Table 3.
Safety overview of IXE with or without concomitant MTX after 52 weeks of treatment
| SPIRIT-P1 and SPIRIT-P2 | ||||
|---|---|---|---|---|
| IXE Q4W (N = 229) | IXE Q2W (N = 226) | |||
| No MTX/cDMARDs (N = 95) | MTXa (N = 85) | No MTX/cDMARDs (N = 82) | MTXa (N = 97) | |
| TEAEs (≥ 1) | 75 (78.9%) | 67 (78.8%) | 71 (86.6%) | 77 (79.4%) |
| Mild | 31 (32.6%) | 39 (45.9%) | 32 (39.0%) | 35 (36.1%) |
| Moderate | 39 (41.1%) | 24 (28.2%) | 32 (39.0%) | 35 (36.1%) |
| Severe | 5 (5.3%) | 4 (4.7%) | 7 (8.5%) | 7 (7.2%) |
| SAEs | 6 (6.3%) | 5 (5.9%) | 4 (4.9%) | 3 (3.1%) |
| Discontinuations due to AE | 5 (5.3%) | 2 (2.4%) | 6 (7.3%) | 9 (9.3%) |
| AEs of special interest | ||||
| Cytopenias | 1 (1.1%) | 3 (3.5%) | 3 (3.7%) | 1 (1.0%) |
| Hepatic events | 6 (6.3%) | 2 (2.4%) | 3 (3.7%) | 9 (9.3%) |
| Infections | 50 (52.6%) | 37 (43.5%) | 41 (50.0%) | 47 (48.5%) |
| Injection-site reactions | 20 (21.1%) | 14 (16.5%) | 23 (28.0%) | 26 (26.8%) |
| Allergic reactions/hypersensitivities | 8 (8.4%) | 4 (4.7%) | 8 (9.8%) | 7 (7.2%) |
| Non-anaphylaxis | 8 (8.4%) | 4 (4.7%) | 8 (9.8%) | 7 (7.2%) |
| Malignancies | 2 (2.1%) | 0 | 0 | 0 |
| Depression | 2 (2.1%) | 4 (4.7%) | 2 (2.4%) | 2 (2.1%) |
Data presented are n (%)
Note: There were no cases of anaphylaxis, cerebro-cardiovascular events, MACE, ILD, IBD, CD, and UC observed in these subpopulations
Abbreviations: AEs adverse events, CD Crohn’s disease, cDMARD conventional disease-modifying antirheumatic drug, IBD inflammatory bowel disease, ILD interstitial lung disease, IXE Q2W 80 mg ixekizumab every 2 weeks, IXE Q4W 80 mg ixekizumab every 4 weeks, MACE major adverse cerebro-cardiovascular events, MTX methotrexate, N number of patients in each group, n number of patients, SAEs serious adverse events, TEAEs treatment-emergent adverse events, UC ulcerative colitis
aPatients with stable dose of MTX from weeks 0 to 52 only