Table 1.
Relative serious infectious event risk associated with baseline age categories and medically treated comorbidities included in age-adjusted comorbidity index
| HR (95% CI) | Weight in the AACIa | |||
|---|---|---|---|---|
| Category | RCT CZP (n = 1224) | All CZP (n = 1506) | ||
| Age, years | <50 | Reference | Reference | 0 |
| ≥50 to < 60 | 1.29 (0.58–2.87) | 1.39 (0.99–1.96) | 1 | |
| ≥60 to < 70 | 1.14 (0.44–2.94) | 1.40 (0.92–2.12) | 1 | |
| ≥70 | 2.18 (0.70–6.84) | 2.93 (1.69–5.09) | 3 | |
| Diabetes mellitus | 1.98 (0.59–6.58) | 1.61 (0.90–2.89) | 2 | |
| COPD/asthma | 2.67 (0.77–9.27) | 1.29 (0.56–2.97) | 2 | |
| Cardiac disorder | N/C | 1.33 (0.52–3.43) | 0 | |
| Hypertension | 1.34 (0.69–2.63) | 0.96 (0.70–1.32) | 0 | |
| Hyperlipidemia | 2.39 (0.82–6.93) | 1.47 (0.81–2.67) | 2 | |
| Thyroid disorder | N/C | 0.87 (0.42–1.78) | 0 | |
| Osteoporosis | 2.30 (0.98–5.39) | 1.16 (0.73–1.86) | 2 | |
| Depression | 1.00 (0.22–4.51) | 1.46 (0.75–2.83) | 1 | |
Abbreviations: SIE Serious infectious event, AACI Age-adjusted comorbidity index, CZP Certolizumab pegol, COPD Chronic obstructive pulmonary disease, N/C Not calculable (no patients with the indicated comorbidity experienced an SIE during the randomized controlled trials), 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
HRs were derived from a Cox proportional hazards model fitted with the indicated age categories and medically treated comorbidities; no other baseline covariates were included
aWeight of each category in the AACI was based on the average HR between the RCT CZP and All CZP populations (HR ≥ 1.2 and < 1.5, weight = 1; HR ≥ 1.5 and < 2.5, weight = 2; HR ≥ 2.5 and < 3.5, weight = 3)