Systemic inflammatory profile and response to anti-tumor necrosis factor therapy in chronic obstructive pulmonary disease

Table 1 Demographic and baseline clinical phenotypes in COPD and control populations

Parameter	T54 COPD^a					BioServe COPD^b		Healthy controls^c		p (COPD vs healthy control)^d
	Total	Placebo	3 mg/kg	5 mg/kg	p-value	Total	p (vs T54)	Ctr1	Ctr2	Ctr1 vs T54, BS	Ctr2 vs T54, BS
Sample size (n)	234^e	68	64	68		160		50	109
Gender(n: male/female)	140/94	43/25	40/24	37/31	0.51	73/87	0.37	30/20	54/42	(1.0, 0.52)	(0.27, 0.63)
Age (years)	65.2 ± 8.8	65.0 ± 8.9	64.4 ± 8.2	64.9 ± 9.6	0.93	65.8 ± 11.8	0.57	38.7 ± 11.8	49.9 ± 14.5	(< 10^-4, < 10^-4)	(< 10^-4, < 10^-4)
BMI (kg/m ² )	27.2 ± 6.1	28.2 ± 6.1	26.6 ± 5.4	27.0 ± 6.6	0.32	26.5 ± 7.0	0.27	27.0 ± 6.8	27.9 ± 6.9	(0.82, 0.65)	(0.46, 0.16)
Race (n)					0.46		0.036			(< 10^-4, < 10^-4)	(< 10^-4, < 10^-4)
Black	10	3	1	4		14		25	41
Caucasian	223	64	63	64		143		5	22
Other	1	1	0	0		3		20	12
Smoking status (n)					0.93		0.00011			(< 10^-4, < 10^-4)	(< 10^-4, < 10^-4)
Current smoker	104	29	29	31		50		33	36
Ex-smoker	130	39	35	37		100
Non-smoker						9		16	24
GOLD stage (n)					0.66		< 10^-9	n/a	n/a	n/a	n/a
stage I	3	1	0	2		40
stage II	74	23	21	20		40
stage III	104	33	31	26		40
stage IV	53	11	16	16		40
Subtype (n)					0.58		< 10^-9	n/a	n/a	n/a	n/a
Chronic bronchitis	54	20	11	15		41
Chronic emphysema	95	26	28	28		80
Both	85	22	25	25		3
FEV ₁ (% predicted)
Baseline	43.4 ± 16.0	45.2 ± 16.2	43.9 ± 17.5	41.8 ± 14.9	0.49	52.7 ± 25.1	0.000051	n/a	n/a	n/a	n/a
Change from baseline	-1.1 ± 6.7	-1.4 ± 7.5	0.3 ± 6.1	-1.9 ± 7.5	0.19	n/a	n/a	n/a	n/a	n/a	n/a
CRQ total score
Baseline	80.4 ± 19.1	83.8 ± 20.1	77.1 ± 17.5	80.2 ± 19.3	0.11	n/a	n/a	n/a	n/a	n/a	n/a
Change from baseline	10.3 ± 18.6	12.3 ± 19.2	12.7 ± 22.7	15.1 ± 10.0	0.70	n/a	n/a	n/a	n/a	n/a	n/a

^aClinical and demographic information for the C0168T54 COPD population is presented for all patients with baseline serum analyses performed (total) and stratified by treatment group (placebo, 3 mg/kg infliximab, or 5 mg/kg infliximab) for patients who had serum samples analyzed for both baseline and week 24 timepoints (n = 200). P-values are presented for significance of differences among the treatment groups.
^bClinical and demographic information for the BioServe COPD population, with p-values presented for significance of differences between BioServe and T54 COPD populations.
^cClinical and demographic information for the healthy control populations. Ctr1, control population samples bioanalyzed in same batch as COPD samples; Ctr2, control population samples bioanalyzed independently of the COPD and Ctr1 samples.
^dP-values for the significance of differences between the indicated control population vs COPD population (T54, BioServe).
^eSummary statistics are sample size (n), mean ± standard deviation, or p-value.
BMI, body mass index; COPD, chronic obstructive pulmonary disease; CRQ, chronic respiratory questionnaire; FEV₁, forced expiratory volume in 1 second; GOLD, Global Initiative for Chronic Obstructive Lung Disease; n/a, not applicable.

ISSN: 1465-993X