Event rates of treatment-emergent AEs by year interval (safety population, N=142)
| Number (rate) of events* | ||||||||
| Any time post first dose of belimumab† | Year 0–1 | Year 1–2 | Year 2–3 | Year 3–4 | Year 4–5 | Year 5–6 | Year 6+‡ | |
| Patient-years=471 | Patient-years=139 | Patient-years=125 | Patient-years=91 | Patient-years=52 | Patient-years=28 | Patient-years=19 | Patient-years=5 | |
| AEs | 2250 (477.2) | 733 (526.0) | 564 (452.9) | 393 (429.8) | 245 (472.9) | 135 (483.5) | 119 (623.9) | 20 (417.6) |
| Treatment-related AEs | 262 (55.6) | 99 (71.0) | 94 (75.5) | 33 (36.1) | 13 (25.1) | 15 (53.7) | 6 (31.5) | 1 (20.9) |
| SAE | 78 (16.5) | 28 (20.1) | 22 (17.7) | 13 (14.2) | 6 (11.6) | 2 (7.2) | 4 (21.0) | 0 |
| Serious infections and infestations | 30 (6.4) | 14 (10.0) | 8 (6.4) | 2 (2.2) | 3 (5.8) | 0 | 2 (10.5) | 0 |
| Severe AEs | 50 (10.6) | 17 (12.2) | 14 (11.2) | 10 (10.9) | 2 (3.9) | 1 (3.6) | 2 (10.5) | 0 |
| AEs resulting in study discontinuation | 8 (1.7) | 1 (0.7) | 4 (3.2) | 2 (2.2) | 0 | 1 (3.6) | 0 | 0 |
| AESI | ||||||||
| Malignant neoplasms§¶ | 1 (0.2) | 0 | 1 (0.8) | 0 | 0 | 0 | 0 | 0 |
| Any postinfusion systemic reactions** | 26 (5.5) | 10 (7.2) | 4 (3.2) | 4 (4.4) | 2 (3.9) | 5 (17.9) | 1 (5.2) | 0 |
| All infections of special interest§†† | 37 (7.8) | 13 (9.3) | 12 (9.6) | 4 (4.4) | 2 (3.9) | 1 (3.6) | 1 (5.2) | 0 |
| Serious | 6 (1.3) | 3 (2.2) | 2 (1.6) | 1 (1.1) | 0 | 0 | 0 | 0 |
| All opportunistic infections‡‡ | 11 (2.3) | 3 (2.2) | 4 (3.2) | 1 (1.1) | 1 (1.9) | 0 | 0 | 0 |
| Serious‡‡ | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Active TB§ | 1 (0.2) | 0 | 0 | 1 (1.1) | 0 | 0 | 0 | 0 |
| Herpes zoster§,§§ | 28 (5.9) | 11 (7.9) | 10 (8.0) | 2 (2.2) | 2 (3.9) | 1 (3.6) | 0 | 0 |
| Serious | 4 (0.8) | 3 (2.2) | 1 (0.8) | 0 | 0 | 0 | 0 | 0 |
| Recurrent opportunistic | 6 (1.3) | 2 (1.4) | 3 (2.4) | 0 | 0 | 0 | 0 | 0 |
| Disseminated opportunistic | 5 (1.1) | 1 (0.7) | 1 (0.8) | 1 (1.1) | 1 (1.9) | 0 | 0 | 0 |
| Sepsis§ | 4 (0.8) | 0 | 0 | 1 (1.1) | 0 | 0 | 1 (5.2) | 0 |
| Depression§§ | 12 (2.5) | 5 (3.6) | 2 (1.6) | 1 (1.1) | 2 (3.9) | 0 | 0 | 0 |
| Deaths*** | 1 (0.2) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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.
*Each column shows the number of reported AEs for that year and the rate of events per 100 patient-years.
†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.
§Per Custom MedDRA query (V.22.0).
¶No skin malignancies reported.
**No serious postinfusion systemic reactions reported.
††All infections of special interest are limited to opportunistic infections, active TB, herpes zoster and sepsis.
‡‡Per sponsor adjudication.
§§Not all herpes zoster events were recurrent or disseminated.
¶¶Per MedDRA preferred term.
***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; AESI, AE of special interest; MedDRA, Medical Dictionary for Regulatory Activities; SAE, serious AE; TB, tuberculosis.