Table 5

Summary of adverse events through week 24

Lupuzor
Group 1 (200 μg every 4 weeks)Group 2 (200 μg every 2 weeks)Group 3 (placebo)
Patients treated, n495149
Patients with ≥1 AE, n (%)20 (40.8)21 (40.4)24 (49.0)
AEs that occurred in ≥5% of patients in any treatment group
 Drop-outs owing to AEs1 (2.0)0 (0.0)4 (8.2)
 Injection-site erythema, n (%)3 (6.1)5 (9.6)1 (2.0)
 Urinary tract infection, n (%)2 (4.1)2 (3.8)5 (10.2)
 Headache, n (%)2 (4.1)3 (5.8)0 (0.0)
 Nasopharyngitis, n (%)1 (2.0)4 (7.7)0 (0.0)
 Bronchitis, n (%)3 (6.1)1 (1.9)0 (0.0)
 Diarrhoea, n (%)2 (4.1)0 (0.0)3 (6.1)
 Pharyngitis, n (%)1 (2.0)0 (0.0)3 (6.1)
3 (6.1)1 (1.9)3 (6.1)
Patients with ≥1 serious AE, n (%)
 Pneumonia, n (%)1 (2.0)0 (0.0)2 (4.1)
 Viral pneumonia (herpes), n (%)0 (0.0)1 (1.9)0 (0.0)
 Soft-tissue infection, n (%)1 (2.0)0 (0.0)0 (0.0)
 Diverticulitis, n (%)0 (0.0)0 (0.0)1 (2.0)
 Gastritis, n (%)1 (2.0)0 (0.0)0 (0.0)
Deaths, n (%)*1 (2.0)0 (0.0)0 (0.0)
  • *The fatal case was considered by the investigator as unrelated to the investigational product.

  • AE, adverse event.