HRP20200628T1 - Metode za liječenje eozinofilnog ezofagitisa primjenom inhibitora il-4r - Google Patents
Metode za liječenje eozinofilnog ezofagitisa primjenom inhibitora il-4r Download PDFInfo
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- HRP20200628T1 HRP20200628T1 HRP20200628TT HRP20200628T HRP20200628T1 HR P20200628 T1 HRP20200628 T1 HR P20200628T1 HR P20200628T T HRP20200628T T HR P20200628TT HR P20200628 T HRP20200628 T HR P20200628T HR P20200628 T1 HRP20200628 T1 HR P20200628T1
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- 238000000034 method Methods 0.000 title claims 21
- 239000003112 inhibitor Substances 0.000 title claims 17
- 206010064212 Eosinophilic oesophagitis Diseases 0.000 title claims 13
- 201000000708 eosinophilic esophagitis Diseases 0.000 title claims 13
- 239000000825 pharmaceutical preparation Substances 0.000 claims 22
- 102000010787 Interleukin-4 Receptors Human genes 0.000 claims 11
- 108010038486 Interleukin-4 Receptors Proteins 0.000 claims 11
- 125000003275 alpha amino acid group Chemical group 0.000 claims 10
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- 108010050456 Eosinophil-Derived Neurotoxin Proteins 0.000 claims 4
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Claims (16)
1. Farmaceutski pripravak koji sadrži inhibitor interleukin-4 receptora (IL-4R) za primjenu u metodi za liječenje ili ublažavanje najmanje jednog simptoma ili indikacije eozinofilnog ezofagitisa (EoE), pri čemu se metoda sastoji od primjene terapijski djelotvorne količine predmetnog farmaceutskog pripravka kod ispitanika kojem je potrebno liječenje, naznačeno time, što je inhibitor IL-4R antitijelo ili njegov fragment koji se vezuje za antigen koji se vezuje za IL-4Ra i sprječava interakciju IL-4R i/ili IL-13 s IL-4 receptorom tipa 1 ili tipa 2, naznačeno time, što antitijelo ili njegov fragment koji se vezuje za antigen sadrži tri HCDR-a (HCDR1, HCDR2 i HCDR3) i tri LCDR-a (LCDR1, LCDR2 i LCDR3), naznačeno time, što HCDR1 sadrži aminokiselinsku sekvencu SEQ ID NO: 3; HCDR2 sadrži aminokiselinsku sekvencu SEQ ID NO:4; HCDR3 sadrži aminokiselinsku sekvencu SEQ ID NO: 5; LCDR1 sadrži aminokiselinsku sekvencu SEQ ID NO: 6, LCDR2 sadrži aminokiselinsku sekvencu SEQ ID NO: 7, a LCDR3 sadrži aminokiselinsku sekvencu SEQ ID NO: 8.
2. Farmaceutski pripravak za primjenu u metodi prema patentnom zahtjevu 1, naznačen time, što se metoda sastoji od:
odabira ispitanika koji ima alergijsku reakciju na alergen koji ispitanika čini podložnim EoE-u; i
primjene terapijski djelotvorne količine predmetnog farmaceutskog pripravka kod ispitanika kojem je potrebno liječenje.
