Title:Safety and Monitoring of the Treatment with Disease-Modifying Therapies
(DMTs) for Multiple Sclerosis (MS)
Volume: 18
Issue: 1
Author(s): Vasileios-Periklis Stamatellos and Georgios Papazisis*
Affiliation:
- Clinical Trials
Unit, Special Unit for Biomedical Research and Education & Department of Clinical Pharmacology School of Medicine,
Faculty of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece
Keywords:
Disease-modifying treatments, multiple sclerosis, adverse events, safety, monitoring, DMT, DMAMS.
Abstract:
Background: Disease-Modifying Therapies (DMTs) for Multiple Sclerosis (MS) are widely
used given their proven efficacy in the relapsing form of the disease, while recently, Siponimod and
Ocrelizumab have been approved for the progressive forms of the disease. Currently, 22 diseasemodifying
drugs are approved by the FDA, while in 2012, only nine were present in the market. From
March 2019 until August 2020, six new drugs were approved. This rapid development of new DMTs
highlighted the need to update our knowledge about their short and long-term safety.
Objective: This review summarizes the available safety data for all the Disease-Modifying Therapies
for Multiple Sclerosis and presents the monitoring plan before and during the treatment.
Methods: A literature search was conducted using PUBMED and COCHRANE databases. Key journals
and abstracts from major annual meetings of Neurology, references of relevant reviews, and relative
articles were also manually searched. We prioritized systematic reviews, large randomized controlled
trials (RCTs), prospective cohort studies, and other observational studies. Special attention was
paid to guidelines and papers focusing on the safety and monitoring of DMTs.
Conclusion: Data for oral (Sphingosine 1-phosphate (S1P) receptor modulators, Fumarates, Teriflunomide,
Cladribine), injectables (Interferons, Glatiramer acetate, Ofatumumab), and infusion therapies
(Natalizumab, Ocrelizumab, Alemtuzumab) are presented.
