Table 2 All-cause TEAEs during TP3 and follow-up (safety population; TP3)
Biosimilar (n = 258) | Week 26 switch (n = 127) | Week 52 switch (n = 120) | Total (N = 505) | |
|---|---|---|---|---|
Number of AEs | 206 | 94 | 146 | 446 |
Patients with events | ||||
AEs | 110 (42.6) | 47 (37.0) | 61 (50.8) | 218 (43.2) |
SAEs | 9 (3.5) | 3 (2.4) | 9 (7.5) | 21 (4.2) |
Grade 3 AEs | 14 (5.4) | 3 (2.4) | 7 (5.8) | 24 (4.8) |
Grade 4 AEs | 0 | 0 | 3 (2.5) | 3 (0.6) |
Grade 5 AEs | 0 | 0 | 1 (0.8) | 1 (0.2) |
Patients who discontinued due to AEs | ||||
From treatment temporarily | 14 (5.4) | 2 (1.6) | 9 (7.5) | 25 (5.0) |
From treatment permanently | 6 (2.3) | 2 (1.6) | 3 (2.5) | 11 (2.2) |
From the study | 4 (1.6) | 1 (0.8) | 3 (2.5) | 8 (1.6) |
AEs occurring in ≥ 2% of patients in any treatment group | ||||
Anemia | 5 (1.9) | 1 (0.8) | 4 (3.3) | 10 (2.0) |
Neutropenia | 1 (0.4) | 3 (2.4) | 1 (0.8) | 5 (1.0) |
Diarrhea | 3 (1.2) | 2 (1.6) | 3 (2.5) | 8 (1.6) |
Bronchitis | 5 (1.9) | 1 (0.8) | 3 (2.5) | 9 (1.8) |
Nasopharyngitis | 13 (5.0) | 10 (7.9) | 3 (2.5) | 26 (5.1) |
Influenza | 4 (1.6) | 1 (0.8) | 3 (2.5) | 8 (1.6) |
Upper respiratory tract infection | 2 (0.8) | 6 (4.7) | 2 (1.7) | 10 (2.0) |
Urinary tract infection | 2 (0.8) | 3 (2.4) | 2 (1.7) | 7 (1.4) |
ALT increased | 3 (1.2) | 3 (2.4) | 3 (2.5) | 9 (1.8) |
AST increased | 3 (1.2) | 1 (0.8) | 3 (2.5) | 7 (1.4) |
Back pain | 2 (0.8) | 2 (1.6) | 3 (2.5) | 7 (1.4) |
Rheumatoid arthritis | 13 (5.0) | 5 (3.9) | 11 (9.2) | 29 (5.7) |
Headache | 6 (2.3) | 0 | 3 (2.5) | 9 (1.8) |
Hypertension | 4 (1.6) | 5 (3.9) | 2 (1.7) | 11 (2.2) |