JPWO2020245766A5 - - Google Patents
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- JPWO2020245766A5 JPWO2020245766A5 JP2021571955A JP2021571955A JPWO2020245766A5 JP WO2020245766 A5 JPWO2020245766 A5 JP WO2020245766A5 JP 2021571955 A JP2021571955 A JP 2021571955A JP 2021571955 A JP2021571955 A JP 2021571955A JP WO2020245766 A5 JPWO2020245766 A5 JP WO2020245766A5
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以下の態様を包含し得る。
［１］ 治療を必要とする対象における乾癬性関節炎を治療する方法であって、前記対象に約５０ｍｇ～約１５０ｍｇの抗ＩＬ－２３抗体を皮下投与することを含み、前記抗体が重鎖可変領域及び軽鎖可変領域を含み、前記重鎖可変領域が、配列番号１の相補性決定領域重鎖１（ＣＤＲＨ１）アミノ酸配列、配列番号２のＣＤＲＨ２、及び配列番号３のＣＤＲＨ３を含み、前記軽鎖可変領域が、配列番号４の相補性決定領域軽鎖１（ＣＤＲＬ１）アミノ酸配列、配列番号５のＣＤＲＬ２、及び配列番号６のＣＤＲＬ３を含み、前記対象が前記治療後に米国リウマチ学会コアセット疾患指数の少なくとも２０％の改善（ＡＣＲ２０）を達成する、方法。
［２］ 前記抗体が、配列番号７のアミノ酸配列の重鎖可変領域と、配列番号８のアミノ酸配列の軽鎖可変領域と、を含む、上記［１］に記載の方法。
［３］ 前記抗体が、配列番号９の重鎖アミノ酸配列と、配列番号１０の軽鎖アミノ酸配列と、を含む、上記［１］に記載の方法。
［４］ 前記抗体が投与当たり約１００ｍｇの用量で投与される、上記［１］に記載の方法。
［５］ 前記抗体が、４週間毎に１回投与される（ｑ４ｗ）、上記［４］に記載の方法。
［６］ ＡＣＲ２０が約２４週間の治療期間の後に達成される、上記［１］に記載の方法。
［７］ ＡＣＲ２０が約５２週間の治療期間の後に達成される、上記［１］に記載の方法。
［８］ 前記治療後、前記対象が、米国リウマチ学会コアセット疾患指数の５０％の改善（ＡＣＲ５０）、米国リウマチ学会コアセット疾患指数の７０％の改善（ＡＣＲ７０）、健康評価質問票障害指数（ＨＡＱ－ＤＩ）、治験責任者によるグローバル評価（ＩＧＡ）、疾病活動性スコア２８（ＤＡＳ２８）Ｃ反応性タンパク質（ＣＲＰ）、腱付着部炎の解消、指炎の解消、リーズ腱付着部炎指数（ＬＥＩ）、指炎評価スコア、精神的及び身体的コンポーネントサマリー（ＭＣＳ及びＰＣＳ）におけるショートフォーム健康調査（ＳＦ－３６）、最小疾患活動性（ＭＤＡ）の達成、非常に低い疾患活動性（ＶＬＤＡ）、バス強直性脊椎炎活動性指数（ＢＡＳＤＡＩ）、ＧＲＡｐｐａ複合スコア（ＧＲＡＣＥ）、乾癬性関節炎疾患活動性スコア（ＰＡＳＤＡＳ）、修正複合乾癬疾患活動性指数（ｍＣＰＤＡＩ）、乾癬の面積及び重症度指数（ＰＡＳＩ）、皮膚のライフクォリティ指数（ＤＬＱＩ）、慢性疾患治療の機能評価（ＦＡＣＩＴ）、患者報告アウトカム測定情報システム－２９（ＰＲＯＭＩＳ－２９）、及びｖｄＨ－Ｓスコアからなる群から選択される少なくとも１つの基準によって決定される疾患活動性の改善を更に達成する、上記［１］に記載の方法。
［９］ 前記対象が、前記治療後に、米国リウマチ学会コアセット疾患指数の少なくとも５０％の改善（ＡＣＲ５０）を更に達成する、上記［８］に記載の方法。
［１０］ 前記対象が、少なくとも約２４週間の治療期間の後に、健康評価質問票障害指数（ＨＡＱ－ＤＩ）の改善を更に達成する、上記［８］に記載の方法。
