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  1. Article: Biosimilares: Consenso de expertos de la Sociedad Latinoamericana de Psoriasis (SOLAPSO) en Argentina.

    Raimondo, Nélida / Echeverría, Cristina / Stengel, Fernando / Pellerano, Graciela / Kreimer, Jennifer / Mazzuoccolo, Luis / Maskin, Matías / Kogan, Nora / Luna, Paula / Gusis, Simón

    Medicina

    2018  Volume 78, Issue 4, Page(s) 272–281

    Abstract: With the appearance of biological treatments, therapeutics has changed in many rheumatological, dermatological and oncological diseases. Due to the high cost of these biological medicaments and the expiration of patents, the pharmacological industry ... ...

    Title translation Biosimilars: Expert consensus of the Latin American Society of Psoriasis (SOLAPSO) in Argentina.
    Abstract With the appearance of biological treatments, therapeutics has changed in many rheumatological, dermatological and oncological diseases. Due to the high cost of these biological medicaments and the expiration of patents, the pharmacological industry develops biosimilars, drugs that are a version (copy) of the substance of the original biological medicine, with the aim of facilitating access to these treatments. These biosimilars are prepared according to the specific requirements of regulatory bodies in terms of quality, efficacy and safety, and must be shown they are comparable to the reference product. This paper reviews the international and national regulatory framework, the controversies surrounding biosimilars, and presents the position of a group of experts regarding the use of biosimilars.
    MeSH term(s) Argentina ; Biosimilar Pharmaceuticals/administration & dosage ; Consensus ; Dermatologic Agents/administration & dosage ; Humans ; Legislation, Drug ; Psoriasis/drug therapy ; Societies, Medical
    Chemical Substances Biosimilar Pharmaceuticals ; Dermatologic Agents
    Language Spanish
    Publishing date 2018-08-16
    Publishing country Argentina
    Document type Journal Article
    ZDB-ID 411586-7
    ISSN 1669-9106 ; 0025-7680 ; 0325-951X
    ISSN (online) 1669-9106
    ISSN 0025-7680 ; 0325-951X
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Análisis de una serie de casos de pacientes adultos con dermatitis atópica severa tratados con dupilumab en Argentina.

    Máspero, Jorge / Angles, María Valeria / Ardusso, Ledit / Brancciforte, Milagros / Castro, Carla / Cruz Iturrieta, Carmen / Chouela, Ezequiel / De Gennaro, Mónica Silvia / Fernández Bussy, Ramón / Galimberti, María Laura / Galimberti, Ricardo Luis / Gattolin, Gabriel / Luna, Paula Carolina / Magariños, Gabriel / Marini, Mariano Gabriel / Maskin, Matías / Plafnik, Romina / Raimondo, Nélida / Russo, Juan Pedro /
    Sevinsky, Luis / Stringa, Matías Federico

    Revista de la Facultad de Ciencias Medicas (Cordoba, Argentina)

    2020  Volume 77, Issue 2, Page(s) 94–99

    Abstract: Introduction: Severe atopic dermatitis (AD) treatment is an unmet need, given the limited efficacy and safety of classical systemic treatments (CSTs). Dupilumab is a monoclonal antibody that blocks the signaling of the interleukins that mediate the ... ...

    Title translation Analysis of a case series of adult patients with severe atopic dermatitis treated with dupilumab in Argentina.
    Abstract Introduction: Severe atopic dermatitis (AD) treatment is an unmet need, given the limited efficacy and safety of classical systemic treatments (CSTs). Dupilumab is a monoclonal antibody that blocks the signaling of the interleukins that mediate the inflammatory response involved in AD.
    Methods: the clinical response of a group of patients from Argentina with severe AD and insufficient response and/or toxicity to CSTs who were treated with dupilumab before commercial availability was analyzed. EASI, SCORAD, DLQI scales and analog visual scales of pruritus and sleep were evaluated, during a median follow-up of 189 days. In addition, the incidence of adverse events was analyzed.
    Results: 20 patients (13 male) were included; median age: 37.5 years; median AD evolution: 20 years; atopic comorbidity: 70%. 100% had received systemic corticosteroids (serious complications: 20%). Main reasons for discontinuation of CSTs were lack of efficacy and occurrence of adverse events. All scores were significantly and steadily reduced, with identifiable clinical response at the second month of treatment. At the end of the follow-up, only 3 patients required concomitant systemic immunosuppressive treatment. Dupilumab was well tolerated, with mild and controllable adverse events.
    Discussion: Dupilumab is the only biological agent with high efficacy demonstrated in clinical and observational studies. In this case series, its effectiveness was confirmed in difficult-to-treat patients with severe AD and inadequate response to CSTs. The safety profile was favorable and consistent.
    MeSH term(s) Adolescent ; Adult ; Aged ; Antibodies, Monoclonal, Humanized/therapeutic use ; Argentina ; Dermatitis, Atopic/drug therapy ; Dermatologic Agents/therapeutic use ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Retrospective Studies ; Severity of Illness Index ; Treatment Outcome ; Young Adult
    Chemical Substances Antibodies, Monoclonal, Humanized ; Dermatologic Agents
    Language Spanish
    Publishing date 2020-06-09
    Publishing country Argentina
    Document type Journal Article
    ZDB-ID 390127-0
    ISSN 1853-0605 ; 0014-6722 ; 0301-7281
    ISSN (online) 1853-0605
    ISSN 0014-6722 ; 0301-7281
    DOI 10.31053/1853.0605.v77.n2.27845
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Biosimilars in psoriasis: Clinical practice and regulatory perspectives in Latin America.

    de la Cruz, Claudia / de Carvalho, André V E / Dorantes, Gladys L / Londoño Garcia, Angela M / Gonzalez, Cesar / Maskin, Matías / Podoswa, Nancy / Redfern, Jan S / Valenzuela, Fernando / van der Walt, Joelle / Romiti, Ricardo

    The Journal of dermatology

    2017  Volume 44, Issue 1, Page(s) 3–12

    Abstract: Latin American countries view biosimilar agents as an effective approach to curtail health-care expenditures while maintaining the safety and efficacy profile of their branded innovator comparators. To understand the complexities of the regulatory ... ...

    Abstract Latin American countries view biosimilar agents as an effective approach to curtail health-care expenditures while maintaining the safety and efficacy profile of their branded innovator comparators. To understand the complexities of the regulatory landscape and key therapeutic issues for use of biosimilars to treat moderate to severe psoriasis in Latin America, the International Psoriasis Council convened dermatology experts from Argentina, Brazil, Chile, Colombia and Mexico in October 2015 to review the definition, approval, marketing and future of biosimilars in each country and develop a consensus statement. The regulatory framework for marketing approval of biosimilars in Latin America is currently a mosaic of disparate, country-specific, regulatory review processes, rules and standards, with considerable heterogeneity in clarity and specificity. Regulations in Argentina, Brazil, Chile and Mexico have undergone multiple refinements whereas Colombia is finalizing draft guidelines. Verification of the similarity in quality, safety and efficacy of biosimilars to the innovator biologic remains a key challenge for policy makers and regulatory authorities. Other key regulatory challenges include: naming of agents and traceability, pharmacovigilance, extrapolation of indications, and interchangeability and substitution. An urgent need exists for more Latin American countries to establish national psoriasis registries and to integrate their common components into a multinational psoriasis network, thereby enhancing their interpretative power and impact. A Latin American psoriasis network similar to PSONET in Europe would assist health-care providers, pharmaceutical companies, regulators and patients to fully comprehend specific products being prescribed and dispensed and to identify potential regional trends or differences in safety or outcomes.
    MeSH term(s) Biosimilar Pharmaceuticals/adverse effects ; Biosimilar Pharmaceuticals/economics ; Biosimilar Pharmaceuticals/therapeutic use ; Drug Compounding/standards ; Drug Substitution/economics ; Drug Substitution/standards ; Drug Substitution/trends ; Humans ; Latin America/epidemiology ; Pharmacovigilance ; Psoriasis/drug therapy ; Psoriasis/epidemiology ; Registries ; Treatment Outcome
    Chemical Substances Biosimilar Pharmaceuticals
    Language English
    Publishing date 2017-01
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 800103-0
    ISSN 1346-8138 ; 0385-2407
    ISSN (online) 1346-8138
    ISSN 0385-2407
    DOI 10.1111/1346-8138.13512
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Primary cutaneous lymphoma in Argentina: a report of a nationwide study of 416 patients.

    Abeldaño, Alejandra / Enz, Paula / Maskin, Matias / Cervini, Andrea B / Torres, Natallia / Acosta, Ana C / Narbaitz, Marina / Vanzulli, Silvia / Orentrajch, Mirta / Villareal, Marta A / Garcia Pazos, Maria L / Arias, Mariana / Zambrano Franco, Evelyn A / Fontana, Maria I / Chuit, Roberto

    International journal of dermatology

    2018  Volume 58, Issue 4, Page(s) 449–455

    Abstract: Background: The aim of this study was to determine the relative frequency of primary cutaneous lymphoma (PCL) in Argentina according to the new World Health Organization (WHO)-European Organization for the Research and Treatment of Cancer (EORTC) ... ...

