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Disclaimer: 'MS Views and News' DOES NOT endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, for your personal knowledge and to keep you informed of current health-related issues. It is not a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly.

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Saturday, September 28, 2019

5 Ways to Have a Better MRI Experience With MS

Probably no one enjoys having an MRI, but the experience can be made more bearable.

Medically Reviewed by Samuel Mackenzie, MD, PhD

People often complain of feeling confined or claustrophobic during MRIs.
Selim Aksan/Getty Images
People often complain of feeling confined or claustrophobic during MRIs.


Magnetic resonance imaging (MRI) scans are commonly performed to establish a diagnosis of multiple sclerosis (MS) and to monitor its progression over time.

MRIs use strong magnets and radio waves to create images of internal structures of the body. An MRI scan of your brain and spinal cord can reveal the lesions, or areas where the myelin that normally protects nerve fibers has been damaged, that are typical of MS.

Over time, repeat MRIs show your doctor whether you have developed additional lesions and whether existing lesions have enlarged or otherwise changed.

Most healthcare professionals recommend that people with MS receive annual MRIs to track progression and assist in treatment decisions. Evidence of new or growing lesions, for example, may indicate that a change in treatment is needed.

Click to read more on Safety Issues, Anxiety and more


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Friday, September 27, 2019

Boster's Corner: Multiple Sclerosis Vlog: SUPPLEMENTS FOR MS? Vitamin D3 and much more


September 2019

Supplements for Multiple Sclerosis? In this video I teach you about nutrition & dietary supplements for MS. Got Vitamin D3? If you want to up your food game, start watching this video! Content was originally recorded during a livestream on this channel. 

What supplements do you take? Please share in the comments section below! I look forward to reading and responding!



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a Boster Video: New MS Drug Results: #Ofatumumab vs #Teriflunomide (ASCLEPIOS trial)

In this video I share brand new MS drug results, comparing a new B-cell killer (Ofatumamab) to Aubagio (teriflunomide). If you'd like to learn the results and better understand Multiple Sclerosis research, then start watching this video right now!



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7 Home Modification to Empower People with Multiple Sclerosis





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Neuropsychological tests useful tool for real life activity in MS

Sept 23, 2019

A recent review of research literature explored the relationship between neuropsychological assessment and predictability of performance of everyday life activities among people with multiple sclerosis. Neuropsychological assessment was found to be among the tools useful for measuring the effect of MS on everyday activities.

People with MS often undergo neuropsychological testing to evaluate the influence of cognitive effects on their ability to perform everyday life activities. To be a useful tool for the clinicians who care for these individuals, it is important that their performance on neuropsychological testing parallels their function in everyday life. Kessler Foundation researchers examined this issue, as well as the broader context for the question: Are neuropsychological tests ecologically valid?

The authors examined the literature on the relationships between cognitive and functional domains in the MS population. Cognitive functions included processing speed, executive function, visuospatial function, learning and memory, working memory, and verbal fluency. Functional domains included driving, employment, internet shopping and financial/medical decision-making. They found that neuropsychological tests do have predictive value for individuals' behavior in these real life settings.

Researchers note that to best serve the clinical needs of individuals with MS, neuropsychological testing needs to be viewed in larger context comprising noncognitive variables, such as motor ability and demographic values, fatigue and depression, and disease activity and level of disability, as well as person-specific factors such as personality and coping styles.

The article was published in the Multiple Sclerosis Journal.



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Novartis ofatumumab demonstrates superiority versus Aubagio® in two head-to-head Phase III multiple sclerosis studies


In ASCLEPIOS I and II, ofatumumab (OMB157) met primary endpoints to reduce the annualized relapse rate over Aubagio®* (teriflunomide) in patients with relapsing forms of MS (RMS)[1]
  • Key secondary endpoints of delaying time to confirmed disability progression were also met[1];  additional secondary endpoints will be presented at ECTRIMS
     
  • Ofatumumab, a potent, fully-human antibody targeting CD20 positive B-cells, delivered sustained efficacy with a favorable safety profile[1]
     
