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Recent Studies Use Annualized Relapse Rate to Assess Treatments for MS

Alison Rodriguez
A recent study evaluated the annualized relapse rate of patients with relapsing multiple sclerosis (MS) who were treated with ozanimod—an oral once-daily immunomodulator that selectively targets sphingosine 1-phosphate receptors 1 and 5—in the RADIANCE Part B study. 
A recent study evaluated the annualized relapse rate (ARR) of patients with relapsing multiple sclerosis (MS) who were treated with ozanimod—an oral once-daily immunomodulator that selectively targets sphingosine 1-phosphate receptors 1 and 5—in the RADIANCE Part B study. 

The study assessed ARR by prespecified baseline subgroups that included prior disease-modifying treatment (DMT) status, Expanded Disability Status Scale (EDSS) score, sex, age, and presence of GdE lesions. The patients with relapsing MS in the RADIANCE Part B trial had received ozanimod HCI 1 or 0.5 mg versus interferon (IFN) β-1a 30 mcg for 24 months.

Of the 1313 patients, over 24 months, ARR was significantly reduced for both doses of ozanimod compared with IFN β-1a. ARR was found to be lower with ozanimod for both doses when compared with IFN β-1a among DMT-naïve patients. ARR was also lower for both doses of ozanimod than for IFN β-1a in patients with baseline EDSS scores of 3.5 or less. 

“Ozanimod had significantly lower ARR than IFN for both doses; in addition, ozanimod showed reduced ARR across a broad range of subgroups, with 1 mg generally having better rate ratios than 0.5 mg, supporting the potential of ozanimod as an effective oral treatment in a broad spectrum of patients with RMS,” concluded the study.

In another study, researchers used data from the CARE-MS I trial to analyze the efficacy and safety outcomes over 7 years in alemtuzumab-treated patients. The CARE-MS I trial found that alemtuzumab significantly improved clinical and magnetic resonance imaging outcomes versus subcutaneous IFN β-1a over 2 years in treatment-naïve patients with relapsing-remitting MS (RRMS).

The researchers assessed for ARR, EDSS scores, 6-month confirmed disability worsening (CDW), 6-month confirmed disability improvement (CDI), no evidence of disease activity, and adverse events (AEs).

Of the 299 patients who completed TOPAZ Y1 (the extension of the evaluation of the CARE-MS I trial), 59% received neither alemtuzumab retreatment nor other DMT after the initial 2 courses. ARR was found to remain low, as 60% were relapse-free in years 3 to 7. 

Additionally, the stable/improved EDSS scores versus baseline remained high at year 7 and the mean change in EDSS score from baseline to year 7 was 0.09. The researchers found that at year 7, 74% were 6-month CDW-free and 37% achieved 6-month CDI. Also, the incidence of AEs decreased over time, according to the study.

“Alemtuzumab efficacy was maintained for 7 [years] in treatment-naive patients, despite 59% receiving no additional treatment since the initial 2 courses. Alemtuzumab safety profile remained consistent,” concluded the study. “Alemtuzumab provides a unique treatment approach for RRMS patients, offering durable efficacy without continuous treatment.”

 
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