JP2009521398A5 - - Google Patents
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- JP2009521398A5 JP2009521398A5 JP2008535568A JP2008535568A JP2009521398A5 JP 2009521398 A5 JP2009521398 A5 JP 2009521398A5 JP 2008535568 A JP2008535568 A JP 2008535568A JP 2008535568 A JP2008535568 A JP 2008535568A JP 2009521398 A5 JP2009521398 A5 JP 2009521398A5
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- 239000000203 mixture Substances 0.000 claims 36
- 230000003042 antagnostic Effects 0.000 claims 22
- 239000005557 antagonist Substances 0.000 claims 22
- 102000004965 antibodies Human genes 0.000 claims 18
- 108090001123 antibodies Proteins 0.000 claims 18
- 210000002381 Plasma Anatomy 0.000 claims 13
- 210000002966 Serum Anatomy 0.000 claims 13
- 229920003013 deoxyribonucleic acid Polymers 0.000 claims 7
- FAPWRFPIFSIZLT-UHFFFAOYSA-M sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 6
- 201000000596 systemic lupus erythematosus Diseases 0.000 claims 6
- 238000009472 formulation Methods 0.000 claims 5
- 238000000034 method Methods 0.000 claims 5
- 229920000954 Polyglycolide Polymers 0.000 claims 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 claims 4
- 229960004618 prednisone Drugs 0.000 claims 4
- 235000010409 propane-1,2-diol alginate Nutrition 0.000 claims 4
- 206010003816 Autoimmune disease Diseases 0.000 claims 3
- 108010028780 Complement C3 Proteins 0.000 claims 3
- 102000016918 Complement C3 Human genes 0.000 claims 3
- 108010028778 Complement C4 Proteins 0.000 claims 3
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims 3
- 206010025135 Lupus erythematosus Diseases 0.000 claims 3
- 201000009596 autoimmune hypersensitivity disease Diseases 0.000 claims 3
- 239000003246 corticosteroid Substances 0.000 claims 3
- 239000008194 pharmaceutical composition Substances 0.000 claims 3
- 239000011780 sodium chloride Substances 0.000 claims 3
- 229960002885 Histidine Drugs 0.000 claims 2
- 229940068968 Polysorbate 80 Drugs 0.000 claims 2
- 101710030862 TNFRSF13C Proteins 0.000 claims 2
- 102100009743 TNFRSF13C Human genes 0.000 claims 2
- 150000001413 amino acids Chemical group 0.000 claims 2
- 238000002650 immunosuppressive therapy Methods 0.000 claims 2
- 210000000056 organs Anatomy 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
- 102000004169 proteins and genes Human genes 0.000 claims 2
- 108090000623 proteins and genes Proteins 0.000 claims 2
- 239000004094 surface-active agent Substances 0.000 claims 2
- QZNNVYOVQUKYSC-JEDNCBNOSA-N (2S)-2-amino-3-(1H-imidazol-5-yl)propanoic acid;hydron;chloride Chemical compound Cl.OC(=O)[C@@H](N)CC1=CN=CN1 QZNNVYOVQUKYSC-JEDNCBNOSA-N 0.000 claims 1
