Table 1.
Demographics of the total and anaphylactic reaction-related reports of asthma biologics on Vigibase.
| Demographics | Total reports (N = 62,883) | Anaphylactic reaction reports (N = 1964) |
|---|---|---|
| Sex (N, %) | ||
| Male | 19,617 (31.2%) | 304 (15.5%) |
| Female | 38,276 (60.9%) | 1410 (71.8%) |
| Not known | 4990 (7.9%) | 250 (12.7%) |
| Age | ||
| < 18 years | 2539 (4.0%) | 137 (7.0%) |
| 18–44 years | 11,941 (19.0%) | 508 (25.9%) |
| 45–64 years | 14,541 (23.1%) | 339 (17.3%) |
| 65–74 years | 4213 (6.7%) | 48 (2.4%) |
| ≥ 75 years | 1932 (3.1%) | 17 (0.9%) |
| Unknown | 27,717 (44.1%) | 915 (46.6%) |
| Reporter | ||
| Consumer/non-healthcare professional | 29,155 (46.4%) | 403 (20.5%) |
| Physician | 20,083 (31.9%) | 1,063 (54.1%) |
| Other healthcare professional | 9707 (15.4%) | 378 (19.3%) |
| Pharmacist | 2373 (3.8%) | 36 (1.8%) |
| Lawyer | 11 (0.02%) | 1 (0.05%) |
| Unknown | 1554 (2.5%) | 83 (4.2%) |
| Serious cases | 22,995 (36.6%) | 1,889 (96.2%) |
| Deaths | 1441 (2.3%) | 16 (0.8%) |
| Continent of the primary source | ||
| Americas | 50,837 (80.8%) | 1565 (79.7%) |
| Europe | 9656 (15.4%) | 240 (12.2%) |
| Asia | 1675 (2.7%) | 88 (4.5%) |
| Oceania | 573 (0.9%) | 63 (3.2%) |
| Africa | 142 (0.2%) | 8 (0.4%) |
| Year | ||
| ≤ 2015 | 10,013 (15.9%) | 897 (45.7%) |
| 2016 | 4488 (7.1%) | 204 (10.4%) |
| 2017 | 9146 (14.5%) | 207 (10.6%) |
| 2018 | 12,845 (20.4%) | 277 (14.1%) |
| 2019 | 26,391 (42.0%) | 379 (19.3%) |
| Conditiona | ||
| Asthma | 24,868 (33.1%) | 996 (41.5%) |
| Urticaria | 7124 (9.5%) | 396 (16.5%) |
| Dermatitis | 12,392 (16.5%) | 21 (0.9%) |
| Others | 4464 (5.9%) | 143 (6.0%) |
| Unknown | 26,290 (35.0%) | 847 (35.3%) |
| Drugsb | ||
| Omalizumab | 32,618 (51.6%) | 1,760 (88.6%) |
| Mepolizumab | 7344 (11.6%) | 103 (5.2%) |
| Benralizumab | 2387 (3.8%) | 67 (3.4%) |
| Reslizumab | 315 (0.5%) | 5 (0.3%) |
| Dupilumab | 20,559 (32.5%) | 51 (2.6%) |
aOne case that reported one or more conditions.
bOne patient that reported one or more drugs and AEs. The cases included suspect, concomitant, and interacting reports.