Table 3.

Long-term outcomes in participants with 6-month B-cell counts ≤4 cells/μL versus >4 cells/μL.

	Rate/year (95% CI) Placebo RCP	Rate/year (95% CI) ≤4 cells/μL after first dosing period	Rate/year (95% CI) >4 cells/μL after first dosing period	RR (95% CI)	p
Post-6-month NMOSD attacks	1.01 (0.79–1.23)	0.034 (0.024–0.04)	0.086 (0.056–0.12)	0.40 (0.16–0.98)	0.045
Post-6-month NMOSD attacks, AQP4+ participants only	1.08 (0.85–1.31)	0.038 (0.026–0.052)	0.088 (0.058–0.12)	0.44 (0.18–1.07)	0.07
Post-6-month EDSS worsening, participants/year	1.66 (1.26–2.05)	0.076 (0.06–0.10)	0.14 (0.10–0.18)	0.55 (0.27–1.11)	0.093
Post-6-month EDSS worsening, participants/year; AQP4+ participants only	1.76 (1.34–2.18)	0.07 (0.06–0.09)	0.15 (0.10–0.19)	0.50 (0.24–1.05)	0.07
Post-6-month new/enlarging T2 MRI lesions	3.03 (2.13–3.92)	0.49 (0.43–0.56)	1.36 (1.12–1.61)	0.36 (0.23–0.56)	<0.0001
Post-6-month new T2 MRI lesions, AQP4+ participants only	3.14 (2.27–4.01)	0.51 (0.44–0.58)	1.38 (1.13–1.63)	0.37 (0.24–0.58)	<0.0001
Post-6-month NMOSD-related inpatient hospitalisations	0.53 (0.28–0.78)	0.08 (0.058–0.104)	0.18 (0.11–0.25)	0.45 (0.17–1.18)	0.11
Post-6-month NMOSD-related inpatient hospitalisations, AQP4+ participants only	0.55 (0.27–0.82)	0.08 (0.05–0.10)	0.19 (0.11–0.26)	0.41 (0.15–1.08)	0.07

AQP4+ = seropositive for immunoglobulin G autoantibodies against the aquaporin-4 water channel, CI = confidence interval, EDSS = Expanded Disability Status Scale, MRI = magnetic resonance imaging, NMOSD = neuromyelitis optica spectrum disorder, RCP = randomised controlled period, RR = rate ratio, W26 = week 26 after treatment initiation.

RR (95% CI) versus W26 B-cell cut-off point of attacks, new/enlarging T2 MRI lesions, EDSS worsening, and NMOSD-related inpatient hospitalisations that occurred after the first dosing period. RRs were calculated by comparing the rate/year at which each endpoint occurred in patients with B cells ≤4 cells/μL versus >4 cells/μL after the first dosing period; p values are shown for this comparison.