Table 2.
Integrated summary of TEAEs and most common TEAEs across Periods I and II
| FKB327 | RP | |
|---|---|---|
| n = 474 | n = 470 | |
| n (%)* | n (%)* | |
| Summary of TEAEs | ||
| Patients with at least one TEAE | 295 (62.2) | 311 (66.2) |
| Patients with at least one severe TEAE | 17 (3.6) | 12 (2.6) |
| Patients with at least one treatment-related TEAE | 122 (25.7) | 132 (28.1) |
| Patients with TEAE leading to treatment discontinuation | 28 (5.9) | 21 (4.5) |
| Patients with TEAE leading to treatment interruption | 56 (11.8) | 62 (13.2) |
| Patients with at least one TESAE | 25 (5.3) | 34 (7.2) |
| Deaths | 2 (0.4) | 1 (0.2) |
| Most common TEAEs (≥ 3% of patients in any group)† | ||
| Blood and lymphatic system disorders | 26 (5.5) | 25 (5.3) |
| Anemia | 14 (3.0) | 13 (2.8) |
| Gastrointestinal disorders | 48 (10.1) | 55 (11.7) |
| Diarrhea | 12 (2.5) | 18 (3.8) |
| General disorders and administration site conditions | 27 (5.7) | 32 (6.8) |
| Infections and infestations | 151 (31.9) | 170 (36.2) |
| Nasopharyngitis | 36 (7.6) | 46 (9.8) |
| Upper respiratory tract infection | 18 (3.8) | 26 (5.5) |
| Bronchitis | 16 (3.4) | 27 (5.7) |
| Urinary tract infection | 24 (5.1) | 17 (3.6) |
| Pharyngitis | 14 (3.0) | 15 (3.2) |
| Latent tuberculosis | 15 (3.2) | 8 (1.7) |
| Injury, poisoning and procedural complications | 27 (5.7) | 31 (6.6) |
| Investigations | 54 (11.4) | 40 (8.5) |
| Metabolism and nutrition disorders | 39 (8.2) | 35 (7.4) |
| Hypercholesterolemia | 20 (4.2) | 16 (3.4) |
| Musculoskeletal and connective tissue disorders | 67 (14.1) | 65 (13.8) |
| RA | 26 (5.5) | 23 (4.9) |
| Nervous system disorders | 29 (6.1) | 34 (7.2) |
| Renal and urinary disorders | 23 (4.9) | 23 (4.9) |
| Respiratory, thoracic, and mediastinal disorders | 21 (4.4) | 20 (4.3) |
| Skin and subcutaneous tissue disorders | 40 (8.4) | 36 (7.7) |
| Vascular disorders | 23 (4.9) | 27 (5.7) |
| Hypertension | 12 (2.5) | 21 (4.5) |
*Percentages are based on the number of patients in the double-blind study safety set who received the given treatment in either Period I or Period II. Hence, patients who switch at week 24 are included in the N count for both treatments
†Each patient was counted only once for each condition
RA rheumatoid arthritis, RP reference product, TEAE treatment-emergent adverse event, TESAE treatment-emergent serious adverse event