HRP20230886T1 - Siguran i učinkovit postupak za liječenje ulcerativnog kolitisa s protutijelom anti-il12/il23 - Google Patents
Siguran i učinkovit postupak za liječenje ulcerativnog kolitisa s protutijelom anti-il12/il23 Download PDFInfo
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- HRP20230886T1 HRP20230886T1 HRP20230886TT HRP20230886T HRP20230886T1 HR P20230886 T1 HRP20230886 T1 HR P20230886T1 HR P20230886T T HRP20230886T T HR P20230886TT HR P20230886 T HRP20230886 T HR P20230886T HR P20230886 T1 HRP20230886 T1 HR P20230886T1
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- 206010009900 Colitis ulcerative Diseases 0.000 title claims 5
- 201000006704 Ulcerative Colitis Diseases 0.000 title claims 5
- 238000000034 method Methods 0.000 title claims 3
- 230000007423 decrease Effects 0.000 claims 6
- 230000004044 response Effects 0.000 claims 6
- 206010038063 Rectal haemorrhage Diseases 0.000 claims 5
- 230000035876 healing Effects 0.000 claims 5
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims 4
- 150000001413 amino acids Chemical group 0.000 claims 4
- 238000001839 endoscopy Methods 0.000 claims 4
- 230000002550 fecal effect Effects 0.000 claims 4
- 208000022559 Inflammatory bowel disease Diseases 0.000 claims 3
- 230000037396 body weight Effects 0.000 claims 3
- 239000003246 corticosteroid Substances 0.000 claims 3
- 229960001334 corticosteroids Drugs 0.000 claims 3
- 239000000825 pharmaceutical preparation Substances 0.000 claims 3
- 230000004797 therapeutic response Effects 0.000 claims 3
- 108010074051 C-Reactive Protein Proteins 0.000 claims 2
- 102100032752 C-reactive protein Human genes 0.000 claims 2
- 102000010445 Lactoferrin Human genes 0.000 claims 2
- 108010063045 Lactoferrin Proteins 0.000 claims 2
- 102000001109 Leukocyte L1 Antigen Complex Human genes 0.000 claims 2
- 108010069316 Leukocyte L1 Antigen Complex Proteins 0.000 claims 2
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 2
- 229930006000 Sucrose Natural products 0.000 claims 2
- 229960002170 azathioprine Drugs 0.000 claims 2
- LMEKQMALGUDUQG-UHFFFAOYSA-N azathioprine Chemical compound CN1C=NC([N+]([O-])=O)=C1SC1=NC=NC2=C1NC=N2 LMEKQMALGUDUQG-UHFFFAOYSA-N 0.000 claims 2
- 239000000090 biomarker Substances 0.000 claims 2
- 229960002885 histidine Drugs 0.000 claims 2
- CSSYQJWUGATIHM-IKGCZBKSSA-N l-phenylalanyl-l-lysyl-l-cysteinyl-l-arginyl-l-arginyl-l-tryptophyl-l-glutaminyl-l-tryptophyl-l-arginyl-l-methionyl-l-lysyl-l-lysyl-l-leucylglycyl-l-alanyl-l-prolyl-l-seryl-l-isoleucyl-l-threonyl-l-cysteinyl-l-valyl-l-arginyl-l-arginyl-l-alanyl-l-phenylal Chemical compound C([C@H](N)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CS)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)NCC(=O)N[C@@H](C)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CS)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](C)C(=O)N[C@@H](CC=1C=CC=CC=1)C(O)=O)C1=CC=CC=C1 CSSYQJWUGATIHM-IKGCZBKSSA-N 0.000 claims 2
- 229940078795 lactoferrin Drugs 0.000 claims 2
- 235000021242 lactoferrin Nutrition 0.000 claims 2
- 238000009115 maintenance therapy Methods 0.000 claims 2
- GLVAUDGFNGKCSF-UHFFFAOYSA-N mercaptopurine Chemical compound S=C1NC=NC2=C1NC=N2 GLVAUDGFNGKCSF-UHFFFAOYSA-N 0.000 claims 2
- 210000004400 mucous membrane Anatomy 0.000 claims 2
- 238000010606 normalization Methods 0.000 claims 2
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 2
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 2
- 229920000053 polysorbate 80 Polymers 0.000 claims 2
- 229940068968 polysorbate 80 Drugs 0.000 claims 2
- 238000007920 subcutaneous administration Methods 0.000 claims 2
- 239000005720 sucrose Substances 0.000 claims 2
