Business Wire

Janssen Highlights Impact of Multiple Sclerosis-Related Fatigue with Real-World Study Data Presentation at MSVirtual2020 and Global Patient Survey

Share

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data from a real-world evidence study demonstrating high levels of fatigue and its impact on patients’ lives in the areas of physical, cognitive/emotional and coping activities, among a majority of adult patients with relapsing multiple sclerosis (RMS). These data are being shared online as a poster presentation (#P1004) during MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting.

The study, which enrolled 200 U.S. patients with RMS measured multiple sclerosis (MS)-related fatigue and its impact on daily life using the Fatigue Symptoms and Impacts Questionnaire – Relapsing Multiple Sclerosis (FSIQ-RMS), a novel disease-specific scale developed using methods consistent with the U.S. Food & Drug Administration guidelines. The FSIQ-RMS is a patient-reported outcome instrument that has demonstrated content and measurement validity for RMS fatigue-related symptom and impact items. The MS symptom with most impact on daily functioning was fatigue (33 percent), followed by walking difficulties (25 percent).1

“MS is one of the most common causes of neurological disability in young and middle-aged adults, with over 700,000 people in Europe affected by the condition,” said Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Janssen Research & Development, LLC. “At Janssen, we approach neurodegenerative conditions holistically, considering both fundamental and secondary – or ‘hidden’ – symptoms. As such, we developed the FSIQ-RMS to better understand and measure the severity of MS-related fatigue and its impact on daily function, so that these insights can be applied to develop meaningful therapeutic options, as well as educational initiatives to help people with MS, and their healthcare team, better manage this prominent symptom.”

Separately, Janssen, in partnership with the National Multiple Sclerosis Society (NMSS), recently conducted a global patient research survey to examine the impact of MS-related fatigue across social and emotional aspects of daily life.2 The survey included 1,300 adult patients with MS living in the United States, Germany, Canada, France, the United Kingdom and Italy.2 The survey results show more than 65 percent of patients with MS experience fatigue on a daily basis with 60 percent stating their fatigue has worsened since their diagnosis.2 Other survey findings reveal:2

  • More than 75 percent of patients agree it’s difficult for others in their life to truly understand how fatigue impacts them.
  • Nearly 70 percent of respondents feel they should hide their fatigue from others.
  • Over 40 percent of respondents reported feeling lonely as a result of their fatigue.
  • Approximately 37 percent stated they had trouble making new friends or had strained friendships because of fatigue.
  • Nearly half of patients take breaks throughout the day to manage their fatigue. In the workplace specifically, 85 percent reported their fatigue impacts how they feel and act at work.
  • More than one-third of respondents reported they either arrived late or left work early, called in sick (from work) or missed family/social activities because of their fatigue.
  • More than 90 percent of patients have discussed their fatigue with their healthcare provider (HCP); however, 56 percent say they don’t feel their HCP fully understands the overall impact fatigue has on their daily lives.

#ENDS#

About Multiple Sclerosis (MS)

MS is a chronic autoimmune inflammatory disease of the central nervous system.3 It affects more than 700,000 people in Europe, and is one of the most common causes of neurological disability in young and middle-aged adults, with females up to three times more frequently impacted than males.4,5,6 While prevalence varies worldwide, it is highest in Europe and North America.7 The disease is characterised by demyelinationand axonal loss leading to neurological impairment and severe disability.8,9 Relapsing forms of MS include clinically isolated syndrome, relapsing-remitting MS (which makes up 85 percent of all MS cases), and secondary progressive MS.10 In addition to the debilitating neurological symptoms of the disease, patients often also suffer from “hidden symptoms,” namely fatigue and depression, both of which are major contributors to reduced quality of life.11 Fatigue is one of the most common symptoms of MS, occurring in about 80 percent of patients.12

Relapses are defined as new, worsening or recurrent neurological symptoms that last for more than 24 hours with the absence of fever or infections. 13 Relapses may be fully resolved over days or weeks or lead to persistent residual deficits and accumulation of disability.9,13

About the National Multiple Sclerosis Society (NMSS)

The National Multiple Sclerosis Society exists because there are people with MS. Our vision is a world free of MS. Everything we do is focused so that people affected by MS can live their best lives as we stop MS in its tracks, restore what has been lost and end MS forever.

We are more than an organisation. We are a movement. United in our collective power to do something about MS now and end this disease forever. The gathering place for people with MS, their family and loved ones, healthcare providers, volunteers, donors, fundraisers, advocates, community leaders and all those that seek a world free of MS. A place to connect and take action. In order to change the world, we mobilise all possible human and financial resources to achieve results.

