Methods of treating ulcerative colitis
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- ELI LILLY & CO
- Filing Date
- 2026-02-03
- Publication Date
- 2026-06-16
Smart Images
Figure 2026097804000001 
Figure 2026097804000002 
Figure 2026097804000003
Abstract
Claims
1. In patients requiring treatment for moderate to severe active ulcerative colitis (UC), The method involves administering at least one induction dose of mirikizumab at approximately 5 mg / kg to approximately 10 mg / kg. The procedure includes administering the drug to the patient in mg / kg, wherein the patient is between 2 years of age and under 18 years of age, A method having a body weight greater than 0 kilograms (kg).
2. The aforementioned patient has a body weight of more than 10 kg but less than or equal to 40 kg, and the induction dose of mirikizumab is approximately The method according to claim 1, wherein the patient is administered 5 mg / kg to approximately 10 mg / kg.
3. Claim 1 or otherwise states that the induction dose of mirikizumab is administered to the patient at approximately 5 mg / kg. This is the method described in 2.
4. Claim 1, in which the induction dose of mirikizumab is administered to the patient at approximately 10 mg / kg. Or the method described in 2.
5. Three induction doses of mirikizumab are administered to the patient, any one of claims 1 to 4. The method described in section [section number].
6. Claims 1 to 1, wherein the induction dose of mirikizumab is administered to the patient at intervals of 4 to 8 weeks. The method described in any one of item 5.
7. The induction dose of mirikizumab is administered to the patient at 4-week intervals, according to claims 1 to 6. The method described in any one of the items.
8. Claims that the induction dose of mirikizumab is administered to the patient at 0, 4, and 8 weeks. The method described in any one of items 1 to 7.
9. The induction dose is delivered over a 12-week induction period, according to any of claims 1 to 8. The method described in any one of the items.
10. If the patient has not achieved a clinical response 4 to 12 weeks after the last induction dose was administered In total, mirikizumab in one, two, or three extended induction doses ranges from approximately 5 mg / kg to approximately 10 mg / kg. The method according to any one of claims 1 to 9, wherein the patient is administered the method at a dose of g / kg.
11. If the patient has a body weight of more than 10 kg but less than or equal to 40 kg, the prolonged induction dose of mirikizuma The drug is administered to the patient at a dose of approximately 5 mg / kg or approximately 10 mg / kg, as described in claim 10. The method.
12. If the patient has a body weight of more than 10 kg but less than or equal to 40 kg, the prolonged induction dose of mirikizuma The method according to claim 10 or 11, wherein the drug is administered to the patient at approximately 10 mg / kg.
13. If the patient has a body weight of more than 10 kg but less than or equal to 40 kg, the prolonged induction dose of mirikizuma The method according to claim 10 or 11, wherein the drug is administered to the patient at a dose of approximately 5 mg / kg.
14. At least one extension induction dose is administered to the patient 4 to 8 weeks after the last maintenance dose. The method according to any one of claims 10 to 13.
15. Three prolongation induction doses of mirikizumab are administered to the patient, according to claims 10 to 14. The method described in either of the above terms.
16. The extended induction dose of mirikizumab is administered to the patient at intervals of 4 to 8 weeks, according to the claim. The method described in any one of items 10 to 15.
17. Claim 10, wherein the extended induction dose of mirikizumab is administered to the patient at 4-week intervals. The method described in any one of the following 16 items.
18. At least one maintenance dose of mirikizumab, approximately 50 mg to 100 mg, is administered to the patient. Further including the provision of the maintenance dose being the last induction dose or the last extension induction dose The method according to any one of claims 1 to 17, administered later.
19. If the aforementioned patient has a body weight of more than 10 kg but less than or equal to 20 kg, the maintenance dose of mirikizumab is The method according to claim 18, wherein approximately 50 mg is administered to the patient.
20. If the aforementioned patient has a body weight of more than 20 kg but less than or equal to 40 kg, the maintenance dose of mirikizumab is The method according to claim 18, wherein approximately 100 mg is administered to the patient.
21. If the patient achieves a clinical response from the last induction or extended induction dose administered to the patient If so, the maintenance dose of mirikizumab is administered to the patient, claims 18-20. The method described in any one of the items.
