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. 2017 Jan 6;6(3):e1277307.
doi: 10.1080/2162402X.2016.1277307. eCollection 2017.

Combining therapeutic antibodies using basiliximab and etanercept for severe steroid-refractory acute graft-versus-host disease: A multi-center prospective study

Yamin Tan  1 , Haowen Xiao  2 , Depei Wu  3 , Yi Luo  1 , Jianping Lan  4 , Qifa Liu  5 , Kang Yu  6 , Jimin Shi  1 , Jingsong He  1 , Weiyan Zheng  1 , Xiaoyu Lai  1 , Yuanyuan Zhu  1 , Kaili Du  1 , Yishan Ye  1 , Yanmin Zhao  1 , Gaofeng Zheng  1 , Yongxian Hu  1 , Xiaoyan Han  1 , Yanlong Zheng  1 , Guoqing Wei  1 , Zhen Cai  1 , He Huang  1
Affiliations

Combining therapeutic antibodies using basiliximab and etanercept for severe steroid-refractory acute graft-versus-host disease: A multi-center prospective study

Yamin Tan et al. Oncoimmunology. .

Abstract

Acute graft versus host disease (aGVHD) remains a major problem after allogeneic hematopoietic stem cell transplantation. Standard frontline therapy for aGVHD involves corticosteroids. However, fewer than half of patients have a lasting complete response. The long-term mortality rate of steroid-refractory aGVHD (SR-aGVHD) remains around 70%. To date, no consensus has been reached regarding the optimal salvage treatment for SR-aGVHD. We performed the first prospective, multi-center clinical trial to assess the efficacy and safety of a novel approach to treat severe (grades III-IV) SR-aGVHD with the combination of basiliximab and etanercept. Sixty-five patients with severe SR-aGVHD from six centers were included. The median number of basiliximab infusions was 4 (range 2-11) and of etanercept was 9 (range 2-12). At day 28 after starting the combination treatment, overall response (complete and partial response: CR+PR) to second-line treatment was 90.8% with 75.4% being CR. The incidences of CR per organ were 100%, 73.8%, and 79.7% for skin, liver, and gut involvement, respectively. Patients >30-y old (p = 0.043, RR = 3.169), development of grades III-IV liver aGVHD (p = 0.007, RR = 5.034) and cytomegalovirus (CMV) reactivation (p = 0.035, RR = 4.02) were independent predictors for incomplete response. Combined treatment with basiliximab and etanercept resulted in improved CR to visceral aGVHD and significantly superior 2-y overall survival (54.7% vs. 14.8%, p <0.001) compared with classical salvage treatments. Our data suggest that the combination of basiliximab and etanercept may constitute a promising new treatment option for SR-aGVHD.

Keywords: Basiliximab; etanercept; hematopoietic stem cell transplantation; steroid-refractory acute GVHD.

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Figures

Figure 1.
Figure 1.
Probabilities of (A) pulmonary fungal infections, (B) relapse, and (C) NRM according to the novel combined second-line therapy.
Figure 2.
Figure 2.
Overall survival by study arm (p < 0.001).
See this image and copyright information in PMC

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