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Table 4 Observed incidence of serious infectious events in patients categorized by age-adjusted comorbidity index and baseline systemic glucocorticoid use

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 IR/100 PY (95% CI)a
Without systemic glucocorticoid use With systemic glucocorticoid use
AACI = 0 AACI = 1 AACI ≥ 2 AACI = 0 AACI = 1 AACI ≥ 2
RCT CZP
 Patients, n 158 250 110 271 295 140
 3 months 2.6 (0.1–14.5) 4.9 (1.0–14.3) 7.8 (1.0–28.2) 4.5 (0.9–13.3) 9.8 (3.9–20.2) 11.9 (3.2–30.5)
 6 months 1.4 (0.0–8.0) 3.7 (1.0–9.6) 6.8 (1.4–19.9) 5.1 (1.9–11.1) 8.6 (4.3–15.4) 12.1 (4.9–25.0)
 1 year 1.0 (0.0–5.3) 3.2 (1.0–7.4) 6.2 (1.7–15.9) 4.6 (2.0–9.1) 6.2 (3.2–10.9) 12.1 (5.8–22.2)
All CZP
 Patients, n 205 302 130 325 379 165
 3 months 2.0 (0.1–11.1) 4.1 (0.8–11.9) 6.6 (0.8–23.7) 3.8 (0.8–11.1) 8.7 (3.8–17.1) 12.6 (4.1–29.4)
 6 months 4.1 (1.1–10.5) 2.8 (0.8–7.1) 5.1 (1.0–14.8) 4.5 (1.8–9.3) 7.8 (4.3–13.1) 11.7 (5.4–22.2)
 1 year 4.8 (2.2–9.1) 2.2 (0.8–4.7) 5.3 (2.0–11.6) 4.3 (2.3–7.4) 8.0 (5.3–11.7) 12.6 (7.5–20.0)
 2 years 3.4 (1.8–6.0) 2.7 (1.5–4.5) 8.9 (5.3–14.0) 3.9 (2.5–5.9) 6.0 (4.3–8.3) 8.4 (5.2–12.8)
  1. Abbreviations: SIE Serious infectious event, CZP Certolizumab pegol, IR Incidence rate, PY Patient-years, 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. aIR of SIEs observed during the indicated time interval since the first day on CZP