Deucravacitinib efficacious in treating systemic lupus erythematosus
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MILAN — Deucravacitinib demonstrated efficacy and safety in treating patients with systemic lupus erythematosus and sustained improvement up to 48 weeks.
Data from the randomized, placebo-controlled, double-blind, multicenter phase 2 trial was presented during the European Academy of Dermatology and Venereology Congress. The study analyzed the efficacy and safety of deucravacitinib in patients with active systemic lupus erythematosus (SLE).
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“An outcome measurement that has been validated and used throughout our trials is called the CLASI, the Cutaneous Lupus Erythematosus Disease Area and Severity Index,” Victoria Werth, MD, chief of dermatology at the Michael J. Crescenz VA Medical Center and professor of dermatology at the University of Pennsylvania, told Healio. “The CLASI has been able to capture, in a granulated way, very meaningful improvement.”
Eligible patients for the study experienced active SLE with moderate to severe disease and met the Systemic Lupus International Collaborating Clinics criteria. Patients were randomly assigned 1:1:1:1 to receive deucravacitinib dosed 3 mg twice daily, 6 mg twice daily or 12 mg once daily, or placebo.
The primary endpoint was the number of patients who achieved an SLE Responder Index-4 (SRI-4) response at week 32. Secondary endpoints at week 48 included continued SRI-4 response, a decrease of at least 50% in CLASI score from those with a baseline measurement of CLASI-10 or less, and the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response.
Of the 363 patients, 76% completed the 48 weeks of treatment. At week 32, 58.2% of the 3 mg group, 49.5% of the 6 mg group and 44.9% of the 12 mg group achieved SRI-4 responses compared with 34.4% of the placebo group. This response was sustained in all deucravacitinib groups at week 48.
Patients treated with deucravacitinib out-performed those with placebo by 10% to 22% in BICLA and 39% to 53% in CLASI-50. They also achieved greater mean changes from the CLASI baseline by 3.1 to 4.9 points.
Additionally, deucravacitinib was well tolerated with fewer serious adverse events occurring in treated patients compared with the placebo group. Deucravacitinib maintained a safety profile consistent with earlier trials in psoriasis and psoriatic arthritis.
“With deucravacitinib, we are beginning to see effects on skin that we have not been able to see in the past,” Werth said. “We are really entering a new era with a more targeting therapy that may allow improvement.”
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Pike M, et al. Poster. Efficacy and safety of deucravacitinib, an oral, selective, allosteric TYK2 inhibitor, in patients with active systemic lupus erythematosus: Results from a phase 2, randomized, double-blind, placebo-controlled study. Presented at: European Academy of Dermatology and Venereology Congress; Sept. 7-10, 2022; Milan.
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