IN ADULTS WITH ACTIVE PSORIATIC ARTHRITIS (PsA)

IMPROVEMENT IN AXIAL DISEASE SYMPTOMS¹

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

WEEK 24

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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.

 

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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 2 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 nonsteroidal anti-inflammatory drugs [NSAIDs]). A stable dose of one selected nonbiologic DMARD, corticosteroids, and NSAIDs was permitted, but not required. The primary endpoint in both DISCOVER 1 and DISCOVER 2 was ACR20 response at Week 24.

Selected Inclusion and Exclusion Criteria

DISCOVER 1¹

• ≥18 years of age
• Active PsA (swollen/tender joints ≥3, C-reactive protein [CRP] ≥0.3 mg/dL) for at least 6 months
• Biologic experience: ≤2 tumor necrosis factor alpha (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 2²

• ≥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

*In DISCOVER 1, 128 patients and in DISCOVER 2, 245 patients were randomized to a q4w dosing regimen. TREMFYA® dosed every 4 weeks is not an FDA-approved dosing regimen.

^†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.

^‡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.

References: 1. 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;395(10230):1115-1125. 2. Mease PJ, Rahman P, Gottlieb AB, et al. Guselkumab in biologic-naïve patients with active psoriatic arthritis (DISCOVER 2): a double-blind, randomized, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1126-1136. 3. Data on file. Janssen Biotech, Inc.