Table 1.
Patient demographics and baseline characteristics
| Variable | MTX-naïve |
MTX-IR |
||||
|---|---|---|---|---|---|---|
| MTX (n = 314) | UPA 15 mg (n = 317) | UPA 30 mg (n = 314) | MTX (n = 216) | UPA 15 mg (n = 217) | UPA 30 mg (n = 215) | |
| Age, years, mean (s.d.) | 53.3 (12.9) | 51.9 (12.6) | 54.9 (12.6) | 55.3 (11.1) | 54.5 (12.2) | 53.1 (12.7) |
| Female, n (%) | 240 (76.4) | 241 (76.0) | 240 (76.4) | 179 (82.9) | 174 (80.2) | 170 (79.1) |
| Race, n (%) | ||||||
| White | 256 (81.5) | 256 (80.8) | 254 (80.9) | 176 (81.5) | 173 (79.7) | 180 (83.7) |
| Black | 12 (3.8) | 8 (2.5) | 13 (4.1) | 11 (5.1) | 15 (6.9) | 9 (4.2) |
| Asian | 37 (11.8) | 35 (11.0) | 34 (10.8) | 24 (11.1) | 24 (11.1) | 21 (9.8) |
| Other | 9 (2.9) | 18 (5.7) | 13 (4.1) | 5 (2.3) | 5 (2.3) | 5 (2.3) |
| Duration of RA, years, mean (s.d.) [median] | 2.6 (5.1) [0.5] | 2.9 (5.4) [0.5] | 2.8 (5.6) [0.6] | 5.8 (6.6) [2.7] | 7.5 (8.9) [3.6] | 6.5 (7.0) [4.2] |
| Duration of prior MTX therapy, years, mean (s.d.) | – | – | – | 3.3 (3.9) | 3.8 (4.8) | 3.8 (4.3) |
| CDAI >22, n (%)a | 281 (94.0) | 282 (93.7) | 279 (92.1) | 180 (90.0) | 192 (91.9) | 180 (89.1) |
| Seropositive for RF, n (%)a | 232 (73.9) | 251 (79.4) | 234 (74.5) | 151 (69.9) | 155 (71.4) | 151 (70.2) |
| Anti-CCP antibody positive, n (%)a | 236 (75.2) | 258 (81.4) | 230 (73.7) | 153 (70.8) | 159 (73.3) | 151 (70.6)b |
| Tender joint count (of 68), mean (s.d.) | 26.4 (16.2) | 25.4 (14.4) | 25.2 (15.0) | 25.2 (16.0) | 24.5 (15.1) | 24.8 (15.2) |
| Swollen joint count (of 66), mean (s.d.) | 16.9 (10.6) | 16.9 (10.4) | 15.7 (9.7) | 16.9 (11.5) | 16.4 (10.9) | 16.9 (10.2) |
| PtGA, mm, mean (s.d.) | 65.8 (21.5) | 66.6 (22.0) | 64.9 (21.6) | 59.6 (21.8) | 62.2 (22.3)c | 59.4 (22.8) |
| Pain VAS, mm, mean (s.d.) | 65.7 (21.5) | 68.4 (20.6) | 65.3 (21.5) | 62.5 (21.3) | 62.3 (22.5)c | 61.9 (22.1) |
| HAQ-DI, mean (s.d.) | 1.6 (0.7) | 1.6 (0.7) | 1.5 (0.7) | 1.5 (0.7) | 1.5 (0.7)c | 1.5 (0.7) |
| FACIT-F, mean (s.d.) | 26.6 (11.7) | 26.4 (11.9) | 27.8 (11.1) | – | – | – |
| AM stiffness, mean (s.d.) | ||||||
| Duration, min | 128.5 (134.2) | 168.9 (227.5) | 136.4 (166.5) | 153.0 (221.7) | 144.2 (215.1) | 133.9 (152.7) |
| Severityd | 6.3 (2.3) | 6.6 (2.3) | 6.4 (2.2) | 6.0 (2.2) | 5.9 (2.4) | 5.9 (2.4) |
| SF-36 summary score, mean (s.d.) | ||||||
| PCS | 33.1 (7.5) | 32.7 (7.7) | 33.7 (7.2) | 33.3 (7.3) | 33.3 (7.9) | 33.9 (7.8)e |
| MCS | 43.2 (10.8) | 42.5 (10.6) | 43.3 (11.6) | 45.1 (11.0) | 44.1 (11.3) | 44.5 (11.5)e |
| SF-36 domains, mean (s.d.) | ||||||
| Physical functioning | 31.8 (9.3) | 31.7 (9.3) | 33.0 (9.4) | 33.0 (9.0) | 32.7 (9.6) | 32.9 (9.3)e |
| Role-physical | 33.9 (8.2) | 33.6 (8.6) | 34.4 (8.5) | 35.6 (8.2) | 34.6 (8.2) | 35.7 (8.6)e |
| Bodily pain | 34.0 (7.2) | 33.0 (6.8) | 34.3 (6.9) | 35.0 (6.8) | 35.3 (6.7) | 35.4 (7.5)e |
| General health | 40.2 (9.1) | 39.7 (9.6) | 39.6 (8.7) | 38.7 (7.6) | 38.1 (8.5) | 39.1 (8.7)e |
| Vitality | 40.9 (9.7) | 40.0 (9.2) | 41.6 (9.2) | 41.4 (9.0) | 41.4 (9.3) | 42.0 (9.0)e |
| Social functioning | 38.0 (10.6) | 37.9 (10.3) | 38.8 (10.8) | 40.0 (10.2) | 39.6 (10.3) | 40.1 (10.2)e |
| Role-emotional | 38.5 (11.5) | 37.9 (11.7) | 38.2 (12.4) | 41.2 (11.5) | 39.8 (11.3) | 39.8 (12.0)e |
| Mental health | 41.1 (10.3) | 40.4 (10.5) | 41.5 (11.0) | 42.5 (10.6) | 41.5 (10.9) | 42.2 (10.9)e |
| SF-6D health utility index scores, mean (s.d.) | 0.54 (0.11) | 0.53 (0.10) | 0.55 (0.10) | 0.56 (0.10) | 0.56 (0.10) | 0.57 (0.11) |
| WPAI activity impairment, mean (s.d.) | 61.9 (26.2) | 64.7 (25.3) | 61.8 (24.4) | – | – | – |
| WPAI overall work impairment,f mean (s.d.) | 55.5 (31.3) | 59.8 (30.6) | 53.2 (29.0) | – | – | – |
a
Percentages calculated on non-missing values.
b
n = 214, one missing value.
c
n = 216.
d
Assessed on a numeric scale of 1–10 with 10 indicating the worst level.
e
n = 214.
f
Calculated only for employed subjects.
AM, morning; CDAI, Clinical Disease Activity Index; FACIT-F, Functional Assessment of Chronic Illness Therapy–Fatigue; HAQ-DI, Health Assessment Questionnaire Disability Index; MCS, Mental Component Summary; MTX-IR, inadequate response to methotrexate; PCS, Physical Component Summary; PtGA, Patient’s Global Assessment of Disease Activity; SF-36, 36-Item Short Form Health Survey; UPA, upadacitinib; VAS, visual analogue scale; WPAI, Work Productivity and Activity Impairment Questionnaire; y, years.