The annual ECTRIMS (European Committee for Treatment and Research in Multiple Sclerosis) conference took place during the second week of October. Over 9,000 clinical and scientific MS experts from all regions of the world gathered for four days to exchange current insights on the diagnosis and therapy of MS. Given the diversity of topics and the abundance of presented research results, it is impossible to provide a complete overview of this most important European MS Congress, and the highlighting of individual aspects is always subjectively shaped. However, almost all MS experts agree these days that the data on the effect of Ocrelizumab on relapsing as well as progressive MS, which was publicly presented for the first time, represent a real “highlight” – these results could significantly change MS therapy in the coming years.
Ocrelizumab (more about it in „MS research“) is a monoclonal antibody that targets the surface protein CD20, which is expressed on the surface of B-lymphocytes. B-lymphocytes are an important part of our immune system alongside T-lymphocytes – they play a crucial role both in the production of defensive substances (antibodies) and in the activation of T-lymphocytes. Therefore, they also occupy an important place in the immune events of MS.
The new active ingredient Ocrelizumab recognizes B-lymphocytes and causes their destruction – we speak of a depletion of the B-lymphocytes. We have been applying the concept of B-cell depletion in selected MS patients and patients with Neuromyelitis optica (an autoimmune disease similar to MS that particularly affects the optic nerve and the spinal cord) for several years now using the active ingredient Rituximab (Mabthera®). Rituximab is an older monoclonal antibody and has already served well in the therapy of rheumatoid arthritis – and the experiences with MS have been very promising so far. Ocrelizumab is, so to speak, the pharmacological further development of Rituximab and as such has now also been tested structured for the first time in MS.
The study program (OPERA I + II) compared the effect of Ocrelizumab with that of Rebif 3 x 44 over 2 years in terms of relapse rate, disability progression, and MRI activity. As a result, the administration of Ocrelizumab was highly significantly superior for all endpoints – undoubtedly an excellent study result in terms of effect, which however was not entirely unexpected due to the preliminary studies. Interestingly, Ocrelizumab – despite its invasive mechanism of action – showed a very good safety profile. The study found only very few serious side effects, even fewer than in the interferon group. Given this very interesting combination of high efficacy and good safety profile, the substance is likely to play an important role in the therapy of active MS after its approval (expected in 2016).
The topic of Ocrelizumab was rounded off by the presentation of a study that tested the effect of Ocrelizumab on primary chronic progressive MS (ORATORIO). In relation to the primary endpoint of the study “12 – week confirmed disability progression”, a significant advantage was shown for the treatment arm. ORATORIO is therefore the first study in progressive MS that has produced a positive result for an accepted primary endpoint for an immunomodulating substance. This result also speaks for the considerable potential of this new substance.
It will be exciting to wait for the approval process and to see which “label” the substance receives from the authorities and which role it will be assigned within the framework of German therapy guidelines. Overall, the congress showed a tendency to give greater importance to the activity of the disease in the therapy decision. Especially if there is still activity in the early phase of the disease, this should be suppressed by all available means. Because as long as there are no clear concepts for neuroprotection, a consistent inflammation inhibition seems to be the best concept to prevent long-term damage to those affected. Therefore, how disease activity is defined and which diagnostic tests should be used to determine activity is still of great importance. The development of imaging plays a major role here, but also the inclusion of cognitive performance tests and patient-based information (fatigue, quality of life) is becoming increasingly important.
One thing is certain – and this was also shown by this ECTRIMS conference – the dynamic development in the field of MS research is still tangible and will lead to further interesting developments in the coming years. I am looking forward to an interesting discussion with you in the AMSEL chat tomorrow Tuesday, not only about new developments but also with regard to very practical aspects that you may have noticed in the contributions of this blog.