- BGFTWECWAICPDG-UHFFFAOYSA-N 2-[bis(4-chlorophenyl)methyl]-4-N-[3-[bis(4-chlorophenyl)methyl]-4-(dimethylamino)phenyl]-1-N,1-N-dimethylbenzene-1,4-diamine Chemical compound C1=C(C(C=2C=CC(Cl)=CC=2)C=2C=CC(Cl)=CC=2)C(N(C)C)=CC=C1NC(C=1)=CC=C(N(C)C)C=1C(C=1C=CC(Cl)=CC=1)C1=CC=C(Cl)C=C1 BGFTWECWAICPDG-UHFFFAOYSA-N 0.000 claims 1
- 108010008014 B-Cell Maturation Antigen Proteins 0.000 claims 1
- 102000006942 B-Cell Maturation Antigen Human genes 0.000 claims 1
- JYGXADMDTFJGBT-VWUMJDOOSA-N Cortisol Chemical compound O=C1CC[C@]2(C)[C@H]3[C@@H](O)C[C@](C)([C@@](CC4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 JYGXADMDTFJGBT-VWUMJDOOSA-N 0.000 claims 1
- 229960003957 Dexamethasone Drugs 0.000 claims 1
- UREBDLICKHMUKA-CXSFZGCWSA-N Dexamethasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@@H](C)[C@@](C(=O)CO)(O)[C@@]1(C)C[C@@H]2O UREBDLICKHMUKA-CXSFZGCWSA-N 0.000 claims 1
- 208000003456 Juvenile Arthritis Diseases 0.000 claims 1
- VHRSUDSXCMQTMA-PJHHCJLFSA-N Methylprednisolone Chemical compound C([C@@]12C)=CC(=O)C=C1[C@@H](C)C[C@@H]1[C@@H]2[C@@H](O)C[C@]2(C)[C@@](O)(C(=O)CO)CC[C@H]21 VHRSUDSXCMQTMA-PJHHCJLFSA-N 0.000 claims 1
- 208000003250 Mixed Connective Tissue Disease Diseases 0.000 claims 1
- 208000005987 Polymyositis Diseases 0.000 claims 1
- OIGNJSKKLXVSLS-VWUMJDOOSA-N Prednisolone Chemical compound O=C1C=C[C@]2(C)[C@H]3[C@@H](O)C[C@](C)([C@@](CC4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 OIGNJSKKLXVSLS-VWUMJDOOSA-N 0.000 claims 1
- 208000003782 Raynaud Disease Diseases 0.000 claims 1
- 206010037912 Raynaud's phenomenon Diseases 0.000 claims 1
- 206010039073 Rheumatoid arthritis Diseases 0.000 claims 1
- 206010039710 Scleroderma Diseases 0.000 claims 1
- 206010040767 Sjogren's syndrome Diseases 0.000 claims 1
- 101710030909 TNFRSF13B Proteins 0.000 claims 1
- 102100009744 TNFRSF13B Human genes 0.000 claims 1
- 125000000539 amino acid group Chemical group 0.000 claims 1
- UIIMBOGNXHQVGW-UHFFFAOYSA-M buffer Substances [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims 1
- 239000006172 buffering agent Substances 0.000 claims 1
- 201000001981 dermatomyositis Diseases 0.000 claims 1
- 229960000890 hydrocortisone Drugs 0.000 claims 1
- 230000006303 immediate early viral mRNA transcription Effects 0.000 claims 1
- 238000000338 in vitro Methods 0.000 claims 1
- 238000009533 lab test Methods 0.000 claims 1
- 229960004584 methylprednisolone Drugs 0.000 claims 1
- 229960005205 prednisolone Drugs 0.000 claims 1
- 108020003175 receptors Proteins 0.000 claims 1
- 102000005962 receptors Human genes 0.000 claims 1
- 201000010874 syndrome Diseases 0.000 claims 1
Claims (32)
- ニュートロカイン−アルファのアンタゴニストを含む、患者の血漿または血清において、ANA力価≧1:80または30IU/mL以上の抗dsDNA抗体を有する患者を治療することに使用するための組成物であって、該アンタゴニストが治療有効量で投与される、組成物。
- 患者の血漿または血清において、ANA力価≧1:80または30IU/mL以上の抗dsDNA抗体を有する患者を治療するための組成物の調製のためのニュートロカイン−アルファのアンタゴニストの使用であって、該アンタゴニストが治療有効量で投与される、使用。
- 前記患者が自己免疫疾患を有する、請求項1記載の組成物または請求項2記載の使用。
- 前記自己免疫疾患が全身エリテマトーデス(SLE)である、請求項3記載の組成物または使用。
