Atacicept in combination with MMF and corticosteroids in lupus nephritis: results of a prematurely terminated trial

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.

ISSN: 1478-6362