Table 4.
Safety summary through week 24
| Placebo N=212 |
Upadacitinib 15 mg QD N=211 |
Upadacitinib 30 mg QD N=218 |
|
| Patients with adverse events (AE), n (%) | |||
| Any AE | 139 (65.6) | 135 (64.0) | 170 (78.0) |
| Serious AE | 4 (1.9) | 12 (5.7) | 18 (8.3) |
| AE leading to discontinuation of trial drug | 11 (5.2) | 15 (7.1) | 20 (9.2) |
| Deaths | 1 (0.5) | 0 | 0 |
| Infection | 73 (34.4) | 71 (33.6) | 108 (49.5) |
| Serious infection | 1 (0.5) | 1 (0.5) | 6 (2.8) |
| Opportunistic infection excl. tuberculosis and herpes zoster | 0 | 0 | 2 (0.9) |
| Herpes zoster | 2 (0.9) | 3 (1.4) | 8 (3.7) |
| Active tuberculosis | 0 | 0 | 0 |
| Hepatic disorder | 3 (1.4) | 4 (1.9) | 18 (8.3) |
| Malignancy | 0 | 3 (1.4) | 3 (1.4) |
| Non-melanoma skin cancer | 0 | 1 (0.5) | 1 (0.5) |
| Malignancy other than NMSC | 0 | 2 (0.9) | 2 (0.9) |
| Lymphoma* | 0 | 1 (0.5) | 0 |
| Anaemia | 2 (0.9) | 4 (1.9) | 14 (6.4) |
| Neutropenia | 1 (0.5) | 2 (0.9) | 6 (2.8) |
| Lymphopenia | 0 | 2 (0.9) | 2 (0.9) |
| Creatine phosphokinase elevation | 4 (1.9) | 4 (1.9) | 12 (5.5) |
| Renal dysfunction | 1 (0.5) | 0 | 1 (0.5) |
| MACE (adjudicated) | 0 | 1 (0.5) | 0 |
| VTE (adjudicated) | 0 | 1 (0.5) | 0 |
| Laboratory data (LS mean change from baseline to week 24±SD) | |||
| Haemoglobin, g/L | −0.7±7.44 | −3.6±9.45 | −5.5±10.78 |
| Neutrophils, 109/L | −0.056±1.6435 | −0.286±1.9578 | −0.610±2.0242 |
| Lymphocytes, 109/L | −0.076±0.5484 | −0.028±0.5460 | −0.057±0.5403 |
| Platelets, 109/L | 1.7±59.35 | 8.4±51.59 | 18.3±72.08 |
| LDL-C, mmol/L | 0.003±0.6839 | 0.219±0.6567 | 0.453±0.9283 |
| HDL-C, mmol/L | −0.008±0.2278 | 0.199±0.2599 | 0.243±0.3451 |
| ALT, U/L | −0.7±10.28 | 6.8±16.05 | 9.1±16.45 |
| AST, U/L | −0.1±8.41 | 6.5±22.17 | 8.3±13.29 |
| Creatinine, umol/L | 2.2±10.87 | 4.7±9.19 | 5.3±9.48 |
| Creatine phosphokinase, U/L | −19.9±140.87 | 166.8±1198.70 | 138.7±165.85 |
AEs were coded per the Medical Dictionary for Regulatory Activities. Laboratory data was graded using the Common Toxicity Criteria of the National Cancer Institute 4.03.
*In the once per day upadacitinib 15 mg arm, one event of treatment-emergent lymphocyte morphology abnormal was identified; per the investigator, no further diagnosis was made.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; LS, least squares; MACE, major adverse cardiovascular events (defined as non-fatal myocardial infarction, non-fatal stroke and cardiovascular death); NMSC, non-melanoma skin cancer; QD, once per day; VTE, venous thromboembolic event (defined as deep vein thrombosis and pulmonary embolism).