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Thursday, May 28, 2020

Treating the Whole Patient: Incorporating Behavioral Medicine into MS Management

Amy Sullivan, PsyD, Director of Behavioral Medicine at the Mellen Center for Multiple Sclerosis at Cleveland Clinic, described the benefits of cognitive behavioral therapy (CBT) in helping patients with MS to manage the "behavioral trio" of depression, adjustment difficulties, and stress."Normalize, don't stigmatize," was the overriding message in the session on “Science, Art, and Practice of Behavioral Medicine” presented by Amy Sullivan, PsyD, ABPP, at the Consortium of Multiple Sclerosis Centers (CMSC) 2020 Virtual Annual Meeting on May 26. Studies have shown that over 50% of patients diagnosed with MS also have been diagnosed with depression, over four times the average rates in the general population (between 2.3% and 16%). Significantly higher risk is seen with other mental health conditions as well: compared to the general population, people with MS are more likely to have an anxiety disorder, adjustment disorder, or bipolar disorder. "It's important to help patients understand that these are common manifestations or comorbidities of neurologic diseases, and the person should not feel different or lesser because of a mental health condition," stated Dr. Sullivan, PysD, ABPP, Director of Behavioral Medicine at the Mellen Center for Multiple Sclerosis at Cleveland Clinic.
"MS takes so much from our patients. We don’t want it to take their joy as well.”Dr. Sullivan spoke about the benefits of collaborative medicine. The Mellen Center uses an interdisciplinary team approach to ensure that patients get access to all areas of care. Screening tools are used to assess patients and track their progress, and include an open dialogue with patients to determine how stress and anxiety affect aspects of daily lives such as sleep quality. The comprehensive care team often encounters what Dr. Sullivan called the “behavioral medicine trio”: depression, difficulty with adjustment to the disease, and stress. "Depression can be a symptom of MS as well as a response to it," she commented. "Explaining this to patients can help to normalize their feelings." Among a variety of treatment approaches for depression, the team often employs cognitive behavioral therapy, which looks at the relationship between thoughts, emotions, and behaviors and their interaction with mood. The second part of the trio is adjustment disorder. This is defined as anxiety or depression in response to a serious diagnosis or chronic illness, and can result in distress and difficulty functioning socially or occupationally. Treatment focuses on normalizing the patient's feelings, educating them about what they are experiencing, and providing management strategies.

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Review of Two Popular Eating Plans within the Multiple Sclerosis Community: Low Saturated Fat and Modified Paleolithic

Abstract

The precise etiology of multiple sclerosis (MS) is unknown but epidemiologic evidence suggests this immune-mediated, neurodegenerative condition is the result of a complex interaction between genes and lifetime environmental exposures. Diet choices are modifiable environmental factors that may influence MS disease activity. Two diets promoted for MS, low saturated fat Swank and modified Paleolithic Wahls Elimination (WahlsElim), are currently being investigated for their effect on MS-related fatigue and quality of life (NCT02914964). Dr. Swank theorized restriction of saturated fat would reduce vascular dysfunction in the central nervous system (CNS). Dr. Wahls initially theorized that detailed guidance to increase intake of specific foodstuffs would facilitate increased intake of nutrients key to neuronal health (Wahls™ diet). Dr. Wahls further theorized restriction of lectins would reduce intestinal permeability and CNS inflammation (WahlsElim version). The purpose of this paper is to review the published research of the low saturated fat (Swank) and the modified Paleolithic (Wahls™) diets and the rationale for the structure of the Swank diet and low lectin version of the Wahls™ diet (WahlsElim) being investigated in the clinical trial.
Keywords: low saturated fat diet, Paleolithic diet, multiple sclerosis, modified Paleolithic diet, Swank diet, Wahls diet, Wahls Elimination diet


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1. Introduction
Multiple Sclerosis (MS) is a chronic, inflammatory, immune-mediated condition that damages nerve fibers and the myelin sheath and affects the brain, spinal cord and optic nerve []. The cause of MS is unknown, however, it is believed to be a result of complex interaction between genetic and environmental exposures, including diet []. Treatment consists of disease-modifying therapies [,], symptom and relapse management and support from physical and occupational therapists [] and dietitians []. Clinical disease course is unpredictable and may result in significant disability including unemployment due to disease progression [,,].
Because modifiable lifestyle factors such as diet quality may impact the disease course [,,,,], dietary guidelines for persons with MS (pwMS) have the potential to reduce MS-related symptoms. Potential mechanisms by which diet quality may influence disease course in MS patients include epigenetic changes in gene expression [] and shifts in the composition of the gut microbiome [] both of which may result in down regulation of inflammation. Diet quality may also influence the sufficiency of nutrients required for neuronal structure [,].




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Siponimod Reduces Risk of Disability Progression Regardless of Prior Relapses in MS

Data from the phase 3 EXPAND clinical trial (NCT01665144) of siponimod (Mayzent; Novartis) demonstrated the treatment’s ability to reduce the risk of confirmed disability progression (CDP) in patients with secondary progressive multiple sclerosis (SPMS) with or without relapses.

The risk reductions in non-relapsing patients in the 1 and 2 years before the study were 18% (hazard ratio [HR], 0.82; 95% CI, 0.66–1.02) and 13% (HR, 0.87; 95% CI, 0.68–1.11), respectively. For 3-and 6-month CDP, the risk reductions were 25% (HR, 0.75; 95% CI, 0.59–0.96) and 18% (HR, 0.82; 95% CI, 0.62–1.08), respectively.

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Data presented at the 2020 Consortium of Multiple Sclerosis Centers (CMSC) Virtual Annual Meeting, May 26-29, 2020 revealed risk reductions of 33% and 33% for 3-month CDP in years 1 and 2, and 30% and 37% for 6-month CDP in years 1 and 2, respectively, in relapsing patients.

Bruce Cree, MD, PhD, MAS, lead author, and neurologist, UCSF Multiple Sclerosis Center, and colleagues found that siponimod reduced 3-month CDP by 14% to 20% and 6-month CDP by 29% to 33% in non-relapsing patients across the Month 12, Month 18, and Month 24 timepoints.

Cox model censoring at relapse confirmed these beneficial effects, reaching nominal statistical significance for 6-month CDP (HR, 0.77; 95% CI, 0.62–0.96).

The goal of the EXPAND trial was to assess the impact of siponimod on CDP in patients with and without relapses to uncouple treatment effects of CDP from those on relapses. EXPAND contained patients aged 18 to 60 years with SPMS and EDSS scores ranging from 3.0 to 6.5, and administered once-daily oral siponimod 2 mg or placebo for up to 3 years.


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THIS DIET MAY EASE FATIGUE FOR PEOPLE WITH MS

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AUGUST 15TH, 2019
POSTED BY MARCENE ROBINSON-BUFFALO

Higher levels of blood high-density lipoprotein—good cholesterol—may improve fatigue in multiple sclerosis patients, according to a new study.

The pilot study, which investigated the effects of fat levels in blood on fatigue caused by multiple sclerosis, shows lowering total cholesterol also reduces exhaustion.
Fatigue is a frequent and debilitating symptom for people with multiple sclerosis that affects quality of life and ability to work full time. Despite fatigue’s prevalence and severity, treatment options are limited and medications used to treat it often come with unwanted side effects.
“Fatigue in people with multiple sclerosis has been viewed as a complex and difficult clinical problem with contributions from disability, depression, and inflammation,” says Murali Ramanathan, professor in the University at Buffalo School of Pharmacy and Pharmaceutical Sciences.
“Our study implicates lipids and fat metabolism in fatigue. This is a novel finding that may open doors to new approaches for treating fatigue.”
In previous studies, Terry Wahls, a clinical professor of internal medicine and neurology and creator of the Wahls Protocol diet, and her team of researchers at the University of Iowa showed that a diet-based intervention accompanied by exercise, stress reduction, and neuromuscular electrical stimulation (NMES) is effective at lowering fatigue. However, researchers didn’t know the physiological changes underlying the improvements.
For the current study in PLOS ONE, researchers examined changes in body mass index (BMI), calories, total cholesterol, HDL, triglycerides, and low-density lipoprotein (LDL)—commonly known as bad cholesterol. Researchers used the Fatigue Severity Scale to measure fatigue.
Researchers followed 18 progressive multiple sclerosis patients who followed the Wahls diet, which is high in fruits and vegetables, over the course of a year. The diet encourages the consumption of meat, plant protein, fish oil, and B vitamins. It excludes gluten, dairy, and eggs.
Participants also took part in a home-based exercise program that included stretches and strength training, NMES to stimulate muscle contraction and movement, and meditation and self-massages for stress reduction. However, adherence to the diet was the main factor associated with reductions in fatigue.