- 前記自己免疫疾患が慢性関節リウマチ、シェーグレン症候群、強皮症、多発性筋炎、皮膚筋炎、フェルティ症候群、混合性結合組織病、レイノー症候群、または若年性慢性関節炎である請求項3記載の組成物または使用。
- 前記ニュートロカイン−アルファのアンタゴニストが抗ニュートロカイン−アルファ抗体である、請求項1〜5のいずれか1項記載の組成物または使用。
- 前記抗体が:
(a)配列番号13のVHドメインおよびVLドメイン;
(b)配列番号14のVHドメインおよびVLドメイン;
(c)配列番号15のVHドメインおよびVLドメイン;
(d)配列番号16のVHドメインおよびVLドメイン;
(e)配列番号17のVHドメインおよびVLドメイン;
(f)配列番号18のVHドメインおよびVLドメイン;
(g)配列番号19のVHドメインおよび配列番号20のVLドメイン;ならびに
(h)配列番号21のVHドメイン、および配列番号22のVLドメイン;
からなる群より選択されるVHドメインおよびVLドメインの組のアミノ酸配列を含む、請求項6記載の組成物または使用。 - ニュートロカイン−アルファのアンタゴニストを含む、全身エリテマトーデスを有する患者を治療することに使用するための組成物であって、ここで、該アンタゴニストは、患者が、該患者の血漿または血清において、ANA力価≧1:80または30IU/mL以上の抗dsDNA抗体を有するという決定が行われた後に、治療有効量で該患者に投与される、組成物。
- 全身エリテマトーデスを有する患者を治療するための組成物の調製のためのニュートロカイン−アルファのアンタゴニストの使用であって、ここで、該アンタゴニストは、患者が、該患者の血漿または血清において、ANA力価≧1:80または30IU/mL以上の抗dsDNA抗体を有するという決定が行われた後に、治療有効量で該患者に投与される、使用。
- 前記ニュートロカイン−アルファのアンタゴニストが、抗CD20抗体と組み合わされて投与される、請求項1〜9のいずれか1項記載の組成物または使用。
- 前記ニュートロカイン−アルファのアンタゴニストは、前記患者が該患者の血漿または血清において、ANA力価≧1:80または30IU/mL以上の抗dsDNA抗体を有するという決定が行われた後に投与される、請求項1〜7および10のいずれか1項記載の組成物または使用。
- 前記ニュートロカイン−アルファのアンタゴニストは、前記患者が:
(a)SELENA SLEDAIスコア≧6;
(b)該患者の血漿または血清における低下したレベルのC3補体因子;
(c)該患者の血漿または血清における低下したレベルのC4補体因子;
(d)該患者が7.5ミリグラム/日以上のプレドニゾンを受容している;および
(e)該患者が、狼瘡関連症状の治療のために、免疫抑制療法を受容している、または以前に受容したことがある;
からなる群より選択される少なくとも1つの特徴を有するという決定が行われた後に投与される、請求項8記載の組成物または請求項9記載の使用。 - ニュートロカイン−アルファのアンタゴニストを含む、全身エリテマトーデスを有する患者に投与されるコルチコステロイドの頻度または量を低下させることに使用するための組成物であって、該アンタゴニストは、治療有効量で該患者に投与される、組成物。
- 全身エリテマトーデスを有する患者に投与されるコルチコステロイドの頻度または量を低下させるための組成物の調製のためのニュートロカイン−アルファのアンタゴニストの使用であって、該アンタゴニストは、治療有効量で該患者に投与される、使用。
- 前記ニュートロカイン−アルファのアンタゴニストは、前記患者が:
(a)ANA力価≧1:80;
(b)該患者の血漿または血清における30IU/mL以上の抗dsDNA抗体;
(c)SELENA SLEDAIスコア≧6;
(d)該患者の血漿または血清における低下したレベルのC3補体因子;
(e)該患者の血漿または血清における低下したレベルのC4補体因子;
(f)該患者が7.5ミリグラム/日以上のプレドニゾンを受容している;および
(g)該患者が、狼瘡関連症状の治療のために免疫抑制療法を受容しているか、または以前に受容したことがある;
からなる群より選択される少なくとも1つの特徴を有するという決定が行われた後に投与される、請求項13記載の組成物または請求項14記載の使用。 - 狼瘡の患者が、医療処置に応答するか否かを決定することを補助するインビトロでの方法であって、該方法は、
(a)医療処置の実施に先立って、該患者のSELENA SLEDAI、BILAGおよびPGAスコアを決定すること;
(b)該医療処置の実施に続いて、該患者のSELENA SLEDAI、BILAGおよびPGAスコアを決定すること;
を含み、ここで、工程(c)で決定されたSELENA SLEDAIスコアが工程(a)において決定されたSELENA SLEDAIスコアより4ポイント以上低く、工程(c)において決定されたBILAG指標スコアが、工程(a)で決定されたBILAGスコアと比較して、新しいBILAG A器官ドメインスコア、または2つの新しいBILAG B器官ドメインスコアを含まず、および工程(c)で決定されたPGAスコアが工程(a)で決定されたPGAスコアから0.3ポイント以上高くはない場合、該患者は医療処置に応答したと考えられる、方法。 - 前記医療処置がニュートロカイン−アルファのアンタゴニストを含む医薬組成物である、請求項16記載の方法。
- 前記患者が、該患者の血漿または血清において、ANA力価≧1:80および30IU/mL以上の抗dsDNA抗体を有する、請求項1〜15のいずれか1項記載の組成物または使用。
- 前記ニュートロカイン−アルファのアンタゴニストは、前記患者が、該患者の血漿または血清において90ミリグラム/デシリットル未満のC3補体因子を有するという決定が行われた後に投与される、請求項8、9、13、14および15のいずれか1項記載の組成物または使用。
- 前記ニュートロカイン−アルファのアンタゴニストは、前記患者が、該患者の血漿または血清において16ミリグラム/デシリットル未満のC4補体因子を有するという決定が行われた後に投与される、請求項8、9、13、14および15のいずれか1項記載の組成物または使用。
- 前記決定が前記患者の医療記録に基づいて、または実験室テストに基づいてなされる、請求項8、9、11および15のいずれか1項記載の組成物または使用。