［１１］ 前記対象が、少なくとも約２４週間の治療期間後に、疾患活動性スコア２８（ＤＡＳ２８）Ｃ反応性タンパク質（ＣＲＰ）の改善を更に達成する、上記［８］に記載の方法。
［１２］ 前記対象が、少なくとも約２４週間の治療期間後に、治験責任者によるグローバル評価（ＩＧＡ）の０（クリア）若しくは１（最小）、又は２以上のグレード低下を前記ＩＧＡにおいて更に達成し、前記対象が、３％以上の体表面積 （ＢＳＡ）の乾癬性病変を有し、前記治療前のベースラインで２以上のＩＧＡスコアを示す、上記［８］に記載の方法。
［１３］ 前記対象が、前記ＰｓＡの標準的治療に対して不十分な応答を有し、任意選択的に、前記対象が、前記治療中に前記標準的治療も受ける、上記［１］に記載の方法。
［１４］ 治療を必要とする対象における乾癬性関節炎を治療する方法であって、０週目に１回、４週目に１回、及びその後８週毎に１回（ｑ８ｗ）、前記対象に約５０ｍｇ～１５０ｍｇの抗ＩＬ－２３抗体を皮下投与することを含み、前記抗体が重鎖可変領域及び軽鎖可変領域を含み、前記重鎖可変領域が、配列番号１の相補性決定領域重鎖１（ＣＤＲＨ１）アミノ酸配列、配列番号２のＣＤＲＨ２、及び配列番号３のＣＤＲＨ３を含み、前記軽鎖可変領域が、配列番号４の相補性決定領域軽鎖１（ＣＤＲＬ１）アミノ酸配列、配列番号５のＣＤＲＬ２、及び配列番号６のＣＤＲＬ３を含み、前記対象が、前記治療前に、直径≧２ｃｍの少なくとも１つの乾癬性プラーク、又は乾癬と一致する爪の変化、又はプラーク乾癬の文書化された病歴を有し、前記対象が、米国リウマチ学会コアセット疾患指数の少なくとも２０％の改善（ＡＣＲ２０）を達成する、方法。
［１５］ 前記抗体が、配列番号７のアミノ酸配列の重鎖可変領域と、配列番号８のアミノ酸配列の軽鎖可変領域と、を含む、上記［１４］に記載の方法。
［１６］ 前記抗体が、配列番号９の重鎖アミノ酸配列と、配列番号１０の軽鎖アミノ酸配列と、を含む、上記［１５］に記載の方法。
［１７］ 前記抗体が投与当たり約１００ｍｇの用量で投与される、上記［１４］に記載の方法。
［１８］ ＡＣＲ２０が約２４週間の治療期間の後に達成される、上記［１７］に記載の方法。
［１９］ ＡＣＲ２０が約５２週間の治療期間の後に達成される、上記［１８］に記載の方法。
［２０］ 前記治療後、前記対象が、米国リウマチ学会コアセット疾患指数の５０％の改善（ＡＣＲ５０）、米国リウマチ学会コアセット疾患指数の７０％の改善（ＡＣＲ７０）、健康評価質問票障害指数（ＨＡＱ－ＤＩ）、治験責任者によるグローバル評価（ＩＧＡ）、疾病活動性スコア２８（ＤＡＳ２８）Ｃ反応性タンパク質（ＣＲＰ）、腱付着部炎の解消、指炎の解消、リーズ腱付着部炎指数（ＬＥＩ）、指炎評価スコア、精神的及び身体的コンポーネントサマリー（ＭＣＳ及びＰＣＳ）におけるショートフォーム健康調査（ＳＦ－３６）、最小疾患活動性（ＭＤＡ）の達成、非常に低い疾患活動性（ＶＬＤＡ）、バス強直性脊椎炎活動性指数（ＢＡＳＤＡＩ）、ＧＲＡｐｐａ複合スコア（ＧＲＡＣＥ）、乾癬性関節炎疾患活動性スコア（ＰＡＳＤＡＳ）、修正複合乾癬疾患活動性指数（ｍＣＰＤＡＩ）、乾癬の面積及び重症度指数（ＰＡＳＩ）、皮膚のライフクォリティ指数（ＤＬＱＩ）、慢性疾患治療の機能評価（ＦＡＣＩＴ）、患者報告アウトカム測定情報システム－２９（ＰＲＯＭＩＳ－２９）、及びｖｄＨ－Ｓスコアからなる群から選択される少なくとも１つの基準によって決定される疾患活動性の改善を更に達成する、上記［１９］に記載の方法。
［２１］ 前記対象が、前記治療後に、米国リウマチ学会コアセット疾患指数の少なくとも５０％の改善（ＡＣＲ５０）を更に達成する、上記［２０］に記載の方法。
［２２］ 前記対象が、少なくとも約２４週間の治療期間の後に、健康評価質問票障害指数（ＨＡＱ－ＤＩ）の改善を更に達成する、上記［２０］に記載の方法。
［２３］ 前記対象が、少なくとも約２４週間の治療期間後に、疾患活動性スコア２８（ＤＡＳ２８）Ｃ反応性タンパク質（ＣＲＰ）の改善を更に達成する、上記［２０］に記載の方法。
