Table 2 Incidence of treatment-emergent adverse events (TEAEs), and the most commonly reported TEAEs (occurring in ≥2 % of patients in any group) during the last 3 months of the double-blind phase 3 study [10] and the first 3 months of the open-label extension [13]
From: Switching from adalimumab to tofacitinib in the treatment of patients with rheumatoid arthritis
ADA to tofacitinib | Tofacitinib to tofacitinib | |||
|---|---|---|---|---|
n = 107 | n = 126 | |||
−3 months to switch (ADA) | Switch to +3 months (tofacitinib) | −3 months to switch (tofacitinib) | Switch to +3 months (tofacitinib) | |
Safety summary | ||||
Number of patients (%) | ||||
DCs due to AEs | 0 | 3 (2.8) | 1 (0.8) | 3 (2.4) |
Serious AEs | 1 (0.9) | 8 (7.5) | 4 (3.2) | 8 (6.3) |
Serious infections | 0 | 2 (1.9) | 1 (0.8) | 2 (1.6) |
Deaths | 0 | 2 (1.9)a | 0 | 0 |
Most commonly reported TEAEs | ||||
Number of patients (%) | ||||
Abdominal pain upper | 0 | 1 (0.9) | 4 (3.2) | 1 (0.8) |
Arthralgia | 0 | 1 (0.9) | 4 (3.2) | 2 (1.6) |
Bronchitis | 4 (3.7) | 3 (2.8) | 6 (4.8) | 2 (1.6) |
Cough | 0 | 1 (0.9) | 1 (0.8) | 3 (2.4) |
Depression | 0 | 1 (0.9) | 3 (2.4) | 1 (0.8) |
Fall | 1 (0.9) | 1 (0.9) | 3 (2.4) | 1 (0.8) |
Hemoglobin decreased | 0 | 3 (2.8) | 0 | 1 (0.8) |
Headache | 0 | 2 (1.9) | 0 | 2 (1.6) |
Nasopharyngitis | 2 (1.9) | 4 (3.7) | 5 (4.0) | 3 (2.4) |
Nausea | 1 (0.9) | 3 (2.8) | 1 (0.8) | 1 (0.8) |
Edema peripheral | 1 (0.9) | 0 | 2 (1.6) | 3 (2.4) |
Oropharyngeal pain | 0 | 0 | 0 | 3 (2.4) |
Upper respiratory tract infection | 3 (2.8) | 5 (4.7) | 3 (2.4) | 6 (4.8) |
Urinary tract infection | 0 | 5 (4.7) | 2 (1.6) | 0 |
Vomiting | 0 | 2 (1.9) | 1 (0.8) | 0 |
Worsening RA | 0 | 0 | 3 (2.4) | 2 (1.6) |