Safety events and discontinuations (all causalities)
| n (%) | Tofacitinib 10 mg twice daily + MTX (N=36) | Tofacitinib 10 mg twice daily monotherapy (N=36) | MTX monotherapy (N=37) |
|---|---|---|---|
| Patients with TEAEs | 25 (69.4) | 31 (86.1) | 30 (81.1) |
| Severity of TEAEs | |||
| Mild/moderate | 89/93 (95.7) | 83/88 (94.3) | 73/74 (98.6) |
| Severe | 4/93 (4.3) | 5/88 (5.7) | 1/74 (1.4) |
| Patients with serious TEAEs | 2 (5.6) | 1 (2.8) | 2 (5.4) |
| Discontinuations | 8 (22.2) | 9 (25.0) | 16† (43.2) |
| Discontinuations due to TEAEs | 4 (11.1) | 2 (5.6) | 5 (13.5) |
| Most common TEAEs by SOC | |||
| Infections and infestations | 14 (38.9) | 10 (27.8) | 9 (24.3) |
| Gastrointestinal disorders | 9 (25.0) | 11 (30.6) | 10 (27.0) |
| Investigations | 11 (30.6) | 7 (19.4) | 10 (27.0) |
| Skin and subcutaneous tissue disorders | 5 (13.9) | 7 (19.4) | 5 (13.5) |
| Musculoskeletal and connective tissue disorders | 4 (11.1) | 6 (16.7) | 6 (16.2) |
| Most common TEAEs occurring in ≥5% of patients in any group | |||
| Increased alanine aminotransferase | 6 (16.7) | 0 (0.0) | 5 (13.5) |
| Hypertension | 1 (2.8) | 6 (16.7) | 0 (0.0) |
| Gastritis | 0 (0.0) | 5 (13.9) | 4 (10.8) |
| Rheumatoid arthritis | 0 (0.0) | 2 (5.6) | 5 (13.5) |
| Rash | 1 (2.8) | 4 (11.1) | 0 (0.0) |
| Alopecia | 3 (8.3) | 0 (0.0) | 3 (8.1) |
| Headache | 3 (8.3) | 2 (5.6) | 2 (5.4) |
| Pharyngitis | 2 (5.6) | 3 (8.3) | 2 (5.4) |
| Upper respiratory tract infection | 3 (8.3) | 2 (5.6) | 2 (5.4) |
| Blood creatinine phosphokinase increased | 1 (2.8) | 3 (8.3) | 1 (2.7) |
| Bronchitis | 3 (8.3) | 0 (0.0) | 0 (0.0) |
| Aspartate aminotransferase increased | 2 (5.6) | 1 (2.8) | 3 (8.1) |
| Influenza | 2 (5.6) | 2 (5.6) | 0 (0.0) |
| Urinary tract infection | 2 (5.6) | 2 (5.6) | 0 (0.0) |
| Upper abdominal pain | 2 (5.6) | 1 (2.8) | 2 (5.4) |
| Hypertransaminasaemia | 2 (5.6) | 1 (2.8) | 1 (5.4) |
| Dyspepsia | 2 (5.6) | 1 (2.8) | 1 (2.7) |
| Hepatic enzyme increased | 2 (5.6) | 1 (2.8) | 2 (5.4) |
| Rhinitis | 2 (5.6) | 1 (2.8) | 1 (2.7) |
| Diarrhoea | 1 (2.8) | 2 (5.6) | 1 (2.7) |
| Hypertriglyceridaemia | 1 (2.8) | 1 (2.8) | 2 (5.4) |
| Back pain | 1 (2.8) | 0 (0.0) | 2 (5.4) |
| Gamma-glutamyl transferase increased | 1 (2.8) | 0 (0.0) | 2 (5.4) |
| Gastroenteritis | 2 (5.6) | 0 (0.0) | 0 (0.0) |
| Dry mouth | 2 (5.6) | 0 (0.0) | 0 (0.0) |
| Transaminase increased | 2 (5.6) | 0 (0.0) | 0 (0.0) |
| Weight increased | 0 (0.0) | 2 (5.6) | 0 (0.0) |
| Menorrhagia | 0 (0.0) | 2 (5.6) | 0 (0.0) |
†Discontinuations due to: insufficient clinical response (n=6); AE (n=5; of which 3 were related to study drug); patient no longer willing to participate in study (n=3); and protocol violation (n=2).
MTX, methotrexate; N, number of patients treated; n, number of unique patients with events; SOC, system organ class; TEAEs, treatment-emergent adverse events.