健康な被験者にミリキズマブを皮下投与した後の自動注射器とプリプリルシリンジの間の薬理学的なブリッジリング
Xin Zhang1, Yuki Otani2, Christopher D Payne2
1Eli Lilly and Company, Lilly Corporate Center, 893 Delaware Street, Indianapolis, IN, 46225, USA. zhang_xin_xz@lilly.com.
Advances in therapy
|September 3, 2025
まとめ
潰瘍性大腸炎とクローン病の治療に使われるミリキジューマブは,自己注射器とプリプリルシリンジ製剤の間の生物同価性を実証した. これは患者の治療に より便利な選択肢となる可能性があります
科学分野:
- 薬理学と薬物投与
- 免疫学
- 胃腸内科
背景:
- ミリキズマブは,中等から重度の潰瘍性大腸炎 (UC) とクローン病 (CD) の治療に承認された抗インターレウキン-23p19単体抗体です.
- 1期試験 (AMBWとAMBX) は,自動注射器で投与されたミリキズマブの薬動学と安全性を比較するために実施された.
研究 の 目的:
- 200 mg (UC維持用量) と300 mg (CD維持用量) で自動注射器で投与されたミリキズマブとPFSの生物等価性を確認する.
- 2つの投与装置の安全性および免疫性プロフィールを評価する.
主な方法:
- 健康な参加者による2つのランダム化オープンフェーズ1試験 (AMBWとAMBX)
- 参加者は,PFS (参照) または自己注射器 (試験) を介して,単発の皮下投与量 (200 mgまたは300 mg) を受けました.
- 薬理学パラメータ (Cmax,AUC0-∞,AUC0-tlast),安全性,および免疫性について評価した.
主要な成果:
- 200 mgの投与量と300 mgの投与量におけるAUCのパラメータについて,生物同等性が実証された.
- 300 mgのCmax比は微小に生物同等性の限界を超えていたが,全体的な薬理学プロファイルは比較可能であった.
- 安全性プロファイルはデバイスごとに似ており,免疫原性は全体的に比較可能で,ある研究では自己注射器群ではわずかに増加した.
結論:
- 自動注射器またはPFSで投与されたミリキズマブは,200 mgおよび300 mgの維持用投与量の両方に生物同価である.
- 自動注射器とPFSは,比較可能な安全性および免疫性プロファイルを示した.
- 自動注射器の利用は,患者によるミリキズマブ治療の好みと従順性を高める可能性があります.
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