22. If the patient loses response during maintenance medication, one, two, or three ad-hoc additional doses may be administered. The claim states that mirikizumab is administered to the patient at a dose of approximately 5 mg / kg to approximately 10 mg / kg. The method described in any one of items 18 to 21.
23. If the aforementioned patient has a body weight of 10 kg to 20 kg or less, an additional dose of mirikizumab may be administered. The method according to claim 22, wherein the patient is administered approximately 5 mg / kg.
24. If the aforementioned patient has a weight of more than 20 kg but less than or equal to 40 kg, an additional dose of mirikizuma may be administered. The method according to claim 22, wherein the drug is administered to the patient at a dose of approximately 10 mg / kg.
25. The aforementioned temporary supplemental dose is administered to the patient 4 to 8 weeks after the last maintenance dose. The method described in any one of the requests 22 to 24.
26. Claims 22 to 25, wherein the aforementioned temporary additional dose is administered to the patient at intervals of 4 to 8 weeks. The method described in either of the above terms.
27. Any of claims 22 to 26, wherein the aforementioned temporary additional dose is administered to the patient at four-week intervals. The method described in item 1.
28. The patient achieved a clinical response 4 to 12 weeks after one, two, or three ad-hoc escalators. In this case, the maintenance dose of mirikizumab is administered to the patient at approximately 50 mg or approximately 100 mg. The method according to any one of claims 22 to 27.
29. The aforementioned maintenance dose of mirikizumab is used as the final induction dose, temporary surcharge dose, or extension induction dose. The amount to be administered to the patient 2 to 8 weeks later, according to any one of claims 18 to 21 or 28 Method of description.
30. The aforementioned maintenance dose of mirikizumab is used as the final induction dose, temporary surcharge dose, or extension induction dose. The amount is administered to the patient four weeks later, according to any one of claims 18-21 or 28-29. Methods used.
31. Claim 18, wherein the maintenance dose of mirikizumab is administered to the patient at intervals of 4 to 8 weeks. The method described in any one of items 21 to 28 to 30.
32. Claims 18-2, wherein the maintenance dose of mirikizumab is administered to the patient at 4-week intervals. The method described in item 1 or any one of items 28 to 31.
33. Claims 18 to 18: The maintenance dose of mirikizumab is administered to the patient by subcutaneous injection. The method described in any one of paragraphs 21 or 28 to 32.
34. Three induction doses of mirikizumab, approximately 5 mg / kg or approximately 10 mg / kg, administered at 4-week intervals. To administer to the patient by intravenous infusion, and thereafter, Two to eight weeks after the last induction dose, the maintenance dose of mirikizumab is administered for approximately 50 ml. This includes administering g to the patient by subcutaneous injection at 4-week intervals, If the aforementioned patient is between 2 and 18 years old and weighs more than 10 kg but not more than 20 kg, The method described in item 1.
35. Three induction doses of mirikizumab, approximately 5 mg / kg or approximately 10 mg / kg, administered at 4-week intervals. To administer to the patient by intravenous infusion, and thereafter, Two to eight weeks after the last induction dose, the maintenance dose of mirikizumab was administered at approximately 100°C. The procedure includes administering the patient a dose of mg by subcutaneous injection at 4-week intervals, If the aforementioned patient is between 2 and 18 years old and weighs more than 20 kg but not more than 40 kg, The method described in item 1.
36. If the patient has not achieved a clinical response 4 to 12 weeks after the last induction dose was administered If not, three extension induction doses of mirikizumab are administered to the patient. If the patient has a body weight of more than 10 kg but less than or equal to 40 kg, the prolonged induction dose of mirikizuma The drug is administered to the patient at approximately 5 mg / kg or approximately 10 mg / kg. The aforementioned extended induction dose of mirikizumab is administered to the patient by intravenous infusion at 4-week intervals. The method according to claim 34 or 35.
37. If a clinical response is achieved 4 to 12 weeks after the last prolongation induction dose is administered, maintenance The dose of mirikizumab is administered to the patient 2 to 8 weeks after the last extension induction dose. The method according to claim 36.
38. If the patient loses response during maintenance medication, one, two, or three ad-hoc additional doses may be administered. The mirikizumab was administered to the aforementioned patient. If the patient has a weight of 10 kg to 40 kg or less, the temporary additional dose of the milliwound Mab is administered to the patient at approximately 5 mg / kg or approximately 10 mg / kg. The aforementioned temporary additional dose of mirikizumab was administered to the patient by intravenous infusion at four-week intervals. The method according to any one of claims 34 to 37.
