Merck's multiple sclerotherapy Crabbin releases positive data
Merck's multiple sclerotherapy Crabbin releases positive data
May 03, 2018 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Recently, the latest data published in the journal Multiple Sclerosis showed that Merck's multiple sclerosis treatment drug Mavenclad (Cladharda Tablet) expressed more subgroups of two patients with high-activity relapsing multiple sclerosis. Results with therapeutic potential.
Cladribine is an antimetabolite that consumes lymphocytes by causing DNA strand breaks and interfering with DNA synthesis. Cladribine has been shown to reduce the frequency of MS recurrence and delay disease progression. Mavenclad is the first oral short-term treatment that provides effective efficacy in the control of disease activity in patients with high activity (including disability progression, annual recurrence rate, and MRI activity).
In 2017, the European Commission approved cladribine 10 mg tablets for the treatment of highly active recurrent MS. Clarendab's approval is based on data from more than 10,000 person-years in clinical trials involving more than 2,700 patients and observations for some patients for up to 10 years. Advances in clinical trials included three Phase 3 trials (CLARITY, CLARITY Extension Study and ORACLE MS), a Phase 2 ONWARD study, and long-term follow-up data from a prospective registry study 8 years ago. The road to treatment of multiple sclerosis is very rough. European regulators and the US Food and Drug Administration rejected applications for the drug in 2010 and 2011, respectively.
In this post hoc analysis, two clinically relevant definitions related to high disease activity were selected to effectively identify patients who are more likely to experience disease progression. Patients from the CLARITY High Disease Activity Study were classified by whether they met the following two overlapping criteria, which reflected the criteria contained in the EU SmPC for Maveclad.
The first is high recurrence activity (HRA), which is ≥ 2 relapses in the year prior to enrollment, regardless of whether or not they receive treatment (DMD). The other is high recurrence plus disease treatment (HRA+DAT): ≥1 recurrence and ≥1T1钆 (Gd)+ or ≥9T2 lesions in the year prior to enrollment, and treatment with other DMDs, regardless of DMD treatment Patients who relapsed ≥ 2 times within the previous year. The trials showed that patients with HRA and HRA+DAT showed clinical and MRI responses to Mavenclad that were generally superior or at least comparable to those previously observed in the overall CLARITY study population.
In two subgroups of highly recurrent disease, Mavenclad showed a 82% reduction in the risk of progression of the Disability Status Scale (EDSS) at 6 months after treatment compared with placebo, compared with a 47% reduction in the overall CLARITY study population.
The newly published analysis also assessed the comparison of signs of disease-free activity. The results showed that treatment with Mavenclad was more likely to lead to disease-free activity in the HRA+DAT subgroup, with an odds ratio of 7.82 (95% CI 4.03-15.19, p < 0.0001), the odds ratio for the non-HRA+DAT subgroup was 4.46 (95% CI 3.13-6.26). The HRA subgroup was also more likely to achieve signs of disease-free activity, but no statistically significant differences were observed compared to the non-HRA group.
In the high-risk subgroup of patients treated with Mavenclad, the relative risk of accumulating new T1Gd+ lesions was also lower, and a strong therapeutic effect was observed in each treatment subgroup. Overall, subgroup-specific safety analyses for HRA and HRA+DAT patients did not reveal new safety evidence compared to previous safety outcomes for the overall CLARITY population.
He is a principal investigator in the CLARITY study and Professor Gavin Giovannoni, a professor of neurology at Buzz and the London School of Medicine and Dentistry, said: "This analysis provides the conclusion that Mavenclad is effective in treating multiple sclerosis patients who still have disease progression. The resulting efficacy data show that for highly active multiple sclerosis patients, the use of Mavenclad can further significantly reduce the risk of EDSS progression."
MS is characterized by demyelinating white matter of the central nervous system, mainly caused by T cell-mediated autoimmune diseases, which occur in young adults. The age of onset is 20-40 years old, more common in women, and high disability. The characteristics of high recurrence, some patients showed progressive exacerbations. So far there is no sure cure. (Sina Pharmaceutical Compilation / Fan Dongdong)
Article, image reference source: Merck's MS treatment shows promise in new data
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