  • Novartis plans to initiate submissions to health authorities by end of 2019. If approved, ofatumumab will potentially become a treatment for a broad RMS population and the first B-cell therapy that can be self-administered at home
Basel, August 30, 2019 – Novartis, a global leader in neuroscience, today announced positive results for #ofatumumab (OMB157) from the Phase III ASCLEPIOS I and II studies. In both head-to-head studies, ofatumumab demonstrated superiority over Aubagio®* (teriflunomide) in patients with relapsing forms of multiple sclerosis (RMS)[1]. The ASCLEPIOS studies investigated the efficacy and safety of monthly subcutaneous ofatumumab 20mg versus once daily oral Aubagio® 14mg in adults with RMS[2],[3].
Both studies met the primary endpoints where ofatumumab showed a highly significant and clinically meaningful reduction in the number of confirmed relapses, evaluated as the annualized relapse rate (ARR)[1]. Key secondary endpoints of delaying time to confirmed disability progression were also met[1]. The top line results of the Phase III ASCLEPIOS studies will be presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), taking place September 11–13, 2019, in Stockholm, Sweden. Overall ofatumumab, a potent, fully-human antibody targeting CD20 positive B-cells, delivered sustained efficacy with a favorable safety profile[1]. The safety profile of ofatumumab as seen in the ASCLEPIOS studies is in line with the observations from Phase II results[1],[4]. Novartis plans to initiate submissions to health authorities by end of 2019.


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Wednesday, September 25, 2019

Puzzling It Out - a Podcast series for MS Patients


"Thoughts and Perspectives from a Clinical Psychologist"

Click the banner to view a podcast series created for MS Patients.






Tuesday, September 24, 2019

The MS Coalition invites you to join us for the 2019 Multiple Sclerosis Summit on Saturday, November 9, 2019 at the Westin Lombard, Illinois


2019 Multiple Sclerosis Summit

Saturday, November 9, 2019 – Lombard, Illinois


The MS Coalition invites you to join us for the 2019 Multiple Sclerosis Summit on Saturday, November 9, 2019 at the Westin Lombard located at 70 Yorktown Center in Lombard, Illinois.

This day-long event includes informative workshops and an interactive expo for people with MS and their care partners.

Access to ALL parts of the MS Summit, including breakfast, lunch, and parking are free-of-charge.

To learn more and register, please visit: http://ms-coalition.org/2019mssummit/


  
This one-of-a-kind program is sponsored by the member organizations of the MS Coalition, a cooperative effort of nine national organizations working to benefit people with MS. Members include: Accelerated Cure Project, the Consortium of MS Centers, Can Do Multiple Sclerosis, the International Organization of MS Nurses, Multiple Sclerosis Association of America, Multiple Sclerosis Foundation, National Multiple Sclerosis Society, United Spinal Association and associate member MS Views and News.

Find the Multiple Sclerosis Coalition online at http://ms-coalition.org or visit MSC on Facebook and on Twitter @MS_Coalition.

Please note: member organizations of the MSC maintain separate mailing lists. As a result, you may receive this message more than once. We apologize for any duplication, but we don’t want you to miss this terrific opportunity!


Arthritis group offers first guidelines for patients who use CBD for joint pain

Sept 24, 2019
As seen on NBC's Today show

By Erika Edwards

CBD has exploded in popularity over the last year, with countless numbers of people trying it as a sleep aid or relief for pain and anxiety. One concern is, there's been no guidance on how to use CBD, or cannabidiol, safely. 

That's one reason why on Tuesday, the Arthritis Foundation released guidelines for people who want to try CBD — the first such guidance on using the cannabis-derived ingredient from any major patient advocacy group.



The recommendations are an attempt to provide some kind of clarity for CBD usage, despite a lack of scientific evidence proving that it works to treat pain.

"It was important to acknowledge the public's interest, and put out some guidelines on the state of the science," said Kevin Boehnke, a research investigator who works in anesthesiology at the University of Michigan. Boehnke helped develop and write the guidelines for the Arthritis Foundation.

The group makes it clear that patients should not abandon arthritis medications already prescribed by doctors.

"The guidelines are not saying, 'you should try this.' They're saying, 'if you want to try, here's how you should do it,'" said Boehnke.

