IN ADULTS WITH ACTIVE PSORIATIC ARTHRITIS (PsA)

BASDAI50 RESPONSE AT WEEK 24¹

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POST HOC POOLED DATA FROM DISCOVER 1 AND DISCOVER 2: BASDAI50 AT WEEK 24 AMONG PATIENTS WITH IMAGING-CONFIRMED SACROILIITIS (NRI ANALYSIS)*^†‡§

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WEEK 24

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.

 

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DISCOVER 1 AND DISCOVER 2 STUDY DESIGNS^1-3

PHASE 3 MULTICENTER, DOUBLE-BLIND TRIALS

DISCOVER 1 and DISCOVER 2 were Phase 3, multicenter, randomized, double-blind, placebo-controlled studies evaluating the efficacy and safety of TREMFYA® administered subcutaneously in patients with active PsA (fulfilling CASPAR criteria) despite standard therapies (nonbiologic disease-modifying antirheumatic drugs [DMARDs], apremilast, and non-steroidal anti-inflammatory drugs [NSAIDs]). A stable dose of 1 selected nonbiologic DMARD, corticosteroids, and NSAIDs were permitted but not required. The primary endpoint in DISCOVER 1 and DISCOVER 2 was ACR20 at Week 24.

Selected Inclusion and Exclusion Criteria

DISCOVER 1

• ≥18 years of age
• Active PsA (swollen/tender joints ≥3, C-reactive protein [CRP] ≥0.3 mg/dL) for at least 6 months
• Prior biologic experience of ≤2 TNFα inhibitors (31%)
• Patients with other inflammatory diseases and those who had previously received Janus kinase (JAK) inhibitors or biologics other than TNFα inhibitors were excluded

DISCOVER 2

• ≥18 years of age
• Active PsA (swollen/tender joints ≥5, CRP ≥0.6 mg/dL) for at least 6 months
• No prior biologic experience
• Previous exposure to biologics or JAK inhibitors precluded participation

DISCOVER 1 (N=381)* AND DISCOVER 2 (N=739)*:

*128 patients in DISCOVER 1 and 246 patients in DISCOVER 2 were randomized to a TREMFYA® 100 mg q4w dosing regimen. TREMFYA® q4w is not an FDA-approved dosing regimen.

^†Open-label active treatment (blinded dosing interval) ran through Week 52.

^‡At Week 24, patients taking placebo crossed over to receive TREMFYA® 100 mg at Week 0, Week 4, then every 4 weeks thereafter. TREMFYA® dosed every 4 weeks is not an approved dosing regimen.

^§At Week 16, patients in all treatment groups who had <5% improvement from baseline in both swollen and tender joint counts were considered as meeting early escape criteria and were allowed to initiate or increase the dose of one of the permitted concomitant medications up to the maximum dose allowed.

TNF=tumor necrosis factor.

 

References: 1. Data on File. Janssen Biotech, Inc. 2. Deodhar A, Helliwell PS, Boehncke WH, et al. Guselkumab in patients with active psoriatic arthritis who were biologic-naïve or had previously received TNFα inhibitor treatment (DISCOVER 1): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;20(30265):1-11. 3. Mease PJ, Rahman P, Gottlieb AB, et al. Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER 2): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;20(30263):1-11.