Table 1.
Demographics and characteristics at baseline
| Placebo N=212 |
Upadacitinib 15 mg QD N=211 |
Upadacitinib 30 mg QD N=218 |
|
| Female, n (%) | 120 (56.6) | 113 (53.6) | 115 (52.8) |
| Age (years) | 54.1±11.5 | 53.0±12.0 | 53.0±11.9 |
| Race, n (%) | |||
| White | 186 (87.7) | 183 (86.7) | 196 (89.9) |
| Black or African American | 7 (3.3) | 5 (2.4) | 5 (2.3) |
| American Indian/Alaska Native | 0 | 3 (1.4) | 0 |
| Native Hawaiian or other Pacific Islander | 1 (0.5) | 1 (0.5) | 1 (0.5) |
| Asian | 17 (8.0) | 19 (9.0) | 16 (7.3) |
| Multiple | 1 (0.5) | 0 | 0 |
| Duration of PsA symptoms (years) | 14.6±11.7 | 12.2±8.8 | 13.3±10.8 |
| Duration since PsA diagnosis (years) | 11.0±10.3 | 9.6±8.4 | 9.7±8.7 |
| Number of prior failed biologic DMARDs, n (%) | |||
| 0* | 18 (8.5) | 16 (7.6) | 17 (7.8) |
| 1 | 135 (63.7) | 126 (59.7) | 130 (59.6) |
| 2 | 35 (16.5) | 35 (16.6) | 46 (21.1) |
| ≥3 | 24 (11.3) | 34 (16.1) | 25 (11.5) |
| Monotherapy, n (%) | 112 (52.8) | 113 (53.6) | 120 (55.0) |
| Any non-biologic DMARD at baseline, n (%) | |||
| MTX alone | 75 (35.4) | 74 (35.1) | 73 (33.5) |
| MTX+another non-biologic DMARD | 7 (3.3) | 6 (2.8) | 5 (2.3) |
| Non-biologic DMARD other than MTX | 18 (8.5) | 18 (8.5) | 20 (9.2) |
| MTX dose for patients with concomitant MTX alone at baseline (mg/week) | |||
| Mean | 16.26 | 15.06 | 16.76 |
| Median | 17.5 | 15.0 | 17.5 |
| Steroid use at baseline, n (%) | 24 (11.3) | 22 (10.4) | 13 (6.0) |
| NSAID use at baseline, n (%) | 125 (59.0) | 124 (58.8) | 129 (59.2) |
| RF status positive, n (%) | 6 (2.8) | 11 (5.2) | 8 (3.7) |
| Anti-CCP status positive, n (%) | 10 (4.7) | 7 (3.3) | 5 (2.3) |
| TJC68 | 25.3±17.6 | 24.9±17.3 | 24.2±15.9 |
| SJC66 | 12.0±8.9 | 11.3±8.2 | 12.9±9.4 |
| hs-CRP >ULN† (mg/L), n (%) | 121 (57.1) | 126 (59.7) | 128 (58.7) |
| hs-CRP (mg/L) | 10.4±18.5 | 11.2±18.5 | 10.5±17.2 |
| HAQ-DI | 1.23±0.7 | 1.10±0.6 | 1.19±0.7 |
| Patient’s assessment of pain (NRS 0–10) | 6.6±2.1 | 6.4±2.1 | 6.2±2.2 |
| BSA-psoriasis ≥3%, n (%) | 131 (61.8) | 130 (61.6) | 131 (60.1) |
| PASI (for baseline BSA-Ps ≥3%) | 11.7±11.4 | 10.1±9.2 | 8.9±9.1 |
| BSA-psoriasis >0%, n (%) | 198 (93.4) | 202 (95.7) | 202 (92.7) |
| BSA-psoriasis (for baseline >0%) | 12.8±18.4 | 10.0±15.7 | 10.0±15.8 |
| sIGA of psoriasis score, n (%) | |||
| 0 | 17 (8.0) | 9 (4.3) | 16 (7.3) |
| 1 | 32 (15.1) | 31 (14.7) | 38 (17.4) |
| 2 | 59 (27.8) | 82 (38.9) | 78 (35.8) |
| 3 | 88 (41.5) | 78 (37.0) | 77 (35.3) |
| 4 | 16 (7.5) | 11 (5.2) | 9 (4.1) |
| Presence of enthesitis | |||
| LEI >0, n (%) | 144 (67.9) | 133 (63.0) | 152 (69.7) |
| SPARCC Enthesitis Index >0, n (%) | 173 (81.6) | 172 (81.5) | 179 (82.1) |
| Presence of dactylitis (defined as LDI >0), n (%) | 64 (30.2) | 55 (26.1) | 50 (22.9) |
| Morning stiffness score‡ | 5.8±2.5 | 6.0±2.5 | 5.7±2.7 |
Values are mean±SD unless noted.
*Patients with intolerance but not inadequate response to a biologic DMARD.
†ULN=2.87 mg/L.
‡Morning stiffness score is the mean of BASDAI questions 5 and 6.
Anti-CCP, anti-cyclic citrullinated peptide; ASDAS, Ankylosing Spondylitis Disease Activity Score; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BSA, body surface area; DMARD, disease-modifying antirheumatic drug; HAQ-DI, Health Assessment Questionnaire-Disability Index; hs-CRP, high-sensitivity C-reactive protein; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; MTX, methotrexate; NRS, Numeric Rating Scale; NSAID, non-steroidal anti-inflammatory drug; PASI, Psoriasis Area Severity Index; Ps, psoriasis; PsA, psoriatic arthritis; QD, once per day; RF, rheumatoid factor; sIGA, Static Investigator Global Assessment; SJC, swollen joint count; SPARCC, Spondyloarthritis Research Consortium of Canada; TJC, tender joint count; ULN, upper limit normal.