RU2018131237A - Способы лечения атопического дерматита с помощью антагониста il-4r - Google Patents
Способы лечения атопического дерматита с помощью антагониста il-4r Download PDFInfo
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- 238000000034 method Methods 0.000 title claims 8
- 206010012438 Dermatitis atopic Diseases 0.000 title claims 3
- 201000008937 atopic dermatitis Diseases 0.000 title claims 3
- 239000005557 antagonist Substances 0.000 title 1
- 108040006852 interleukin-4 receptor activity proteins Proteins 0.000 title 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 14
- 239000012634 fragment Substances 0.000 claims 8
- 239000000427 antigen Substances 0.000 claims 6
- 102000036639 antigens Human genes 0.000 claims 6
- 108091007433 antigens Proteins 0.000 claims 6
- 239000003246 corticosteroid Substances 0.000 claims 6
- 229960001334 corticosteroids Drugs 0.000 claims 6
- 230000000699 topical effect Effects 0.000 claims 6
- 102000010787 Interleukin-4 Receptors Human genes 0.000 claims 5
- 108010038486 Interleukin-4 Receptors Proteins 0.000 claims 5
- 208000003251 Pruritus Diseases 0.000 claims 5
- 208000037851 severe atopic dermatitis Diseases 0.000 claims 4
- 230000007803 itching Effects 0.000 claims 3
- 229940122739 Calcineurin inhibitor Drugs 0.000 claims 2
- 102100024123 Calcineurin-binding protein cabin-1 Human genes 0.000 claims 2
- 101710192106 Calcineurin-binding protein cabin-1 Proteins 0.000 claims 2
- 229940125379 topical corticosteroid Drugs 0.000 claims 2
- 101001033312 Homo sapiens Interleukin-4 receptor subunit alpha Proteins 0.000 claims 1
- 125000003275 alpha amino acid group Chemical group 0.000 claims 1
- 230000000694 effects Effects 0.000 claims 1
- 102000054663 human IL4R Human genes 0.000 claims 1
- 230000001771 impaired effect Effects 0.000 claims 1
- 230000001988 toxicity Effects 0.000 claims 1
- 231100000419 toxicity Toxicity 0.000 claims 1
- 238000011282 treatment Methods 0.000 claims 1
- 238000011269 treatment regimen Methods 0.000 claims 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
- A61K38/1793—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
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- A—HUMAN NECESSITIES
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- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
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- A—HUMAN NECESSITIES
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- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
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- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- A61P17/00—Drugs for dermatological disorders
- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
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- A61P17/04—Antipruritics
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- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- A61P37/00—Drugs for immunological or allergic disorders
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- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
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- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2866—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
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- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6854—Immunoglobulins
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- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/20—Dermatological disorders
- G01N2800/202—Dermatitis
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/52—Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
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Claims (15)
1. Фармацевтическая композиция, содержащая терапевтически эффективное количество антитела к рецептору интерлейкина-4 (IL-4R) человека или его антигенсвязывающего фрагмента для лечения, уменьшения выраженности, ослабления, облегчения или предупреждения кожного зуда у пациента, где пациент страдает от умеренно тяжелого до тяжелого атопического дерматита (АД).
2. Фармацевтическая композиция по п. 1, где пациент, страдающий от умеренно тяжелого до тяжелого атопического дерматита, демонстрирует балл по числовой шкале оценки интенсивности кожного зуда (NRS) ≥5 и/или балл cогласно 5-D Pruritus ≥18.
3. Фармацевтическая композиция по п. 1 или 2, где пациент, страдающий от умеренно тяжелого до тяжелого атопического дерматита, является устойчивым к лечению топическим кортикостероидом (ТКС) или ингибитором кальциневрина.
4. Фармацевтическая композиция по п. 3, где устойчивость включает ухудшение соблюдения пациентом режима и схемы лечения и/или токсичность и побочные эффекты, и/или неэффективность топических кортикостероидов или ингибитора кальциневрина, вводимых для лечения, снижения, ослабления или предупреждения кожного зуда.
5. Фармацевтическая композиция по любому из пп. 1-4, где фармацевтическая композиция содержит от около 50 до около 600 мг антитела к IL-4R человека или его антигенсвязывающего фрагмента.
6. Фармацевтическая композиция по любому из пп. 1-4, где фармацевтическая композиция содержит около 300 мг антитела к IL-4R человека или его антигенсвязывающего фрагмента.
7. Фармацевтическая композиция по любому из пп. 1-6, где антитело или его антигенсвязывающий фрагмент содержат определяющие комплементарность участки (CDR) тяжелой и легкой цепей в паре аминокислотных последовательностей вариабельной области тяжелой цепи/вариабельной области легкой цепи (HCVR/LCVR), содержащей SEQ ID NO: 162/164.
8. Фармацевтическая композиция по п. 7, где антитело или его антигенсвязывающий фрагмент содержат три CDR тяжелой цепи (HCDR), содержащие SEQ ID NO: 148, 150 и 152, соответственно; и три последовательности CDR легкой цепи (LCDR), содержащие SEQ ID NO: 156, 158 и 160, соответственно.
9. Способ лечения, уменьшения выраженности, ослабления, облегчения или предупреждения кожного зуда у пациента, где пациент страдает от умеренно тяжелого до тяжелого атопического дерматита (АД), включающий введение фармацевтической композиции по любому из пп. 1-8 указанному пациенту.
