L'effet du guselkumab sur l'inhibition de la progression radiographique chez les patients atteints de rhumatisme psoriasique actif : Protocole d'étude pour APEX, un essai de phase 3b, multicentrique, randomisé, en double aveugle, contrôlé par placebo
Trials. 2023 doi: 10.1186/s13063-022-06945-y
Guselkumab was approved for treating the signs and symptoms of active PsA following two Phase 3 global studies, DISCOVER-1 and DISCOVER-2. The Phase 3b APEX study has been designed to address the limitations of DISCOVER-2 and further assess the effects of guselkumab Q4W and Q8W on PsA outcomes.
These outcomes includes clinical efficacy, radiographic progression, and HRQoL, in a biologic-naïve patient population which has been enriched for those more likely to demonstrate radiographic progression.