Table 1.
Patient demographic and clinical characteristics (safety analysis set and effectiveness analysis set)
| Safety analysis set (N = 228) | Effectiveness analysis set (N = 224) | |
|---|---|---|
| Age, years, mean ± SD | 54.2 ± 13.1 | 54.4 ± 13.0 |
| Sex, n (%) | ||
| Male | 34 (14.9) | 33 (14.7) |
| Female | 194 (85.1) | 191 (85.3) |
| Duration of NMOSD, years, median (min–max) | 6.4 (0.1–40.6) | 6.3 (0.1–40.6) |
| Symptoms at NMOSD diagnosis, n (%) | ||
| Optic neuritis | 117 (51.3) | 114 (50.9) |
| Acute myelitis | 164 (71.9) | 160 (71.4) |
| Area postrema symptoms (e.g., nausea, vomiting, hiccups) | 40 (17.5) | 40 (17.9) |
| Acute brainstem syndrome | 31 (13.6) | 31 (13.8) |
| Symptomatic narcolepsy or acute diencephalic syndrome with diencephalic MRI lesions | 4 (1.8) | 4 (1.8) |
| Symptomatic cerebral syndrome with brain MRI lesions | 16 (7.0) | 16 (7.1) |
| Time from most recent NMOSD relapse to inebilizumab initiation, n (%) | ||
| ≤ 365 days | 117 (51.3) | 117 (52.2) |
| ≥ 366 days | 97 (42.5) | 93 (41.5) |
| Unknown/missing | 14 (6.1) | 14 (6.3) |
| EDSS, mean ± SD | 4.21 ± 2.35 | 4.23 ± 2.35 |
| ≥ 4.5, n (%) | 97 (42.5) | 97 (43.3) |
| ≥ 7.0, n (%) | 33 (14.5) | 33 (14.7) |
| Unknown/missing, n (%) | 31 (13.6) | 30 (13.4) |
| Comorbidities, n (%) | 157 (68.9) | 154 (68.8) |
| Hepatitis B | 3 (1.9) | 3 (1.9) |
| HIV infection | 0 | 0 |
| Other infectious diseases | 5 (3.2) | 5 (3.2) |
| Rheumatoid arthritis | 1 (0.6) | 1 (0.6) |
| Hashimoto’s disease | 8 (5.1) | 8 (5.2) |
| Systemic lupus erythematosus | 3 (1.9) | 3 (1.9) |
| Sjögren’s syndrome | 15 (9.6) | 15 (9.7) |
| Myasthenia gravis | 4 (2.5) | 4 (2.6) |
| Pernicious anemia | 1 (0.6) | 1 (0.6) |
| Other autoimmune diseases | 12 (7.6) | 12 (7.8) |
| Renal impairment | 5 (3.2) | 5 (3.2) |
| Hepatic impairment | 16 (10.2) | 16 (10.4) |
| Malignancy | 1 (0.6) | 1 (0.6) |
| Other | 134 (85.4) | 131 (85.1) |
| Glucocorticoid/immunosuppressant use at inebilizumab initiation, n (%) | ||
| Glucocorticoid use only | 142 (62.3) | 141 (62.9) |
| Immunosuppressant use only | 6 (2.6) | 6 (2.7) |
| Both glucocorticoid and immunosuppressant use | 65 (28.5) | 65 (29.0) |
| Neither glucocorticoid nor immunosuppressant use | 15 (6.6) | 12 (5.4) |
| Immunosuppressant drugs used at inebilizumab initiation, n (%) | ||
| Cyclosporine | 6 (2.6) | 6 (2.7) |
| Azathioprine | 23 (10.1) | 23 (10.3) |
| Tacrolimus hydrate | 40 (17.5) | 40 (17.9) |
| Methotrexate | 1 (0.4) | 1 (0.4) |
| Mycophenolate mofetil | 1 (0.4) | 1 (0.4) |
EDSS Expanded Disability Status Scale, HIV human immunodeficiency virus, MRI magnetic resonance imaging, NMOSD neuromyelitis optica spectrum disorder, SD standard deviation