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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- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IG], 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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- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2866—Immunoglobulins [IG], 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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- 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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- 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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- 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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- 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 |
|---|---|---|---|
| RU2015108073A Division RU2666630C2 (ru) | 2012-09-07 | 2013-09-04 | Способы лечения атопического дерматита с помощью антагониста il-4r |
Publications (3)
| 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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| RU2015108073A RU2666630C2 (ru) | 2012-09-07 | 2013-09-04 | Способы лечения атопического дерматита с помощью антагониста il-4r |
| RU2018131237A RU2698907C2 (ru) | 2012-09-07 | 2013-09-04 | Способы лечения атопического дерматита с помощью антагониста il-4r |
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| Application Number | Title | Priority Date | Filing Date |
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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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| Country | Link |
|---|---|
| US (3) | US20140072583A1 (ru) |
| EP (5) | EP3889181B1 (ru) |
| JP (4) | JP6353838B2 (ru) |
| KR (3) | KR102385501B1 (ru) |
| CN (3) | CN118286417A (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 (3) | ES2981062T3 (ru) |
| HR (1) | HRP20181227T1 (ru) |
| HU (2) | HUE039387T2 (ru) |
| IL (1) | IL237328B (ru) |
| LT (1) | LT2892927T (ru) |
| MX (1) | MX363193B (ru) |
| NZ (3) | NZ748451A (ru) |
| PL (2) | PL2892927T3 (ru) |
| PT (2) | PT3889181T (ru) |
| RS (1) | RS57520B1 (ru) |
| RU (2) | RU2666630C2 (ru) |
| SG (2) | SG10201701798TA (ru) |
| SI (1) | SI2892927T1 (ru) |
| SM (1) | SMT201800396T1 (ru) |
| TR (1) | TR201808181T4 (ru) |
| TW (4) | TWI690328B (ru) |
| UY (1) | UY35013A (ru) |
| WO (1) | WO2014039461A1 (ru) |
Families Citing this family (59)
| Publication number | Priority date | Publication date | Assignee | Title |
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| US7608693B2 (en) | 2006-10-02 | 2009-10-27 | Regeneron Pharmaceuticals, Inc. | High affinity human antibodies to human IL-4 receptor |
| NZ609557A (en) | 2010-10-06 | 2014-12-24 | Regeneron Pharma | Stabilized formulations containing anti-interleukin-4 receptor (il-4r) antibodies |
| US9574004B2 (en) | 2012-08-21 | 2017-02-21 | Sanofi Biotechnology | Methods for treating or preventing asthma by administering an IL-4R antagonist |
| PT3889181T (pt) | 2012-09-07 | 2024-05-29 | Regeneron Pharma | Um anticorpo antagonista de il-4r para utilização no tratamento da dermatite atópica por administração |
| TWI633891B (zh) | 2013-06-04 | 2018-09-01 | 再生元醫藥公司 | 藉由投與ｉｌ－４ｒ抑制劑以治療過敏及增強過敏原－特異之免疫療法的方法 |
| CN111437387B (zh) | 2013-06-21 | 2024-10-01 | 赛诺菲生物技术公司 | 通过施用il-4r拮抗剂治疗鼻息肉症的方法 |
| TWI682781B (zh) | 2013-07-11 | 2020-01-21 | 美商再生元醫藥公司 | 藉由投與ｉｌ－４ｒ抑制劑治療嗜酸性食道炎的方法 |
| IL315136A (en) | 2014-02-21 | 2024-10-01 | Sanofi Biotechnology | Methods for treating or preventing asthma by administering an il-4rantagonist |
| WO2015130975A1 (en) | 2014-02-28 | 2015-09-03 | Regeneron Pharmaceuticals, Inc. | Methods for treating skin infection by administering an il-4r antagonist |
| SI3158054T1 (sl) * | 2014-06-17 | 2025-06-30 | Crown Laboratories, Inc. | Genetsko modificirane bakterije in postopki za genetsko modifikacijo bakterij |
| TW201628647A (zh) * | 2014-06-27 | 2016-08-16 | 賽諾菲公司 | 抗－ｉｌ４－ｉｌ１３雙特異性抗體 |
| AU2015346150B2 (en) * | 2014-11-14 | 2021-08-19 | Regeneron Pharmaceuticals, Inc. | Methods for treating chronic sinusitis with nasal polyps by administering an IL-4R antagonist |
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