TABLE 1.
Descriptions of Italian ADR reports related to drugs for MS collected into the RAM system from January 2002 to December 2020.
| Suspected drug | Total | Seriousness | Gender | Age group | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Serious n (%) | Not serious n (%) | NA n (%) | Female n (%) | Male n (%) | NA n (%) | <18 years n (%) | 18–65 years n (%) | ≥66 years n (%) | NA n (%) | ||
| Immunostimulants | |||||||||||
| IFN β-1a | 3,097 | 349 (11.3) | 2,378 (76.8) | 370 (11.9) | 2,271 (73.3) | 804 (26.0) | 22 (0.7) | 41 (1.3) | 1,666 (53.8) | 19 (0.6) | 1,313 (42.4) |
| IFN β-1b | 541 | 80 (14.8) | 271 (50.1) | 190 (35.1) | 391 (72.3) | 138 (25.5) | 12 (2.2) | 2 (0.2) | 509 (94.1) | 16 (3.0) | 15 (2.8) |
| PEG-IFN β-1a | 558 | 66 (11.8) | 461 (82.6) | 31 (5.6) | 373 (66.8) | 102 (18.3) | 83 (14.9) | 317 (56.8) | 3 (0.5) | 238 (42.7) | |
| GA | 2,047 | 446 (21.8) | 1,562 (76.3) | 39 (1.9) | 1,588 (77.6) | 428 (20.9) | 31 (1.5) | 14 (0.7) | 1,617 (79.0) | 41 (2.0) | 375 (18.3) |
| Immunosuppressants | |||||||||||
| Alem | 1,226 | 359 (29.3) | 851 (69.4) | 16 (1.3) | 853 (69.6) | 357 (29.1) | 16 (1.3) | 2 (0.2) | 1,076 (87.8) | 7 (0.6) | 141 (11.5) |
| Cladr | 72 | 13 (18.1) | 59 (81.9) | 57 (79.2) | 15 (20.8) | 59 (81.9) | 13 (18.1) | ||||
| DMF | 1,326 | 326 (24.6) | 979 (73.8) | 21 (1.6) | 962 (72.5) | 339 (25.6) | 25 (1.9) | 5 (0.4) | 1,067 (80.5) | 18 (1.4) | 236 (17.8) |
| FNG | 2,652 | 1,112 (41.9) | 1,418 (53.5) | 122 (4.6) | 1,805 (68.1) | 815 (30.7) | 32 (1.2) | 13 (0.5) | 2,391 (90.2) | 19 (0.7) | 229 (8.6) |
| NTZ | 1,265 | 496 (39.2) | 741 (58.6) | 28 (2.2) | 923 (73.0) | 317 (25.1) | 25 (2.0) | 13 (1.0) | 1,054 (83.3) | 48 (3.8) | 150 (11.9) |
| OCZ | 340 | 138 (40.6) | 200 (58.8) | 2 (0.6) | 188 (55.3) | 143 (42.1) | 9 (2.6) | 286 (84.1) | 8 (2.4) | 46 (13.5) | |
| TRF | 756 | 236 (31.2) | 506 (66.9) | 14 (1.9) | 538 (71.2) | 195 (25.8) | 23 (3.0) | 575 (76.1) | 24 (3.2) | 157 (20.8) | |
| Total | 13,880 | 3,621 (26.1) | 9,426 (67.9) | 833 (6.0) | 9,949 (71.7) | 3,653 (26.3) | 278 (2.0) | 90 (0.6) | 10,617 (76.5) | 203 (1.5) | 2,913 (21.0) |
ADR, adverse drug reaction; Alem, alemtuzumab; Cladr, cladribine; DMF, dimethyl fumarate; FNG, fingolimod; GA, glatiramer acetate; IFN β-1a, interferon β-1a; IFN β-1b, interferon β-1b; MS, multiple sclerosis; NA, not available; NTZ, natalizumab; OCZ, ocrelizumab; PEG-IFN β-1a, peginterferon β-1a; RAM, Reports of Adverse Reactions of Medicines; TRF, teriflunomide.