TITUSVILLE, N.J., Sept. 2, 2020 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that 13 company-sponsored data presentations from its multiple sclerosis (MS) research program are now available as part of MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting.
Among the data presented are results from a new study of a patient-reported outcome instrument, the Fatigue Symptoms and Impacts Questionnaire – Relapsing MS (FSIQ-RMS), a real-world evidence study characterizing the symptoms and impact of fatigue in U.S. adults with relapsing MS (RMS); a study that examined the demographics, comorbidities and healthcare resources of adults with RMS-related fatigue; and a meta-analysis examining the effect of treatment with ponesimod versus teriflunomide on disability measures in patients with RMS.
"We are proud of our expanded research and development into neurodegenerative conditions, like MS, where we can leverage our deep understanding of brain disorders to develop transformational medicines," said Bill Martin, Ph.D., Global Therapeutic Head, Neuroscience, Janssen Research & Development, LLC. "We are delighted to present our latest MS research highlighting disease insights and the encouraging efficacy and safety of our investigational RMS therapy, ponesimod, at MSVirtual2020."
Key Janssen Data Presentations Include:
A Real-World Study Characterizing Symptoms and Impacts of Fatigue in U.S. Adults with Relapsing Multiple Sclerosis Using a Novel Disease Specific Scale (Presentation #P1004)
Using the novel Patient Reported Outcome instrument, the Fatigue Symptoms and Impacts Questionnaire-Relapsing Multiple Sclerosis (FSIQ-RMS), this study measured MS fatigue and its impact on daily life in a real-world patient population.
Comorbidity and Economic Burdens of Fatigue Among Patients with Relapsing-Remitting Multiple Sclerosis in the United States (Presentation #P0857)
MS-related fatigue is a common symptom of RMS, yet the demographic and clinical characteristics of these patients, as well as associated economic and health burden, are poorly understood. This study sought to identify demographics, comorbidities and healthcare resources of adults with RMS with low to high levels of fatigue in comparison to adults without MS.
Effect on Disability Measures and Multiple Sclerosis Functional Composite (MSFC) in Patients with Relapsing Multiple Sclerosis from the Phase 3 Ponesimod Versus Teriflunomide OPTIMUM Study (Presentation #P0204)
This study assessed treatment effect of ponesimod in comparison to teriflunomide on disability progression using a variety of impairment and disability analyses.
A complete listing of Janssen-sponsored abstracts is provided below and available on the MSVirtual2020 website: https://msvirtual2020.org/.
In addition, Janssen will host an interactive virtual booth inclusive of educational videos, information and resources addressing RMS and fatigue for meeting participants. Separately, the company will also feature a two-part educational product theater session on the science and pathophysiology of MS, and the patient perspective on MS-related fatigue.
Effect of Oral Ponesimod on Clinical Disease Activity and MRI-based Outcomes in Patients with Relapsing Multiple Sclerosis: Phase 3 OPTIMUM Study
Effect on Disability Measures and MSFC in Patients with Relapsing Multiple Sclerosis from the Phase 3 Ponesimod Versus Teriflunomide OPTIMUM Study
A Real-World Study Characterizing Symptoms and Impacts of Fatigue in U.S. Adults with Relapsing Multiple Sclerosis Using a Novel Disease Specific Scale
Cardiac Safety of Ponesimod in Relapsing Multiple Sclerosis in the Randomized, Active-Controlled, Double-Blind, Parallel-Group Phase 3 OPTIMUM Study
Long-Term Efficacy and Safety of Ponesimod: Results from Randomized Phase II Core and Extension Studies in Relapsing–Remitting Multiple Sclerosis
Pharmacokinetic-Pharmacodynamic Models of Lymphocyte Count and Heart Rate Following Ponesimod Dosing in a Phase 2 Study in Multiple Sclerosis Patients
Treatment Preferences of Patients with Refractory Multiple Sclerosis: A Discrete Choice Experiment
Comparative Efficacy of Relapsing Multiple Sclerosis Therapies: A Model-Based Meta-Analysis for Annual Relapse Rate
Establishing Meaningful Change Threshold in Multiple Sclerosis-Related Fatigue on Fatigue Symptoms & Impacts Questionnaire-Relapsing MS (FSIQ-RMS)
Comparative Efficacy of Relapsing Multiple Sclerosis Therapies: A Longitudinal Model-Based Meta-Analysis for Confirmed Disability Accumulation
Systematic Literature Review on Economic and QoL of MS-Related Fatigue (results show higher cost, lower QoL with MS)
Treatment Persistency for Patients in a Phase 2 Long-Term Extension Study of Ponesimod
Comorbidity and Economic Burdens of Fatigue Among Patients with Relapsing-Remitting Multiple Sclerosis in the United States
Ponesimod is an investigational highly-selective sphingosine-1-phosphate receptor 1 (S1P1) modulator that functionally inhibits S1P receptor activity and, in so doing, is believed to reduce the number of circulating lymphocytes that can cross the blood-brain barrier. In patients with MS, the movement of immune cells into the brain damages myelin, the protective sheath that insulates nerve cells. Damage to myelin slows or halts nerve conduction, producing the neurologic signs and symptoms of MSi.
A member of the Janssen Pharmaceutical Companies of Johnson & Johnson, Actelion Pharmaceuticals Ltd is party to a revenue-sharing agreement with Idorsia Pharmaceuticals Ltd, which provides for certain payments to Idorsia related to the sales of ponesimod.
About Multiple Sclerosis (MS)
MS is a chronic autoimmune inflammatory disease of the central nervous system affecting 2.3 million people worldwide,ii with females more impacted than males.iii The disease is characterized by demyelinationii and axonal loss leading to neurological impairment and severe disability.iv Relapsing forms of MS, which make up 85 percent of all MS cases, include clinically isolated syndrome, relapsing-remitting MS and active secondary progressive MS.v 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 health-related quality of life.vi Fatigue is one of the most common symptoms of MS, occurring in about 80 percent of patients.vii
Relapses are defined as new, worsening or recurrent neurological symptoms that last for more than 24 hours with the absence of fever or infections. Relapses may be fully resolved over days or weeks or lead to persistent residual deficits and accumulation of disability.viii
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.
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding ponesimod. 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 materialize, 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 behavior 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.