Safety and efficacy of tocilizumab versus azathioprine in highly relapsing neuromyelitis optica spectrum disorder (TANGO): an open-label, multicentre, randomised, phase 2 trial

Zhang, Chao; Zhang, Meini; Qiu, Wei; Ma, Hongshan; Zhang, Xinghu; Zhu, Zilong; Yang, Chun-Sheng; Jia, Dongmei; Zhang, Tianxiang; Yuan, Meng; Yan, Feng; Yang, Li; Lu, Wenli; Yu, Chunshui; Bennett, Jeffrey L.; Shi, Fu‐Dong; Investigators, Tango Study

doi:10.1016/s1474-4422(20)30070-3

Cited by 190 publications

(160 citation statements)

References 27 publications

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“…The results indicated that subcutaneous injection might be a more convenient route for administration of TCZ in patients with NMOSD. In a recently published phase II randomized controlled clinical trial (TANGO trial), 118 patients with NMOSD were randomly divided into a group receiving TCZ (n=59) and a group receiving AZA (n=59) (38). In addition to the original treatment with immunosuppressive agents, TCZ or AZA was taken for a total of 60 weeks, and the results showed that the median time to first relapse was longer in patients taking TCZ compared with patients taking AZA (78.9 vs. 56.7 weeks; P=0.0026).…”

Section: Interleukin (Il)-6 Receptor (Il-6r) Antagonistsmentioning

confidence: 99%

New progress in the treatment of neuromyelitis optica spectrum disorder with monoclonal antibodies (Review)

Xie

Sun

et al. 2020

Exp Ther Med

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Section: Interleukin (Il)-6 Receptor (Il-6r) Antagonistsmentioning

confidence: 99%

New progress in the treatment of neuromyelitis optica spectrum disorder with monoclonal antibodies (Review)

Xie

Sun

et al. 2020

Exp Ther Med

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“…Satralizumab and tocilizumab are both humanized recombinant monoclonal antibodies targeting interleukin-6 receptor (IL-6R), however, according to previous studies satralizumab has better pharmacokinetics than tocilizumab via antibody recovery technique. Further, based on previous clinical trials, satralizumab, and tocilizumab both reduced the NMOSD relapse risk (25)(26)(27), while satralizumab appeared to have no effects on reducing the pain and fatigue of patients (27). Eculizumab can reduce the damage related with the inflammatory response to the nervous system by inhibiting the complement protein C5 and blocking terminal complement activation (28).…”

Section: Introductionmentioning

confidence: 99%

Different Targets of Monoclonal Antibodies in Neuromyelitis Optica Spectrum Disorders: A Meta-Analysis Evidenced From Randomized Controlled Trials

Xue

Chen

et al. 2020

Front. Neurol.

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Background: Neuromyelitis optica spectrum disorder (NMOSD), an autoimmune inflammatory disorder of the central nervous system, often leads to vision loss or paralysis. This meta-analysis focused on the assessment of the monoclonal antibody therapy in NMOSD and compared different targets of monoclonal antibodies with each other in terms of efficacy and safety outcomes.Method: We searched through the databases of MEDLINE, EMBASE, Central Register of Controlled Trials (CENTRAL), and clinicaltrials.gov for randomized controlled trials (RCTs) evaluating monoclonal antibody therapy in NMOSD up to April 2020.Results: We identified seven randomized controlled trials (RCTs), including 775 patients (monoclonal antibody group, n = 485 and placebo group, n = 290). Monoclonal antibody therapy decreased relapse risk (RR 0.33, 95% CI 0.21–0.52, P < 0.00001), annualized relapse rate (ARR) (mean −0.28, 95% CI −0.35−0.20, P < 0.00001), expanded disability status scale score (EDSS) (mean −0.19, 95% CI −0.32−0.07, P = 0.002) and serious adverse events (RR 0.78, 95% CI 0.61–1.00, P = 0.05). However, we did not observe any significant difference in terms of adverse events or mortality. Further, the subgroup analysis demonstrated that the anti-complement protein C5 monoclonal antibody (eculizumab) might have a lower relapse risk (RR 0.07, 95% CI 0.02–0.23, P < 0.0001) in the AQP4 seropositive patients, and anti-interleukin-6 receptor monoclonal antibodies (satralizumab and tocilizumab) showed decreased EDSS score (mean −0.17, 95% CI −0.31−0.02, P = 0.02) more effectively than other monoclonal antibodies.Conclusions: Monoclonal antibodies were effective and safe in NMOSD. Different targets of monoclonal antibodies might have their own advantages.

