芦可替尼乳膏效果怎么样

Ruxolitinib cream (RUX) demonstrated potent anti-inflammatory and antipruritic efficacy in a Phase 2 study in adults with atopic dermatitis (AD). Two phase 3 studies evaluated the efficacy and safety of ruxolitinib cream for 8 weeks in patients with AD (adult atopic dermatitis).

Methods: Topical evaluation of ruxolitinib cream in Atopic Dermatitis Study 1 (NCT03745638) and Study 2 (NCT0374 5651) included patients with AD aged ≥12 years, duration ≥2 years, with an investigator global assessment score of 2/3 and affected body surface area of 3%-20%. Patients were randomized in a 2:2:1 ratio to receive 0.75% RUX cream, 1.5% RUX cream, or vehicle cream twice daily for 8 weeks. The primary endpoint was investigator's global assessment of treatment success at Week 8 (investigator's global assessment score of 0/1, ≥2-grade improvement from baseline).

Results: In the topical evaluation of Atopic Dermatitis Studies 1 and 2, 631 and 618 patients were randomized (631/577 patients for efficacy analysis). At week 8, significantly more patients achieved investigator global assessment of treatment success using 0.75% RUX cream (50.0%/39.0%) and 1.5% RUX ointment (53.8%/51.3%) compared with vehicle (15.1%/7.6%). Itching was significantly reduced within 12 hours after the first application of 1.5% RUX.

Conclusion: Ruxolitinib cream has anti-inflammatory and rapid antipruritic effects, and its efficacy is better than that of vehicle.

In a phase 2 study (NCT03011892), 307 adult AD patients with an investigator global assessment score of 2 or 3 (mild or moderate) and an affected body surface area of 3% to 20% were randomized on average into 8 weeks, received double-blind treatment with RUX (1.5% twice daily [BID], 1.5% once daily [QD], 0.5% once daily, 0.15% once daily), vehicle, or triamcinolone acetonide cream (0.1% BID 4 weeks, then vehicle for 4 weeks). Patients can then undergo an additional 4 weeks of open-label treatment with RUX BID 1.5%. The primary endpoint was to compare mean percent change from baseline in eczema area and severity index at week 4 for RUX Cream 1.5% BID and vehicle.

RESULTS: All RUX regimens showed treatment effect at week 4; 1.5% BID produced the greatest improvement in the Eczema Area and Severity Index (71.6% vs. 15.5%; P < .0001) and Investigator's Global Assessment Response (38.0% vs. 7.7%; P < .001). Pruritus Numerical Rating Scale scores declined rapidly within 36 hours (1.5% BID vs vehicle, -1.8 vs -0.2; P < .0001) and continued through 12 weeks. Patients who transitioned to 1.5% RUX BID improved on all measures. RUX is not associated with clinically significant application site reactions.

Conclusion: Ruxolitinib cream can quickly and continuously improve AD symptoms and is well tolerated.

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References

[1.]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.

[2.]Kim BS, Howell MD, Sun K, Papp K, Nasir A, Kuligowski ME; INCB 18424-206 Study Investigators. Treatment of atopic dermatitis with ruxolitinib cream (JAK1/JAK2 inhibitor) or triamcinolone cream. J Allergy Clin Immunol. 2020 Feb;145(2):572-582. doi: 10.1016/j.jaci.2019.08.042. Epub 2019 Oct 17. PMID: 31629805.