From: Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis
Treatment naive (n = 1018) | Previously treated with another DMT (n = 163) | Recently treated with another DMT (n = 158) | Overall population (N = 1696)b | |
---|---|---|---|---|
Patients with any AE, n (%) | 918 (90.2) | 157 (96.3) | 145 (91.8) | 1503 (88.6) |
Patients with any SAE, n (%) | 196 (19.3) | 40 (24.5) | 34 (21.5) | 312 (18.4) |
Patients with any AE leading to death, n (%) | 7 (0.7) | 0 | 0 | 10 (0.6) |
Patients with any AE leading to permanent treatment discontinuation, n (%) | 155 (15.2) | 33 (20.2) | 31 (19.6) | 244 (14.4) |
AEs with incidence > 10% in any prior DMT subgroup, n (%) | ||||
Nasopharyngitis | 249 (24.5) | 47 (28.8) | 36 (22.8) | 391 (23.1) |
ALT increase | 185 (18.2) | 25 (15.3) | 18 (11.4) | 246 (14.5) |
Headache | 185 (18.2) | 32 (19.6) | 40 (25.3) | 296 (17.5) |
Diarrhea | 178 (17.5) | 41 (25.2) | 35 (22.2) | 284 (16.7) |
Hair thinning (alopecia) | 157 (15.4) | 28 (17.2) | 25 (15.8) | 226 (13.3) |
Back pain | 148 (14.5) | 34 (20.9) | 21 (13.3) | 231 (13.6) |
Fatigue | 136 (13.4) | 26 (16.0) | 25 (15.8) | 203 (12.0) |
Influenza | 133 (13.1) | 26 (16.0) | 17 (10.8) | 200 (11.8) |
Nausea | 121 (11.9) | 26 (16.0) | 21 (13.3) | 184 (10.8) |
Pain in extremity | 121 (11.9) | 24 (14.7) | 14 (8.9) | 181 (10.7) |
Upper respiratory tract infection | 121 (11.9) | 31 (19.0) | 23 (14.6) | 202 (11.9) |
Urinary tract infection | 113 (11.1) | 29 (17.8) | 21 (13.3) | 197 (11.6) |
Paresthesia | 102 (10.0) | 24 (14.7) | 15 (9.5) | 157 (9.3) |
Hypoesthesia | 99 (9.7) | 22 (13.5) | 14 (8.9) | 148 (8.7) |
Hypertension | 94 (9.2) | 18 (11.0) | 21 (13.3) | 157 (9.3) |
Arthralgia | 93 (9.1) | 22 (13.5) | 14 (8.9) | 147 (8.7) |
Bronchitis | 78 (7.7) | 18 (11.0) | 15 (9.5) | 126 (7.4) |
Sinusitis | 68 (6.7) | 24 (14.7) | 16 (10.1) | 126 (7.4) |
Fall | 67 (6.6) | 20 (12.3) | 17 (10.8) | 120 (7.1) |
Abdominal pain, upper | 60 (5.9) | 10 (6.1) | 19 (12.0) | 98 (5.8) |
Insomnia | 56 (5.5) | 20 (12.3) | 12 (7.6) | 94 (5.5) |
Gastroenteritis | 50 (4.9) | 18 (11.0) | 13 (8.2) | 94 (5.5) |