized relapse rate by 55.5%, the number of T1 gadolinium-enhancing lesions by 86.6%, and the number of new T2 lesions by 81%. The relative differences in change from baseline in T2 lesion volume, MSWS-12, and percent brain volume change were 79.1%, 39.7%, and 23.4%, respectively, versus placebo. Siponimod's effects were more pronounced in patients with relapses at baseline, compared with those without, said Dr. Kappos.
—Erik Greb
BOSTON—Siponimod reduces the risk of three-month and six-month confirmed disability progression in patients with secondary progressive multiple sclerosis (MS), according to research described at the 69th Annual Meeting of the American Academy of Neurology. The treatment also appears to reduce relapse rate and the number of new lesions. The study is “the largest controlled double-blind study in secondary progressive MS,” according to Ludwig Kappos, MD, Chair of Neurology at University Hospital Basel in Switzerland.
Siponimod is a selective sphingosine 1-phosphate receptor-1 and -5 modulator with effects on the CNS and the peripheral nervous system. The treatment may have effects related to remyelination and neuroprotection, according to Dr. Kappos. He and his colleagues conducted a randomized, double-blind, placebo-controlled, phase III study to compare the effects of siponimod and placebo in patients with secondary progressive MS. The investigators randomized patients 2:1 to once-daily siponimod (2 mg) or placebo. Patients were treated for as long as three years in the double-blind phase of the study. In a subsequent extension study, participants were treated for as long as seven years.
The event- and exposure-driven study's primary end point was time to three-month confirmed disability progression, as assessed by the Expanded Disability Status Scale (EDSS). Key secondary end points included time to confirmed worsening of 20% or more from baseline in the Timed 25-Foot Walk test (T25FW) and T2 lesion volume change from baseline. Other secondary end points included six-month confirmed disability progression, annualized relapse rate, 12-item MS Walking Scale (MSWS-12), number of T1 gadolinium-enhancing and T2 lesions, and percent brain volume change.
The investigators randomized 1,651 patients. The population's mean age was 50, and mean EDSS score was 5.5. The sample was typical of the population of patients with secondary progressive MS.
Siponimod reduced the risk of three-month confirmed disability progression by 21% versus placebo. Dr. Kappos and colleagues consistently observed point estimates in favor of siponimod across predefined subgroups, including patients with no relapses in the two years before study initiation and patients without gadolinium-enhancing lesions at baseline.
The risk reduction observed for the T25FW was 6.2%, but was not statistically significant. Siponimod reduced the risk of six-month confirmed disability progression by 26%. In addition, siponimod reduced the annualized relapse rate by 55.5%, the number of T1 gadolinium-enhancing lesions by 86.6%, and the number of new T2 lesions by 81%. The relative differences in change from baseline in T2 lesion volume, MSWS-12, and percent brain volume change were 79.1%, 39.7%, and 23.4%, respectively, versus placebo. Siponimod's effects were more pronounced in patients with relapses at baseline, compared with those without, said Dr. Kappos.
—Erik Greb
BOSTON—Siponimod reduces the risk of three-month and six-month confirmed disability progression in patients with secondary progressive multiple sclerosis (MS), according to research described at the 69th Annual Meeting of the American Academy of Neurology. The treatment also appears to reduce relapse rate and the number of new lesions. The study is “the largest controlled double-blind study in secondary progressive MS,” according to Ludwig Kappos, MD, Chair of Neurology at University Hospital Basel in Switzerland.
Siponimod is a selective sphingosine 1-phosphate receptor-1 and -5 modulator with effects on the CNS and the peripheral nervous system. The treatment may have effects related to remyelination and neuroprotection, according to Dr. Kappos. He and his colleagues conducted a randomized, double-blind, placebo-controlled, phase III study to compare the effects of siponimod and placebo in patients with secondary progressive MS. The investigators randomized patients 2:1 to once-daily siponimod (2 mg) or placebo. Patients were treated for as long as three years in the double-blind phase of the study. In a subsequent extension study, participants were treated for as long as seven years.
The event- and exposure-driven study's primary end point was time to three-month confirmed disability progression, as assessed by the Expanded Disability Status Scale (EDSS). Key secondary end points included time to confirmed worsening of 20% or more from baseline in the Timed 25-Foot Walk test (T25FW) and T2 lesion volume change from baseline. Other secondary end points included six-month confirmed disability progression, annualized relapse rate, 12-item MS Walking Scale (MSWS-12), number of T1 gadolinium-enhancing and T2 lesions, and percent brain volume change.
The investigators randomized 1,651 patients. The population's mean age was 50, and mean EDSS score was 5.5. The sample was typical of the population of patients with secondary progressive MS.
Siponimod reduced the risk of three-month confirmed disability progression by 21% versus placebo. Dr. Kappos and colleagues consistently observed point estimates in favor of siponimod across predefined subgroups, including patients with no relapses in the two years before study initiation and patients without gadolinium-enhancing lesions at baseline.
The risk reduction observed for the T25FW was 6.2%, but was not statistically significant. Siponimod reduced the risk of six-month confirmed disability progression by 26%. In addition, siponimod reduced the annualized relapse rate by 55.5%, the number of T1 gadolinium-enhancing lesions by 86.6%, and the number of new T2 lesions by 81%. The relative differences in change from baseline in T2 lesion volume, MSWS-12, and percent brain volume change were 79.1%, 39.7%, and 23.4%, respectively, versus placebo. Siponimod's effects were more pronounced in patients with relapses at baseline, compared with those without, said Dr. Kappos.
—Erik Greb