ES2983809T3 - Mirikizumab en el tratamiento de la colitis ulcerosa - Google Patents
Mirikizumab en el tratamiento de la colitis ulcerosa Download PDFInfo
- Publication number
- ES2983809T3 ES2983809T3 ES19722256T ES19722256T ES2983809T3 ES 2983809 T3 ES2983809 T3 ES 2983809T3 ES 19722256 T ES19722256 T ES 19722256T ES 19722256 T ES19722256 T ES 19722256T ES 2983809 T3 ES2983809 T3 ES 2983809T3
- Authority
- ES
- Spain
- Prior art keywords
- mirikizumab
- dose
- patients
- week
- treatment
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
- 238000011282 treatment Methods 0.000 title claims abstract description 115
- 206010009900 Colitis ulcerative Diseases 0.000 title claims abstract description 86
- 201000006704 Ulcerative Colitis Diseases 0.000 title claims abstract description 86
- 229950009792 mirikizumab Drugs 0.000 title claims description 251
- 230000006698 induction Effects 0.000 claims description 172
- 238000012423 maintenance Methods 0.000 claims description 158
- 238000001990 intravenous administration Methods 0.000 claims description 58
- 238000001802 infusion Methods 0.000 claims description 14
- 238000010254 subcutaneous injection Methods 0.000 claims description 9
- 239000007929 subcutaneous injection Substances 0.000 claims description 9
- 206010066901 Treatment failure Diseases 0.000 claims description 6
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 abstract description 33
- 201000010099 disease Diseases 0.000 abstract description 26
- 230000004044 response Effects 0.000 description 140
- 229940068196 placebo Drugs 0.000 description 85
- 239000000902 placebo Substances 0.000 description 85
- 206010038063 Rectal haemorrhage Diseases 0.000 description 51
- 238000007920 subcutaneous administration Methods 0.000 description 48
- 238000000034 method Methods 0.000 description 30
- 239000003814 drug Substances 0.000 description 26
- 229940079593 drug Drugs 0.000 description 25
- GLVAUDGFNGKCSF-UHFFFAOYSA-N mercaptopurine Chemical compound S=C1NC=NC2=C1NC=N2 GLVAUDGFNGKCSF-UHFFFAOYSA-N 0.000 description 22
- 230000001225 therapeutic effect Effects 0.000 description 22
- 238000001839 endoscopy Methods 0.000 description 21
- 102000013264 Interleukin-23 Human genes 0.000 description 20
- 108010065637 Interleukin-23 Proteins 0.000 description 20
- 238000001815 biotherapy Methods 0.000 description 20
- 229940124829 interleukin-23 Drugs 0.000 description 20
- 239000003246 corticosteroid Substances 0.000 description 15
- LMEKQMALGUDUQG-UHFFFAOYSA-N azathioprine Chemical compound CN1C=NC([N+]([O-])=O)=C1SC1=NC=NC2=C1NC=N2 LMEKQMALGUDUQG-UHFFFAOYSA-N 0.000 description 13
- 229960002170 azathioprine Drugs 0.000 description 13
- 229960001428 mercaptopurine Drugs 0.000 description 13
- 238000012216 screening Methods 0.000 description 13
- 238000004458 analytical method Methods 0.000 description 12
- 238000011156 evaluation Methods 0.000 description 12
- 238000012360 testing method Methods 0.000 description 12
- 230000002411 adverse Effects 0.000 description 11
- 230000008901 benefit Effects 0.000 description 11
- 230000001939 inductive effect Effects 0.000 description 11
- KBOPZPXVLCULAV-UHFFFAOYSA-N mesalamine Chemical compound NC1=CC=C(O)C(C(O)=O)=C1 KBOPZPXVLCULAV-UHFFFAOYSA-N 0.000 description 11
- 208000024891 symptom Diseases 0.000 description 11
- 210000004369 blood Anatomy 0.000 description 10
- 239000008280 blood Substances 0.000 description 10
- 238000011419 induction treatment Methods 0.000 description 10
- 206010009887 colitis Diseases 0.000 description 8
- 229960004963 mesalazine Drugs 0.000 description 8
- 241000193163 Clostridioides difficile Species 0.000 description 7
- 102000013462 Interleukin-12 Human genes 0.000 description 7
- 108010065805 Interleukin-12 Proteins 0.000 description 7
