Browsing by Author "Steinberg, Judith"

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    Coronavirus disease 2019 in Latin American patients with multiple sclerosis
    (ELSEVIER SCI LTD, 2021) Fragoso, Yara D.; Schiavetti, Irene; Carmisciano, Luca; Ponzano, Marta; Steinberg, Judith; Trevino Frenk, Irene; Ciampi, Ethel; Vecino, Maria Cecilia A.; Correa, Edgar P.; Carcamo Rodriguez Claudia Andrea; Gomes, Sidney; Pimentel, Maria Lucia V.; Santos, Gutemberg A. C.; Vrech, Carlos; Winckler, Thereza C. A.; Sormani, Maria Pia
    Patients with multiple sclerosis (MS) who present coronavirus disease 2019 (COVID-19) are of particular interest to neurologists. These patients have a neuroimmune disease and receive immunomodulatory or immunosuppressive therapies in the long-term. We present here data from 73 patients with MS and a confirmed diagnosis of COVID-19 from five Latin American countries. Fifteen patients (20.5%) were hospitalized and two patients died. The use of anti-CD20 therapies was the only risk factor associated to hospitalization and death. Despite the small sample size, this study highlights the awareness regarding therapeutic options for MS during the pandemic.
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    Practical Issues Concerning the Approval and Use of Biosimilar Drugs for the Treatment of Multiple Sclerosis in Latin America
    (2019) Steinberg, Judith; Dadalti Fragoso, Yara; Duran Quiroz, Juan Carlos; García,Juan Raul; Guerra, Caroline; Rodriguez, Virginia; Cárcamo Rodríguez, Claudia Andrea; Ciampi Diaz, Ethel Leslie; Correa-Diaz, Edgar; Macías, Miguel; Novarro, Nelson; Vizcarra, Darwin; Oehninger Gatti, Carlos; Orozco, Geraldine; Carrá, Adriana
    The use of biosimilar drugs for multiple sclerosis (MS) has become widespread in Latin America, with the goal of reducing costs of treatments, promoting the sustainability of healthcare systems, and improving patient access to these therapies. There is currently a need to define and comply with requirements to guarantee the efficacy, safety, and quality of these drugs. Thus, the objective of the present study was to compile up-to-date information from each Latin American country assessed on (a) approval of biosimilar drugs by regulatory agencies; (b) use of biosimilar drugs, pharmacovigilance plans, risk management; and (c) update in the knowledge on different molecules. To do so, a group of experts from Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, Panama, Peru, Uruguay, and Venezuela met to discuss the current situation regarding good practices and risks associated with the use of biosimilar drugs in their respective countries. Regulation, risk management plans, and pharmacovigilance in the whole continent must guide the strategies on the commercialization and access of biosimilar drugs and copies of complex molecules. Current regulations must be implemented for the registration of biosimilar drug products and complex molecules. It is paramount to ensure that new products follow the best quality standards at all stages beyond being safe and efficient. Uncontrolled interchangeability between original biological and biosimilar should be avoided. Latin America requires the implementation and full use of strong pharmacovigilance programs. National and multinational clinical studies are required to demonstrate the similarity in safety, efficacy, and immunogenicity profiles of complex molecules, as well as biological and biosimilar products.
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    Practical issues concerning the use of Magnetic Resonance Imaging in Multiple Sclerosis in Latin America: discussion from 16 centres on behalf of the Foro Latam EM Study Group
    (Elsevier B.V., 2022) Ciampi, Ethel; Guerra-Posada, Carolina; Treviño-Frenk, Irene; Cortes-Enriquez, Fernando; Correa-Díaz, Edgar Patricio; Steinberg, Judith; Fragoso, Yara; Garcia Bonitto, Juan; Macias, Miguel Angel; Novarro, Nelson; Carra, Adriana; Vizcarra, Darwin; Vrech, Carlos; Cárcamo Rodríguez, Claudia Andrea
    MAGNIMS-CMSC-NAIMS consensus recommendations on the use of MRI in patients with multiple sclerosis have been recently published, and they have been fundamental for improving patient care. Implementation of these and previous MAGNIMS recommendations have not been established in many countries. Addressing the local limitations behind these difficulties is needed. A panel of 14 MS neurologists from 16 different reference centres from Chile, Argentina, Mexico, Colombia, Ecuador, Panamá, Perú and Brazil met to discuss the current situation regarding the use of MRI in MS including a) Access and availability, b) Standardized acquisition protocols and reports, and c) Multicentric research potential.