JP2019525944A - 潰瘍性大腸炎を治療するための方法 - Google Patents
潰瘍性大腸炎を治療するための方法 Download PDFInfo
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Abstract
Description
本出願は、2016年8月3日出願の米国仮特許出願第62/370,508号および2016年11月23日出願の米国特許出願第15/360,703号の利益を主張するものであり、これらの出願は、これらの全内容が参照により本明細書に組み込まれる。
排便頻度、直腸出血、内視鏡検査での粘膜の外観、および医師による総合評価(PGA)を取り入れた4〜10の総Mayoスコアを有する臨床的および内視鏡的活動性潰瘍性大腸炎を有する18〜75歳の男性および女性を含む患者が含まれる。内視鏡スコアは1以上、PGAスコアは2点以下である必要がある。さらに、このような潰瘍性大腸炎は、3ヶ月よりも長い期間にわたって続いている必要がある。5cm未満の孤立性直腸炎を除き、いかなる程度の潰瘍性大腸炎も治療される。全ての包含基準に関する表4を参照されたい。
これらに限定されないが炎症性腸疾患および過敏性腸症候群を含む消化管疾患の病歴または現症状を有しない18〜65歳の男性および女性を含む糞便ドナーが含まれる。ドナーは、いかなる大きな活動性の医学的併存疾患を有していない必要がある。ドナーは、提供以前の3ヶ月のうちに、抗菌剤、プロバイオティクス、プロトンポンプ阻害剤を含まない薬物治療であって、便の活動を妨げる可能性のある医薬品による最小限の定期的な薬物治療を全く受けていない必要がある。全てのドナー包含基準に関する表7を参照されたい。
FMT注入は、微生物の不均一性を高めるために、3〜7人のドナーの混合糞便で構成される。各患者は、全てのFMT注入物を同じドナー集団から受け入れて、注入される糞便微生物叢の一貫性および再現性を確保する。
患者は、FMT後8週目に最終レビューが行われる盲検および非盲検試験期間中、2週間毎にレビューされる。血液検査および糞便検査は、試験治療中は4週間毎に実施される。血液検査には、CBC、EUC、LFT、ESR、およびCRPが含まれる。糞便検査では、糞便中のカルプロテクチンを測定する。
微生物学的分析は、患者、個人ドナー、およびFMT集団糞便サンプルに対して行われる。サンプルを−80℃で保存する。糞便細菌DNAを抽出する。16S rRNA遺伝子フラグメントをF27および519Rプライマーを使用して増幅し、次にIllumina MiSeqプラットフォーム(2x300bp化学)でハイスループットシークエンシングに供して、微生物叢の多様性および存在量を確保する。生配列は、MOTHUR(SchlossらによるAppl.Environ.Microbiol.2009;75:7537〜41)を用いて分析される。 統計的検定は、計数および相対存在量に対して行われる。
44歳の治療未経験の男性患者(患者DM)は、下痢、血便および粘膜便、けいれん/腹痛、および体重減少の1年間の病歴を提示している。患者は、排便時の激しい痛み、運転中の失禁、食欲不振、吐き気、辛い食べ物および魚を食べられないこと、ブレインフォグ(脳に霧がかかったような状態)、および16ポンド(7257グラム)の体重減少を経験している。患者はまた、便の硬さが7(ブリストル)の状態の重度の鼓腸、重度の腹部不快感、および深刻な衝動を伴う1日当たり10〜12回の排便を経験している。患者は重症の全結腸炎と診断される。凍結乾燥されたドナー由来の非選択糞便微生物叢を含有する耐酸性/遅延放出二重カプセル化経口カプセル剤を含む治療計画を用いる。簡単に言うと、ドナー糞便を収集して凍結保護剤と均質化し、得られたスラリーを凍結乾燥して、約1.6×1011の生細胞/カプセルを含むDRcaps(登録商標)カプセルに封入する。患者は、13週間の導入期間にわたって総404カプセルで治療される。この期間中に、症状の質問票を回収し、便を、病原体の培養を目的として培養してLFSM治療の有効性を評価する。