CBD products became widely available after Congress passed the Farm Bill in 2018, which removed hemp from the controlled substance list. By itself, CBD does not cause a “high.” (Marijuana's psychoactive effects instead come from a different compound, THC, or tetrahydrocannabinol.)
Since then, the task of regulating CBD products has fallen on the Food and Drug Administration, but so far the agency has not done so.

The result has been a public frenzy around CBD products, which are marketed and sold with a variety of health claims, including relief for pain, insomnia and stress. Those assertions caught the attention of those suffering from arthritis, a condition for which there is no cure. 

CLICK HERE to READ MORE


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Monday, September 23, 2019

Sanofi and Happify Health solidify collaboration around prescription DTx designed to address mental health in people with MS

September 2019

– Companies plan to seek FDA clearance for digital therapeutics approach –

The list of physical symptoms of multiple sclerosis (MS) is long and varied, including fatigue, numb limbs and tremors. But many people living with MS also experience mental health conditions — particularly depression and anxiety. People with MS develop a form of major depression at a rate two to five times higher than the general population, depending on the country studied.

“Many patients with MS face significant burdens, and we have an obligation to help them not only maximize their physical health, but their mental health as well,” said Bozidar Jovicevic, Sanofi’s global head of digital medicine.

Sanofi is collaborating with Happify Health, which provides evidence-based mental health digital therapeutics, to develop and study an app to help manage and improve psychological outcomes in people with MS.

Digital therapeutics (DTx) deliver to patients evidence-based therapeutic interventions to patients that are driven by high quality software programs to help prevent, manage, and treat a medical disorder or disease. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes. Investment in such approaches is part of a broader strategic effort at Sanofi, which includes digital health innovations, such as software- or hardware-based interventions, virtual health care and partnerships with solution providers with the goal of improving outcomes and the patient experience.

Studies have shown that poor mental health during an MS journey has been associated with reduced quality of life and decreased treatment adherence.

“Physical health and mental health are linked,” said Ameet Nathwani, chief digital officer and chief medical officer of Sanofi. “Through its collaboration with Happify Health, Sanofi aims to provide real-time, constant support for mental health conditions and improve quality of life.”

The collaboration will create — and study via clinical trials — an app that introduces cognitive behavior therapy to help improve mental health through education and other activities.

“Patients are getting more interested in their own health and are looking for solutions. Developing technologies that can potentially help support their mental health management can be a perfect complement to traditional therapies,” Nathwani said.

Based on randomized clinical trial results, Sanofi and Happify aim to submit the app for U.S. Food and Drug Administration for clearance, subjecting it to a regulatory process for software as a medical device. This process includes more rigorous quality testing, privacy protection and security considerations than ordinary consumer apps undergo. If FDA clears the app, it would be available by prescription.

“The ubiquity of smartphones and PCs has the potential to introduce new self-care and augmented-care delivery models that are dynamic, highly personalized and engaging,” said Ofer Leidner, co-founder and president of Happify Health. “Further, our evidence-based digital platform is designed to maximize efficacy, safety and patient engagement at scale, three areas which are difficult to attain with one solution.”

Just as molecular understanding and adherence create the biologic basis for effective drug-based therapy, medical understanding and engagement provide the keys to success with a digitized cognitive behavior therapy program. This collaboration will marry Sanofi’s patient focus and medical and scientific expertise in MS with Happify Health’s skill in creating platforms designed for maximum engagement.

“This new intersection between tech companies and pharmaceutical companies requires a real effort to learn together, to build a new interface between industries,” Leidner said. “Sanofi has demonstrated a commitment to digital transformation, and we have found that our collaboration is ideal for the development of technologies with the potential to change our approach to anxiety and depression for people living with MS.”

“While there is no shortage of digital mental health interventions, our differentiation is in providing proven, efficacious digital therapies that fit seamlessly with pharmaceutical therapies to offer a true ‘beyond the pill’ experience for patients,” said Chris Wasden, Ed.D., Head of DTx, Happify Health. “Our interventions are tested in randomized clinical trials and published in peer-reviewed journals, testaments to our commitment to putting forward only evidence-based, safe and effective digital therapies.”

