Table 3.
Overview of safety outcomes in teriflunomide-treated patients from the phase II, TEMSO, TOWER and TOPIC core studies and phase II and TEMSO long-term extensions.20
| Patients with adverse events, n (%)* | Teriflunomide 7 mg (n = 1204) | Teriflunomide 14 mg (n = 1134) |
|---|---|---|
| All adverse events | 1056 (87.7) | 1020 (89.9) |
| Serious adverse events | 246 (20.4) | 219 (19.3) |
| Events leading to permanent treatment discontinuation | 184 (15.3) | 172 (15.2) |
| Death | 4 (0.3) | 4 (0.4) |
| Intensity$ | ||
| Mild | 270 (22.4) | 252 (22.2) |
| Moderate | 559 (46.4) | 558 (49.2) |
| Severe | 227 (18.9) | 210 (18.5) |
| Common adverse events‡ | ||
| Nasopharyngitis | 278 (23.1) | 272 (24.0) |
| Headache | 256 (21.3) | 215 (19.0) |
| ALT increase | 205 (17.0) | 211 (18.6) |
| Diarrhea | 189 (15.7) | 192 (16.9) |
| Fatigue | 177 (14.7) | 170 (15.0) |
| Hair thinning§ | 127 (10.5) | 166 (14.6) |
| Back pain | 150 (12.5) | 157 (13.8) |
| Influenza | 136 (11.3) | 149 (13.1) |
| Upper respiratory tract infection | 153 (12.7) | 145 (12.8) |
| Nausea | 120 (10.0) | 142 (12.5) |
| Urinary tract infection | 136 (11.3) | 130 (11.5) |
| Paresthesia | 115 (9.6) | 129 (11.4) |
| Pain in extremity | 128 (10.6) | 123 (10.8) |
| Arthralgia | 138 (11.5) | 103 (9.1) |
*
Includes patients initially randomized to placebo in core studies.
$
Mild: no modification of daily activities and/or does not require symptomatic treatment; moderate: hinders normal daily activities and/or requires symptomatic treatment; severe: prevents daily activities and requires symptomatic treatment.
‡
Events with a crude incidence rate of at least 10% in either teriflunomide group; listed in descending order in the teriflunomide 14 mg group.
§
MedDRA-preferred term: alopecia.
ALT, alanine aminotransferase; MedDRA, Medical Dictionary for Regulatory Activities.