Humanized anti-CD25 monoclonal antibody as a salvage therapy for steroid-refractory acute graft-versus-host disease after hematopoietic stem cell transplantation.
10.3760/cma.j.issn.0253-2727.2023.09.009
- Author:
Ya Xue WU
1
;
De Pei WU
2
;
Xiao MA
2
;
Shan Shan JIANG
1
;
Meng Jia HOU
1
;
Yu Tong JING
1
;
Bin LIU
1
;
Qian LI
1
;
Xin WANG
1
;
Yuan Bing WU
1
;
Xiao Hui HU
2
Author Information
1. Soochow Hopes Hematology Hospital, Suzhou 215006, China.
2. Jiangsu Institute of Hematology, National Clinical Research Center for Hematology Disease, NHC Key Laboratory of Thrombosis and Hemostasis, The First Affiliated Hospital of Soochow University, Suzhou 215006, China.
- Publication Type:Journal Article
- Keywords:
Acute graft-versus-host disease;
Hematopoietic stem cell transplantation;
Humanized anti-CD 25 monoclonal antibody
- MeSH:
Adult;
Female;
Humans;
Male;
Middle Aged;
Acute Disease;
Antibodies, Monoclonal/therapeutic use*;
Graft vs Host Disease/therapy*;
Hematopoietic Stem Cell Transplantation/adverse effects*;
Retrospective Studies;
Salvage Therapy/methods*;
Steroids;
Adolescent;
Young Adult
- From:
Chinese Journal of Hematology
2023;44(9):755-761
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To investigate the efficacy of humanized anti-CD25 monoclonal antibody for steroid-refractory acute graft-versus-host disease (SR-aGVHD) in allogeneic hematopoietic stem cell transplantation (allo-HSCT) recipients. Methods: A total of 64 patients with SR-aGVHD between June 2019 and October 2020 in Suchow Hopes Hematology Hospital were enrolled in this study. Humanized anti-CD25 monoclonal antibodies 1 mg·kg(-1)·d(-1) were administered on days 1, 3, and 8, and then once per week according to the disease progression. Efficacy was assessed at days 7, 14, and 28 after humanized anti-CD 25 treatment. Results: Of the 64 patients with a median age of 31 (15-63) years, 38 (59.4%) were male and 26 (40.6%) were female. The overall response (OR) rate of the humanized CD25 monoclonal antibody in 64 patients with SR-aGVHD on days 7, 14, and 28 were 48.4% (31/64), 53.1% (34/64), and 79.7% (51/64), respectively. Liver involvement is an independent risk factor for poor efficacy of humanized CD25 monoclonal antibody for SR-aGVHD at day 28 (OR=9.588, 95% CI 0.004-0.291, P=0.002). The median follow-up time for all patients was 17.1 (0.2-50.8) months from the start of humanized CD25 monoclonal antibody therapy. The 1- and 2-year OS rates were 63.2% (95% CI 57.1% -69.3%) and 52.6% (95% CI 46.1% -59.1%), respectively. The 1- and 2-year DFS rates were 58.4% (95% CI 52.1% -64.7%) and 49.8% (95% CI 43.4% -56.2%), respectively. The 1- and 2-year NRM rates were 28.8% (95% CI 23.1% -34.5%) and 32.9% (95% CI 26.8% -39.0%), respectively. The results of the multifactorial analysis showed that liver involvement (OR=0.308, 95% CI 0.108-0.876, P=0.027) and GVHD grade Ⅲ/Ⅳ (OR=9.438, 95% CI 1.211-73.577, P=0.032) were independent risk factors for OS. Conclusion: Humanized CD25 monoclonal antibody has good efficacy and safety for SR-aGVHD. This study shows that SR-aGVHD with pretreatment grade Ⅲ/Ⅳ GVHD and GVHD involving the liver has poor efficacy and prognosis and requires early intervention.