Table 1

Demographic characteristics, disease history, duration on study and reasons for discontinuation

Patient #

Race

Disease history^a

Prior therapy

Study drug treatment duration

(Days)

Reason for discontinuation

SLE

(Months)

LN

(Months)

Prior renal flare

MMF

CTX

2

African American

38

< 1

-

-

-

148

Leukocytoclastic vasculitis

8

3

Caucasian

46

38

+

+

-

85

Study termination

African American

< 1

< 1

-

-

-

29

H. influenzae pneumonia,

IgG < 3 g/l

5

African American

3

< 1

-

-

-

230

Study termination

13

African American

52

52

+

+

+

31

IgG < 3 g/l^b

14

Asian

32

< 1

+

+

+

18

IgG < 3 g/l

Patients' mean (SD) height and weight were 169.3 (9.7) cm and 83.3 (20.8) kg, respectively. Patients #2 and #8 randomized to placebo; Patients #3, #5, #13 and#14 randomized to atacicept 150 mg subcutaneously twice weekly (4 weeks), then 150 mg weekly (48 weeks). ^aDisease history: time between SLE/LN diagnosis and consent. All patients had Class IV renal disease. ^bPatient #13 diagnosed with severe Legionella pneumonia on Day 34, 1 day after study discontinuation. CTX, cyclophosphamide; IgG, immunoglobulin G; LN, lupus nephritis; MMF, mycophenolate mofetil; SLE, systemic lupus erythematosus.

Ginzler et al. Arthritis Research & Therapy 2012 14:R33   doi:10.1186/ar3738