MS News That Caught My Eye Last Week: FDA and Tysabri, COVID-19 and CD20, Gilenya Infections, Therapeutic Lag

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by Ed Tobias |

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FDA Rejects Under-the-skin Tysabri for Relapsing MS

I expect this decision will be a disappointment for those who had hoped to be able to self-administer highly effective Tysabri as a shot rather than an IV infusion. But I switched from Avonex to Tysabri, because after a few years of Avonex, I couldn’t stand sticking myself in the thigh any longer. A monthly infusion fit my lifestyle much better.

Interestingly, the FDA hasn’t revealed its reason for rejecting Biogen’s application, and neither has Biogen. It seems to me that we should know this, wouldn’t you agree?

The U.S. Food and Drug Administration (FDA) has rejected Biogen‘s request for approval of under-the-skin administration of Tysabri (natalizumab) as a treatment for relapsing forms of multiple sclerosis (MS).

“This response from the FDA does not affect the intravenous administration of Tysabri, a well-established high-efficacy treatment with a well-characterized safety profile, which over the last 15 years has treated more than 200,000 people worldwide with relapsing MS,” Maha Radhakrishnan, MD, chief medical officer at Biogen, said in a press release.

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#AANAM – Ocrevus, Rituximab Linked to More Severe COVID-19 Cases in Italy

The past several months have seen anecdotal reports of some disease-modifying therapies (DMTs) reducing the ability of COVID-19 vaccines to fight off the novel coronavirus. It’s seemed particularly true for DMTs that target CD20 B-cells in the immune system, and Ocrevus and Rituximab fit that description.

This statistical analysis of more than 1,500 COVID-19 patients who also have MS reports the risk of severe COVID-19 for patients treated with a CD20-depleting therapy was roughly twice that of MS patients who were untreated. This is a good reason to speak with your neurologist about coordinating DMTs with COVID-19 vaccine shots.

Disease-modifying therapies (DMTs) that target CD20 are associated with worse outcomes from COVID-19 in multiple sclerosis (MS) patients, an analysis of patient data from Italy suggests.

Conversely, interferon-based DMTs and Aubagio (teriflunomide) were associated with less severe COVID-19 cases in the analysis.

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Gilenya Increases Patient Infection Risk, Clinical Data Suggest

This story is notable because Gilenya is the only DMT approved by the FDA for use by children as young as 10. It works by reducing the number of immune cells in circulation, and researchers are concerned that it may also reduce the immune system’s ability to fight off infectious pathogens. This study reports the risk was was 14% greater for a general infection, but increased to 49% for serious infections. It also significantly increased the risk of lower respiratory infections by 48%, and of infection by the herpes virus by 34%, compared to a control group.

The multiple sclerosis (MS) treatment Gilenya (fingolimod) is associated with a 16% greater risk of infections, compared with a placebo or control treatment, according to data from 12 randomized clinical trials.

The findings were published in a study, “Incidence and Risk of Infection Associated With Fingolimod in Patients With Multiple Sclerosis: A Systematic Review and Meta-Analysis of 8,448 Patients From 12 Randomized Controlled Trials,” in the journal Frontiers in Immunology.

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#AANAM – Research Focuses on Measuring Therapeutic Lag

Therapeutic lag is the gap between when a person starts taking a medication and when the medication becomes fully effective. This layman isn’t surprised that therapies take longer to work when disability is greater or when relapses are frequent before a treatment is started. Doesn’t that just make sense?

A novel method to calculate how long it takes therapies for multiple sclerosis (MS) to become fully effective was described in a presentation at the 2021 Virtual American Academy of Neurology Annual Meeting.

Findings from the analysis indicate that MS therapies take longer to be effective for people with greater disability or with a higher rate of relapses prior to starting treatment.

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Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Multiple Sclerosis News Today or its parent company, BioNews, and are intended to spark discussion about issues pertaining to multiple sclerosis.


Brigitte Dewilde avatar

Brigitte Dewilde

I got Secondary Progressive MS diagnosed 23 years ago.


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