TABLE 1.
Clinical characteristics of reports with secukinumab from the FAERS database (January 2015 to September 2021).
| Characteristics | Case number, n | Case proportion, % |
|---|---|---|
| Number of events | 89,228 | |
| Gender | ||
| Female | 50,251 | 56.32 |
| Male | 34,098 | 38.21 |
| Unknown | 4,879 | 5.47 |
| Age (years) | ||
| <18 | 113 | 0.13 |
| 18≤ and ≤65 | 27,556 | 30.88 |
| >65 | 5,539 | 6.21 |
| Unknown | 56,020 | 62.78 |
| Indications (TOP five) | ||
| Psoriasis | 35,870 | 40.20 |
| Psoriatic arthropathy | 16,991 | 19.04 |
| Ankylosing spondylitis | 6,474 | 7.26 |
| Rheumatoid arthritis | 401 | 0.45 |
| Pustular psoriasis | 158 | 0.18 |
| Serious Outcome | ||
| Death | 1,438 | 1.61 |
| Life-threatening | 693 | 0.78 |
| Hospitalization | 7,247 | 8.12 |
| Disability | 560 | 0.63 |
| Congenital anomaly | 22 | 0.02 |
| Required intervention to prevent permanent impairment/damage | 18 | 0.02 |
| Other serious medical events | 18,528 | 20.76 |
| Reported Countries (Top five) | ||
| America | 30,913 | 34.64 |
| Canada | 2,034 | 2.28 |
| Britain | 1,303 | 1.46 |
| Germany | 1,270 | 1.42 |
| Japan | 632 | 0.71 |
| Reported Person | ||
| Health profession | ||
| Physician | 12,918 | 14.48 |
| Pharmacist | 3,517 | 3.94 |
| Other health professional | 14,665 | 16.43 |
| Non-healthcare professional | ||
| Consumer | 55,809 | 62.55 |
| Unknown | 2,319 | 2.60 |
| Reporting year | ||
| 2021 Q3 a | 15,358 | 17.21 |
| 2020 | 19,958 | 22.37 |
| 2019 | 17,834 | 19.99 |
| 2018 | 18,142 | 20.33 |
| 2017 | 10,097 | 11.32 |
| 2016 | 5,409 | 6.06 |
| 2015 | 2,430 | 2.72 |
The third quarter of 2021.