Oral drugs in multiple sclerosis therapy: an overview and a critical appraisal

Abstract

Multiple sclerosis (MS) is characterized by demyelination and axonal loss that results in progressive disability. Recent advances in understanding the immune pathogenesis of MS resulted in the introduction of numerous effective drugs with diverse mechanisms of actions, routes of administration and benefit–risk profiles. New oral drugs recently approved for MS treatment has led to significant achievements in MS management. The oral route of administration promotes patient satisfaction and increases therapeutic compliance; but their introduction has raised concerns regarding safety and tolerability; and a thorough analysis of the benefit/risk ratio is required. This article reviews the mechanisms of action, safety and efficacy of the licensed and experimental oral drugs in MS. Moreover, we put into perspective the disease, drug and patient-related factors that should be taken into account when considering the appropriate oral drug and treatment strategy to the appropriate patient, thus paving the road for personalized medicine in MS.

Keywords:

• escalation therapy
• induction therapy
• multiple sclerosis
• oral drugs
• safety
• therapy

Financial & competing interests disclosure

F Patti has received funding for clinical researches from Biogen Idec, Genzyme, Novartis, Teva, Merck-Serono, Almirall. He has received advisory board fees for all companies reported above. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Key issues

• Oral drugs represent a cornerstone in the new therapeutic area of multiple sclerosis treatment.

• Probably, oral drugs will represent the first choice of multiple sclerosis patients in a shared decision-making scenario.

• So far, few data are available regarding safety of oral drugs.

• Scarce data are available about their safety in pregnancy.

• Long-term follow-up data for efficacy and safety are required.