Summary of pooled safety of secukinumab in PSO and PsA
| PSO | PsA | |
|---|---|---|
| Any secukinumab | Any secukinumab | |
| N=3893 | N=1128 | |
| Total exposure, patient-years ) | 7769.0 | 1907.0 |
| Min–max exposure (days) | 1–1526 | 16–1464 |
| Death, n (%) | 7 (0.2) | 4 (0.4) |
| AE's by EAIR: AE per 100 Pt-years (95% Cl) | ||
| Any AE | 196.9 (190.3, 203.6) | 173.7 (162.5, 185.5) |
| Any serious AE | 7.2 (6.6, 7.8) | 8.5 (7.2, 10.0) |
| Frequent AEs1 | ||
| Nasopharyngitis | 18.2 (17.1, 19.3) | 13.7 (12.0, 15.7) |
| Headache | 6.3 (5.7, 6.9) | 4.8 (3.9, 5.9) |
| Upper respiratory tract infections | 6.2 (5.6, 6.8) | 11.2 (9.6, 12.9) |
| Arthralgia | 5.1 (4.6, 5.6) | 4.3 (3.4, 5.3) |
| AEs of special interest | ||
| Candida infections | 2.1 (1.8, 2.4) | 2.3 (1.6, 3.1) |
| Serious infections | 1.4 (1.2, 1.7) | 1.8 (1.3, 2.5) |
| Inflammatory Bowel Disease | 0.3 (0.2, 0.4) | 0.5 (0.2, 0.9) |
| Crohn's disease | 0.1 (0.0, 0.1) | 0 |
| Ulcerative colitis | 0.2 (0.1, 0.3) | 0.1 (0.0, 0.4) |
| MACE | 0.3 (0.2, 0.5) | 0.3 (0.1, 0.6) |
| Neutropenia | 0.4 (0.3, 0.5) | 0.7 (0.4, 1.2) |
1Adverse events in the secukinumab group that occurred with an IR >5.0 during the entire safety period in either of the spooled groups; AE, adverse event; EAIR, exposure adjusted incidence rate per 100 patient-years; MACE, major adverse cardiac event; N, number of patients in the analysis.