Table 1.
Demographic and baseline clinical characteristics of the patientsa
| Cohort 1 (MTX‐IR) | Cohort 2 (TNF‐IR) | ||||||
|---|---|---|---|---|---|---|---|
| Placebo (n = 110) | Fenebrutinib 50 mg once daily (n = 40) | Fenebrutinib 150 mg once daily (n = 109) | Fenebrutinib 200 mg twice daily (n = 110) | Adalimumab 40 mg every other week (n = 111) | Placebo (n = 50) | Fenebrutinib 200 mg twice daily (n = 48) | |
| Age, years | 50 ± 12 | 52 ± 12 | 50 ± 11 | 50 ± 12 | 50 ± 12 | 55 ± 12b | 51 ± 13b |
| Sex, no. (%) female | 90 (82) | 35 (88) | 92 (84) | 85 (77) | 87 (78) | 37 (76)b | 37 (76)b |
| Race, no. (%) white | 95 (86) | 36 (90) | 96 (88) | 96 (87) | 99 (89) | 42 (86)b | 42 (86)b |
| BMI, kg/m2 | 28 ± 6 | 27 ± 6 | 27 ± 5 | 28 ± 6 | 27 ± 5 | 27 ± 5b | 26 ± 5b |
| RA duration, median (range) years | 5 (0.3–25) | 8 (0.3–32) | 5 (0.3–31) | 5 (0.3–38) | 5 (0.3–30) | 9 (1.2–29)b | 7 (2.0–36)b |
| Antibody positive, no. (%) | |||||||
| ACPA | 102 (93) | 39 (98) | 100 (91) | 105 (95) | 103 (92) | 42 (84) | 46 (96) |
| RF | 98 (89) | 38 (95) | 108 (99) | 103 (94) | 104 (93) | 49 (98) | 46 (96) |
| No. of swollen joints (66‐joint count) | 16 ± 10 | 13 ± 8 | 14 ± 8 | 14 ± 8 | 14 ± 8 | 15 ± 8 | 15 ± 8 |
| No. of tender joints (68‐joint count) | 24 ± 13 | 24 ± 13 | 24 ± 13 | 22 ± 12 | 24 ± 13 | 27 ± 16 | 24 ± 12 |
| HAQ DI | 1.6 ± 0.6 | 1.8 ± 0.5 | 1.7 ± 0.5 | 1.7 ± 0.6 | 1.8 ± 0.7 | 1.8 ± 0.5 | 1.5 ± 0.6 |
| DAS28‐CRP | 5.9 ± 0.8 | 5.7 ± 0.9 | 5.9 ± 0.8 | 5.8 ± 1.0 | 5.8 ± 0.9 | 6.0 ± 1.0 | 5.9 ± 0.9 |
| CRP, mg/dl | 2.0 ± 1.9 | 1.6 ± 1.4 | 2.0 ± 2.0 | 2.5 ± 3.1 | 2.1 ± 2.6 | 3.1 ± 4.1 | 2.5 ± 2.8 |
| ESR, mm/hour | 45 ± 21 | 45 ± 20 | 43 ± 21 | 45 ± 23 | 41 ± 22 | 61 ± 32 | 52 ± 29 |
| IgM, gm/liter | 1.58 ± 0.81 | 1.43 ± 0.52 | 1.64 ± 1.02 | 1.38 ± 0.60 | 1.45 ± 0.60 | 1.72 ± 0.84 | 1.56 ± 0.72 |
| IgG, gm/liter | 12.91 ± 3.00 | 12.50 ± 2.99 | 12.45 ± 3.68 | 13.17 ± 4.71 | 12.71 ± 3.55 | 13.23 ± 3.81 | 13.33 ± 4.95 |
a
Except where indicated otherwise, values are the mean ± SD. RA = rheumatoid arthritis; MTX‐IR = inadequate response to methotrexate; TNF‐IR = inadequate response to tumor necrosis factor inhibitors; BMI = body mass index; ACPA = anti–citrullinated protein antibody; RF = rheumatoid factor; HAQ DI = Health Assessment Questionnaire disability index; DAS28‐CRP = Disease Activity Score in 28 joints using the C‐reactive protein level; ESR = erythrocyte sedimentation rate.
b
n = 49.