Overall summary of treatment-emergent AE* incidence by year interval (safety population; N=424)
| Number (%) of patients | ||||||
| Any time post-first dose of belimumab† | Year 0–1 | Years 1–2 | Years 2–3 | Years 3–4 | Year 4+‡ | |
| (N=424) | (n=424) | (n=404) | (n=319) | (n=251) | (n=130) | |
| AE | 359 (84.7) | 277 (65.3) | 236 (58.4) | 176 (55.2) | 122 (48.6) | 49 (37.7) |
| AE preferred terms occurring in ≥5% of patients: | ||||||
| Upper respiratory tract infection | 150 (35.4) | 70 (16.5) | 78 (19.3) | 41 (12.9) | 35 (13.9) | 12 (9.2) |
| Viral upper respiratory tract infection | 59 (13.9) | 23 (5.4) | 20 (5.0) | 21 (6.6) | 5 (2.0) | 4 (3.1) |
| Urinary tract infection | 41 (9.7) | 23 (5.4) | 15 (3.7) | 7 (2.2) | 1 (0.4) | 1 (0.8) |
| Herpes zoster | 40 (9.4) | 19 (4.5) | 9 (2.2) | 2 (0.6) | 8 (3.2) | 2 (1.5) |
| Fever | 37 (8.7) | 17 (4.0) | 11 (2.7) | 5 (1.6) | 4 (1.6) | 2 (1.5) |
| Bacterial upper respiratory tract infection | 37 (8.7) | 15 (3.5) | 11 (2.7) | 15 (4.7) | 7 (2.8) | 3 (2.3) |
| Cough | 30 (7.1) | 14 (3.3) | 6 (1.5) | 9 (2.8) | 2 (0.8) | 0 |
| Diarrhoea | 28 (6.6) | 17 (4.0) | 9 (2.2) | 3 (0.9) | 2 (0.8) | 0 |
| Hypokalaemia | 24 (5.7) | 14 (3.3) | 13 (3.2) | 1 (0.3) | 3 (1.2) | 1 (0.8) |
| Nasopharyngitis | 24 (5.7) | 14 (3.3) | 4 (1.0) | 2 (0.6) | 3 (1.2) | 2 (1.5) |
| Bacterial urinary tract infection | 23 (5.4) | 18 (4.2) | 1 (0.2) | 7 (2.2) | 0 | 0 |
| Arthralgia | 22 (5.2) | 9 (2.1) | 4 (1.0) | 6 (1.9) | 1 (0.4) | 1 (0.8) |
| Treatment-related AE | 181 (42.7) | 93 (21.9) | 94 (23.3) | 80 (25.1) | 52 (20.7) | 14 (10.8) |
| SAE | 96 (22.6) | 23 (5.4) | 36 (8.9) | 25 (7.8) | 20 (8.0) | 4 (3.1) |
| SAE preferred terms occurring in >2 (0.5%) of patients: | ||||||
| Lupus nephritis§ | 12 (2.8) | 1 (0.2) | 5 (1.2) | 5 (1.6) | 0 | 0 |
| Herpes zoster | 6 (1.4) | 2 (0.5) | 1 (0.2) | 0 | 2 (0.8) | 1 (0.8) |
| Osteonecrosis | 6 (1.4) | 1 (0.2) | 2 (0.5) | 2 (0.6) | 2 (0.8) | 0 |
| Pneumonia | 4 (0.9) | 1 (0.2) | 0 | 0 | 3 (1.2) | 0 |
| Severe AE¶ | 35 (8.3) | 12 (2.8) | 9 (2.2) | 8 (2.5) | 7 (2.8) | 1 (0.8) |
| Severe AE preferred terms occurring in ≥2 (0.5%) of patients: | ||||||
| Osteonecrosis | 6 (1.4) | 2 (0.5) | 1 (0.2) | 2 (0.6) | 2 (0.8) | 0 |
| Lupus nephritis§ | 3 (0.7) | 1 (0.2) | 1 (0.2) | 0 | 0 | 0 |
| Abdominal pain | 2 (0.5) | 2 (0.5) | 0 | 0 | 0 | 0 |
| Granulocytopaenia | 2 (0.5) | 0 | 1 (0.2) | 1 (0.3) | 0 | 0 |
| Necrosis ischaemic | 2 (0.5) | 1 (0.2) | 1 (0.2) | 0 | 0 | 0 |
| AE resulting in study drug discontinuation | 26 (6.1) | 3 (0.7) | 9 (2.2) | 6 (1.9) | 6 (2.4) | 2 (1.5) |
| Deaths** | 1 (0.2) | 0 | 0 | 1 (0.3) | 0 | 0 |
*Treatment-emergent AEs are defined as AEs that started on or after first belimumab dose.
†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 4+ represents year 4–5 and year 5–6 of belimumab treatment.
§Active nephritis requiring acute therapy not permitted by protocol (eg, IV cyclophosphamide).
¶For severe AEs, events listed as life-threatening were included in the count.
**Accidental fall unrelated to study treatment.
AE, adverse event; IV, intravenous; SAE, serious AE.