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Deucravacitinib, a novel cure for patients with active SLE
Australia: Deucravacitinib (DEUC) showed statistically significant and sustained clinical efficacy and safety in patients with active systemic lupus erythematosus (SLE), states a phase 2 trial data published in Annals of the Rheumatic Diseases. DEUC may be a new treatment option for SLE.
Systemic lupus erythematosus is a chronic autoimmune disease.TYK2 mediates the signal of key cytokines involved in lupus pathogenesis. Deucravacitinib (DEUC) is an oral, selective, allosteric TYK2 inhibitor with a unique mechanism of action, distinct from Janus kinase (JAK) 1/2/3 inhibitors. It has already shown efficacy in psoriasis and psoriatic arthritis. It is a topic of discussion among Rheumatologists as a wonder drug for the treatment of a wide range of conditions
The author Eric Morand, Monash University in Victoria, Australia and colleagues conducted a study to evaluate the efficacy and safety of DEUC in patients with active systemic lupus erythematosus (SLE).
The study was a 48-week (wk), randomized, double-blind, placebo (PBO)-controlled, phase 2 trial. Researchers enrolled a total of 363 patients with active SLE and randomized them in 1:1:1:1 to PBO or DEUC (3 mg BID, 6 mg BID, 12 mg QD). The primary endpoint was the proportion of patients achieving SLE Responder Index Level 4 (SRI4) at wk 32. Key secondary endpoints at wk 48 included SRI(4), BICLA, LLDAS, CLASI-50, and change from baseline in the active (tender and swollen) joint count.
Key findings from the trial data,
• At wk 32, a greater proportion of patients achieved SRI(4) responses in DEUC 3 mg BID and 6 mg BID groups compared to PBO
• SRI(4) response was sustained across all DEUC groups for up to 48 wks.
• At wk 48, the DEUC 3 mg BID group demonstrated statistical significance in BICLA, LLDAS, CLASI-50, and active joint count, and the two other DEUC groups demonstrated clinically meaningful differences compared to PBO.
• Rates of adverse events (AEs), serious AEs, and AEs of interest were similar between DEUC and PBO groups. There were no deaths, major cardiac events, thrombotic events, systemic opportunistic infections, or active tuberculosis.
• Malignancies were rare with similar rates of occurrence across all groups.
• There were no meaningful abnormalities in mean levels of haematology and chemistry laboratory parameters.
The authors conclude that DEUC has shown noteworthy and sustained clinical efficacy in SRI (4), improvement across multiple composites and organ-specific measures up to 48 wks and it was well tolerated in active SLE patients. The authors wrote that data shows DEUC as a novel therapy for SLE and warrants further investigation in phase III trials.
Morand E, Pike M, Merrill JT, et alLB0004 EFFICACY AND SAFETY OF DEUCRAVACITINIB, AN ORAL, SELECTIVE, ALLOSTERIC TYK2 INHIBITOR, IN PATIENTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDYAnnals of the Rheumatic Diseases 2022;81:209.
BDS
Dr. Hiral patel (BDS) has completed BDS from Gujarat University, Baroda. She has worked in private dental steup for 8years and is currently a consulting general dentist in mumbai. She has recently completed her advanced PG diploma in clinical research and pharmacovigilance. She is passionate about writing and loves to read, analyses and write informative medical content for readers. She can be contacted at editorial@medicaldialogues.in.
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751