［２４］ 前記対象が、少なくとも約２４週間の治療期間後に、治験責任者によるグローバル評価（ＩＧＡ）の０（クリア）若しくは１（最小）、又は２以上のグレード低下を前記ＩＧＡにおいて更に達成し、前記対象が、３％以上の体表面積（ＢＳＡ）の乾癬性病変を有し、前記治療前のベースラインで２以上のＩＧＡスコアを示す、上記［２０］に記載の方法。
［２５］ 前記対象が、前記ＰｓＡの標準的治療に対して不十分な応答を示した、上記［１］に記載の方法。
［２６］ 前記対象が、前記治療中に前記標準的治療も行われる、上記［２５］に記載の方法。
The following aspects may be included.
[1] A method of treating psoriatic arthritis in a subject in need thereof, comprising subcutaneously administering to said subject from about 50 mg to about 150 mg of an anti-IL-23 antibody, said antibody comprising a heavy chain variable region and a light chain variable region, said heavy chain variable region comprising the complementarity determining region heavy chain 1 (CDRH1) amino acid sequence of SEQ ID NO: 1, CDRH2 of SEQ ID NO: 2, and CDRH3 of SEQ ID NO: 3, wherein said light chain wherein the variable region comprises the complementarity determining region light chain 1 (CDRL1) amino acid sequence of SEQ ID NO: 4, CDRL2 of SEQ ID NO: 5, and CDRL3 of SEQ ID NO: 6, and wherein said subject has a score of the American College of Rheumatology Core Set Disease Index after said treatment; A method that achieves at least a 20% improvement (ACR20).
[2] The method of [1] above, wherein the antibody comprises a heavy chain variable region having the amino acid sequence of SEQ ID NO:7 and a light chain variable region having the amino acid sequence of SEQ ID NO:8.
[3] The method of [1] above, wherein the antibody comprises the heavy chain amino acid sequence of SEQ ID NO:9 and the light chain amino acid sequence of SEQ ID NO:10.
[4] The method of [1] above, wherein the antibody is administered at a dose of about 100 mg per administration.
[5] The method of [4] above, wherein the antibody is administered once every four weeks (q4w).