- MJZJYWCQPMNPRM-UHFFFAOYSA-N 6,6-dimethyl-1-[3-(2,4,5-trichlorophenoxy)propoxy]-1,6-dihydro-1,3,5-triazine-2,4-diamine Chemical group CC1(C)N=C(N)N=C(N)N1OCCCOC1=CC(Cl)=C(Cl)C=C1Cl MJZJYWCQPMNPRM-UHFFFAOYSA-N 0.000 claims 1
- ZGTMUACCHSMWAC-UHFFFAOYSA-L EDTA disodium salt (anhydrous) Chemical compound [Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC(O)=O)CC([O-])=O ZGTMUACCHSMWAC-UHFFFAOYSA-L 0.000 claims 1
- FFEARJCKVFRZRR-UHFFFAOYSA-N L-Methionine Natural products CSCCC(N)C(O)=O FFEARJCKVFRZRR-UHFFFAOYSA-N 0.000 claims 1
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims 1
- 229930195722 L-methionine Natural products 0.000 claims 1
- 230000009266 disease activity Effects 0.000 claims 1
- 238000001990 intravenous administration Methods 0.000 claims 1
- 238000012423 maintenance Methods 0.000 claims 1
- 229960001428 mercaptopurine Drugs 0.000 claims 1
- 229960004452 methionine Drugs 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 238000002560 therapeutic procedure Methods 0.000 claims 1
- 229960003824 ustekinumab Drugs 0.000 claims 1
- 229960004914 vedolizumab Drugs 0.000 claims 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
-
- C—CHEMISTRY; METALLURGY
- 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
- C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/244—Interleukins [IL]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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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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- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
- C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
- C07K2317/565—Complementarity determining region [CDR]
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
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- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
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Claims (13)
1. Protutijelo anti-IL-12/IL-23p40, naznačeno time, da je za uporabu u postupku za liječenje umjereno do jako aktivnog ulcerativnog kolitisa (UC) kod ljudskog pojedinca kojemu je to potrebno,
pri čemu protutijelo sadrži varijabilnu regiju jakog lanca s aminokiselinskim slijedom SEQ ID NO: 7 i varijabilnu regiju slabog lanca s aminokiselinskim slijedom SEQ ID NO: 8,
dok postupak obuhvaća:
a. intravenoznu primjenu protutijela na pojedincu u prvom farmaceutskom pripravku u tjednu 0 od liječenja s dozom od 260 mg za pojedince s tjelesnom masom ≥ 35 kg i ≤ 55 kg, 390 mg za pojedince s tjelesnom masom > 55 kg i ≤ 85 kg, te 520 mg za pojedince s tjelesnom masom > 85 kg, i
b. supkutanu primjenu protutijela na pojedincu u drugom farmaceutskom pripravku s dozom od 90 mg po davanju, u tjednu 8 od liječenja, te u dozi održavanja svakih 8 tjedana ili svakih 12 tjedana nakon liječenja u tjednu 8, pri čemu je pojedinac u kliničkoj remisiji bez kortikosteroida najmanje 44 tjedna nakon tjedna 0.
2. Protutijelo za uporabu prema patentnom zahtjevu 1, naznačeno time, da protutijelo je ljudsko IgG protutijelo.
3. Protutijelo za uporabu prema patentnom zahtjevu 1, naznačeno time, da protutijelo je potpuno ljudsko IgG1k monoklonsko protutijelo.
4. Protutijelo za uporabu prema bilo kojem prethodnom patentnom zahtjevu, naznačeno time, da protutijelo sadrži varijabilnu regiju jakog lanca s aminokiselinskim slijedom SEQ ID NO: 10 i varijabilnu regiju slabog lanca s aminokiselinskim slijedom SEQ ID NO: 11.
5. Protutijelo za uporabu prema patentnom zahtjevu 1, naznačeno time, da protutijelo je ustekinumab.
6. Protutijelo za uporabu prema bilo kojem od patentnih zahtjeva 1-5, naznačeno time, da terapija za održavanje obuhvaća supkutanu primjenu protutijela anti-IL-12/IL-23p40 na pojedincu u dozi od 90 mg po davanju, jednom svakih 8 tjedana ili jednom svakih 12 tjedana, te time, da se terapija za održavanje provodi u trajanju od 44 tjedna.
