Table 3.

Baseline characteristics of patients who did and those who did not develop solid malignancies after WGET^* trial closeout (September 2003).

	Solid malignancy N=13	No solid malignancy N=140	P value **
Treatment assignment			0.40
Etanercept, no (%)	8 (10)	69 (90)
Control, no (%)	5 (7)	71 (93)
Age at enrollment, mean ± SD, years	57 (13)	50 (16)	0.07
Male/female, no (%)	10 (77)/3 (23)	84 (60)/56 (40)	0.37
Limited/severe disease, no (%)	5 (38)/8 (62)	42 (30)/98 (70)	0.54
Age at onset of vasculitic symptoms, years, mean (SD)	51 (13)	46 (16)	0.26
Relapsing disease, no (%)	11 (85)	75 (54)	0.04
Duration since onset symptoms, years, mean (SD)	6.4 (3.9)	3.3 (4.8)	0.001
Duration since diagnosis, years, years, mean (SD)	5.1 (4.4)	2 (3.8)	0.0006
History of cancer before trial, no (%)	4 (31)	12(9)	0.03
Family history of cancer, no (%)	0 (0)	29 (21)	0.13
Current tobacco use, no. (%)	0 (0)	5 (4)	1.0
Prior treatment wt immunosuppressive drugs, no (%)	11(85)	80(57)	0.08
Ever treated for WG	13 (100)	125 (89)	0.37
CYC treatment, no (%)
Ever used †, daily or intermittent	13 (100)	125 (89)	0.4
During WGET	8 (62)	113 (81)	0.13
MTX treatment, n (%)
Ever used †, oral or SC or IM	9 (69)	82 (59)	0.56
During WGET	11 (85)	110 (79)	1.0
AZA treatment, n (%)
Ever used†	7 (54)	49 (35)	0.23
During WGET	4 (31)	45 (32)	1.0

^*WGET = Wegener’s Granulomatosis Etanercept Trial; SC = subcutaneous; IM = intramuscular.

^**By chi-square or Fisher’s exact test for categorical data, and Wilcoxon’s rank sum test for continuous data.

^†Including before, during or after trial periods.

^##Previous history of cancer was as follows: in the no solid malignancy group, skin basal cell carcinoma (4 patients), colon (3 patients), breast cancer (1), lymphoma (1), pre-cancerous or cancerous skin lesion (1 patient), prostate cancer (1 patient), rectal-skin (1 patient); in the solid malignancy group, bladder (1 patient), breast carcinoma (1 patient), melanoma and basal cell (1 patient) and skin (1 patient).