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IN ADULTS WITH ACTIVE PSORIATIC ARTHRITIS (PsA)
POST HOC POOLED DATA FROM DISCOVER 1 AND DISCOVER 2: BASDAI50 RESPONSE 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.
*Included 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.
†BASDAI is a subject self-assessment of axial disease, which asks patients to rate their symptoms on a scale of 0 to 10, with higher scores indicating greater disease severity.
‡After Week 24, patients and doctors knew that all patients were on TREMFYA® (open label with a blinded dosing interval), which may have affected the results.
§The prespecified as-observed analyses at Weeks 52 and 100 are not shown.
||Patients with BASDAI >0 at baseline.
¶Patients with missing data were considered nonresponders.
#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 the 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.
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.