39. The patient showed a clinical response 4 to 12 weeks after the one, two, or three adjunct doses. If achieved, further maintenance doses of mirikizumab are administered subcutaneously to the patient at 4-week intervals. The method according to claim 38, administered to [a person].
40. The aforementioned patients achieved a clinical response and clinical remission within approximately 2 to 48 weeks of mirikizumab administration. Endoscopic remission, endoscopic improvement, symptomatic remission, symptomatic response, clinical remission without surgery, cortico Steroid-free clinical remission, histological endoscopic mucosal remission, histological endoscopic mucosal improvement Among the following, the least common: relief of defecation urgency, improvement of defecation urgency, improvement of bowel movement frequency, and improvement of rectal bleeding. The method according to any one of claims 1 to 39, wherein one or more therapeutic effects are achieved.
41. At least one therapeutic effect was observed approximately 2 weeks, 4 weeks, and 8 weeks after treatment with mirikizumab. Intervals of 12, 16, 20, 24, 28, 32, 36, and 40 weeks The method according to claim 46, which is achieved within 48 hours or 48 weeks.
42. Claims that at least one therapeutic effect is achieved during induction or extended induction. The method described in 40 or 41.
43. Claims 40 to 42 wherein one or more of the aforementioned therapeutic effects are sustained during the maintenance period. The method described in any one of the items.
44. If surgery is not performed at 52 weeks, for at least 12 weeks prior to 52 weeks of mirikizumab administration The method according to claim 43, wherein clinical remission is maintained without the use of steroids.
45. Claims 1 to 4, wherein the patient has not used any biological agents and / or has not used any advanced therapy. The method described in any one of item 4.
46. The method according to any one of claims 1 to 45, wherein the patient is a patient who has not responded to conventional medication.
47. Claims 1 to 44, wherein the patient has experienced biological agents and / or advanced therapy. or the method described in any one of paragraphs 46.
48. Claim 1, wherein the patient is a patient who has failed biological agents and / or a patient who has failed advanced therapy. The method described in any one of paragraphs 44, 46, or 47.
49. The aforementioned patient was unresponsive to at least one prior treatment for ulcerative colitis. Claim 1: Present, has an insufficient response, has lost its response, or is intolerant. The method described in any one of paragraphs 44 to 48.
50. Claims 47-4, wherein the biological agent is an anti-TNF therapeutic agent and / or an anti-α4β7 therapeutic agent. The method described in any one of item 9.
51. The aforementioned advanced therapy is a JAK inhibitor, an S1P receptor modulator, or a TYK2 inhibitor. The method described in any one of the requests 47 to 49.
52. In patients requiring treatment for moderate to severe active ulcerative colitis (UC), the treatment This is mirikizumab for therapeutic use, with an induction dose of approximately 5 mg / kg of mirikizumab. The patient is administered approximately 10 mg / kg, and the patient is between 2 and under 18 years of age. Mirkizumab for use in individuals with a body weight exceeding one kilogram (kg).
53. If the patient has a body weight of more than 10 kg but less than or equal to 40 kg, the induction dose is milliki Mab is administered to the patient at a dose of approximately 5 mg / kg to approximately 10 mg / kg, as described in claim 52. Mirkizumab for use.
54. Claim 52, in which the induction dose of mirikizumab is administered to the patient at approximately 5 mg / kg. Or mirikizumab for use as described in 53.
55. Claim 5, in which the induction dose of mirikizumab is administered to the patient at approximately 10 mg / kg. Millikizumab for use as described in 2 or 53.
56. Any of claims 52 to 55, in which three induction doses of mirikizumab are administered to the patient. Mirkizumab for use as described in item 1.
57. Claim 52, in which the induction dose of mirikizumab is administered to the patient at intervals of 4 to 8 weeks. Mirkizumab for use as described in any one of items ~56.
58. Claims 52-5, wherein the induction dose of mirikizumab is administered to the patient at 4-week intervals. Millikizumab for use as described in any one of item 7.
59. The induction dose of mirikizumab is administered to the patient at intervals of 0, 4, and 8 weeks. Millikizumab for use as described in any one of the requests 52 to 58.
