Tocilizumab versus Azathioprine in highly relapsing neuromyelitis optica spectrum disorders (TANGO): a head-to-head comparative study
ECTRIMS Online Library. Shi F. Sep 12, 2019; 279439; 140
Fu-Dong Shi
Fu-Dong Shi
Contributions
Abstract

Abstract: 140

Type: Free Communications

Abstract Category: Clinical aspects of MS - Neuro-ophthalmology

C. Zhang1, M. Zhang2, W. Qiu3, H. Ma4, X. Zhang5, Z. Zhu6, C. Yang1,5, Y. Liu1, D. Jia1, R. Zhang1, M. Yuan1, T. Zhang1, Y. Feng1, L. Yang1, C. Yu7, F.-D. Shi1,5,8

1Neurology, Tianjin Medical University General Hospital, Tianjin, 2Neurology, First Hospital of Shanxi Medical University, Taiyuan, 3Neurology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 4The Third People's Hospital of Datong, Datong, 5National Clinical Research Center for Neurological Diseases of China, Center for Neuroinflammation, Beijing Tiantan Hospital, Beijing, 6Huanhu Hospital, 7Radiology, Tianjin Medical University General Hospital, Tianjin, China, 8Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, AZ, United States

Introduction and aims: Tocilizumab, a humanised anti-IL-6R monoclonal antibody, reduced disease progression of neuromyelitis optica spectrum disorders (NMOSD) in previous non-randomised case series studies. We aim to compare the safety and efficacy of tocilizumab and azathioprine in patients with highly relapsing NMOSD.
Methods: In the ongoing, investigator-initiated, randomised, open-label, parallel-group study (TANGO: ClinicalTrials.gov, number NCT03350633), NMOSD patients aged 18-65 years with at least two attacks in the preceding year or three attacks in the previous 2 years were enrolled. Patients were randomly assigned 1:1 to receive 8 mg/kg intravenous tocilizumab monthly or 2-3 mg/kg oral azathioprine daily. Treatment was administered in conjunction with gradual discontinuation of the previous treatments, followed by monotherapy for 12 months. The primary endpoint was set at the first relapse following beginning of study participation. .
Results: Between Oct, 2017 and Aug, 2018, we screened 198 patients and enrolled 118 as potential participants across six centers throughout China. Random assortment of these patients assigned 59 to receive tocilizumab and 59 were assigned to receive azathioprine. After a mean observation period of 48 weeks (in the interim), the proportion of relapse-free was 91.5% in the tocilizumab group and 67.8% in the azathioprine group (hazard ratio [HR]=0.32, 95%CI 0.14-0.70, p=0.004). Sustained reduction in disability was more likely among patients treated with tocilizumab than patients with azathioprine (HR=0.34, 95% CI 0.13-0.90, p=0.03). Serum levels of anti-AQP4-ab were reduced significantly by 42% with tocilizumab compared to 15% with azathioprine (p=0.03). Treatment-associated adverse events were reported in 20 patients (34%) receiving tocilizumab including fatigue, skin rash, leukopenia or elevated liver enzyme. 33 patients (56%) receiving azathioprine presented with leukopenia, liver dysfunction, or infection. Three patients receiving azathioprine had severe adverse events that led to withdrawal.
Interpretation: TANGO interim results show that tocilizumab had a significant risk reduction and a favorable safety profile over azathioprine for highly relapsing NMOSD. The final trial outcomes will be announced in September 2019.
Disclosure: Chao Zhang: nothing to disclose
Meini Zhang: nothing to disclose
Wei Qiu: nothing to disclose
Hongshan Ma: nothing to disclose
Xinghu Zhang: nothing to disclose
Zilong Zhu: nothing to disclose
Chunsheng Yang: nothing to disclose
Ye Liu: nothing to disclose
Dongmei Jia: nothing to disclose
Rui Zhang: nothing to disclose
Meng Yuan: nothing to disclose
Tianxiang Zhang: nothing to disclose
Yan Feng: nothing to disclose
Li Yang: nothing to disclose
Chunshui Yu: nothing to disclose
Fu-Dong Shi: nothing to disclose

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