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. 2021 Feb 4;27(13):2052–2061. doi: 10.1177/1352458521988926

Table 1.

Subgroup analyses of key secondary endpoints: cumulative number of active MRI lesions, randomized controlled period.

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.