IL-23 Inhibitor Tildrakizumab Effective in Psoriatic Arthritis Save
Tildrakizumab, a monoclonal antibody targeting interleukin-23p19 studied in adults with psoriatic arthritis (PsA), was found to be superior to placebo and well tolerated without reports of uveitis, systemic fungal infections, inflammatory bowel disease, major cardiac events or death.
A total of 391 adult PsA patients were enrolled in this randomised, double-blind, placebo-controlled, phase IIb study, wherein they received either placebo or tildrakizumab 200 mg every 4 weeks (Q4W); tildrakizumab 200, 100 or 20 mg Q12W; or placebo Q4W. At week 12, those on tildrakizumab 20 mg or placebo switched to tildrakizumab 200 mg Q12W and continued to week 52. The primary efficacy endpoint was proportion of patients with ACR20 response.
ACR 20 responses at week 24 was 71.4%–79.5% for tildrakizumab versus 50.6% in placebo-treated patients (all p<0.01). Similarly, tildrakizumab had significantly higher rates of ACR50, DAS28-CRP <3.2, minimal disease activity and PASI 75/90/100 scores at weeks 24 and 52. However, improvement in dactylitis and enthesitis was not observed. Serious adverse events were seen in 3.3%, and were comparable among treatment arms.
Tildrakizumab significantly improved joint and skin manifestations of PsA, but not dactylitis and enthesitis.