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TRANSPLANTED BRAIN CELLS REPAIR MS DAMAGE IN MICE



When researchers transplanted specific human brain cells into animal models of multiple sclerosis and other white matter diseases, the cells repaired damage and restored function, according to a new study.


The study provides one of the final pieces of scientific evidence necessary to advance this treatment strategy to clinical trials.
“These findings demonstrate that through the transplantation of human glial cells, we can effectively achieve remyelination in the adult brain,” says lead author Steve Goldman, professor of neurology and neuroscience at the University of Rochester Medical Center and co-director of the Center for Translational Neuromedicine.
“These findings have significant therapeutics implications and represent a proof-of-concept for future clinical trials for multiple sclerosis and potential other neurodegenerative diseases.”
As reported in Cell Reports, the findings represent the culmination of more than 15 years of research understanding support cells found in the brain called glia, how the cells develop and function, and their role in neurological disorders.
Goldman’s lab has developed techniques to manipulate the chemical signaling of embryonic and induced pluripotent stem cells to create glia. A subtype of these, called glial progenitor cells, gives rise to the brain’s main support cells, astrocytes and oligodendrocytes, which play important roles in the health and signaling function of nerve cells.
In multiple sclerosis, an autoimmune disorder, glial cells are lost during the course of the disease. Specifically, the immune system attacks oligodendrocytes. These cells make a substance called myelin, which, in turn, produce the “insulation” that allows neighboring nerve cells to communicate with one another.
As myelin is lost during disease, signals between nerve cells become disrupted, which results in the loss of function reflected in the sensory, motor, and cognitive deficits.
In the early stages of the disease, referred to as relapsing multiple sclerosis, oligodendrocytes replenish the lost myelin. However, over time these cells become exhausted, can no longer serve this function, and the disease becomes progressive and irreversible.
In the new study, Goldman’s lab showed that when researchers transplanted human glia progenitor cells into adult mouse models of progressive multiple sclerosis, the cells migrated to where the brain needed them, created new oligodendrocytes, and replaced the lost myelin.
The study also shows that this process of remyelination restored motor function in the mice. The researchers believe this approach could also apply to other neurological disorders, such as pediatric leukodystrophies — childhood hereditary diseases in which myelin fails to develop—and certain types of stroke affecting the white matter in adults.
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BACK Novartis builds case for MS drug ofatumumab as FDA decision looms


May 27, 2020


Novartis has reported new data with its multiple sclerosis (MS) drug ofatumumab showing that it can suppress disease activity for up to two years, as it waits for an FDA decision on the drug next month.

New results from the Swiss drugmaker’s clinical trials programme for ofatumumab (OMB157) showed that 47% of patients with relapsing MS had no evidence of disease activity (NEDA) in the first year after treatment, rising to almost 88% in the second year.


Ofatumumab – a CD20-targeting antibody – is already used as an intravenous treatment for chronic lymphocytic leukaemia (CLL) under the Arzerra brand name, but has seen its use in that indication pegged back by increased competition.


Novartis reckons the subcutaneous version of the drug can make sales of $1 billion-plus per year as an MS therapy, and challenge other new therapies like Roche’s fast-growing Ocrevus (ocrelizumab), which also targets CD20 and brought in CHF 3.7 billion last year ($3.8 billion) in only its second full year on the market.