60. The induction dose is delivered over a 12-week induction period, according to claims 52 to 59. Millikizumab for use as described in any one of the items.
61. If the patient has not achieved a clinical response 4 to 12 weeks after the last induction dose was administered In that case, mirikizumab is administered in one, two, or three extended induction doses, ranging from approximately 5 mg / kg to approximately 1 The use described in any one of claims 52 to 60, administered to the patient at a dose of 0 mg / kg Mirikizumab for this purpose.
62. If the patient has a body weight of more than 10 kg but less than or equal to 40 kg, the extended induction dose is millikid. Mab is administered to the patient at a dose of approximately 5 mg / kg or approximately 10 mg / kg, as described in claim 61. Millikizumab for use in the publication.
63. If the patient has a body weight of more than 10 kg but less than or equal to 40 kg, the prolonged induction dose of mirikizuma The use of the product according to claim 61 or 62, wherein the product is administered to the patient at approximately 10 mg / kg. Mirikizumab for this purpose.
64. If the patient has a body weight of more than 10 kg but less than or equal to 40 kg, the extended induction dose is millikid. The use of mab according to claim 61 or 62, wherein mab is administered to the patient at approximately 5 mg / kg. Mirikizumab for this purpose.
65. The extended induction dose is administered to the patient 4 to 8 weeks after the last maintenance dose. Millikizumab for use as described in any one of the requests 61 to 64.
66. Three extended induction doses of mirikizumab are administered to the patient, according to claims 61 to 65. Mirkizumab for use as described in item 1.
67. The extended induction dose of mirikizumab is administered to the patient at intervals of 4 to 8 weeks, according to the claim. Millikizumab for use as described in any one of items 61 to 66.
68. Claim 61, in which the extended induction dose of mirikizumab is administered to the patient at 4-week intervals. Mirkizumab for use as described in any one of items ~67.
69. This includes administering a maintenance dose of mirikizumab to the patient at a dose of approximately 50 mg to 100 mg. The maintenance dose is administered after the last induction dose or the last extension induction dose has been administered. A mirikizumab for use provided according to any one of claims 61 to 68.
70. If the aforementioned patient has a body weight of more than 10 kg but less than or equal to 20 kg, the maintenance dose of mirikizumab is , mirikizumab for use according to claim 69, administered to the patient at approximately 50 mg. 。
71. If the aforementioned patient has a body weight of more than 20 kg but less than or equal to 40 kg, the maintenance dose of mirikizumab is , administered to the patient at approximately 100 mg, myrikisma for use according to claim 69 Bu.
72. If the patient achieves a clinical response from the last induction or extended induction dose administered to the patient If so, the maintenance dose of mirikizumab is administered to the patient, claims 69-71. Millikizumab for use as described in any one of the items.
73. If the patient loses response during maintenance medication, one, two, or three ad-hoc additional doses may be administered. The claim states that mirikizumab is administered to the patient at a dose of approximately 5 mg / kg to approximately 10 mg / kg. Millikizumab for use as described in any one of paragraphs 69 to 72.
74. If the patient has a weight of 10 kg to 20 kg or less, the temporary additional dose of the milliscar Mab is administered to the patient at approximately 5 mg / kg, according to claim 73. Likizumab.
75. If the aforementioned patient has a weight of more than 20 kg but less than or equal to 40 kg, an additional dose of mirikizuma may be administered. The milli for use according to claim 73, in which the b is administered to the patient at a dose of 10 mg / kg. Kizumab.
76. The aforementioned temporary supplemental dose is administered to the patient 4 to 8 weeks after the last maintenance dose. Millikizumab for use as described in any one of items 73 to 75.
77. The aforementioned temporary additional dose is administered to the patient at intervals of 4 to 8 weeks, according to claims 73 to 76. Mirkizumab for use as described in item 1.
78. The aforementioned temporary additional dose is administered to the patient at four-week intervals, as per any of claims 73 to 77. Mirkizumab for use as described in item 1.
79. The patient achieved a clinical response 4 to 12 weeks after one, two, or three ad-hoc escalators. In such cases, the maintenance dose is administered to the patient at approximately 50 mg or approximately 100 mg, claim 7. Millikizumab for use as described in any one of items 3 to 78.
