Claims for Patent: 12,365,689

Summary for Patent: 12,365,689

Title:	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Abstract:	The present disclosure relates to solid-state forms and corresponding pharmaceutical compositions of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide, and methods of treatment, including treatment of rheumatoid arthritis and juvenile idiopathic arthritis using the same. The treatment methods generally comprise administering to a patient (e.g., a pediatric patient) a therapeutically effective amount of upadacitinib as a stable liquid pharmaceutical composition or a solid dosage form, at a dose based on patient body weight.
Inventor(s):	Mohamed-Eslam F. Mohamed, Ahmed A. Othman, Aileen L. Pangan, Ben Klünder, Heidi S. Camp, Robert J. Padley, Jeffrey W. Voss, Cheng Thiam Tan
Assignee:	AbbVie Inc
Application Number:	US18/913,645
Patent Claims:	1. A method for treating juvenile idiopathic arthritis in a human patient in need thereof, comprising orally administering once daily to the patient a tablet comprising a therapeutically effective amount of (3S,4R)-3-ethyl-4-(3H-imidazo [1,2-a]pyrrolo [2,3-e]pyrazin-8-yl)-N-(2,2,2-trifluoroethyl) pyrrolidine-1-carboxamide (Compound 1), wherein the therapeutically effective amount is 15 mg. 2. The method of claim 1, wherein the patient achieves an ACR50 score at week 12 of treatment. 3. The method of claim 1, wherein the patient achieves an ACR70 score at week 12 of treatment. 4. A method for treating polyarticular course juvenile idiopathic arthritis (pcJIA) in a pediatric patient in need thereof, the method comprising administering a therapeutically effective amount of upadacitinib to the pediatric patient, wherein: if the pediatric patient has a body weight in a range from about 10 kg to less than about 20 kg, administering upadacitinib twice daily as an oral pharmaceutical solution at a dose of 3 mg each (3 mg BID); if the pediatric patient has a body weight in a range from about 20 kg to less than about 30 kg, administering upadacitinib twice daily as an oral pharmaceutical solution at a dose of 4 mg each (4 mg BID); and if the pediatric patient has a body weight of about 30 kg or greater, administering upadacitinib twice daily as an oral pharmaceutical solution at a dose of 6 mg each (6 mg BID), or administering upadacitinib once daily as a tablet at a dose of 15 mg (15 mg QD). 5. The method of claim 4, wherein the pediatric patient has a body weight in a range from about 10 kg to less than about 20 kg, and the method comprises administering upadacitinib twice daily as an oral pharmaceutical solution at a dose of 3 mg each (3 mg BID). 6. The method of claim 4, wherein the pediatric patient has a body weight in a range from about 20 kg to less than about 30 kg, and the method comprises administering upadacitinib twice daily as an oral pharmaceutical solution at a dose of 4 mg each (4 mg BID). 7. The method of claim 4, wherein the pediatric patient has a body weight of about 30 kg or greater, and the method comprises administering upadacitinib twice daily as an oral pharmaceutical solution at a dose of 6 mg each (6 mg BID). 8. The method of claim 4, wherein the pediatric patient has a body weight of about 30 kg or greater, and the method comprises administering upadacitinib once daily as a tablet at a dose of 15 mg (15 mg QD). 9. The method of claim 4, wherein the pcJIA is rheumatoid factor-positive JIA. 10. The method of claim 4, wherein the pcJIA is rheumatoid factor-negative polyarticular JIA. 11. The method of claim 4, wherein the pcJIA is extended oligoarticular JIA. 12. The method of claim 4, wherein the pcJIA is systemic JIA with active arthritis and without active systemic features. 13. The method of claim 4, wherein the pediatric patient achieves a JIA ACR pediatric 30 response at 12 weeks after the first daily administration. 14. The method of claim 4, wherein the pediatric patient achieves a JIA ACR pediatric 50 response at 12 weeks after the first daily administration. 15. The method of claim 4, wherein the pediatric patient achieves a JIA ACR pediatric 70 response at 12 weeks after the first daily administration. 16. The method of claim 4, wherein the pediatric patient achieves a JIA ACR pediatric 90 response at 12 weeks after the first daily administration. 17. The method of claim 4, wherein the pediatric patient achieves a JIA ACR pediatric 30 response at 48 weeks after the first daily administration. 18. The method of claim 4, wherein the pediatric patient achieves a JIA ACR pediatric 50 response at 48 weeks after the first daily administration. 19. The method of claim 4, wherein the pediatric patient achieves a JIA ACR pediatric 70 response at 48 weeks after the first daily administration. 20. The method of claim 4, wherein the pediatric patient achieves a JIA ACR pediatric 90 response at 48 weeks after the first daily administration. 21. The method of claim 1, wherein the subject has had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). 22. The method of claim 21, wherein the DMARD is methotrexate. 23. The method of claim 21, wherein the DMARD is an anti-TNF biologic agent. 24. The method of claim 4, wherein the subject has had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). 25. The method of claim 24, wherein the DMARD is methotrexate. 26. The method of claim 24, wherein the DMARD is an anti-TNF biologic agent. 27. The method of claim 4, wherein the pediatric patient has an age in a range from about 2 to less than about 18 years. 28. The method of claim 27, wherein the subject has had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). 29. The method of claim 28, wherein the DMARD is methotrexate. 30. The method of claim 28, wherein the DMARD is an anti-TNF biologic agent.