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

Table 2 Baseline patient characteristics

		RCT CZP (n = 1224)	All CZP (n = 1506)
Female sex, n (%)		1008 (82.4)	1245 (82.7)
Age, years, n (%)	<50	470 (38.4)	580 (38.5)
	≥50 to < 60	440 (35.9)	546 (36.3)
	≥60 to < 70	247 (20.2)	300 (19.9)
	≥70	67 (5.5)	80 (5.3)
Disease duration (years), n (%)	<2	261 (21.3)	323 (21.4)
Disease duration (years), n (%)	≥2	963 (78.7)	1183 (78.6)
DAS28(CRP), mean (SD)		6.20 (0.83)	6.20 (0.85)
HAQ-DI, mean (SD)		1.65 (0.60)	1.65 (0.60)
CRP, mg/L, median (IQR)		15.0 (6.0–32.0)	15.0 (6.0–32.0)
Rheumatoid factor, IU/ml, median (IQR)		68.3 (18.9–201.1)	70.0 (19.4–200.0)
mTSS, median (IQR)		20.0 (5.5–54.7)	20.0 (6.0–55.0)
BMI, kg/m², n (%)	<20	83 (6.8)	104 (6.9)
	20–30	833 (68.1)	1024 (68.0)
	>30	308 (25.2)	378 (25.1)
Glucocorticoid dose, mg/day, n (%)	0	518 (42.3)	637 (42.3)
	>0–5	332 (27.1)	402 (26.7)
	>5	374 (30.6)	467 (31.0)
Systemic MTX dose, mg/week, n (%)	≤15	1018 (83.2)	1261 (83.7)
Systemic MTX dose, mg/week, n (%)	>15	206 (16.8)	245 (16.3)
Medically treated comorbidities, n (%)^a
Diabetes mellitus		47 (3.8)	53 (3.5)
COPD/asthma		34 (2.8)	38 (2.5)
Cardiac disorder^b		15 (1.2)	17 (1.1)
Hypertension^c		387 (31.6)	465 (30.9)
Hyperlipidemia		55 (4.5)	66 (4.4)
Thyroid disorder		55 (4.5)	63 (4.2)
Osteoporosis		92 (7.5)	113 (7.5)
Depression		37 (3.0)	45 (3.0)

Abbreviations: CZP Certolizumab pegol, RCT Randomized controlled trial, DAS28(CRP) 28-joint Disease Activity Score with C-reactive protein, CRP C-reactive protein, HAQ-DI Health Assessment Questionnaire Disability Index, mTSS Modified total Sharp score, MTX Methotrexate, BMI Body mass index, COPD Chronic obstructive pulmonary disease, 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
^aMedically treated comorbidities were identified on the basis of patients’ medical histories and medications at baseline
^bCardiac disorder included coronary artery disease and heart failure
^cHypertension included patients with history of cerebrovascular disorder (n = 5 in RCT CZP and n = 5 in All CZP) and transient ischemic attack (n = 4 in RCT CZP and n = 5 in All CZP)