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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