TABLE 2.
Descriptions of Sicilian ADR reports related to drugs for MS collected into the RNF 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 | 197 | 30 (15.2) | 136 (69.0) | 31 (15.7) | 130 (66.0) | 65 (33.0) | 2 (1.0) | - | 168 (85.3) | 1 (0.5) | 28 (14.2) |
| IFN β-1b | 87 | 22 (25.3) | 48 (55.2) | 17 (19.5) | 68 (78.2) | 18 (20.7) | 1 (1.1) | - | 81 (93.1) | 3 (3.4) | 3 (3.4) |
| PEG-IFN β-1a | 38 | 7 (18.4) | 27 (71.1) | 4 (10.5) | 28 (73.7) | 10 (26.3) | - | - | 33 (86.8) | - | 5 (13.2) |
| GA | 103 | 25 (24.3) | 70 (68.0) | 8 (7.8) | 73 (70.9) | 27 (26.2) | 3 (2.9) | 1 (1.0) | 96 (93.2) | 2 (1.9) | 4 (3.9) |
| Immunosuppressants | |||||||||||
| Alem | 58 | 15 (25.9) | 41 (70.7) | 2 (3.4) | 38 (65.5) | 20 (34.5) | - | - | 55 (94.8) | - | 3 (5.2) |
| Cladr | 31 | 5 (16.1) | 26 (83.9) | - | 29 (93.5) | 2 (6.5) | - | - | 31 (100.0) | - | - |
| DMF | 124 | 32 (25.8) | 89 (71.8) | 3 (2.4) | 95 (76.6) | 28 (22.6) | 1 (0.8) | - | 114 (91.9) | - | 10 (8.1) |
| FNG | 172 | 59 (34.3) | 108 (62.8) | 5 (2.9) | 131 (76.2) | 40 (23.3) | 1 (0.6) | - | 166 (96.5) | - | 6 (3.5) |
| NTZ | 212 | 69 (32.5) | 138 (65.1) | 5 (2.4) | 154 (72.6) | 55 (25.9) | 3 (1.4) | 2 (0.9) | 192 (90.6) | 8 (3.8) | 10 (4.7) |
| OCZ | 13 | 7 (53.8) | 6 (46.2) | - | 9 (69.2) | 4 (30.8) | - | - | 11 (84.6) | 1 (7.7) | 1 (7.7) |
| TRF | 81 | 23 (28.4) | 57 (70.4) | 1 (1.2) | 52 (64.2) | 28 (34.6) | 1 (1.2) | - | 73 (90.1) | 2 (2.5) | 6 (7.4) |
| FNG + DMF or + NTZ | 3 | 3 (100) | 2 (66.6) | 1 (33.3) | 2 (66.6) | 1 (33.3) | |||||
| Total | 1,119 | 297 (26.5) | 746 (66.7) | 76 (6.8) | 809 (72.3) | 298 (26.6) | 12 (1.1) | 3 (0.3) | 1,022 (91.3) | 18 (1.6) | 76 (6.8) |
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; RNF, Rete Nazionale di Farmacovigilanza; TRF, teriflunomide.