If approved it would become the first B-cell-targeting therapy for relapsing forms of MS that can be self-administered by patients at home once a month. A verdict is also due from the European Medicines Agency (EMA) in the first half of this year.


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Wednesday, May 27, 2020

Consortium of Multiple Sclerosis Centers Annual Meeting 2020, event updates


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The annual meeting of the Consortium of Multiple Sclerosis Centers (#CMSC) brings together health care providers, patients, caregivers, and advocates for an educational event highlighting the latest information on the treatment and management of multiple sclerosis. 

The 2020 Annual Meeting was held virtually due to the COVID-19 pandemic. 


CLICK here to see today's event topics of discussion


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Natalizumab (Tysabri) Provides Superior 'Feel Good' Experience in MS Over Other Treatments

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By: Marco Meglio  - Neurology LIVE

Increases in physical, emotional, and cognitive functioning were more common in patients receiving natalizumab than in patients receiving other disease modifying therapies


Data from a patient-centric survey study presented at the 2020 Annual Meeting of the  Consortium of Multiple Sclerosis Centers (CMSC) suggests that treatment with natalizumab (Tysabri; Biogen) is associated with a greater “feel-good” experience compared with other disease modifying therapies (DMTs) for patients with relapsing-remitting multiple sclerosis (RRMS).1
John Foley, MD
          John Foley, MD

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Research conducted by John Foley, MD, neurology specialist, Rocky Mountain MS Clinic, and colleagues showed a significantly higher percentage of natalizumab patients “felt good” while on natalizumab (n = 95; 63%) compared with other DMT-treated patients (45%; n = 252; P = .001).

In total, 78% of natalizumab-treated patients self-reported physical benefits compared with 67% of other-DMT patients (P = .017). Additionally, significantly higher rates of improved energy (23% vs 12%; P = .011) and coordination (22% vs 12%; P = .017) were observed in natalizumab compared with other-DMT patients.

Improvements in organizing thoughts, a cognitive component of the assessment, was significantly higher for natalizumab patients versus other-DMT patients (24% vs 14%; P = .021). Associations of “feel-good” experiences such as increased physical, emotional, and cognitive functioning, which were more commonly observed in natalizumab patients, were consistent with qualitative interviews.

In previous studies, patients had self-reported a “feel-good” experience while receiving natalizumab treatment. This study aimed to confirm previous reports by comparing surveys results of “feel-good” experiences in adult patients with RRMS who were on either natalizumab or other DMTs . The surveys asked patients about their current DMT use and its “feel-good” effect assessed by self-reported improvements in physical, emotional, and cognitive domains.


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A Tattoo Therapy with Nanoparticles, may help treat Multiple Sclerosis : STUDY

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With a recent request from an MS patient, we are posting this article, from Sept 2016

A temporary tattoo containing antioxidant nanoparticles may help treat autoimmune diseases such as multiple sclerosis in the future, according to a new study.

The study led by Christine Beeton from Baylor College of Medicine in the US shows that nanoparticles modified with polyethylene glycol (PEG) are conveniently choosy as they are taken up by cells in the immune system.

That could be a plus for patients with autoimmune diseases like multiple sclerosis, researchers said."Placed just under the skin, the carbon-based particles form a dark spot that fades over about one week as they are slowly released into the circulation," Beeton said.

T and B lymphocyte cells and macrophages are key components of the immune system. However, in many autoimmune diseases like multiple sclerosis, T cells are the key players.

One suspected cause is that T cells lose their ability to distinguish between invaders and healthy tissue and attack both.In tests, nanoparticles were internalised by T cells, which inhibited their function, but ignored by macrophages.

"The ability to selectively inhibit one type of cell over others in the same environment may help doctors gain more control over autoimmune diseases," Beeton said.

"The majority of current treatments are general, broad-spectrum immunosuppressants," said Redwan Huq, lead author of the study and a graduate student in the Beeton lab.

