TABLE 2.
Clinical characteristics of patients with AEs associated with S1PR modulators in FAERS database (2010Q4 to 2023Q2).
| Fingolimod | Siponimod | Ozanimod | Total | |
|---|---|---|---|---|
| Number of reports | 80,384 | 6,913 | 4,681 | 91,978 |
| Gender, n (%) | ||||
| Male | 16,776 (20.87) | 1,535 (22.20) | 1,220 (26.06) | 19,531 (21.23) |
| Female | 59,600 (74.14) | 4,941(71.47) | 3,257 (69.58) | 67,798 (73.71) |
| Unknown | 4,008 (4.99) | 437 (6.32) | 204 (4.36) | 4,649 (5.05) |
| Age, years | ||||
| Median (interquartile) | 44.00 (35-53) | 55.00 (48-62) | 49.00 (38-58) | |
| <18, n (%) | 636 (0.79) | 6 (0.09) | 4 (0.09) | 646 (0.70) |
| 18-44, n (%) | 22,086 (27.48) | 532 (7.70) | 1,420 (30.34) | 24,038 (26.13) |
| 45-64, n (%) | 19,943 (24.81) | 1918 (27.74) | 1,660 (35.46) | 23,521 (25.57) |
| 65-74, n (%) | 1716 (2.13) | 392 (5.67) | 366 (7.82) | 2,474 (2.69) |
| ≥75, n (%) | 120 (0.15) | 59 (0.85) | 71 (1.52) | 250 (0.27) |
| Unknown, n (%) | 35,883 (44.64) | 4,006 (57.95) | 1,160 (24.78) | 41,049 (44.63) |
| Reporting country, n (%) | ||||
| United States | 51,270 (63.78) | 5,438 (78.66) | 4,321 (92.31) | 61,029 (66.35) |
| Other/Unknown | 29,114 (36.22) | 1,475 (21.34) | 360 (7.69) | 30,949 (33.65) |
| Reporting year, n (%) | ||||
| 2010 (October-December) | 21 (0.03) | - | - | 21 (0.02) |
| 2011 | 2,174 (2.70) | - | - | 2,174 (2.36) |
| 2012 | 3,229 (4.02) | - | - | 3,229 (3.51) |
| 2013 | 7,818 (9.73) | - | - | 7,818 (8.50) |
| 2014 | 2,970 (3.69) | - | - | 2,970 (3.23) |
| 2015 | 6,510 (8.10) | - | - | 6,510 (7.08) |
| 2016 | 8,981 (11.17) | - | - | 8,981 (9.76) |
| 2017 | 9,112 (11.34) | - | - | 9,112 (9.91) |
| 2018 | 10,338 (12.86) | - | - | 10,338 (11.24) |
| 2019 | 10,395 (12.93) | 683 (9.88) | - | 11,078 (12.04) |
| 2020 | 8,588 (10.68) | 1805 (26.11) | 214 (4.57) | 10,607 (11.53) |
| 2021 | 4,504 (5.60) | 1848 (26.73) | 1952 (41.70) | 8,304 (9.03) |
| 2022 | 4,061 (5.05) | 1,658 (23.98) | 1752 (37.43) | 7,471 (8.12) |
| 2023 (January-June) | 1,683 (2.09) | 919 (13.29) | 763 (16.30) | 3,365 (3.66) |
| Type of reporter, n (%) | ||||
| Consumer | 50,611 (62.96) | 4,367 (63.17) | 1,604 (34.27) | 56,582 (61.52) |
| Healthcare professional | 28,781 (35.80) | 2,351 (34.01) | 3,061 (65.39) | 34,193 (37.18) |
| Other/unknown | 992 (1.23) | 195 (2.82) | 16 (0.34) | 1,203 (1.31) |
| Outcome, n (%) | ||||
| Death | 1,053 (1.31) | 151 (2.18) | 52 (1.11) | 1,256 (1.37) |
| Life-threatening | 1,121 (1.39) | 69 (1.00) | 48 (1.03) | 1,238 (1.35) |
| Hospitalization | 10,146 (12.62) | 980 (14.18) | 450 (9.61) | 11,576 (12.59) |
| Disability | 1,140 (1.42) | 63 (0.91) | 68 (1.45) | 1,271 (1.38) |
| Congenial anomaly | 138 (0.17) | 0 (0.00) | 1 (0.02) | 139 (0.15) |
| Required intervention | 23 (0.03) | 4 (0.06) | 0 (0.00) | 27 (0.03) |
| Other serious | 32,362 (40.26) | 2,123 (30.71) | 1,101(23.52) | 34,485 (37.49) |
| Indication, n (%) | ||||
| Multiple sclerosis | 64,525 (80.27%) | 4,668 (67.52%) | 2,978 (63.62) | 72,172 (78.47%) |
| Ulcerative colitis | 0 | 0 | 924 (19.74) | 924 (1.00%) |
| Others | 547 (0.68%) | 56 (0.82%) | 120 (2.56%) | 722 (0.78%) |
| Unknown | 15,312 (19.05) | 2,189 (31.66) | 659 (14.08) | 18,160 (19.74) |