Time since first CZP dose | Data | ||||||
---|---|---|---|---|---|---|---|
RCT CZP | Percentage of patients affected by the first SIEa | Without systemic glucocorticoid use | With systemic glucocorticoid use | ||||
AACI = 0 (n = 158) | AACI = 1 (n = 250) | AACI ≥ 2 (n = 110) | AACI = 0 (n = 271) | AACI = 1 (n = 295) | AACI ≥ 2 (n = 140) | ||
3 months | Predicted (95% CI) | 0.5 (0.0–1.0) | 0.7 (0.1–1.3) | 1.4 (0.2–2.7) | 1.2 (0.3–2.1) | 1.7 (0.6–2.8) | 3.8 (1.4–6.1) |
Observed | 0.6 | 1.2 | 1.8 | 1.1 | 2.4 | 2.9 | |
6 months | Predicted (95% CI) | 0.9 (0.1–1.8) | 1.2 (0.3–2.2) | 2.5 (0.4–4.5) | 2.1 (0.6–3.5) | 3.0 (1.2–4.7) | 6.5 (2.7–10.1) |
Observed | 0.6 | 1.6 | 2.7 | 2.2 | 3.7 | 5.0 | |
1 year | Predicted (95% CI)b | 1.5 (0.2–2.8) | 1.9 (0.4–3.4) | 3.9 (0.7–7.0) | 3.3 (1.0–5.5) | 4.7 (2.0–7.2) | 10.0 (4.3–15.4) |
Observed | 0.6 | 2.0 | 3.6 | 3.0 | 4.1 | 7.1 | |
All CZP | Percentage of patients affected by the first SIEa | Without systemic glucocorticoid use | With systemic glucocorticoid use | ||||
AACI = 0 (n = 205) | AACI = 1 (n = 302) | AACI ≥ 2 (n = 130) | AACI = 0 (n = 325) | AACI = 1 (n = 379) | AACI ≥ 2 (n = 165) | ||
3 months | Predicted (95% CI) | 0.9 (0.4–1.3) | 1.2 (0.6–1.8) | 2.2 (1.1–3.3) | 1.1 (0.6–1.6) | 1.5 (0.8–2.2) | 2.8 (1.5–4.1) |
Observed | 0.5 | 1.0 | 1.5 | 0.9 | 2.1 | 3.0 | |
6 months | Predicted (95% CI) | 1.6 (0.9–2.3) | 2.3 (1.4–3.2) | 4.2 (2.5–5.8) | 2.1 (1.2–2.9) | 2.9 (1.9–3.9) | 5.2 (3.3–7.2) |
Observed | 2.0 | 1.3 | 2.3 | 2.2 | 3.7 | 5.5 | |
1 year | Predicted (95% CI) | 3.3 (2.1–4.5) | 4.6 (3.2–6.1) | 8.3 (5.5–11.0) | 4.1 (2.8–5.5) | 5.8 (4.1–7.5) | 10.4 (7.2–13.4) |
Observed | 4.4 | 2.0 | 4.6 | 4.0 | 7.1 | 10.9 | |
2 years | Predicted (95% CI) | 5.5 (3.6–7.4) | 7.7 (5.5–9.9) | 13.7 (9.5–17.7) | 6.9 (4.8–8.9) | 9.6 (7.2–12.0) | 16.9 (12.3–21.3) |
Observed | 5.9 | 4.6 | 13.8 | 6.8 | 9.8 | 12.7 |