31歳の患者(患者TD)を糞便微生物治療で治療する。凍結乾燥されたドナー由来の非選択糞便微生物叢を含有する耐酸性/遅延放出二重カプセル化経口カプセル剤を含む治療計画を用いる。患者の症状には、便の硬さ2の1日当たり4回の排便、中等度の膨満感、中等度の腹部不快感、軽度の衝動、および脚のピン治療ならびに針治療の感覚、および疲労が含まれる。患者は、導入期間中、1週間当たり1回の結腸鏡検査における糞便微生物治療液注入および1〜2回の直腸内への浣腸液注入を行う6週間の治療プロトコールを受ける。患者は維持期間中、4週間にわたって1日当たり4カプセルを服用する。患者の鼓脹の症状は減弱し、腹部の不快感および衝動の症状は消える。患者は、便の硬さ3の1日当たり1回の排便を経験する。患者はまた、軽度の鼓腸および全身倦怠感を経験する。カプセル治療後2週目では、患者は、243μg/gのカルプロテクチン測定値を有する。最初のカルプロテクチン検査から3週目では、および最初のカプセル服用から4週目では、患者のカルプロテクチンレベルは88μg/gに減少する。
Claims (20)
- 治療を必要とする被検体の潰瘍性大腸炎(UC)を治療するための方法であって、生きた非病原性糞便細菌を含む薬学的組成物を少なくとも4週間にわたって、1週間当たり少なくとも1回投与することを含む治療計画で、前記被検体を治療することを含み、前記治療計画は、プラセボからの主要転帰率に対して、少なくとも2倍高い主要転帰率を達成することができ、前記主要転帰は、前記治療計画終了時のステロイドフリーでの臨床的寛解および内視鏡的寛解または奏効として定義され、前記臨床的寛解は、総Mayoスコアが2点以下、かつ全てのサブスコアが1点以下として定義され、前記内視鏡的寛解または奏効は、Mayo内視鏡スコアのベースラインからの少なくとも1点の低減として定義される、方法。
- 前記治療計画は、少なくとも8週間にわたって1週間当たり少なくとも3回、生きた非病原性糞便細菌を含む薬学的組成物を投与することを含む、請求項1に記載の方法。
- 前記治療計画は、少なくとも25%の主要転帰率を達成することができる、請求項2に記載の方法。
- 前記治療計画は、前記治療計画の完了後の8週目に、少なくとも40%の臨床的寛解維持率を達成することができる、請求項2に記載の方法。
- 前記治療計画は、プラセボからのステロイドフリーでの臨床的寛解率に対して、少なくとも2倍高いステロイドフリーでの臨床的寛解率を達成することができ、前記臨床的寛解は、直腸出血および排便頻度に関する合計Mayoスコアが1点以下として定義される、請求項1に記載の方法。
- 前記治療計画は、少なくとも40%のステロイドフリーでの臨床的寛解率を達成することができる、請求項5に記載の方法。
- 前記治療計画は、プラセボからのステロイドフリーでの臨床的奏効率に対して、少なくとも2倍高いステロイドフリーでの臨床的奏効率を達成することができ、前記臨床的奏効は、3点以上の総Mayoスコア減少、または直腸出血および排便頻度に関する合計スコアのベースラインからの50%以上の低減として定義される、請求項1に記載の方法。
- 前記治療計画は、少なくとも50%のステロイドフリーでの臨床的奏効率を達成することができる、請求項7に記載の方法。
- 前記治療計画は、プラセボからの内視鏡的奏効率に対して、少なくとも2倍高い内視鏡的奏効率を達成することができ、前記内視鏡的奏効は、ベースラインからの3点以上の総UCEISスコア減少、または50%以上の総UCEISスコア低減として定義される、請求項1に記載の方法。
- 前記治療計画は、少なくとも30%の内視鏡的奏効率を達成することができる、請求項9に記載の方法。
- 前記方法は、前記被検体のベースラインの腸内細菌多様性を判定することをさらに含む、請求項1に記載の方法。
