Summary of infections in patients with IgG/IgM <LLN for at least 4 months
| Patients with IgG<LLN* | Patients with IgM<LLN* | |||||
|---|---|---|---|---|---|---|
| Before <LLN (n=112) | During/after <LLN (n=112) | Never <LLN (n=3082) | Before <LLN (n=717) | During/after <LLN (n=717) | Never <LLN (n=2477) | |
| Total pt-years | 223 | 307 | 11 432 | 1171 | 2084 | 8707 |
| Infections, n | 325 | 262 | 9179 | 1264 | 1699 | 6803 |
| Infections/100 pt-years (95% CI) | 146 (131 to 162) | 85 (76 to 96) | 80 (79 to 82) | 108 (10 to 114) | 82 (78 to 86) | 78 (76 to 80) |
| SIEs, n | 18 | 28 | 425 | 34 | 98 | 339 |
| SIEs/100 pt-years (95% CI) | 8.06 (5.08 to 12.80) | 9.13 (6.30 to 13.22) | 3.72 (3.38 to 4.09) | 2.90 (2.0 to 4.06) | 4.70 (3.86 to 5.73) | 3.89 (3.50 to 4.33) |
*Below LLN for ≥4 months. LLN of Ig levels varied according to the central laboratory used and depended on various patient-related factors (such as age and gender). ‘Before’ refers to patient follow-up after rituximab treatment but prior to Ig levels falling below LLN. ‘During/after’ refers to follow-up once Ig levels have fallen below LLN.
Ig, immunoglobulin; LLN, lower limit of normal; pt-year, patient-year; SIE, serious infection event.