Model-Informed Drug Development-Based Bridging from Subcutaneous to Intravenous Secukinumab Dosing: Approval in Psoriatic Arthritis and Axial Spondyloarthritis.

ABSTRACT: The objective of this modeling and simulation analysis was to determine an intravenous (IV) secukinumab dosing regimen with steady-state exposure within the ranges of the approved subcutaneous (SC) regimens (300 and 150 mg every 4 weeks [q4w]) and to predict the efficacy and safety of this IV regimen for patients with psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA). This approach was suggested by the US Food and Drug Administration (FDA) following review of the primary endpoint analysis results of secukinumab 3 mg/kg q4w IV in patients with PsA (INVIGORATE-2 study). Noting the higher exposure of the investigated IV regimen compared to the approved SC regimens, the FDA considered that the INVIGORATE-2 data available through Week 16 only may not convey sufficient safety informat

SUBMITTER: Dumortier T 

PROVIDER: S-EPMC12272323 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature