Table 1.
Subgroup | Placebo (N = 56) | Inebilizumab (N = 174) | Analysis | ||||
---|---|---|---|---|---|---|---|
Patients, n/N | Lesions, mean (SD) | Patients, n/N | Lesions, mean (SD) | RR (95% CI) | p value | Interaction test p value | |
Disease duration < 5 years | 25/46 | 2.3 (1.2) | 64/144 | 1.6 (1.0) | 0.555 (0.363–0.849) | 0.0066 | 0.8462 |
Disease duration ⩾ 5 years | 7/10 | 2.3 (1.7) | 15/30 | 1.9 (1.1) | 0.603 (0.259–1.406) | 0.2419 | |
Baseline EDSS score < 5 | 22/39 | 2.5 (1.4) | 59/129 | 1.6 (1.0) | 0.538 (0.341–0.848) | 0.0076 | 0.6901 |
Baseline EDSS score ⩾ 5 | 10/17 | 2.0 (1.1) | 20/45 | 1.7 (0.9) | 0.643 (0.319–1.295) | 0.2163 | |
Prior NMOSD attacks < 4 | 16/31 | 1.9 (1.1) | 39/93 | 1.6 (1.0) | 0.650 (0.372–1.139) | 0.1322 | 0.4503 |
Prior NMOSD attacks ⩾ 4 | 16/25 | 2.8 (1.3) | 40/81 | 1.7 (1.0) | 0.484 (0.288–0.813) | 0.0061 | |
Time to last attack < 26w | 17/33 | 2.3 (1.3) | 48/103 | 1.6 (0.9) | 0.645 (0.378–1.062) | 0.0844 | 0.4460 |
Time to last attack ⩾ 26w | 15/23 | 2.3 (1.3) | 31/71 | 1.7 (1.2) | 0.476 (0.265–0.855) | 0.0130 | |
White | 15/28 | 2.3 (1.3) | 37/92 | 1.3 (0.5) | 0.428 (0.254–0.722) | 0.0015 | 0.1887 |
Non-White | 17/28 | 2.4 (1.3) | 42/82 | 1.9 (1.3) | 0.709 (0.416–1.209) | 0.2065 | |
Asian | 6/8 | 1.7 (0.8) | 21/39 | 2.0 (1.1) | 0.886 (0.385–2.043) | 0.7772 | 0.2638 |
Non-Asian | 26/48 | 2.5 (1.3) | 58/135 | 1.5 (1.0) | 0.489 (0.318–0.752) | 0.0011 | |
Underweight/healthy | 15/29 | 2.5 (1.4) | 39/95 | 1.9 (1.3) | 0.584 (0.316–1.080) | 0.0864 | 0.8479 |
Overweight/obese | 17/27 | 2.1 (1.2) | 38/77 | 1.4 (0.6) | 0.543 (0.344–0.859) | 0.0090 | |
Prior maintenance therapy, yes | 23/38 | 2.3 (1.3) | 56/114 | 1.7 (1.0) | 0.609 (0.393–0.944) | 0.0265 | 0.5903 |
Prior maintenance therapy, no | 9/18 | 2.4 (1.3) | 23/60 | 1.5 (1.1) | 0.493 (0.236–1.030) | 0.5930 |
CI: confidence interval; EDSS: Expanded Disability Status Scale; MRI: magnetic resonance imaging; NMOSD: neuromyelitis optica spectrum disorder; RR: rate ratio; SD: standard deviation; w: weeks.