RESUMO
Itolizumab is a humanized monoclonal antibody that selectively targets the CD6-ALCAM pathway. This article reports on the safety and efficacy of itolizumab in the treatment of moderate-to-severe plaque psoriasis in a clinical study conducted in Cuba in the setting of an expanded-access program (EAP). The study included 84 patients who had previously received conventional anti-psoriatic systemic therapies but were either intolerant, had an inadequate response, or had contraindications to these therapies. It consisted of multiple phases, including a 12-week induction phase, a 40-week maintenance phase, and a 24-week off-treatment follow-up phase, using either a 0.4 or 1.6 mg/Kg dose. The results showed that itolizumab monotherapy was safe and effective during 52 weeks of continuous treatment and the subsequent 24 follow-up weeks. Itolizumab treatment resulted in a significant improvement (PASI 75) in 80 % of patients at the end of the induction phase, and this effect was sustained till week 52 during the maintenance phase. Moreover, 24 weeks after treatment stopped nearly two-thirds of patients still showed a PASI ≥ 75. The observed effects were dose-dependent, with 1.6 mg/kg being the most convenient dose. This study further supports the strategy of targeting the CD6-ALCAM signaling pathway for the treatment of psoriasis and the use of itolizumab as a valuable asset in the armamentarium of anti-psoriasis drugs.
Assuntos
Anticorpos Monoclonais Humanizados , Psoríase , Humanos , Psoríase/tratamento farmacológico , Anticorpos Monoclonais Humanizados/uso terapêutico , Masculino , Feminino , Pessoa de Meia-Idade , Adulto , Resultado do Tratamento , Índice de Gravidade de Doença , Idoso , CubaRESUMO
Se realizó un estudio descriptivo y transversal de 51 pacientes incluidos en ensayos clínicos efectuados en la provincia de Santiago de Cuba, de enero a diciembre del 2012, a fin de conocer la comprensión alcanzada por estos en cuanto a la información que le proporcionaron durante el proceso de consentimiento informado. A tales efectos, se aplicó un cuestionario estructurado y se definió la comprensión mediante 3 categorías, para luego correlacionarla con el nivel escolar del sujeto y la metodología de aplicación del consentimiento. Pudo concluirse que la mayoría de los participantes en los ensayos clínicos con productos del Centro de Inmunología Molecular, recibían la información requerida en el proceso de consentimiento informado, y que el nivel de escolaridad de los sujetos y la metodología adecuada para la aplicación del consentimiento informado, determinan una mayor comprensión de los elementos de la investigación(AU)
A descriptive and cross-sectional study of 51 patients included in clinical trials made in Santiago de Cuba was carried out from January to December, 2012, in order to know the understanding reached by them regarding the information which they received during the process of informed consent, for which a structured questionnaire was applied and was the understanding was defined by means of 3 categories, correlating it with the person's school level and the methodology for applying the consent. It could be concluded that most of the participants in the clinical trials with products of the Center for Molecular Immunology of this province, received the information required in the process of informed consent. The school level of the participants and the appropriate methodology for the application of the informed consent, determine the higher understanding of the investigation(AU)
Assuntos
Humanos , Masculino , Feminino , Consentimento Livre e Esclarecido , Competência Mental , Compreensão , Epidemiologia Descritiva , Estudos TransversaisRESUMO
Se realizó un estudio descriptivo y transversal de 51 pacientes incluidos en ensayos clínicos efectuados en la provincia de Santiago de Cuba, de enero a diciembre del 2012, a fin de conocer la comprensión alcanzada por estos en cuanto a la información que le proporcionaron durante el proceso de consentimiento informado. A tales efectos, se aplicó un cuestionario estructurado y se definió la comprensión mediante 3 categorías, para luego correlacionarla con el nivel escolar del sujeto y la metodología de aplicación del consentimiento. Pudo concluirse que la mayoría de los participantes en los ensayos clínicos con productos del Centro de Inmunología Molecular, recibían la información requerida en el proceso de consentimiento informado, y que el nivel de escolaridad de los sujetos y la metodología adecuada para la aplicación del consentimiento informado, determinan una mayor comprensión de los elementos de la investigación.
A descriptive and cross-sectional study of 51 patients included in clinical trials made in Santiago de Cuba was carried out from January to December, 2012, in order to know the understanding reached by them regarding the information which they received during the process of informed consent, for which a structured questionnaire was applied and was the understanding was defined by means of 3 categories, correlating it with the person's school level and the methodology for applying the consent. It could be concluded that most of the participants in the clinical trials with products of the Center for Molecular Immunology of this province, received the information required in the process of informed consent. The school level of the participants and the appropriate methodology for the application of the informed consent, determine the higher understanding of the investigation.
