New treatment guidelines for multiple sclerosis (MS) patients in Europe were set in place through an initiative undertaken by the European Academy of Neurology (EAN) and the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
Launched in parallel to the 4th Congress of the European Academy of Neurology (EAN) that recently concluded in Lisbon, the effort brought together neurologists from 13 countries who established 21 recommendations for MS treatment.
It was prompted by the recent approval of Mavenclad (cladribine) and Ocrevus (ocrelizumab) by the European Medicines Agency (EMA), opening new treatment options to patients with relapsing MS and — for a first time — those with primary progressive disease (PPMS).
The European guidelines, published in the Multiple Sclerosis Journal in January, are based on data from clinical studies, and were setup to help physicians in weighing the risks and benefits of each treatment available.
“This new guideline is part of the EAN guideline program under which all important neurological diseases are to be reappraised. About 20 of the guidelines are currently being worked on,” Günther Deuschl, MD, a professor at Kiel University in Germany and president of the EAN, said in a press release.
“These efforts,” he added, aim to provide “important principles not only to medical practitioners but also for health care policy.”
Mavenclad was developed by Merck KGaA, known as EMD Serono in the U.S. and Canada, to treat relapsing MS. It is currently available to treat MS patients in Argentina, Canada, Australia, Israel, Europe, and United Arab Emirates, and the company is seeking approval in the United States.
The treatment is designed to target immune T- and B-cells that trigger relapsing MS without suppressing the entire immune system. With a maximum of 20 days of treatment over two years, the oral drug has shown the potential to help patients remain relapse-free for up to four years while working to “reset” the immune system.
Despite its demonstrated potential, however, it is not yet clear how successfully, or for how long, the treatment can sustain low MS activity, the release states. Further experience with it over the long term is still needed to fully understand its safety profile.
This treatment targets immune B-cells that contribute for MS progression. Following an initial administration of Ocrevus, additional infusions are required every six months to ensure low disease activity. More long-term studies are also warranted to fully recognize Ocrevus’ safety and efficacy profiles, the release states.
“MS treatment today is focused on avoiding relapses to the greatest possible extent and to halt the progression of disability. However, some of these drugs may also cause dangerous side effects which have to be considered when counseling our patients,” said Franz Fazekas, MD, a professor at the Medical University of Graz in Austria and EAN president-elect.
“The possibility to choose among many drugs allows neurologists to adapt MS treatment to the individual needs of their patients and along the course of their disease. MS diagnosis means that patients have to live with the condition for 60 or 70 years, so we have to help them to control MS as efficiently as possible considering both benefits and risks,” Fazekas concluded.