80. The aforementioned maintenance dose of mirikizumab is used as the final induction dose, temporary surcharge dose, or extension induction dose. The amount to be administered to the patient 2 to 8 weeks later, according to any one of claims 69 to 72 or 79 The milikizumab described for use.
81. The aforementioned maintenance dose of mirikizumab is used as the final induction dose, temporary surcharge dose, or extension induction dose. The amount administered to the patient four weeks later, as per any of claims 69-72 or 79 or 80. Mirkizumab for use as described in item 1.
82. Claim 69, wherein the maintenance dose of mirikizumab is administered to the patient at intervals of 4 to 8 weeks. Millikizumab for use as described in any one of paragraphs 72 or 79-81.
83. Claims 69-7, wherein the maintenance dose of mirikizumab is administered to the patient at 4-week intervals. Millikizumab for use as described in item 2 or any one of items 79 to 82.
84. Claims 69 to 69: The maintenance dose of mirikizumab is administered to the patient by subcutaneous injection. Millikizumab for use as described in any one of paragraphs 72 or 79-83.
85. Three induction doses of mirikizumab, approximately 5 mg / kg or approximately 10 mg / kg, administered at 4-week intervals. To administer to the patient by intravenous infusion, Two to eight weeks after the last induction dose, the maintenance dose of mirikizumab is administered for approximately 50 ml. This includes administering g to the patient by subcutaneous injection at 4-week intervals, If the aforementioned patient is between 2 and 18 years old and weighs more than 10 kg but not more than 20 kg, Millikizumab for use as described in item 52.
86. Three induction doses of mirikizumab, approximately 5 mg / kg or approximately 10 mg / kg, administered at 4-week intervals. To administer to the patient by intravenous infusion, Two to eight weeks after the last induction dose, the maintenance dose of mirikizumab was administered at approximately 100°C. The procedure includes administering the patient a dose of mg by subcutaneous injection at 4-week intervals, If the aforementioned patient is between 2 and 18 years old and weighs more than 20 kg but not more than 40 kg, Millikizumab for use as described in item 52.
87. If the patient has not achieved a clinical response 4 to 12 weeks after the last induction dose was administered If not, three extension induction doses of mirikizumab are administered to the patient. If the patient has a body weight of more than 10 kg but less than or equal to 40 kg, the milky value of the extended induction dose Zumab is administered to the patient at approximately 5 mg / kg or approximately 10 mg / kg. The aforementioned extended induction dose of mirikizumab is administered to the patient by intravenous infusion at 4-week intervals. Myrikizumab for use according to claim 85 or 86.
88. If a clinical response is achieved 4 to 12 weeks after the last prolongation induction dose is administered, maintenance The dose of mirikizumab is administered to the patient 2 to 8 weeks after the last extension induction dose. , mirikizumab for use as described in claim 87.
89. If the patient loses response during maintenance medication, one, two, or three ad-hoc additional doses may be administered. The mirikizumab was administered to the aforementioned patient. If the patient has a weight of 10 kg to 40 kg or less, the temporary additional dose of the milliwound Mab is administered to the patient at approximately 5 mg / kg or approximately 10 mg / kg. The aforementioned temporary additional dose of mirikizumab was administered to the patient by intravenous infusion at four-week intervals. Myrikizumab for use according to any one of claims 85 to 102.
90. The patient showed a clinical response 4 to 12 weeks after the one, two, or three adjunct doses. If achieved, a maintenance dose of mirikizumab is administered to the patient by subcutaneous injection at 4-week intervals. Myrikizumab for use as described in claim 89.
91. The aforementioned patients showed a clinical response within approximately 2 weeks to 48 weeks of treatment with mirikizumab. Endoscopic remission, endoscopic remission, endoscopic improvement, symptomatic remission, symptomatic response, clinical remission without surgery, Luticosteroid-free clinical remission, histological endoscopic mucosal remission, endoscopic histological inflammation Improvement of symptoms, relief of urgency to defecate, improvement of urgency to defecate, relief of bowel movement frequency, improvement of bowel movement frequency, rectal discharge Achieves at least one therapeutic effect of improving blood circulation, any one of claims 52 to 90. Mirkizumab for use as described in item 1.
92. At least one therapeutic effect was observed approximately 2 weeks, 4 weeks, and 8 weeks after treatment with mirikizumab. Intervals of 12, 16, 20, 24, 28, 32, 36, and 40 weeks Myrikizumab for use according to claim 91, achieved within 48 weeks or between.
