Table 1:
Baseline characteristics
| Patients receiving satralizumab (n=63) | Patients receiving placebo (n=32) | |
|---|---|---|
| Age, years | 45·3 (12·0) | 40·5 (10·5) |
| Age at clinical presentation, years | 36·4(107) | 39·3 (13·3) |
| Sex | ||
| Male | 17(27%) | 1 (3%) |
| Female | 46 (73%) | 31(97%) |
| Diagnosis* | ||
| Neuromyelitis optica | 47(75%) | 24(75%) |
| Neuromyelitis optica spectrum disorder | 16 (25%) | 8 (25%) |
| AQP4-lgG seropositive | 41(65%) | 23 (72%) |
| Annualised relapse rate | 1·4 (0·6) | 1·5(07) |
| Expanded Disability Status Scale score | 3·9 (1·5) | 3·7(1·6) |
| Visual Analogue Scale pain score | ||
| Mean (SD) | 31·7(28·9) | 27·6(30·8) |
| Median (range) | 25 (0–94) | 9 (0–90) |
| Functional Assessment of Chronic Illness Therapy fatigue score | ||
| Mean (SD) | 30·6(11·7) | 29·7(12·9) |
| Median (range) | 30(6–52) | 31(5–48) |
| Race or ethnicity | ||
| American Indian or Alaska Native | 2(3%) | 0 |
| Asian (non-Japanese) | 8 (13%) | 6 (19%) |
| Black or African American | 13 (21%) | 3 (9%) |
| White | 37(59%) | 22 (69%) |
| Other | 3(5%) | 1(3%) |
| Previous treatment | ||
| B-cell-depleting therapy | 8 (13%) | 4(13%) |
| Immunosuppressants or other | 55(87%) | 28 (88%) |
| Disease duration, weeks | 317·8 (340·9) | 214·7(201·3) |
| Type of most recent attack | ||
| First attack | 7(11%) | 4(13%) |
| Relapse | 56(89%) | 28 (88%) |
Data are mean (SD) or n (%).
*
Patients had neuromyelitis optica by Wingerchuk and colleagues’ 2006 criteria23 (aquaporin-4 autoantibodies [AQP4-lgG] seropositive or seronegative); or neuromyelitis optica spectrum disorder by Wingerchuk and colleagues’ 2007 criteria7 (AQP4-lgG seropositive only), with idiopathic single or recurrent events of longitudinally extensive myelitis (≥3 vertebral segment spinal cord MRI lesion) or single, recurrent, or simultaneous bilateral optic neuritis.