The effect of 24-week belimumab treatment withdrawal followed by treatment restart in patients with SLE: an open-label, non-randomised 52-week study

Table 2 Efficacy outcomes (52-week study period; ITT population)

	TH (n = 12)			TC (n = 29)	LTD (n = 39)
	24-week holiday phase (n = 12)	28-week restart phase (n = 11)	Overall 52-week period (n = 12)	TC (n = 29)	LTD (n = 39)
Patients with an SFI flare, n (%)	4 (33.3)	2 (18.2)	5 (41.7)^a	9 (31.0)	28 (71.8)
Time to first SFI flare, median (IQR) days^b	- (30.0, -)	- (-, -)	- (30.0, -)^a	- (365.0, -)	183.0 (91.0, 370.0)
Unadjusted rate of SFI flares/patient-year	1.0	0.3	0.6^a	0.6	2.1
Number of SFI flares	5	2	7^a	17	74
Patients with a severe SFI flare, n (%)	0	0	0	0	9 (23.1)
Patients with a renal flare^c, n (%)	0	0	0	0	4 (10.3)
Daily prednisone use^d, median (IQR) days
> 7.5 mg/day and/or 25% increase vs baseline^e	168.0 (168.0, 170.0)	196.0 (196.0, 196.0)	364.0 (364.0, 364.0)	364.0 (311.5, 371.0)	278.0 (133.0, 344.0)
≤ 7.5 mg/day and/or 25% decrease vs baseline^f	166.0 (161.0, 168.0)	200.0 (196.0, 202.0)	364.0 (359.0, 364.0)	364.0 (364.0, 364.0)	362.0 (227.0, 365.0)

IQR interquartile range, ITT intention-to-treat, LTD long-term discontinuation, SFI SELENA-SLEDAI Flare Index, SELENA Safety of Estrogens in Lupus Erythematosus National Assessment, SLEDAI SLE Disease Activity Index, TC treatment continuation, TH treatment holiday
^aProvided by post hoc analysis
^bEstimated using the Kaplan–Meier method; statistics are missing when the number of events is too low to estimate the value
^cDefined in Additional file 1
^dAverage daily prednisone dose at baseline is based on all days from the screening visit date of the current study up to and including day 0 of the current study
^eTH: n = 6, TC: n = 12; LTD: n = 13
^fTH: n = 6, TC: n = 19; LTD: n = 25

ISSN: 1478-6362