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.