- 前記方法は、前記被検体の腸内のフソバクテリウム(Fusobacterium)、サテレラ(Sutterella)、バルネシエラ(Barnesiella)、パラバクテロイデス(Parabacteroides)、クロストリジウムIV(Clostridium IV)、ルミノコッカス(Ruminococcus)、ブラウチア(Blautia)、ドレア(Dorea)、ルミノコッカス2(Ruminococcus2)、およびクロストリジウムXVIII(Clostridium XVIII)からなる群から選択される1種類以上の細菌のレベルを判定することをさらに含む、請求項1に記載の方法。
- 前記薬学的組成物は、糞便微生物調製物を含む、請求項1に記載の方法。
- 前記被検体は、前記治療前に少なくとも4点のMayoスコアを示す、請求項1に記載の方法。
- 治療を必要とし、3点以下のMayo内視鏡スコアを示す被検体の潰瘍性大腸炎(UC)を治療するための方法であって、前記方法は、前記被検体に、生きた非病原性糞便細菌を含む薬学的組成物を投与することを含む、方法。
- 前記投与は、毎日、1週間当たり少なくとも1回、1週間当たり少なくとも2回、および1週間当たり少なくとも3回からなる群から選択される頻度で、少なくとも8週間の治療計画に従って行われる、請求項15に記載の方法。
- 前記被検体は、主要転帰を前記治療計画の終了時に達成することができ、前記主要転帰は、前記治療計画終了時のステロイドフリーでの臨床的寛解および内視鏡的寛解または奏効として定義され、前記ステロイドフリーでの臨床的寛解は、総Mayoスコアが2点以下、かつ全てのサブスコアが1点以下として定義され、前記内視鏡的寛解または奏効は、内視鏡スコアのベースラインからの少なくとも1点の低減として定義される、請求項16に記載の方法。
- 治療を必要とする被検体の潰瘍性大腸炎(UC)を治療するための方法であって、前記方法は、前記被検体に、生きた非病原性糞便細菌を含む薬学的組成物を投与することを含み、前記被検体は、コルチコステロイドの併用を前記方法実施中に行わず、前記方法を開始する直前のコルチコステロイド使用がない、方法。
- 前記投与は、少なくとも8週間および1週間当たり少なくとも3回の治療計画に従う、請求項18に記載の方法。
- 前記被検体は、主要転帰を前記治療計画の終了時に達成することができ、前記主要転帰は、前記治療計画終了時のステロイドフリーでの臨床的寛解および内視鏡的寛解または奏効として定義され、前記ステロイドフリーでの臨床的寛解は、総Mayoスコアが2点以下、かつ全てのサブスコアが1点以下として定義され、前記内視鏡的寛解または奏効は、内視鏡スコアのベースラインからの少なくとも1点の低減として定義される、請求項19に記載の方法。
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US20210330717A1 (en) | 2021-10-28 |
CA3032004A1 (en) | 2018-02-08 |
JP2023010890A (ja) | 2023-01-20 |
AU2017306303A1 (en) | 2019-02-14 |
US10195235B2 (en) | 2019-02-05 |
US20180036352A1 (en) | 2018-02-08 |
US20190175665A1 (en) | 2019-06-13 |
WO2018026913A1 (en) | 2018-02-08 |
US11071759B2 (en) | 2021-07-27 |
US20200113949A1 (en) | 2020-04-16 |
US20180125899A1 (en) | 2018-05-10 |
US10561690B2 (en) | 2020-02-18 |
EP3493822A1 (en) | 2019-06-12 |
CN109803667A (zh) | 2019-05-24 |
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