Review of the Clinical Debate Regarding Interventions for Multiple Sclerosis

Ryan, Melody; Deno, Sara; Zwibel, Howard

doi:10.18553/jmcp.2009.15.s1-b.1

Cited by 4 publications

(5 citation statements)

References 58 publications

(67 reference statements)

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“…Duration of trial (mo) 6 placebo recipients in the PP population (primary endpoint) [table II], with the benefits of fingolimod treatment evident from 2 months onwards. [48] Secondary MRI endpoints, as assessed in the PP population, also generally favoured fingolimod 1.25 or 5 mg/day relative to placebo treatment at 6 months, including the mean number of T1 Gdenhanced lesions/patient and the percentage of patients free of T1 Gd-enhanced lesions (table II).…”

Section: Fty720 D2201 Study Group Trialmentioning

confidence: 99%

“…[4,5] Clinical signs and symptoms commonly include paraesthesia or numbness, motor weakness, visual disturbances and lack of co-ordination. [3,4,6] The various subtypes of the disease are classified according to the most common clinical course of the disease, with the majority of patients (»80-85%) having relapsingremitting (RR) MS at onset. [4] The exact course of the disease for any given individual shows a high degree of heterogeneity in terms of clinical, immunological and pathomorphological changes.…”

Section: Introductionmentioning

confidence: 99%

“…[5] Approximately 60% of patients with MS are no longer ambulatory within 20 years of disease onset. [4,6] MS is a treatable, but as yet incurable, disease for which there are a limited number of licensed disease-modifying therapies (DMTs) available. [3,4,6] The various subtypes of the disease are classified according to the most common clinical course of the disease, with the majority of patients (»80-85%) having relapsingremitting (RR) MS at onset.…”

Section: Introductionmentioning

confidence: 99%

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Fingolimod

Scott

2011

CNS Drugs

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Oral fingolimod (Gilenya™), a sphingosine 1-phosphate (S1P) receptor agonist, is the first oral agent and the first in a novel class of disease-modifying therapies (DMTs) to be approved for use in the US for the treatment of relapsing forms of multiple sclerosis (MS). In the EU, fingolimod is approved for use as a single-agent DMT in selected patients with highly-active, relapsing-remitting (RR) MS. This article reviews the pharmacological properties and clinical use of the drug in patients with RRMS. Fingolimod is rapidly converted in vivo to the active moiety S-fingolimod-phosphate, which binds with high affinity to S1P receptors, thereby sequestering lymphocytes in the lymph nodes and preventing their egress into the peripheral circulation. As a consequence, there is a reduction in the infiltration of autoaggressive lymphocytes into the CNS. Fingolimod-phosphate also acts as a functional antagonist, as its binding to S1P receptors results in their internalization and degradation, thereby downregulating S1P receptors on the lymphocyte cell surface. Since fingolimod crosses the blood : brain barrier, it also potentially acts at S1P receptors on neural cells in the CNS to mitigate neuropathological processes associated with MS. In large multinational trials in adult patients with RRMS, oral fingolimod 0.5 mg/day was more effective than oral placebo (FREEDOMS) and recommended dosages of intramuscular interferon-β (IFNβ)-1a (TRANSFORMS) in reducing the annualized relapse rate and was also generally more effective at slowing progression of neurological disability and at reducing the burden and activity of disease. Fingolimod was generally well tolerated in these trials of up to 2 years' duration, with most adverse events being manageable and of mild to moderate severity; there were two deaths from opportunistic infections, albeit these occurred with fingolimod 1.25 mg/day (higher than the recommended dosage). Limited long-term data indicated that no new safety concerns had arisen after 5 years of fingolimod treatment. However, further clinical experience is required to fully determine the long-term safety profile of fingolimod, particularly with regard to any potentially serious or life-threatening adverse events. In the absence of robust pharmacoeconomic studies and of head-to-head trials comparing fingolimod with other formulations of IFNβ and glatiramer acetate, the relative position of fingolimod with respect to other DMTs remains to be fully determined. In the meantime, given its convenient once-daily oral treatment regimen and better efficacy than intramuscular IFNβ-1a, fingolimod is a valuable emerging option for the treatment of adult patients with relapsing forms of MS.

