TWI837532B - 治療潰瘍性結腸炎之方法 - Google Patents
治療潰瘍性結腸炎之方法 Download PDFInfo
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- TWI837532B TWI837532B TW110139868A TW110139868A TWI837532B TW I837532 B TWI837532 B TW I837532B TW 110139868 A TW110139868 A TW 110139868A TW 110139868 A TW110139868 A TW 110139868A TW I837532 B TWI837532 B TW I837532B
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| KR20220141847A (ko) * | 2020-02-14 | 2022-10-20 | 얀센 바이오테크 인코포레이티드 | 항-il12/il23 항체로 궤양성 결장염을 치료하는 안전하고 효과적인 방법 |
| CA3183927A1 (en) | 2020-05-21 | 2021-11-25 | Janssen Biotech, Inc. | Method of treating inflammatory bowel disease with a combination therapy of antibodies to il-23 and tnf alpha |
| JP7423815B2 (ja) * | 2020-10-20 | 2024-01-29 | セトラスホールディングス株式会社 | 治験管理装置、治験管理方法、治験管理プログラム及び治験管理システム |
| TW202241506A (zh) * | 2021-01-06 | 2022-11-01 | 美商艾伯維有限公司 | 治療克羅恩氏病及潰瘍性結腸炎之方法 |
| JP2024520202A (ja) * | 2021-05-20 | 2024-05-22 | ヤンセン バイオテツク，インコーポレーテツド | Ｉｌ－２３に対する抗体及びｔｎｆアルファに対する抗体の組み合わせ療法を用いた炎症性腸疾患を治療する方法 |
| EP4347018A1 (en) * | 2021-05-28 | 2024-04-10 | Eli Lilly and Company | Anti-il-23p19 antibody regulation of genes involved in ulcerative colitis |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20070009526A1 (en) * | 2005-06-30 | 2007-01-11 | Jacqueline Benson | Anti-IL-23 antibodies, compositions, methods and uses |
| WO2010062663A1 (en) * | 2008-11-03 | 2010-06-03 | Schering Corporation | Inflammatory bowel disease biomarkers and related methods of treatment |
| US20120282269A1 (en) * | 2010-11-04 | 2012-11-08 | Boehringer Ingelheim International Gmbh | Anti-IL-23 Antibodies |
| US20170002060A1 (en) * | 2014-01-08 | 2017-01-05 | Moderna Therapeutics, Inc. | Polynucleotides for the in vivo production of antibodies |
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| DK2548577T3 (en) | 2005-12-29 | 2017-03-13 | Janssen Biotech Inc | HUMAN ANTI-IL-23 ANTIBODIES, COMPOSITIONS, PROCEDURES AND APPLICATIONS |
| US8293883B2 (en) | 2007-02-23 | 2012-10-23 | Schering Corporation | Engineered anti-IL-23P19 antibodies |
| JO3244B1 (ar) | 2009-10-26 | 2018-03-08 | Amgen Inc | بروتينات ربط مستضادات il – 23 البشرية |
| JOP20140049B1 (ar) | 2013-03-08 | 2021-08-17 | Lilly Co Eli | أجسام مضادة ترتبط بـ il-23 |
| MX2020009265A (es) * | 2018-03-05 | 2020-10-01 | Janssen Biotech Inc | Metodos para tratar la enfermedad de crohn con un anticuerpo especifico anti-il23. |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20070009526A1 (en) * | 2005-06-30 | 2007-01-11 | Jacqueline Benson | Anti-IL-23 antibodies, compositions, methods and uses |
| WO2010062663A1 (en) * | 2008-11-03 | 2010-06-03 | Schering Corporation | Inflammatory bowel disease biomarkers and related methods of treatment |
| US20120282269A1 (en) * | 2010-11-04 | 2012-11-08 | Boehringer Ingelheim International Gmbh | Anti-IL-23 Antibodies |
| US20170002060A1 (en) * | 2014-01-08 | 2017-01-05 | Moderna Therapeutics, Inc. | Polynucleotides for the in vivo production of antibodies |
Non-Patent Citations (1)
| Title |
|---|
| 期刊 Mariangela Allocca et al. Evolving strategies and goals of treatment in ulcerative colitis. Best Practice & research. Clinical Gastroenterology. 32-33. 1 Feb 2018. 1-2. * |
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