Deucravacitinib: A Ray of Hope after a decade of wait! BMS plans to progress its potential game-changer oral TYK2 inhibitor into late-stage clinical development
Efficacy and safety of deucravacitinib, an oral, selective, allosteric TYK2 inhibitor, in patients with active Systemic Lupus Erythematosus (SLE): a Phase II, randomized, double-blind, placebo-controlled study (LB0004)
Bristol Myer Squibb’s deucravacitinib, which is an oral selective, allosteric tyrosine kinase 2 (TYK2) inhibitor has been evaluated for multiple immune-mediated diseases, including psoriasis arthritis, inflammatory bowel diseases, active discoid and subacute cutaneous lupus.
In the PAISLEY (NCT03252587) proof of concept study, the medication was compared to a placebo in individuals with moderate to severe SLE. Deucravacitinib (3 mg BID, 6 mg BID, and 12 mg QD) or placebo were given to patients on conventional background medicines. The proportion of patients who achieved SRI (4) at week 32 was the primary goal. Key secondary endpoints at week 48 included SRI (4), BICLA, LLDAS, CLASI-50, and change from baseline in the active (tender and swollen) joint count.
New systemic lupus treatments are desperately needed. New oral medicine has not been approved in decades, and up to half of the patients may not respond sufficiently to current treatment alternatives. These clinically meaningful results represent a huge potential step forward in the development of a new lupus therapy to help meet the immense need of patients living with this disease.
Conclusion
Because systemic lupus erythematosus is such a varied disease, new therapeutic alternatives are needed because up to half of the patients may not respond well to present treatments. Deucravacitinib's positive safety, tolerability, and efficacy results in several measures of disease activity, including overall and organ-specific activity, when compared to the placebo group for the treatment of SLE, represent a huge potential step forward in the development of a new lupus therapy to help meet the immense need for patients living with this disease.
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