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Abstract
Background Deucravacitinib is a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, approved in multiple countries for the treatment of adults with plaque psoriasis.¹ ² Deucravacitinib demonstrated efficacy across the primary endpoint and all key secondary endpoints in a phase 2 trial in patients with systemic lupus erythematosus (SLE).³ Here, we describe 2 phase 3 trials currently underway to assess the efficacy and safety of deucravacitinib in patients with active SLE. These phase 3 trials have been designed to replicate the successful elements of the phase 2 trial, including its glucocorticoid-tapering strategy and rigorous management structure.³
Methods In these phase 3, randomized, double-blind, placebo-controlled, global trials (POETYK SLE-1 [NCT05617677], POETYK SLE-2 [NCT05620407]), adults (aged 18–75) with active SLE on background standard-of-care treatment will be randomized (1:1) to placebo or deucravacitinib for 52 weeks of double-blind treatment (figure 1). Patients on glucocorticoids will be instructed to taper, unless significant disease activity is present, to a threshold dose level during the double-blind treatment period. At week 52, patients may choose to continue in a 104-week open-label extension phase, in which all patients receive deucravacitinib. Key eligibility criteria and study design are depicted below (figure 1) rimary endpoint of SLE Responder Index (SRI[4]) and all secondary endpoints will be assessed at week 52 (table 1) safety and tolerability will be assessed throughout the trial
Results Planned randomization in each trial includes 490 patients (245 per treatment group) in 27 countries across North and South America, Europe, and Asia-Pacific.
Conclusions The phase 3 POETYK SLE trials will further evaluate the efficacy and safety of deucravacitinib, an oral, selective, TYK2 inhibitor, in patients with active SLE.
POETYK SLE-1 and POETYK SLE-2 Trial Design
Primary and Secondary Endpoints Assessed at Week 52
References
Armstrong A, et al. J Am Acad Dermatol 2022;S0190-9622(22)02256-3.
Strober B, et al. J Am Acad Dermatol 2022;S0190-9622(22)02643-3.
Morand E, et al. Arthritis Rheumatol 2022;Nov 11 (Epub ahead of print). doi: 10.1002/art.42391.
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