Highly active MS and specific treatment

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Highly active MS and specific treatment

Post by frodo » Tue Jun 30, 2020 12:37 am

It is not an official but regulatory agencies considered the highly active MS (HAMS) separated from the rest in their approval processes for cladribine/mavenclad (https://www.merckgroup.com/en/news/mave ... -2017.html)

Now is the same for Russia



Currently, special attention is paid to timely treatment for active forms of multiple sclerosis (MS), especially for highly active MS (HAMS), in which there are ≥2 exacerbations and corresponding activity signs that are detected by magnetic resonance imaging (MRI) regardless of previous therapy with MS-modifying drugs (MSMDs) or there is ≥1 exacerbation and corresponding activity signs revealed by MRI during therapy with other MSMDs.

A group of expert neurologists from various clinics in Russia, who actively participate in the clinical trials of cladribine tablets in MS, presents a consensus on the practical aspects of using the tablets of cladribine registered in Russia in March 2020 for the treatment of patients with HAMS.

The paper mentions the groups of patients in whom the drug, an examination before starting a therapy cycle, routes of administration, and dose, and a monitoring scheme during and after treatment cycles are indicated. This drug acts on the principle of selective immunoreconstitution and may occupy an important place in the treatment of HAMS.

And also an international panel has approved the definition for HAMS

https://journals.sagepub.com/doi/10.117 ... 6420935019


A steering committee (SC) of nine international MS experts led the programme and developed 11 clinical questions concerning the practical use of cladribine tablets. Statements to address each question were drafted using available evidence, expert experiences and perspectives from the SC and an extended faculty of 33 MS experts, representing 19 countries. Consensus on recommendations was achieved when ⩾75% of respondents expressed an agreement score of 7–9, on a 9-point scale.


In order to address some of the unanswered questions relating to the use of cladribine tablets, we describe a consensus-based programme led by international MS experts with the aim of providing practical recommendations to support its use in real-life clinical practice. The questions focussed on six topics:

The definition of highly active disease;

The patterns of treatment response in patients treated with cladribine tablets;

Management of patients with evidence of disease activity while being treated with cladribine tablets;

Infection risk and immune function in patients being treated with cladribine tablets;

Management of pregnancy planning and malignancy risk in patients being treated with cladribine tablets;

Treatment switching to and from cladribine tablets and monitoring considerations.

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