[6] The method of [1] above, wherein ACR20 is achieved after a treatment period of about 24 weeks.
[7] The method of [1] above, wherein ACR20 is achieved after a treatment period of about 52 weeks.
[8] After said treatment, said subject achieved a 50% improvement in the American College of Rheumatology Core Set Disease Index (ACR50), a 70% improvement in the American College of Rheumatology Core Set Disease Index (ACR70), a Health Assessment Questionnaire Disability Index ( HAQ-DI), Investigator Global Assessment (IGA), Disease Activity Score 28 (DAS28) C-reactive protein (CRP), enthesitis resolution, dactylitis resolution, Leeds enthesitis index ( LEI), Dactylitis Assessment Score, Short Form Health Survey (SF-36) in Mental and Physical Component Summary (MCS and PCS), Achievement of Minimal Disease Activity (MDA), Very Low Disease Activity (VLDA) , Bass Ankylosing Spondylitis Activity Index (BASDAI), GRAppa Composite Score (GRACE), Psoriatic Arthritis Disease Activity Score (PASDAS), Modified Combined Psoriasis Disease Activity Index (mCPDAI), Psoriasis Area and Severity Index ( PASI), Skin Life Quality Index (DLQI), Functional Assessment of Chronic Disease Treatment (FACIT), Patient Reported Outcome Measurement Information System-29 (PROMIS-29), and vdH-S score. The method of [1] above, further achieving improvement in disease activity as determined by two criteria.
[9] The method of [8] above, wherein said subject further achieves at least a 50% improvement in the American College of Rheumatology Core Set Disease Index (ACR50) after said treatment.
[10] The method of [8] above, wherein the subject further achieves improvement in the Health Assessment Questionnaire Disability Index (HAQ-DI) after a treatment period of at least about 24 weeks.
[11] The method of [8] above, wherein the subject further achieves an improvement in Disease Activity Score 28 (DAS28) C-reactive protein (CRP) after a treatment period of at least about 24 weeks.
[12] said subject further achieves an investigator's global assessment (IGA) of 0 (clear) or 1 (minimum), or a grade reduction of 2 or more in said IGA after a treatment period of at least about 24 weeks; The method of [8] above, wherein said subject has psoriatic lesions of 3% body surface area (BSA) or greater and exhibits an IGA score of 2 or greater at baseline prior to said treatment.
[13] The above [1], wherein said subject has an inadequate response to said standard therapy for PsA, and optionally said subject also receives said standard therapy during said treatment. the method of.
[14] A method of treating psoriatic arthritis in a subject in need thereof, comprising administering to said subject once at week 0, once at week 4, and once every eight weeks thereafter (q8w) administering about 50 mg to 150 mg of an anti-IL-23 antibody subcutaneously, said antibody comprising a heavy chain variable region and a light chain variable region, said heavy chain variable region comprising the complementarity determining region heavy chain of SEQ ID NO: 1 1 (CDRH1) amino acid sequence, CDRH2 of SEQ ID NO:2, and CDRH3 of SEQ ID NO:3, wherein said light chain variable region comprises the complementarity determining region light chain 1 (CDRL1) amino acid sequence of SEQ ID NO:4, CDRH3 of SEQ ID NO:5. CDRL2, and CDRL3 of SEQ ID NO: 6, wherein said subject has at least one psoriatic plaque ≧2 cm in diameter, or nail changes consistent with psoriasis, or a documented history of plaque psoriasis prior to said treatment wherein said subject achieves at least a 20% improvement in the American College of Rheumatology Core Set Disease Index (ACR20).
[15] The method of [14] above, wherein the antibody comprises a heavy chain variable region having the amino acid sequence of SEQ ID NO:7 and a light chain variable region having the amino acid sequence of SEQ ID NO:8.
[16] The method of [15] above, wherein the antibody comprises the heavy chain amino acid sequence of SEQ ID NO:9 and the light chain amino acid sequence of SEQ ID NO:10.
