JPWO2020188466A5 - - Google Patents
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当業者は、広い発明概念から逸脱することなく前述の実施形態に変更を行うことができることを理解するであろう。したがって、本発明は、開示された特定の実施形態に限定されるものではなく、具体的な説明によって定義された本発明の精神と範囲内の変更をカバーすることが意図されていることが理解される。
以下の態様を包含し得る。
[1] それを必要とする小児患者の乾癬を治療する方法であって、安全かつ有効な量の抗IL-12/IL-23p40抗体を含む医薬組成物を前記小児患者に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アミノ酸配列、及び配列番号3のCDRH3アミノ酸配列を含み、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アミノ酸配列、及び配列番号6のCDRL3アミノ酸配列を含み、前記小児患者が、少なくとも6歳かつ12歳未満であり、治療後に0又は1の医師総合評価(PGA)スコアを有すると識別され、及び/又は乾癬面積及び重症度指数スコア(PASI)が少なくとも75%、90%又は100%減少したと識別されることによる、前記抗IL-12/IL-23p40抗体による治療に対する応答者である、方法。
[2] 前記抗体が、前記小児患者に皮下投与される、請求項1に記載の方法。
[3] 前記小児患者が、前記投与時に60kg未満の体重を有し、前記抗IL-12/IL-23p40抗体が、投与当たり、前記小児患者の体重に対して、約0.5mg/kg~1.0mg/kg、好ましくは0.75mg/kgの前記安全かつ有効な量で前記患者に皮下投与される、請求項2に記載の方法。
[4] 前記小児患者が、前記投与時に60kg~100kgの体重を有し、前記抗IL-12/IL-23p40抗体が、投与当たり、約35mg~55mgの前記安全かつ有効な量で、前記患者に皮下投与される、請求項2に記載の方法。
[5] 前記抗IL-12/IL-23p40抗体が、投与当たり、45mgで投与される、請求項4に記載の方法。
[6] 前記小児患者が、前記投与時に100kgを超える体重を有し、前記抗IL-12/IL-23p40抗体が、投与当たり、約80mg~100mgの前記安全かつ有効な量で、前記患者に皮下投与される、請求項2に記載の方法。
[7] 前記抗IL-12/IL-23p40抗体が、投与当たり、90mgで投与される、請求項6に記載の方法。
[8] 前記抗体が、配列番号7のアミノ酸配列を有する重鎖可変領域と、配列番号8のアミノ酸配列を有する軽鎖可変領域と、を含む、請求項1に記載の方法。
[9] 前記抗体が、配列番号10のアミノ酸配列を有する重鎖と、配列番号11のアミノ酸配列を有する軽鎖と、を含む、請求項1に記載の方法。
[10] 前記安全かつ有効な量の前記抗IL-12/IL-23p40抗体が、前記小児患者に繰り返し投与される、請求項1に記載の方法。
[11] 前記安全かつ有効な量の前記抗IL-12/IL-23p40抗体が、前記治療の0週目及び4週目に前記小児患者に投与される、請求項1に記載の方法。
[12] 前記安全かつ有効な量の前記抗IL-12/IL-23p40抗体が、4週目後12週毎に、前記小児患者に更に投与される、請求項11に記載の方法。
[13] 前記小児患者が、乾癬薬又は乾癬治療にナイーブである、請求項1に記載の方法。
[14] 前記小児患者が、局所剤、光線療法、非生物学的全身性薬剤、及び生物学的薬剤からなる群から選択される少なくとも1つの乾癬薬又は乾癬治療を受けたことがある、請求項1に記載の方法。
[15] 前記小児患者が、前記少なくとも1つの乾癬薬又は乾癬治療に応答性がないか、又は応答性が悪い、請求項14に記載の方法。
[16] 前記小児患者が、局所剤に応答性がないか、又は応答性が悪い、請求項15に記載の方法。
[17] 前記小児患者が、前記抗IL-12/IL-23p40抗体による前記治療に対する応答者であり、前記治療の52週目、28週目又は12週目までに0又は1の医師総合評価(PGA)スコアを有すると識別される、請求項1に記載の方法。
[18] 前記小児患者が、前記抗IL-12/IL-23p40抗体による前記治療に対する応答者であり、前記治療の52週目、28週目、又は12週目までに前記乾癬面積及び重症度指数スコア(PASI)が少なくとも75%、90%、又は100%減少していると識別される、請求項1に記載の方法。
[19] 前記小児患者が、前記抗IL-12/IL-23p40抗体による前記治療に対する応答者であり、前記治療の12週目までに小児の皮膚科的生活の質指数(CDLQI)のベースラインからの変化を有すると識別される、請求項1に記載の方法。
[20] 前記小児患者が、前記抗IL-12/IL-23p40抗体の定常状態のトラフ血清濃度を有し、前記定常状態のトラフ血清濃度が、前記治療の52週目、40週目、又は28週目までに達成される、請求項1に記載の方法。
[21] 前記定常状態のトラフ血清濃度が、前記治療の52週目まで維持される、請求項20に記載の方法。
[22] 前記抗IL-12/23p40抗体が、ウステキヌマブである、請求項1に記載の方法。