- 238000002052 colonoscopy Methods 0.000 description 7
- 229960001334 corticosteroids Drugs 0.000 description 7
- 208000035475 disorder Diseases 0.000 description 7
- 230000000694 effects Effects 0.000 description 7
- 230000001965 increasing effect Effects 0.000 description 7
- 229940117681 interleukin-12 Drugs 0.000 description 7
- 230000029087 digestion Effects 0.000 description 6
- 239000012634 fragment Substances 0.000 description 6
- 230000035876 healing Effects 0.000 description 6
- 238000011418 maintenance treatment Methods 0.000 description 6
- 238000002483 medication Methods 0.000 description 6
- 239000000047 product Substances 0.000 description 6
- 238000002560 therapeutic procedure Methods 0.000 description 6
- 206010009944 Colon cancer Diseases 0.000 description 5
- 208000001333 Colorectal Neoplasms Diseases 0.000 description 5
- 208000011231 Crohn disease Diseases 0.000 description 5
- 230000002550 fecal effect Effects 0.000 description 5
- 230000007774 longterm Effects 0.000 description 5
- 229960004914 vedolizumab Drugs 0.000 description 5
- 108010088751 Albumins Proteins 0.000 description 4
- 102000009027 Albumins Human genes 0.000 description 4
- 108010074051 C-Reactive Protein Proteins 0.000 description 4
- 102100032752 C-reactive protein Human genes 0.000 description 4
- 102000057297 Pepsin A Human genes 0.000 description 4
- 108090000284 Pepsin A Proteins 0.000 description 4
- 239000003124 biologic agent Substances 0.000 description 4
- 239000002131 composite material Substances 0.000 description 4
- 230000003247 decreasing effect Effects 0.000 description 4
- 238000003745 diagnosis Methods 0.000 description 4
- 239000002955 immunomodulating agent Substances 0.000 description 4
- 229940121354 immunomodulator Drugs 0.000 description 4
- 239000003018 immunosuppressive agent Substances 0.000 description 4
- 229940124589 immunosuppressive drug Drugs 0.000 description 4
- 229940111202 pepsin Drugs 0.000 description 4
- 229960004618 prednisone Drugs 0.000 description 4
- XOFYZVNMUHMLCC-ZPOLXVRWSA-N prednisone Chemical compound O=C1C=C[C@]2(C)[C@H]3C(=O)C[C@](C)([C@@](CC4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 XOFYZVNMUHMLCC-ZPOLXVRWSA-N 0.000 description 4
- 230000002035 prolonged effect Effects 0.000 description 4
- 108090000623 proteins and genes Proteins 0.000 description 4
- 230000009467 reduction Effects 0.000 description 4
- 150000003431 steroids Chemical class 0.000 description 4
- 208000004998 Abdominal Pain Diseases 0.000 description 3
- 238000000729 Fisher's exact test Methods 0.000 description 3
- 102000001109 Leukocyte L1 Antigen Complex Human genes 0.000 description 3
- 108010069316 Leukocyte L1 Antigen Complex Proteins 0.000 description 3
- 208000025865 Ulcer Diseases 0.000 description 3
- 239000005557 antagonist Substances 0.000 description 3
- 229960000074 biopharmaceutical Drugs 0.000 description 3
- 230000037396 body weight Effects 0.000 description 3
- 229950009342 brazikumab Drugs 0.000 description 3
- 230000008859 change Effects 0.000 description 3
- 239000003795 chemical substances by application Substances 0.000 description 3
- 210000001072 colon Anatomy 0.000 description 3
- 238000012790 confirmation Methods 0.000 description 3
- 238000009093 first-line therapy Methods 0.000 description 3
- 229950010864 guselkumab Drugs 0.000 description 3
- 238000007477 logistic regression Methods 0.000 description 3
- 238000009115 maintenance therapy Methods 0.000 description 3
- 229940124624 oral corticosteroid Drugs 0.000 description 3
- 230000036961 partial effect Effects 0.000 description 3
- 230000037361 pathway Effects 0.000 description 3
- 210000000664 rectum Anatomy 0.000 description 3
- 229950007943 risankizumab Drugs 0.000 description 3