3. Farmaceutski pripravak za primjenu u metodi prema patentnom zahtjevu 1 ili 2, naznačen time, što:
(a) simptom ili indikacija EoE-a odabrana je iz skupine koja se sastoji od eozinofilne infiltracije jednjaka, zadebljanja stjenke jednjaka, odbijanja hrane, povraćanja, bolova u abdomenu, žgaravice, regurgitacije, disfagije i zadržavanja hrane;
(b) ispitanik ima alergijsku reakciju na alergen iz hrane koji se nalazi u prehrambenom proizvodu odabranom iz skupine koja se sastoji od mliječnog proizvoda, jaja, pšenice, soje, kukuruza, ribe, školjkaša, kikirikija, orašastih plodova, govedine, piletine, zobi, ječma, svinjetine, mahuna, jabuka i ananasa ili ispitanik ima alergijsku reakciju na alergen koji ne potječe iz hrane dobiven iz prašine, polena, plijesni, biljaka, mačaka, pasa ili kukaca; i/ili
(c) primjene inhibitora IL-4R dovodi do smanjenja razine biomarkera povezanog s EoE-om kod ispitanika, poželjno naznačeno time, što je biomarker povezan s EoE-om odabran iz skupine koja se sastoji od eozinofila jednjaka, eotaksina-3, periostina, serumskog IgE (ukupnog i specifičnog za alergen), IL-13, IL-5, serumskog kemokina reguliranog timusom i aktivacijom (TARC), limfopoetina strome timusa (TSLP), serumskog eozinofilnog kationskog proteina (ECP) i neurotoksina dobivenog iz eozinofila (EDN).
4. Farmaceutski pripravak za primjenu u metodi prema patentnom zahtjevu 1, naznačen time, što se metoda sastoji od:
odabira ispitanika koji ispoljava najmanje jedan simptom ili indikaciju EoE-a, naznačeno time, što ispitanik ima povišenu razinu biomarkera odabranog iz skupine koja se sastoji od eozinofila jednjaka, eotaksina 3, periostina, serumskog IgE (ukupnog i specifičnog za alergen), IL-13, IL-5, TARC-a, TSLP-a, serumskog ECP-a i EDN-a; i
primjene terapijski djelotvorne količine predmetnog farmaceutskog pripravka kod ispitanika kojem je potrebno liječenje.
5. Farmaceutski pripravak za primjenu u metodi prema patentnom zahtjevu 4, naznačen time, što se ispitanik bira na osnovu sljedećeg:
(a) ispoljavanja ≥ 15 eozinofila po vidnom polju velikog povećanja (HPF) u jednjaku prije ili u vrijeme liječenja („početna vrijednost“), poželjno naznačeno time, što ispitanik ispoljava najmanje 50 %-tno smanjenje broja eozinofila po HPF-u 10. dana nakon primjene inhibitora IL-4R u odnosu na početnu vrijednost; ili
(b) ispoljavanja razine eotaksina-3 veće od 50 pg/ml prije ili u vrijeme liječenja („početna vrijednost“), poželjno naznačeno time, što ispitanik ispoljava najmanje 50 %-tno smanjenje razine eotaksina-3 10. dana nakon primjene u odnosu na početnu vrijednost.
6. Farmaceutski pripravak za primjenu u metodi prema patentnom zahtjevu 4 ili 5, naznačen time, što:
(a) ispitanik ima alergijsku reakciju na alergen iz hrane koji se nalazi u prehrambenom proizvodu odabranom iz skupine koja se sastoji od mliječnog proizvoda, jaja, pšenice, soje, kukuruza, ribe, školjkaša, kikirikija, orašastih plodova, govedine, piletine, zobi, ječma, svinjetine, mahuna, jabuka i ananasa ili ispitanik ima alergijsku reakciju na alergen koji ne potječe iz hrane dobiven iz prašine, polena, plijesni, biljaka, mačaka, pasa ili kukaca; i/ili
(b) indikacija je odabrana iz skupine koja se sastoji od eozinofilne infiltracije jednjaka, zadebljanja stjenke jednjaka, odbijanja hrane, povraćanja, bolova u abdomenu, žgaravice, regurgitacije, disfagije i zadržavanja hrane.
