Table 3. Treatment-Emergent Adverse Events (TEAEs) During Administration of UPA Through Week 52.
| AEs | UPA 15 mg | UPA 30 mg | ||||
|---|---|---|---|---|---|---|
| Measure Up 1 (n = 401)a | Measure Up 2 (n = 396)a | Combined (n = 797)b | Measure Up 1 (n = 408)a | Measure Up 2 (n = 403)a | Combined (n = 811)b | |
| Events (events/100 PY) | ||||||
| PY = 490.9 | PY = 462.4 | PY = 953.3 | PY = 501.0 | PY = 477.2 | PY = 978.2 | |
| Any TEAE | 1288 (262.4) | 1114 (240.9) | 2402 (252.0) | 1658 (330.9) | 1293 (270.9) | 2951 (301.7) |
| Serious AEs | 32 (6.5) | 33 (7.1) | 65 (6.8) | 50 (10.0) | 33 (6.9) | 83 (8.5) |
| AEs leading to discontinuation of study drug | 22 (4.5) | 21 (4.5) | 43 (4.5) | 39 (7.8) | 31 (6.5) | 70 (7.2) |
| Deaths | 0 | 0 | 0 | 1 (0.2)c | 0 | 1 (0.1) |
| AESIs d | ||||||
| Serious infections | 10 (2.0) | 11 (2.4) | 21 (2.2) | 23 (4.6) | 12 (2.5) | 35 (3.6) |
| Opportunistic infection excluding tuberculosis and herpes zoster | 5 (1.0) | 13 (2.8) | 18 (1.9) | 15 (3.0) | 5 (1.0) | 20 (2.0) |
| Herpes zostere | 17 (3.5) | 17 (3.7) | 34 (3.6) | 28 (5.6) | 25 (5.2) | 53 (5.4) |
| Active tuberculosis | 1 (0.2) | 0 | 1 (0.1) | 0 | 1 (0.2) | 1 (0.1) |
| NMSCf | 1 (0.2) | 3 (0.6) | 4 (0.4) | 3 (0.6) | 1 (0.2) | 4 (0.4) |
| Cancer other than NMSCg | 2 (0.4) | 0 | 2 (0.2) | 2 (0.4) | 3 (0.6) | 5 (0.5) |
| Lymphoma | 0 | 0 | 0 | 0 | 1 (0.2)h | 1 (0.1) |
| Hepatic disorder | 29 (5.9) | 27 (5.8) | 56 (5.9) | 52 (10.4) | 42 (8.8) | 94 (9.6) |
| Adjudicated gastrointestinal perforation | 0 | 0 | 0 | 0 | 0 | 0 |
| Anemia | 3 (0.6) | 12 (2.6) | 15 (1.6) | 19 (3.8) | 18 (3.8) | 37 (3.8) |
| Neutropenia | 11 (2.2) | 5 (1.1) | 16 (1.7) | 23 (4.6) | 11 (2.3) | 34 (3.5) |
| Lymphopenia | 4 (0.8) | 3 (0.6) | 7 (0.7) | 7 (1.4) | 2 (0.4) | 9 (0.9) |
| CPK elevation | 36 (7.3) | 31 (6.7) | 67 (7.0) | 58 (11.6) | 51 (10.7) | 109 (11.1) |
| Kidney dysfunction | 0 | 0 | 0 | 2 (0.4) | 1 (0.2) | 3 (0.3) |
| Adjudicated MACE | 1 (0.2) | 0 | 1 (0.1) | 0 | 0 | 0 |
| Adjudicated VTE | 1 (0.2) | 0 | 1 (0.1) | 0 | 1 (0.2) | 1 (0.1) |
Abbreviations: AE, adverse event; AESI, adverse event of special interest; CPK, creatine phosphokinase; MACE, major adverse cardiovascular event; NMSC, nonmelanoma skin cancer; PY, patient year; TEAE, treatment-emergent adverse event; UPA, upadacitinib; VTE, venous thromboembolic event.
Includes all patients in the main study who received at least 1 dose of UPA.
Data from Measure Up 1 and Measure Up 2 studies.10
Myocardial infarction (COVID-19 related) occurred in a patient in their 60s 28 days after the last dose of study medication.
Prespecified AESIs were based on the known UPA safety profile6 and previous safety observations for UPA7 and other JAK inhibitors.14
Searched using a prespecified grouped term.
Four cases of NMSC were reported in the UPA 15-mg group: 1 Bowen disease (patient in their 50s on day 7), 1 basal cell carcinoma (patient in their 60s on day 22), and 2 cases of squamous cell carcinoma (1 in a patient in their 50s on day 21 and 1 in a patient in their 50s on day 113); 4 NMSCs were reported in the UPA 30-mg group: 1 basal cell carcinoma (patient in their 50s on day 610), 2 cases of squamous cell carcinoma of the skin (1 in a patient in their 60s on day 218 and 1 in a patient in their 60s on day 434), and 1 cutaneous T-cell lymphoma stage I (see footnote h).
Breast and colon cancer were diagnosed on days 520 and 550 in a patient in their 40s taking UPA 15 mg; 1 case each of endometrial adenocarcinoma (patient in their 60s on day 515), kidney cell carcinoma (patient in their 50s on day 318), anal squamous cell cancer (patient in their 60s on day 64), breast cancer (patient in their 50s on day 21), and gastric cancer (patient in their 70s on day 36) in the UPA 30-mg group.
A case of cutaneous T-cell lymphoma in a patient in their 50s taking UPA 30 mg on day 194 deemed unrelated to study drug and nonserious by the investigator; after medical review, the patient likely had cutaneous T-cell lymphoma at baseline.