Table 3 Safety overview of IXE with or without concomitant MTX after 52 weeks of treatment
| Â | 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%) |