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.

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.

If ocrelizumab is licensed, the National Institute and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC) will then decide whether to make it available on the NHS.

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.

"MS can be challenging and unpredictable and the 15,000 people in the UK living with primary progressive MS currently have no treatments available to slow the worsening of their condition. Before this treatment is available on the NHS it needs to be licensed by the European Medicines Agency and assessed for cost-effectiveness."

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.

Article: Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis, Xavier Montalban, M.D., Stephen L. Hauser, M.D., Ludwig Kappos, M.D., Douglas L. Arnold, M.D., Amit Bar-Or, M.D., Giancarlo Comi, M.D., Jérôme de Seze, M.D., Gavin Giovannoni, M.D., Hans-Peter Hartung, M.D., Bernhard Hemmer, M.D., Fred Lublin, M.D., Kottil W. Rammohan, M.D., Krzysztof Selmaj, M.D., Anthony Traboulsee, M.D., Annette Sauter, Ph.D., Donna Masterman, M.D., Paulo Fontoura, M.D., Ph.D., Shibeshih Belachew, M.D., Ph.D., Hideki Garren, M.D., Ph.D., Nicole Mairon, M.D., Peter Chin, M.D., and Jerry S. Wolinsky, M.D., for the ORATORIO Clinical Investigators, New England Journal of Medicine, doi: 10.1056/NEJMoa1606468, published 21 December 2016.