Effect of Secukinumab on the Different GRAPPA-OMERACT Core Domains in Psoriatic Arthritis: A Pooled Analysis of 2049 Patients.
Orbai A-M., McInnes IB., Coates LC., Husni ME., Gladman DD., Gossec L., Pricop L., Chambenoit O., Meng X., Mease PJ.
OBJECTIVE: To compare the efficacy of secukinumab with that of placebo across the updated Group for Research and Assessment of Psoriasis and Psoriatic Arthritis and Outcome Measures in Rheumatology (GRAPPA-OMERACT) individual PsA core domains using pooled data from 4 phase 3 psoriatic arthritis (PsA) studies and 1 phase 3 ankylosing spondylitis (AS) study. METHODS: Data were pooled from 2049 patients with PsA participating in 4 on-label phase 3 PsA studies (FUTURE 2-5), and the efficacy of each GRAPPA-OMERACT PsA core domain (musculoskeletal disease activity, skin disease activity, pain, patient global assessment, physical function, health-related quality of life, fatigue, and systemic inflammation) was assessed using multiple measures and definitions specific to each domain. The MEASURE 2 study, a phase 3 clinical trial in patients with AS, was used to assess improvement in spine symptoms at Week 16. RESULTS: Treatment with secukinumab demonstrated robust and consistent efficacy across all GRAPPA-OMERACT PsA core domains, with secukinumab 300 mg showing the greatest response rates across most PsA core domains compared with placebo at Week 16. Notably, among patients treated with secukinumab 300 mg, 34.3% and 19.5% achieved complete resolution of swollen and tender joint counts, respectively, 53.2% and 61.5% achieved complete resolution of enthesitis and dactylitis, respectively, and 33.2% achieved 100% improvement in Psoriasis Area and Severity Index (all P < 0.05 vs placebo); similar improvements were shown for all other core domains. CONCLUSION: This analysis suggests that secukinumab can benefit people with PsA across the clinical phenotypic spectrum commonly encountered in this disease.