Ruxolitinib formulation for reduction of itch in atopic dermatitis
This disclosure relates to methods of reducing itch in patients with atopic dermatitis and treating patients with atopic dermatitis by administering a topical 0.75% or 1.5% ruxolitinib cream two times per day.
1. A method of treating moderate atopic dermatitis in a human patient in need thereof comprising:
administering to the human patient's skin a topical formulation, comprising 1.5% (w/w) on a free base basis of ruxolitinib, or a pharmaceutically acceptable salt thereof, two times per day, and
continuing the administration of the topical formulation for at least 8 weeks,
wherein the human patient has a Body Surface Area (BSA) of atopic dermatitis involvement ranging from 3% to 20% at baseline,
wherein the patient has an itch Numerical Rating Scale score of ≥4 at baseline,
wherein the human patient achieves IGA treatment success (IGA-TS) as a score of 0 (clear) or 1 (almost clear) with ≥2 grade improvement from baseline at week 8 of the administration, and
wherein the human patient achieves at least a 4 point reduction in itch Numerical rating Scale score from baseline at week 8 of the administration.
2. The method of claim 1 , wherein administering the topical formulation continues for 12 weeks.
3. The method of claim 1 , further comprising stopping the administration of the topical formulation after at least 8 weeks when the patient's skin resolves the atopic dermatitis.
4. The method of claim 1 , wherein the patient achieves at least a 4 point reduction in itch Numerical Rating Scale score from baseline at week 2 with administration.
5. The method of claim 1 , wherein the patient achieves at least a 4 point reduction in itch Numerical Rating Scale score from baseline at week 4 of with administration.
6. The method of claim 1 , wherein the ruxolitinib, or the pharmaceutically acceptable salt thereof, is ruxolitinib phosphate.
7. The method of claim 1 , wherein the patient has been diagnosed with atopic dermatitis as defined by the Hanifin and Rajka criteria.
8. The method of claim 7 , wherein the patient has a history of atopic dermatitis for at least 2 years.
9. The method of claim 8 , wherein the ruxolitinib, or the pharmaceutically acceptable salt thereof, is ruxolitinib phosphate.
10. The method of claim 1 , wherein the patient achieves an Investigator's Global Assessment score of 0 or 1 with an improvement of at least 2 points from baseline at week 2 of the administration.
11. The method of claim 1 , wherein the patient achieves an Investigator's Global Assessment score of 0 or 1 with an improvement of at least 2 points from baseline at week 4 of the administration.
12. The method of claim 1 , wherein the patient achieves at least a 1 point reduction in itch Numerical Rating Scale score from baseline at day 1 of the administration.
13. The method of claim 1 , wherein the patient achieves at least a 1 point reduction in itch Numerical Rating Scale score from baseline at day 2 of said administration.
14. The method of claim 1 , wherein the patient has a BSA of atopic dermatitis involvement of ≥10% at baseline.
15. The method of claim 14 , wherein the patient has an Eczema Area and Severity Index score of ≥16 at baseline.
16. The method of claim 14 , wherein the patient has been diagnosed with atopic dermatitis as defined by the Hanifin and Rajka criteria.
17. The method of claim 16 , wherein the patient has a history of atopic dermatitis for at least 2 years.
18. The method of claim 17 , wherein the ruxolitinib, or the pharmaceutically acceptable salt thereof, is ruxolitinib phosphate.