7. Protutijelo za uporabu prema bilo kojem od patentnih zahtjeva 1-6, naznačeno time, da:
a. prvi farmaceutski pripravak nadalje sadrži otopinu koja sadrži 10 mM L-histidina, 8,5% (m/v) saharoze, 0,04% (m/v) polisorbata 80, 0,4 mg/mL L-metionina, i 20 μg/mL EDTA dinatrijeve soli, dehidrat, na pH 6,0; ili
b. drugi farmaceutski pripravak nadalje sadrži otopinu koja sadrži 6,7 mM L-histidina, 7,6% (m/v) saharoze, 0,004% (m/v) polisorbata 80, na pH 6,0.
8. Protutijelo za uporabu prema bilo kojem prethodnom patentnom zahtjevu, naznačeno time, da pojedinac ima terapijski odgovor na liječenje s protutijelom i on je:
a. identificiran tako da ima endoskopsko zalječenje koje se nastavlja najmanje 44 tjedna nakon tjedna 0; i/ili
b. identificiran tako da postiže klinički odgovor na temelju pokazatelja podvrijednosti endoskopske pretrage Mayo (engl. Mayo endoscopy subscore), što se nastavlja najmanje 44 tjedna nakon tjedna 0; i/ili
c. identificiran tako da ima promjenu od početne vrijednosti prema izlaznoj vrijednosti pokazatelja u Upitniku za upalnu bolest crijeva (IBDQ score - engl. Inflammatory Bowel Disease Questionnaire), što se nastavlja najmanje 44 tjedna nakon tjedna 0; i/ili
d. identificiran tako da ima zalječenje mukoznog tkiva koje se nastavlja najmanje 44 tjedna nakon tjedna 0; i/ili
e. identificiran tako da ima opadanje od početne vrijednosti u pokazateljima Mayo izlaznih vrijednosti (engl. Mayo score), što se nastavlja najmanje 44 tjedna nakon tjedna 0; i/ili
f. identificiran tako da ima normalizaciju jednoga ili više biomarkera odabranih iz skupine koju čine C-reaktivni protein, fekalni laktoferin, i fekalni kalprotektin, što se nastavlja najmanje 44 tjedna nakon tjedna 0; i/ili
g. u kliničkom odgovoru koji se određuje putem opadanja od početne vrijednosti prema Mayo pokazateljima izlaznih vrijednosti (engl. Mayo score) sa ≥ 30% i ≥ 3 boda te opadanja od početne vrijednosti prema podvrijednosti (engl. subscore) rektalnog krvarenja za ≥ 1 boda ili podvrijednosti (engl. subscore) rektalnog krvarenja od 0 ili 1,
što se nastavlja najmanje 44 tjedna nakon tjedna 0.
9. Protutijelo za uporabu prema bilo kojem prethodnom patentnom zahtjevu, naznačeno time, da pojedinac ima terapijski odgovor na liječenje s protutijelom i on je identificiran tako da ima kliničku remisiju na temelju najmanje jedne od globalne definicije i US definicije do tjedna 16, poželjno do tjedna 8, još poželjnije do tjedna 2, od liječenja, te kliničku remisiju koja se nastavlja najmanje 44 tjedna nakon tjedna 0.
10. Protutijelo za uporabu prema bilo kojem prethodnom patentnom zahtjevu, naznačeno time, da pojedinac ima terapijski odgovor na liječenje s protutijelom i on je identificiran tako da ima statistički značajno poboljšanje u aktivnosti bolesti, kao što se određuje putem pokazatelja prema Endoskopskom indeksu jakosti ulcerativnog kolitisa (UCEIS - engl. Ulcerative Colitis Endoscopic Index of Severity - score) od ≤ 4 do tjedna 8 od liječenja s protutijelom.
11. Protutijelo za uporabu prema bilo kojem prethodnom patentnom zahtjevu, naznačeno time, da pojedinac prethodno nije imao uspjeha u liječenju ili nije dobro podnosio najmanje jednu terapiju odabranu iz skupine koju čine: anti-TNF, vedolizumab, kortikosteroidi, azatioprin (AZA), i 6 merkaptopurin (6 MP), ili je pojedinac pokazivao ovisnost o kortikosteroidima.
