An additional analysis of data from the CLARITY study confirmed the long-term benefits of treatment with Mavenclad (cladribine tablets) for patients with highly active relapsing forms of multiple sclerosis (MS).
The post-hoc analysis, “Efficacy of Cladribine Tablets in high disease activity subgroups of patients with relapsing multiple sclerosis: A post hoc analysis of the CLARITY study,” was published in the Multiple Sclerosis Journal.
The safety and effectiveness of the therapy was evaluated in several Phase 2 and 3 trials and extension studies, which involved more than 2,700 relapsing MS patients, some of whom were followed for more than 10 years.
To further evaluate the effectiveness of Mavenclad, researchers reanalyzed data from the Phase 3 CLARITY trial (NCT00213135) in patients with high disease activity. They included all patients whose condition fulfilled one of two clinically relevant definitions of high disease activity, which are commonly linked to poorer treatment response.
One group included all patients who had two or more relapses during the year prior to study entry, regardless of treatment status — the high relapse activity (HRA) group. The second group included patients who had one or more relapses and evidence of disease progression (increased number of brain lesions) during the year prior to study entry while on treatment, plus patients with HRA — high relapse activity plus disease activity on treatment (HRA+DAT).
Collectively, the post-hoc analysis included 289 MS patients who participated in the CLARITY trial. Of those who met the HRA+DAT criteria, 149 received placebo during the study and 140 were treated with 3.5 mg/kg of Mavenclad.
HRA and HRA+DAT patients showed increased rates of disease activity, as demonstrated by higher relapse rates, reduced time to first relapse, and worse disability scores, as measured by the expanded disability status scale (EDSS), compared with the overall MS population of the study.
Previous results of the CLARITY trial covering all 870 MS patients who participated revealed that treatment with 3.5 mg/kg of Mavenclad reduced the risk of six-month confirmed EDSS progression by 47%, compared with placebo.
We are sorry that this post was not useful for you!
Let us improve this post!
Tell us how we can improve this post?