- 前記アンタゴニストが、TACIのニュートロカイン−アルファ結合ドメイン(配列番号6)、BCMAのニュートロカイン−アルファ結合ドメイン(配列番号8)、BAFF−Rのニュートロカイン−アルファ結合ドメイン(配列番号10)、または配列番号26のアミノ酸残基2〜70のアミノ酸配列を有するBAFF−Rニュートロカイン−アルファ結合ドメインの変異体を含むタンパク質である、請求項1、2、8、9、13、14および17のいずれか1項記載の組成物または使用。
- 前記アンタゴニストがニュートロカイン−アルファ結合ペプチド、ペプチボディ、ニュートロカイン−アルファタンパク質変異体、または抗ニュートロカイン−アルファ受容体抗体である、請求項1、2、8、9、13、14および17のいずれか1項記載の組成物または使用。
- 前記アンタゴニストが抗ニュートロカイン−アルファ抗体である、請求項8、9、13、14および17のいずれか1項記載の組成物または使用。
- 前記ニュートロカイン−アルファタンパク質変異体がドミナントネガティブとして作用する、請求項23記載の組成物または使用。
- 前記コルチコステロイドがプレドニゾン、プレドニゾロン、ヒドロコルチゾン、メチルプレドニゾロンおよびデキサメタゾンからなる群より選択される、請求項13または14記載の組成物または使用。
- 患者に投与されるプレドニゾンの量が、少なくとも25%ないし7.5ミリグラム/日以下低下する請求項26記載の組成物または使用。
- 約5.5〜約6.5のpHを持ち、治療有効量の抗体、約5mM〜約50mMの量の緩衝剤、約150mM〜約500mMの量のNaCl、約0.003%〜約0.05%の量の界面活性剤を含む水性医薬製剤。
- 前記抗体がヒトIgG1/λ抗体であり、前記緩衝剤が10mMヒスチジンであり、前記界面活性剤が0.01%w/vの量のポリソルベート80であり、前記NaClが150mMであって、前記製剤が6.0のpHを有する、請求項28記載の製剤。
- 約2〜8℃の温度において少なくとも1年間または少なくとも2年間安定である、請求項29記載の製剤。
- 前記抗体が100mg/mlの量で存在する、請求項29記載の製剤。
- 100mg/mlのIgG1/λ抗体、0.74mg/mlのL−ヒスチジン、1.1mg/mlのL−ヒスチジン一塩酸塩、8.8mg/mlのNaClおよび0.1mg/mlのポリソルベート80を含み、前記製剤が6.0のpHを有する、請求項28記載の水性医薬製剤。
Applications Claiming Priority (53)
Application Number | Priority Date | Filing Date | Title |
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US72562805P | 2005-10-13 | 2005-10-13 | |
US72562505P | 2005-10-13 | 2005-10-13 | |
US72562705P | 2005-10-13 | 2005-10-13 | |
US72562605P | 2005-10-13 | 2005-10-13 | |
US72562905P | 2005-10-13 | 2005-10-13 | |
US60/725,629 | 2005-10-13 | ||
US60/725,626 | 2005-10-13 | ||
US60/725,627 | 2005-10-13 | ||
US60/725,628 | 2005-10-13 | ||
US60/725,625 | 2005-10-13 | ||
US73596405P | 2005-11-14 | 2005-11-14 | |
US73598805P | 2005-11-14 | 2005-11-14 | |
US73598705P | 2005-11-14 | 2005-11-14 | |
US73596705P | 2005-11-14 | 2005-11-14 | |
US73596305P | 2005-11-14 | 2005-11-14 | |
US60/735,988 | 2005-11-14 | ||
US60/735,963 | 2005-11-14 | ||
US60/735,964 | 2005-11-14 | ||
US60/735,987 | 2005-11-14 | ||
US60/735,967 | 2005-11-14 | ||
US77665906P | 2006-02-27 | 2006-02-27 | |
US77666406P | 2006-02-27 | 2006-02-27 | |
US77665806P | 2006-02-27 | 2006-02-27 | |
US77666006P | 2006-02-27 | 2006-02-27 | |
US77666506P | 2006-02-27 | 2006-02-27 | |
US60/776,658 | 2006-02-27 | ||
US60/776,665 | 2006-02-27 | ||
US60/776,664 | 2006-02-27 | ||
US60/776,660 | 2006-02-27 | ||
US60/776,659 | 2006-02-27 | ||
US78138706P | 2006-03-13 | 2006-03-13 | |
US60/781,387 | 2006-03-13 | ||
US78755706P | 2006-03-31 | 2006-03-31 | |
US60/787,557 | 2006-03-31 | ||
US79736006P | 2006-05-04 | 2006-05-04 | |
US79735106P | 2006-05-04 | 2006-05-04 | |
US60/797,351 | 2006-05-04 | ||
US60/797,360 | 2006-05-04 | ||
US81486906P | 2006-06-20 | 2006-06-20 | |
US81487006P | 2006-06-20 | 2006-06-20 | |
US60/814,870 | 2006-06-20 | ||
US60/814,869 | 2006-06-20 | ||
US81555906P | 2006-06-22 | 2006-06-22 | |
US81555806P | 2006-06-22 | 2006-06-22 | |