7. Farmaceutski pripravak za primjenu u metodi prema patentnom zahtjevu 1, naznačen time, što ispitanik ima povišenu razinu biomarkera povezanog s eozinofilnog ezofagitisa (EoE), naznačeno time, što:
(a) biomarker povezan s EoE-om je odabran iz skupine koja se sastoji od broja eozinofila u jednjaku, eotaksina-3, TARC-a, periostina, IgE, IL-5, IL-13, limfopoetina strome timusa (TSLP) i neurotoksina dobivenog iz eozinofila (EDN), poželjno naznačeno time, što ispitanik ispoljava ≥ 15 eozinofila po vidnom polju velikog povećanja (HPF) u jednjaku prije ili u vrijeme liječenja („početna vrijednost“), poželjnije naznačeno time, što je broj eozinofila u jednjaku smanjen za najmanje 50 % do 10. dana nakon primjene inhibitora IL-4R u odnosu na početnu vrijednost;
(b) ispitanik ima alergijsku reakciju na alergen iz hrane koji se nalazi u prehrambenom proizvodu odabranom iz skupine koja se sastoji od mliječnog proizvoda, jaja, pšenice, soje, kukuruza, ribe, školjkaša, kikirikija, orašastih plodova, govedine, piletine, zobi, ječma, svinjetine, mahuna, jabuka i ananasa;
(c) ispitanik ima alergijsku reakciju na alergen koji ne potječe iz hrane dobiven iz izvora odabranog iz prašine, polena, plijesni, biljaka, mačaka, pasa ili kukaca; i/ili
(d) ispitanik ima eozinofilni ezofagitis (EoE).
8. Farmaceutski pripravak za primjenu u metodi prema bilo kojem patentnom zahtjevu od 1 do 7, naznačen time, što ispitanik, prije ili u vrijeme primjene inhibitora IL-4R, ima ili mu je dijagnosticirana bolest ili poremećaj odabran iz skupine koja se sastoji od atopijskog dermatitisa, astme, alergijskog rinitisa i alergijskog konjuktivitisa.
9. Farmaceutski pripravak za primjenu u metodi prema bilo kojem patentnom zahtjevu od 1 do 8, naznačen time, što se inhibitor IL-4R primjenjuje u kombinaciji s drugim terapijskim sredstvom ili terapijom, naznačeno time, što je drugo terapijsko sredstvo ili terapija odabrana iz skupine koja se sastoji od inhibitora IL-1 beta, inhibitora IL-5, inhibitora IL-9, inhibitora IL-13, inhibitora IL-17, inhibitora IL-25, inhibitora TNFalfa, inhibitora eotaksina-3, inhibitora IgE-a, inhibitora prostaglandina D2, imunosupresiva, kortikosteroida, glukokortikoida, inhibitora protonske pumpe, protuupalnog nesteroidnog lijeka, eliminacije alergena ili kontroliranja prehrane.
10. Farmaceutski pripravak za primjenu u metodi prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, što HCVR sadrži aminokiselinsku sekvencu SEQ ID NO: 1, a LCVR sadrži aminokiselinsku sekvencu SEQ ID NO: 2.
11. Farmaceutski pripravak za primjenu u metodi prema patentnom zahtjevu 1, naznačen time, što antitijelo ili njegov fragment koji se vezuje za antigen sadrži teški lanac s aminokiselinskom sekvencom SEQ ID NO: 13 i laki lanac s aminokiselinskom sekvencom SEQ ID NO: 14.
12. Farmaceutski pripravak za primjenu u metodi prema bilo kojem patentnom zahtjevu od 1 do 11, naznačen time što je inhibitor IL-4R dupilumab.
13. Farmaceutski pripravak za primjenu u metodi prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, što se metoda sastoji od supkutane primjene farmaceutskog pripravka.
14. Farmaceutski pripravak za primjenu u metodi prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, što se farmaceutski pripravak nalazi u štrcaljki.
15. Farmaceutski pripravak za primjenu u metodi prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, što se farmaceutski pripravak nalazi u brizgalici.
16. Farmaceutski pripravak za primjenu u metodi prema patentnom zahtjevu 15, naznačen time, što je brizgalica: (a) višekratna brizgalica koja sadrži zamjenjivu patronu napunjenu farmaceutskim pripravkom; ili (b) jednokratna brizgalica napunjena farmaceutskim pripravkom.
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| PCT/US2014/046170 WO2015006571A1 (en) | 2013-07-11 | 2014-07-10 | Methods for treating eosinophilic esophagitis by administering an il-4r inhibitor |
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