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“…Although not a standard strategy, long-term oral low-dose corticosteroids are also used as relapse prevention therapy in some facilities (17,18). Other monoclonal antibodies, such as eculizumab, tocilizumab, satralizumab, and inebilizumab, are also known to effectively suppress autoimmunity and relapses in NMOSD, although not all these listed drugs have been approved yet (19)(20)(21)(22).…”

Section: Introductionmentioning

confidence: 99%

Rapid Administration of High-Dose Intravenous Methylprednisolone Improves Visual Outcomes After Optic Neuritis in Patients With AQP4-IgG-Positive NMOSD

et al. 2020

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The purpose of this study was to elucidate the rapid impact of high-dose intravenous methylprednisolone pulse therapy (1,000 mg/day for 3 days) on the eventual visual prognosis in patients with serum anti-aquaporin-4 immunoglobulin G (AQP4-IgG)-positive neuromyelitis optica spectrum disorders (NMOSDs) who had an attack of optic neuritis (ON). Methods: Data from 32 consecutive NMOSD patients (1 male and 31 female) with at least one ON attack, involving a total of 36 ON-involved eyes, were evaluated. The following variables at ON onset were evaluated: sex, age at the first ON episode, visual acuity at nadir, visual acuity after 1 year, duration from ON onset to treatment for an acute ON attack, cycles of high-dose intravenous methylprednisolone pulse therapy for the ON attack, and cycles of plasmapheresis for the ON attack. Among the 36 ON-involved eyes, 27 eyes were studied using orbital MRI with a short-T1 inversion recovery sequence and gadolinium-enhanced fat-suppressed T1 imaging before starting treatment in the acute phase. Results: In univariate analyses, a shorter duration from ON onset to the initiation of high-dose intravenous methylprednisolone pulse therapy favorably affected the eventual visual prognosis 1 year later (Spearman's rho = 0.50, p = 0.0018). The lesion length on orbital MRI was also correlated with the eventual visual prognosis (rho = 0.68, p < 0.0001). Meanwhile, the days to steroid pulse therapy and lesion length on orbital MRI did not show a significant correlation. These findings suggest that the rapidness of steroid pulse therapy administration affects the eventual visual prognosis independent of the severity of ON. In multivariate analysis, a shorter time from ON onset to the start of acute treatment (p = 0.0004) and a younger age at onset (p = 0.0071) were significantly associated with better visual outcomes. Akaishi et al. IVMP Pulse Therapy in AQP4-ON Conclusions: Rapid initiation of high-dose intravenous methylprednisolone pulse therapy is essential to preserve the eventual visual acuity in patients with serum AQP4-IgG-positive NMOSD. Once clinicians suspect acute ON with serum AQP4-IgG, swift administration of steroid pulse therapy before confirming the positivity of serum AQP4-IgG would be beneficial for preserving visual function.

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Safety and efficacy of tocilizumab versus azathioprine in highly relapsing neuromyelitis optica spectrum disorder (TANGO): an open-label, multicentre, randomised, phase 2 trial

Cited by 190 publications

References 27 publications

New progress in the treatment of neuromyelitis optica spectrum disorder with monoclonal antibodies (Review)

New progress in the treatment of neuromyelitis optica spectrum disorder with monoclonal antibodies (Review)

Different Targets of Monoclonal Antibodies in Neuromyelitis Optica Spectrum Disorders: A Meta-Analysis Evidenced From Randomized Controlled Trials

Rapid Administration of High-Dose Intravenous Methylprednisolone Improves Visual Outcomes After Optic Neuritis in Patients With AQP4-IgG-Positive NMOSD

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