Table 1.
Baseline demographic and clinical characteristics of patients
| Characteristic | OHZORA trial | NATSUZORA trial | |||
|---|---|---|---|---|---|
| Placebo + MTX (n = 75) | Ozoralizumab 30 mg + MTX (n = 152) | Ozoralizumab 80 mg + MTX (n = 154) | Ozoralizumab 30 mg (n = 94) | Ozoralizumab 80 mg (n = 46) | |
| Age, years | 54.3 ± 12.1 | 54.8 ± 11.2 | 55.5 ± 10.9 | 58.0 ± 12.3 | 57.6 ± 13.1 |
| < 65 years, n (%) | 56 (74.7) | 119 (78.3) | 116 (75.3) | 59 (62.8) | 28 (60.9) |
| Female, n (%) | 57 (76.0) | 105 (69.1) | 123 (79.9) | 71 (75.5) | 40 (87.0) |
| Body weight, kg | 58.4 ± 13.5 | 60.0 ± 12.8 | 57.6 ± 11.6 | 59.7 ± 14.6 | 59.0 ± 12.7 |
| Disease duration, years | 7.6 ± 7.4 | 6.8 ± 6.4 | 7.8 ± 7.5 | 7.0 ± 7.4 | 10.0 ± 10.2 |
| Serum albumin, g/dL | 3.9 ± 0.3 | 3.9 ± 0.3 | 3.9 ± 0.3 | 3.8 ± 0.3 | 3.8 ± 0.4 |
| eGFR, mL/min/1.73 m2 | 90.6 ± 17.7 | 92.0 ± 19.6 | 87.6 ± 19.8 | 81.2 ± 19.7 | 82.1 ± 18.0 |
| Dosage of MTX, mg/week | 10.2 ± 3.0 | 10.0 ± 2.9 | 10.1 ± 2.7 | — | — |
| csDMARD use, n (%) | — | — | — | 51 (54.3) | 21 (45.7) |
| Glucocorticoid use, n (%) | 37 (49.3) | 62 (40.8) | 64 (41.6) | 49 (52.1) | 21 (45.7) |
| Rheumatoid factor, IU/mL | 112 ± 189 | 148 ± 267 | 145 ± 239 | — | — |
| Seropositive RA, n (%)a | 64 (85.3) | 140 (92.1) | 136 (88.3) | — | — |
| DAS28-CRP | 5.1 ± 1.0 | 5.2 ± 1.1 | 5.1 ± 0.9 | 5.3 ± 1.0 | 5.2 ± 1.1 |
| DAS28-ESR | 5.8 ± 1.0 | 5.9 ± 1.0 | 5.8 ± 0.9 | 5.8 ± 1.0 | 5.8 ± 1.0 |
| Tender joint count in 68 joints | 15.5 ± 9.6 | 16.6 ± 8.8 | 15.6 ± 8.9 | 16.4 ± 9.8 | 14.1 ± 8.1 |
| Swollen joint count in 66 joints | 13.2 ± 8.5 | 13.8 ± 7.2 | 12.8 ± 6.4 | 12.1 ± 6.0 | 11.4 ± 6.7 |
| hs-CRP, mg/dL | 1.3 ± 1.7 | 1.6 ± 2.0 | 1.3 ± 1.8 | 2.1 ± 2.3 | 2.1 ± 2.2 |
| ESR, mm/h | 36.4 ± 17.3 | 40.3 ± 22.3 | 38.6 ± 20.6 | 41.1 ± 22.9 | 45.7 ± 28.4 |
Data are expressed as mean ± standard deviation in the full analysis set
CRP C-reactive protein, csDMARD conventional synthetic disease-modifying antirheumatic drug, DAS28-CRP Disease Activity Score in 28 joints based on CRP, DAS28-ESR Disease Activity Score in 28 joints based on ESR, eGFR estimated glomerular filtration rate, ESR erythrocyte sedimentation rate, hs-CRP high-sensitivity C-reactive protein, MTX methotrexate, RA rheumatoid arthritis
aSeropositive RA indicates an anti–cyclic citrullinated peptide antibody level ≥ 4.5 U/mL and/or rheumatoid factor level > 15 IU/mL