"They're going to affect all of these cells, but patients are exposed to side effects from infections to increased chances of developing cancer. So we get excited when we see something new that could potentially enable selectivity," Huq said.

Since the macrophages and other splenic immune cells are unaffected, most of a patient's existing immune system remains intact, he said. The soluble nanoparticles synthesised at Rice University in the US have shown no signs of acute toxicity in prior rodent studies, he said.


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Ofatumumab Increases NEDA-3 ( no evidence of disease activity) Likelihood in MS, Compared With Teriflunomide

Novartis’s anti-CD20 monoclonal antibody has been shown to increase the odds of patients with multiple sclerosis achieving no evidence of disease activity status by more than 3-fold in the first year and more than 8-fold in the second year.

New data from a pooled analysis of the phase 3 ASCLEPIOS I and II clinical trials suggest that patients with multiple sclerosis (MS) treated with ofatumumab have an increased likelihood of achieving no evidence of disease activity (NEDA-3) than those treated with teriflunomide (Aubagio; Sanofi).1

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All told, the odds of achieving NEDA-3 status—defined as a composite of no 6-month confirmed disability worsening (6mCDW), no confirmed MS relapse, no new/enlarging T2 lesions, and no gadolinium-enhancing (Gd+) T1 lesions—were more than 3-fold higher for those administered ofatumumab from Months 0 to 12 (47%) compared to those taking teriflunomide (24.5%; odds ratio [OR], 3.36 [95%CI, 2.67–4.21]; P <.001). From Months 12 to 24, those odds increased to more than 8-fold higher for those on ofatumumab (87.8%) compared with teriflunomide (48.2%; OR, 8.09 [95%CI, 6.26–10.45]; P <.001).

The data were analyzed by Stephen L. Hauser, MD, director, UCSF Weill Institute for Neurosciences, and professor of neurology, UCSF School of Medicine, and colleagues, and were presented at the 2020 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC 2020). The analysis included data on 927 patients from ASCLEPIOS I (NCT02792218) and 955 patients from ASCLEPIOS II (NCT02792231), and investigated the effect of subcutaneous ofatumumab 20-mg monthly compared with oral teriflunomide 14-mg once daily.


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Amid the COVID-19 Pandemic, Neurologists in Canada Report Pulling Back from EMD Serono’s Mavenclad and Sanofi Genzyme’s Lemtrada, While Roche’s Ocrevus Stalls, According to Spherix Global Insights

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Use in treatment-naïve patients drives recent growth of Biogen’s Tecfidera and Genzyme’s Aubagio in Canada, as reported switch share has remained flat over the past year – reflecting the continued shift in using established oral agents earlier in the multiple sclerosis treatment algorithm
EXTON, Pa., May 27, 2020 /PRNewswire/ — The COVID-19 pandemic has (at least temporarily) transformed neurology practices and multiple sclerosis (MS) patient management patterns across Canada, according to the most recent report included in Spherix’s RealTime Dynamix™: Multiple Sclerosis (Canada) service. The report, which collected the responses of 50 Canadian neurologists surveyed between April 6th and May 2nd, found that 90% of respondents indicate the novel coronavirus outbreak has had a high impact on their practice. While preference for induction versus escalation treatment was clearly on the rise prior to the pandemic, new data suggest a potentially transient reversion to more conservative disease-modifying therapy (DMT) treatment patterns.
Neurologists express hesitation to prescribe or re-dose patients with immunosuppressive DMTs, namely Roche’s Ocrevus, Sanofi Genzyme’s Lemtrada, and EMD Serono’s Mavenclad, due to increased risk of complications or death among MS patients infected with the novel coronavirus. One surveyed neurologist states “becoming more aggressive in [the] treatment of highly active MS” prior to the COVID-19 pandemic, which has now resulted in “more caution with immune-suppressing therapies.” This mindset has resulted in a leveling off of reported shares for the immunosuppressant DMTs.

