Table 2.
6-month B-cell counts versus long-term disease activity.
| RR (95% CI) | Number of participants | Total patient-years of observation | p | |
|---|---|---|---|---|
| Annualised attack rate | ||||
| Log10 memory B cells | 2.06 (1.11−3.81) | 170 | 527 | 0.022 |
| Log10 6-month CD20+ B cells | 1.61 (1.04−2.49) | 197 | 582 | 0.031 |
| Rate of new/enlarging T2 MRI lesions | ||||
| Log10 memory B cells | 1.93 (1.44−2.59) | 145 | 392 | <0.0001 |
| Log10 6-month CD20+ B cells | 1.62 (1.32−1.99) | 166 | 432 | <0.0001 |
| EDSS worsening rate | ||||
| Log10 memory B cells | 1.56 (0.99−2.47) | 169 | 508 | 0.058 |
| Log10 6-month CD20+ B cells | 1.24 (0.89−1.74) | 196 | 562 | 0.210 |
| NMOSD-related inpatient hospitalisation rate | ||||
| Log10 memory B cells | 1.87 (1.01–3.45) | 170 | 533 | 0.047 |
| Log10 6-month CD20+ B cells | 1.56 (0.99−2.45) | 197 | 589 | 0.056 |
CI = confidence interval, EDSS = Expanded Disability Status Scale, MRI = magnetic resonance imaging, NMOSD = neuromyelitis optica spectrum disorder, OLP = open-label period, RCP = randomised controlled period, RR = rate ratio, W26 = week 26 after treatment initiation, W28 = week 28 after treatment initiation.
Negative binomial regression analysis of B-cell counts at 6 months after treatment (W28 RCP for participants treated with inebilizumab who completed the RCP, W26 OLP for participants randomised to placebo and participants treated with inebilizumab who transitioned into the OLP early) versus the annualised attack rate, rate of new/enlarging T2 MRI lesions, EDSS worsening rate (participants/year), and rate of NMOSD-related inpatient hospitalisations that occurred after the first dosing period of inebilizumab treatment.