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- Efficacy in PsO
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- Efficacy in PsA
POST HOC POOLED DATA FROM DISCOVER 1 AND DISCOVER 2: BASDAI50 AT WEEK 24 AMONG PATIENTS WITH IMAGING-CONFIRMED SACROILIITIS (NRI ANALYSIS)*†‡§
This endpoint was not adjusted for multiplicity; therefore, statistical significance has not been established.
*Subsets of DISCOVER 1 and DISCOVER 2 patients with sacroiliitis at baseline who had either documented imaging confirmation of sacroiliitis in the past or pelvic X-ray confirmation of sacroiliitis at screening based on investigators’ judgment of presence/absence of sacroiliitis are included.
†Through Week 24, patients were considered to be nonresponders after meeting treatment failure criteria: discontinued study agent for any reason, terminated study participation for any reason, initiated or increased dose of DMARDs or oral corticosteroids over baseline for PsA, or initiated protocol-prohibited medications/therapies for PsA. After Week 24, treatment failure rules were not applied.
‡Patients with missing data were considered as nonresponders.
§Included patients with BASDAI >0 at baseline.
Reference: 1. Helliwell P, Gladman DD, Poddubnyy D, et al. 0P0054 Efficacy of guselkumab, a monoclonal antibody that specifically binds to the p19-subunit of IL-23, on endpoints related to axial involvement in patients with active PsA with imaging-confirmed sacroiliitis: week-24 results from two phase 3, randomized, double-blind-placebo controlled studies. Ann Rheum Dis. 2020;79:36-37.