Table 2

Overall summary of treatment-emergent AE* incidence by year interval (safety population; N=142)

Number of patients (%)†
Any time post first dose of belimumab‡ (N=142)Year 0−1 (n=142)Year 1−2 (n=136)Year 2−3 (n=108)Year 3−4 (n=79)Year 4−5 (n=32)Year 5−6 (n=24)Year 6+§ (n=13)
AE139 (97.9)133 (93.7)122 (89.7)81 (75.0)59 (74.7)30 (93.8)24 (100.0)9 (69.2)
AE preferred terms occurring in ≥10% of patients:
 Nasopharyngitis86 (60.6)49 (34.5)60 (44.1)33 (30.6)22 (27.8)16 (50.0)7 (29.2)3 (23.1)
 Headache40 (28.2)22 (15.5)15 (11.0)9 (8.3)6 (7.6)4 (12.5)3 (12.5)0
 Cough26 (18.3)14 (9.9)9 (6.6)6 (5.6)4 (5.1)3 (9.4)1 (4.2)0
 Herpes zoster26 (18.3)10 (7.0)10 (7.4)2 (1.9)2 (2.5)1 (3.1)00
 Viral upper respiratory tract infection26 (18.3)11 (7.7)14 (10.3)4 (3.7)1 (1.3)000
 Upper abdominal pain23 (16.2)13 (9.2)3 (2.2)4 (3.7)4 (5.1)2 (6.3)00
 Nausea23 (16.2)14 (9.9)8 (5.9)1 (0.9)3 (3.8)1 (3.1)4 (16.7)0
 Diarrhoea22 (15.5)10 (7.0)9 (6.6)5 (4.6)3 (3.8)2 (6.3)2 (8.3)0
 Upper respiratory tract infection22 (15.5)6 (4.2)10 (7.4)8 (7.4)2 (2.5)2 (6.3)2 (8.3)1 (7.7)
 Fever21 (14.8)7 (4.9)5 (3.7)3 (2.8)6 (7.6)2 (6.3)1 (4.2)1 (7.7)
 Influenza20 (14.1)6 (4.2)2 (1.5)5 (4.6)6 (7.6)1 (3.1)2 (8.3)1 (7.7)
 Confusion19 (13.4)9 (6.3)1 (0.7)5 (4.6)4 (5.1)1 (3.1)1 (4.2)0
 Gastroenteritis19 (13.4)7 (4.9)3 (2.2)2 (1.9)4 (5.1)2 (6.3)01 (7.7)
 Back pain18 (12.7)11 (7.7)2 (1.5)6 (5.6)3 (3.8)000
 Abdominal pain17 (12.0)8 (5.6)6 (4.4)2 (1.9)2 (2.5)000
 Constipation17 (12.0)8 (5.6)4 (2.9)1 (0.9)2 (2.5)04 (16.7)1 (7.7)
 Insomnia17 (12.0)7 (4.9)3 (2.2)3 (2.8)1 (1.3)1 (3.1)2 (8.3)1 (7.7)
 Arthralgia16 (11.3)5 (3.5)4 (2.9)6 (5.6)3 (3.8)000
 Myalgia16 (11.3)8 (5.6)8 (5.9)0001 (4.2)0
 Vomiting16 (11.3)8 (5.6)3 (2.2)3 (2.8)01 (3.1)2 (8.3)0
Treatment-related
AE
81 (57.0)46 (32.4)38 (27.9)20 (18.5)11 (13.9)9 (28.1)3 (12.5)1 (7.7)
SAE48 (33.8)24 (16.9)18 (13.2)9 (8.3)6 (7.6)2 (6.3)3 (12.5)0
 Serious infections and infestations24 (16.9)14 (9.9)5 (3.7)2 (1.9)3 (3.8)01 (4.2)0
SAE preferred terms occurring in ≥2 (1.0%) patients
 Cellulitis3 (2.1)001 (0.9)1 (1.3)01 (4.2)0
 Contusion3 (2.1)1 (0.7)01 (0.9)1 (1.3)000
 Herpes
 zoster
3 (2.1)2 (1.4)1 (0.7)00000
 Endocarditis2 (1.4)01 (0.7)00000
 Osteonecrosis2 (1.4)01 (0.7)1 (0.9)0000
 Pyelonephritis acute2 (1.4)2 (1.4)000000
 Fever2 (1.4)02 (1.5)00000
 Uterine leiomyoma2 (1.4)01 (0.7)01 (1.3)000
Severe AE¶27 (19.0)12 (8.5)10 (7.4)7 (6.5)2 (2.5)1 (3.1)1 (4.2)0
Severe AE preferred terms occurring in ≥2 (1.0%) patients
 Myalgia3 (2.1)1 (0.7)2 (1.5)00000
 Fever2 (1.4)1 (0.7)1 (0.7)00000
AE resulting in study drug discontinuation7 (4.9)1 (0.7)3 (2.2)2 (1.9)01 (3.1)00
Deaths**1 (0.7)0000000
  • *Treatment-emergent AEs were defined as AEs that started on or after first dose of belimumab (see the Statistical analysis section).

  • †Each column shows number of patients who had ≥1 AE meeting the criterion for that year. Percentages were based on number of patients who started each year of treatment.

  • ‡Post first belimumab dose (baseline) includes time on study up to the 16-week follow-up visit post last dose. Data from Year 0 to a patient’s exit visit (4 weeks post last dose) are shown by years of study participation.

  • §Year 6+ represents Year 6–7 of belimumab treatment. No patients had exposure >7 years.

  • ¶For severe AEs, events listed as life-threatening were included in the count.

  • **This event occurred during the 16-week follow-up period. The corresponding AE started after the exit visit, and therefore is counted only in the ‘Any time post first dose of belimumab’ column and not in any year interval.

  • AE, adverse event; SAE, serious AE.