“We are working to create a future where rigorously vetted digital therapeutics can create behavioral change and work alongside traditional approaches to continue our focus on treating people holistically so they can live a better life,” Jovicevic said. ........................................................................................................
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EMD Serono Initiates Pivotal Phase III Program for Investigational Evobrutinib in Relapsing Multiple Sclerosis

EVOLUTION RMS 1 and 2 pivotal Phase III trials will investigate the efficacy and safety of evobrutinib in relapsing multiple sclerosis
- Evobrutinib is the first oral, highly selective Bruton's Tyrosine Kinase inhibitor to show clinical proof of concept in relapsing multiple sclerosis
- Decision to initiate Phase III program based on effect seen with evobrutinib on magnetic resonance imaging endpoints at 24 weeks and annualized relapse rate over 48 weeks in Phase II
- Unique collaboration with Accelerated Cure Project for Multiple Sclerosis provided guidance on patient-reported outcomes measures and clinical study design

NEWS PROVIDED BY
Sep 10, 2019, 08:00 ET

ROCKLAND, Mass.Sept. 10, 2019 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced the initiation of two global pivotal Phase III trials (EVOLUTION RMS 1 and 2) studying the efficacy and safety of Evobrutinib, an oral, highly selective Bruton's Tyrosine Kinase (BTK) inhibitor in adult patients with relapsing multiple sclerosis (RMS).
"Evobrutinib is a potential innovation for people living with MS, as it may offer a novel dual mechanism of action that is thought to impact myeloid cells in addition to B-cells and thus could address MS pathobiology in a fundamentally new way," said Luciano Rossetti, Head of Global R&D for EMD Serono. "Evobrutinib, which was developed in our own laboratories, is an oral, highly selective BTK inhibitor that has shown clinical proof of concept in RMS. Progressing this molecule into Phase III is an important step for us and the MS community, with an opportunity to further advance on benefit-risk considerations for RMS patients."
Evobrutinib is entering Phase III trials following the results of the Phase II clinical trial, which met its primary endpoint over 24 weeks of treatment, where the total cumulative number of T1 gadolinium-enhancing (Gd+) lesions was reduced with evobrutinib compared with placebo. The reduction of T1 Gd+ lesions was observed at 12 weeks, the first time point at which magnetic resonance imaging (MRI) data was available, and maintained through 48 weeks with evobrutinib 75 mg QD (once a day) and 75 mg BID (twice a day). Further data show that the effect on relapse reduction observed at Week 24 was maintained through 48 weeks.
In the Phase II trial, the most commonly observed adverse events of any grade associated with evobrutinib included nasopharyngitis and increases in levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and lipase. All events had an onset within 24 weeks of treatment initiation and were reversible on treatment discontinuation with no clinical consequences within the 52-week safety period. During the course of the study, 85% of patients (227 out of 267) completed 52 weeks of treatment.
EVOLUTION RMS 1 and 2 are multicenter, randomized, parallel group, double-blind, active-controlled studies comparing evobrutinib twice-daily with interferon beta-1a given intramuscularly once a week. The primary endpoint of both studies is annualized relapse rate (ARR) at Week 96. Secondary endpoints include time to first occurrence of 12- and 24-week confirmed Expanded Disability Status Scale (EDSS) Progression and total number of Gd+ T1 lesions and new or enlarging T2 lesions assessed by MRI.



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MS Patients Should Be Informed about Pregnancy Risks and Family Planning, Experts Say

SEPTEMBER 11, 2019 - BY ANA PENA, PHD of Medical News Today
 
While pregnancy does not appear to affect the disease course of multiple sclerosis (MS), questions remain about the best time to stop or resume treatment before conception and after delivery, the safety of new medications, and the importance of family planning.
Pregnancy was the “hot topic” discussion today in a session, titled “MS Pregnancy in the treatment era,” at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), which is being held Sept. 11–13 in Stockholm, Sweden.
 
