03Nov 2021
Long‐term Efficacy and Safety of Guselkumab, a Monoclonal Antibody Specific to the p19 Subunit of Interleukin‐23, Through 2 Years: Results from a Phase 3, Randomized, Double‐blind, Placebo‐controlled Study Conducted in Biologic‐naïve Patients with Active Psoriatic Arthritis

Long‐term Efficacy and Safety of Guselkumab, a Monoclonal Antibody Specific to the p19 Subunit of Interleukin‐23, Through 2 Years: Results from a Phase 3, Randomized, Double‐blind, Placebo‐controlled Study Conducted in Biologic‐naïve Patients with Active Psoriatic Arthritis

Assess long‐term efficacy and safety of guselkumab, an IL‐23p19‐subunit inhibitor, in patients with active psoriatic arthritis (PsA) from the Phase‐3 DISCOVER‐2 trial. In DISCOVER‐2, patients with active PsA (≥5 swollen and ≥5 tender joints; CRP ≥0.6 mg/dL) despite prior nonbiologic therapy were randomized to: guselkumab 100mg every‐4‐weeks (Q4W); at Week0, Week4, and Q8W; or placebo➔guselkumab Q4W at Week24. Efficacy assessments included ≥20%/50%/70% improvement in ACR components (ACR20/50/70), Investigator’s Global Assessment of psoriasis score=0 (IGA=0; indicating complete skin clearance), enthesitis (Leeds Enthesitis Index) and dactylitis (Dactylitis Severity Score) resolution, and changes in PsA‐modified van der Heijde‐Sharp (vdH‐S) radiographic scores...

  • #orthopaedics

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