    Abstract Background: The aim of this study was to determine the relative frequency of primary cutaneous lymphoma (PCL) in Argentina according to the new World Health Organization (WHO)-European Organization for the Research and Treatment of Cancer (EORTC) classification system.
    Methods: A total of 416 patients from 21 dermatology services were included during a 5-year period (2010-2015); these patients were classified using WHO-EORTC criteria.
    Results: There were 231 (55.2%) males and 185 (44.8%) females; the male-to-female ratio was 1.35. The median age of the patients was 57 years (range, 0-90 years). Most patients were Caucasian (79%), and only 16% of patients were registered as Amerindian. Most patients (387/416, 93%) had cutaneous T-cell lymphoma (CTCL); 28 patients (6.7%) were diagnosed with cutaneous B-cell lymphoma (CBCL). The most frequent CTCL subtypes, in decreasing order of prevalence, were mycosis fungoides (MF), including its variants (75.7%); CD30+ primary cutaneous lymphoproliferative disorders (7.2%); and Sézary syndrome (SS) (3.1%). Cutaneous follicle center lymphoma was the most common CBCL subtype (2.9%). In the subset of patients ≤20 years of age, the most common condition was MF (57%), followed by extranodal NK-T nasal-type lymphoma (14%).
    Conclusions: This study revealed relatively higher rates of MF and lower rates of CBCL in Argentinean patients that have been reported in American and European countries.
    MeSH term(s) Adolescent ; Adult ; Aged ; Aged, 80 and over ; Argentina/epidemiology ; Child ; Child, Preschool ; Female ; Humans ; Incidence ; Infant ; Infant, Newborn ; Lymphoma, B-Cell/epidemiology ; Lymphoma, Extranodal NK-T-Cell/epidemiology ; Lymphoma, Follicular/epidemiology ; Male ; Middle Aged ; Mycosis Fungoides/epidemiology ; Sezary Syndrome/epidemiology ; Skin Neoplasms/epidemiology ; Young Adult
    Language English
    Publishing date 2018-10-07
    Publishing country England
    Document type Journal Article
    ZDB-ID 412254-9
    ISSN 1365-4632 ; 0011-9059 ; 1461-1244
    ISSN (online) 1365-4632
    ISSN 0011-9059 ; 1461-1244
    DOI 10.1111/ijd.14262
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article: Unusual variants of mycosis fungoides.

    Abeldaño, Alejandra / Arias, Mariana / Benedetti, Adriana / Ochoa, Karina / Maskin, Matías / Pellerano, Graciela / Kien, María Cristina / Chouela, Edgardo

    Skinmed

    2011  Volume 9, Issue 4, Page(s) 218–222

    Abstract: Unusual variants of mycosis fungoides (MF) differ substantially from the classical presentation, and most of them resemble other dermatologic diseases. The authors reviewed files of patients with MF who consulted our clinic between November 1995 and June ...

    Abstract Unusual variants of mycosis fungoides (MF) differ substantially from the classical presentation, and most of them resemble other dermatologic diseases. The authors reviewed files of patients with MF who consulted our clinic between November 1995 and June 2010 to evaluate the relative frequency and clinical behavior of these variants. Among 98 patients with MF, 32 (32.65%) had unusual variants. The most common types included follicular MF (31.25%), hypopigmented MF (18.75%), poiquilodermic MF (15.6%), and erythrodermic MF (12.5%). Less common variants included unilesional MF, bullosa MF, ichthyosiform MF, granulomatous slack skin, and pigmented purpura-like MF. Progressive disease and MF-related death were most commonly associated with follicular MF, bullosa MF, and erythrodermic MF.
    MeSH term(s) Adolescent ; Adrenal Cortex Hormones/therapeutic use ; Adult ; Aged ; Angiogenesis Inhibitors/therapeutic use ; Child ; Female ; Humans ; Immunologic Factors/therapeutic use ; Interferon-alpha/therapeutic use ; Male ; Middle Aged ; Mycosis Fungoides/drug therapy ; Mycosis Fungoides/pathology ; Mycosis Fungoides/radiotherapy ; Neoplasm Staging ; PUVA Therapy ; Prognosis ; Retrospective Studies ; Skin Neoplasms/drug therapy ; Skin Neoplasms/pathology ; Skin Neoplasms/radiotherapy ; Sunlight ; Thalidomide/therapeutic use ; Young Adult
    Chemical Substances Adrenal Cortex Hormones ; Angiogenesis Inhibitors ; Immunologic Factors ; Interferon-alpha ; Thalidomide (4Z8R6ORS6L)
    Language English
    Publishing date 2011-07
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2171125-2
    ISSN 1540-9740
    ISSN 1540-9740
    Database MEDical Literature Analysis and Retrieval System OnLINE

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