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. Author manuscript; available in PMC: 2012 Jun 1.
Published in final edited form as: J Am Acad Dermatol. 2011 Feb 18;64(6):1035–1050. doi: 10.1016/j.jaad.2010.09.734

Table 2.

Malignancies and Infectious Events Occurring in Randomized Controlled Trialsa

Treatment Group (n = 4598) Placebo Group (n = 2313)
Source Treatment (Dose)b No. of
Pts		 Pts with
≥ 1
Serious
Infection		 Pts with
≥ 1
Infectious
Event		 No. of
Maligc 		Type of
Malignancyd 		Time of
Malig,
wk		 No.
of
Pts		 Pts with
≥ 1
Serious
Infection		 Pts with
≥ 1
Infectious
Event		 No. of
Malig		 Type of
Malignancy		 Time of
Malig,
wk
Mease et al,
200547 		Adalimumab (40 mg eow) 151 1 68 0 162 1 64 0
Gordon et al,
200646 		Adalimumab (40 mg eow)
Adalimumab (40 mg weekly)		 45
50		 0
1		 5
13		 1
1		 Metastatic SCCe
Breast Cancer		 2.1
5.1		 52 0 8 0
Genovese et
al, 200757 		Adalimumab (40 mg eow) 51 0 9 0 49 1 16 0
Menter et al,
200850 		Adalimumab (80 mg at wk 0, then 40
mg eow starting at wk 1)		 814 5 235 6 NMSC × 4

Breast cancer
Melanoma in situ		 8.1, 8.1,
13, 15.6
1.6
4.1		 398 4 89 2 NMSC
Uterine-
carcinoma		 13.9
4.1
Saurat et al,
200851 		Adalimumab (80 mg at wk 0, then 40
mg eow starting at wk 1)		 108 0 51 0 52 0 23 0
Akihiko et al,
201078 		Adalimumab (80 mg at wk 0, then 40
    mg eow starting at wk 1)
Adaliumumab (40 mg eow)
Adalimumab (80 mg eow)		 38
43
42		 0
0
0		 21
18
21		 0 46 0 23 0
Unpublished41 Certolizumab pegol (400 mg at wk 0,
    then 200 mg every 2 wks)
Certolizumab pegol (400 mg every 2
    wks)		 59

58		 1

2		 16

27		 0 59 0 24 0
Mease et al,
200048 		Etanercept (25 mg twice weekly) 30 0 17f 0 30 0 17f 0
Gottlieb et al,
200352 		Etanercept (25 mg twice weekly) 57 0 28g 0 55 1 14g 0
Leonardi et al,
200342 		Etanercept (25 mg weekly)
Etanercept (25 mg twice weekly)
Etanercept (50 mg twice weekly)		 160
162
164		 2
0
1		 18g
15
10		 1
0
2 		BCC

BCC
Prostate Cancer 		11.6
9.1

7.3		 166 2 22g 2 SCC × 2 0.7, 1.9
Mease et al,
200449 		Etanercept (25 mg twice weekly) 101 0 33 0 104 1 39 0
Papp et al,
200544 		Etanercept (25 mg twice weekly)
Etanercept (50 mg twice weekly)		 196
194		 1
0		 36h
35		 0
4 		Breast Cancer
SCC
BCC × 2 		1.9
7.9
8.0, 12.0		 193 1 29h 0
Tyring et al,
200755 		Etanercept (50 mg twice weekly) 312 1 88 3 SCC
BCC
Pancreatic-
Carcinoma		 0.6
Unknown
10.7		 306 1 71 1 Bladder-
carcinoma		 11.0
van de
Kerkhof et al,
200843 		Etanercept (50 mg weekly) 96 0 27 0 46 0 12 0
Kavanaugh et
al, 200945 		Golimumab (50 mg every 4 wks)
Golimumab (100 mg every 4 wks)

All Golimumabi 		146
146

343		 1
1

2		 48
60

118		 0
3

3		 BCC × 2
Prostate cancer
As above 		19.3,19.8
9.9
As above 		113 4 27 0
Gottlieb et al,
58 		Infliximab (3 mg/kg at wks 0, 2, 6)
Infliximab (5 mg/kg at wks 0, 2, 6)		 98
99		 0
1		 31
37		 2
1		 SCC × 2
BCC		 8.9, 7.8
31.8		 51 0 11 0
Antoni et al,
200556 		Infliximab (5 mg/kg at wks 0, 2, 6, 14) 52 1 6 0 51 0 9 0
Antoni et al,
200540 		Infliximab (5 mg/kg wks 0, 2, 6, 14, 22)
All Infliximabc 		100
150		 3
3		 34
47		 0
0		 97 2 29 1 BCC 9
9
Reich et al,
54 		Infliximab (5 mg/kg wks 0, 2, 6, 14, 22) 298 3 125 2 SCC
BCC		 5.7
5.2		 76 0 30 0
Menter et al,
200753 		Infliximab (3 mg/kg at wks 0, 2, 6)
Infliximab (5 mg/kg at wks 0, 2, 6)		 313
314		 0
1		 106
97		 1
1		 BCC
BCC		 9.9
9.4		 207 1 62 0
a

A total of 9 malignancies (in bold) were unpublished and obtained from industry sponsors.

b

Eow = every other week

c

Malig = malignancy

d

SCC = Squamous cell carcinoma; BCC = Basal cell carcinoma; NMSC = non-melanoma skin cancer (unspecified)

e

Non-cutaneous metastatic SCC on the left side of the neck. Swollen lymph node on the left side of the neck was present at screening.

f

Only upper respiratory tract events reported.

g

Only upper respiratory tract infections (URIs) and sinusitis reported.

h

Only URIs and flu syndrome reported.

i

Early escape at week 16. All malignancies occurred in patients receiving only the 100 mg dose