New treatment for multiple sclerosis has promising initial results

Tuesday November 27 2018

"Hope for multiple sclerosis patients as scientists discover attacking the glandular fever virus can combat symptoms," reports the Mail Online.

This virus – called the Epstein-Barr virus (EBV) – "is found in almost all people with multiple sclerosis and has long been thought to cause it," explains the news site.

Multiple sclerosis (MS) is an autoimmune condition where the immune system for some reason attacks the brain or spinal cord of the nervous system.

This can trigger a wide range of symptoms, including problems with vision, numbness and tingling, muscle spasms and mobility problems.

The news comes from a study that looked at a new treatment being developed for MS that involves extracting a sample of a specific type of the patient's own immune cells, called T-cells.

The T-cells are "trained" (in a laboratory) to target and kill EBV cells. They're then introduced back into the patient's bloodstream.

The study treated 13 people who either had primary or secondary progressive MS.

Researchers found patients tolerated the treatment well, with only 1 person experiencing side effects thought to be associated with the treatment (an altered sense of taste).

Seven of the 10 participants who completed treatment either reported or showed measurable improvements in symptoms.

This research suggests that the new treatment has some promise. But it's still at an early stage.

Larger studies will be needed to determine the most effective dose for the treatment and how it compares with a "dummy" treatment and existing treatments.

These sorts of trials are being planned.

Where did the story come from?

The study was carried out by researchers from the University of Queensland and other research centres and hospitals in Australia, as well as Atara Biotherapeutics, the biotech company developing the new treatment.

The authors declared various potential conflicts of interests, mainly relating to having done consulting or being on advisory boards for various pharmaceutical companies, including Atara Biotherapeutics.

It was funded by MS Queensland, MS Research Australia, Perpetual Trustee Company Ltd and private individuals (who wished to remain anonymous).

The study was published in the peer-reviewed journal JCI Insight and is free to read online.

The Mail Online reported the study accurately, noting that it was small and larger placebo-controlled studies are being planned.

What kind of research was this?

This was a phase I uncontrolled trial looking at the effects of a new treatment for MS in a small group of patients.

This type of trial is the first stage of testing in people, where researchers want to make sure a new treatment is safe before it's tested on larger numbers of patients.

Researchers can also see if the treatment appears to be having a positive effect on the disease.

We don't fully understand what causes MS. It's likely that a number of factors play a role, including a person's genetics, history of infections and lifestyle factors such as smoking.

The new treatment being tested attacks the Epstein-Barr virus (EBV). This virus is very common (more than 90% of the population get infected with it at some point) and causes glandular fever in some of these people.

The virus can lie dormant within a type of immune system cell called B-cells.

The virus has been linked to an increased risk of developing MS (it's thought to trigger the immune system). This is why the researchers targeted the EBV virus with their new treatment.

The treatment involves extracting a sample of 1 type of immune system cell – T-cells – from the patient's blood. These T-cells are then treated in a way that trains them to attack B-cells infected with EBV.

Once enough of these cells have been collected, they're injected back into the patient's bloodstream.

The researchers had previously tried their treatment on 1 patient, and now wanted to try it on more patients.

If the findings from phase I studies are good, the drug is tested in larger studies that look at what dose works best and how well it compares with "dummy" placebo treatment or existing treatments.

These studies make sure that any improvements seen are down to the treatment, and not just patients improving over time. They also make sure the treatments are safe enough to be used more widely.

What did the research involve?

The researchers enrolled 13 adult patients who'd had MS for at least 2 years (range 3 to 27 years), and gave them the new treatment while monitoring them closely for any side effects.

They also measured the patients' symptoms and how their nervous systems were functioning to see if the treatment seemed to be working.

The patients in this study had a difficult-to-treat type of MS: either primary or secondary progressive MS.

The most common form of MS is relapsing-remitting MS, where people have symptom-free periods called remissions.

Eventually, most people with this form of the condition get steadily worse, developing secondary progressive MS.

In primary progressive MS, the disease gradually gets worse from the start, with no periods of improvement.

The researchers were able to successfully grow enough EBV-targeting T-cells in the lab for 11 out of the 13 patients.

One patient left the trial as they developed a malignant condition, so 10 people were given a weekly infusion of these T-cells into their bloodstream for 4 weeks, with the dose increasing each time.

The researchers monitored the participants for any adverse effects, as well as their level of tiredness (fatigue) and other MS-related symptoms over 27 weeks.

They also looked at the level of MS-related damage that could be seen in their brain and spinal cord on MRI scans.

What were the basic results?

There were no serious adverse events during the trial. One patient experienced an altered sense of taste thought to be caused by the treatment.

This patient also experienced some nausea, dizziness and insomnia, which were possibly related to the treatment.

Seven of the 10 patients who completed treatment reported an improvement in symptoms like fatigue, balance, concentration, sleep and distance that could be walked without support.

In 6 of the patients, this included improvements in objectively measured outcomes, such as vision or disability score.

These improvements started between 2 and 14 weeks after the first infusion of the T-cells.

One patient reported an improvement in symptoms, but there was no obvious improvement in their MRI results.

The researchers found patients whose T-cells showed a stronger ability to attack EBV-infected cells were more likely to improve with the treatment than those whose T-cells showed a weaker response.

How did the researchers interpret the results?

The researchers concluded that their new T-cell-based treatment was well tolerated, and that further trials are needed to look at how effective the treatment is.

They also said their findings support the theory that EBV plays a role in MS.

Conclusion

This early study shows some promise for this new T-cell-based treatment.

This treatment has been used in people with primary or secondary progressive MS.

These forms of the condition are hard to treat, so new treatments would be very welcome.

This first stage of testing is largely about making sure the treatment is safe enough to allow further studies to be carried out in more people.

Later stages of testing will need to confirm the improvements seen in symptoms.

The company that manufactures the treatment is now said to be planning the next stage of research.

Analysis by Bazian
Edited by NHS Website