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at www.janssen.com/emea. Follow us at www.twitter.com/JanssenEMEA. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

_____________________________

1 Azoulai M, et al. A real-world study characterizing symptoms and impacts of fatigue in US adults with relapsing multiple sclerosis using a novel disease specific scale. Accessed September 2020 at MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting on 11 September 2020.

2 Janssen Data on File. RF-139281.

3 National Multiple Sclerosis Society. Multiple Sclerosis FAQs. Available at: https://www.nationalmssociety.org/What-is-MS/MS-FAQ-s. Accessed September 2020.

4 Gitto L. Multiple Sclerosis: Living with Multiple Sclerosis in Europe: Pharmacological Treatments, Cost of Illness, and Health-Related Quality of Life Across Countries. In: Multiple Sclerosis: Perspectives in Treatment and Pathogenesis. Ian S. Zagon and Patricia J. McLaughlin (Editors), Codon Publications, Brisbane, Australia. ISBN: 978-0-9944381-3-3.

5 Gitto L. Multiple Sclerosis patients’ awareness of disease and compliance to pharmacological treatment with Disease Modifying Drugs (DMDs). Eur J Pers Cent Healthc. 2016 Dec;4(4):599–608.

6 National Multiple Sclerosis Society. Who Gets MS. Available at: https://www.nationalmssociety.org/What-is-MS/Who-Gets-MS. Accessed September 2020.

7 MS International Federation. Who gets MS? Available at: https://www.msif.org/about-ms/epidemiology-of-ms/ Accessed September 2020.

8 National Multiple Sclerosis Society. What is myelin? Available at: https://www.nationalmssociety.org/What-is-MS/Definition-of-MS/Myelin. Accessed September 2020.

9 Lublin FD, Baier M, Cutter G. Effect of relapses on development of residual deficit in multiple sclerosis. Neurology. 2003;61:1528-1532.

10 National Multiple Sclerosis Society. What is MS? Types of MS. Available at: https://www.nationalmssociety.org/What-is-MS/Types-of-MS. Accessed September 2020.

11 Biernacki T, Sandi D, Kincses ZT, et al. Contributing factors to health-related quality of life in multiple sclerosis. Brain Behav. 2019;00:e01466. https://doi.org/10.1002/brb3.1466.

12 National Multiple Sclerosis Society. Fatigue. Available at: https://www.nationalmssociety.org/Symptoms-Diagnosis/MS-Symptoms/Fatigue. Accessed September 2020.

13 Multiple Sclerosis Association of America. What is an MS relapse? Available at: https://mymsaa.org/publications/ms-relapse-toolkit/what-relapse/. Accessed September 2020.

EM-41433

September 2020

Contact information

Media:
Cristiana Maria
Mobile: +32 473 11 28 10
Email: cmaria@its.jnj.com

Investor Relations:
Chris DelOrefice
Office: +1 (732) 524-2955
Jennifer McIntyre
Office: +1 (732) 524-3922

About Business Wire

Business Wire
Business Wire



Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

GPD Companies, Inc. to Acquire Distrupol22.1.2021 14:33:00 CETPress release

GPD Companies, Inc., an affiliate of One Rock Capital Partners, LLC (“One Rock”), today announced that it has entered into a definitive agreement to acquire Distrupol, a subsidiary of Univar Solutions Inc. (NYSE: UNVR) and a leading European distributor of thermoplastics to the polymer processing industry. Terms of the transaction, which is expected to close in the first half of 2021, were not disclosed. Headquartered in Surrey, England, with broad geographic reach across Europe, Distrupol has provided value-added sales and application development of thermoplastic resins for over 50 years. Through its decades-long relationships with world class supply partners, the company offers a robust array of superior performance products and solutions that meet the needs of diverse end users from leading and emerging industries, such as the consumer, medical, automotive, and electrical sectors, among others. Distrupol caters to over 1,300 customers across 13 countries with a portfolio of over 4,0

Schlumberger Announces Fourth-Quarter and Full-Year 2020 Results22.1.2021 12:50:00 CETPress release

Schlumberger Limited (NYSE: SLB) today reported results for the fourth-quarter and full-year 2020. Fourth-Quarter Results(Stated in millions, except per share amounts)Three Months EndedChangeDec. 31, 2020Sept. 30, 2020Dec. 31, 2019SequentialYear-on-yearRevenue $5,532 $5,258 $8,228 5% -33%Income (loss) before taxes - GAAP basis $471 $(54) $452 n/m 4%Net income (loss) - GAAP basis $374 $(82) $333 n/m 12%Diluted EPS (loss per share) - GAAP basis $0.27 $(0.06) $0.24 n/m 12% Adjusted EBITDA* $1,112 $1,018 $1,648 9% -33%Adjusted EBITDA margin* 20.1% 19.4% 20.0% 73 bps 6 bpsPretax segment operating income* $654 $575 $1,006 14% -35%Pretax segment operating margin* 11.8% 10.9% 12.2% 90 bps -40 bpsNet income, excluding charges & credits* $309 $228 $545 35% -43%Diluted EPS, excluding charges & credits* $0.22 $0.16 $0.39 37% -44% Revenue by Geography International $4,343 $4,210 $5,834 3% -26%North America 1,167 1,034 2,339 13% -50%Other 22 14 55 n/m n/m $5,532 $5,258 $8,228 5% -33% *These are non-

