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Observational Study
. 2025 Aug;122(2):257-266.
doi: 10.1007/s12185-025-03973-7. Epub 2025 Mar 25.

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

Yoshihiro Inamoto  1   2 , Ayumu Ito  3 , Toshihisa Nakashima  4 , Asako Usui  3 , Wataru Takeda  3 , Takashi Tanaka  3 , Sung-Won Kim  3 , Shigehisa Kitano  5   6 , Keisuke Watanabe  7 , Kana Kusaba  7   8 , Yu Aruga  9   10 , Chiaki Ikeda  9 , Minoru Kojima  3 , Naoki Maezawa  9 , Hirotaka Matsui  9   10 , Hironobu Hashimoto  4 , Chitose Ogawa  11 , Takahiro Fukuda  3
Affiliations
Observational Study

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

Yoshihiro Inamoto et al. Int J Hematol. 2025 Aug.

Abstract

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.

Keywords: Beclomethasone; Biomarker; Gastrointestinal; Graft-versus-host disease; Prognosis.

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Conflict of interest statement

Declarations. Conflict of interest: Y.I. and H.M. are lead reviewers of the International Journal of Hematology. Y.I. reports personal fees from Novartis, Janssen, and Meiji Seika Pharma outside the submitted work. K.W. is a stockholder and a board member as a co-founder of ARC Therapies Corp. Other authors declare no conflicts of interest.

References

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