93. Claim 9: At least one therapeutic effect is achieved during the induction period or extended induction period. Millikizumab for use as described in 1 or 92.
94. Claims 91 to 93, wherein one or more of the aforementioned therapeutic effects are sustained during the maintenance period. Millikizumab for use as described in any one of the items.
95. If surgery is not performed at 52 weeks, at least 12 weeks prior to 52 weeks of mirikizumab treatment. The use of the method according to claim 94, which maintains clinical remission without the use of steroids over a period of time. Mirkizumab for use.
96. Claims 52-9, wherein the patient has not used any biological agents and / or has not used any advanced therapy. Millikizumab for use as described in any one of item 5.
97. The patient is a patient who has not responded to conventional medications, and the use described in any one of claims 52 to 96 Mirikizumab for this purpose.
98. Claims 52-95, the patient has experienced biological agents and / or advanced therapy. or mirikizumab for use as described in any one of paragraphs 97.
99. Claims that the patient is a biological agent failure and / or a highly invasive therapy failure. Millikizumab for use as described in any one of paragraphs 52-95, 97, or 98.
100. The aforementioned patient was unresponsive to at least one prior treatment for ulcerative colitis. Claim 5 Millikizumab for use as described in any one of paragraphs 2-95 or 97-99.
101. Claims 98-1, wherein the biological agent is an anti-TNF therapeutic agent and / or an anti-α4β7 therapeutic agent. Millikizumab for use as described in any one of the items in paragraph 00.
102. The aforementioned advanced therapy is a JAK inhibitor, an S1P receptor modulator, or a TYK2 inhibitor. Millikizumab for use as described in any one of the requests 98 to 100.
103. In patients requiring treatment for moderate to severe active ulcerative colitis (UC), The use of mirikizumab in the manufacture of pharmaceuticals for the purpose of performing the act, wherein the induction dose of mirikizumab is The patient is administered approximately 5 mg / kg to approximately 10 mg / kg, and the patient is between 2 and 18 years old. Use is permitted for those weighing less than 10 kilograms (kg) but more than 10 kilograms (kg).
104. If the patient has a body weight of more than 10 kg but less than or equal to 40 kg, the induction dose is milliki Mab is administered to the patient at a dose of approximately 5 mg / kg to approximately 10 mg / kg, as described in claim 103. Use on a vehicle.
105. Claim 10, in which the induction dose of mirikizumab is administered to the patient at approximately 5 mg / kg. Use as described in 3 or 104.
106. Claim 1, in which the induction dose of mirikizumab is administered to the patient at approximately 10 mg / kg. Use as described in 03 or 104.
107. Three induction doses of mirikizumab are administered to the patient, according to claims 103 to 106. Use as described in either item.
108. Claim 10, wherein the induction dose of mirikizumab is administered to the patient at intervals of 4 to 8 weeks. Use as described in any one of items 3 to 107.
109. Claim 103 to Use as described in any one of paragraphs 108.
110. The induction dose of mirikizumab is administered to the patient at intervals of 0, 4, and 8 weeks. Use as described in any one of the requests 103 to 109.
111. Claims 103-11, wherein the induction dose is delivered over a 12-week induction period. Use as described in any one of item 0.
112. If the patient has not achieved a clinical response 4 to 12 weeks after the last induction dose was administered If not, mirikizumab is administered in one, two, or three extended induction doses, ranging from 5 mg / kg to approximately 10 mg / kg. The use according to any one of claims 103 to 111, administered to the patient at a dose of mg / kg. 。
113. If the patient has a body weight of more than 10 kg but not exceeding 40 kg, the extended induction dose is milli Claim 11: Kizumab is administered to the patient at a dose of approximately 5 mg / kg or approximately 10 mg / kg. Use as described in 2.
114. If the patient has a body weight of more than 10 kg but less than or equal to 40 kg, the milky value of the extended induction dose The zumab is administered to the patient at approximately 10 mg / kg according to claim 112 or 113. use.
115. If the patient has a body weight of more than 10 kg but not exceeding 40 kg, the extended induction dose is milli The present invention according to claim 112 or 113, wherein kizumab is administered to the patient at approximately 5 mg / kg. use.
