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 4 Most common AEs by SOC^a, all SAEs, AESI, and TRAEs (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^a (n = 12)	TC (n = 29)	LTD (n = 39)
≥ 1 AE by SOC^b,c, n (%)	7 (58.3)	10 (90.9)	11 (91.7)	21 (72.4)	37 (94.9)
Infections and infestations	4 (33.3)	7 (63.6)	8 (66.7)	14 (48.3)	23 (59.0)
≥ 1 SAE by preferred term, n (%)	0	1 (9.1)	1 (8.3)	2 (6.9)	6 (15.4)
Lupus nephritis	0	0	0	0	2 (5.1)
Acute respiratory failure	0	0	0	0	1 (2.6)
Arthritis	0	0	0	1 (3.4)	0
Chronic obstructive pulmonary disease	0	0	0	0	1 (2.6)
Diarrhoea infectious	0	0	0	0	1 (2.6)
Generalised oedema	0	0	0	0	1 (2.6)
Lumbar vertebral fracture	0	1 (9.1)	1 (8.3)	0	0
Pericarditis lupus	0	0	0	0	1 (2.6)
Pneumonia pseudomonal	0	0	0	0	1 (2.6)
Respiratory failure	0	0	0	0	1 (2.6)
Sepsis	0	0	0	0	1 (2.6)
Upper respiratory tract infection	0	0	0	1 (3.4)	0
AESI by category, n (%)
Malignancies	0	0	0	0	0
Post-infusion systemic reactions	0	0	0	1 (3.4)^d	0
Infections of special interest^e	0	0	0	1 (3.4)	3 (7.7)
Depression	0	0	0	1 (3.4)^f	1 (2.6)^f
Deaths	0	0	0	0	0
TRAEs by system organ class, n (%)
Any event	2 (16.7)	1 (9.1)	3 (25.0)	6 (20.7)^g	0
Infections and infestations	2 (16.7)	0	2 (16.7)	5 (17.2)	0
Respiratory, thoracic and mediastinal disorders	0	0	0	2 (6.9)	0
Gastrointestinal disorders	0	1 (9.1)	1 (8.3)	0	0
Skin and subcutaneous tissue disorders	0	0	0	1 (3.4)	0

AE, adverse event; AESI, AE of special interest; ITT, intention-to-treat; LTD, long-term discontinuation; SAE, serious AE; SOC, system organ class; TC, treatment continuation; TH, treatment holiday; TRAE, treatment-related AE
^aProvided by post hoc analysis
^bReported in > 50% of patients in any treatment group
^cNasopharyngitis was the most common AE in all three treatment groups (LTD, TC and restart phase)
^dPost-infusion systemic reactions per anaphylactic reaction customised MedDRA query broad search
^eBy preferred term, herpes simplex (TC, n = 1; LTD, n = 1), recurrent opportunistic herpes zoster (LTD, n = 1), serious sepsis (LTD, n = 1)
^fDepression including mood disorders and anxiety
^g> 1 event occurred in 1 patient

ISSN: 1478-6362