アムジェン株式会社（本社：東京、代表取締役社長：スザナ・ムルテイラ、以下「当社」）は、本日、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の効能又は効果の追加に係る製造販売承認事項一部変更承認（以下「一変承認」）を日本において取得しましたのでお知らせします。
掌蹠膿疱症（Palmoplantar Pustulosis：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。
今回の一変承認は、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、並行群間比較試験の肯定的な結果に基づくものです。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および2024年9月に開催された欧州皮膚科性病学会（European Academy of Dermatology and Venerology：EADV）年次総会におけるLate-Breaking Research Sessionにて発表されています6,7。
当社代表取締役社長のスザナ・ムルテイラは次のように述べています。「このたび、オテズラをPPPに対する新たな治療選択肢として日本の患者さんにお届けできることを大変うれしく思います。PPPは患者さんの生活の質に深刻な影響を及ぼす疾患ですが、依然として治療の選択肢が限られています。本一変承認が、患者さんの負担を軽減し、日常生活の質を向上させる一助となることを心から願っています。アムジェンは、これからも患者さんを第一に考え、科学とイノベーションの力でより良い未来を築くために尽力してまいります。」
日本大学総合科学研究所 教授（研究所）、日本大学医学部附属板橋病院 皮膚科の照井 正先生は次のように述べています。「PPPは、手掌や足蹠に繰り返し発症する症状が患者さんに大きな負担を強いる疾患であり、特に日常生活における痛みや痒み、不便さが深刻です。従来の治療法では効果が十分ではない場合が多く、全身療法としての新たな治療選択肢が求められてきました。このような中、オテズラが局所療法で効果が不十分な患者さんにとって画期的な治療選択肢となることを期待しています。治療の利便性が向上することで、より多くの患者さんが安定した治療を受けられるようになることを願っています。」
日本においてオテズラは、「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」の効能又は効果においても製造販売承認を取得しています。
製品概要（下線部：今回の一変承認に伴う改訂箇所）
| 販売名： | オテズラⓇ錠10mg・20mg・30mg | |||||||||||||||||||||||||||||||||
| 一般名： | アプレミラスト | |||||||||||||||||||||||||||||||||
| 効果又は効能： |
〇局所療法で効果不十分な尋常性乾癬 〇乾癬性関節炎 〇局所療法で効果不十分な掌蹠膿疱症 〇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 | |||||||||||||||||||||||||||||||||
| 用法及び用量： |
通常、成人にはアプレミラストとして以下のとおり経口投与し、6日目以降はアプレミラストとして1回30mgを1日2回、朝夕に経口投与する。
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| 効能又は効果に関連する注意： |
〈局所療法で効果不十分な尋常性乾癬、乾癬性関節炎〉 ・ 以下のいずれかを満たす尋常性乾癬又は乾癬性関節炎患者に投与すること。 –ステロイド外用剤等で十分な効果が得られず、皮疹が体表面積の10%以上に及ぶ患者 –難治性の皮疹又は関節症状を有する患者 〈局所療法で効果不十分な掌蹠膿疱症〉 ・ 中等症から重症の膿疱・小水疱病変を有する患者に投与すること。 |
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| 用法及び用量に関連する注意： |
〈効能共通〉
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※詳細は最新の添付文書をご覧ください。
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8。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9。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3,10。
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 https://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