Table 1.
Subject demographics and baseline characteristics, safety population
| Characteristic | Part 1: open-label | Part 2: double-blind | |
|---|---|---|---|
| RCI (n = 259) | Placebo (n = 77) | RCI (n = 77) | |
| Age, mean (SD), years | 51.0 (12.2) | 50.9 (11.3) | 50.1 (12.2) |
| Female sex, no. (%) | 231 (89.2) | 69 (89.6) | 67 (87.0) |
| Race, no. (%) | |||
| White | 170 (65.6) | 53 (68.8) | 53 (68.8) |
| Black or African American | 15 (5.8) | 2 (2.6) | 1 (1.3) |
| Asian | 3 (1.2) | 1 (1.3) | 0 |
| Americana Indian or Alaska native | 40 (15.4) | 14 (18.2) | 12 (15.6) |
| Native Hawaiian or other Pacific Islander | 0 | 0 | 0 |
| Other | 31 (12.0) | 7 (9.1) | 11 (14.3) |
| Ethnicity, no. (%) | |||
| Hispanic or Latino | 213 (82.2) | 69 (89.6) | 73 (94.8) |
| Country, no. (%) | |||
| United States | 88 (34.0) | 19 (24.7) | 19 (24.7) |
| Mexico | 120 (46.3) | 46 (59.7) | 41 (53.2) |
| Argentina | 24 (9.3) | 7 (9.1) | 9 (11.7) |
| Peru | 27 (10.4) | 5 (6.5) | 8 (10.4) |
| Weight, mean (SD), kg | 72.9 (17.0) | 72.4 (14.5) | 70.8 (15.7) |
| BMI, mean (SD), kg/m2 | 28.8 (5.7) | 29.0 (5.4) | 28.2 (5.7) |
| Disease duration, mean (SD), years | 10.3 (8.0) | 9.4 (8.8) | 10.1 (6.8) |
| Prednisone (or equivalent) dose, mean (SD), mg/day | 6.3 (5.0) | 6.9 (8.7) | 5.9 (1.7) |
| Medical history of note, no. (%) [no. ongoing] | |||
| Hypertension | 74 (28.6) [73] | 20 (26.0) [20] | 20 (26.0) [20] |
| Obesity | 6 (2.3) [6] | 1 (1.3) [1] | 0 |
| Myocardial infarction | 2 (0.8) [0] | 1 (1.3) [0] | 0 |
| Arrhythmia | 1 (0.4) [1] | 0 | 0 |
| Cerebrovascular accident | 1 (0.4) [0] | 0 | 1 (1.3) [0] |
| Cerebrovascular disorder | 1 (0.4) [0] | 1 (1.3) [0] | 0 |
| Coronary artery disease | 1 (0.4) [1] | 0 | 0 |
| Type 2 diabetes mellitus | 1 (0.4) [1] | 1 (1.3) [1] | 0 |
| Methotrexate use, no. (%) | |||
| Prior | 253 (97.7) | 77 (100.0) | 77 (100.0) |
| Concomitant | 248 (95.8) | 77 (100.0) | 77 (100.0) |
| Most common (≥ 3% of subjects) prior DMARDs, no. (%) | |||
| Biologicb | 60 (23.2) | 7 (9.1) | 13 (16.9) |
| Adalimumab | 26 (10.0) | 3 (3.9) | 4 (5.2) |
| Etanercept | 22 (8.5) | 1 (1.3) | 4 (5.2) |
| Abatacept | 16 (6.2) | 1 (1.3) | 6 (7.8) |
| Certolizumab pegol | 13 (5.0) | 1 (1.3) | 2 (2.6) |
| Tocilizumab | 10 (3.9) | 0 | 2 (2.6) |
| Infliximab | 9 (3.5) | 1 (1.3) | 2 (2.6) |
| Nonbiologicc | 232 (89.6) | 74 (96.1) | 71 (92.2) |
| Hydroxychloroquine | 105 (40.5) | 26 (33.8) | 39 (50.7) |
| Sulfasalazine | 56 (21.6) | 19 (24.7) | 10 (13.0) |
| Leflunomide | 53 (20.5) | 20 (26.0) | 12 (15.6) |
| Chloroquine | 33 (12.7) | 13 (16.9) | 13 (16.9) |
| Tofacitinib | 8 (3.1) | 1 (1.3) | 3 (3.9) |
| Most common (≥ 3% of subjects) concomitant DMARDs, no. (%) | |||
| Biologicd | 45 (17.4) | 9 (11.7) | 17 (22.1) |
| Adalimumab | 12 (4.6) | 1 (1.3) | 1 (1.3) |
| Certolizumab pegol | 9 (3.5) | 1 (1.3) | 2 (2.6) |
| Etanercept | 9 (3.5) | 1 (1.3) | 1 (1.3) |
| Abatacept | 8 (3.1) | 1 (1.3) | 3 (3.9) |
| Nonbiologice | 224 (86.5) | 57 (74.0) | 59 (76.6) |
| Hydroxychloroquine | 97 (37.5) | 25 (32.5) | 38 (49.4) |
| Sulfasalazine | 54 (20.9) | 19 (24.7) | 9 (11.7) |
| Leflunomide | 46 (17.8) | 0 | 0 |
| Chloroquine | 33 (12.7) | 13 (16.9) | 13 (16.9) |
| DAS28-ESR, mean (SD) | 6.3 (1.0) | 6.2 (1.0) | 6.2 (0.9) |
| ESR, mean (SD) | 43.6 (24.8) | 42.0 (22.9) | 40.3 (21.5) |
| DAS28-ESR at week 12, mean (SD) | 3.6 (1.4) | 2.7 (0.5) | 2.8 (0.4) |
| ESR at week 12, mean (SD) | 24.0 (21.5) | 15.2 (12.6) | 15.8 (12.2) |
| Tender joint count, mean (SD)f | 14.7 (7.1) | 13.5 (7.2) | 13.5 (6.1) |
| Swollen joint count, mean (SD)f | 10.9 (5.4) | 10.1 (4.9) | 9.7 (4.3) |
| HAQ-DIf | 1.7 (0.6) | 1.7 (0.6) | 1.7 (0.5) |
| FACIT-Ff | 22.8 (8.4) | 22.6 (9.0) | 22.7 (7.7) |
BMI body mass index, DAS28 Disease Activity Score with 28 joint count, DMARD disease-modifying antirheumatic drug, ESR erythrocyte sedimentation rate, FACIT-F Functional Assessment of Chronic Illness Therapy-Fatigue, HAQ-DI Health Assessment Questionnaire-Disability Index, mITT modified intent-to-treat, RA rheumatoid arthritis, RCI repository corticotropin injection, SD standard deviation
aNorth, Central, or South American Indian
bGolimumab, rituximab, clazakizumab, sarilumab, and sirukumab each were taken by < 3% of subjects
cFilgotinib was taken by < 3% of subjects
dGolimumab, infliximab, and certolizumab each were taken by < 3% of subjects
eTofacitinib was taken by < 3% of subjects
fData are from the mITT population