Safety outcome data for anakinra 50–150 mg compared to placebo†.
| Anakinra, n/N (%) | Placebo, n/N (%) | Absolute Risk Difference (%) | NNH* | Risk Ratio (Confidence intervals) | Studies | |
|---|---|---|---|---|---|---|
| Withdrawals | 331/1479 (22.4) | 106/478 (22.2) | 0.2 | 500 | 1.04 (0.86, 1.27) | Cohen 200235
Fleischman 200334 Bresnihan 199833 |
| Deaths | 4/1116 (0.4) | 1/283 (0.4) | 0 | α | 1.01 (0.11, 9.04) | Fleischman 200334 |
| Adverse events | 1252/1366 (91.7) | 464/534 (86.9) | 4.8 | 20.8 | 1.05 (0.94, 1.17) | Fleischman 200334
Cohen 200436 |
| Serious adverse events | 96/1366 (7.0) | 30/534 (5.6) | 1.4 | 71 | 1.04 (0.70, 1.56) | Fleischman 200334
Cohen 200436 |
| Injection site reactions | 1235/1729 (71.4) | 204/729 (28.0) | 43.4 | 2.3 | 2.45 (2.17, 2.77) | Cohen 200235
Cohen 200436 Fleischman 200334 Bresnihan 199833 |
| Total infections | 543/1366 (39.8) | 188/534 (35.2) | 4.5 | 22 | 1.08 (0.80, 1.45) | Fleischman 200334
Cohen 200436 |
| Serious infections | 25/1366 (1.8) | 3/534 (0.6) | 1.2 | 83 | 3.15 (0.81, 12.20) | Fleischman 200334
Cohen 200436 |