12. Protutijelo za uporabu prema bilo kojem prethodnom patentnom zahtjevu, naznačeno time, da je pojedinac:
a. identificiran tako da ima kliničku remisiju na temelju barem jedne od:
i. globalne definicije, pri čemu globalna definicija je globalna definicija kliničke remisije prema Mayo izlaznoj vrijednosti (engl. Mayo score) od ≤ 2 boda s niti jednom individualnom podvrijednosti > 1; i
ii. US definicije, pri čemu US definicija je US definicija kliničke remisije s apsolutnim brojem stolica ≤ 3, podvrijednosti rektalnog krvarenja od 0 i pokazateljem podvrijednosti endoskopske pretrage Mayo (engl. Mayo endoscopy subscore) od 0 ili 1; i/ili
b. identificiran tako da ima endoskopsko zalječenje, opcionalno gdje je pojedinac identificiran tako da ima endoskopsko zalječenje s pokazateljima podvrijednosti endoskopske pretrage Mayo (engl. Mayo endoscopy subscore) od 0 ili 1; i/ili
c. identificiran tako da postiže klinički odgovor na temelju pokazatelja podvrijednosti endoskopske pretrage Mayo (engl. Mayo endoscopy subscore); i/ili
d. identificiran tako da ima promjenu od početne vrijednosti prema pokazateljima izlaznih vrijednosti u Upitniku za upalnu bolest crijeva (IBDQ score - engl. Inflammatory Bowel Disease Questionnaire); i/ili
e. identificiran tako da ima zalječenje mukoznog tkiva; i/ili
f. identificiran tako da ima opadanje od početne vrijednosti u pokazateljima Mayo izlaznih vrijednosti (engl. Mayo score); i/ili
g. identificiran tako da ima normalizaciju jednoga ili više biomarkera odabranih iz skupine koju čine C-reaktivni protein, fekalni laktoferin, i fekalni kalprotektin; i/ili
h. u kliničkom odgovoru koji se određuje putem opadanja od početne vrijednosti prema Mayo izlaznoj vrijednosti (engl. Mayo score) za ≥ 30% i ≥ 3 boda te opadanja od početne vrijednosti prema podvrijednosti (engl. subscore) rektalnog krvarenja za ≥ 1 boda ili podvrijednosti (engl. subscore) rektalnog krvarenja od 0 ili 1;
opcionalno do tjedna 16, poželjno do tjedna 8, još poželjnije do tjedna 2, od liječenja.
13. Protutijelo za uporabu prema patentnom zahtjevu 11 ili zahtjevu 12, naznačeno time, da pojedinac nema klinički odgovor na liječenje s protutijelom do tjedna 8 i ima klinički odgovor na liječenje s protutijelom do tjedna 16 od liječenja.
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201862735501P | 2018-09-24 | 2018-09-24 | |
US201862769818P | 2018-11-20 | 2018-11-20 | |
US201962895774P | 2019-09-04 | 2019-09-04 | |
PCT/IB2019/058098 WO2020065532A1 (en) | 2018-09-24 | 2019-09-24 | Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody |
EP19867085.3A EP3883606B9 (en) | 2018-09-24 | 2019-09-24 | Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody |
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HRP20230886T1 true HRP20230886T1 (hr) | 2023-11-24 |
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HRP20230886TT HRP20230886T1 (hr) | 2018-09-24 | 2019-09-24 | Siguran i učinkovit postupak za liječenje ulcerativnog kolitisa s protutijelom anti-il12/il23 |
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EP (1) | EP3883606B9 (hr) |
JP (3) | JP7359845B2 (hr) |
KR (2) | KR20230148273A (hr) |
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AU (8) | AU2019346134B2 (hr) |
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JP2022534020A (ja) | 2019-05-23 | 2022-07-27 | ヤンセン バイオテツク,インコーポレーテツド | Il-23及びtnfアルファに対する抗体の併用療法による炎症性腸疾患の治療方法 |
WO2021074897A2 (en) * | 2019-10-18 | 2021-04-22 | Janssen Biotech, Inc. | Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody |
AU2021308574A1 (en) * | 2020-07-13 | 2023-03-09 | Janssen Biotech, Inc. | Safe and effective method of treating psoriatic arthritis with anti-IL23 specific antibody |
AU2021315081A1 (en) * | 2020-07-30 | 2023-03-30 | Janssen Biotech, Inc. | Method of treating psoriasis in pediatric subjects with anti-IL12/IL23 antibody |
US20220102008A1 (en) * | 2020-09-30 | 2022-03-31 | Genentech, Inc. | Methods and systems for placebo response modeling |
WO2022184114A1 (zh) * | 2021-03-03 | 2022-09-09 | 苏州盛迪亚生物医药有限公司 | 抗il-17抗体治疗自身免疫性疾病和炎症的方法 |
WO2023009979A1 (en) * | 2021-07-26 | 2023-02-02 | Avalo Therapeutics, Inc. | Methods of treating ulcerative colitis with anti-light antibodies |
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