Amgen Worldwide
A biotechnology pioneer since 1980, Amgen has reached millions of patients around the world.
オンラインリソース
アムジェンは、患者さんが関心のある分野について学べるよう、多数のリソースを用意しております。
疾患教育
重点領域
A biotechnology pioneer since 1980, Amgen has reached millions of patients around the world.
アムジェンは、患者さんが関心のある分野について学べるよう、多数のリソースを用意しております。
アムジェン株式会社（本社：東京、代表取締役社長：ニール・マグレガー、以下「当社」）は本日、インスリン様成長因子1受容体（IGF-1R）阻害剤であるテプロツムマブについて、活動性甲状腺眼症を予定効能又は効果として、日本国内で製造販売承認申請を行いました。この度の申請は、日本人の活動性甲状腺眼症の患者さんを対象とした第III相臨床試験（OPTIC-J）のデータに基づいて行われました。
甲状腺眼症（TED）は、深刻で進行性かつ潜在的に失明の恐れがある希少な自己免疫疾患で、眼球突出（眼球が前に出てくる）、複視（二重に見える）、目の痛み、発赤／充血および浮腫を引き起こすことがあります1。初期症状には、ドライアイ、異物感、充血、瞼の腫れ、過度の涙、眼瞼後退、眼球突出、目の奥の圧迫感や眼痛、複視などがあります。日本における甲状腺眼症の発症率は、人口10万人あたり7.3人（男性3.6人、女性13.0人）で、患者数は約3万5千人と推定されています2。
テプロツムマブの日本国内での臨床試験であるOPTIC-Jは、日本における中等度から重度の活動性甲状腺眼症患者に対するテプロツムマブの有効性、忍容性、安全性を評価する無作為化二重遮蔽プラセボ対照並行群間比較多施設共同第III相臨床試験です。本試験の主要評価項目である、24週目に眼球突出が 2mm 以上減少した患者の割合は、テプロツムマブ群で89%、プラセボ群 で11%であり、有意差が認められました（P<0.0001）。安全性プロファイルについては、テプロツムマブのこれまでの臨床試験で確認されたものと一致しています。テプロツムマブは、国外では2020年1月に米国食品医薬品庁（FDA）より、疾患活動性や罹患期間に関わらないTEDに対する最初の薬剤として承認されています。
テプロツムマブについて
テプロツムマブは、完全ヒト型モノクローナル抗体（mAb）で、インスリン様成長因子1受容体（IGF-1R）の標的阻害薬です。テプロツムマブは、3週間に一度、合計8回の点滴で患者に投与される生物製剤です。米国食品医薬品庁から優先審査、希少疾病用医薬品、ファストトラック、およびブレークスルーセラピーに指定されています。過去の治験において最も多く見られた有害反応（≥5%の発生率でプラセボより多数）は、筋痙攣や吐き気、脱毛症、下痢、疲労感、高血糖、聴覚障害、味覚障害、頭痛、乾燥肌、月経障害でした。
甲状腺眼症（TED）について
甲状腺眼症は、深刻で、進行性かつ潜在的に視力低下の恐れがある希少な自己免疫疾患です1。その多くはバセドウ病に伴ってみられますが、後眼窩の細胞でインスリン様成長因子１受容体（IGF-1R）を介したシグナル複合体を活性化する自己抗体によって引き起こされる個別の疾患です3,4。これらが一連の症状につながり、失明など長期にわたる不可逆な損傷を引き起こす可能性があります5,6。甲状腺眼症の初期症状には、ドライアイ、異物感、充血、瞼の腫れ、過度の涙、眼瞼後退、眼球突出、目の奥の圧迫感や眼痛、複視などがあります。
OPTIC-J試験について
OPTIC-J試験は、日本における中等度から重度の活動性甲状腺眼症患者に対するテプロツムマブの有効性、忍容性、安全性を評価する無作為化二重遮蔽プラセボ対照並行群間比較多施設共同第III相臨床試験です。試験方法は、欧米で実施された第III相臨床試験（OPTIC試験）に基づいています。組み入れ基準を満たした成人の参加者は、テプロツムマブ投与群（n=27）またはプラセボ投与群（n=27）に1対1の割合で無作為に割り付けられ、3週間に1回、計8回の投与（初回は10mg/kg、残り7回は20mg/kg）が行われました。無作為化されたすべての参加者は、24週目の評価を完了しました。
有効性の主要評価項目は、24週目の眼球突出改善率であり、評価対象の眼の眼球突出がベースラインから2mm以上減少し、僚眼の眼球突出に悪化（2mm以上の増加）が認められない参加者の割合で評価されます。二重遮蔽投与期間終了時（24週目）に眼球突出の改善が認められなかった参加者は、その後のオープンラベル継続投与試験でテプロツムマブ投与（8回）を受けることができます。
この臨床試験は、医薬品医療機器総合機構（PMDA）との協議に基づいて設計されました。試験の詳細は、臨床研究等提出・公開システムのウェブサイト（実施計画番号jRCT2031210453）を参照してください。
アムジェン株式会社について
アムジェン株式会社は、世界最大規模の独立バイオテクノロジー企業である米国アムジェン社の日本法人です。アムジェン株式会社では、循環器疾患、がん、骨疾患、炎症・免疫性疾患、神経疾患を始めとするアンメット・メディカル・ニーズが高い領域に焦点を絞り、「To
serve patients – 患者さんのために、今できるすべてを」というミッションのもと、臨床開発から販売までの活動を行っています。詳細については http://www.amgen.co.jp をご覧になるか、https://www.facebook.com/amgenjapan をフォローしてください。
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注意事項（アムジェン株式会社）
このニュースリリースに含まれている医薬品（開発中のものを含む）に関する情報は、宣伝広告、医学的アドバイスを目的とするものではありません。
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References