[23] 前記治療される乾癬が、中程度から重度の慢性プラーク乾癬である、請求項1に記載の方法。
[24] 前記治療される乾癬が、少なくとも3の医師総合評価(PGA)スコア、少なくとも12の乾癬面積及び重症度指数スコア(PASI)、及び/又は少なくとも10%の影響を受けた体表面積(BSA)のパーセント、によって定義される重度の慢性プラーク乾癬である、請求項23に記載の方法。
[25] 小児患者の重度の慢性プラーク乾癬を治療する方法であって、前記重度の慢性プラーク乾癬が、少なくとも3の医師総合評価(PGA)スコア、少なくとも12の乾癬面積及び重症度指数スコア(PASI)、及び/又は少なくとも10%の影響を受けた体表面積(BSA)のパーセントによって定義され、前記方法が、前記小児患者に、安全かつ有効な量の抗IL-12/IL-23p40抗体を皮下投与することを含み、前記抗体が、(i)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アミノ酸配列、及び配列番号3のCDRH3アミノ酸配列を含む重鎖可変領域、並びに配列番号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アミノ酸配列、及び配列番号6のCDRL3アミノ酸配列を含む軽鎖可変領域、(ii)配列番号7のアミノ酸配列を有する重鎖可変領域、及び配列番号8のアミノ酸配列を有する軽鎖可変領域、又は(iii)配列番号10のアミノ酸配列を有する重鎖、及び配列番号11のアミノ酸配列を有する軽鎖、を含む重鎖可変領域を含み、前記安全かつ有効な量の前記抗IL-12/IL-23p40抗体が、
1)前記小児患者が前記投与時に60kg未満の体重を有する場合、投与当たり、前記小児患者の体重に対し、約0.5mg/kg~1.0mg/kg、好ましくは0.75mg/kg、
2)前記小児患者が前記投与時に60kg~100kgの体重を有する場合、投与当たり、約35mg~55mg、好ましくは約45mg、又は
3)前記小児患者が前記投与時に100kgを超える体重を有する場合、投与当たり、約80mg~100mg、好ましくは90mg、である、
方法。
Those skilled in the art will appreciate that changes can be made to the above-described embodiments without departing from the broad inventive concept. It is therefore understood that the invention is not limited to the particular embodiments disclosed, but is intended to cover modifications within the spirit and scope of the invention defined by the specific description. be done.
The following aspects may be included.
[1] A method of treating psoriasis in a pediatric patient in need thereof comprising administering to said pediatric patient a pharmaceutical composition comprising a safe and effective amount of an anti-IL-12/IL-23p40 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 amino acid sequence of SEQ ID NO: 2, and the sequence 3, wherein said light chain variable region comprises the complementarity determining region light chain 1 (CDRL1) amino acid sequence of SEQ ID NO: 4, the CDRL2 amino acid sequence of SEQ ID NO: 5, and the CDRL3 amino acid sequence of SEQ ID NO: 6. wherein said pediatric patient is at least 6 years old and less than 12 years old, is identified as having a Physician Global Assessment (PGA) score of 0 or 1 after treatment, and/or has a Psoriasis Area and Severity Index score (PASI) is a responder to treatment with said anti-IL-12/IL-23p40 antibody by being identified as being reduced by at least 75%, 90% or 100%.
