Opzelura(Ruxolitinib)的益处是否超过潜在风险?美国食品药品监督管理局批准的非节段性白癜风(NSV)治疗方法

Pub Date : 2023-06-01 DOI:10.1016/j.ijso.2023.100630
Amna Iqbal, Madiha Salman
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引用次数: 0

摘要

最近,Ruxolitinib (Opzelura)已被美国食品和药物管理局(FDA)批准作为非节段性白癜风的第一种治疗药物。非节段性白癜风是由于自身免疫性疾病导致的白垩白色斑点,边缘清晰。这种乳霜的作用模式是抑制JAK,逐渐促进新的健康皮肤细胞的生长,最终,在受影响的区域发生色素沉着。事实上,这种药物在皮肤病学领域具有重要意义,因为几乎3/4 %的面部白癜风得到了解决,但高昂的成本将成为促进患者的障碍,应该得到补贴。此外,处方医生和药剂师应该意识到FDA发出的黑框警告,因为这是严重的警告。应该进行更多的临床试验,以了解12岁以下儿童的安全性。
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Do the benefits of Opzelura (Ruxolitinib) outweigh the potential risks? An insight into the FDA-approved treatment for non-segmental vitiligo (NSV)

Recently, Ruxolitinib (Opzelura) has been approved by the Food and Drug Administration (FDA) as the first treatment for non-segmental vitiligo, which results in chalky white macules with clear edges due to an autoimmune disorder. The mode of action of this cream is JAK inhibition which progressively enhances the growth of new, healthy skin cells, and eventually, repigmentation occurs in the affected area. Indeed, this medication represents significance in the field of dermatology as almost 3/4th % of facial vitiligo was resolved but the high cost will be a hindrance in facilitating the patients and should be subsidized. Moreover, prescribers and pharmacists should be aware of the black box warnings issued by FDA as severe caution is indicated. More clinical trials should be conducted to know the safety of children under 12 years of age.

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