116. The aforementioned extended induction dose of mirikizumab was administered to the patient 4 to 8 weeks after the last maintenance dose. The use according to any one of claims 112 to 115, to be administered.
117. Claims 112-116, in which three extended induction doses of mirikizumab are administered to the patient. Use as described in any one of the items.
118. The extended induction dose of mirikizumab is administered to the patient at intervals of 4 to 8 weeks, according to the claim. Use as described in any one of paragraphs 112 to 117.
119. Claim 11, in which the extended induction dose of mirikizumab is administered to the patient at 4-week intervals. Use as described in any one of items 2 to 118.
120. Further administering a maintenance dose of mirikizumab to the aforementioned patients at approximately 50 mg to 100 mg is also recommended. Including, the maintenance dose is administered after the last induction dose or the last extension induction dose has been administered. The use according to any one of claims 112 to 119, administered to the patient.
121. If the patient has a body weight of more than 10 kg but less than or equal to 20 kg, the maintenance dose of mirikizuma The use according to claim 120, wherein the drug is administered to the patient at a dose of approximately 50 mg.
122. If the patient has a body weight of more than 20 kg but less than or equal to 40 kg, the maintenance dose of mirikizuma The use according to claim 120, wherein the drug is administered to the patient at a dose of approximately 100 mg.
123. If the patient achieves a clinical response from the last induction or extended induction dose administered to the patient If so, the maintenance dose of mirikizumab is administered to the patient, claim 120-1 Use as described in any one of paragraphs 22.
124. If the patient loses response during maintenance medication, one, two, or three ad-hoc additional doses may be administered. The claim states that mirikizumab is administered to the patient at a dose of approximately 5 mg / kg to approximately 10 mg / kg. Use as described in any one of paragraphs 120 to 123.
125. If the patient has a weight of 10 kg to 20 kg or less, the temporary additional dose of the milliscar The use according to claim 124, wherein mab is administered to the patient at approximately 5 mg / kg.
126. If the patient has a weight of more than 20 kg but not exceeding 40 kg, the temporary additional dose is 1 The use according to claim 124, wherein the patient is administered 0 mg / kg.
127. Claim that the aforementioned temporary supplemental dose is administered to the patient 4 to 8 weeks after the last maintenance dose. Use as described in any one of paragraphs 124 to 126.
128. Claims 124-127, wherein the aforementioned temporary additional dose is administered to the patient at intervals of 4 to 8 weeks. Use as described in any one of the items.
129. The aforementioned temporary additional dose is administered to the patient at four-week intervals, according to claims 124 to 128. Use as described in either item.
130. The patient achieved a clinical response 4 to 12 weeks after one, two, or three ad-hoc escalators. In such cases, the maintenance dose is administered to the patient at approximately 50 mg or approximately 100 mg, claim 1 Use as described in any one of paragraphs 24 to 129.
131. The maintenance dose of mirikizumab is the last induction dose, temporary bolus dose, or extension induction dose. Any one of claims 120 to 123 or 130, which is administered to the patient 2 to 8 weeks later. Use as described above.
132. The aforementioned maintenance dose of mirikizumab is used as the final induction dose, temporary surcharge dose, or extension induction dose. A dose administered to the patient four weeks later, according to claims 120-123 or 130 or 131. Use as described in any one of the items.
133. Claim 12, wherein the maintenance dose of mirikizumab is administered to the patient at intervals of 4 to 8 weeks. Use as described in any one of paragraphs 0-123 or 130-132.
134. Claim 120 - The maintenance dose of mirikizumab is administered to the patient at 4-week intervals. Use as described in any one of paragraphs 123 or 130-133.
135. Claim 120, wherein the maintenance dose of mirikizumab is administered to the patient by subcutaneous injection. Use as described in any one of paragraphs 123 to 134.
136. Three induction doses of mirikizumab, approximately 5 mg / kg or approximately 10 mg / kg, administered at 4-week intervals. To administer to the patient by intravenous infusion, and thereafter, Two to eight weeks after the last induction dose, the maintenance dose of mirikizumab is administered for approximately 50 ml. This includes administering g to the patient by subcutaneous injection at 4-week intervals, If the aforementioned patient is between 2 and 18 years old and weighs more than 10 kg but not more than 20 kg, Use as described in item 103.