Three presentations focused on different aspects of pregnancy, including the risks for the mother and child, and the importance of early counseling for patients wishing to become parents.
Until the 1980s, women with MS were discouraged from having children due to the false belief that pregnancy would worsen their disease course.
A shift in knowledge occurred in 1998 when the PRIMS study (Pregnancy in Multiple Sclerosis multicenter European study) showed that, overall, pregnancy did not affect the long-term clinical course of MS. In fact, the study provided evidence that relapse rates go down during pregnancy in MS women, and then restart after giving birth — of note, relapses can get particularly worse in the first three months after delivery.
 
The PRIMS study also showed that disability progression is similar between pregnant MS women and the general MS population, suggesting that the overall impact of pregnancy on MS course seems to be neutral.
However, over the last three decades, the emergence of a variety of disease-modifying therapies (DMTs) has raised many questions about the risks of each therapy for the fetus, and about which medicines to stop or restart and when to do so.

The mother’s & Child's perspective, plus family planning




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Sunday, September 22, 2019

Upcoming MS Patient Round Table with Aaron Boster, MD, in Columbus, OH and another event in Louisville, KY

Hear Ye, Hear Ye: FOR ALL within Driving distance to Columbus, Ohio, join Dr. Boster and Me, as we square off in a Round Table discussion that will concern "MANY" affected by MS..

This event is on Thursday evening, December 5th.
(www.events.msvn.org) - MS Views and News is providing this dinner event. -- 

Following this MS program, we will be driving to Louisville, KY to do another event on December 7th, a Saturday luncheon.

Also presenting in Louisville is Mindy Eisenberg on Adaptive Yoga for MS and Paul Pelland our patient advocate with his great story. 

For ALL wanting to see Dr. Boster in un-edited format, click here (www.events.msvn.org) to find the event and to register. 


#ECTRIMS2019 – Tysabri During Pregnancy and After Delivery Seems Safe, Reduces Relapse Risk, Study Finds

