Table 2 Overview of safety and efficacy of RTX treatment stratified by age
All patients | Age group (years) | |||
|---|---|---|---|---|
<40 | 40 to <60 | ≥60 | ||
Safety, n (%) | ||||
No. of patients | 2,484 | 204 | 1,187 | 1,029 |
ADRs | 532 (21.4) | 52 (25.5) | 264 (22.2) | 200 (19.4) |
Serious ADRs | 76 (3.1) | 5 (2.5) | 30 (2.5) | 33 (3.2) |
Infusion reactions | 157 (6.3) | 25 (12.3)* | 83 (7.0)* | 42 (4.1)* |
Deaths | 9 (0.4) | 0 | 3 (0.3) | 6 (0.6) |
Efficacy, DAS28 (mean [SD]) | ||||
Course 1 | ||||
No. of patients (baseline) | 1,954 | 163 | 975 | 814 |
Baseline | 5.7 (1.2) | 5.3 (1.3) | 5.7 (1.2) | 5.8 (1.2) |
Month 4 | 4.3 (1.4) | 4.0 (1.5) | 4.3 (1.4) | 4.3 (1.3) |
Month 8 | 4.3 (1.4) | 3.8 (1.7) | 4.4 (1.5) | 4.3 (1.3) |
Course 2 | ||||
No. of patients (baseline) | 1,315 | 117 | 660 | 537 |
Baseline | 5.0 (1.3) | 4.7 (1.5) | 5.0 (1.3) | 5.1 (1.2) |
Month 4 | 4.0 (1.3) | 3.6 (1.4) | 4.0 (1.4) | 4.0 (1.3) |
Month 8 | 4.0 (1.4) | 3.5 (1.6) | 4.1 (1.3) | 3.9 (1.4) |