Baseline characteristics of patients with primary Sjögren syndrome by treatment with tocilizumab or placebo
| Tocilizumab n=55 | Placebo n=55 | |
| Age, years, mean (SD) | 50.9 (12.4) | 54.8 (10.7) |
| Female | 54 (98.2%) | 50 (90.9%) |
| Weight, kg, mean (SD) | 69.1 (16.8) | 69.3 (14.5) |
| Time/first symptoms, years, median (IQR) | 7.1 (3.3–13.5) | 6.9 (4.6–13.8) |
| Time/diagnosis, years, median (IQR) | 4.4 (1.6–9.0) | 4.9 (1.7–7.3) |
| Anti-SSA antibodies | 48/53 (90.6%) | 43/53 (81.1%) |
| Anti-SSB antibodies | 29/53 (54.7%) | 19/51 (37.3%) |
| Rheumatoid factor | 37/51 (72.5%) | 27/54 (50.0%) |
| IgG, mean (SD) | 16.2 (6.2) | 15.1 (6.2) |
| IgA, mean (SD) | 2.9 (1.2) | 2.3 (1.3) |
| IgM, mean (SD) | 1.2 (0.71) | 1.3 (1.0) |
| ESR, median (IQR) | 20 (12–4) | 20 (10–28) |
| CRP, median (IQR) | 4.4 (1.6–9.0) | 4 (2–5.2) |
| Abnormal Schirmer test (≤5 mm in 5 min) | 29 (56.9%) | 34 (68.0%) |
| Decreased unstimulated salivary flow (≤0.1 mL/min) | 28 (62.2%) | 31 (68.9%) |
| ESSDAI, median (IQR) | 11 (8–13.5) | 10 (8–14.8) |
| ClinESSDAI, median (IQR) | 9(6–13) | 9(6–12) |
| Physician’s global evaluation of systemic disease activity, mean (SD) | 5.2 (1.7) | 5.1 (1.5) |
| Prednisone | 9 (16.4%) | 5 (9.1%) |
| Other immunomodulatory drugs | 7 (12.7%) | 6 (10.9%) |
| Number of tender joints, median (IQR) | 4 (0–11) | 5.5(1–12) |
| Number of swollen joints, median (IQR) | 0.5 (0–4) | 0.5 (0–3.5) |
| ESSPRI, mean (SD) | 6.4 (1.8) | 6.4 (1.9) |
| NAS score for dryness (0–10), mean (SD) | 6.7 (2.2) | 6.6 (2.2) |
| NAS score for pain (0–10), mean (SD) | 6.9 (2.2) | 7.0 (2.3) |
| NAS score for fatigue (0–10), mean (SD) | 5.9 (2.6) | 5.6 (2.4) |
| FACIT, mean (SD) | 21.2 (12.0) | 25.0 (11.2) |
| SF-36 PCS, mean (SD) | 166.0 (75.3) | 174.9 (76.9) |
| SF-36 MCS, mean (SD) | 164.7 (81.0) | 183.8 (85.3) |
| HAD score D, mean (SD) | 9.0 (4.7) | 7.6 (4.7) |
| HAD score A, mean (SD) | 10.2 (3.7) | 9.1 (4.4) |
Data are no (%) unless otherwise indicated.
A, anxiety; ClinESSDAI, clinical ESSDAI; CRP, C reactive protein; D, depression; ESR, erythrocyte sedimentation rate; ESSDAI, European League Against Rheumatism Sjögren's Syndrome Disease Activity Index; ESSPRI, EULAR Sjögren’s Syndrome Patient Reported Index; FACIT, Functional Assessment of Chronic Illness Therapy; HAD, Hospital Anxiety and Depression scale; MCS, Mental Component Score; NAS, Numeric Analogue Scale; PCS, Physical Component Score; SF-36, Medical Outcomes Survey Short-form 36.