Continuing Tysabri (natalizumab) treatment up to week 28 of pregnancy, and restarting soon after birth, reduces the risk of relapses in women with multiple sclerosis and appears to be safe for the mother and the baby, new research suggests.
Doriana Landi, MD, PhD, from Italy’s University of Rome Tor Vergata, presented the findings at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), held Sept. 11–13 in Stockholm, Sweden.
What therapy to choose, and for how long to take it, have been emerging issues for women with MS who are pregnant or planning to become pregnant.
“We all know that not all treatments are compatible with pregnancy planning, especially second-line treatments which are usually used for highly active MS women,” Landi said.
One problem is the lack of data that can elucidate the risks, and guide therapy choices before, during, and after pregnancy. In particular, there is a lack on information “on how to manage our highly active patients,” such as those treated with Tysabri (marketed by Biogen), Landi added.
Suspension of Tysabri treatment is currently discouraged in patients planning pregnancy, due to concerns of disease reactivation or worsening — patients may become exposed to a higher risk of relapses, Landi said.
2018 study showed that “suspending natalizumab treatment before conception was associated with a higher risk of disease relapses during pregnancy,” Landi said, while “receiving the last natalizumab infusion after the onset of the last menstrual period led to an approximately 3-fold reduction of the risk of relapses during pregnancy.”
Data from the German MS registry suggested that the best option would be to continue Tysabri treatment until the 30th week of gestation, as a way to minimize flares in the mother while assuring the safety of the fetus.
Further, recent guidelines from the Association of British Neurologists recommend maintaining Tysabri up to approximately 34 weeks of gestation, and restarting treatment soon after birth to mitigate the risk of rebound disease activity. Those guidelines recommend treatment be restarted within 8-12 weeks after the last dose pre-delivery.
Prior studies suggested that Tysabri use over the first trimester of pregnancy is not tied to major fetal risks. However, the medicine can be found in the blood of newborns, and they commonly have blood alterations, especially in the third trimester, such as low red blood cell or platelet counts. These alterations are usually self-resolving, Landi said.
Given the lack of information, the researchers said more data was needed. They sought to confirm Tysabri’s safety and efficacy, and to find the best management strategy for women taking this medicine who plan to become mothers.
The team therefore analyzed data from a group of 86 pregnant women with MS (90 pregnancies), who were on Tysabri treatment, and were followed at 19 Italian MS centers. The patients’ mean age was 31 years, and median EDSS was 2.0, indicating minimal disability.
The women were divided into three groups according to the time of the last Tysabri infusion: before conception (31 newborns); within the first trimester of pregnancy (30 newborns); and those who continued treatment after the first trimester (31 newborns). All women were asked to restart Tysabri after delivery, and all have at least one year data of follow-up.
No difference in terms of demographic characteristics were found among the study groups.
Most women who remained on treatment beyond the first trimester continued up to at least the 28 week of gestation. They received a median of five — ranging from 3 to 5 — Tysabri infusions, with a mean interval of 33 days between doses.
Importantly, these women restarted Tysabri treatment significantly earlier after giving birth — a median of 25 days after delivery — compared with women in the other groups. The women who stopped Tysabri before conception restarted treatment a median of 55 days after delivery. Those who stopped Tysabri during the first trimester restarted a median of 50 days after delivery.
Researchers then compared the annualized relapse rate (ARR) during pregnancy, and one year after delivery, as well as newborn outcomes, across groups.
During pregnancy, there was a significantly higher relapse rate in the women with “wash-out” pregnancies — those who stopped Tysabri before getting pregnant. Conversely, the lowest ARR was observed in women who continued on Tysabri while pregnant.
ARR was 1.06 in women stopping Tysabri before conceiving, 0.49 in those prolonging treatment up to the first trimester of pregnancy, and 0.09 in those continuing beyond this period.
A similar trend was maintained in the postpartum period, one year after delivery, the results showed. The women stopping Tysabri earlier had the highest relapse rates (0.39), while those who remained on treatment had fewer relapses — 0.23 in those prolonging treatment up to the first trimester of pregnancy, and 0.10 in those continuing beyond this period.
Researchers believe that early treatment resumption was important to lessen the risk of relapses in the group of women who continued Tysabri treatment after the first trimester of pregnancy.
Landi emphasized that “relapses are really relevant in terms of disability accumulation.” She noted that women who stopped Tysabri before conception had the highest accumulation of disability, as measured by EDSS, in the postpartum period.
Regarding newborn outcomes and fetal safety, no significant changes were registered between the three groups of mothers, either on mean gestational age (the number of weeks of the pregnancy), birthweight, or length.
Anemia — low red blood cell counts — was more frequent in newborns exposed to Tysabri beyond the first trimester. Five newborns from that group had anemia, versus none in the other two groups. However, Landi noted that three of these five babies were premature newborns, and a link has previously been reported between prematurity and anemia.
Major birth defects only happened in pregnancies exposed to Tysabri — both up to the first trimester (one case of a major malformation called clubfoot), and beyond the first trimester (four cases, all heart defects, specifically patent foramen ovalepatent ductus arteriosuspulmonary valve stenosis, and coarctation of the aorta).
Nonetheless, Landi stressed that factors other than Tysabri treatment could have accounted for this higher number of birth defects. One such factor that raises the risk is the birth of twins — which occurred with two of the babies with heart defects.
Overall, the findings support that “continuation of natalizumab [Tysabri] beyond conception reduces the risk of relapse during pregnancy, and is not associated with major fetal risks,” Landi said.
“It is worth noting that in case of treatment prolongation up to the third trimester, it is desirable to resume infusions within 12 weeks from the last pre-partum infusion to minimize the risk of disease rebound,” she added.
Of note, more data on Tysabri was presented at ECTRIMS 2019. That data support Tysabri’s long-term benefit for people with early relapsing-remitting MS (RRMS). It also showed that Tysabri can reduce disease relapse rates when given at an extended interval dosing, specifically every six weeks, relative to standard dosing every four weeks.
In her presentation, Landi also said the question of whether “extending dosing [meaning at 6-week intervals] is as protective as regular dosing [4-week intervals] needs to be assessed by future studies, although no differences were seen in our cohort.”
Additional studies with larger patient samples also are needed “to correctly estimate the incidence of fetal complications in Tysabri-exposed pregnancies, and provide conclusive data useful for patient counseling,” Landi added.
Pregnancy was the topic of discussion in a large session on ECTRIMS’ first day. To learn more about that session, please see the following article.


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