دورية أكاديمية
Changing rate of serious infections in biologic-exposed rheumatoid arthritis patients. Data from South American registries BIOBADABRASIL and BIOBADASAR
| العنوان: | Changing rate of serious infections in biologic-exposed rheumatoid arthritis patients. Data from South American registries BIOBADABRASIL and BIOBADASAR |
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| المؤلفون: | Ranza, R., de la Vega, M. C., Laurindo, I. M. M., Gómez, M. G., Titton, D. C., Kakehasi, A. M., Brigante, A., Benitez, A., Ranzolin, A., Granel, A., Cappuccio, A. M., Quinteros, A., Hayata, A. L. S., Smichowski, A., Duarte, Â L. B. P., Kahlow, B. S., Andia, C. S., Brenol, C. V., Velozo, E., Mussano, E., Soriano, E. R., Christopoulos, G. B., da Rocha Castelar Pinheiro, G., de Castro, G. R. W., Casado, G., da Silveira Carvalho, H. M., Exeni, I. E., da Silveira, I. G., Petkovic, I., Pereira, I. A., da Costa, I. P., Rosa, J. E., Miranda, J. R. S., de Moraes, J. C. B., Bertolo, M. B., Buhl, M., Lázaro, M. A., da Sauma, M. F. L. C., de Medeiros Pinheiro, M., Díaz, M., de Vechi, M. V. S. S., Cerda, O. L., Astesana, P., Curi, P. F., Louzada-Jr, P., Teodoro, R. B., Toledo, R. A., Papasidero, S., Valim, V., Fernandes, V., Saurit, V., Bianchi, W. A., de Melo Costa Pinto, R., Descalzo, M. A., Gómez-Reino Carnota, Juan Jesús |
| المساهمون: | Biobadabrasil study group Sociedade Brasileira de Reumatologia, Biobadasar study group Sociedad Argentina de Reumatologia |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | Tumor Necrosis Factor-alpha, Risk Factors, Infectious Disease Medicine, Adult, Biological Products, Middle Aged, Humans, Registries, Antirheumatic Agents, Arthritis, Aged, Incidence, anciano, incidencia, productos biológicos, factores de riesgo, factor de necrosis tumoral alfa, mediana edad, medicina de enfermedades infecciosas, humanos, antirreumáticos, adulto, sistema de registros, artritis, CHUS, IDIS |
| الوصف: | OBJECTIVE: Most reports on serious infections (SI) in rheumatoid arthritis (RA) patients treated with biological disease-modifying antirheumatic drugs (bDMARDs) are from the USA and Western Europe. Data from other regions are largely missing. We report data from South American countries with different backgrounds and health-care systems but similar registries. METHODS: We merged 2010-2016 data from two registries, BIOBADABRASIL (Brazil) and BIOBADASAR (Argentina), which share the same protocol, online platform and data monitoring process. Patients with active RA were included when they began the first bDMARD or a conventional synthetic DMARD (csDMARD, control group). The SI incidence rate (IR) per 1000 patient/years and adjusted IR ratio (aIRR) were estimated for bDMARDs and csDMARDs. RESULTS: Data were analysed for 3717 RA patients with an exposure of 13,380 patient/years. The 2591 patients treated with bDMARDs (64% tumour necrosis factor-alpha inhibitors (TNFi)) had a follow-up of 9300 years, and the 1126 treated with csDMARDs had an exposure of 4081 patient/years. The SI IR was 30.54 (CI 27.18-34.30) for all bDMARDs and 5.15 (CI 3.36-7.89) for csDMARDs. The aIRR between the two groups was 2.03 ([1.05, 3.9] p = 0.034) for the first 6 months of treatment but subsequently increased to 8.26 ([4.32, 15.76] p < 0.001). The SI IR for bDMARDs decreased over time in both registries, dropping from 36.59 (28.41-47.12) in 2012 to 7.27 (4.79-11.05) in 2016. CONCLUSION: While SI remains a major concern in South American patients with RA treated with bDMARDs, a favourable trend toward a reduction was observed in the last years.Key Points* New comprehensive data on biologic drugs safety from international collaboration in South America.* First proposal for national registries data merging in South America.* Serious infections remain a major concern in RA patients treated with biologics.* A significant reduction of serious infections in RA patients exposed to biologics was observed over a 7 years period. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 0770-3198 |
| العلاقة: | https://link.springer.com/content/pdf/10.1007/s10067-019-04516-2.pdfTest; https://www.ncbi.nlm.nih.gov/pubmed/31016578Test; http://hdl.handle.net/20.500.11940/15794Test; 31820 |
| DOI: | 10.1007/s10067-019-04516-2 |
| الإتاحة: | https://doi.org/20.500.11940/15794Test https://doi.org/10.1007/s10067-019-04516-2Test https://hdl.handle.net/20.500.11940/15794Test https://www.ncbi.nlm.nih.gov/pubmed/31016578Test |
| حقوق: | Atribución 4.0 Internacional ; http://creativecommons.org/licenses/by/4.0Test/ ; openAccess |
| رقم الانضمام: | edsbas.72359094 |
| قاعدة البيانات: | BASE |
| تدمد: | 07703198 |
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| DOI: | 10.1007/s10067-019-04516-2 |