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) | |
| AE | 139 (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: | ||||||||
| Nasopharyngitis | 86 (60.6) | 49 (34.5) | 60 (44.1) | 33 (30.6) | 22 (27.8) | 16 (50.0) | 7 (29.2) | 3 (23.1) |
| Headache | 40 (28.2) | 22 (15.5) | 15 (11.0) | 9 (8.3) | 6 (7.6) | 4 (12.5) | 3 (12.5) | 0 |
| Cough | 26 (18.3) | 14 (9.9) | 9 (6.6) | 6 (5.6) | 4 (5.1) | 3 (9.4) | 1 (4.2) | 0 |
| Herpes zoster | 26 (18.3) | 10 (7.0) | 10 (7.4) | 2 (1.9) | 2 (2.5) | 1 (3.1) | 0 | 0 |
| Viral upper respiratory tract infection | 26 (18.3) | 11 (7.7) | 14 (10.3) | 4 (3.7) | 1 (1.3) | 0 | 0 | 0 |
| Upper abdominal pain | 23 (16.2) | 13 (9.2) | 3 (2.2) | 4 (3.7) | 4 (5.1) | 2 (6.3) | 0 | 0 |
| Nausea | 23 (16.2) | 14 (9.9) | 8 (5.9) | 1 (0.9) | 3 (3.8) | 1 (3.1) | 4 (16.7) | 0 |
| Diarrhoea | 22 (15.5) | 10 (7.0) | 9 (6.6) | 5 (4.6) | 3 (3.8) | 2 (6.3) | 2 (8.3) | 0 |
| Upper respiratory tract infection | 22 (15.5) | 6 (4.2) | 10 (7.4) | 8 (7.4) | 2 (2.5) | 2 (6.3) | 2 (8.3) | 1 (7.7) |
| Fever | 21 (14.8) | 7 (4.9) | 5 (3.7) | 3 (2.8) | 6 (7.6) | 2 (6.3) | 1 (4.2) | 1 (7.7) |
| Influenza | 20 (14.1) | 6 (4.2) | 2 (1.5) | 5 (4.6) | 6 (7.6) | 1 (3.1) | 2 (8.3) | 1 (7.7) |
| Confusion | 19 (13.4) | 9 (6.3) | 1 (0.7) | 5 (4.6) | 4 (5.1) | 1 (3.1) | 1 (4.2) | 0 |
| Gastroenteritis | 19 (13.4) | 7 (4.9) | 3 (2.2) | 2 (1.9) | 4 (5.1) | 2 (6.3) | 0 | 1 (7.7) |
| Back pain | 18 (12.7) | 11 (7.7) | 2 (1.5) | 6 (5.6) | 3 (3.8) | 0 | 0 | 0 |
| Abdominal pain | 17 (12.0) | 8 (5.6) | 6 (4.4) | 2 (1.9) | 2 (2.5) | 0 | 0 | 0 |
| Constipation | 17 (12.0) | 8 (5.6) | 4 (2.9) | 1 (0.9) | 2 (2.5) | 0 | 4 (16.7) | 1 (7.7) |
| Insomnia | 17 (12.0) | 7 (4.9) | 3 (2.2) | 3 (2.8) | 1 (1.3) | 1 (3.1) | 2 (8.3) | 1 (7.7) |
| Arthralgia | 16 (11.3) | 5 (3.5) | 4 (2.9) | 6 (5.6) | 3 (3.8) | 0 | 0 | 0 |
| Myalgia | 16 (11.3) | 8 (5.6) | 8 (5.9) | 0 | 0 | 0 | 1 (4.2) | 0 |
| Vomiting | 16 (11.3) | 8 (5.6) | 3 (2.2) | 3 (2.8) | 0 | 1 (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) |
| SAE | 48 (33.8) | 24 (16.9) | 18 (13.2) | 9 (8.3) | 6 (7.6) | 2 (6.3) | 3 (12.5) | 0 |
| Serious infections and infestations | 24 (16.9) | 14 (9.9) | 5 (3.7) | 2 (1.9) | 3 (3.8) | 0 | 1 (4.2) | 0 |
| SAE preferred terms occurring in ≥2 (1.0%) patients | ||||||||
| Cellulitis | 3 (2.1) | 0 | 0 | 1 (0.9) | 1 (1.3) | 0 | 1 (4.2) | 0 |
| Contusion | 3 (2.1) | 1 (0.7) | 0 | 1 (0.9) | 1 (1.3) | 0 | 0 | 0 |
| Herpes zoster | 3 (2.1) | 2 (1.4) | 1 (0.7) | 0 | 0 | 0 | 0 | 0 |
| Endocarditis | 2 (1.4) | 0 | 1 (0.7) | 0 | 0 | 0 | 0 | 0 |
| Osteonecrosis | 2 (1.4) | 0 | 1 (0.7) | 1 (0.9) | 0 | 0 | 0 | 0 |
| Pyelonephritis acute | 2 (1.4) | 2 (1.4) | 0 | 0 | 0 | 0 | 0 | 0 |
| Fever | 2 (1.4) | 0 | 2 (1.5) | 0 | 0 | 0 | 0 | 0 |
| Uterine leiomyoma | 2 (1.4) | 0 | 1 (0.7) | 0 | 1 (1.3) | 0 | 0 | 0 |
| 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 | ||||||||
| Myalgia | 3 (2.1) | 1 (0.7) | 2 (1.5) | 0 | 0 | 0 | 0 | 0 |
| Fever | 2 (1.4) | 1 (0.7) | 1 (0.7) | 0 | 0 | 0 | 0 | 0 |
| AE resulting in study drug discontinuation | 7 (4.9) | 1 (0.7) | 3 (2.2) | 2 (1.9) | 0 | 1 (3.1) | 0 | 0 |
| Deaths** | 1 (0.7) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
*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.