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Abstract(s)
Introdução: a Doença de Behçet (DB) corresponde a uma vasculite de envolvimento
multissistémico cuja variabilidade demográfica, clínica, terapêutica e prognóstica, a tornam
numa doença de elevada complexidade. Embora rara, associa-se a morbimortalidade
prematura e significativa.
Objetivo: avaliar a ação dos fármacos biotecnológicos nas diferentes manifestações clínicas
da DB em adultos.
Métodos: foi realizada uma revisão sistemática da literatura incluindo estudos de avaliação
de eficácia e segurança do uso de fármacos biotecnológicos nas diversas manifestações
clínicas da DB. A pesquisa foi realizada nas bases de dados PubMed/MEDLINE e EMBASE,
sem limite temporal na busca. Todos os títulos e abstracts foram avaliados, de forma
independente, por dois revisores. A extração de dados dos artigos elegíveis foi realizada com
base em formulário próprio elaborado para a extração dos mesmos. O risco de viés das
publicações foi avaliado com base na “National Heart, Lung and Blood Institute: Study
Quality Assessment Tools”. Os outcomes aferidos foram a eficácia do tratamento,
capacidade de induzir a remissão e a segurança, nomeadamente, possíveis eventos/efeitos
adversos, necessidade de hospitalização e mortalidade subjacente ao uso destes fármacos.
No final da análise dos estudos e da avaliação dos outcomes supracitados, procedeu-se à
síntese narrativa dos resultados adquiridos.
Resultados: identificámos vinte e um estudos que cumpriam critérios de inclusão. Destes,
dois eram ensaios clínicos randomizados e, os restantes, eram estudos observacionais tipo
coorte (onze) e série de casos (oito). Os anti-TNF-a, anti-IL1, anti-IL17, anti-IL12-23 e antiIL-6 foram os biotecnológicos investigados, isoladamente ou em conjunto com outros
biotecnológicos ou com outras classes farmacológicas. O número mínimo de doentes
incluídos nos estudos variou entre 20 e 473, sendo que, na grande maioria o sexo masculino
prevalecia. Nesta revisão, os anti-TNF-a, nomeadamente o Infliximab e o Adalimumab,
demonstraram ser eficazes e seguros em todas as manifestações clínicas escrutinadas
isoladamente ou em conjunto. Adicionalmente, o Gevokizumab foi eficaz e seguro no
envolvimento ocular, o Tocilizumab e Golimumab no envolvimento cardíaco, o Etarnecept
e Ustekinumab no envolvimento mucocutâneo e o Anakinra e o Canakinumab no
envolvimento multissistémico da DB.
Discussão: a análise isolada de cada um dos artigos aponta para um efeito positivo dos
biotecnológicos sobre as múltiplas manifestações clínicas avaliadas. Em relação aos outcomes, os biotecnológicos provaram ser eficazes e capazes de induzir a remissão clínica,
alguns dos quais com relevância estatística altamente significativa. Tal verificou-se,
globalmente, com o aumento das remissões completas e sustentadas no tempo, com a
diminuição da frequência de agudizações, com diminuição analítica dos marcadores de fase
aguda e com a diminuição dos imunossupressores utilizados. Além disso, demonstraram
um perfil de segurança positivo pois apesar de presentes múltiplos efeitos adversos estes
eram pouco graves, como é verificado pelas, hospitalizações e mortes reduzidas e/ou nulas.
Conclusões: os biotecnológicos tem um impacto positivo na eficácia e indução terapêutica,
ao mesmo tempo que, apresentam um perfil de segurança confiável, com hospitalizações e
mortalidade reduzidas.
