Table 2

Domains of the European League Against Rheumatism Sjögren’s Syndrome Disease Activity Index (ESSDAI) at enrolment by treatment

Tocilizumab n=55Placebo n=55
Skin048 (87.3%)48 (88.9%)
13 (5.5%)3 (5.6%)
24 (7.3%)1 (1.9%)
30 (0%)2 (3.7%)
Pulmonary044 (80%)33 (61.1%)
18 (14.6%)12 (22.2%)
22 (3.6%)9 (16.7%)
31 (1.8%)0 (0%)
Renal054 (98.2%)54 (100%)
10 (0%)0 (0%)
21 (1.8%)0 (0%)
30 (0%)0 (0%)
Articular016 (29.1%)13 (24.1%)
115 (27.3%)19 (35.2%)
216 (29.1%)13 (24.1%)
38 (14.6%)9 (16.7%)
Muscular051 (92.7%)52 (96.3%)
12 (3.6%)1 (1.9%)
21 (1.8%)1 (1.9%)
31 (1.8%)0 (0%)
Peripheral neuropathy046 (83.6%)45 (83.3%)
17 (12.7%)2 (3.7%)
22 (3.6%)7 (13.0%)
30 (0%)0 (0%)
Central nervous system054 (98.2%)54 (100%)
21 (1.8%)0 (0%)
30 (0%)0 (0%)
Glandular026 (47.3%)26 (48.2%)
119 (34.6%)16 (29.6%)
210 (18.2%)12 (22.2%)
Constitutional040 (72.7%)39 (72.2%)
115 (27.3%)14 (25.9%)
20 (0%)1 (1.9%)
Haematological033 (60%)30 (55.6%)
120 (36.4%)21 (38.9%)
22 (3.6%)3 (5.6%)
30 (0%)0 (0%)
Lymphadenopathy047 (87.0%)50 (92.6%)
16 (11.1%)4 (7.41%)
21 (1.9%)0 (0%)
30 (0%)0 (0%)
Biological019 (35.2%)25 (46.3%)
112 (22.2%)12 (22.2%)
223 (42.6%)17 (31.5%)
  • Clinical involvement corresponding to each of the 12 domains is defined according to the ESSDAI. 0: no activity; 1: low activity; 2: moderate activity; 3: high disease activity. Sum of all frequencies do not add up to 55 in each group because of missing data. Percentages are computed on non-missing data.