ECTRIMS/EAN Guideline on the pharmacological treatment of people with multiple sclerosis

Abstract

Background and scopeMultiple sclerosis (MS) is an inflammatory-demyelinating disease of the central nervous system (CNS) that is characterized by inflammation, demyelination and degenerative changes. MS usually begins around the age between 20 and 40 years and affects two to three times as many women as men; it also constitutes the most frequent cause of non-traumatic disability in the young adult population. 1 The incidence of MS varies across regions, with rates as high as 8 to 10 new cases per 100,000 in high latitudinal regions. 2,3 Current estimates suggest that over 700,000 people are affected in Europe, with over 2.5 million cases worldwide, 4 which represent a significant burden in terms of impact on quality of life, societal costs and personal expenses. 5,6 Most patients (85%-90%) have a relapsing course from onset that is characterized by relapses and remissions of neurological symptoms Methods: This guideline has been developed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology and following the updated EAN recommendations. Clinical questions were formulated in Patients-Intervention-Comparator-Outcome (PICO) format and outcomes were prioritized. The quality of evidence was rated into four categories according to the risk of bias. The recommendations with assigned strength (strong and weak) were formulated based on the quality of evidence and the risk-benefit balance. Consensus between the panelists was reached by use of the modified nominal group technique. Results: A total of 10 questions were agreed, encompassing treatment efficacy, response criteria, strategies to address suboptimal response and safety concerns and treatment strategies in MS and pregnancy. The guideline takes into account all disease-modifying drugs approved by the European Medicine Agency (EMA) at the time of publication. A total of 21 recommendations were agreed by the guideline working group after three rounds of consensus. Conclusion:The present guideline will enable homogeneity of treatment decisions across Europe. associated with areas of CNS inflammation, and over the course of two decades, more than half of untreated patients transition to a phase of gradual worsening independent of acute attacks. 7,8 Progressive forms of MS can be present as the initial disease course (primary-progressive MS) in approximately 10%-15% of patients. 9,10 There is no curative treatment available for MS, and the current therapeutic strategy is aimed at reducing the risk of relapses and potentially disability progression. The treatment era for MS began in 1993, when the first interferon became available, and recent years have seen a large expansion in the therapeutic options for MS, with 11 disease-modifying therapies (DMTs) approved by the European Medicine Agency (EMA) in both injectable and oral formulations by the beginning of 2017. 11 The growing armamentarium of therapies brings new opportunities for individualized therapy where patients and providers must balance considerations around efficacy,...

The efficacy and safety of fingolimod in patients with relapsing multiple sclerosis: A meta‐analysis

“…Multiple sclerosis (MS) is a chronic disease that affects the central nervous system and is characterized by inflammation, demyelination and degenerative changes. [1][2][3] Relapsing-remitting MS (RRMS) is the most common disease course and characterized by clearly defined attacks of new or increasing neurological symptoms. Relapses are followed by periods of partial or complete recovery.…”

Real-World Treatment of Patients with Multiple Sclerosis per MS Subtype and Associated Healthcare Resource Use: An Analysis Based on 13,333 Patients in Germany

“…MS symptoms should be treated with appropriate medicinal/nonmedicinal therapies. To date, there is only one (recently) approved and recommended immunomodulatory treatment available for PPMS [10,11]. Beyond that, patients should receive symptomatic treatment in the manner of best supportive care (BSC) [2,5,6].…”

Recommendations from the Expert Meeting «Secondary progressive multiple sclerosis: unresolved issues and prospects»

“…В исследовании ИНФβ-1а в дозе 44 мкг при ВПРС также продемонстрирована эффективность только у пациентов с сохраняющейся клинической или радиологической воспалительной активностью заболевания [12]. На основании полученных результатов препараты высокодозных интерферонов бета включены в клинические рекомендации для лечения только пациентов с ВПРС, протекающим с обострениями [13,14]. Исследования эффективности финголимода при ППРС и натализумаба при ВПРС также не доказали влияния этих препаратов на прогрессирование инвалидизации [15,16].…”