Clinical study of anti-human T cell porcine immunoglobulin with recombinant human tumor necrosis factor-α receptor II: IgG Fc in the treatment of 35 cases of grade III/IV acute graft-versus-host disease after allo-HSCT
10.3760/cma.j.issn.0253-2727.2020.09.007
- VernacularTitle:抗人T细胞猪免疫球蛋白联合重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗异基因造血干细胞移植后Ⅲ/Ⅳ度急性移植物抗宿主病35例临床研究
- Author:
Deyan LIU
1
;
Shu YAN
;
Dandan MA
;
Chi ZHANG
;
Kangbo FU
;
Xiaomei LIU
;
Xiaohong LIU
;
Yang WANG
;
Xiangqian LI
;
Jingqi ZHANG
;
Yingying XIU
;
Xiaojuan PENG
Author Information
1. 河北燕达陆道培医院造血干细胞移植科，廊坊 065201
- Keywords:
Anti-human T cell porcine immunoglobulin;
Recombinant human tumor necrosis factor-α receptorⅡ: IgG Fc;
Graft versus host disease
- From:
Chinese Journal of Hematology
2020;41(9):743-748
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the efficacy and safety of anti-human T lymphocyte porcine immunoglobulin (P-ATG) with recombinant human tumor necrosis factor-α receptor Ⅱ:IgG Fc fusion protein (rhTNFR∶Fc, Etanercept) on grade Ⅲ/Ⅳ acute graft-versus-host disease (aGVHD) after allogenic hematopoietic stem cell transplantation (allo-HSCT) .Methods:Thirty-five patients with Grade Ⅲ/Ⅳ aGVHD who received P-ATG with etanercept therapy after allo-HSCT were retrospectively analyzed. P-ATGs (5 mg·kg -1·d -1) were administrated for 3 to 5 days, and then 5mg/kg was sequentially administrated, QOD to BIW. Etanercepts were administrated 25 mg, twice a week (12.5 mg, BIW for pediatric patients) . Results:Among the 35 patients with grade Ⅲ/Ⅳ aGVHD, 21 were males and 14 females, with a median age of 10 (3-54) years. A total of 19 cases of acute myeloid leukemia, 13 of acute lymphoblastic leukemia, 1 of severe aplastic anemia, 1 of myelodysplastic syndrome, and 1 of mixed phenotypic acute leukemia were noted. The overall response (OR) rate of P-ATG with etanercept was 85.7% (30/35) , with complete response (CR) and partial response (PR) rates of 34.3% (12/35) and 51.4% (18/35) , respectively, on day 28. The OR rate of grade Ⅲ aGVHD group was higher than of grade IV aGVHD group [100% (19/19) vs. 68.8% (11/16) , P=0.004]. On day 56, the OR rate became 77.2% (27/35) , with CR and PR rates of 62.9% (22/35) and 14.3% (5/35) , respectively. The OR rate of grade Ⅲ aGVHD group was also higher than of grade Ⅳ aGVHD group [89.5% (17/19) vs. 62.5% (10/16) , P=0.009]. Thirty-five patients had no adverse effects such as fever, chills, and rash during the P-ATG infusion, and no obvious liver and kidney function damage was observed after treatment. The main treatment-related complication was infection. The reactivation rates of CMV and EBV were 77.1% (27/35) and 22.9% (8/35) , respectively, and the bacterial infection rate was 48.6% (17/35) . With a median follow-up time of 13 (1-55) months after HSCT, the 1-year and 2-year OS rates were (68.1±8.0) % and (64.3±8.4) % , respectively. The 1-year OS rate of grade Ⅲ aGVHD group was superior to grade Ⅳ aGVHD group [ (84.2±8.4) % vs. (47.6±13.1) % , χ2=3.38, P=0.05]. Conclusion:This study demonstrated that P-ATG with etanercept was effective and safe in treating grade Ⅲ-Ⅳ aGVHD after allo-HSCT.
