番茄社区

Patients with multiple sclerosis (MS) treated with cladribine tablets (Mavenclad) were less likely to experience disease relapse than those who were treated with other oral disease-modifying therapies, real-world data from the GLIMPSE study showed.

Relapse and discontinuation outcomes favored cladribine tablets over oral fingolimod (Gilenya), dimethyl fumarate (Tecfidera), and teriflunomide (Aubagio), reported Helmut Butzkueven, PhD, of Monash University in Melbourne, Australia, at ACTRIMS Forum 2022, the annual meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis.

The findings came from data in the registry, a collection of standardized records of more than 79,000 people with MS around the world.

There are few clinical trials or real-world studies comparing the effectiveness of cladribine tablets to other oral disease-modifying therapies, the researchers noted.

"Many treatment choices that patients and their care teams have to make are not or not yet examined in classical randomized trials," Butzkueven told 番茄社区. "Sophisticated analysis of data gathered systematically and prospectively in clinical care is proving a valuable alternative to examine and compare the outcomes of different treatment choices in all kinds of scenarios."

"Oral agents for use in relapsing MS are very convenient and effective treatment choices," he added. "This work directly compares outcomes for people with MS who chose cladribine tablets versus other oral drugs."

Cladribine, a chemotherapy drug, was approved by the FDA for active secondary progressive disease and relapsing MS in 2019. The FDA's decision was based on results from the phase III clinical trial, which showed that cladribine significantly decreased the number of MS relapses and reduced the progression of disability compared with placebo.

GLIMPSE was a longitudinal study that included data starting in January 2018 for 633 MS patients on cladribine, 1,195 on fingolimod, 912 on dimethyl fumarate, and 735 on teriflunomide.

Patients taking cladribine were propensity-score matched with those taking oral comparators on age, sex, Expanded Disability Status Scale () scores, pre-treatment relapses, prior disease-modifying treatments, and country.

MS patients taking cladribine had an average age of 44, and 76% were women. Their mean disease duration was 12.48 years, and their median EDSS score was 2.5. About 22% were treatment naive. Most patients (87%) had relapsing-remitting MS.

Median follow-up times in the study were between 11 and 13 months. In pairwise comparisons, cladribine versus fingolimod had 520 matched participants per group: the annualized relapse rate (ARR) was 0.09 compared with 0.15, respectively (P=0.02), the hazard ratio (HR) for time to first relapse was 0.60 (95% CI 0.41-0.88, P=0.01), and the HR for time to discontinuation was 0.22 (95% CI 0.14-0.34, P<0.001).

For cladribine versus dimethyl fumarate (450 people per group), the ARR was 0.10 compared with 0.15 (P=0.03), the HR for time to first relapse was 0.58 (95% CI 0.37-0.90, P=0.02), and the HR for time to discontinuation was 0.10 (95% CI 0.06-0.17, P<0.001).

The cladribine versus teriflunomide (458 people per group) comparisons showed the ARR was 0.09 compared with 0.17 (P<0.001), the HR for time to first relapse was 0.33 (95% CI 0.21-0.52, P<0.001), and the HR for time to discontinuation was 0.10 (95% CI 0.06-0.17, P<0.001).

In the GLIMPSE analysis, P values were not adjusted for multiple testing and should be considered nominal, the researchers noted. Future analyses with longer follow-up comparing disability progression events are needed, they added.

Comment