Adverse event incidence (rate/100 patient-years) in patients treated with belimumab*.
| Interval (year) | 1 (0–1), n = 424 | 2 (1–2), n = 339 | 3 (2–3), n = 274 | 4 (3–4), n = 248 | 5 (4–5), n = 223 | 6 (5–6), n = 208 | 7 (6–7), n = 190 |
|---|---|---|---|---|---|---|---|
| Patient-years, no. | 374.0 | 299.1 | 258.1 | 234.2 | 215.8 | 197.6 | 167.0 |
| Overall AE | 413 (110.4) | 322 (107.7) | 260 (100.8) | 237 (101.2) | 211 (97.8) | 191 (96.7) | 172 (103.0) |
| Serious AE | 70 (18.7) | 52 (17.4) | 49 (19.0) | 31 (13.2) | 41 (19.0) | 32 (16.2) | 30 (18.0) |
| Discontinuations due to AE | 24 (6.4) | 8 (2.7) | 5 (1.9) | 8 (3.4) | 6 (2.8) | 6 (3.0) | 5 (3.0) |
| Overall infections | 313 (83.7) | 237 (79.2) | 192 (74.4) | 181 (77.3) | 145 (67.2) | 126 (63.8) | 128 (76.6) |
| Serious infections | 22 (5.9) | 14 (4.7) | 8 (3.1) | 8 (3.4) | 6 (2.8) | 8 (4.0) | 5 (3.0) |
| Infusion reactions including hypersensitivity† | 87 (23.3) | 32 (10.7) | 14 (5.4) | 14 (6.0) | 8 (3.7) | 6 (3.0) | 2 (1.2) |
| Serious | 0 | 0 | 1 (0.4) | 0 | 0 | 0 | 0 |
| Malignancies‡ | 1 (0.3) | 5 (1.7) | 3 (1.2) | 4 (1.7) | 4 (1.9) | 5 (2.5) | 2 (1.2) |
| Mortality | 3§ (0.8) | 0 | 1 (0.4) | 1 (0.4) | 0 | 0 | 2 (1.2) |
↵* Data presented as no. of patients with AE (no./100 patient-yrs) unless specified; based on no. of patients remaining on study at end of each 1-year interval;
↵† infusion reactions included > 160 MedDRA preferred terms (e.g., erythema, flushing, rash, urticaria) occurring on day of infusion with duration of ≤ 7 days; hypersensitivity reactions were defined as following MedDRA preferred terms that started on day of infusion (regardless of AE duration): anaphylactic reaction, anaphylactic shock, anaphylactoid reaction, anaphylactoid shock, angioedema, drug hypersensitivity, hypersensitivity, and tachyphylaxis;
↵‡ includes definite and unspecified solid organ, skin melanoma and non-skin melanoma, and hematologic malignancies;
↵§ in the Year 1 interval, 2 belimumab patients died during the 52-week, double-blind period; and 1 patient treated with placebo during double-blind period and subsequently switched to belimumab 10 mg/kg died after ∼ 232 days of belimumab exposure. AE: adverse events; MedDRA: Medical Dictionary for Regulatory Activities.