Number of AEs and incidence rates in the complete set, overall, and by different time windows.a
| Time Windowb | 1–6 Months | 7–12 Months | 13–18 Months | 19–24 Months | > 24 Months | Overall | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| N | 306 | 194 | 144 | 106 | 104 | 306 | |||||||
| PYc | 117.3 | 80.2 | 58.1 | 47.0 | 206.7 | 509.3 | |||||||
| SOC | PT | nd | Rate (95% CI)e | nd | Rate (95% CI)e | nd | Rate (95% CI)e | nd | Rate (95% CI)e | nd | Rate (95% CI)e | nd | Rate (95% CI)e |
| All | All | 116 | 98.9 (75.8–129.0) | 26 | 32.4 (19.6–53.5) | 16 | 27.5 (14.5–52.2) | 7 | 14.9 (6.0–37.1) | 36 | 17.4 (11.1–27.4) | 201 | 39.5 (30.8–50.6) |
| Infections and infestations | All | 23 | 19.6 (12.4–31.0) | 12 | 15.0 (6.8–32.9) | 5 | 8.6 (3.6–20.7) | – | – | 12 | 5.8 (2.4–14.1) | 52 | 10.2 (6.7–15.6) |
| Pneumonia | 2 | 1.7 (0.4–6.8) | 1 | 1.2 (0.2–8.8) | 1 | 1.7 (0.2–12.2) | – | – | – | – | 4 | 0.8 (0.3–2.1) | |
| Respiratory tract infection | 2 | 1.7 (0.4–6.8) | – | – | 2 | 3.4 (0.9–13.7) | – | – | – | – | 4 | 0.8 (0.3–2.1) | |
| Skin and subcutane tissue disorders | All | 18 | 15.3 (9.5–24.7) | 3 | 3.7 (1.2–11.5) | 1 | 1.7 (0.2–12.2) | – | – | 3 | 1.5 (0.5–4.4) | 25 | 4.9 (3.2–7.5) |
| Rash | 6 | 5.1 (2.0–12.8) | 1 | 1.2 (0.2–8.8) | – | – | – | – | 1 | 0.5 (0.1–3.5) | 8 | 1.6 (0.7–3.4) | |
| General disorders and administration site conditions | All | 16 | 13.6 (8.2–22.7) | 3 | 3.7 (1.2–11.5) | 1 | 1.7 (0.2–12.2) | 1 | 2.1 (0.3–15.1) | 2 | 1.0 (0.2–3.8) | 23 | 4.5 (2.9–7.0) |
| Injection-site reaction | 7 | 6.0 (2.9–12.4) | – | – | – | – | – | – | 1 | 0.5 (0.1–3.3) | 8 | 1.6 (0.8–3.1) | |
| Gastrointestinal disorders | All | 13 | 11.1 (6.0–20.4) | 1 | 1.2 (0.2–8.8) | – | – | 1 | 2.1 (0.3–14.9) | 3 | 1.5 (0.5–4.3) | 18 | 3.5 (2.1–5.9) |
| Constipation | 5 | 4.3 (1.8–10.2) | – | – | – | – | – | – | 1 | 0.5 (0.1–3.5) | 6 | 1.2 (0.5–2.7) | |
| Abdominal pain | 3 | 2.6 (0.8–7.9) | 1 | 1.2 (0.2–8.8) | – | – | – | – | – | – | 4 | 0.8 (0.3–2.1) | |
| Injury, poisoning and procedural complications | All | 10 | 8.5 (4.6–15.8) | 1 | 1.2 (0.2–8.8) | 2 | 3.4 (0.9–13.6) | 1 | 2.1 (0.3–15.1) | 2 | 1.0 (0.3–3.7) | 16 | 3.1 (1.9–5.2) |
| Injection-related reaction | 6 | 5.1 (2.3–11.4) | 1 | 1.2 (0.2–8.8) | 2 | 3.4 (0.9–13.6) | – | – | 1 | 0.5 (0.1–3.3) | 10 | 2.0 (1.1–3.7) | |
| Immune system disorders | All | 7 | 6.0 (2.8–12.5) | 1 | 1.2 (0.2–8.8) | 2 | 3.4 (0.9–13.6) | – | – | 3 | 1.5 (0.5–4.4) | 13 | 2.6 (1.4–4.6) |
| HLH | 7 | 6.0 (2.8–12.5) | 1 | 1.2 (0.2–8.8) | 1 | 1.7 (0.2–12.2) | – | – | 3 | 1.5 (0.5–4.4) | 12 | 2.4 (1.3–4.3) |
↵a Events with a frequency of > 10 by overall SOC and > 3 by overall PT are presented in this table. For the complete table, please refer to the Supplementary Material (available with the online version of this article).
↵b In relation to baseline (beginning of anakinra treatment).
↵c PY: patient-year; only time while anakinra treatment was ongoing and 2 days after discontinuation were counted.
↵d No. of events. Only AEs occurring during anakinra exposed periods and 2 days after discontinuation were counted.
↵e Incidence rate per 100 PY. AE: adverse event; HLH: hemophagocytic lymphohistiocytosis; MedDRA: Medical Dictionary for Regulatory Activities; N: no. of patients ever treated with anakinra during the time window irrespectively of the length of any unexposed periods; PT: preferred term, MedDRA version 21.1; SOC: system organ class.