JEOL: Release of a New Cold Field Emission Cryo-Electron Microscope CRYO ARM™ 300 II (JEM-3300)22.1.2021 07:00:00 CETPress release

JEOL Ltd. (TOKYO:6951) (President & COO Izumi Oi) announces the release of a new cold field emission cryo-electron microscope (cryo-EM), the CRYO ARM™ 300 II (JEM-3300), to be released in January 2021. This new cryo-EM has been developed based on the concept of "Quick and easy to operate and get high-contrast and high-resolution images". This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210121005316/en/ Cold Field Emission Cryo-Electron Microscope CRYO ARM(TM) 300 II (JEM-3300) (Photo: Business Wire) Development Background Recent dramatic improvement of resolution in single particle analysis (SPA) using cryo-EM has led to SPA as an essential method for structural analysis of proteins. To address this market, JEOL released the CRYO ARM™ 300 in 2017. Equipped with a cold field emission gun (Cold FEG) for enhanced resolution and a cryo-stage for loading multiple samples, the CRYO ARM™ 300 has continued to achieve best-in-class res

ViiV Healthcare announces FDA approval of Cabenuva (cabotegravir, rilpivirine), the first and only complete long-acting regimen for HIV treatment21.1.2021 23:12:00 CETPress release

ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) approved Cabenuva, the first and only complete long-acting regimen for the treatment of HIV-1 infection in adults. Cabenuva is provided as a co-pack with two injectable medicines — ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine— dosed once monthly, as an option to replace the current antiretroviral (ARV) regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per milliliter [mL]) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine. Prior to initiating treatment of Cabenuva, oral dosing of cabotegravir and rilpivirine should be administered for approximately one month to assess the tolerability of each therapy.1 Lynn Baxter, Head of North America, ViiV He

Incyte Announces Acceptance and Priority Review of BLA for Retifanlimab as a Potential Treatment for Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC)21.1.2021 22:30:00 CETPress release

Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. The BLA submission is based on data from the Phase 2 POD1UM-202 trial evaluating retifanlimab in previously treated patients with locally advanced or metastatic SCAC who have progressed on, or are intolerant of, standard platinum-based chemotherapy. The trial enrolled 94 patients, including several with well-controlled human immunodeficiency virus (HIV) infection. The study, which was recently presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, resulted in an objective response rate (ORR) of 14% for retifanlimab monotherapy as determined by inde

Wistron and Kalray Announce FURIO1200™ Storage Appliance21.1.2021 17:45:00 CETPress release

Wistron, a leader in ICT (Information and communications technology) products, and Kalray (Paris:ALKAL) (Euronext Growth Paris: ALKAL), a leading provider in new generation of processors specialized in Intelligent Data Processing from Cloud to Edge, announce the availability of FURIO1200™, a 24-Flash-Drive NVMe-oF based storage node appliance, integrating Kalray’s NVMe-oF K200™ smart storage adapter, powered by its MPPA® Coolidge™ intelligent processor, and Wistron LYMMA chassis. FURIO1200™ is a new type of hyper-fast disaggregated storage solution delivering ultra-high throughput and reliability. It is the ideal solution for Cloud Service Providers and Enterprises running applications with intensive AI and Data Analytics workloads as well as to optimize their next generation storage. Data Centers are undergoing a very important revolution due to the explosion of usages, the surge of data to be processed and the exponential growth of the number of machines to be managed to support this

NumAlim Selects Dawex and Orange Business Services for its Data and Services Exchange Platform21.1.2021 17:40:00 CETPress release

NumAlim announced an agreement with Dawex, the leader in Data Exchange technology, and Orange Business Services, a network-native digital services company, to deploy its agri-food digital exchange platform. By relying on these two leading players, NumAlim chose secure technological solutions guaranteeing the sovereignty of French food data. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210121005722/en/ (Photo: Dawex) As early as Q1 2021, the NumAlim data and services exchange "Hub" will offer 18,000 companies in the food industry the opportunity to valorize, acquire and enrich all types of data: production, consumption, traceability, consumer opinions and research, as well as a wide range of services based on data (trend analysis, reformulation, regulatory watch…). "NumAlim is the answer to the needs for transparency, value creation and trust expressed by the food industry, consumers, and public authorities.” says Jérôme Fr

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom