Table 1.
Demographic and clinical characteristics of patients at baseline.
| CT-P10 | RTX originator | p-value | |
|---|---|---|---|
| n (%) | n (%) | ||
| Number | 8 | 9 | — |
| Age, mean (SD), years | 60.1 (9.1) | 51.8 (12.8) | ns |
| Female gender, n (%) | 7 (87) | 8 (89) | ns |
| Disease duration, mean (SD), years | 1.29 (1.5) | 1.75 (1.6) | ns |
| Focus score ≥ 1, n (%) | 8 (100) | 9 (100) | ns |
| Xerostomia, n (%) | 8 (100) | 8 (89) | ns |
| Xerophthalmia, n (%) | 8 (100) | 9 (100) | ns |
| Salivary gland enlargement, n (%) | 1 (12) | 3 (33) | ns |
| ESSDAI, mean (SD) | 12.0 (7.3) | 12.6 (6.6) | ns |
| ClinESSDAI, mean (SD) | 11.4 (7.1) | 11.4 (6.4) | ns |
| ESSDAI domains, n (%) | |||
| Constitutional | 1 (12) | 6 (67) | ns |
| Lymphoadenopathy | 3 (37) | 3 (33) | ns |
| Glandular | 1 (12) | 3 (33) | ns |
| Articular | 8 (100) | 8 (89) | ns |
| Cutaneous | 1 (12) | 1 (11) | ns |
| Pulmonary | 1 (12) | 1 (11) | ns |
| Renal | 0 (0) | 0 (0) | ns |
| Muscular | 0 (0) | 0 (0) | ns |
| PNS | 3 (37) | 3 (33) | ns |
| CNS | 1 (12) | 0 (0) | ns |
| Hematological | 0 (0) | 2 (22) | ns |
| Biological | 4 (50) | 7 (78) | ns |
| Hypergammaglobulinemia, n (%) | 3 (37) | 5 (55) | ns |
| Reduced complement fractions, n (%) | 2 (25) | 3 (33) | ns |
| Autoantibodies, n (%) | |||
| Neither anti-Ro nor anti-La | 3 (37) | 5 (55) | ns |
| Anti-Ro only | 4 (50) | 2 (22) | ns |
| Anti-Ro and anti-La | 1 (12) | 2 (22) | ns |
| RF | 5 (62) | 4 (44) | ns |
| ESSPRI, mean (SD) | 6.8 (2.1) | 7.8 (2.0) | ns |
| GH, mean (SD) | 30 (16.0) | 33.3 (22.9) | ns |
| csDMARDs, n (%) | 4 (50) | 4 (44) | ns |
| Prednisone, n (%) | 5 (62) | 8 (89) | ns |
RTX, rituximab; SD, standard deviation; ns, not statistically significant; ESSDAI, EULAR Sjögren's syndrome disease activity index; PNS, peripheral nervous system; CNS, central nervous system; RF, rheumatoid factor; ESSPRI, EULAR Sjögren's Syndrome Patient-Reported Index; GH, global health; csDMARDs, conventional synthetic disease-modifying antirheumatic drugs.