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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