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氘可来昔替尼的适应证,用法用量,作用功效,副作用?

Author: Medicalhalo
Release time: 2025-10-19 11:44:20

(商品名为Sotyktu)是由美国百时美施贵宝公司研发的全球首个口服选择性酪氨酸激酶2(TYK2)变构抑制剂,2022年9月9日获FDA批准,用于治疗适合系统治疗或光疗的中重度斑块型银屑病成人患者。 On September 26, 2022, Japan approved its use for the treatment of plaque psoriasis, generalized pustular psoriasis and erythrodermic psoriasis.

Indications for deuterated colexitinib

SOTYKTU is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. SOTYKTU is not recommended for use in combination with other strong immunosuppressants.

Deuterated colexitinib dosage and dosage

1. Recommended evaluation and immunizations before starting treatment

Before initiating treatment with SOTYKTU, evaluate patients for active and latent tuberculosis (TB) infection. If positive, initiate TB treatment before using SOTYKTU. Update immunizations according to current immunization guidelines.

2. Recommended dosage

The recommended dose of SOTYKTU is 6 mg administered once daily with or without food. Do not crush, cut, or chew tablets.

3. Recommended dosage for patients with liver damage

SOTYKTU is not recommended for use in patients with severe hepatic impairment (Child-Pugh C) and no dose adjustment is required in patients with mild to moderate hepatic impairment.

The role of deuterated colexitinib

氘可来昔替尼与其他生物制剂相比,可选择性靶向TYK2,抑制多种促炎因子(包括IL-12、IL-23和IFN-α),从而治疗中重度斑块型银屑病。 Deuterated colexitinib is highly selective for TYK2.在细胞实验中,氘可来昔替尼对TYK2的选择性比JAK1/3高100倍,同时比JAK2高2000倍,对TYK2的这种高选择性使氘可来昔替尼具有更好的安全性。

Efficacy of deuterated colexitinib

POETYK PSO-3(NCT04167462)22是在中国大陆、中国台湾地区和韩国开展的一项多中心、随机、双盲、安慰剂对照的II期研究,以评估氘可来昔替尼在中重度斑块型银屑病成人患者中的疗效和安全性。

In this trial, 220 patients were randomly assigned into two groups. The deuterated colexitinib group was orally administered 6 mg once a day, while the placebo group received placebo once a day.

结果表明,第16周时,氘可来昔替尼组和安慰剂组达到PASI75的患者比例分别为68.8%和8.1%,达到sPGA评分0或1分的患者比例分别为55.6%和6.8%,证明氘可来昔替尼治疗中重度斑块型银屑病成人患者具有很好的疗效。

Deuterated colexitinib side effects

Here are the treatments for the most common side effects of colexitinib:

1. Common colds, sore throats and sinus infections

对于普通感冒和咽喉痛,可以采取以下措施缓解症状:多喝水,适当休息,使用盐水漱口和温水淋浴来缓解咽喉不适。 For sinus infections, you can use a saline nasal rinse to cleanse your nasal passages, and use a topical nasal spray or oral medication as recommended by your doctor.

2. Ulcers on the inner lips, gums, tongue or roof (upper respiratory tract infection)

Oral ulcers can be treated with gargles or sprays to relieve pain and promote healing. At the same time, maintain oral hygiene and good oral hygiene, and avoid the intake of spicy and irritating foods.

3. Oral ulcers, cold sores (herpes simplex), pore inflammation (folliculitis), and acne

To combat these skin problems, you can take the following measures: keep your skin clean, avoid greasy foods and irritating substances, avoid pinching acne, use mild facial cleansers and moisturizing products, avoid sun exposure and use sunscreen.

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