Post-hoc analysis of a clinical study on extracorporeal photopheresis in patients with chronic graft-versus-host disease in Japan

DOI Web Site 24 References
  • Sugita Junichi
    Department of Hematology, Hokkaido University Faculty of Medicine Department of Hematology, Sapporo Hokuyu Hospital
  • Ozawa Yukiyasu
    Department of Hematology, Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
  • Mori Takehiko
    Department of Hematology, Tokyo Medical and Dental University
  • Kobayashi Tomomi
    Medical Affairs Department, Mallinckrodt Pharma K. K.
  • Teshima Takanori
    Department of Hematology, Hokkaido University Faculty of Medicine

Bibliographic Information

Other Title
  • 慢性GVHDにおける体外フォトフェレーシス（extracorporeal photopheresis）の国内臨床試験のpost-hoc解析

Search this article

Description

<p> Extracorporeal photopheresis (ECP) has been approved by the Japanese regulatory authorities in December 2020 as a specially controlled medical device for second-line treatment of chronic graft-versus-host disease (GVHD) based on the results of a clinical study in patients with steroid-refractory, -dependent, or -intolerant chronic GVHD. The present study included 15 patients registered with the clinical study, and we performed post-hoc analysis to evaluate the therapeutic effect and safety up to 36 weeks after the start of ECP therapy. Three patients discontinued the study, and 12 patients completed up to Week 36. The steroid dose was decreased in 11/12 patients at Week 36. Patients with shorter duration of chronic GVHD at the start of ECP therapy tended to show greater reduction in steroid dose at Week 36. Mean change in individual organ-specific scores showed improvement as follows: mouth: after Week 4, skin and joint/fascia: after Week 8, and eyes: after Week 12. Notably, these improvements were maintained until Week 36. Patients’ general condition improved or was maintained at baseline levels in 11/12 patients at Week 36. With regard to quality of life evaluation, “pain/discomfort” and “self-care” scores improved over time.</p>

Journal

References(24)*help

See more

Keywords

Details 詳細情報について

Report a problem

Back to top