Cytokine Signalling Forum

Publications





November 19

Análise de Exposição-Resposta de Eficácia e Segurança de Upadacitinib em Estudos de Fase 2 e 3 para Apoiar a Avaliação de Risco-Benefício na Artrite Reumatoide

Nader A, Mohamed M-EF, Winzenborg I, Doelger E, Noertersheuser P, Pangan AL, Othman AA.
Clin Pharmacol Ther . 2020 Apr;107(4):994-1003. doi: 10.1002/cpt.1671.

UPA 15 mg provided the optimal benefit-risk in RA through maximizing efficacy with only small incremental benefit with 30 mg, and with consistency across RA subpopulations and with UPA monotherapy or combination with csDMARDs. Exposure-response analyses were conducted using combined data from two Phase 2b and five Phase 3 studies in order to characterise the relationship between plasma exposure and efficacy, as well as to select safety parameters using the totality of the data in subjects with...

Keywords: JAK, Upadacitinib, Clinical, Efficacy

Translated by: Igor Kos