‡P<0.0001 vs placebo.
Study Designs: DISCOVER 1 and DISCOVER 2 were Phase 3, multicenter, randomized, double-blind, placebo-controlled studies evaluating the efficacy and safety of TREMFYA® administered q8w subcutaneously after starter doses at Week 0 and Week 4 (n=127 and n=248, respectively) or placebo (n=126 and n=246, respectively) with starter doses at Week 0, and then every 4 weeks 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. In DISCOVER 1, eligible patients (≥18 years of age) had active PsA (swollen/tender joints ≥3, C-reactive protein [CRP] ≥0.3 mg/dL) for at least 6 months and included patients with prior biologic experience of ≤2 anti-TNFα treatments. Patients with other inflammatory diseases and those who had previously received Janus kinase (JAK) inhibitors or biologics other than TNFα inhibitors were excluded. In DISCOVER 2, eligible patients (≥18 years of age) had active PsA (swollen/tender joints ≥5, CRP ≥0.6 mg/dL) for at least 6 months and no prior JAK inhibitor or biologic experience. 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 and were allowed to initiate or increase the dose of one of the permitted concomitant medications up to the maximum dose allowed. The primary endpoint in DISCOVER 1 and DISCOVER 2 was ACR20 at Week 24.1,3,4
*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.
†Patients with missing data were considered nonresponders.
PATIENT SUPPORT FOR TREMFYA®
Access, affordability, and treatment support available through Janssen CarePath.
ONE DESTINATION FOR TREMFYA® ACCESS AND RESOURCES
Tools and resources to help you support patients to start and stay on TREMFYA®.
TREMFYA® VIDEO LIBRARY
Videos of important information about TREMFYA®.