Table 3.
Safety summary: COAST-V and COAST-W (ETP population (weeks 16 to 52) and all ixekizumab exposure safety population (weeks 0 to 52))
| COAST-V (bDMARD-naive) ETP population (weeks 16–52) |
COAST-W (TNFi-experienced) ETP population (weeks 16–52) |
COAST-V+COAST W All ixekizumab exposure safety population (weeks 0–52) |
|||||||
| PBO/ IXE (n=86) n (%) |
ADA/ IXE (n=86) n (%) |
IXE Q4W/ IXE Q4W (n=78) n (%) |
IXE Q2W/ IXE Q2W (n=79) n (%) |
PBO/ IXE (n=93) n (%) |
IXE Q4W/ IXE Q4W (n=98) n (%) |
IXE Q2W/ IXE Q2W (n=90) n (%) |
Total IXE Q4W (n=327) n (%) (IR*) |
Total IXE Q2W (n=314) n (%) (IR*) |
|
| Exposure, patient-years | 58.5 | 51.7 | 51.9 | 53.2 | 59.6 | 64.1 | 58.2 | 259.4 | 250.8 |
| Any TEAE | 57 (66.3) | 50 (58.1) | 50 (64.1) | 44 (55.7) | 52 (55.9) | 69 (70.4) | 58 (64.4) | 234 (71.6) (90.2) | 217 (69.1) (86.5) |
| Mild | 31 (36.0) | 32 (37.2) | 34 (43.6) | 28 (35.4) | 21 (22.6) | 30 (30.6) | 24 (26.7) | 115 (35.2) (44.3) | 97 (30.9) (38.7) |
| Moderate | 22 (25.6) | 15 (17.4) | 13 (16.7) | 13 (16.5) | 23 (24.7) | 33 (33.7) | 30 (33.3) | 101 (30.9) (38.9) | 98 (31.2) (39.1) |
| Severe | 4 (4.7) | 3 (3.5) | 3 (3.8) | 3 (3.8) | 8 (8.6) | 6 (6.1) | 4 (4.4) | 18 (5.5) (6.9) | 22 (7.0) (8.8) |
| Discontinuation due to AE | 2 (2.3) | 3 (3.5) | 1 (1.3) | 2 (2.5) | 1 (1.1) | 4 (4.1) | 5 (5.6) | 17 (5.2) (6.6) | 17 (5.4) (6.8) |
| SAEs | 4 (4.7) | 7 (8.1) | 4 (5.1) | 3 (3.8) | 6 (6.5) | 2 (2.0) | 1 (1.1) | 17 (5.2) (6.6) | 19 (6.1) (7.6) |
| Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0.3) (0.4) |
| Most common TEAEs† | |||||||||
| Nasopharyngitis | 17 (19.8) | 7 (8.1) | 8 (10.3) | 7 (8.9) | 3 (3.2) | 3 (3.1) | 4 (4.4) | 37 (11.3) (14.3) | 25 (8.0) (10.0) |
| Injection site reaction | 8 (9.3) | 8 (9.3) | 3 (3.8) | 6 (7.6) | 3 (3.2) | 2 (2.0) | 5 (5.6) | 13 (4.0) (5.0) | 30 (9.6) (12.0) |
| Upper respiratory tract infection | 4 (4.7) | 4 (4.7) | 4 (5.1) | 8 (10.1) | 5 (5.4) | 4 (4.1) | 8 (8.9) | 29 (8.9) (11.2) | 27 (8.6) (10.8) |
| AEs of special interest | |||||||||
| Grade 3 or 4 neutropenia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0.3) (0.4) | 0 |
| Infections | 34 (39.5) | 19 (22.1) | 25 (32.1) | 25 (31.6) | 32 (34.4) | 29 (29.6) | 33 (36.7) | 134 (41.0) (51.7) | 118 (37.6) (47.1) |
| Serious infections | 1 (1.2) | 1 (1.2) | 0 | 1 (1.3) | 2 (2.2) | 0 | 1 (1.1) | 3 (0.9) (1.2) | 7 (2.2) (2.8) |
| Candida infection | 2 (2.3) | 0 | 0 | 0 | 0 | 2 (2.0) | 0 | 4 (1.2) (1.5) | 1 (0.3) (0.4) |
