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Ocrevus - ocrelizumab - Primary progressive multiplesclerosis ocrelizumab | CADTH.ca Find the information you need ocrelizumab ocrelizumab Last Updated: May 9, 2018 Result type: Reports Project Number: SR0542-000 Product Line: Generic Name: ocrelizumab Brand Name: Ocrevus Manufacturer: Hoffman-La Roche Limited Indications: Primary progressive multiplesclerosis Submission Type: New Indication Project Status: Complete Biosimilar: No Date Recommendation Issued: April 26, 2018 Recommendation Type (...) to applicant and drug plans April 05, 2018 Embargo period ended and validation of redacted CDR review report(s) received April 19, 2018 CDEC Final Recommendation issued to applicant and drug plans April 26, 2018 CDEC Final Recommendation posted April 30, 2018 Final CDR review report(s) and patient input posted May 08, 2018 Tags multiplesclerosis, multiplesclerosis, chronic progressive, multiplesclerosis, relapsing-remitting, Ocrevus; ocrelizumab; PPMS; primary progressive multiplesclerosis Files Follow
Ocrelizumab (Ocrevus Genentech Inc.) for primary progressive and relapsing-remitting multiplesclerosis Ocrelizumab (Ocrevus; Genentech Inc.) for primary progressive and relapsing-remitting multiplesclerosis Ocrelizumab (Ocrevus; Genentech Inc.) for primary progressive and relapsing-remitting multiplesclerosis HAYES, Inc Record Status This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database (...) . Citation HAYES, Inc. Ocrelizumab (Ocrevus; Genentech Inc.) for primary progressive and relapsing-remitting multiplesclerosis. Lansdale: HAYES, Inc. Healthcare Technology Brief Publication. 2017 Authors' conclusions Multiplesclerosis (MS) is an autoimmune disorder that impacts the spinal cord and brain. MS presents in various forms, including relapsing-remitting MS (RRMS) or primary progressive MS (PPMS). Technology Description: Ocrelizumab (Ocrevus) is a humanized monoclonal antibody therapy
29 Year Old Man with MultipleSclerosis and Schizophrenia: A Case Report Multiplesclerosis (MS) is the most common debilitating neurological disease that affects adults, whether young adults or middle-aged. Although, most attention is toward the neurological signs of the disease, the neuropsychiatric signs are not uncommon. This case report presents a 29 year old male with a record of obsessive-compulsive disorder (OCD) without psychotic disorder, which coincides with the diagnosis MS, has
Ocrelizumab versus Interferon Beta-1a in Relapsing MultipleSclerosis. B cells influence the pathogenesis of multiplesclerosis. Ocrelizumab is a humanized monoclonal antibody that selectively depletes CD20+ B cells.In two identical phase 3 trials, we randomly assigned 821 and 835 patients with relapsing multiplesclerosis to receive intravenous ocrelizumab at a dose of 600 mg every 24 weeks or subcutaneous interferon beta-1a at a dose of 44 μg three times weekly for 96 weeks. The primary end (...) to 0.81; P<0.001), as was the percentage of patients with disability progression confirmed at 24 weeks (6.9% vs. 10.5%; hazard ratio, 0.60; 95% CI, 0.43 to 0.84; P=0.003). The mean number of gadolinium-enhancing lesions per T1-weighted magnetic resonance scan was 0.02 with ocrelizumab versus 0.29 with interferon beta-1a in trial 1 (94% lower number of lesions with ocrelizumab, P<0.001) and 0.02 versus 0.42 in trial 2 (95% lower number of lesions, P<0.001). The change in the MultipleSclerosis
Ocrelizumab versus Placebo in Primary Progressive MultipleSclerosis. An evolving understanding of the immunopathogenesis of multiplesclerosis suggests that depleting B cells could be useful for treatment. We studied ocrelizumab, a humanized monoclonal antibody that selectively depletes CD20-expressing B cells, in the primary progressive form of the disease.In this phase 3 trial, we randomly assigned 732 patients with primary progressive multiplesclerosis in a 2:1 ratio to receive intravenous (...) of serious adverse events and serious infections.Among patients with primary progressive multiplesclerosis, ocrelizumab was associated with lower rates of clinical and MRI progression than placebo. Extended observation is required to determine the long-term safety and efficacy of ocrelizumab. (Funded by F. Hoffmann-La Roche; ORATORIO ClinicalTrials.gov number, NCT01194570 .).