[2] The method of Claim 1, wherein said antibody is administered subcutaneously to said pediatric patient.
[3] the pediatric patient has a body weight of less than 60 kg at the time of administration, and the anti-IL-12/IL-23p40 antibody is about 0.5 mg/kg to the body weight of the pediatric patient per administration; 3. The method of claim 2, wherein said safe and effective amount of 1.0 mg/kg, preferably 0.75 mg/kg is administered subcutaneously to said patient.
[4] said pediatric patient has a body weight of 60 kg to 100 kg at said administration, and said anti-IL-12/IL-23p40 antibody is administered in said safe and effective amount of about 35 mg to 55 mg per administration; 3. The method of claim 2, wherein the method is administered subcutaneously to
[5] The method of claim 4, wherein said anti-IL-12/IL-23p40 antibody is administered at 45 mg per administration.
[6] said pediatric patient has a body weight greater than 100 kg at said administration, and said anti-IL-12/IL-23p40 antibody is administered to said patient in said safe and effective amount of about 80 mg to 100 mg per administration; 3. The method of claim 2, administered subcutaneously.
[7] The method of claim 6, wherein the anti-IL-12/IL-23p40 antibody is administered at 90 mg per administration.
[8] The method of [1], 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.
[9] The method of Claim 1, wherein the antibody comprises a heavy chain having the amino acid sequence of SEQ ID NO:10 and a light chain having the amino acid sequence of SEQ ID NO:11.
10. The method of claim 1, wherein said safe and effective amount of said anti-IL-12/IL-23p40 antibody is repeatedly administered to said pediatric patient.
11. The method of claim 1, wherein said safe and effective amount of said anti-IL-12/IL-23p40 antibody is administered to said pediatric patient at weeks 0 and 4 of said treatment.
12. The method of claim 11, wherein said safe and effective amount of said anti-IL-12/IL-23p40 antibody is further administered to said pediatric patient every 12 weeks after 4 weeks.
13. The method of claim 1, wherein the pediatric patient is naive to psoriasis drugs or psoriasis treatments.
[14] wherein the pediatric patient has received at least one psoriasis drug or psoriasis treatment selected from the group consisting of topical agents, phototherapy, non-biologic systemic agents, and biological agents; Item 1. The method according to item 1.
15. The method of Claim 14, wherein said pediatric patient is unresponsive or poorly responsive to said at least one psoriasis drug or psoriasis treatment.
[16] The method of Claim 15, wherein the pediatric patient is unresponsive or poorly responsive to topical agents.
[17] said pediatric patient is a responder to said treatment with said anti-IL-12/IL-23p40 antibody and has a Physician Global Rating of 0 or 1 by Week 52, Week 28 or Week 12 of said treatment 2. The method of claim 1, identified as having a (PGA) score.
[18] said pediatric patient is a responder to said treatment with said anti-IL-12/IL-23p40 antibody and said psoriasis area and severity by week 52, week 28, or week 12 of said treatment; 2. The method of claim 1, wherein the index score (PASI) is identified as decreasing by at least 75%, 90%, or 100%.
[19] said pediatric patient is a responder to said treatment with said anti-IL-12/IL-23p40 antibody and has a baseline Pediatric Dermatological Quality of Life Index (CDLQI) by week 12 of said treatment; 2. The method of claim 1, identified as having a variation from .
[20] said pediatric patient has a steady-state trough serum concentration of said anti-IL-12/IL-23p40 antibody, wherein said steady-state trough serum concentration is at week 52, week 40, or of said treatment; 2. The method of claim 1, achieved by week 28.
[21] The method of Claim 20, wherein said steady-state trough serum concentration is maintained up to week 52 of said treatment.
