Cytokine Signalling Forum

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Upadacitinib versus Placebo o Adalimumab en Pacientes con Artritis Reumatoide y una Respuesta inadecuada a Metotrexate: Resultados de un Estudio de Fase 3, aleatorizado, controlado doble ciego

Fleischmann R, Pangan AL, Song IH, Mysler E, Bessette L, Peterfy C, Durez P, Ostor AJ, Li Y, Zhou Y, Othman AA, Genovese MC. - Arthritis Rheumatol 2019 DOI: 10.1002/art.41032

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.