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」）はこのたび、環状アデノシン一リン酸（cAMP）に特異的なホスホジエステラーゼ4（PDE4）に対する経口低分子阻害剤であるオテズラ®錠（一般名：アプレミラスト、以下「オテズラ」）について、局所療法で効果不十分な掌蹠膿疱症（Palmoplantar Pustulosis：PPP）に対する日本国内における効能又は効果の追加に係わる製造販売承認事項一部変更申請（以下「一変申請」）を行いましたので、お知らせいたします。
PPPは膿疱、紅斑および鱗屑を伴い、手のひら（手掌）および足の裏（足蹠）に限局して発現する慢性的かつ激しい炎症性の皮膚疾患です1,2,3。手掌の症状は人目に付き、また足蹠は歩行時に痛みを伴うなど、QOLにも大きな影響を及ぼします4,5。2010年に実施された、厚生労働省のレセプトデータを用いた全国規模の疫学調査では、日本人のPPP患者数は136,224人であり、男女比は1：2で女性の割合が高い結果でした。
PPPの薬物治療は現時点では対症療法にとどまっています6。基本的な治療法は外用療法ですが、手掌および足蹠の厚い角質層が妨げになるため、有効性は限定的です。また、外用療法で十分な効果が得られない場合、光線療法や内服療法が用いられますが、その有効性は限定的であることが報告されています7。さらに、現在、既存治療で効果不十分な掌蹠膿疱症を効能又は効果として本邦において承認されている生物学的製剤は注射剤であり、原則的に自己注射は認められていません。日本皮膚科学会によって承認された991の医療機関（2024年1月22日現在）においてのみ投与が可能なため、利便性の面で課題があります8。以上のことから、中等度から重度のPPP患者さんに対して、有効かつ忍容性が良好であり、利便性が高い全身療法が求められており、大きなアンメット・メディカル・ニーズが存在しています。
今回の一変申請は、日本人PPP患者を対象にオテズラの有効性および安全性を評価した、第Ⅲ相、多施設共同、無作為化、プラセボ対照、二重盲検、並行群間比較試験から得られた結果に基づき行いました。本試験のデータは、2024年3月に開催された米国皮膚科学会（American Academy of Dermatology Association：AAD）年次総会におけるLate-Breaking Research Sessionにて発表されています9。
現在、日本におけるオテズラの効能又は効果は「局所療法で効果不十分な尋常性乾癬」「乾癬性関節炎」「局所療法で効果不十分なベーチェット病による口腔潰瘍」です。
当社は可能な限り早くオテズラをPPPの患者さんに提供するべく、規制当局と協働してまいります。
掌蹠膿疱症（PPP）について
PPPは膿疱、紅斑および鱗屑を伴い、手のひら（手掌）および足の裏（足蹠）に限局して発現する慢性的かつ激しい炎症性の皮膚疾患です1,2,3。炎症性の角質増殖を伴い、中年の男女に多く発症し、その多くが喫煙者です10。手掌の症状は人目に付き、また足蹠は歩行時に痛みを伴うなど、QOLにも大きな影響を及ぼします4,5。2010年に実施された、厚生労働省のレセプトデータを用いた全国規模の疫学調査では、日本人のPPP患者数は136,224人であり、男女比は1：2で女性の割合が高い結果でした。
PPPの病因は不明であり、PPPと限局性膿疱性乾癬が異なる病態であるかについては未だ見解が分かれていますが、2007年に国際乾癬学会（International Psoriasis council）により、独立した疾患として再分類されています11。典型的なPPPは、乾癬の既往歴や家族歴のない患者さんで認められ、PPPと乾癬が免疫遺伝学的に異なる疾患であることを示唆しています3,12。
オテズラ®（アプレミラスト）について
オテズラは、環状アデノシン一リン酸（cAMP）に特異的なホスホジエステラーゼ4（PDE4）に対する経口低分子阻害剤です。PDE4を阻害すると細胞内cAMP濃度が上昇し、炎症性メディエーターの産生を間接的に調節すると考えられています。オテズラが患者においてその治療作用を発揮する特定のメカニズムは十分に明らかにされていません。
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、希少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 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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TEL 080-4950-6230
References