Table 2.
Percentage of patients with at least one infection during the treatment period a
| n / N (%) | ||
|---|---|---|
| 60 mg ( N = 60) | 60 mg/120 mg ( N = 121) | |
| B cells, cells/μl | ||
| >50% reduction | 10/38 (26%) | 29/66 (44%) |
| ≤50% reduction | 9/16 (56%) | 21/42 (50%) |
| No reduction | 3/5 (60%) | 6/10 (60%) |
| Serum IgG | ||
| ≥5.65 g/L | 22/58 (38%) | 56/118 (48%) |
| <5.65 to ≥4.24 g/L | 0/1 (0%) | 2/2 (100%) |
| <4.24 g/L | 0/0 (0%) | 0/1 (0%) |
| Serum IgM | ||
| ≥0.40 g/L | 22/57 (39%) | 55/113 (49%) |
| <0.40 to ≥0.30 g/L | 0/2 (0%) | 1/4 (25%) |
| <0.30 g/L | 0/0 (0%) | 2/4 (50%) |
| Serum IgA | ||
| ≥0.70 g/L | 22/59 (37%) | 58/120 (48%) |
| <0.70 to ≥0.525 g/L | 0/0 (0%) | 0/0 (0%) |
| <0.525 g/L | 0/0 (0%) | 0/1 (0%) |
aIg, Immunoglobulin; n, Number of patients with at least one infection with analyte measurement in that category; N, Number of patients with analyte measurement in that category; RCT, Randomized control trial. For patients assigned to receive tabalumab in the first or second randomized controlled trial (RCT1 or RCT2, respectively) pretabalumab baseline data were collected at week 0 of RCT1 or RCT2. For patients assigned to receive placebo in RCT1 or RCT2, pretabalumab baseline data were collected either before receiving an optional 80-mg tabalumab rescue dose at week 16 in RCT1 or at the time of open-label extension study entry.