TEAEs in patients with upadacitinib compared with placebo and active controls*
| E/100 PY (95% CI), unless stated otherwise | PBO pooled, n=1042 | MTX pooled, n=530 | ADA 40 mg EOW, n=579 | UPA all phase III long term | |
| UPA 15 mg once daily, n=2630 | 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) | ||
| Total PY of exposure, years | 256.8 | 368.7 | 467.8 | 2655.1 | 1365.0 |
| Median exposure, days (range) | 97.0 (1 to 128) | 179.5 (7 to 865) | 257.0 (14 to 894) | 375.0 (2 to 898) | 431.0 (1 to 857) |
| Any AE | 447.4 (421.9 to 474.1) | 321.7 (303.6 to 340.5) | 294.8 (279.4 to 310.8) | 295.7 (289.2 to 302.3) | 368.7 (358.6 to 379.0) |
| Any SAE | 9.3 (6.0 to 13.9) | 11.9 (8.7 to 16.0) | 15.6 (12.2 to 19.6) | 15.0 (13.6 to 16.6) | 21.3 (18.9 to 23.9) |
| Any AE leading to discontinuation | 10.9 (7.2 to 15.8) | 9.5 (6.6 to 13.2) | 11.1 (8.3 to 14.6) | 8.4 (7.4 to 9.6) | 13.3 (11.5 to 15.4) |
| Deaths† | 0.8 (0.1 to 2.8) | 0.3 (0.0 to 1.5) | 0.9 (0.2 to 2.2) | 0.5 (0.3 to 0.8) | 1.0 (0.5 to 1.7) |
*Patients who switched from PBO, ADA or MTX to UPA were included in the UPA analysis set from the start of UPA treatment, while those who switched from UPA to ADA were included in the ADA dataset from the start of ADA. There was no switch between UPA doses in any study.
†Deaths included non-treatment-emergent deaths that occurred >30 days after the last dose of study drug (UPA 15 mg, 3; UPA 30 mg, 3; and ADA, 1). When non-treatment deaths are included, the exposures are 2925.0 PY for UPA 15 mg and 1410.3 PY for UPA 30 mg.
ADA, adalimumab; AE, adverse event; csDMARD, conventional synthetic disease-modifying antirheumatic drug; EOW, every other week; MTX, methotrexate; PBO, placebo; E/100 PY, event per 100 patient-years; SAE, serious adverse event; TEAE, treatment-emergent adverse event; UPA, upadacitinib.