Exposure and overview of TEAEs
| Parameter | RA | PsA | AS | AD | ||||
| UPA 15 mg QD N=3209 | ADA 40 mg EOW N=579 | MTX N=314 | UPA 15 mg QD N=907 | ADA 40 mg EOW N=429 | UPA 15 mg QD N=182 | UPA 15 mg QD N=1340 | UPA 30 mg QD N=1353 | |
| Exposure | ||||||||
| Total (PY) | 9079.1 | 1307.7 | 781.7 | 1872.3 | 903.7 | 320.1 | 2035.8 | 2118.0 |
| Median (minimum, maximum) (years)* | 3.46 (0, 5.45) | 2.23 (0.04, 5.44) | 2.57 (0.02, 5.15) | 2.25 (0, 3.9) | 1.5 (0.04, 3.22) | 1.76 (0.02, 3.26) | 1.62 (0, 2.75) | 1.65 (0, 2.84) |
| Overall TEAEs, E/100 PYs (95% CI) | ||||||||
| Any AE | 205.5 (202.5, 208.5) | 203.6 (196.0, 211.5) | 206.9 (196.9, 217.2) | 244.8 (237.8, 252.0) | 229.9 (220.2, 240.0) | 241.2 (224.5, 258.8) | 250.5 (243.7, 257.5) | 278.1 (271.0, 285.2) |
| Any serious AE | 12.4 (11.7, 13.2) | 13.7 (11.8, 15.8) | 9.6 (7.5, 12.0) | 11.1 (9.7, 12.7) | 9.0 (7.1, 11.1) | 6.6 (4.1, 10.0) | 7.1 (6.0, 8.4) | 8.2 (7.0, 9.5) |
| Any AE leading to discontinuation | 4.9 (4.4, 5.3) | 5.9 (4.6, 7.4) | 5.8 (4.2, 7.7) | 5.4 (4.4, 6.6) | 5.5 (4.1, 7.3) | 5.3 (3.1, 8.5) | 4.5 (3.6, 5.5) | 5.3 (4.4, 6.4) |
| Deaths,† E/100 PY (95% CI) | 0.8 (0.6, 1.0) | 0.9 (0.5, 1.6) | 0.8 (0.3, 1.7) | 0.8 (0.4, 1.3) | 0.1 (0.0, 0.6) | 0 | 0 | 0.1 (0.0, 0.4) |
*Minimum in days are as follows: RA: UPA 15 mg, 2 days; ADA 40 mg, 14 days; MTX, 7 days. PsA: UPA 15 mg, 1 day; ADA 40 mg, 14 days. AS: UPA 15 mg, 6 days. AD: UPA 15 mg, 1 day; UPA 30 mg, 1 day.
†Non-treatment emergent deaths included.
AD, atopic dermatitis; ADA, adalimumab; AE, adverse event; AS, ankylosing spondylitis; EOW, every other week; MTX, methotrexate; PsA, psoriatic arthritis; E/100 PY, exposure-adjusted rates per 100 patient years; PY, patient-years; QD, once a day; RA, rheumatoid arthritis; TEAE, treatment-emergent adverse event; UPA, upadacitinib.