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Section: Fty720 D2201 Study Group Trialmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Fingolimod

Scott

2011

CNS Drugs

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“…12 The McDonald criteria require the dissemination in space (DIS) and time (DIT) of MS lesions determined by either clinical, paraclinical, or laboratory analyses (including evaluation of cerebrospinal fluid [CSF] and visual evoked potential [VEP]) and integrate magnetic resonance imaging (MRI) into the diagnosis. 13,14 One of the challenges in diagnosing MS is the overlap of other medical conditions (either demyelinating or nondemyelinating) with respect to both neurological symptoms on patient presentation and the presence of similar appearing lesions on MRI scans.…”

Section: Diagnosis Of Msmentioning

confidence: 99%

“…The overall efficacy and safety of these agents have been described in detail in Ryan et al (2009). 12 This supplement is designed to provide a specific overview of the use of glatiramer acetate and IFNβ in patients with CIS. Natalizumab and mitoxantrone, which are currently approved only as second-line therapies for MS, are not addressed in detail in this supplement.…”

Section: Treatment Of Patients With Cis: Overview Of Clinical Trialsmentioning

confidence: 99%

Current and Future Directions in MS Management: Key Considerations for Managed Care Pharmacists

Lipsy

Schapiro²,

Prostko³

2009

JMCP

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This educational activity discusses several medications that are in phase III clinical trials and have not been approved by the FDA for treatment or management of multiple sclerosis at the time of publication. This list of medications includes cladribine, dimethyl fumarate, fingolimod, laquinimod, teriflunomide, fampridine, alemtuzumab, daclizumab, and rituximab. AcknowledgementsThe authors wish to thank Frank L. Urbano, MD, FACP, of PRIME ® for his assistance with the development of this publication. Alexandria, VA 22314; 703.683.8416; 703.683.8417 (fax F a c u l t y Supplement Policy Statement Standards for Supplements to the Journal of Managed Care PharmacySupplements to the Journal of Managed Care Pharmacy are intended to support medical education and research in areas of clinical practice, health care quality improvement, or efficient administration and delivery of health benefits. The following standards are applied to all JMCP supplements to ensure quality and assist readers in evaluating potential bias and determining alternate explanations for findings and results. 1. Disclose the principal sources of funding in a manner that permits easy recognition by the reader. 2. Disclose the existence of all potential conflicts of interest among supplement contributors, including financial or personal bias. 3. Describe all drugs by generic name unless the use of the brand name is necessary to reduce the opportunity for confusion among readers. 4. Identify any off-label (unapproved) use by drug name and specific off-label indication. 5. Strive to report subjects of current interest to managed care pharmacists and other managed care professionals. 6. Seek and publish content that does not duplicate content in the Journal of Managed Care Pharmacy. 7. Subject all supplements to expert peer review. S1 Introduction S3 Results of Educational Needs Assessment S3 Immunopathology of MS S4 Diagnosis of MS S4 Clinically Isolated Syndrome S5 Is the Current Definition of CIS Adequate? S6 Imaging Modalities in MS S7 Treatment of Patients with CIS: Overview of Clinical Trials S8 Key Implications of Clinical Trials for Managed Care Pharmacists S9 Emerging Therapies for MS S9 Oral Agents S12 Monoclonal Antibodies S12 Key Implications of Emerging Therapies for Managed Care Pharmacists S13 Summary S16 Continuing Education: CE/CME Submission Instructions and Posttest QuestionsTarget Audience This activity is intended for managed care pharmacists and managed care physicians. This is an application-based learning activity. Learning ObjectivesUpon completion of this program, participants will be able to:1. Evaluate data submitted by managed care pharmacists pertaining to current pharmacy practice trends in multiple sclerosis (MS) management.2. Assess newest evidence in MS diagnosis and treatment impacting pharmacy practice.3. Identify paradigm shifts in MS treatment and management and the rapidly evolving role of the managed care pharmacist. Funding and Original Presentation of This Learning ActivityThis supplement was sponsored by P...

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Squinting Through Layers of Fog: Assessing the Cost Effectiveness of Treatments for Multiple Sclerosis

Hawton

Shearer

Goodwin

et al. 2013

Appl Health Econ Health Policy

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There are many complexities for those designing and reporting cost-effectiveness studies of treatments for MS. Analysts, and ultimately decision makers, face multiple data and methodological challenges. Policy makers, technology developers, clinicians, patients and researchers need to acknowledge and address these challenges and to consider recommendations that will improve the current scenario. There is a need for further research that can constructively inform decision-making regarding the funding of treatments for MS.

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Review of the Clinical Debate Regarding Interventions for Multiple Sclerosis

Cited by 4 publications

References 58 publications

Fingolimod

Fingolimod

Current and Future Directions in MS Management: Key Considerations for Managed Care Pharmacists

Squinting Through Layers of Fog: Assessing the Cost Effectiveness of Treatments for Multiple Sclerosis

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