Table 4

Summary of grade 3 and 4 laboratory and hematologic toxicities

Parameter

Grade

Placebo (n = 13)

Belimumab

1.0 mg/kg (n = 15)

4.0 mg/kg (n = 14)

10 mg/kg (n = 14)

20 mg/kg (n = 14)

All active (n = 57)

Activated partial thromboplastin time

3

0

0

1 (7)

0

1 (7)

2 (4)

Creatinine

3

0

0

0

0

1 (7)^a

1 (2)

Hemoglobin

3

0

1 (7)

0

0

0

1 (2)

Hyperglycemia

3

0

1 (7)

0

0

1 (2)

Neutropenia

3

0

0

1 (7)^b

2 (14)

0

3 (5)

Thrombocytopenia

4

0

0

1 (7)^b

0

0

1 (2)

Proteinuria

3

0

0

0

1 (7)

1 (7)^a

2 (4)

4

0

0

0

0

1 (7)

1 (2)

Prothrombin time

3

3 (23)^c

1 (7)^c

0

0

0

1 (2)

4

2 (15)^c

0

0

0

0

0

Values are expressed as n (%). ^aOne patient had grade 3 serum creatinine and grade 3 proteinuria. ^bOne patient with grade 3 neutropenia and grade 4 thrombocytopenia after the first 10-mg/kg dose was rechallenged at grade 1 neutropenia, without further decline after the second dose. ^cFour of six patients with grade 3 or 4 prothrombin time reported concomitant warfarin use, including the two patients with grade 4 prothrombin time.

Furie et al. Arthritis Research & Therapy 2008 10:R109   doi:10.1186/ar2506