Table 2.
Summary of safety
| GA/DRF n = 166 |
IFN/DRF n = 182 |
EVOLVE-MS-2 rollovers | ||
|---|---|---|---|---|
| DRF-rollover n = 239 |
DMF-rollover n = 225 |
|||
| Any AE | 154 (92.8) | 161 (88.5) | 210 (87.9) | 203 (90.2) |
| Mild | 52 (31.3) | 42 (23.1) | 66 (27.6) | 71 (31.6) |
| Moderate | 88 (53.0) | 103 (56.6) | 121 (50.6) | 109 (48.4) |
| Severe | 14 (8.4) | 16 (8.8) | 23 (9.6) | 23 (10.2) |
| GI AEs (occurring in ≥ 5% of patients in any group) | 58 (34.9) | 69 (37.9) | 70 (29.3) | 64 (28.4) |
| Diarrhea | 25 (15.1) | 20 (11.0) | 18 (7.5) | 25 (11.1) |
| Nausea | 20 (12.0) | 12 (6.6) | 12 (5.0) | 15 (6.7) |
| Constipation | 6 (3.6) | 13 (7.1) | 9 (3.8) | 12 (5.3) |
| Upper abdominal pain | 6 (3.6) | 11 (6.0) | 5 (2.1) | 4 (1.8) |
| Vomiting | 4 (2.4) | 10 (5.5) | 7 (2.9) | 10 (4.4) |
| Infections | 83 (50.0) | 89 (48.9) | 108 (45.2) | 119 (52.9) |
| Serious infections | 2 (1.2) | 1 (0.5) | 2 (0.8) | 2 (0.9) |
| Opportunistic Infections | 3 (1.8) | 1 (0.5) | 2 (0.8) | 1 (0.4) |
| Oral candidiasis | 2 (1.2) | 0 | 1 (0.4) | 0 |
| Candida infection | 0 | 1 (0.5) | 0 | 1 (0.4) |
| Vulvovaginal candidiasis | 1 (0.6) | 0 | 1 (0.4) | 0 |
| Esophageal candidiasis | 0 | 1 (0.5) | 0 | 1 (0.4) |
| COVID-19 | 0 | 1 (0.5) | 0 | 2 (0.9) |
| AEs leading to treatment discontinuation | 19 (11.4) | 19 (10.4) | 23 (9.6) | 13 (5.8) |
| GI AEs leading to treatment discontinuation | 0 | 1 (0.5) | 1 (0.4) | 1 (0.4) |
| SAEsa,b,c,d | 20 (12.0) | 18 (9.9) | 28 (11.7) | 23 (10.2) |
| Deathe | 0 | 0 | 1 (0.4) | 0 |
AE adverse event, DMF dimethyl fumarate, DRF diroximel fumarate, GA glatiramer acetate, GI gastrointestinal, IFN interferon, SAE serious AE
aSAEs in the DRF-rollover group included MS relapse, n = 19; and 1 patient each with gastritis; inguinal hernia; chronic gastritis; eosinophilic esophagitis; appendicitis; pharyngitis; cardiac arrest; stress cardiomyopathy; parathyroid tumor benign; endometrial hyperplasia; vaginal prolapse; cholecystitis; cholelithiasis; alanine aminotransferase increased; pyrexia. Some patients may have experienced more than 1 SAE
bSAEs in the DMF-rollover group included MS relapse, n = 10; abdominal pain, n = 2; and 1 patient each with cerebellar embolism; idiopathic intracranial hypertension; seizure; gastritis; vomiting; fall; accidental overdose; joint injury; cellulitis; urinary tract infection; myocardial infarction; benign neoplasm of bladder; diffuse large B cell lymphoma; cholecystitis; cholestatic liver injury; back pain; flank pain; bipolar I disorder; pulmonary embolism; Leriche syndrome; chorioretinopathy. Some patients may have experienced more than 1 SAE
cSAEs in the GA/DRF group included MS relapse, n = 7; and 1 patient each with uterine leiomyoma; fallopian tube cyst; abortion spontaneous; cardiac failure; diffuse large B cell lymphoma; sepsis; cellulitis; suicidal ideation; pelvic prolapse; sciatica; cholelithiasis; chorioretinopathy; bipolar I disorder
dSAEs in the IFN/DRF group included MS relapse, n = 7; MS relapse, cholecystitis, abdominal pain, fall, vomiting, back pain, flank pain, accidental overdose, n = 1; and 1 patient each with stress cardiomyopathy; abdominal pain; pneumonia and respiratory failure; invasive ductal breast carcinoma; road traffic accident; lower limb fracture; seizure; liver function test increased; suicidal ideation; osteonecrosis; spontaneous abortion
eDue to cardiac arrest that was probably not related to study drug