- 210000002966 serum Anatomy 0.000 description 3
- 229950005515 tildrakizumab Drugs 0.000 description 3
- HDBQZGJWHMCXIL-UHFFFAOYSA-N 3,7-dihydropurine-2-thione Chemical compound SC1=NC=C2NC=NC2=N1 HDBQZGJWHMCXIL-UHFFFAOYSA-N 0.000 description 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 compound CC1(C)N=C(N)N=C(N)N1OCCCOC1=CC(Cl)=C(Cl)C=C1Cl MJZJYWCQPMNPRM-UHFFFAOYSA-N 0.000 description 2
- 208000023275 Autoimmune disease Diseases 0.000 description 2
- 102000019034 Chemokines Human genes 0.000 description 2
- 108010012236 Chemokines Proteins 0.000 description 2
- 206010008609 Cholangitis sclerosing Diseases 0.000 description 2
- 102000004127 Cytokines Human genes 0.000 description 2
- 108090000695 Cytokines Proteins 0.000 description 2
- 206010012735 Diarrhoea Diseases 0.000 description 2
- 206010015150 Erythema Diseases 0.000 description 2
- 208000032843 Hemorrhage Diseases 0.000 description 2
- 102000013691 Interleukin-17 Human genes 0.000 description 2
- 108050003558 Interleukin-17 Proteins 0.000 description 2
- 102000015617 Janus Kinases Human genes 0.000 description 2
- 108010024121 Janus Kinases Proteins 0.000 description 2
- 241001465754 Metazoa Species 0.000 description 2
- 201000004681 Psoriasis Diseases 0.000 description 2
- 210000000068 Th17 cell Anatomy 0.000 description 2
- 206010051259 Therapy naive Diseases 0.000 description 2
- 239000004012 Tofacitinib Substances 0.000 description 2
- 206010054094 Tumour necrosis Diseases 0.000 description 2
- 239000000090 biomarker Substances 0.000 description 2
- 210000004027 cell Anatomy 0.000 description 2
- 238000012321 colectomy Methods 0.000 description 2
- 238000011340 continuous therapy Methods 0.000 description 2
- 238000011443 conventional therapy Methods 0.000 description 2
- 230000034994 death Effects 0.000 description 2
- 231100000517 death Toxicity 0.000 description 2
- 230000003111 delayed effect Effects 0.000 description 2
- 230000009266 disease activity Effects 0.000 description 2
- 230000003628 erosive effect Effects 0.000 description 2
- 231100000321 erythema Toxicity 0.000 description 2
- 238000009541 flexible sigmoidoscopy Methods 0.000 description 2
- 230000002962 histologic effect Effects 0.000 description 2
- 208000027866 inflammatory disease Diseases 0.000 description 2
- 238000002347 injection Methods 0.000 description 2
- 239000007924 injection Substances 0.000 description 2
- 239000003446 ligand Substances 0.000 description 2
- 210000003097 mucus Anatomy 0.000 description 2
- 210000000440 neutrophil Anatomy 0.000 description 2
- 208000014965 pancolitis Diseases 0.000 description 2
- 239000008194 pharmaceutical composition Substances 0.000 description 2
- 229940012957 plasmin Drugs 0.000 description 2
- 201000000742 primary sclerosing cholangitis Diseases 0.000 description 2
- 102000004169 proteins and genes Human genes 0.000 description 2
- 238000009118 salvage therapy Methods 0.000 description 2
- 208000010157 sclerosing cholangitis Diseases 0.000 description 2
- 230000000391 smoking effect Effects 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 230000002459 sustained effect Effects 0.000 description 2
- 238000002626 targeted therapy Methods 0.000 description 2
- 230000008685 targeting Effects 0.000 description 2
- 238000011287 therapeutic dose Methods 0.000 description 2
- MNRILEROXIRVNJ-UHFFFAOYSA-N tioguanine Chemical class N1C(N)=NC(=S)C2=NC=N[C]21 MNRILEROXIRVNJ-UHFFFAOYSA-N 0.000 description 2
- 210000001519 tissue Anatomy 0.000 description 2
- 229960001350 tofacitinib Drugs 0.000 description 2
- UJLAWZDWDVHWOW-YPMHNXCESA-N tofacitinib Chemical compound C[C@@H]1CCN(C(=O)CC#N)C[C@@H]1N(C)C1=NC=NC2=C1C=CN2 UJLAWZDWDVHWOW-YPMHNXCESA-N 0.000 description 2
- 239000003053 toxin Substances 0.000 description 2
- 231100000765 toxin Toxicity 0.000 description 2
