Publication of ocrelizumab trials: hope for progressive MS
Published date: 22 Dec 2016 at 8:25AM
Ocrelizumab can slow progression of MS. This is according to the newly published results of its phase 3 trials.
It is the first treatment that can slow the advancement of primary progressive MS. It can also treat relapsing MS.
The full results of three final stage clinical trials were published in the New England Journal of Medicine today.
Treating primary progressive MS
In a phase 3 trial, ocrelizumab reduced the MS progression by 25% in people with primary progressive MS. This was compared with a placebo over the course of two years.
Scientists focused on symptoms defined in the Expanded Disability Status Scale. These include problems with walking, thinking and swallowing.
The team also found that treatment with ocrelizumab decreased the total volume of brain lesions seen on MRI, whereas lesion volume increased in those treated with placebo.
What about relapsing MS?
For relapsing MS, ocrelizumab stopped all MS symptoms in 50% of people taking the treatment for just under two years. This was assessed by measuring relapses, MRI activity and disability progression.
In comparison, beta interferons stopped these symptoms in only 25-30% of people.
Over 1,600 people with relapsing MS were involved in the two phase 3 trials.
What happens next?
Ocrelizumab is currently being reviewed for licensing in Europe as a treatment for both primary progressive and relapsing MS. Its long term safety profile will need to be investigated, in further trials and in the real world.
We expect a decision to be announced by the European Medicines Agency (EMA) in late 2017.
This decision will be based on how cost effective the treatment is. NICE will look at both the price and how much it can help people. Ocrelizumab is also being considered for licensing by the US Food and Drug Administration in the USA.
A first in MS treatments
Dr Aisling McMahon, our Head of Clinical Trials at the MS Society said:
"This is really big news for people with the primary progressive form of multiple sclerosis. It’s the first time a treatment has shown the potential to reduce disability progression for this type of MS, which offers a lot of hope for the future."
More study needed
While these results are very encouraging, we have to note that the treatment may not be of benefit to everyone. The primary progressive MS trial included younger patients, and people who showed evidence of inflammatory disease.
More study is needed but it’s possible that ocrelizumab will not be effective in the later stages of the condition. More guidance may be provided if and when the drug is licensed as a treatment for MS.