Basiliximab for steroid-refractory acute graft-versus-host disease: A real-world analysis,American Journal of Hematology

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Basiliximab for steroid-refractory acute graft-versus-host disease: A real-world analysis
American Journal of Hematology ( IF 10.1 ) Pub Date : 2022-01-22 , DOI: 10.1002/ajh.26475
Xiao-Dong Mo _{1,

2} , Shen-Da Hong ₃ , Yan-Li Zhao ₄ , Er-Lie Jiang ₅ , Jing Chen ₆ , Yang Xu ₇ , Zi-Min Sun ₈ , Wei-Jie Zhang ₉ , Qi-Fa Liu ₁₀ , Dai-Hong Liu ₁₁ , Ding-Ming Wan ₁₂ , Wen-Jian Mo ₁₃ , Han-Yun Ren ₁₄ , Ting Yang ₁₅ , He Huang ₁₆ , Xi Zhang ₁₇ , Xiao-Ning Wang ₁₈ , Xian-Min Song ₁₉ , Su-Jun Gao ₂₀ , Xin Wang ₂₁ , Yi Chen ₂₂ , Bing Xu ₂₃ , Ming Jiang ₂₄ , Xiao-Bing Huang ₂₅ , Xin Li ₂₆ , Hong-Yu Zhang ₂₇ , Hong-Tao Wang ₂₈ , Zhao Wang ₂₉ , Ting Niu ₃₀ , Ji-Shi Wang ₃₁ , Ling-Hui Xia ₃₂ , Xiao-Dan Liu ₃₃ , Fei Li ₃₄ , Fang Zhou ₃₅ , Tao Lang ₃₆ , Jiong Hu ₃₇ , Sui-Jing Wu ₃₈ , Xiao-Jun Huang _{1,

2,

39,

40}

Affiliation

Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Beijing, China.
Research Unit of Key Technique for Diagnosis and Treatments of Hematologic Malignancies, Chinese Academy of Medical Sciences (2019RU029), Beijing, China.
National Institute of Health Data Science at Peking University, Peking University Health Science Center, Beijing, China.
Hebei Yanda Lu Daopei Hospital, Beijing Lu Daopei Institute of Hematology, Beijing, China.
State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China.
Department of Hematology and Oncology, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
National Clinical Research Center for Hematologic Diseases, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.
Department of Hematology, the First Affiliated Hospital of University of Science and Technology of China, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.
Department of Hematology, Aerospace Center Hospital, Beijing, China.
Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Department of Hematology, Chinese PLA General Hospital, Beijing, China.
Department of Hematology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Department of Hematology, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, Guangzhou, China.
Department of Hematology, Peking University First Hospital, Beijing, China.
Fujian Medical University Union Hospital, Fujian Institute of Hematology, Department of Hematology, Fujian Provincial Key Laboratory of Hematology, Fuzhou, China.
Bone Marrow Transplantation Center, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Medical Center of Hematology, Xinqiao Hospital, Army Medical University; State Key Laboratory of Trauma, Burn and Combined Injury, Chongqing, China.
Department of Hematology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Department of Hematology, Shanghai general Hospital affiliated to Shanghai Jiaotong University, Shanghai, China.
Department of Hematology, the First Hospital of Jilin University, Changchun, China.
Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China.
Department of Hematology, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou Key Laboratory of Hematology, Wenzhou, China.
The First Affiliated Hospital of Xiamen University, Xiamen University Institute of Hematology, Xiamen, China.
Hematologic Disease Center, the First Affiliated Hospital of Xinjiang Medical University, Xinjiang Uygur Autonomous Region Research Institute of Hematology Xinjiang Medical University, Urumqi, China.
Department of Hematology, Sichuan Provincial People's Hospital, Affiliated Hospital of University of Electronic Science and Technology of China, Chengdu, China.
Department of Hematology, the Third Xiangya Hospital, Central South University, Changsha, China.
Department of Hematology, Peking University Shenzhen Hospital, Shenzhen, China.
Department of Hematology, Shengjing Hospital of China Medical University, Shenyang, China.
Department of Hematology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
Department of Hematology, West China hospital, Sichuan University, Chengdu, China.
Guizhou Province Hematopoietic Stem Cell Transplantation Center, Department of Hematology, Key Laboratory of Hematological Disease Diagnostic and Treat Centre of Guizhou Province, The Affiliated Hospital of Guizhou Medical University, Guiyang, China.
Division of Bone Marrow Transplantation, Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Department of Hematology, the Affiliated Hospital of Qingdao University, Qingdao, China.
Department of Hematology, the First Affiliated Hospital of Nanchang University, Nanchang, China.
Department of Hematology, the 960 Hospital of the PLA Joint Logistics Support Force, Jinan, China.
Department of Hematology, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China.
Blood and Marrow Transplantation Center, Department of Hematology, Shanghai Institute of Hematology, Collaborative Innovation Center of Hematology, Rui Jin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Department of Hematology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, Guangzhou, China.
Peking-Tsinghua Center for Life Sciences, Beijing, China.
Collaborative Innovation Center of Hematology, Peking University, Beijing, China.

Steroid-refractory (SR) acute graft-versus-host disease (aGVHD) is one of the leading causes of early mortality after allogeneic hematopoietic stem cell transplantation (allo-HSCT). We investigated the efficacy, safety, prognostic factors, and optimal therapeutic protocol for SR-aGVHD patients treated with basiliximab in a real-world setting. Nine hundred and forty SR-aGVHD patients were recruited from 36 hospitals in China, and 3683 doses of basiliximab were administered. Basiliximab was used as monotherapy (n = 642) or in combination with other second-line treatments (n = 298). The cumulative incidence of overall response rate (ORR) at day 28 after basiliximab treatment was 79.4% (95% confidence interval [CI] 76.5%–82.3%). The probabilities of nonrelapse mortality and overall survival at 3 years after basiliximab treatment were 26.8% (95% CI 24.0%–29.6%) and 64.3% (95% CI 61.2%–67.4%), respectively. A 1:1 propensity score matching was performed to compare the efficacy and safety between the monotherapy and combined therapy groups. Combined therapy did not increase the ORR; conversely, it increased the infection rates compared with monotherapy. The multivariate analysis showed that combined therapy, grade III–IV aGVHD, and high-risk refined Minnesota aGVHD risk score before basiliximab treatment were independently associated with the therapeutic response. Hence, we created a prognostic scoring system that could predict the risk of having a decreased likelihood of response after basiliximab treatment. Machine learning was used to develop a protocol that maximized the efficacy of basiliximab while maintaining acceptable levels of infection risk. Thus, real-world data suggest that basiliximab is safe and effective for treating SR-aGVHD.

更新日期：2022-01-22

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