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Pressing DMT questions, concerns? International MS group answers them in detailed report

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  • Pressing DMT questions, concerns? International MS group answers them in detailed report

    This is a big read, but this consortium breaks it all down with recommendations and advice on MS disease modifying therapies. Covers people currently on therapy, off therapy, and the full range of MS (relapsing and progressive). -D

    Ther Adv Neurol Disord. 2021; 14: 17562864211039648.
    Published online 2021 Aug 18. doi: 10.1177/17562864211039648

    Multiple Sclerosis Therapy Consensus Group (MSTCG): position statement on disease-modifying therapies for multiple sclerosis (white paper)

    Heinz Wiendl, Ralf Gold, et al


    Multiple sclerosis is a complex, autoimmune-mediated disease of the central nervous system characterized by inflammatory demyelination and axonal/neuronal damage. The approval of various disease-modifying therapies and our increased understanding of disease mechanisms and evolution in recent years have significantly changed the prognosis and course of the disease. This update of the Multiple Sclerosis Therapy Consensus Group treatment recommendation focuses on the most important recommendations for disease-modifying therapies of multiple sclerosis in 2021. Our recommendations are based on current scientific evidence and apply to those medications approved in wide parts of Europe, particularly German-speaking countries (Germany, Austria, and Switzerland).

    Essential facts at a glance

    Multiple sclerosis (MS) is a complex, most likely autoimmune-mediated inflammatory neurodegenerative disease of the central nervous system (CNS), characterized by inflammatory demyelination and axonal/neuronal damage. In Germany, an estimated 250,000 people suffer from MS. In recent years, the approval of various therapies has significantly changed the course and prognosis of the disease. This position statement (white paper) by members of the KKNMS (Competence Network Multiple Sclerosis), members of the BDN (Association of German Neurologists), members of the DGN (German Society of Neurology), and members of the Austrian and Swiss neurological societies describes – based on available evidence – crucial issues and current status of disease-modifying pharmacological therapies for people with MS.

    Currently, the distinction between relapsing MS (RMS), relapsing-remitting MS (RRMS), primary progressive MS (PPMS), and secondary progressive MS (SPMS) is still the pre-dominant description in regulatory documents. Whereas clinical classification of MS into (1) relapsing and (2) progressive forms, each of which can progress with and without activity [measured both clinically and with magnetic resonance imaging (MRI)], is much closer to clinical reality and better matches the underlying pathobiology.

    Data from real-world cohort and registry studies gathered in recent years reveal, first, an early therapeutic intervention yields long-term benefits, and second, for patients with disease activity, early treatment with a high-efficacy therapy may have advantages over an escalation approach that favors lower-efficacy therapies for initial treatment.

    Presently, two treatment approaches/schools of thought dominate the selection of optimal therapy for (highly) active MS. Both strategies are based on evaluating the individual patient’s risk of further MS progression and considering the risk versus efficacy of the specific disease-modifying therapies (DMTs).
    1. According to the escalation approach, lower-efficacy therapies with a known and relatively safe risk profile are selected for initial treatment. If – despite sufficiently long and regular treatment – disease activity persists/recurs, treatment is escalated to a more potent therapy option.
    2. Alternatively, treatment can be initiated with a high-efficacy DMT already at the time of diagnosis, for example, with alemtuzumab, cladribine, natalizumab, ocrelizumab, ofatumumab, or S1P modulators (fingolimod, ozanimod, ponesimod).
    Data from observational studies suggest that initial treatment with a high-efficacy DMT may be associated with a lower risk of conversion to SPMS in patients with disease activity.

    When starting or switching treatment, it is essential to continuously monitor patients, including a thorough neurological examination and MRI of the brain at regular intervals.

    It is advisable to take a ‘de-risking approach’ and perform a complete laboratory and vaccination status check (currently obligatory for several therapies but not for all) before starting a DMT.

    Furthermore, crucial questions regarding the management of MS patients in the COVID pandemic have recently sprung up. In this context, it is necessary to point out that (1) according to current data, MS patients do not per se have an increased risk for SARS-CoV-2 infection or a severe course of the disease, while a higher degree of disability due to MS can nevertheless increase the risk for severe COVID-19; (2) the principles behind DMTs and their application are not fundamentally changed by the pandemic; and (3) MS patients are recommended to be vaccinated.

    For further guidance on treatment effects and side effects of each drug and information on necessary examinations and laboratory controls before therapy initiation or switch, we refer to the descriptions in the summary of product characteristics (SmPC) of the respective medicines.

    Dave Bexfield