Upadacitinib versus Placebo ou Adalimumab em Pacientes com Artrite Reumatoide e uma Resposta Inadequada a Metotrexato: Resultados de um Estudo de Fase 3, randomizado, controlado, duplo cego
UPA demonstrated superiority to ADA in terms of clinical, functional and patient-reported outcomes with comparable radiographic inhibition. As many RA patients fail to achieve LDA and remission with TNF inhibitors and MTX there is a requirement for additional treatment options. In this SELECT-COMPARE study the clinical and functional outcomes of UPA were compared to ADA in MTX-IR patients.
1629 MTX-IR were randomly assigned 2:2:1 to; UPA 15mg QD, ADA 40mg Q2W or PBO, with background MTX. Key endpoints for UPA versus ADA were; ACR50, DAS28(CRP)≤3.2, mean change in pain using VAS, HAQ-DI, and the proportion of patients with no radiographic progression. Non-responders were rescued to opposing ADA/UPA groups, however these patients were excluded from AE safety assessments at Wk26.
UPA and ADA groups had a similar safety profile, with a greater frequency of HZ, CPK elevations, lymphopenia and ALT/AST elevations in UPA. The authors concluded UPA 15mg + MTX had a favourable benefit/risk profile for the treatment of RA.