US60/815,558 | 2006-06-22 | ||
US60/815,559 | 2006-06-22 | ||
US81582706P | 2006-06-23 | 2006-06-23 | |
US60/815,827 | 2006-06-23 | ||
US83415206P | 2006-07-31 | 2006-07-31 | |
US83415006P | 2006-07-31 | 2006-07-31 | |
US60/834,150 | 2006-07-31 | ||
US60/834,152 | 2006-07-31 | ||
PCT/US2006/038756 WO2007142667A2 (en) | 2005-10-13 | 2006-10-05 | Treatment of patients with autoantibody positive disease |
Related Child Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2012253135A Division JP5936994B2 (ja) | 2005-10-13 | 2012-11-19 | 自己抗体陽性疾患を有する患者の処置に使用するための方法および組成物 |
JP2012253134A Division JP2013040207A (ja) | 2005-10-13 | 2012-11-19 | 自己抗体陽性疾患を有する患者の処置に使用するための方法および組成物 |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2009521398A JP2009521398A (ja) | 2009-06-04 |
JP2009521398A5 true JP2009521398A5 (ja) | 2009-11-26 |
JP5905184B2 JP5905184B2 (ja) | 2016-04-20 |
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Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
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JP2008535568A Active JP5905184B2 (ja) | 2005-10-13 | 2006-10-05 | 自己抗体陽性疾患を有する患者の処置に使用するための方法および組成物 |
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-
2006
- 2006-10-05 KR KR1020147011916A patent/KR20140077946A/ko not_active Application Discontinuation
- 2006-10-05 WO PCT/US2006/038756 patent/WO2007142667A2/en active Application Filing
- 2006-10-05 EA EA200801071A patent/EA015860B1/ru unknown
- 2006-10-05 AU AU2006344395A patent/AU2006344395B2/en active Active
- 2006-10-05 JP JP2008535568A patent/JP5905184B2/ja active Active
- 2006-10-05 EP EP15190050.3A patent/EP3037544A1/en not_active Withdrawn
- 2006-10-05 NZ NZ597082A patent/NZ597082A/xx unknown
- 2006-10-05 NZ NZ568204A patent/NZ568204A/en not_active IP Right Cessation
- 2006-10-05 US US11/543,024 patent/US20070086979A1/en not_active Abandoned
- 2006-10-05 CA CA2626082A patent/CA2626082C/en active Active
- 2006-10-05 EP EP06851283A patent/EP1933873A4/en not_active Withdrawn
- 2006-10-05 KR KR1020087011124A patent/KR20080074120A/ko not_active Application Discontinuation
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2008
- 2008-04-08 IL IL190733A patent/IL190733A0/en unknown
- 2008-04-16 NO NO20081842A patent/NO20081842L/no not_active Application Discontinuation
- 2008-08-05 US US12/186,404 patent/US20090081213A1/en not_active Abandoned
- 2008-08-27 HK HK16110651.1A patent/HK1222681A1/zh unknown
- 2008-11-21 US US12/275,804 patent/US20090081231A1/en not_active Abandoned
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2012
- 2012-01-19 IL IL217632A patent/IL217632A/en active IP Right Grant
- 2012-11-19 JP JP2012253135A patent/JP5936994B2/ja active Active
- 2012-11-19 JP JP2012253134A patent/JP2013040207A/ja active Pending
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