- 230000036269 ulceration Effects 0.000 description 2
- 229960003824 ustekinumab Drugs 0.000 description 2
- 230000002792 vascular Effects 0.000 description 2
- VOVIALXJUBGFJZ-KWVAZRHASA-N Budesonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@@H]2[C@@H]1[C@@H]1C[C@H]3OC(CCC)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O VOVIALXJUBGFJZ-KWVAZRHASA-N 0.000 description 1
- 206010007559 Cardiac failure congestive Diseases 0.000 description 1
- 208000017667 Chronic Disease Diseases 0.000 description 1
- 108020004705 Codon Proteins 0.000 description 1
- 208000014311 Cushing syndrome Diseases 0.000 description 1
- 208000016192 Demyelinating disease Diseases 0.000 description 1
- 206010012305 Demyelination Diseases 0.000 description 1
- 206010058314 Dysplasia Diseases 0.000 description 1
- 108010017213 Granulocyte-Macrophage Colony-Stimulating Factor Proteins 0.000 description 1
- 102100039620 Granulocyte-macrophage colony-stimulating factor Human genes 0.000 description 1
- 206010019280 Heart failures Diseases 0.000 description 1
- 102000008394 Immunoglobulin Fragments Human genes 0.000 description 1
- 108010021625 Immunoglobulin Fragments Proteins 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 208000022559 Inflammatory bowel disease Diseases 0.000 description 1
- 102000014150 Interferons Human genes 0.000 description 1
- 108010050904 Interferons Proteins 0.000 description 1
- 102100036672 Interleukin-23 receptor Human genes 0.000 description 1
- 101710195550 Interleukin-23 receptor Proteins 0.000 description 1
- 102000004889 Interleukin-6 Human genes 0.000 description 1
- 108090001005 Interleukin-6 Proteins 0.000 description 1
- 229940122245 Janus kinase inhibitor Drugs 0.000 description 1
- FBOZXECLQNJBKD-ZDUSSCGKSA-N L-methotrexate Chemical compound C=1N=C2N=C(N)N=C(N)C2=NC=1CN(C)C1=CC=C(C(=O)N[C@@H](CCC(O)=O)C(O)=O)C=C1 FBOZXECLQNJBKD-ZDUSSCGKSA-N 0.000 description 1
- 206010025327 Lymphopenia Diseases 0.000 description 1
- 208000029725 Metabolic bone disease Diseases 0.000 description 1
- 208000007101 Muscle Cramp Diseases 0.000 description 1
- 206010028817 Nausea and vomiting symptoms Diseases 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 108091028043 Nucleic acid sequence Proteins 0.000 description 1
- BBRBUTFBTUFFBU-LHACABTQSA-N Ornoprostil Chemical compound CCCC[C@H](C)C[C@H](O)\C=C\[C@H]1[C@H](O)CC(=O)[C@@H]1CC(=O)CCCCC(=O)OC BBRBUTFBTUFFBU-LHACABTQSA-N 0.000 description 1
- 206010049088 Osteopenia Diseases 0.000 description 1
- 208000001132 Osteoporosis Diseases 0.000 description 1
- 206010033645 Pancreatitis Diseases 0.000 description 1
- 108090000526 Papain Proteins 0.000 description 1
- 239000004365 Protease Substances 0.000 description 1
- 201000001263 Psoriatic Arthritis Diseases 0.000 description 1
- 208000036824 Psoriatic arthropathy Diseases 0.000 description 1
- 208000013738 Sleep Initiation and Maintenance disease Diseases 0.000 description 1
- 210000000447 Th1 cell Anatomy 0.000 description 1
- 230000005856 abnormality Effects 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- VOVIALXJUBGFJZ-AMTWPJRWSA-N ac1l1y6y Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@@H]2[C@@H]1[C@@H]1C[C@H]3O[C@H](CCC)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O VOVIALXJUBGFJZ-AMTWPJRWSA-N 0.000 description 1
- 229960002964 adalimumab Drugs 0.000 description 1
- OFCNXPDARWKPPY-UHFFFAOYSA-N allopurinol Chemical compound OC1=NC=NC2=C1C=NN2 OFCNXPDARWKPPY-UHFFFAOYSA-N 0.000 description 1
- 229960003459 allopurinol Drugs 0.000 description 1
- 230000003321 amplification Effects 0.000 description 1
- 230000000259 anti-tumor effect Effects 0.000 description 1
- 239000000427 antigen Substances 0.000 description 1
- 210000000612 antigen-presenting cell Anatomy 0.000 description 1