[22] The method of claim 1, wherein the anti-IL-12/23p40 antibody is ustekinumab.
23. The method of claim 1, wherein the psoriasis to be treated is moderate to severe chronic plaque psoriasis.
[24] The treated psoriasis has a Physician Global Assessment (PGA) score of at least 3, a Psoriasis Area and Severity Index (PASI) score of at least 12, and/or body surface area affected (BSA) of at least 10% 24. The method of claim 23, wherein severe chronic plaque psoriasis is defined by the percentage of
[25] A method of treating severe chronic plaque psoriasis in a pediatric patient, wherein said severe chronic plaque psoriasis has a Physician Global Assessment (PGA) score of at least 3, a Psoriasis Area and Severity Index score (PASI) of at least 12 ), and/or by a percent body surface area (BSA) affected of at least 10%, wherein the method includes subcutaneously administering to the pediatric patient a safe and effective amount of an anti-IL-12/IL-23p40 antibody. wherein the antibody comprises (i) a complementarity determining region heavy chain 1 (CDRH1) amino acid sequence of SEQ ID NO:1, a CDRH2 amino acid sequence of SEQ ID NO:2, and a CDRH3 amino acid sequence of SEQ ID NO:3. (ii) a light chain variable region comprising a variable region and a complementarity determining region light chain 1 (CDRL1) amino acid sequence of SEQ ID NO:4, a CDRL2 amino acid sequence of SEQ ID NO:5, and a CDRL3 amino acid sequence of SEQ ID NO:6; and a light chain variable region having the amino acid sequence of SEQ ID NO:8, or (iii) a heavy chain having the amino acid sequence of SEQ ID NO:10 and a light chain having the amino acid sequence of SEQ ID NO:11 wherein said safe and effective amount of said anti-IL-12/IL-23p40 antibody comprises:
1) about 0.5 mg/kg to 1.0 mg/kg, preferably 0.75 mg/kg, of the pediatric patient's body weight per administration, if the pediatric patient has a weight of less than 60 kg at the time of administration;
2) about 35 mg to 55 mg, preferably about 45 mg per administration, when said pediatric patient has a body weight of 60 kg to 100 kg at said administration, or
3) about 80 mg to 100 mg, preferably 90 mg per dose, if said pediatric patient weighs more than 100 kg at said dose;
Method.
Claims (25)
前記医薬組成物が、安全かつ有効な量の抗IL-12/IL-23p40抗体を含み、
前記方法が、前記医薬組成物を前記小児患者に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アミノ酸配列、及び配列番号3のCDRH3アミノ酸配列を含み、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アミノ酸配列、及び配列番号6のCDRL3アミノ酸配列を含み、前記小児患者が、少なくとも6歳かつ12歳未満であり、治療後に0又は1の医師総合評価(PGA)スコアを有すると識別され、及び/又は乾癬面積及び重症度指数スコア(PASI)が少なくとも75%、90%又は100%減少したと識別されることによる、前記抗IL-12/IL-23p40抗体による治療に対する応答者である、医薬組成物。 A pharmaceutical composition for use in a method of treating psoriasis in a pediatric patient in need thereof comprising:
said pharmaceutical composition comprises a safe and effective amount of an anti-IL-12/IL-23p40 antibody;
The method comprises administering the pharmaceutical composition to the pediatric patient, wherein 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 region of SEQ ID NO:1. a chain 1 (CDRH1) amino acid sequence, a CDRH2 amino acid sequence of SEQ ID NO:2, and a CDRH3 amino acid sequence 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 , the CDRL2 amino acid sequence of SEQ ID NO:5, and the CDRL3 amino acid sequence of SEQ ID NO:6, wherein the pediatric patient is at least 6 years old and less than 12 years old and has a Physician Global Assessment (PGA) score of 0 or 1 after treatment. response to treatment with said anti-IL-12/IL-23p40 antibody by being identified as having at least a 75%, 90% or 100% reduction in Psoriasis Area and Severity Index Score (PASI) A pharmaceutical composition .