[17] The method of [14] above, wherein the antibody is administered at a dose of about 100 mg per administration.
[18] The method of [17] above, wherein ACR20 is achieved after a treatment period of about 24 weeks.
[19] The method of [18] above, wherein ACR20 is achieved after a treatment period of about 52 weeks.
[20] After said treatment, said subject achieved a 50% improvement in the American College of Rheumatology Core Set Disease Index (ACR50), a 70% improvement in the American College of Rheumatology Core Set Disease Index (ACR70), a Health Assessment Questionnaire Disability Index ( HAQ-DI), Investigator Global Assessment (IGA), Disease Activity Score 28 (DAS28) C-reactive protein (CRP), enthesitis resolution, dactylitis resolution, Leeds enthesitis index ( LEI), Dactylitis Assessment Score, Short Form Health Survey (SF-36) in Mental and Physical Component Summary (MCS and PCS), Achievement of Minimal Disease Activity (MDA), Very Low Disease Activity (VLDA) , Bass Ankylosing Spondylitis Activity Index (BASDAI), GRAppa Composite Score (GRACE), Psoriatic Arthritis Disease Activity Score (PASDAS), Modified Combined Psoriasis Disease Activity Index (mCPDAI), Psoriasis Area and Severity Index ( PASI), Skin Life Quality Index (DLQI), Functional Assessment of Chronic Disease Treatment (FACIT), Patient Reported Outcome Measurement Information System-29 (PROMIS-29), and vdH-S score. The method of [19] above, further achieving improvement in disease activity as determined by two criteria.
[21] The method of [20] above, wherein the subject further achieves at least a 50% improvement in the American College of Rheumatology Core Set Disease Index (ACR50) after the treatment.
[22] The method of [20] above, wherein the subject further achieves improvement in the Health Assessment Questionnaire Disability Index (HAQ-DI) after a treatment period of at least about 24 weeks.
[23] The method of [20] above, wherein the subject further achieves an improvement in Disease Activity Score 28 (DAS28) C-reactive protein (CRP) after a treatment period of at least about 24 weeks.
[24] said subject further achieves an investigator's global assessment (IGA) of 0 (clear) or 1 (minimum), or a grade reduction of 2 or more in said IGA after a treatment period of at least about 24 weeks; The method of [20] above, wherein said subject has psoriatic lesions of 3% body surface area (BSA) or greater and exhibits an IGA score of 2 or greater at baseline prior to said treatment.
[25] The method of [1] above, wherein the subject has shown an inadequate response to standard therapy for the PsA.
[26] The method of [25] above, wherein the subject is also undergoing the standard treatment during the treatment.
Claims (26)
前記医薬組成物が抗ＩＬ－２３抗体を含み、
前記方法が、前記対象に約５０ｍｇ～約１５０ｍｇの前記抗ＩＬ－２３抗体を皮下投与することを含み、
前記抗体が重鎖可変領域及び軽鎖可変領域を含み、前記重鎖可変領域が、配列番号１の相補性決定領域重鎖１（ＣＤＲＨ１）アミノ酸配列、配列番号２のＣＤＲＨ２、及び配列番号３のＣＤＲＨ３を含み、前記軽鎖可変領域が、配列番号４の相補性決定領域軽鎖１（ＣＤＲＬ１）アミノ酸配列、配列番号５のＣＤＲＬ２、及び配列番号６のＣＤＲＬ３を含み、
前記対象が前記治療後に米国リウマチ学会コアセット疾患指数の少なくとも２０％の改善（ＡＣＲ２０）を達成する、医薬組成物。 A pharmaceutical composition for use in a method of treating psoriatic arthritis in a subject in need thereof, comprising:
wherein said pharmaceutical composition comprises an anti-IL-23 antibody;
said method comprising subcutaneously administering to said subject about 50 mg to about 150 mg of said anti-IL-23 antibody;
The antibody comprises a heavy chain variable region and a light chain variable region, wherein the heavy chain variable region comprises the complementarity determining region heavy chain 1 (CDRH1) amino acid sequence of SEQ ID NO:1, the CDRH2 of SEQ ID NO:2, and the CDRH3, wherein said light chain variable region comprises the complementarity determining region light chain 1 (CDRL1) amino acid sequence of SEQ ID NO:4, CDRL2 of SEQ ID NO:5, and CDRL3 of SEQ ID NO:6;
A pharmaceutical composition , wherein said subject achieves at least a 20% improvement in the American College of Rheumatology Core Set Disease Index (ACR20) after said treatment.