| Injection site reactions | 15 (17.4) | 13 (15.1) | 5 (6.4) | 9 (11.4) | 8 (8.6) | 3 (3.1) | 7 (7.8) | 30 (9.2) (11.6) | 54 (17.2) (21.5) |
| Allergic reactions/ hypersensitivities | 4 (4.7) | 4 (4.7) | 4 (5.1) | 2 (2.5) | 2 (2.2) | 6 (6.1) | 4 (4.4) | 20 (6.1) (7.7) | 20 (6.4) (8.0) |
| Potential anaphylaxis | 0 | 1 (1.2) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0.3) (0.4) |
| Hepatic | 6 (7.0) | 1 (1.2) | 3 (3.8) | 4 (5.1) | 4 (4.3) | 2 (2.0) | 2 (2.2) | 16 (4.9) (6.2) | 13 (4.1) (5.2) |
| Cerebrocardiovascular events‡, adjudicated | 1 (1.2) | 0 | 0 | 0 | 1 (1.1) | 1 (1.0) | 0 | 3 (0.9) (1.2) | 3 (1.0) (1.2) |
| MACE | 0 | 0 | 0 | 0 | 1 (1.1) | 0 | 0 | 0 | 1 (0.3) (0.4) |
| Malignancies | 0 | 1 (1.2) | 0 | 0 | 0 | 0 | 0 | 2 (0.6) (0.8) | 0 |
| Anterior uveitis | 2 (2.3) | 2 (2.3) | 1 (1.3) | 1 (1.3) | 2 (2.2) | 4 (4.1) | 5 (5.6) | 9 (2.8) (3.5) | 11 (3.5) (4.4) |
| Depression | 0 | 0 | 0 | 0 | 0 | 1 (1.0) | 1 (1.1) | 1 (0.3) (0.4) | 2 (0.6) (0.8) |
| Crohn’s disease | 1 (1.2) | 1 (1.2) | 0 | 0 | 0 | 0 | 0 | 2 (0.6) (0.8) | 2 (0.6) (0.8) |
| Ulcerative colitis | 1 (1.2) | 0 | 0 | 0 | 0 | 0 | 0 | 2 (0.6) (0.8) | 0 |
| IBD not otherwise specified | 0 | 0 | 1 (1.3) | 0 | 0 | 0 | 0 | 2 (0.6) (0.8) | 0 |
| Psoriasis | 0 | 0 | 0 | 0 | 0 | 3 (3.1) | 1 (1.1) | 4 (1.2) (1.5) | 1 (0.3) (0.4) |
*IR calculated per 100 patient-years.
†Defined as events reported by ≥5% of all patients in either of the two studies in the ETP population.
‡Cerebrocardiovascular events included death, cardiac ischaemic events including myocardial infarction and hospitalisation for unstable angina, hospitalisation for heart failure, serious arrhythmia, resuscitated sudden death, cardiogenic shock, coronary revascularisation procedure, stroke/transient ischaemic attack, peripheral revascularisation procedure and peripheral arterial event and hospitalisation for hypertension.
ADA, adalimumab; AE, adverse event; bDMARD, biological disease-modifying antirheumatic drug; ETP, dose double-blind extended treatment period; IBD, inflammatory bowel disease; IR, incidence rate; IXE, IXE Q4W and IXE Q2W combined; MACE, major adverse cerebrocardiovascular events; PBO, placebo; IXE Q2W, ixekizumab 80 mg every 2 weeks; IXE Q4W, ixekizumab 80 mg every 4 weeks; SAE, serious adverse event; TEAE, treatment-emergent adverse event; TNFi, tumour necrosis factor inhibitor.