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、疾患活動性の尺度であるclinical activity score（CAS）が高い日本人の甲状腺眼症患者を対象とした、活動性甲状腺眼症（TED）の治療薬としてテプロツムマブを評価する第Ⅲ相臨床試験OPTIC-Jの新たなデータを発表しましたのでお知らせします。このデータは、日本甲状腺学会（JTA）学術集会の口頭セッションで発表されました。TEDは、重篤で進行性、かつ衰弱性で、視力を脅かす可能性のある希少な自己免疫疾患であり、眼球突出（眼球が前に出てくる）、複視（ものが二重に見える）、眼痛、充血、瞼の腫脹を引き起こすことがあります1。
本治験の共同責任医師である久留米大学医療センター 名誉教授の廣松雄治 医師は次のように述べています。「甲状腺眼症の患者さんは、臨床試験で症状の改善が証明された医薬品を必要としています。現在の主要な治療法であるステロイドは、眼球突出などの症状を実質的に改善するエビデンスが乏しいからです。今回発表されたデータは、テプロツムマブの有効性と安全性を裏付けるものであり、甲状腺眼症の重大な身体的・精神的な影響に苦しむ患者さんに、希望をもたらす可能性があることを示しています」
既報のとおり、第Ⅲ相臨床試験は有効性の主要評価項目を達成しました。24週時点で、プラセボ投与群（11%）と比較して、テプロツムマブ投与群では89%の患者において、臨床的に意味のある眼球突出（2 mm以上）の改善が認められました（p＜0.0001）。安全性プロファイルは、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。
JTAで発表された新たなデータによると、テプロツムマブ投与群では眼球突出がベースラインから2.36 mm減少したのに対し、プラセボ投与群では0.37 mmでした（P＜0.0001）。テプロツムマブはまた、CAS（疼痛、発赤、腫脹などの炎症の徴候や症状に基づいて疾患活動性を測定する7段階の尺度）も有意に改善することが示されました。CASスコアが1点以下に達した患者の割合は、テプロツムマブ投与群で59.3%であったのに対し、プラセボ投与群では22.2%でした（P=0.0031）。複視が改善した患者の割合は、テプロツムマブ投与群で63.6%であったのに対し、プラセボ投与群では45.0%（P=0.243）でした。複視が完全に消失した患者の割合は、テプロツムマブ投与群で50.0%であったのに対し、プラセボ投与群では20.0%でした。
アムジェン株式会社メディカルアフェアーズExecutive Director 平方 利幸は次のように述べています。「今回発表されたデータは、テプロツムマブを日本で製造販売承認申請するための前向きな一歩であり、規制当局と検討を進めていくことを楽しみにしています。テプロツムマブは甲状腺眼症の原因にアプローチする薬剤であり、治療方法に変革をもたらす可能性があると考えています」
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34,913人、有病率は0.034%と推定されています2。
現在日本では、慢性かつ長期間にわたる甲状腺眼症およびCASが低値の成人患者さんを対象とした、テプロツムマブを評価する2つ目の第III相臨床試験が進行中です。この試験では、試験開始の2～10年前に甲状腺眼症と初めて診断され、疾患活動性が低い患者さんを対象としています。
試験デザイン
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、両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。臨床試験期間の終了後、24週目に眼球突出に対する奏効がみられない参加者は、非盲検期間を延長し、さらに8回のテプロツムマブの投与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。
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、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。
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