Assessing Efficacy, Safety and Tolerability of Rituximab for Rheumatoid Arthritis: Meta-Analyses of Randomized Controlled Trials

Abstract

225 Biomedical and Biopharmaceutical Research J o r n a l d e I n v e s t i g a ç ã o B i o m é d i c a e B i o f a r m a c ê u t i c a Assessing Efficacy, Safety and Tolerability of Rituximab for Rheumatoid Arthritis: Meta-Analyses of Randomized Controlled Trials AbstractRheumatoid arthritis is a chronic disease with autoimmune nature. Rituximab is one of several pharmacological and nonpharmacological interventions which are used for its treatment and control. The aim of this study was to assess the efficacy, safety and tolerability of rituximab in the treatment of rheumatoid arthritis. A systematic review (up to June 2011) and meta-analyses were performed which included randomized controlled clinical trials that compared rituximab versus placebo, both with concomitant methotrexate. Only high or moderate quality studies were included. The efficacy was evaluated based on changes in ACR20, 50 and 70; the safety was assessed based on serious adverse events; and the tolerability was evaluated by the withdrawals due to adverse events. All these parameters were evaluated within 24 weeks of treatment. Four studies met the inclusion criteria, comprising 1 280 patients. The rituximab group presented higher efficacy results for ACR20, ACR50 and ACR70 (Relative Risk (RR) of 2,24 [1,86; 2,71], 3,29 [2,31; 4,68] and 3,90 [1,88; 8,09], respectively). For serious adverse events no significant difference between the groups was noticed (RR = 0,83 [0,54;1,26]. For withdrawals due to AE, no statistically significant difference between the groups was obtained either (RR = 1,49 [0,46;4,84]. In conclusion, the rituximab showed a higher efficacy compared to placebo without significant differences between the groups in terms of safety and tolerability. Keywords: rituximab, rheumatoid arthritis, efficacy, biologic agent, meta-analysis ResumoA artrite reumatoide é uma patologia de natureza autoimmune que apresenta diversas intervenções farmacológicas e não-farmacológicas para seu tratamento e controle, incluindo o rituximabe. O objetivo deste trabalho consistiu em avaliar a eficácia, segurança e tolerabilidade do rituximabe no tratamento da artrite reumatoide. Foram realizadas uma revisão sistemática (até junho de 2011) e meta-análises incluindo estudos clínicos controlados randomizados que comparassem o rituximabe com o placebo, ambos com concomitante metotrexato. Somente estudos com qualidade média ou alta foram incluídos. A eficácia foi avaliada baseando-se nas mudanças dos ACR20, 50 e 70; a segurança foi avaliada baseando-se nos eventos adversos sérios; a tolerabilidade foi avaliada pelos abandonos do tratamento devido a eventos adversos. Todos os parâmetros foram avaliados após 24 semanas de tratamento. Quatro estudos atingiram os critérios de inclusão, incluindo 1280 pacientes. O grupo do rituximabe apresentou maior eficácia para os parâmetros avaliados (ACR20, ACR50 e ACR70 -Risco Relativo (RR) de 2,24 [1,86; 2,71], 3,29 [2,31; 4,68] e 3,90 [1,88; 8,09], respectivamente). Para os eventos adversos sérios, não foi detectada difere...