Change in disease activity in each domain of the ESSDAI
Domains | Tocilizumab W0 % of no/low/moderate/high | Tocilizumab W24 % of no/low/moderate/high | % improvement in tocilizumab group | Placebo W0 % of no/low/moderate/high | Placebo W24 % of no/low/moderate/high | % improvement in placebo group | Comparison of % improvement % difference (95% CI) |
Skin | n=55 87.3/5.5/7.3/0 | n=49 80.0/1.8/7.3/0 | 8.2 | n=54 87.3/5.5/1.8/3.6 | n=50 85.5/1.8/3.6/0 | 8.0 | −0.2 (−11.7 to 11.3), Pr(diff >0)=0.49 |
Pulmonary | n=55 80.0/14.5/3.6/1.8 | n=49 80.0/5.5/3.6/0 | 12.2 | n=54 60.0/21.8/16.4/0 | n=50 78.2/5.5/5.5/1.8 | 24.0 | 12.3 (−2.9 to 27.7), Pr(diff >0)=0.94 |
Renal | n=55 98.2/0/1.8/0 | n=49 87.3/0/1.8/0 | NA | n=54 98.2/0/0/0 | n=50 90.9/0/0/0 | NA | 0 (−5.8 to 5.6), Pr(diff >0)=0.5 |
Articular | n=55 29.1/27.3/29.1/14.5 | n=49 45.5/25.5/18.2/0 | 49.0 | n=54 23.6/34.5/23.6/16.4 | n=50 49.1/16.4/20.0/5.5 | 46.0 | −2.9 (−21.8 to 16.3), Pr(diff >0)=0.38 |
Muscular | n=55 92.7/3.6/1.8/1.8 | n=49 85.5/1.8/0/1.8 | 2.0 | n=54 94.5/1.8/1.8/0 | n=50 89.1/1.8/0/0 | 2.0 | −0.1 (−7.8 to 7.6), Pr(diff >0)=0.49 |
Peripheral neuropathy | n=55 83.6/12.7/3.6/0 | n=49 78.2/7.3/3.68/0 | 2.0 | n=54 81.8/3.6/12.7/0 | n=50 81.8/3.6/5.5/0 | 12.0 | 9.5 (−0.6 to 20.8), Pr(diff >0)=0.97 |
CNS | n=55 98.2/0/1.8/0 | n=49 87.3/0/1.8/0 | NA | n=54 98.2/0/0/0 | n=50 90.9/0/0/0 | NA | 0 (−5.8 to 5.6), Pr(diff >0)=0.5 |
Glandular | n=55 47.3/34.5/18.2 | n=49 63.6/20.0/5.56 | 34.7 | n=54 47.3/29.1/21.8 | n=50 63.6/16.4/10.9 | 34.0 | −0.7 (−18.9 to 17.5), Pr(diff >0)=0.47 |
Constitutional | n=55 72.7/27.3/0 | n=49 70.9/16.4/1.8 | 14.3 | n=54 70.9/25.5/1.8 | n=50 80.0/10.9/0 | 20.0 | 5.5 (−9.3 to 20.3), Pr(diff >0)=0.77 |
Haematological | n=54 60.0/36.4/3.6/0 | n=49 40.0/40/9.1/0 | 8.2 | n=54 54.5/38.2/5.5/0 | n=50 49.1/38.2/1.8/1.8 | 18.0 | 9.4 (−3.8 to 23,0), Pr(diff >0)=0.92 |
Lymphadenopathy | n=54 85.5/10.9/1.8/0 | n=49 87.3/1.8/0/0 | 14.6 | n=54 90.9/7.3/0/0 | n=50 89.1/1.8/0/0 | 8.0 | −6.4 (−19.5 to 6.3), Pr(diff >0)=0.16 |
Biological | n=54 34.5/21.8/41.8 | n=49 14.5/41.8/32.7 | 10.4 | n=54 45.5/21.8/30.9 | n=50 43.6/20.0/27.3 | 8.0 | −2.4 (−14.6 to 9.6), Pr(diff >0)=0.34 |
CNS, central nervous system; ESSDAI, European League Against Rheumatism Sjögren's Syndrome Disease Activity Index; NA, not assessed.