Proportion of patients with potentially clinically significant haematological and clinical chemistry values
| n/N Obs (%) | PBO pooled, n=1042 | MTX pooled, n=530 | ADA 40 mg EOW, n=579 | UPA all phase III long term | |
| Any UPA 15 mg once daily, n=2630 | Any UPA 30 mg once daily, n=1204 | ||||
| Short-term data up to 12/14 weeks | Long-term MTX monotherapy Mean exposure: 36 weeks (data censored at rescue) | Long-term ADA Mean exposure: 42 weeks (includes UPA→ADA post-switch) | Long-term UPA (monotherapy or in combination with MTX/other csDMARDs) Mean exposures: 53 weeks (UPA 15 mg) and 59 weeks (UPA 30 mg) | ||
| Haemoglobin (g/L) | |||||
| Grade 3 (70 to <80 or decreased 21 to <30) | 23/1036 (2.2) | 28/526 (5.3) | 18/576 (3.1) | 150/2622 (5.7) | 133/1193 (11.1) |
| Grade 4 (<70 or decreased ≥30) | 8/1036 (0.8) | 12/526 (2.3) | 6/576 (1.0) | 39/2622 (1.5) | 49/1193 (4.1) |
| Platelets (×109/L) | |||||
| Grade 3 (20 to <50) | 0/1032 | 0/525 | 0/576 | 1/2619 (<0.1) | 1/1192 (<0.1) |
| Grade 4 (<20) | 0/1032 | 0/525 | 0/576 | 1/2619 (<0.1) | 1/1192 (<0.1) |
| Neutrophils (×109/L) | |||||
| Grade 3 (0.5 to <1.0) | 1/1036 (<0.1) | 2/526 (0.4) | 2/576 (0.3) | 22/2622 (0.8) | 28/1192 (2.3) |
| Grade 4 (<0.5) | 0/1036 | 0/526 | 1/576 (0.2) | 7/2622 (0.3) | 2/1192 (0.2) |
| Lymphocytes (×109/L) | |||||
| Grade 3 (0.5 to <1.0) | 119/1036 (11.5) | 79/526 (15.0) | 44/576 (7.6) | 451/2622 (17.2) | 250/1192 (21.0) |
| Grade 4 (<0.5) | 7/1036 (0.7) | 5/526 (1.0) | 2/576 (0.3) | 30/2622 (1.1) | 29/1192 (2.4) |
| Leucocytes (×109/L) | |||||
| Grade 3 (1.0 to <2.0) | 0/1036 | 0/526 | 1/576 (0.2) | 9/2622 (0.3) | 7/1193 (0.6) |
| Grade 4 (<1.0) | 0/1036 | 0/526 | 0/576 | 0/2622 | 2/1193 (0.2) |
| ALT (U/L) | |||||
| Grade 3 (3.0 to <8.0× ULN) | 13/1037 (1.3) | 23/527 (4.4) | 9/577 (1.6) | 76/2620 (2.9) | 37/1195 (3.1) |
| Grade 4 (>8.0× ULN) | 2/1037 (0.2) | 5/527 (0.9) | 3/577 (0.5) | 11/2620 (0.4) | 6/1195 (0.5) |
| AST (U/L) | |||||
| Grade 3 (3.0 to <8.0× ULN) | 6/1036 (0.6) | 13/527 (2.5) | 6/577 (1.0) | 46/2620 (1.8) | 17/1195 (1.4) |
| Grade 4 (>8.0× ULN) | 1/1036 (<0.1) | 1/527 (0.2) | 4/577 (0.7) | 7/2620 (0.3) | 5/1195 (0.4) |
| CPK (U/L) | |||||
| Grade 3 (>5.0 to 10.0× ULN) | 3/1037 (0.3) | 2/527 (0.4) | 1/577 (0.2) | 38/2620 (1.5) | 22/1196 (1.8) |
| Grade 4 (>10.0× ULN) | 0/1037 | 0/527 | 1/577 (0.2) | 10/2620 (0.4) | 11/1196 (0.9) |
N Obs indicates the number of patients with baseline and post-baseline values for the respective parameters.
ADA, adalimumab; ALT, alanine transaminase; AST, aspartate transaminase; CPK, creatine phosphokinase; csDMARD, conventional synthetic disease-modifying antirheumatic drug; EOW, every other week; MTX, methotrexate; PBO, placebo; ULN, upper limit of normal; UPA, upadacitinib.