Modelling disease progression in relapsing-remitting onset multiplesclerosis using multilevel models applied to longitudinal data from two natural history cohorts and one treated cohort Modelling disease progression in relapsing-remitting onset multiplesclerosis using multilevel models applied to longitudinal data from two natural history cohorts and one treated cohort Modelling disease progression in relapsing-remitting onset multiplesclerosis using multilevel models applied to longitudinal (...) multiplesclerosis using multilevel models applied to longitudinal data from two natural history cohorts and one treated cohort. Health Technology Assessment 2016; 20(81) Authors' objectives The ability to better predict disease progression represents a major unmet need in multiplesclerosis (MS), and would help to inform therapeutic and management choices. This study aims to develop multilevel models using longitudinal data on disease progression in patients with relapsing–remitting MS (RRMS
Diagnosis of multiplesclerosis: progress and challenges. The diagnosis of multiplesclerosis is based on neurological symptoms and signs, alongside evidence of dissemination of CNS lesions in space and time. MRI is often sufficient to confirm the diagnosis when characteristic lesions accompany a typical clinical syndrome, but in some patients, further supportive information is obtained from cerebrospinal fluid examination and neurophysiological testing. Differentiation is important from other (...) diseases in which demyelination is a feature (eg, neuromyelitis optica spectrum disorder and acute disseminated encephalomyelitis) and from non-demyelinating disorders such as chronic small vessel disease and other inflammatory, granulomatous, infective, metabolic, and genetic causes that can mimic multiplesclerosis. Advances in MRI and serological and genetic testing have greatly increased accuracy in distinguishing multiplesclerosis from these disorders, but misdiagnosis can occur. In this Series
Progressive multiplesclerosis: prospects for disease therapy, repair, and restoration of function. Multiplesclerosis is a major cause of neurological disability, which accrues predominantly during progressive forms of the disease. Although development of multifocal inflammatory lesions is the underlying pathological process in relapsing-remitting multiplesclerosis, the gradual accumulation of disability that characterises progressive multiplesclerosis seems to result more from diffuse (...) immune mechanisms and neurodegeneration. As a result, the 14 anti-inflammatory drugs that have regulatory approval for treatment of relapsing-remitting multiplesclerosis have little or no efficacy in progressive multiplesclerosis without inflammatory lesion activity. Effective therapies for progressive multiplesclerosis that prevent worsening, reverse damage, and restore function are a major unmet need. In this Series paper we summarise the current status of therapy for progressive multiple
Evolving concepts in the treatment of relapsing multiplesclerosis. In the past 20 years the treatment scenario of multiplesclerosis has radically changed. The increasing availability of effective disease-modifying therapies has shifted the aim of therapeutic interventions from a reduction in relapses and disability accrual, to the absence of any sign of clinical or MRI activity. The choice for therapy is increasingly complex and should be driven by an appropriate knowledge of the mechanisms
Disease modifying therapies for relapsing multiplesclerosis. Multiplesclerosis (MS) is a common, disabling, putatively autoimmune neurological disease with worldwide distribution. It typically begins as a relapsing disorder that later evolves to a secondary progressive phase. Inflammatory and neurodegenerative mechanisms seem to operate in both phases, but their relative contributions and interactions are incompletely understood. Disease modifying therapies (DMTs) approved for relapsing (...) multiplesclerosis interfere with a variety of immunological mechanisms to reduce rates of relapse, accumulation of disease burden measured by magnetic resonance imaging (MRI), and decline in neurological function over the two to three year duration of typical randomized controlled trials. Benefits of longer duration of therapy on disability are less clear, as data beyond three years are largely limited to observational studies. However, current DMTs do not slow accrual of disability once progressive
Daclizumab (Zinbryta) - multiplesclerosis Zinbryta (daclizumab) Injection U.S. Department of Health and Human Services Search FDA Submit search Zinbryta (daclizumab) Injection Zinbryta Company: Biogen Inc. Application No.: 761029 Approval Date: 05/27/2016 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) Date created: July 7, 2016 Vision
The Effectiveness of Group Cognitive Behavioral Therapy in Treating Obsessive-Compulsive Disorder in Women with MultipleSclerosis (MS): A randomized double-blind controlled trial. Obsessive-compulsive disorder (OCD) is one of the most prevalent psychiatric disorders and can cause problems for individuals in all aspects of life, including social and personal dimensions.To study the effect of group cognitive-behavioral therapy on the reduction of OCD symptoms in female participants with multiple (...) sclerosis (MS).This double-blind randomized control trial was conducted from May 2012 to December 2014. The participants included 75 patients with MS who suffered from OCD and were referred to the Loghman Hakim and Imam Khomeini hospitals in Tehran, Iran. Thirty participants had been diagnosed through Yale-Brown Obsessive-Compulsive Symptoms (Y-BOCS). The participants were randomly divided into an experimental group (n=15) and a control group (n=15). Eleven sessions of cognitive-behavioral therapy were
