ABSTRACT
BACKGROUND/OBJECTIVE: To evaluate the efficacy and safety of SARS-CoV-2 vaccine in patients with rheumatic and immune-mediated inflammatory diseases (IMIDs) in Argentina: the SAR-CoVAC registry. METHODS: SAR-CoVAC is a national, multicenter, and observational registry. Adult patients with rheumatic or IMIDs vaccinated for SARS-CoV-2 were consecutively included between June 1 and September 17, 2021. Sociodemographic data, comorbidities, underlying rheumatic or IMIDs, treatments received, their modification prior to vaccination, and history of SARS-CoV-2 infection were recorded. In addition, date and place of vaccination, type of vaccine applied, scheme, adverse events (AE), disease flares, and new immune-mediated manifestations related to the vaccine were analyzed. RESULTS: A total of 1234 patients were included, 79% were female, with a mean age of 57.8 (SD 14.1) years. The most frequent diseases were rheumatoid arthritis (41.2%), osteoarthritis (14.5%), psoriasis (12.7%), and spondyloarthritis (12.3%). Most of them were in remission (28.5%) or low disease activity (41.4%). At the time of vaccination, 21% were receiving glucocorticoid treatment, 35.7% methotrexate, 29.7% biological (b) disease modifying anti-rheumatic drugs (DMARD), and 5.4% JAK inhibitors. In total, 16.9% had SARS-CoV-2 infection before the first vaccine dose. Most patients (51.1%) received Gam-COVID-Vac as the first vaccine dose, followed by ChAdOx1 nCoV-19 (32.8%) and BBIBP-CorV (14.5%). Half of them (48.8%) were fully vaccinated with 2 doses; 12.5% received combined schemes, being the most frequent Gam-COVID-Vac/mRAN-1273. The median time between doses was 51 days (IQR 53). After the first dose, 25.9% of the patients reported at least one AE and 15.9% after the second, being flu-like syndrome and local hypersensitivity the most frequent manifestations. There was one case of anaphylaxis. Regarding efficacy, 63 events of SARS-CoV-2 infection were reported after vaccination, 19% occurred during the first 14 days post-vaccination, 57.1% after the first dose, and 23.8% after the second. Most cases (85.9%) were asymptomatic or mild and 2 died due to COVID-19. CONCLUSIONS: In this national cohort of patients, the most common vaccines used were Gam-COVID-Vac and ChAdOx1 nCoV-19. A quarter of the patients presented an AE and 5.1% presented SARS-CoV-2 infection after vaccination, in most cases mild. STUDY REGISTRATION: This study has been registered in ClinicalTrials.gov under the number: NCT04845997. Key Points ⢠This study shows real-world data about efficacy and safety of SARS-CoV-2 vaccination in patients with rheumatic and immune-mediated inflammatory diseases. Interestingly, different types of vaccines were used including vector-based, mRNA, and inactivated vaccines, and mixed regimens were enabled. ⢠A quarter of the patients presented an adverse event. The incidence of adverse events was significantly higher in those receiving mRAN-1273 and ChAdOx1 nCoV-19. ⢠In this cohort, 5.1% presented SARS-CoV-2 infection after vaccination, in most cases mild.
Subject(s)
COVID-19 Vaccines , COVID-19 , Adult , Aged , Antirheumatic Agents/therapeutic use , Argentina/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , ChAdOx1 nCoV-19 , Female , Glucocorticoids , Humans , Janus Kinase Inhibitors , Male , Methotrexate , Middle Aged , Preliminary Data , RNA, Messenger , Registries , SARS-CoV-2 , Vaccination , Vaccines, InactivatedABSTRACT
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.
Subject(s)
Biosimilar Pharmaceuticals/administration & dosage , Dermatologic Agents/administration & dosage , Legislation, Drug , Psoriasis/drug therapy , Argentina , Consensus , Humans , Societies, MedicalABSTRACT
Con la aparición de los tratamientos biológicos, se ha modificado la terapéutica de muchas enfermedades, en especial las reumatológicas, dermatológicas y oncológicas. Debido al alto costo de estos productos y el vencimiento de las patentes, la industria farmacológica desarrolla los biosimilares, fármacos que son una versión (copia) de la sustancia de un medicamento biológico original, y que pueden facilitar el acceso a estos tratamientos. Son elaborados de acuerdo a exigencias específicas de organismos reguladores en cuanto a calidad, eficacia y seguridad, y debe demostrarse que son comparables al medicamento de referencia. Este trabajo revisa las normativas regulatorias internacionales y nacionales, las controversias que rodean a los biosimilares y presenta la posición de un grupo de expertos con respecto al uso de biosimilares.