10. Способ по п. 9, где фармацевтическую композицию вводят в первоначальной дозе пациенту и вводят одну или более последующих доз пациенту.
11. Способ по п. 10, где первоначальная доза содержит около 300 или около 600 мг антитела к IL-4R человека или его антигенсвязывающего фрагмента, и где каждая последующая доза содержит от около 75 до около 300 мг антитела к IL-4R человека или его антигенсвязывающего фрагмента.
12. Способ по п. 10 и 11, где каждую дозу вводят через 1 неделю или 2 недели после непосредственно предшествующей дозы.
13. Способ по любому из пп. 9-12, где топические кортикостероиды вводят пациенту одновременно с фармацевтической композицией.
14. Способ по п. 13, где топические кортикостероиды вводят одновременно с фармацевтической композицией пациенту во время начального периода, и где дозу топических кортикостероидов постепенно уменьшают во время последующего периода, когда дозу топических кортикостероидов постепенно уменьшают, тогда как антитело к IL-4R человека или его антигенсвязывающий фрагмент вводят в тех же дозах, как во время начального периода.
15. Способ по п. 14, где доза топических кортикостероидов снижается на 10%, 20%, 30%, 40%, 50% или более во время последующего периода по сравнению с дозой в начальный период.
Applications Claiming Priority (18)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261697972P | 2012-09-07 | 2012-09-07 | |
| US61/697,972 | 2012-09-07 | ||
| US201261738715P | 2012-12-18 | 2012-12-18 | |
| US61/738,715 | 2012-12-18 | ||
| US201361748588P | 2013-01-03 | 2013-01-03 | |
| US61/748,588 | 2013-01-03 | ||
| US201361764624P | 2013-02-14 | 2013-02-14 | |
| US61/764,624 | 2013-02-14 | ||
| US201361768229P | 2013-02-22 | 2013-02-22 | |
| US61/768,229 | 2013-02-22 | ||
| US201361770091P | 2013-02-27 | 2013-02-27 | |
| US61/770,091 | 2013-02-27 | ||
| US201361782420P | 2013-03-14 | 2013-03-14 | |
| US61/782,420 | 2013-03-14 | ||
| US201361816191P | 2013-04-26 | 2013-04-26 | |
| US61/816,191 | 2013-04-26 | ||
| FR1356759 | 2013-07-10 | ||
| FR1356759 | 2013-07-10 |
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| Application Number | Title | Priority Date | Filing Date |
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| RU2015108073A Division RU2666630C2 (ru) | 2012-09-07 | 2013-09-04 | Способы лечения атопического дерматита с помощью антагониста il-4r |
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| Publication Number | Publication Date |
|---|---|
| RU2018131237A true RU2018131237A (ru) | 2018-10-04 |
| RU2018131237A3 RU2018131237A3 (ru) | 2019-03-14 |
| RU2698907C2 RU2698907C2 (ru) | 2019-09-02 |
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| Application Number | Title | Priority Date | Filing Date |
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| RU2018131237A RU2698907C2 (ru) | 2012-09-07 | 2013-09-04 | Способы лечения атопического дерматита с помощью антагониста il-4r |
| RU2015108073A RU2666630C2 (ru) | 2012-09-07 | 2013-09-04 | Способы лечения атопического дерматита с помощью антагониста il-4r |
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| RU2015108073A RU2666630C2 (ru) | 2012-09-07 | 2013-09-04 | Способы лечения атопического дерматита с помощью антагониста il-4r |
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| US (3) | US20140072583A1 (ru) |
| EP (5) | EP3889181B1 (ru) |
| JP (4) | JP6353838B2 (ru) |
| KR (3) | KR102122708B1 (ru) |
| CN (3) | CN118286430A (ru) |
| AR (1) | AR092475A1 (ru) |
| AU (4) | AU2013312868B2 (ru) |
| BR (1) | BR112015005048A8 (ru) |
| CA (1) | CA2883936C (ru) |
| CY (1) | CY1121906T1 (ru) |
| DK (1) | DK2892927T3 (ru) |
| ES (2) | ES2981062T3 (ru) |
| HR (1) | HRP20181227T1 (ru) |
| HU (2) | HUE066738T2 (ru) |
| IL (1) | IL237328B (ru) |
| LT (1) | LT2892927T (ru) |
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| NZ (3) | NZ630178A (ru) |
| PL (1) | PL2892927T3 (ru) |
| PT (1) | PT3889181T (ru) |
| RS (1) | RS57520B1 (ru) |
| RU (2) | RU2698907C2 (ru) |
| SG (2) | SG11201501011WA (ru) |
| SI (1) | SI2892927T1 (ru) |
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Families Citing this family (58)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7608693B2 (en) | 2006-10-02 | 2009-10-27 | Regeneron Pharmaceuticals, Inc. | High affinity human antibodies to human IL-4 receptor |
| BR112013008366B1 (pt) | 2010-10-06 | 2022-02-08 | Regeneron Pharmaceuticals, Inc | Formulações farmacêuticas líquidas estáveis contendo anticorpos anti-receptor de interleucina-4 humana alfa, e recipiente contendo as referidas formulações |
| PT4011915T (pt) | 2012-08-21 | 2024-01-02 | Regeneron Pharma | Métodos para o tratamento ou prevenção da asma através da administração de um antagonista de il-4r |
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