The news has been known since 01.12.2014, but it is still so fresh that it is worth picking up. It is known that the therapy of relapsing MS has received numerous innovations in recent years, but there are still no reasonable drug approaches for the treatment of primary chronic progressive MS. Although attempts have been made over the past few years to treat this particular subtype of MS with medication, most recently with Copaxone and also with Rituximab – all these studies were, apart from a few interesting aspects from certain subgroup analyses, negative. Just to define again: Primary chronic progressive MS (PPMS) is characterized by a course entirely without relapses. Typically, those affected complain from the beginning of a slowly increasing paralysis of the lower extremity over several years. The MRI findings are often not as pronounced as the usually quite clear clinical manifestation and often focus on the spinal cord. The disease usually only starts around the age of 40 and affects women and men equally. This clearly differentiates it from classic MS, which is why it is often discussed whether it might be a “different” disease. However, as there are families in which MS patients suffer from both classic MS and PPMS, the current view tends to see it as a special subtype rather than a separate disease. About 10% of MS patients suffer from PPMS.
PPMS must be clearly distinguished from the secondary chronic progressive course (SPMS). An SPMS develops in 20-30 percent of patients after 10 – 15 years from relapsing MS – i.e. the course of these patients also starts with relapses. However, these then recede into the background in the SPMS phase and the course is characterized by a slowly creeping deterioration.
In the INFORMS study, the effect of Fingolimod on PPMS was compared with placebo over 3 years. Since Fingolimod (1) has shown quite promising data in its approval studies for relapsing MS in preventing brain atrophy in MS and (2) as a small molecule also enters the CNS, there was justified hope that its use would lead to a modulation of PPMS. Unfortunately, the manufacturer of Fingolimod announced in a brief press release last December that the primary endpoint of the study, namely the delay in disability progression, was not achieved. This is unfortunately not good news for all patients with such a course of disease. It is now eagerly awaited what the data looks like and whether certain groups can be identified who have benefited from the medication. These results will be presented for the first time in April at the meeting of the American Academy of Neurology. I will definitely report on it.
