重组抗CD25人源化单克隆抗体挽救性治疗糖皮质激素耐药型急性移植物抗宿主病64例疗效分析

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.