Introduction: Behçet's Disease (BD) corresponds to a vasculitis with multisystem involvement whose demographic, clinical, therapeutic and prognostic variability make it a highly complex disease. Although rare, it is associated with premature and significant morbidity and mortality. Objective: to evaluate the action of biotechnological drugs on the different clinical manifestations of BD in adults. Methods: a systematic review of the literature was performed, including studies evaluating the efficacy and safety of biotechnological drugs in the various clinical manifestations of BD. The search was carried out in the PubMed/MEDLINE and EMBASE databases, with no time limit on the search. All titles and abstracts were independently evaluated by two reviewers. Data extraction from eligible articles was performed based on a specific form created for their extraction. The risk of bias was assessed based on the “National Heart, Lung and Blood Institute: Study Quality Assessment Tools”. Outcomes assessed were treatment efficacy, ability to induce remission and safety, namely, possible adverse events/effects, hospitalization and mortality underlying the use of these drugs. At the end of the analysis of the studies and the evaluation of the aforementioned outcomes, a narrative synthesis of the acquired results was carried out. Results: we identified twenty studies that meet the inclusion criteria. Of these, two were randomized clinical trials and the remaining were observational cohort (eleven) and case series (eight) studies. Anti-TNF-a, anti-IL1, anti-IL17, anti-IL12-23 and anti-IL-6 were the biotechnologicals investigated, alone or together with other biotechnologicals or with other pharmacological classes. The minimum number of patients included in the studies ranged from 20 to 473, with the majority being male. In this review, anti-TNF-a, namely Infliximab and Adalimumab, are effective and safe in all manifestations as clinically intended alone or in combination. In addition, Gevokizumab was effective and safe in ocular involvement, Tocilizumab and Golimumab in cardiac involvement, Etarnecept and Ustekinumab in mucocutaneous involvement, and Anakinra and Canakinumab in the multisystem involvement of BD. Discussion: the isolated analysis of each of the articles points to a positive effect of biotechnology on the multiple clinical manifestations evaluated. Regarding outcomes, biotechnologicals proved to be effective and capable of inducing clinical remission, some of which have highly significant statistical significance. This was globally observed with the increase in complete and sustained remissions over time, with the decrease in the frequency of exacerbations, with an analytical decrease in acute phase markers and with the decrease in immunosuppressants used. In addition, they demonstrated a positive safety profile because, despite the presence of multiple adverse effects, they were not very serious, as seen by reduced and/or zero hospitalizations and deaths. Conclusions: biotechnologicals have a positive impact on therapeutic efficacy and induction, while presenting a reliable safety profile, with reduced hospitalizations and mortality.
Introduction: Behçet's Disease (BD) corresponds to a vasculitis with multisystem involvement whose demographic, clinical, therapeutic and prognostic variability make it a highly complex disease. Although rare, it is associated with premature and significant morbidity and mortality. Objective: to evaluate the action of biotechnological drugs on the different clinical manifestations of BD in adults. Methods: a systematic review of the literature was performed, including studies evaluating the efficacy and safety of biotechnological drugs in the various clinical manifestations of BD. The search was carried out in the PubMed/MEDLINE and EMBASE databases, with no time limit on the search. All titles and abstracts were independently evaluated by two reviewers. Data extraction from eligible articles was performed based on a specific form created for their extraction. The risk of bias was assessed based on the “National Heart, Lung and Blood Institute: Study Quality Assessment Tools”. Outcomes assessed were treatment efficacy, ability to induce remission and safety, namely, possible adverse events/effects, hospitalization and mortality underlying the use of these drugs. At the end of the analysis of the studies and the evaluation of the aforementioned outcomes, a narrative synthesis of the acquired results was carried out. Results: we identified twenty studies that meet the inclusion criteria. Of these, two were randomized clinical trials and the remaining were observational cohort (eleven) and case series (eight) studies. Anti-TNF-a, anti-IL1, anti-IL17, anti-IL12-23 and anti-IL-6 were the biotechnologicals investigated, alone or together with other biotechnologicals or with other pharmacological classes. The minimum number of patients included in the studies ranged from 20 to 473, with the majority being male. In this review, anti-TNF-a, namely Infliximab and Adalimumab, are effective and safe in all manifestations as clinically intended alone or in combination. In addition, Gevokizumab was effective and safe in ocular involvement, Tocilizumab and Golimumab in cardiac involvement, Etarnecept and Ustekinumab in mucocutaneous involvement, and Anakinra and Canakinumab in the multisystem involvement of BD. Discussion: the isolated analysis of each of the articles points to a positive effect of biotechnology on the multiple clinical manifestations evaluated. Regarding outcomes, biotechnologicals proved to be effective and capable of inducing clinical remission, some of which have highly significant statistical significance. This was globally observed with the increase in complete and sustained remissions over time, with the decrease in the frequency of exacerbations, with an analytical decrease in acute phase markers and with the decrease in immunosuppressants used. In addition, they demonstrated a positive safety profile because, despite the presence of multiple adverse effects, they were not very serious, as seen by reduced and/or zero hospitalizations and deaths. Conclusions: biotechnologicals have a positive impact on therapeutic efficacy and induction, while presenting a reliable safety profile, with reduced hospitalizations and mortality.
Description
Keywords
Adultos Doença de Behçet Fármacos Biotécnológicos Inibidores Tnf.Alfa