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Table 2 Number of patients with one or more malignancies through week 268 compared with the expected number of malignancies from the general US population according to the SEER database

From: Golimumab in patients with active rheumatoid arthritis after treatment with tumor necrosis factor α inhibitors: findings with up to five years of treatment in the multicenter, randomized, double-blind, placebo-controlled, phase 3 GO-AFTER study

 

Golimumab

 

50 mg only

50 and 100 mg

100 mg only

All patients

Treated patients in the study

98

195

138

431

All malignancies

    

 Observed number of patients

3

11

6

20

 Incidence (95% CI)/100 pt-yrsa

1.23 (0.25, 3.59)

1.59 (0.79, 2.85)

1.42 (0.52, 3.10)

1.47 (0.90, 2.28)

 SIRb

1.36

1.20

0.81

1.11

 (95% CI)c

(0.28, 3.98)

(0.48, 2.47)

(0.17, 2.36)

(0.59, 1.89)

Type of malignancy

    

Lymphoma

    

 Observed number of patients

0

2

2

4

 Incidence (95% CI)/100 pt-yrsa

0.00 (0.00, 1.22)

0.28 (0.03, 1.03)

0.47 (0.06, 1.68)

0.29 (0.08, 0.74)

 SIRb

0.00

8.13

12.32

7.96

 (95% CI)c

(0.00, 31.87)

(0.99, 29.38)

(1.49, 44.49)

(2.17, 20.39)

Other malignancies

    

 Observed number of patients

3

5

1

9

 Incidence (95% CI)/100 pt-yrsa

1.23 (0.25, 3.59)

0.71 (0.23, 1.66)

0.23 (0.01, 1.30)

0.65 (0.30, 1.24)

 SIRb

1.42

0.89

0.28

0.80

 (95% CI)c

(0.29, 4.15)

(0.29, 2.07)

(0.01, 1.56)

(0.36, 1.51)

Nonmelanoma skin cancer

    

 Observed number of patients

0

5

3

8

 Incidence (95% CI)/100 pt-yrsa

0.00 (0.00, 1.22)

0.72 (0.23, 1.69)

0.71 (0.15, 2.08)

0.59 (0.25, 1.16)

  1. CI, confidence interval; pt-yrs, patient-years of follow-up; SEER, Surveillance, Epidemiology, and End Results. aThe incidences (95% CIs) for placebo through week 24 were 0.00 (0.00, 6.20) for lymphoma, 0.00 (0.00, 6.20) for nonmelanoma skin cancer, 0.00 (0.00, 6.20) for other malignancies, and 0.00 (0.00, 6.20) for all malignancies. bStandardized Incidence Ratio (SIR) (observed number of patients with malignancy based on the SEER database [14], adjusted for age, gender, and race divided by expected number of patients with malignancy). SIRs (95% CIs) for placebo through week 24 were 0.00 (0.00, 175.37) for lymphoma, 0.00 (0.00, 7.82) for other malignancies, and 0.00 (0.00, 7.51) for all malignancies. bConfidence intervals based on an exact method.