n (%) | SB4/SB4 (n=126) | ETN/SB4 (n=119) |
≥1 TEAE | 60 (47.6) | 58 (48.7) |
Frequently reported TEAEs (≥3%) | ||
Upper respiratory tract infection | 10 (7.9) | 9 (7.6) |
Pharyngitis | 9 (7.1) | 5 (4.2) |
Rheumatoid arthritis | 7 (5.6) | 3 (2.5) |
Bronchitis | 6 (4.8) | 7 (5.9) |
Nasopharyngitis | 6 (4.8) | 5 (4.2) |
Viral infection | 4 (3.2) | 1 (0.8) |
Laryngitis | 4 (3.2) | 0 (0.0) |
Hypertension | 1 (0.8) | 5 (4.2) |
≥1 serious TEAE | 6 (4.8) | 2 (1.7) |
TEAE leading to study drug discontinuation | 4 (3.2) | 2 (1.7) |
Serious infection | 1 (0.8) | 1 (0.8) |
Active tuberculosis | 0 (0.0) | 0 (0.0) |
Injection-site reaction* | 0 (0.0) | 0 (0.0) |
Malignancy† | 1 (0.8) | 0 (0.0) |
Death† | 1 (0.8) | 0 (0.0) |
*TEAE with high-level group term of administration site reaction.
†Hepatic cancer, which was considered related to study drug.
ETN, reference etanercept; TEAE, treatment emergent adverse event.