- 102000036639 antigens Human genes 0.000 description 1
- 108091007433 antigens Proteins 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 230000001363 autoimmune Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000003339 best practice Methods 0.000 description 1
- 230000000740 bleeding effect Effects 0.000 description 1
- 229960004436 budesonide Drugs 0.000 description 1
- 201000011510 cancer Diseases 0.000 description 1
- 230000011712 cell development Effects 0.000 description 1
- 238000012512 characterization method Methods 0.000 description 1
- 238000003776 cleavage reaction Methods 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 210000004443 dendritic cell Anatomy 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 239000003085 diluting agent Substances 0.000 description 1
- 231100000673 dose–response relationship Toxicity 0.000 description 1
- 239000003937 drug carrier Substances 0.000 description 1
- 238000002651 drug therapy Methods 0.000 description 1
- 230000002255 enzymatic effect Effects 0.000 description 1
- 210000000981 epithelium Anatomy 0.000 description 1
- 230000007717 exclusion Effects 0.000 description 1
- 238000013265 extended release Methods 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 238000010353 genetic engineering Methods 0.000 description 1
- 229960001743 golimumab Drugs 0.000 description 1
- 201000001421 hyperglycemia Diseases 0.000 description 1
- 230000002519 immonomodulatory effect Effects 0.000 description 1
- 210000002865 immune cell Anatomy 0.000 description 1
- 230000001900 immune effect Effects 0.000 description 1
- 230000005847 immunogenicity Effects 0.000 description 1
- 230000002584 immunomodulator Effects 0.000 description 1
- 230000001976 improved effect Effects 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 230000002757 inflammatory effect Effects 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 229960000598 infliximab Drugs 0.000 description 1
- 239000003112 inhibitor Substances 0.000 description 1
- 206010022437 insomnia Diseases 0.000 description 1
- 102000006495 integrins Human genes 0.000 description 1
- 108010044426 integrins Proteins 0.000 description 1
- 229940079322 interferon Drugs 0.000 description 1
- 229940100601 interleukin-6 Drugs 0.000 description 1
- 210000000936 intestine Anatomy 0.000 description 1
- 238000002642 intravenous therapy Methods 0.000 description 1
- 229940043355 kinase inhibitor Drugs 0.000 description 1
- 238000002372 labelling Methods 0.000 description 1
- 230000000670 limiting effect Effects 0.000 description 1
- 238000007449 liver function test Methods 0.000 description 1
- 238000011866 long-term treatment Methods 0.000 description 1
- 231100001023 lymphopenia Toxicity 0.000 description 1
- 210000002540 macrophage Anatomy 0.000 description 1
- 230000036210 malignancy Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 229960000485 methotrexate Drugs 0.000 description 1
- 230000003278 mimic effect Effects 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000001823 molecular biology technique Methods 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 210000004400 mucous membrane Anatomy 0.000 description 1
- 230000003472 neutralizing effect Effects 0.000 description 1
- 238000003199 nucleic acid amplification method Methods 0.000 description 1
- 229940055729 papain Drugs 0.000 description 1
- 235000019834 papain Nutrition 0.000 description 1
- 230000007170 pathology Effects 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 239000003757 phosphotransferase inhibitor Substances 0.000 description 1
- 230000036470 plasma concentration Effects 0.000 description 1
- 108091033319 polynucleotide Proteins 0.000 description 1
- 239000002157 polynucleotide Substances 0.000 description 1
