Tocilizumab vs Azathioprine in Neuromyelitis Optica Spectrum Disorders

Summary

In neuromyelitis optica spectrum disorder (NMOSD),interleukin-6 (IL-6) may play an important role in facilitating plasma cells to produce pathological aquaporin 4 (AQP4) autoantibody. Inhibition of IL-6 signaling pathway by Tocilizumab (ACTEMRA®), a humanized monoclonal antibody may have shown beneficial clinical effects in a few patients with NMOSD. Larger scale clincial trials may be needed to observe its efficacy and safety. Here, by choosing azathioprine, one of the most frequently used medication in case of relapses, the investigators compare the safety and efficacy of tocilizumab in preventing NMOSD attacks.

Timeline

Start

2017-11-01

Primary completion

2019-09-01

Completion

2019-09-01

Outcome

Met primary endpoint

paper median time to the first relapse was longer in the tocilizumab group than the azathioprine group (78·9 weeks [IQR 58·3-90·6] vs 56·7 [32·9-81·7] weeks; p=0·0026). PMID 32333897 ↗

paper Tocilizumab significantly reduced the risk of a subsequent NMOSD relapse compared with azathioprine. PMID 32333897 ↗

Publications

• Zhang C, Zhang M, Qiu W, Ma H, Zhang X, Zhu Z, Yang CS, Jia D, Zhang TX, Yuan M, Feng Y, Yang L, Lu W, Yu C, Bennett JL, Shi FD; TANGO Study Investigators. Safety and efficacy of tocilizumab versus azathioprine in highly relapsing neuromyelitis optica spectrum disorder (TANGO): an open-label, multicentre, randomised, phase 2 trial. Lancet Neurol. 2020 May;19(5):391-401. doi: 10.1016/S1474-4422(20)30070-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Azathioprine	Small molecule	2 mg/kg	Oral
Comparator	Azathioprine	Small molecule	3 mg/kg	Oral
Subject	Tocilizumab	Monoclonal antibody	8 mg/kg	Intravenous

Indications