Delta-9-tetrahydrocannabinol/Cannabidiol for Spasticity in MultipleSclerosis: Clinical Effectiveness and Guidelines Delta-9-tetrahydrocannabinol/Cannabidiol for Spasticity in MultipleSclerosis: Clinical Effectiveness and Guidelines | CADTH.ca Find the information you need Delta-9-tetrahydrocannabinol/Cannabidiol for Spasticity in MultipleSclerosis: Clinical Effectiveness and Guidelines Delta-9-tetrahydrocannabinol/Cannabidiol for Spasticity in MultipleSclerosis: Clinical Effectiveness (...) and Guidelines Published on: May 4, 2016 Project Number: RB0983-000 Product Line: Research Type: Drug Report Type: Summary of Abstracts Result type: Report Question 1. What is the clinical effectiveness of delta-9-tetrahydrocannabinol/cannabidiol for the treatment of spasticity in patients with MultipleSclerosis? 2. What are the evidence-based guidelines associated with delta-9-tetrahydrocannabinol/cannabidiol for the treatment of spasticity in patients with MultipleSclerosis? Key Message Three systematic
Modifiable Risk Factors in the Progression of MultipleSclerosis Management Briefs eBrief-no111 -- Enter search terms Button to search HSRD ® Inside VA Budget and Performance Inside the News Room National Observances Special Events » » » » » Management Briefs eBrief-no111 -- Health Services Research & Development Management eBrief no. 111 » Issue 111 April 2016 The report is a product of the VA/HSR&D Evidence Synthesis Program. Systematic Review: Modifiable Risk Factors in the Progression (...) of MultipleSclerosisMultiplesclerosis (MS) is the most common progressive disease of the central nervous system in young adults and the cause of serious physical disability in adults of working age. MS disease presentation is very heterogeneous with variable clinical manifestations that evolve over time. In about 50 percent of patients the course of MS changes from relapsing-remitting to secondary progressive disease after ten years. Relapsing-remitting disease manifests in relapses followed by periods
Evaluation of KIR4.1 as an Immune Target in MultipleSclerosis. 27074083 2016 04 25 2018 11 13 1533-4406 374 15 2016 Apr 14 The New England journal of medicine N. Engl. J. Med. Evaluation of KIR4.1 as an Immune Target in MultipleSclerosis. 1495-6 10.1056/NEJMc1513302 Chastre Anne A Yale School of Medicine, New Haven, CT email@example.com. Hafler David A DA Yale School of Medicine, New Haven, CT firstname.lastname@example.org. O'Connor Kevin C KC Yale School of Medicine, New Haven, CT (...) NIH HHS United States U19 AI046130 AI NIAID NIH HHS United States GM093080 GM NIGMS NIH HHS United States Letter Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't United States N Engl J Med 0255562 0028-4793 0 Antibodies, Monoclonal 0 Autoantibodies 0 Biomarkers 0 Kcnj10 (channel) 0 Potassium Channels, Inwardly Rectifying AIM IM Antibodies, Monoclonal Autoantibodies blood Biomarkers blood Case-Control Studies Enzyme-Linked Immunosorbent Assay Humans MultipleSclerosis diagnosis
Teriflunomide for multiplesclerosis. This is an update of the Cochrane review "Teriflunomide for multiplesclerosis" (first published in The Cochrane Library 2012, Issue 12).Multiplesclerosis (MS) is a chronic immune-mediated disease of the central nervous system. It is clinically characterized by recurrent relapses or progression, or both, often leading to severe neurological disability and a serious decline in quality of life. Disease-modifying therapies (DMTs) for MS aim to prevent (...) , fingolimod, dimethyl fumarate, alemtuzumab) for modifying the disease course in people with MS.We searched the Cochrane MultipleSclerosis and Rare Diseases of the CNS Group Specialised Trials Register (30 September 2015). We checked reference lists of published reviews and retrieved articles and searched reports (2004 to September 2015) from the MS societies in Europe and America. We also communicated with investigators participating in trials of teriflunomide and the pharmaceutical company, Sanofi
Vitamin D for the Treatment or Prevention of MultipleSclerosis: A Review of the Clinical Effectiveness Vitamin D for the Treatment or Prevention of MultipleSclerosis: A Review of the Clinical Effectiveness | CADTH.ca Find the information you need Vitamin D for the Treatment or Prevention of MultipleSclerosis: A Review of the Clinical Effectiveness Vitamin D for the Treatment or Prevention of MultipleSclerosis: A Review of the Clinical Effectiveness Published on: March 10, 2016 Project (...) Number: RC0755-000 Product Line: Research Type: Drug Report Type: Summary with Critical Appraisal Result type: Report Question What is the clinical effectiveness of vitamin D supplementation for the prevention of multiplesclerosis? What is the clinical effectiveness of high versus low dose vitamin D supplementation for the prevention of multiplesclerosis? What is the clinical effectiveness of vitamin D supplementation for the treatment of multiplesclerosis? What is the clinical effectiveness