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 In a phase 2 trial in SLE patients on background standard therapy, deucravacitinib demonstrated efficacy vs placebo across multiple endpoints, including SRI(4) at week 32 (primary endpoint) and at week 48 (secondary endpoint), as well as BICLA at week 48 (secondary endpoint).3 This post-hoc analysis further evaluated efficacy and time to response with deucravacitinib vs placebo in these responses in the phase 2 trial.
Methods This 48-week, double-blind trial (NCT03252587) randomized 363 patients with active SLE 1:1:1:1 to placebo or deucravacitinib 3 mg BID, 6 mg BID, or 12 mg QD. Endpoints included the proportions of patients achieving SRI(4), BICLA, and simultaneous (dual) SRI(4)/BICLA responses at weeks 32 and 48, proportions of patients with sustained responses through week 48 (responder at every visit from week 32 through week 48), and time to onset of responses. BICLA response, and therefore dual response, were measurable at the first visit after steroid taper completion (week 24 [day 168]). Analyses were descriptive.
Results At weeks 32 and 48, SRI(4), BICLA, and dual response rates were numerically higher with deucravacitinib vs placebo (figure 1). Median time intervals to onset of SRI(4), BICLA, and dual responses were lower with deucravacitinib treatment compared with placebo (table 1). Median times to onset of dual response were 196–282 days with deucravacitinib. A higher percentage of patients treated with deucravacitinib sustained their SRI(4), BICLA, and dual responses through week 48 vs placebo (table 1).
Conclusions Deucravacitinib treatment elicited higher and faster SRI(4), BICLA, and dual responses compared with placebo. Patients were more likely to sustain their treatment responses from weeks 32 through 48 with deucravacitinib treatment vs placebo. These data support the robust efficacy of deucravacitinib across multiple SLE response indices.
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Morand E, et al. Arthritis Rheumatol. 2022; Nov 11 (Epub ahead of print).
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