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<p>The real-world outcomes of oral beclomethasone dipropionate (BDP) for gastrointestinal graft-versus-host disease (GVHD) were evaluated in a single-center, prospective, observational study of 167 patients who developed histologically confirmed gastrointestinal GVHD. The median patient age was 55&#xa0;years (range 10–71). The initial GVHD grade was mostly IIa (n = 138). BDP was used without systemic corticosteroids in 73 patients (44%), resulting in a decreased proportion of patients who received systemic corticosteroid administration from 76 to 58% (<i>P</i> = 0.001). The 4-week gastrointestinal response rate after BDP therapy, the primary endpoint, was 73% (95% CI 66–80%) compared with 68% (95% CI 55–78%) before BDP implementation. The proportion of patients with maximum gastrointestinal stage ≥ 2 was lower after than before BDP implementation (18% versus 35%, respectively, <i>P</i> = 0.004). The 1&#xa0;year cumulative incidence of nonrelapse mortality (NRM) after gastrointestinal GVHD therapy was 15% after and 22% before BDP implementation (<i>P</i> = 0.12). The 4-week gastrointestinal response rate was lower in patients with elevated ST2 or REG3α levels than the remaining patients (36% versus 73%, <i>P</i> = 0.03). The 1&#xa0;year NRM was higher in patients with elevated ST2 or ANG2 levels than the remaining patients (64% versus 12%, <i>P</i> &lt; 0.001). This study characterized the outcomes of BDP therapy in real-world patients.</p>

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Oral beclomethasone dipropionate therapy and prognostic plasma biomarkers for gastrointestinal graft-versus-host disease

  • 期刊论文

  • 发表日期：

    2025年3月25日

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  • Yoshihiro Inamoto,
  • Ayumu Ito,
  • Toshihisa Nakashima,
  • Asako Usui,
  • Wataru Takeda,
  • Takashi Tanaka,
  • Sung-Won Kim,
  • Shigehisa Kitano,
  • Keisuke Watanabe,
  • Kana Kusaba,
  • Yu Aruga,
  • Chiaki Ikeda,
  • Minoru Kojima,
  • Naoki Maezawa,
  • Hirotaka Matsui,
  • Hironobu Hashimoto,
  • Chitose Ogawa,
  • Takahiro Fukuda

摘要

The real-world outcomes of oral beclomethasone dipropionate (BDP) for gastrointestinal graft-versus-host disease (GVHD) were evaluated in a single-center, prospective, observational study of 167 patients who developed histologically confirmed gastrointestinal GVHD. The median patient age was 55 years (range 10–71). The initial GVHD grade was mostly IIa (n = 138). BDP was used without systemic corticosteroids in 73 patients (44%), resulting in a decreased proportion of patients who received systemic corticosteroid administration from 76 to 58% (P = 0.001). The 4-week gastrointestinal response rate after BDP therapy, the primary endpoint, was 73% (95% CI 66–80%) compared with 68% (95% CI 55–78%) before BDP implementation. The proportion of patients with maximum gastrointestinal stage ≥ 2 was lower after than before BDP implementation (18% versus 35%, respectively, P = 0.004). The 1 year cumulative incidence of nonrelapse mortality (NRM) after gastrointestinal GVHD therapy was 15% after and 22% before BDP implementation (P = 0.12). The 4-week gastrointestinal response rate was lower in patients with elevated ST2 or REG3α levels than the remaining patients (36% versus 73%, P = 0.03). The 1 year NRM was higher in patients with elevated ST2 or ANG2 levels than the remaining patients (64% versus 12%, P < 0.001). This study characterized the outcomes of BDP therapy in real-world patients.