- 102000040430 polynucleotide Human genes 0.000 description 1
- 201000009395 primary hyperaldosteronism Diseases 0.000 description 1
- 238000011002 quantification Methods 0.000 description 1
- 239000002464 receptor antagonist Substances 0.000 description 1
- 229940044551 receptor antagonist Drugs 0.000 description 1
- 238000010188 recombinant method Methods 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 230000007017 scission Effects 0.000 description 1
- 230000002269 spontaneous effect Effects 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000013589 supplement Substances 0.000 description 1
- 230000008093 supporting effect Effects 0.000 description 1
- 238000004448 titration Methods 0.000 description 1
- 231100000397 ulcer Toxicity 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
Classifications
-
- 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
- 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
-
- 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
-
- 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
- A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- General Chemical & Material Sciences (AREA)
- Biophysics (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Molecular Biology (AREA)
- Immunology (AREA)
- Biochemistry (AREA)
- Engineering & Computer Science (AREA)
- Genetics & Genomics (AREA)
- Dermatology (AREA)
- Epidemiology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201862650314P | 2018-03-30 | 2018-03-30 | |
| PCT/US2019/024633 WO2019191464A1 (en) | 2018-03-30 | 2019-03-28 | Methods of treating ulcerative colitis |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2983809T3 true ES2983809T3 (es) | 2024-10-24 |
Family
ID=66429483
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES19722256T Active ES2983809T3 (es) | 2018-03-30 | 2019-03-28 | Mirikizumab en el tratamiento de la colitis ulcerosa |
Country Status (29)
| Country | Link |
|---|---|
| US (2) | US12152072B2 (enExample) |
| EP (2) | EP3773715B1 (enExample) |
| JP (4) | JP7119114B2 (enExample) |
| KR (1) | KR102552693B1 (enExample) |
| CN (1) | CN111936165A (enExample) |
| AU (2) | AU2019243283C1 (enExample) |
| BR (1) | BR112020018099A2 (enExample) |
| CA (1) | CA3095297A1 (enExample) |
| DK (1) | DK3773715T3 (enExample) |
| EA (1) | EA202091989A1 (enExample) |
| ES (1) | ES2983809T3 (enExample) |
| FI (1) | FI3773715T3 (enExample) |
| HR (1) | HRP20240904T1 (enExample) |
| HU (1) | HUE067445T2 (enExample) |
| IL (2) | IL277514B2 (enExample) |
| LT (1) | LT3773715T (enExample) |
| MA (1) | MA52216B1 (enExample) |
| MD (1) | MD3773715T2 (enExample) |
| MX (1) | MX2020010269A (enExample) |
| MY (1) | MY202368A (enExample) |
| PL (1) | PL3773715T3 (enExample) |
| PT (1) | PT3773715T (enExample) |
| RS (1) | RS65661B1 (enExample) |
| SG (1) | SG11202009526RA (enExample) |
| SI (1) | SI3773715T1 (enExample) |
| TW (2) | TWI837532B (enExample) |
| UA (1) | UA128578C2 (enExample) |
| WO (1) | WO2019191464A1 (enExample) |
| ZA (1) | ZA202005388B (enExample) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2020279987A1 (en) | 2019-05-23 | 2021-11-18 | Janssen Biotech, Inc. | Method of treating inflammatory bowel disease with a combination therapy of antibodies to IL-23 and TNF alpha |
| 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 |
| WO2024110898A1 (en) * | 2022-11-22 | 2024-05-30 | Janssen Biotech, Inc. | Method of treating ulcerative colitis with anti-il23 specific antibody |
| KR20250156783A (ko) | 2023-03-10 | 2025-11-03 | 일라이 릴리 앤드 캄파니 | 궤양성 결장염을 치료하는 방법 |
| TW202500185A (zh) * | 2023-06-16 | 2025-01-01 | 大陸商信達生物製藥（蘇州）有限公司 | 重組抗白介素２３ｐ１９亞基抗體在治療炎症性腸病中的用途 |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| HRP20130400T1 (en) * | 2005-06-30 | 2013-06-30 | Janssen Biotech, Inc. | Anti-il-23 antibodies, compositions, methods and uses |
