An update on the safety of treating relapsing-remitting multiple sclerosis

ABSTRACT

Introduction: In the last 20 years the armamentarium for multiple sclerosis (MS) treatment has been enriched from an increasingly wider variety of new drugs in order to reach a better control of the disease with a better patient compliance.

Areas covered: With this great variety of therapeutic options, physicians may face new and major challenges. The huge amount of data from pilot studies and real-life settings showed that the first-line therapies have a better safety profile. On the other hand, the risks associated with newer drugs, with more selective mechanism of action and targeting specific pathways of MS pathophysiology, are not yet fully established. In particular, real-life use of these advanced drugs has raised important safety issues as long-term effects and potential risks are not yet known and remain to be carefully evaluated.

Expert opinion: No time like the present, the physician faces new and major challenges in order to choose the best available therapy for MS. With the increasing number of drugs for treating MS and the lack of safety data, observational studies and post-marketing surveillance activities are crucial in order to improve the knowledge about the safety profile of these drugs and the therapeutic management in clinical practice settings.

KEYWORDS:

• Multiple sclerosis
• disease-modifying therapies
• drug safety
• drug monitoring

Article highlights

• Treatment of relapsing MS has made great progress over the last years.

• First-line MS therapies exhibit an acceptable long-term safety profile.

• Side effects and potential risks of newer drugs are not fully understood.

• The risk for increased infections and malignancies of the new agents have to be taken seriously into account.

• No time like the present, the physician has to balance risks and benefits in order to choose the best available agent.

This box summarizes the key points contained in the article.

Declaration of interest

CG Chisari received research grants from Sanofi, and travel payment and grants for congress participation from Novartis, Biogen, Genzyme, Almirall, Bayer Schering, Merck Serono, and Teva. F Patti received honoraria for speaking activities by Biogen, Novartis, Teva, Sanofi, Genzyme, Bayer Schering, Merck Serono, Almirall, Roche, and Celgene, and has served as an advisory board member for Bayer Schering, Roche, Biogen, Merck and Novartis. F Patti was funded by Pfizer and FISM for epidemiological studies, and has received grants for congress participation for Biogen, Novartis, Teva, Sanofi Genzyme, Bayer Schering, Merck Serono, Almirall, and Roche. E D’Amico has received speaking and advisory honoraria from Teva and Bayer, and had received travel payment and grants for congress participation from Novartis, Biogen, Roche, Genzyme, Bayer Schering, Merck Serono, and Teva. S Lo Fermo has received honoraria for scientific lectures from Biogen, Merck Serono, and Teva, and travel payment and grants for congress participation from Novartis, Biogen Idec, Genzyme, Almirall, Bayer Schering, Merck Serono and Teva. S Lo Fermo serves on scientific advisory boards for Biogen, Novartis, and Merck Serono. M Zappia has received compensation for consulting services from Boehringer-Ingerheim, Lundbeck and Union Chimique Belge, and scientific grants from AIFA-Agenzia Italiana del Farmaco, Novartis and Lundbeck. M Zappia has received honoraria for scientific lectures from Biogen, Merck Serono, Teva, Novartis, and Sanofi. 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.

Reviewer disclosures

A reviewer on this manuscript has disclosed that they have received speakers honoraria and/or served on advisory boards for Biogen, Merck, Sanofi, Genzyme, and Teva. All other peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper was not funded.