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Tuesday, May 26, 2020

Nose to Brain ( N2B) Patch for Multiple Sclerosis - Study

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The Nose-to-Brain-patch (N2B-patch) project is an EU-funded project that started in January 2017. N2B-patch stands for Nose-to-Brain-patch. We aim to develop an innovative technology for multiple sclerosis (MS) treatment by developing a ‘nose to brain’ delivery system which will avoid the need for injections and oral medicine.

The long-term objective is to improve treatment of MS patients.



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Long-Term Data Show Sustained Benefit of Siponimod (Mayzent) for Secondary Progressive MS

April 22, 2020
Siponimod (Mayzent, Novartis) had a sustained effect on slowing disability progression in patients with secondary progressive multiple sclerosis (SPMS), according to new long-term data from a phase 3 study.  
The FDA approved siponimod, a next-generation selective sphingosine-1 phosphate receptor modulator, in March 2019 for the treatment of SPMS, making it the first treatment to be approved for the condition in 15 years. Siponimod is indicated for the treatment of adults with various relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Newly-released 5-year data from the EXPAND open-label extension trial assessed the long-term efficacy and safety of siponimod in patients with SPMS who, on entering the extension trial, either continued on siponimod treatment or switched from a placebo to siponimod.
The study, which is ongoing for up to a total of 7 years, is the largest randomized, controlled study in SPMS to date, and includes 1651 individuals with a diagnosis of SPMS, according to Novartis.
According to the data, patients in the siponimod treatment group were significantly less likely to experience both 3- and 6-month confirmed disability progression (CDP) (p=0.0064 and p=0.0048, respectively) compared with the placebo switch group.
Additionally, the results also demonstrated a 52% reduction in annualized relapse rate (ARR) observed in the siponimod group compared with the placebo switch group. According to the Symbol Digit Modalities Test, risk of confirmed worsening of cognitive impairment at 6 months was reduced by 23% for the siponimod group when compared with the placebo switch group. These benefits were sustained for up to 5 years.
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Monday, May 25, 2020

Are people with Multiple Sclerosis immunosuppressed? Are folks with MS at higher risk to contract COVID19

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A Video by Aaron Boster, MD

Are people with Multiple Sclerosis immunosuppressed? 

Are folks with MS at higher risk to contract COVID19, or at higher risk for a more severe infection? 

If you'd like to hear Dr. Boster's answers, then start watching right now!

CLICK VIDEO BANNER:  



THEN, Learn What YOU Need to Know about the disease Modifying Therapies, FAQ's and more CLICK HERE 


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Interferons in the Therapy of Severe Coronavirus Infections: A Critical Analysis and Recollection of a Forgotten Therapeutic Regimen with Interferon Beta

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Abstract

The pharmacological and immunological properties of interferons, especially those of interferon beta, and the corresponding treatment strategies are described, and the results of studies with different interferons in coronavirus infections are analysed. Furthermore, the data obtained with high-dosed native interferon beta in life-threatening acute viral diseases as well as the results of clinical pilot studies with high-dosed recombinant interferon beta-1a are provided because they serve as the rationale for the proposed therapeutic regimen to be applied in acute viral infections. This regimen differs from those approved for treatment of multiple sclerosis and consists of interferon beta-1a administered as a 24 hour intravenous infusion at a daily dose of up to 90 µg for 3–5 consecutive days. Since under this regimen transient severe side effects can occur, it is analysed which patients are suitable for this kind of treatment in general and if patients with severe coronavirus infections could also be treated accordingly.

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#

Introduction

The outbreak of the recent respiratory syndrome COVID-19 caused by the novel coronavirus SARS-CoV-2 has spread from China to many countries in the world. On 11 March 2020 the World Health Organization (WHO) made the assessment that COVID-19 can be characterized as a pandemic [1]. Although most affected patients suffer from mild to moderate symptoms, the total number of fatal cases exceeds that of other coronavirus infections, severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), [2] [3] [4].
Regardless of the fact that currently numerous therapeutic options are under review, so far no effective therapy could be identified [5] [6] [7]. Among others, interferons are considered as possible effective antiviral drugs against coronavirus infections.

Properties of interferons and corresponding treatment strategies

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