前記医薬組成物が抗IL-12/IL-23p40抗体を含み、
前記重度の慢性プラーク乾癬が、少なくとも3の医師総合評価(PGA)スコア、少なくとも12の乾癬面積及び重症度指数スコア(PASI)、及び/又は少なくとも10%の影響を受けた体表面積(BSA)のパーセントによって定義され、
前記方法が、前記小児患者に、安全かつ有効な量の抗IL-12/IL-23p40抗体を皮下投与することを含み、前記抗体が、(i)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アミノ酸配列、及び配列番号3のCDRH3アミノ酸配列を含む重鎖可変領域、並びに配列番号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アミノ酸配列、及び配列番号6のCDRL3アミノ酸配列を含む軽鎖可変領域、(ii)配列番号7のアミノ酸配列を有する重鎖可変領域、及び配列番号8のアミノ酸配列を有する軽鎖可変領域、又は(iii)配列番号10のアミノ酸配列を有する重鎖、及び配列番号11のアミノ酸配列を有する軽鎖、を含み、前記安全かつ有効な量の前記抗IL-12/IL-23p40抗体が、
1)前記小児患者が前記投与時に60kg未満の体重を有する場合、投与当たり、前記小児患者の体重に対し、約0.5mg/kg~1.0mg/kg、好ましくは0.75mg/kg、
2)前記小児患者が前記投与時に60kg~100kgの体重を有する場合、投与当たり、約35mg~55mg、好ましくは約45mg、又は
3)前記小児患者が前記投与時に100kgを超える体重を有する場合、投与当たり、約80mg~100mg、好ましくは90mg、である、
医薬組成物。
A pharmaceutical composition for use in a method of treating severe chronic plaque psoriasis in a pediatric patient comprising:
wherein said pharmaceutical composition comprises an anti-IL-12/IL-23p40 antibody;
said severe chronic plaque psoriasis has a Physician Global Assessment (PGA) score of at least 3, a Psoriasis Area and Severity Index score (PASI) of at least 12, and/or a body surface area affected (BSA) of at least 10% defined by a percentage,
The method comprises subcutaneously administering to the pediatric patient a safe and effective amount of an anti-IL-12/IL-23p40 antibody, wherein the antibody comprises (i) the complementarity determining region heavy chain 1 of SEQ ID NO: 1 a heavy chain variable region comprising the (CDRH1) amino acid sequence , the CDRH2 amino acid sequence of SEQ ID NO:2, and the CDRH3 amino acid sequence of SEQ ID NO:3, and the complementarity determining region light chain 1 (CDRL1) amino acid sequence of SEQ ID NO:4, SEQ ID NO:5 and the CDRL3 amino acid sequence of SEQ ID NO:6, (ii) 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; or (iii) a heavy chain having the amino acid sequence of SEQ ID NO: 10 and a light chain having the amino acid sequence of SEQ ID NO: 11, wherein the safe and effective amount of the anti-IL-12/IL-23p40 antibody is
1) about 0.5 mg/kg to 1.0 mg/kg, preferably 0.75 mg/kg, of the pediatric patient's body weight per administration, if the pediatric patient has a weight of less than 60 kg at the time of administration;
2) about 35 mg to 55 mg, preferably about 45 mg per dose, if said pediatric patient weighs between 60 kg and 100 kg at said administration; or 3) if said pediatric patient weighs more than 100 kg at said dose. is about 80 mg to 100 mg, preferably 90 mg, per
pharmaceutical composition .
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US201962819860P | 2019-03-18 | 2019-03-18 | |
US62/819,860 | 2019-03-18 | ||
PCT/IB2020/052387 WO2020188466A1 (en) | 2019-03-18 | 2020-03-16 | Method of treating psoriasis in pediatric subjects with anti-il12/il23 antibody |
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JPWO2020188466A5 true JPWO2020188466A5 (en) | 2023-03-27 |
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EP4188443A4 (en) * | 2020-07-30 | 2024-09-18 | Janssen Biotech Inc | Method of treating psoriasis in pediatric subjects with anti-il12/il23 antibody |
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