Studies presented at MS conference show mixed results

October 21, 2016 Pavle Repovic, MD, PhD

The annual meeting of the European Committee on Treatment and Research in Multiple Sclerosis, the largest scientific conference dedicated to MS, took place in September in London. Here are some of the highlights from more than 1,500 topics presented.

Results presented of study of injectable therapies

In the early 2000s, the advisory committee to the British health care system questioned the long-term benefits of treatment with injectable MS therapies. Together with the manufacturers of these therapies (interferons and Copaxone), the committee devised the Risk-Sharing Scheme, a 10-year, real-world trial to examine this question. It was a massive undertaking.

Thousands of MS patients in the United Kingdom who started treatment with injectable therapies were enrolled. Importantly, these patients were on average nine years into their diagnosis of MS – an important distinction from our approach in the U.S., where we treat MS much earlier.

Compared to historical, untreated patients from 1980s (when no MS treatments were available), the Risk-Sharing Scheme found that the injectable therapies worked modestly. They slowed the progression of disability, albeit modestly, and decreased health care costs (both health care and medication costs are different in the UK). The most surprising finding was that all of the benefits of these medications, while long-lasting, accrued in the first few years of treatment.

Siponimod succeeds in delaying disability

Secondary progressive MS (SPMS) develops in some patients initially diagnosed with relapsing-remitting MS. SPMS patients may exhibit a gradual progression with or without superimposed relapses. In a large Phase III trial, Siponimod, a novel therapeutic agent related to an existing medication, Gilenya, reduced the progression of disability among SPMS patients by 21 percent compared to patients who took a placebo. This finding was a pleasant surprise to all, given that Gilenya did not show similar benefits in a trial involving patients with primary progressive MS.

Sodium channel blocker did not improve recovery from optic neuritis

In a trial with 48 patients conducted in the UK, patients with acute (recent) optic neuritis treated for five months with the sodium-blocking medication amiloride showed no benefit compared to patients who took a placebo. The authors suggested that the delay in treatment, an average 15 days after the onset of optic neuritis, may have missed the window of opportunity. It was also concerning that one of the vision measures, visual evoked potentials (which assesses the visual pathway of the eye along the optic nerve to the brain), was actually worse in the amiloride group.

Anti-LINGO remyelination treatment did not succeed in Phase II trial

Opicinumab, an anti-LINGO antibody medication, has been shown to promote remyelination, the restoration of nerve function, in animal models of MS, but it failed to do so in a Phase II clinical trial. Dr. Peiqing Qian, a neurologist at the MS Center at Swedish, was among the investigators.

In a previous study, opicinumab led to some improvements, compared to a placebo, in recovery from optic neuritis, which can cause pain and temporary vision loss. In this latest trial, patients with MS were treated weekly with interferon plus a placebo, or interferon and anti-LINGO. Four different doses of anti-LINGO were used, but no improvement in disability was documented.

Although the trial was not successful, subgroup analyses suggested that there may be some benefit for younger patients who have had MS for a shorter time. It is not clear at this point whether this is the end of the road for anti-LINGO, or if additional studies will be planned.

Vitamin D supplements and MS activity

A fairly large randomized, double-blind, placebo-controlled Phase II study examined the effect of supplementing interferon-beta (Rebif) with vitamin D3. Over 48 weeks, 116 MS patients received only Rebif, while 113 patients received Rebif and vitamin D3.

The relapse rates and disability progression were no different between the groups. However, there was evidence that patients taking vitamin D had less MRI activity.

A possible confounding factor that was not presented was the existing levels of vitamin D in the patients in both groups prior to the study.

The MS Center at Swedish currently has 33 active research studies. Patients interested in learning more about them can contact the research department at 206-320-2647.

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