Tocilizumab vs Azathioprine in Neuromyelitis Optica Spectrum Disorders

Proportion of patients who experience relapse-free

To record whether the patients had no relapses in the follow-ups

Time frame: From baseline to 60 weeks

Worsening in EDSS

The Expanded Disability Status Scale (EDSS) is a rating system that is frequently used for classifying and standardizing the severity and progression. EDSS ranges from 0 to 10.

Time frame: Worsening from baseline in EDSS to 60 weeks

Time to Onset of Confirmed Disability Progression (CDP) for at Least 12 Weeks

Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) \>=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (\<=) 5.5 B) \>=0.5 point from the baseline EDSS score when the baseline score was \>5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 12 weeks after the initial documentation of neurological worsening. Participants who had initial disability progression with no confirmatory EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.

Time frame: From baseline to 60 weeks

Percentage of Participants With Confirmed Disability Improvement (CDI) for at Least 12 Weeks

Disability improvement was assessed only for the subgroup of participants with a baseline EDSS score of \>= 2.0. It was defined as a reduction in EDSS score of: A) \>=1.0 from the baseline EDSS score when the baseline score was \>=2 and \<=5.5 B) \>= 0.5 when the baseline EDSS score \> 5.5. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death).

Time frame: From baseline to 60 weeks

Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks

Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) \>=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (\<=) 5.5 B) \>=0.5 point from the baseline EDSS score when the baseline score was \>5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death). Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 24 weeks after the initial documentation of neurological worsening. Participants who had initial disability progression with no confirmatory EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.

Time frame: From baseline to 60 weeks

Percentage of Participants With Confirmed Disability Improvement (CDI) for at Least 24 Weeks

Disability improvement was assessed only for the subgroup of participants with a baseline EDSS score of \>= 2.0. It was defined as a reduction in EDSS score of: A) \>=1.0 from the baseline EDSS score when the baseline score was \>=2 and \<=5.5 B) \>= 0.5 when the baseline EDSS score \> 5.5. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death).

Time frame: From baseline to 60 weeks

Percentage Change in Spectral-domain Optical Coherence Tomography (SD-OCT) Average Retinal Nerve Fiber Layer (RNFL) Thickness at Week 60

Adjusted mean percentage change in thickness of the RNFL at Week 60 for the affected eye from the baseline as determined by SD-OCT.

Time frame: From baseline to 60 weeks

Percentage change in SD-OCT Average Retinal Ganglion Cell Layer/Inner Plexiform Retinal Layer (RGCL/IPL) at Week 60

Adjusted mean change in thicknesses of the RGCL/IPL at Week 60 for the affected eye from the baseline as determined by segmentation of SD-OCT.

Time frame: From baseline to 60 weeks

Change in Low-contrast Letter Acuity (LCLA) at Week 60

Adjusted mean change in LCLA at Week 60 from baseline as determined by 2.5% low contrast Sloan letter charts, adjusted for the baseline LCLA value.

Time frame: From baseline to 60 weeks

Change in High-contrast Letter Acuity (HCLA) at Week 60

Adjusted mean change in HCLA at Week 60 from baseline as determined by 100% high contrast Sloan letter charts, adjusted for the baseline HCLA value.

Time frame: From baseline to 60 weeks

Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Brain Magnetic Resonance Imaging (MRI)

The total number of new and/or enlarging T2 lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 12, 36, and 60

Time frame: From baseline to 60 weeks

Overall safety and tolerability of tocilizumab or azathioprine

Adverse events related to tocilizumab or azathioprine are recorded.

Time frame: From baseline to 60 weeks

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Treatment-emergent adverse events, treatment-emergent serious adverse events (TESAEs), including laboratory measurements as well as their changes or shift from baseline over time

Time frame: From baseline to 60 weeks

Counts of peripheral blood B cell subsets

Compare peripheral blood plasma cells before and one year after initial intervention

Time frame: From baseline to 60 weeks

Determination of serum immunoglobulins

Compare immunoglobulins before and one year after initial intervention

Time frame: From baseline to 60 weeks

Determination of serum AQP4 antibodies

Compare serum AQP4-ab titers before and one year after initial intervention

Time frame: From baseline to 60 weeks

Determination of serum cytokines

Compare serum cytokines before and one year after initial intervention

Time frame: From baseline to 60 weeks