Table 3.
Safety outcomes at week 52
| Safety outcomes | IXE treatment arm | ADA treatment arm | ||
|---|---|---|---|---|
| No MTX (N = 116) | MTX (N = 167) | No MTX (N = 114) | MTX (N = 169) | |
| Treatment-emergent adverse events ≥ 1 | 92 (79.3) | 117 (70.1) | 80 (70.2) | 114 (67.5) |
| Mild | 43 (37.1) | 52 (31.1) | 31 (27.2) | 54 (32.0) |
| Moderate | 44 (37.9) | 61 (36.5) | 39 (34.2) | 50 (29.6) |
| Severea | 5 (4.3) | 4 (2.4) | 10 (8.8) | 10 (5.9) |
| Serious adverse eventsb | 8 (6.9) | 4 (2.4) | 17 (14.9) | 18 (10.7) |
| Deaths | 0 | 0 | 0 | 0 |
| Discontinuations due to adverse events | 8 (6.9) | 4 (2.4) | 9 (7.9) | 12 (7.1) |
| Adverse events of special interest | ||||
| Infections | 54 (46.6) | 65 (38.9) | 49 (43.0) | 62 (36.7) |
| Nasopharyngitis | 21 (18.1) | 17 (10.2) | 12 (10.5) | 11 (6.5) |
| Upper respiratory tract infection | 5 (4.3) | 13 (7.8) | 7 (6.1) | 11 (6.5) |
| Serious infections | 4 (3.4) | 1 (0.6) | 5 (4.4) | 3 (1.8) |
| Malignancies | 0 | 0 | 1 (0.9) | 3 (1.8) |
| MACE | 0 | 0 | 1 (0.9) | 1 (0.6) |
| IBDc | 1 (0.9) | 1 (0.6) | 0 | 0 |
| Injection site reactions | 13 (11.2) | 17 (10.2) | 3 (2.6) | 7 (4.1) |
| Depression | 4 (3.4) | 1 (0.6) | 5 (4.4) | 4 (2.4) |
| Liver function test valuesd | ||||
| ALT elevatione | 1 (0.4) | 2 (0.7) | 2 (0.7) | 9 (3.2) |
| AST elevatione | 1 (0.4) | 1 (0.4) | 1 (0.4) | 6 (2.1) |
| Total bilirubinf | 0 | 3 (1.1) | 0 | 2 (0.7) |
| ALPf | 1 (0.4) | 4 (1.4) | 1 (0.4) | 4 (1.4) |
| Cytopenias | 3 (2.6) | 6 (3.6) | 3 (2.6) | 9 (5.3) |
| Neutropenia | 2 (1.7) | 2 (1.2) | 1 (0.9) | 4 (2.4) |
Unless otherwise indicated, values are presented as a number with the percentage (n/N) given in parentheses
ALP Alkaline phosphatase, ALT alanine aminotransferase, AST aspartate aminotransferase, IBD inflammatory bowel disease, MACE major adverse cardiovascular events, n number of patients in a group, N number of patients, ULN upper limit normal from performed laboratoy reference ranges
aSeverity of an adverse event is judged by patient or investigator
bSerious adverse event met the serious criteria of the International Council for Harmonization
cTwo IBD events were reported in the IXE treatment group during the 0- to 24-week period but only 1 case was adjudicated as confirmed Crohn’s disease. One event was reported as colitis ulcerative but was not adjudicated as confirmed ulcerative colitis [21]
dLiver function test values were calculated as percentages using the denominator total of 283 for both the IXE and ADA groups
ePost-baseline ≥ 3 ULN
fPost-baseline bilirubin ≥ 1.5 ULN; post-baseline ALP > 1.5 ULN