Claims for Patent: 11,602,536

Summary for Patent: 11,602,536

Title:	Topical treatment of vitiligo by a JAK inhibitor
Abstract:	The present disclosure relates to topical treatment of vitiligo using ruxolitinib, or a pharmaceutically acceptable salt thereof.
Inventor(s):	Kathleen BUTLER, Jim Lee, Kang Sun, Fiona KUO, Michael Howell
Assignee:	Incyte Corp
Application Number:	US16/897,923
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,602,536
Patent Claims:	1. A method of treating vitiligo in an affected area of a patient comprising: topically administering on the affected skin area of the patient a pharmaceutical composition comprising about 1.5% w/w ruxolitinib, or a pharmaceutically acceptable salt thereof, on a free base basis, twice per day, and the vitiligo is nonsegmental vitiligo; and continuing topically administering until the patient achieves a 25% or greater improvement in Vitiligo Area Scoring Index on the affected skin area, wherein the affected area is selected from lower extremities, trunk, and feet of the patient, and wherein the method does not comprise administering laser or phototherapy. 2. The method of claim 1, wherein the ruxolitinib, or the pharmaceutically acceptable salt thereof, is ruxolitinib phosphate. 3. The method of claim 1, wherein the affected skin area comprises the lower extremities of the patient. 4. The method of claim 1, wherein the affected skin area comprises the trunk of the patient. 5. The method of claim 1, wherein the affected skin area comprises the feet of the patient. 6. The method of claim 1, wherein the step of continuing topically administering is continued until the patient achieves a 50% or greater improvement in Vitiligo Area Scoring Index on the affected skin area. 7. The method of claim 1, wherein the step of continuing topically administering is continued until the patient achieves a 75% or greater improvement in Vitiligo Area Scoring Index on the affected skin area. 8. The method of claim 1, wherein the patient has one or more of: at least 0.5% facial body surface area affected by vitiligo, at least 3% non-facial body surface area affected by vitiligo, at least 0.5% facial body surface area affected by vitiligo and at least 3% non-facial body surface area affected by vitiligo, and clinically diagnosed with vitiligo. 9. The method of claim 1, wherein the patient is 18 years old to 75 years old. 10. The method of claim 1, wherein the patient achieves a 25% or greater improvement in Vitiligo Area Scoring Index score on the feet of the patient at Week 4, Week 8, Week 18, Week 24, Week 32, Week 38, Week 42, Week 48, or Week 52. 11. The method of claim 1, wherein the patient achieves a 25% or greater improvement in Vitiligo Area Scoring Index score on the lower extremities of the patient at Week 4, Week 8, Week 18, Week 24, Week 32, Week 38, Week 42, Week 48, or Week 52. 12. The method of claim 1, wherein the patient achieves a 25% or greater improvement in Vitiligo Area Scoring Index score on the trunk of the patient at Week 4, Week 8, Week 18, Week 24, Week 32, Week 38, Week 42, Week 48, or Week 52. 13. The method of claim 1, wherein the pharmaceutical composition is a cream. 14. The method of claim 13, wherein the cream is an oil-in-water emulsion. 15. The method of claim 14, wherein the cream contains 1.5% w/w ruxolitinib phosphate on a free base basis. 16. The method of claim 15, wherein the cream has a pH of about 2.8 to about 3.9. 17. The method of claim 1, wherein there is no substantial difference in response between patients having baseline total body surface area affected by vitiligo (T-BSA) equal to or less than 20% and patients having baseline T-BSA greater than 20%. 18. A method of treating generalized vitiligo in an effected area of a patient comprising: topically administering on the affected skin area of the patient in need thereof a cream comprising 1.5% w/w ruxolitinib phosphate on a free base basis, twice per day, and continuing topically administering until the patient achieves a 50% or greater improvement in Vitiligo Area Scoring Index score on the affected skin area, wherein: the affected area is selected from lower extremities, trunk, and feet; the patient is aged 18 or older; the patient suffers from generalized vitiligo with depigmented area of: (i) 0.5% or greater body surface area (BSA) on the face, (ii) 3% or greater BSA on non-facial areas, and (iii) not exceeding 10% BSA on total body area; and the method does not comprise administering laser or any kind of phototherapy. 19. The method of claim 1, wherein continuing topically administering is for 4 weeks, 8 weeks, 18 weeks, 24 weeks, 32 weeks, 38 weeks, 42 weeks, 48 weeks, or 52 weeks. 20. The method of claim 1, wherein continuing topically administering is continued until the patient achieves a 75% or greater improvement in facial Vitiligo Area Scoring Index after 24 weeks of the administering. 21. The method of claim 1, wherein continuing topically administering is continued until the patient achieves a 75% or greater improvement in facial Vitiligo Area Scoring Index after 52 weeks of the administering. 22. The method of claim 1, wherein continuing topically administering is continued until the patient achieves a 75% or greater improvement in total body Vitiligo Area Scoring Index after 24 weeks of the administering. 23. The method of claim 1, wherein continuing topically administering is continued until the patient achieves a 75% or greater improvement in total body Vitiligo Area Scoring Index after 52 weeks of the administering.