Table 3.
Event rate of treatment-emergent AEs (safety population; N=424)
| Number (rate per 100 patient-years) of events* | ||||||
| Any time post-first dose of belimumab† | Year 0–1 | Years 1–2 | Years 2–3 | Years 3–4 | Year 4+‡ | |
| Patient-years=1384 | Patient-years=415 | Patient-years=364 | Patient-years=282 | Patient-years=197 | Patient-years=65 | |
| AE | 2285 (165.1) | 863 (207.9) | 566 (155.7) | 439 (155.5) | 260 (132.1) | 86 (131.6) |
| Treatment-related AE | 659 (47.6) | 202 (48.7) | 170 (46.8) | 167 (59.2) | 88 (44.7) | 21 (32.1) |
| SAE | 135 (9.8) | 28 (6.7) | 41 (11.3) | 31 (11.0) | 23 (11.7) | 6 (9.2) |
| Serious infections and infestations | 25 (1.8) | 4 (1.0) | 6 (1.7) | 3 (1.1) | 9 (4.6) | 1 (1.5) |
| Severe AE | 47 (3.4) | 13 (3.1) | 11 (3.0) | 11 (3.9) | 9 (4.6) | 2 (3.1) |
| AEs resulting in study discontinuation | 29 (2.1) | 3 (0.7) | 11 (3.0) | 6 (2.1) | 6 (3.0) | 3 (4.6) |
| AESI | ||||||
| Malignant neoplasms§¶ | 2 (0.1) | 1 (0.2) | 0 | 0 | 1 (0.5) | 0 |
| Any post-infusion systemic reactions**†† | 21 (1.5) | 11 (2.7) | 5 (1.4) | 2 (0.7) | 2 (1.0) | 1 (1.5) |
| All infections of special interests§‡‡ | 50 (3.6) | 21 (5.1) | 14 (3.9) | 3 (1.1) | 9 (4.6) | 2 (3.1) |
| Serious | 8 (0.6) | 2 (0.5) | 2 (0.6) | 0 | 3 (1.5) | 1 (1.5) |
| All opportunistic infections§§ | 15 (1.1) | 8 (1.9) | 4 (1.1) | 1 (0.4) | 2 (1.0) | 0 |
| Serious | 3 (0.2) | 2 (0.5) | 1 (0.3) | 0 | 0 | 0 |
| Active TB§ | 2 (0.1) | 0 | 1 (0.3) | 0 | 1 (0.5) | 0 |
| Herpes zoster¶¶ | 42 (3.0) | 19 (4.6) | 10 (2.8) | 2 (0.7) | 8 (4.1) | 2 (3.1) |
| Serious | 6 (0.4) | 2 (0.5) | 1 (0.3) | 0 | 2 (1.0) | 1 (1.5) |
| Recurrent opportunistic | 5 (0.4) | 1 (0.2) | 1 (0.3) | 1 (0.4) | 2 (1.0) | 0 |
| Disseminated opportunistic | 8 (0.6) | 6 (1.4) | 2 (0.6) | 0 | 0 | 0 |
| Sepsis§ | 0 | 0 | 0 | 0 | 0 | 0 |
| Depression*** | 14 (1.0) | 3 (0.7) | 8 (2.2) | 1 (0.4) | 2 (1.0) | 0 |
| Deaths | 1 (<0.1) | 0 | 0 | 1 (0.4) | 0 | 0 |
*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 4+ represents years 4–5 and years 5–6 of belimumab treatment.
§Per Custom MedDRA query (CMQ, version 21.1).
¶No skin malignancies reported.
**No serious post-infusion systemic reactions reported.
††Per anaphylactic reaction CMQ broad search.
‡‡All infections of special interest are limited to opportunistic infections, active TB, herpes zoster and sepsis.
§§Per sponsor adjudication.
¶¶Herpes zoster events that were recurrent or disseminated are also counted under ‘All opportunistic infections’.
***Per MedDRA preferred term.
AE, adverse event; AESI, AE of special interest; CMQ, custom MedDRA query; MedDRA, Medical Dictionary for Regulatory Activities; SAE, serious AE; TB, tuberculosis.