芦可替尼乳膏的效果怎么样？

The treatment effect of vitiligo and atopic dermatitis is remarkable, and the discomfort symptoms of patients can be significantly improved, and the drug is well tolerated and less frequent.

The effect of ruxolitinib cream in treating vitiligo

Research background: Vitiligo is a chronic autoimmune disease that causes skin depigmentation. Ruxolitinib cream caused hyperpigmentation in a phase 2 trial in adults with vitiligo.

STUDY METHODS: Two phase 3, double-blind, vehicle-controlled trials (Evaluation of Topical Ruxolitinib in Vitiligo Study 1 [TRuE-V1] and 2 [TRuE-V2]) were conducted in patients 12 years or older with non-segmental vitiligo with depigmentation accounting for 10% or less of total surface area. Patients were randomly assigned in a 2:1 ratio to all areas of vitiligo on the face and body to apply ruxolitinib 1.5% cream or vehicle control twice daily for 24 weeks, after which all patients could apply ruxolitinib 1.5% cream until week 52.

Study Results: In TRuE-V1, the percentage of patients experiencing an F-VASI75 response at Week 24 was 29.8% in the ruxolitinib cream group and 7.4% in the vehicle group. In TRuE-V2 they are 30.9% and 11.4% respectively. The results showed that ruxolitinib cream was superior to the vehicle control group.

Ruxolitinib cream for the treatment of atopic dermatitis

Background: Ruxolitinib cream demonstrated effective anti-inflammatory and antipruritic efficacy in a Phase 2 study in adults with atopic dermatitis (AD).

Study purpose: To evaluate the efficacy and safety of ruxolitinib cream for 8 weeks in adult patients with atopic dermatitis.

Methods: Evaluation of topical ruxolitinib cream in Atopic Dermatitis Studies 1 and 2 enrolled patients ≥12 years of age with ≥2 years of AD with an overall investigator assessment score of 2/3 and affected body surface area of 3%-20%.

Patients were randomly assigned in a 2:2:1 ratio to ruxolitinib 0.75% cream, ruxolitinib 1.5% cream, or vehicle cream twice daily for 8 weeks.

Results: In the evaluation of topical ruxolitinib cream in Atopic Dermatitis Studies 1 and 2, in which 631 and 618 patients were randomized, 50.0% of patients using ruxolitinib 0.75% cream and 53.8% of patients using ruxolitinib 1.5% cream achieved investigator's overall assessment of treatment success compared with patients using vehicle.

Within 12 hours after the first use of 1.5% ruxolitinib cream, itching was significantly reduced and the efficacy was better than that of the vehicle. The application site reaction of ruxolitinib cream was less and lower than that of the vehicle.

Ruxolitinib Cream Dosage

The patient applies a thin layer to the affected area no more than 20% of the body surface area, twice a day, and the weekly dosage should not exceed 60g. Ruxolitinib cream is for topical use only and cannot be used on other skin or mucous membranes such as the eyes, mouth, or vagina. The drug needs to be discontinued when symptoms subside.

References:

1. Rosmarin D, Passeron T, Pandya AG, Grimes P, Harris JE, Desai SR, Lebwohl M, Ruer-Mulard M, Seneschal J, Wolkerstorfer A, Kornacki D, Sun K, Butler K, Ezzedine K; TRuE-V Study Group. Two Phase 3, Randomized, Controlled Trials of Ruxolitinib Cream for Vitiligo. N Engl J Med. 2022 Oct 20;387(16):1445-1455. doi: 10.1056/NEJMoa2118828. PMID: 36260792.

2. Papp K, Szepietowski JC, Kircik L, Toth D, Eichenfield LF, Leung DYM, Forman SB, Venturanza ME, Sun K, Kuligowski ME, Simpson EL. Efficacy and safety of ruxolitinib cream for the treatment of atopic dermatitis: Results from 2 phase 3, randomized, double-blind studies. J Am Acad Dermatol. 2021 Oct;85(4):863-872. doi: 10.1016/j.jaad.2021.04.085. Epub 2021 May 4. PMID: 33957195.

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