137. Three induction doses of mirikizumab, approximately 5 mg / kg or approximately 10 mg / kg, administered at 4-week intervals. To administer to the patient by intravenous infusion, and thereafter, Two to eight weeks after the last induction dose, the maintenance dose of mirikizumab was administered at approximately 100°C. The procedure includes administering the patient a dose of mg by subcutaneous injection at 4-week intervals, If the aforementioned patient is between 2 and 18 years old and weighs more than 20 kg but not more than 40 kg, Use as described in item 103.
138. If the patient has not achieved a clinical response 4 to 12 weeks after the last induction dose was administered If not, three extension induction doses of mirikizumab are administered to the patient. If the patient has a body weight of more than 10 kg but less than or equal to 40 kg, the prolonged induction dose of mirikizuma The drug is administered to the patient at approximately 5 mg / kg or approximately 10 mg / kg. The aforementioned extended induction dose of mirikizumab is administered to the patient by intravenous infusion at 4-week intervals. The use described in claim 136 or 137.
139. If a clinical response is achieved 4 to 12 weeks after the last prolongation induction dose is administered, maintenance The dose of mirikizumab is administered to the patient 2 to 8 weeks after the last extension induction dose. , the use described in claim 138.
140. If the patient loses response during maintenance medication, one, two, or three ad-hoc additional doses may be administered. The mirikizumab was administered to the aforementioned patient. If the patient has a weight of 10 kg to 40 kg or less, the temporary additional dose of the milliwound Mab is administered to the patient at approximately 5 mg / kg or approximately 10 mg / kg. The aforementioned temporary additional dose of mirikizumab was administered to the patient by intravenous infusion at four-week intervals. The use described in any one of claims 136 to 139.
141. The patient showed a clinical response 4 to 12 weeks after the one, two, or three adjunct doses. If achieved, a maintenance dose of mirikizumab is administered to the patient by subcutaneous injection at 4-week intervals. The use described in claim 140.
142. The aforementioned patients showed a clinical response within approximately 2 weeks to 48 weeks of treatment with mirikizumab. Endoscopic remission, endoscopic remission, endoscopic improvement, symptomatic remission, symptomatic response, clinical remission without surgery, Luticosteroid-free clinical remission, histological endoscopic mucosal remission, endoscopic histological inflammation Improvement of symptoms, relief of urgency to defecate, improvement of urgency to defecate, relief of bowel movement frequency, improvement of bowel movement frequency, rectal discharge Achieves at least one therapeutic effect of improving blood circulation, according to claims 103 to 141. Use as described in either item.
143. At least one therapeutic effect was observed approximately 2 weeks, 4 weeks, and 8 weeks after treatment with mirikizumab. Intervals of 12, 16, 20, 24, 28, 32, 36, and 40 weeks The use according to claim 142, achieved within 48 weeks.
144. At least one therapeutic effect is achieved during the induction period or extended induction period, Use as described in paragraph 142 or 143.
145. Claim 142 or 1, in which one or more of the aforementioned therapeutic effects are sustained during the maintenance period. Use as described in section 43.
146. If surgery is not performed at 52 weeks, at least 12 weeks prior to 52 weeks of mirikizumab treatment. The patient described in claim 145 has maintained clinical remission without the use of steroids over a period of time. use.
147. Claims 103- Use as described in any one of paragraphs 146.
148. The patient is a patient who has not responded to conventional medication, and the use of any one of claims 103 to 147 For.
149. Claims 103-1, wherein the patient has experienced biological agents and / or advanced therapy. Use as described in either paragraph 46 or 148.
150. Claims that the patient is a biological agent failure and / or a highly invasive therapy failure. Use as described in any one of paragraphs 103-146, 148, or 149.
151. The aforementioned patient was unresponsive to at least one prior treatment for ulcerative colitis. Claim 1: Present, has an insufficient response, has lost its response, or is intolerant. Use as described in any one of paragraphs 03-146 or 148-150.
152. Claims 149 to 149: The biological agent is an anti-TNF therapeutic agent and / or an anti-α4β7 therapeutic agent. Use as described in any one of paragraphs 151.
153. The aforementioned advanced therapy is a JAK inhibitor, an S1P receptor modulator, or a TYK2 inhibitor. Use as described in any one of the requests 149 to 151.