前記医薬組成物が、抗ＩＬ－２３抗体を含み、
前記方法が、０週目に１回、４週目に１回、及びその後８週毎に１回（ｑ８ｗ）、前記対象に約５０ｍｇ～１５０ｍｇの前記抗ＩＬ－２３抗体を皮下投与することを含み、
前記抗体が重鎖可変領域及び軽鎖可変領域を含み、前記重鎖可変領域が、配列番号１の相補性決定領域重鎖１（ＣＤＲＨ１）アミノ酸配列、配列番号２のＣＤＲＨ２、及び配列番号３のＣＤＲＨ３を含み、前記軽鎖可変領域が、配列番号４の相補性決定領域軽鎖１（ＣＤＲＬ１）アミノ酸配列、配列番号５のＣＤＲＬ２、及び配列番号６のＣＤＲＬ３を含み、
前記対象が、前記治療前に、直径≧２ｃｍの少なくとも１つの乾癬性プラーク、又は乾癬と一致する爪の変化、又はプラーク乾癬の文書化された病歴を有し、
前記対象が、米国リウマチ学会コアセット疾患指数の少なくとも２０％の改善（ＡＣＲ２０）を達成する、医薬組成物。 A pharmaceutical composition for use in a method of treating psoriatic arthritis in a subject in need thereof, comprising:
the pharmaceutical composition comprises an anti-IL-23 antibody;
said method comprising subcutaneously administering to said subject about 50 mg to 150 mg of said anti-IL-23 antibody once at week 0, once at week 4, and once every eight weeks thereafter (q8w). including
The antibody comprises a heavy chain variable region and a light chain variable region, wherein the heavy chain variable region comprises the complementarity determining region heavy chain 1 (CDRH1) amino acid sequence of SEQ ID NO:1, the CDRH2 of SEQ ID NO:2, and the CDRH3, wherein said light chain variable region comprises the complementarity determining region light chain 1 (CDRL1) amino acid sequence of SEQ ID NO:4, CDRL2 of SEQ ID NO:5, and CDRL3 of SEQ ID NO:6;
said subject has at least one psoriatic plaque ≧2 cm in diameter or nail changes consistent with psoriasis or a documented history of plaque psoriasis prior to said treatment;
A pharmaceutical composition , wherein said subject achieves at least a 20% improvement in the American College of Rheumatology Core Set Disease Index (ACR20).
26. The pharmaceutical composition of claim 25, wherein said subject is also receiving said standard of care during said treatment.
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| ES2729603T3 (en) * | 2012-06-27 | 2019-11-05 | Merck Sharp & Dohme | IL-23 anti-human crystalline antibodies |
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| US11208474B2 (en) * | 2016-11-16 | 2021-12-28 | Janssen Biotech, Inc. | Method of treating psoriasis with anti-IL23 specific antibody |
| WO2019090329A1 (en) * | 2017-11-06 | 2019-05-09 | Janssen Biotech, Inc. | Safe and effective method of treating psoriatic arthritis with anti-il23 specific antibody |
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| CN117337302A (en) * | 2021-03-12 | 2024-01-02 | 詹森生物科技公司 | Methods of treating psoriatic arthritis patients with inadequate response to TNF therapy with anti-IL 23 specific antibodies |
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