| 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 |
| US20110212104A1 (en) * | 2008-11-03 | 2011-09-01 | Schering Corporation | Inflammatory bowel disease biomarkers and related methods of treatment |
| JO3244B1 (ar) | 2009-10-26 | 2018-03-08 | Amgen Inc | بروتينات ربط مستضادات il – 23 البشرية |
| JP6126532B2 (ja) * | 2010-11-04 | 2017-05-10 | ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング | 抗ｉｌ−２３抗体 |
| JOP20140049B1 (ar) | 2013-03-08 | 2021-08-17 | Lilly Co Eli | أجسام مضادة ترتبط بـ il-23 |
| US20170002060A1 (en) * | 2014-01-08 | 2017-01-05 | Moderna Therapeutics, Inc. | Polynucleotides for the in vivo production of antibodies |
| MX2020009265A (es) * | 2018-03-05 | 2020-10-01 | Janssen Biotech Inc | Metodos para tratar la enfermedad de crohn con un anticuerpo especifico anti-il23. |
-
2019
- 2019-03-27 TW TW110139868A patent/TWI837532B/zh active
- 2019-03-27 TW TW108110767A patent/TWI744617B/zh active
- 2019-03-28 RS RS20240698A patent/RS65661B1/sr unknown
- 2019-03-28 US US16/981,915 patent/US12152072B2/en active Active
- 2019-03-28 SI SI201930750T patent/SI3773715T1/sl unknown
- 2019-03-28 HR HRP20240904TT patent/HRP20240904T1/hr unknown
- 2019-03-28 CN CN201980023563.3A patent/CN111936165A/zh active Pending
- 2019-03-28 JP JP2020552872A patent/JP7119114B2/ja active Active
- 2019-03-28 KR KR1020207027982A patent/KR102552693B1/ko active Active
- 2019-03-28 WO PCT/US2019/024633 patent/WO2019191464A1/en not_active Ceased
- 2019-03-28 EP EP19722256.5A patent/EP3773715B1/en active Active
- 2019-03-28 PL PL19722256.5T patent/PL3773715T3/pl unknown
- 2019-03-28 ES ES19722256T patent/ES2983809T3/es active Active
- 2019-03-28 UA UAA202005571A patent/UA128578C2/uk unknown
- 2019-03-28 LT LTEPPCT/US2019/024633T patent/LT3773715T/lt unknown
- 2019-03-28 PT PT197222565T patent/PT3773715T/pt unknown
- 2019-03-28 DK DK19722256.5T patent/DK3773715T3/da active
- 2019-03-28 FI FIEP19722256.5T patent/FI3773715T3/fi active
- 2019-03-28 BR BR112020018099-8A patent/BR112020018099A2/pt unknown
- 2019-03-28 SG SG11202009526RA patent/SG11202009526RA/en unknown
- 2019-03-28 IL IL277514A patent/IL277514B2/en unknown
- 2019-03-28 IL IL312807A patent/IL312807B2/en unknown
- 2019-03-28 MD MDE20210135T patent/MD3773715T2/ro unknown
- 2019-03-28 EA EA202091989A patent/EA202091989A1/ru unknown
- 2019-03-28 CA CA3095297A patent/CA3095297A1/en active Pending
- 2019-03-28 MX MX2020010269A patent/MX2020010269A/es unknown
- 2019-03-28 MY MYPI2020004942A patent/MY202368A/en unknown
- 2019-03-28 HU HUE19722256A patent/HUE067445T2/hu unknown
- 2019-03-28 AU AU2019243283A patent/AU2019243283C1/en active Active
- 2019-03-28 MA MA52216A patent/MA52216B1/fr unknown
- 2019-03-28 EP EP23215626.5A patent/EP4327866B1/en active Active
-
2020
- 2020-08-28 ZA ZA2020/05388A patent/ZA202005388B/en unknown
-
2022
- 2022-08-03 JP JP2022123689A patent/JP7331219B2/ja active Active
-
2023
- 2023-08-09 JP JP2023130117A patent/JP7571225B2/ja active Active
- 2023-10-11 AU AU2023248103A patent/AU2023248103A1/en active Pending
-
2024
- 2024-10-09 JP JP2024176901A patent/JP2025020134A/ja active Pending
- 2024-10-16 US US18/917,597 patent/US20250034243A1/en active Pending
Also Published As
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| ES2983809T3 (es) | Mirikizumab en el tratamiento de la colitis ulcerosa | |
| JP2023116680A (ja) | クローン病を治療する方法に使用するためのミリキズマブ | |
| HK40036550A (en) | Mirikizumab in the treatment of ulcerative colitis | |
| HK40036550B (en) | Mirikizumab in the treatment of ulcerative colitis | |
| HK40101440A (en) | Mirikizumab in the treatment of ulcerative colitis | |
| EA049081B1 (ru) | Способы лечения язвенного колита | |
| Bubna | Secukinumab: Introduction |