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Table 3 Predicted and observed percentages of patients affected by first serious infectious event

From: Use of a baseline risk score to identify the risk of serious infectious events in patients with rheumatoid arthritis during certolizumab pegol treatment

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
  1. Abbreviations: SIE Serious infectious event, CZP Certolizumab pegol, AACI Age-adjusted comorbidity index, RCT CZP Patients randomized to CZP in the RAPID1/RAPID2 randomized controlled trials, All CZP All patients treated with CZP during the RAPID1/RAPID2 randomized controlled trials and/or open label extensions, CI Confidence interval
  2. aPercentage of patients affected by the first SIE up to the indicated time since the first CZP dose
  3. bOne-year predicted rates in RCT CZP correspond to 301 days (~10 months) because Kaplan-Meier estimates were not defined beyond the last SIE date