氘可来昔替尼治疗银屑病的优势？

Deuterated colexitinib

It is a tyrosine kinase 2 (TYK2) inhibitor, a new oral drug that selectively inhibits TYK2, has a low risk of off-target effects, works through an allosteric mechanism, binds to the catalytically inactive pseudokinase regulatory domain of TYK2, and stabilizes the inhibitory interaction between the regulatory and catalytic domains.

Deuterated colexitinib is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, but its use in combination with other potent immunosuppressants is not recommended.

Deuterated colexitinib approval status

Deuterated colexitinib was approved in the United States for the treatment of adults with moderate to severe plaque psoriasis on September 9, 2022, and in Japan on September 26, 2022, for the treatment of plaque psoriasis, generalized pustular psoriasis, and erythrodermic psoriasis.

Deuterated colexitinib for the treatment of psoriasis

In the 52-week, double-blind, Phase 3 POETYK PSO-1 trial, patients were randomized in a 2:1:1 ratio to receive deuterated colexitinib 6 mg daily (n=332), placebo (n=166), or apremilast 30 mg twice daily (n=168). The primary endpoint included response rate from baseline of ≥75% reduction in Psoriasis Area and Severity Index (PASI 75) and a Static Physician's Global Assessment score of 0 or 1 (sPGA 0/1) at Week 16 compared with placebo.

At week 16, more than 50% of patients treated with colexitinib achieved PASI75, meaning that more than 50% of patients had a ≥75% reduction in Psoriasis Area and Severity Index score from baseline. The treatment response rate at PASI75 was significantly higher, 58.4% in the colexitinib group and 53.6% in sPGA 0/1. Efficacy improved after week 16 and continued through week 52.

Deuterated colexitinib was superior to placebo and apremilast and was well tolerated in moderate to severe plaque psoriasis.

Deuterated colexitinib side effects

Mainly include upper respiratory tract infection, elevated blood creatine phosphokinase, herpes simplex, oral ulcers, folliculitis, acne, etc. Serious side effects mainly include infection, malignant tumors, and abnormal laboratory tests.

References:

1. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial. J Am Acad Dermatol. 2023 Jan;88(1):29-39. doi: 10.1016/j.jaad.2022.07.002. Epub 2022 Jul 9. PMID: 35820547.

2. Hoy SM. Deucravacitinib: First Approval. Drugs. 2022 Nov;82(17):1671-1679. doi: 10.1007/s40265-022-01796-y. PMID: 36401743; PMCID: PMC9676857.

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