Last week, the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) took place in Stockholm. ECTRIMS is the world’s largest and most significant conference on Multiple Sclerosis – therefore, a look at this year’s content is naturally worthwhile.
Given the more than 1,500 submitted works, my selection is understandably limited and subjective – therefore, feel free to take a look at the congress homepage and get an idea of the current activities in MS research (https://www.ectrims-congress.eu/2019.html).
From my point of view, the presentation of the study data from the ASCLEPIOS I and II studies was a very important point. These studies tested the efficacy and safety of the monoclonal antibody Ofatumumab compared to Teriflunomide (Aubagio). Ofatumumab is an antibody that, similar to Ocrelizumab (Ocrevus), is directed against the surface antigen CD20 and leads to the depletion of B cells in peripheral blood. Unlike Ocrelizumab, this antibody is administered subcutaneously at monthly intervals and is therefore also suitable for home use – it is ultimately easier to handle logistically.
The currently presented results on efficacy are quite impressive – compared to Teriflunomide (Aubagio – i.e., an already approved and established MS drug), Ofatumumab reduces the annual relapse rate by more than 50% and the progression of disability (confirmed after 3 or 6 months) is significantly reduced. Also interesting is the significant reduction of the biomarker NfL (Neurofilament light) detectable after just 3 months, which is considered a promising marker for neurodegeneration in MS.
From my point of view, the most impressive are – as already seen in studies on other B-cell depleting therapies – the MRI data. Compared to Teriflunomide, which has already shown a significant reduction in inflammatory activity in MRI in its approval studies, for example, Gadolinium-enhancing MRI lesions are reduced by more than 90% – this corresponds to an almost complete prevention of contrast agent-absorbing foci during the study period.
As far as safety data is concerned, both the ASCLEPIOS I and ASCLEPIOS II studies are characterized by a low dropout rate – the drugs were generally well tolerated. Understandably, more injection-related side effects were found in the Ofatumumab group, while Teriflunomide patients suffered more from diarrhea and hair thinning, the typical Teriflunomide side effects. Serious side effects were equally distributed in both treatment groups. Particularly for tumor diseases, no relevant safety signal was identified.
With Ofatumumab, there will soon be another efficient therapy for relapsing-remitting MS available, once again highlighting the very good effect of B-cell depleting therapies. The fact that this therapy can be applied with 20 mg s.c. every four weeks and the injection side effects are essentially limited to the first administration, will mean that this effective concept can be carried out soon with less logistical effort and will therefore gain more importance away from large MS centers.
