MS News that Caught My Eye Last Week: PML Treatment, Gilenya for Kids, Rituximab, and an MS trial that is Enrolling

Complications from Gilenya Treatment Managed Successfully, Case Report Says

This wasn’t a minor complication. It was a version of PML, a brain disease that can be fatal. PML is also a known side effect of Tysabri, so the report of a successful treatment should be important to thousands of MS patients who are being treated with either of those medications.

A case study reported the successful management of a multiple sclerosis (MS) patient who developed a rare condition in the brain — progressive multifocal leukoencephalopathy (PML) — due to treatment with Novartis Pharmaceutical’s Gilenya (fingolimod).

The study, titled “Fingolimod-associated PML with mild IRIS in MS: A clinicopathologic study,” was published in the journal Neurology Neuroimmunology & Neuroinflammation.

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Gilenya Approved by FDA as First DMT for Children, Ages 10 and Older, with Relapsing MS

It’s about time. Finally, the approval of a medication to treat pediatric-onset MS is here. The number of youngsters who are 10 to 17 and have MS isn’t large, but these young people are just getting started with their lives. It’s time they had a potent medication that might stop their MS progression in its tracks.

Gilenya (fingolimod) has become the first disease-modifying therapy approved by the U.S. Food and Drug Administration (FDA) to treat children and adolescents with relapsing forms of multiple sclerosis (MS).

This expanded approval allows Gilenya, previously indicated for adults patients 18 or older, to be used to treat pediatric relapsing MS patients starting at age 10.

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Rituximab Seen as Effective and Generally Safe RRMS and PMS Treatment in Study

Rituximab isn’t an approved MS treatment in the United States. It is approved for MS use in Europe and elsewhere, but not in America. The medication is sold in the U.S. as Rituxan, but it’s only approved as a cancer treatment. To use it for MS, neurologists in the U.S. need to prescribe it “off-label.” Here’s another study that suggests it’s time for the FDA to approve it.

Rituximab is generally safe and effective in treating multiple sclerosis — with comparable effectiveness to Tysabri (natalizumab) in people with relapsing-remitting forms of the disease, a Swiss study reports.

But patients using this therapy can develop recurrent infections, its researchers noted, and doctors should be vigilant.

The observational study, “Effectiveness and safety of Rituximab in multiple sclerosis: an observational study from Southern Switzerland,” was published in the journal PLOS One.

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Impact of Early Aggressive vs. Standard Therapy on Disability in RRMS To Be Tested in Trial

Interested in enrolling in an MS study? Doctors at Johns Hopkins University are looking for nearly 1,000 MS patients for one that they’re running. The study will look at the benefits of traditional therapies, using pills or shots, compared with more aggressive treatments using infusions.

A Johns Hopkins University-initiated clinical trial is starting to enroll an estimated 900 relapsing-remitting multiple sclerosis (RRMS) patients to assess the benefits of switching therapies to prevent or reduce disability.

The TREAT-MS study (NCT03500328) will evaluate whether RRMS patients with disease activity while on a traditional first-line disease-modifying therapy — including injectable and oral medications — should switch to another similar treatment or start on a more aggressive infusion therapy. These treatments, while considered more effective, can have more and more serious side effects.

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