TABLE 2.
Crude incidence rate of first anaphylactic events per 10 000 IvIg administrations by indication for IvIg, calendar period 2009–18
| Indication 1 | IvIg administrations | Anaphylactic event risk per 10 000 administrations | |||||
|---|---|---|---|---|---|---|---|
| All events | Moderate events | Severe events | |||||
| n | IR (0.95 CI) | n | IR (0.95 CI) | n | IR (0.95 CI) | ||
| All indications | 174 413 | 128 | 7.3 (6.1–8.8) | 124 | 7.1 (5.9–8.5) | 4 | 0.2 (0.0–0.6) |
| High‐dose indications | 95 335 | 78 | 8.2 (6.4–10.3) | 77 | 8.1 (6.3–10.1) | 1 | NA |
| Neurological | 65 058 | 37 | 5.7 (4.0–7.9) | 36 | 5.5 (3.8–7.7) | 1 | NA |
| Hematological | 26 899 | 34 | 12.6 (8.7–17.7) | 34 | 12.6 (8.7–17.7) | 0 | NA |
| Autoimmune | 3378 | 7 | 20.7 (8.3–42.7) | 7 | 20.7 (8.3–42.7) | 0 | NA |
| Low‐dose indications | 68 045 | 36 | 5.3 (3.7–7.4) | 34 | 5.0 (3.4–7.0) | 2 | NA |
| Immunodeficiency | 64 301 | 33 | 5.1 (3.5–7.3) | 32 | 5.0 (3.4–7.1) | 1 | NA |
| Lymphoid/blood 2 | 2282 | 2 | NA | 1 | NA | 1 | NA |
| Anti‐cancer therapy | 314 | 1 | NA | 1 | NA | 0 | NA |
| Sepsis/septicemia | 1148 | 0 | NA | 0 | NA | 0 | NA |
| Unknown indication | 11 033 | 14 | 12.7 (6.9–21.3) | 13 | 11.8 (6.2–20.2) | 1 | NA |
CI = confidence interval; IR = incidence rate; IvIg = intravenous immunoglobulin; NA = not applicable due to cell counts ≤3.
1
Mutually exclusive indication per IvIg administration determined by applying the following hierarchy: neurological disease (highest level), hematological disease, autoimmune disease, immunodeficiency, lymphoid/blood, anti‐cancer therapy and sepsis/septicemia.
2
Malignant lymphoid or hematopoietic neoplasm.