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https://www.arca.fiocruz.br/handle/icict/50915
PATIENT REPORTS OF THE FREQUENCY AND SEVERITY OF ADVERSE REACTIONS ASSOCIATED WITH BIOLOGICAL AGENTS PRESCRIBED FOR PSORIASIS IN BRAZIL
Author
Affilliation
University of Sorocaba. Pharmaceutical Sciences Post graduate Course. Programa de Mestrado em Ciencias Farmaceuticas. Sorocaba, SP, Brazil
University of Sorocaba. Pharmaceutical Sciences Post graduate Course. Programa de Mestrado em Ciencias Farmaceuticas. Sorocaba, SP, Brazil
University of Sorocaba. Pharmaceutical Sciences Post graduate Course. Programa de Mestrado em Ciencias Farmaceuticas. Sorocaba, SP, Brazil
University of Sorocaba. Pharmaceutical Sciences Post graduate Course. Programa de Mestrado em Ciencias Farmaceuticas. Sorocaba, SP, Brazil
Fundacao Oswaldo Cruz. Centro de Pesquisas Ren e Rachou. Laboratorio de Educacao em Saude e Ambiente. Belo Horizonte, Brazil
Fundacao Oswaldo Cruz. Escola Nacional de Saude Publica Sergio Arouca. Nucleo de Assistencia Farmaceutica. Rio de Janeiro, RJ, Brazil
University of Sorocaba. Pharmaceutical Sciences Post graduate Course. Programa de Mestrado em Ciencias Farmaceuticas. Sorocaba, SP, Brazil
University of Sorocaba. Pharmaceutical Sciences Post graduate Course. Programa de Mestrado em Ciencias Farmaceuticas. Sorocaba, SP, Brazil
McMaster University. Department of Clinical Epidemiology and Biostatistics. Hamilton, Ontario, Canada
University of Sorocaba. Pharmaceutical Sciences Post graduate Course. Programa de Mestrado em Ciencias Farmaceuticas. Sorocaba, SP, Brazil
University of Sorocaba. Pharmaceutical Sciences Post graduate Course. Programa de Mestrado em Ciencias Farmaceuticas. Sorocaba, SP, Brazil
University of Sorocaba. Pharmaceutical Sciences Post graduate Course. Programa de Mestrado em Ciencias Farmaceuticas. Sorocaba, SP, Brazil
Fundacao Oswaldo Cruz. Centro de Pesquisas Ren e Rachou. Laboratorio de Educacao em Saude e Ambiente. Belo Horizonte, Brazil
Fundacao Oswaldo Cruz. Escola Nacional de Saude Publica Sergio Arouca. Nucleo de Assistencia Farmaceutica. Rio de Janeiro, RJ, Brazil
University of Sorocaba. Pharmaceutical Sciences Post graduate Course. Programa de Mestrado em Ciencias Farmaceuticas. Sorocaba, SP, Brazil
University of Sorocaba. Pharmaceutical Sciences Post graduate Course. Programa de Mestrado em Ciencias Farmaceuticas. Sorocaba, SP, Brazil
McMaster University. Department of Clinical Epidemiology and Biostatistics. Hamilton, Ontario, Canada
Abstract
Background: The safety of biological agents used to treat psoriasis remains uncertain. Objective: The authors determined the frequency and severity of adverse effects associated with use of biologic agents for psoriasis through patient-registered lawsuits to the government of SÃO Paulo, Brazil. Methods: Sources of information included legal records, dispensing pharmacy data and interviews with patients. Research staff conducted telephone interviews with patients who used biologic drugs during 2004 - 2011, inquiring about medication-related adverse drug reactions (ADRs) and serious adverse events (SAEs). Results: Of the 218 patients identified, 15 proved ineligible or refused participation. 203 patients were interviewed, with 111 (54.7%) taking infliximab, 43 (21.2%) efalizumab, 35 (17.2%) etanercept and 14 (6.9%) adalimumab. Of 84 (41.4%) patients who experienced one or more ADR related to biological agents, 57 (67.9%) experienced one or more SAE. The only risk factor associated with ADRs was comorbidity odds ratio = 6.54 (95% confident interval [CI] 3.20 - 13.32), p < 0.0001. Conclusion: Biologic agents were associated with high rates of ADRs and SAEs. The data suggests that for patients taking a biologic agent to treat psoriasis and who have one or more comorbidities, warnings of possible adverse events and enhanced surveillance are warranted
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