ABSTRACT
With evolving diagnostic criteria and the advent of new oral and parenteral therapies for Multiple Sclerosis (MS), most current diagnostic and treatment algorithms need revision and updating. The diagnosis of MS relies on incorporating clinical and paraclinical findings to prove dissemination in space and time and exclude alternative diseases that can explain the findings at hand. The differential diagnostic workup should be guided by clinical and laboratory red flags to avoid unnecessary tests. Appropriate selection of MS therapies is critical to maximize patient benefit. The current guidelines review the current diagnostic criteria for MS and the scientific evidence supporting treatment of acute relapses, radiologically isolated syndrome, clinically isolated syndrome, relapsing remitting MS, progressive MS, pediatric cases and pregnant women. The purpose of these guidelines is to provide practical recommendations and algorithms for the diagnosis and treatment of MS based on current scientific evidence and clinical experience.
Subject(s)
Multiple Sclerosis, Chronic Progressive , Multiple Sclerosis, Relapsing-Remitting , Multiple Sclerosis , Pregnancy , Female , Humans , Child , Multiple Sclerosis/diagnosis , Multiple Sclerosis/therapy , Consensus , Multiple Sclerosis, Relapsing-Remitting/diagnosis , RecurrenceABSTRACT
With evolving diagnostic criteria and the advent of new oral and parenteral therapies for MS, most current diagnostic and treatment algorithms need revision and updating. The diagnosis of MS relies on incorporating clinical and paraclinical findings to prove dissemination in space and in time, and exclude alternative diseases that can explain the findings at hand. The differential diagnostic workup should be guided by clinical and laboratory red flags to avoid unnecessary tests. Appropriate selection of multiple sclerosis (MS) therapies is critical to maximize patient benefit. The current guidelines review the scientific evidence supporting treatment of acute relapses, radiologically isolated syndrome, clinically isolated syndrome, relapsing remitting MS, and progressive MS. The purpose of these guidelines is to provide practical recommendations and algorithms for the diagnosis and treatment of MS based on current scientific evidence and clinical experience.
Subject(s)
Consensus , Multiple Sclerosis/diagnosis , Multiple Sclerosis/therapy , Practice Guidelines as Topic , Africa, Northern , Humans , Middle EastABSTRACT
With evolving diagnostic criteria and the advent of new oral and parenteral therapies for MS, most current diagnostic and treatment algorithms need re-evaluation and updating. The diagnosis of MS relies on incorporating clinical and paraclinical findings to prove dissemination in space and in time, and exclude alternative diseases that can explain the findings at hand. The differential diagnostic workup should be guided by clinical and laboratory red flags to avoid unnecessary tests. Appropriate multiple sclerosis (MS) therapy selection is critical to maximize patient benefit. The current guidelines review the scientific evidence supporting treatment of acute relapses, radiologically isolated syndrome, clinically isolated syndrome, relapsing remitting MS, secondary progressive MS, and primary progressive MS. The purpose of these guidelines is to provide practical recommendations and algorithms for the diagnosis and treatment of MS based on current scientific evidence and clinical experience.
Subject(s)
Multiple Sclerosis, Relapsing-Remitting/diagnosis , Multiple Sclerosis/diagnosis , Practice Guidelines as Topic , Africa, Northern , Consensus , Humans , Middle East , Multiple Sclerosis/therapy , Multiple Sclerosis, Relapsing-Remitting/therapy , RecurrenceABSTRACT
The diagnosis of multiple sclerosis (MS) is dependent on the presence of clinical and paraclinical evidence demonstrating dissemination of central nervous system lesions in both space and time, as well as the exclusion of other disorders. Diagnostic criteria were originally promulgated in 1965 by the Schumacher committee and modified subsequently by the Poser committee to include paraclinical evidence. The most recent criteria are the 2010 modifications of the 2001 McDonald criteria, which are focused on making an earlier diagnosis of MS. This article provides guidelines, derived from clinical experience as well as evidence-based medicine, for the diagnosis and management of MS with special emphasis on practices in the Middle East.
Subject(s)
Immunosuppressive Agents/therapeutic use , Multiple Sclerosis/diagnosis , Multiple Sclerosis/therapy , Antibodies, Monoclonal, Humanized/therapeutic use , Fingolimod Hydrochloride , Humans , Interferon beta-1a , Interferon beta-1b , Interferon-beta/therapeutic use , Middle East , Myelitis/diagnosis , Natalizumab , Optic Nerve Diseases/diagnosis , Optic Neuritis/diagnosis , Propylene Glycols/therapeutic use , Sphingosine/analogs & derivatives , Sphingosine/therapeutic use , Spinal Cord Diseases/diagnosisABSTRACT
BACKGROUND: Several biotechnology-derived drugs are reaching the end of their patent lives. As a result, so-called biosimilar products are in development, and a few have already gained approval in Europe and other countries such as the USA. Biosimilars, unlike generic versions of conventional drugs, are not identical to their reference product, and their production is complex and sensitive to even slight changes in the manufacturing and storage process. Therefore, the registration of these products requires more stringent evaluation than that for conventional generics. METHODS AND SCOPE: A consensus group of experts from the Near and Middle East discussed the currently available guidelines for registration of biosimilars--including those produced by the European Medicines Agency (EMEA)--and their application in this region. To inform this report, a literature search was also conducted on PubMed in January 2008, using the search terms 'biosimilar' and 'follow-on biologic'. This paper provides an overview of the issues in the development and registration of biosimilars, a description of the EMEA guidelines and the recommendations of the consensus group for the registration of biosimilars in the Middle East. FINDINGS: Because of the complex nature of biosimilars and their potential immunogenicity, these products cannot undergo the abbreviated approval process used for generic agents. Instead demonstration of their quality, safety and efficacy, in comparison with their reference biological product, is required. CONCLUSIONS: The consensus group recommended the implementation of the EMEA guidelines as the basis of Regional guidelines for the registration of biosimilars in the Near and Middle East. Registration would, therefore, require demonstration of the robustness of the manufacturing process and quality-control methods, the comparability of pharmacokinetics, pharmacodynamics, efficacy and safety between the biosimilar and reference product and plans for post-marketing surveillance of the long-term risks and immunogenicity of new biosimilars.