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.
Subject(s)
Humans , Psoriasis/drug therapy , Dermatologic Agents/administration & dosage , Biosimilar Pharmaceuticals/administration & dosage , Legislation, Drug , Argentina , Societies, Medical , ConsensusABSTRACT
Introducción. El lupus eritematoso (LE) es una enfermedad inflamatoria multisistémica de etiología desconocida que comprende una variedad de formas clínicas. Material y método. Se efectuó un estudio retrospectivo y descriptivo de los pacientes que consultaron en el Servicio de Dermatología del Policlínico Bancario durante el período comprendido entre enero de 1994 y enero de 2009. Se incluyeron aquellos pacientes mayores de 18 años con diagnóstico histopatológico de lupus eritematoso. Objetivos. Identificar las distintas variantes clínicas de lupus eritematoso, establecer su distribución por sexo y edad, y comparar los resultados con las estadísticas nacionales e internacionales. Resultados. Se evaluaron 46 pacientes (33 mujeres [71,73%]).Edad promedio al diagnóstico: 42 años; rango: 19-70 años. Presentaron lesiones específicas de LE 42 pacientes (91,30%), 28 correspondieron a la variante de lupus eritematoso cutáneo crónico (67%), 6 a lupus eritematoso cutáneo subagudo (14%) y 8 a lupus eritematoso cutáneo agudo (19%). Las lesiones inespecíficas se presentaron en 21 pacientes (45%) y las halladas con mayor frecuencia fueron: fotosensibilidad (38,09%) alopecia difusa (33,33%) y alteraciones vasculares (28,57%). Conclusión. Nuestros hallazgos son similares a los señalados en la bibliografía consultada, a excepción de la edad de presentación, que fue superior.
Subject(s)
Humans , Lupus Erythematosus, Cutaneous/classification , Lupus Erythematosus, Cutaneous/epidemiology , Lupus Erythematosus, Discoid/classification , Lupus Erythematosus, Discoid/epidemiology , Skin Diseases/etiologyABSTRACT
Introducción. El penfigoide ampollar (PA) es una enfermedad autoinmune que afecta con mayor frecuencia a personas de edad avanzada.Objetivos. Identificar la edad de presentación, sexo y variantes clínicas del PA. Establecer la asociación con otras enfermedades, la respuesta terapéutica y comparar los resultados con las estadísticas publicadas.Materiales y métodos. Se realizó un análisis retrospectivo y descriptivo de los pacientes que consultaron en el Servicio de Dermatología del Policlínico Bancario en el período comprendido entre agosto de 1995 y el mismo mes de 2010. Se incluyeron aquellos pacientes con diagnóstico de PA. La recolección de datos se obtuvo de los registros histológicos y de las correspondientes historias clínicas.Resultados. Se registraron 45 pacientes; 25 (55,5%) femeninos y 20 (44,5%) masculinos. La edad media fue de 75,9 años. Variantes clínicas: 35 pacientes (77,7%) clásica; 5 (11,1%) localizada; 1(2,2%) vesicular; 2 (4,4%) nodular. Asociación con DBT: 15 pacientes (33,3%); HTA: 29 (64,4%); otras enfermedades sistémicas: 19 (42,2%); enfermedades dermatológicas: 7 (15,5%). La respuesta terapéutica fue buena.Conclusiones. La edad promedio al momento del diagnóstico fue avanzada. No hallamos marcada diferencia en cuanto a la distribución por sexo. La forma clásica predominó sobre las otras variantes clínicas. La asociación con enfermedades sistémicas podría deberse a que estas patologías se dan con mayor frecuencia en el mismo grupo etario. La asociación con enfermedades dermatológicas fue conpsoriasis (la de mayor representación). La respuesta terapéutica fue altamente satisfactoria. En general, nuestros datos son similares a las estadísticas publicadas.
