The FDA's decision was based on data from the Phase 3 PARADIGMS study (N=215) which evaluated the safety and efficacy of oral fingolimod vs interferon beta-1a injection in pediatric patients aged 10 to <18 years with relapsing MS.
The guideline, published in the journal Neurology, provides recommendations on initiating, switching, and discontinuing DMTs relevant to patients with relapsing-remitting MS (RRMS), secondary progressive MS, primary progressive MS (PPMS), and clinically isolated syndromes of demyelination.
Siponimod is an investigational, selective modulator of specific subtypes of the sphingosine-1-phosphate (S1P) receptor.
Of the total patients, 178 (29.7%) discontinued DMT during the study period with only 1 documented relapse occurring in the discontinuers.
Because of its safety profile, the use of Zinbryta is generally reserved for patients who have had an inadequate response to 2 or more MS drugs.
Rituximab associated with lower drug discontinuation and disease relapse rates in multiple sclerosis
Rituximab was associated with lower discontinuation rates as compared to other disease-modifying treatments in newly diagnosed patients with relapsing-remitting multiple sclerosis.
Of the 494 patients, 43.5% received an injectable DMT, 17.4% dimethyl fumarate, 3.4% fingolimod, 10.1% natalizumab, 24.3% rituximab, and 1.2% other DMT.
The FDA has granted Breakthrough Therapy designation for fingolimod for the treatment of children and adolescents 10 years of age or older with relapsing multiple sclerosis (MS).
The researchers found that having dietary quality scores in the highest versus the lowest quintile correlated with lower levels of disability.
There was no difference in the composite functional measure (walking control, balance, manual dexterity, postvoid residual urine volume, and visual acuity) between the PTA and sham groups (41.7 vs. 48.7%; odds ratio, 0.75; 95% confidence interval, 0.34 to 1.68; P=0.49).
Children and adolescents with relapsing MS had an 82% lower relapse rate with fingolimod vs. interferon beta-1a
Approximately 80% of patients from the CARE-MS I trial (n=139) and the CARE-MS II trial (n=143) had elected to enter the extension phase of the study.
Data show superiority of Ocrevus compared to Rebif (interferon beta-1a) in significantly reducing disability Progression Independent of Relapse Activity (PIRA) in people with relapsing multiple sclerosis (RMS)
The overall two-year data showed that compared to placebo, Aubagio significantly reduced cortical gray matter volume (CGMV) loss (Aubagio 7mg, P=0.0089; Aubagio 14mg, P=0.0052) and the risk of CDMD conversion.
The mechanism by which glatiramer acetate exerts its therapeutic effect in MS is unknown, however it is thought to act by modifying immune processes that are believed to be responsible for the pathogenesis of MS.
Data showed that a 50nmol/L increase in 25(OH)D correlated with a 39% decreased risk of MS. Specifically, a 43% increased risk of MS was seen in women with 25(OH)D levels <30nmol/L vs. women with levels ≥50nmol/L.
MPR interviewed Dr. John Stoffel to discuss the strategies for diagnosis and management of urinary retention in MS patients, as well as his recommendations for optimal care for these patients.
Delayed-release DMF exerts anti-inflammatory and neuroprotective properties for the treatment of relapsing multiple sclerosis, a disease that often develops in women between the ages of 20 and 40.
The post-hoc analyses found Ocrevus to significantly decrease disease activity and disability progression in patients with RMS and PPMS, as assessed by No Evidence of Progression or Active Disease (NEPAD), a new composite endpoint in MS.
This new software allows patients currently using the electronic BETACONNECT autoinjector to administer Betaseron (interferon beta-1b) to connect their autoinjector to the new myBETAapp through their mobile device or computer.