Table 2.

AEs reported by ≥2% of patients in pooled MUSE, TULIP-1 and TULIP-2 data

AE*	Anifrolumab 300 mg (n=459)	Placebo (n=466)
	n (%)	n (%)
Nasopharyngitis†	75 (16.3)	44 (9.4)
Upper respiratory tract infection†	71 (15.5)	45 (9.7)
Urinary tract infection	55 (12.0)	63 (13.5)
Bronchitis†	45 (9.8)	20 (4.3)
Infusion-related reaction	43 (9.4)	33 (7.1)
Headache	37 (8.1)	45 (9.7)
Herpes zoster†	28 (6.1)	6 (1.3)
Back pain	24 (5.2)	20 (4.3)
Sinusitis	24 (5.2)	24 (5.2)
Cough	23 (5.0)	15 (3.2)
Arthralgia	22 (4.8)	9 (1.9)
Pharyngitis	21 (4.6)	17 (3.6)
Vomiting	18 (3.9)	12 (2.6)
Nausea	17 (3.7)	25 (5.4)
Oral herpes	17 (3.7)	12 (2.6)
Pneumonia	15 (3.3)	13 (2.8)
Diarrhoea	14 (3.1)	25 (5.4)
Respiratory tract infection	14 (3.1)	2 (0.4)
Depression	13 (2.8)	8 (1.7)
Gastroenteritis	13 (2.8)	14 (3.0)
Hypersensitivity	13 (2.8)	3 (0.6)
Influenza	12 (2.6)	9 (1.9)
Gastroenteritis (viral)	11 (2.4)	7 (1.5)
Gastro-oesophageal reflux disease	11 (2.4)	12 (2.6)
Pain in extremity	11 (2.4)	3 (0.6)
Anxiety	10 (2.2)	8 (1.7)
Dizziness	10 (2.2)	12 (2.6)
Fatigue	10 (2.2)	9 (1.9)
Peripheral oedema	10 (2.2)	4 (0.9)
SLE	10 (2.2)	14 (3.0)
Insomnia	9 (2.0)	19 (4.1)

EAIR was reported per 100 patient-years and calculated as the number of patients with an event/[sum of time at risk in days/(365.25×100)].

*AEs were coded by MedDRA V.22.1. An AE during the intervention period was defined as an AE with a date of onset on or after the day of the first dose of anifrolumab or placebo and on or before the day of the last dose of anifrolumab or placebo plus 28 days.

†AEs more common in the anifrolumab 300 mg group than in the placebo group (ie, ≥5% difference, or ≥5% incidence in the anifrolumab group and at least twice the reported rate of the placebo group).

AE, adverse event; MedDRA, Medical Dictionary for Regulatory Activities.