Patients meeting the primary endpoint and/or each of its components (decrease of at least 3 points in the ESSDAI and no occurrence of moderate or severe activity in any new domain of the ESSDAI compared with enrolment and no worsening in physician’s global assessment on a Visual Numeric Scale ≥1/10)
| Tocilizumab n/N (%) | Placebo n/N (%) | Difference between placebo and tocilizumab % difference (95% CrI) | Pr(diff >0) | |
| Primary endpoint | ||||
| W12 | 20/44 (45.5) | 25/44 (56.8) | −10.9 (−30.7 to 9.4) | 0.15 |
| W24 (ITT) | 29/55 (52.7) | 35/55 (63.6) | 11 (−9.0 to 30.6) | 0.86 |
| W24 | 24/46 (52.2) | 29/46 (63.0) | 10.4 (−9.2 to 29.7) | 0.85 |
| W32 | 24/43 (55.8) | 19/43 (44.2) | −11.1 (−31.2 to 9.4) | 0.14 |
| W44 | 21/41 (51.2) | 21/38 (55.3) | 3.8 (−17.4 to 24.9) | 0.64 |
| 3-point decrease in ESSDAI | ||||
| W12 | 29/49 (59.2) | 29/49 (59.2) | 0.0 (−14.9 to 14.9) | 0.50 |
| W24 | 28/49 (57.1) | 35/50 (70) | 12.4 (−6.1 to 30.5) | 0.91 |
| W32 | 30/46 (65.2) | 29/47 (61.7) | −3.4 (−22.3 to 15.7) | 0.36 |
| W44 | 26/43 (60.5) | 28/44 (63.6) | 3.0 (−16.7 to 22.7) | 0.62 |
| No new systemic complication | ||||
| W12 | 51/51 (100) | 48/50 (96) | 1.0 (−12.7 to 14.6) | 0.56 |
| W24 | 38/49 (77.6) | 42/50 (84) | 6.2 (−9.2 to 21.7) | 0.79 |
| W32 | 40/47 (85.1) | 42/49 (85.7) | 0.7 (−13.6 to 15.1) | 0.53 |
| W44 | 40/47 (85.1) | 44/49 (89.8) | 4.6 (−8.9 to 18.3) | 0.75 |
| No worsening according to the physician | ||||
| W12 | 36/47 (76.6) | 42/45 (93.3) | 11.49 (−1.4 to 24.3) | 0.96 |
| W24 | 44/46 (95.7) | 39/46 (84.8) | −10.4 (−23.5 to 1.7) | 0.05 |
| W32 | 41/46 (89.1) | 34/45 (75.6) | −13.0 (−28.6 to 2.3) | 0.05 |
| W44 | 36/44 (81.8) | 34/42 (81.0) | −0.9 (−17.4 to 15.5) | 0.46 |
CrI, credible interval; ESSDAI, European League Against Rheumatism Sjögren’s Syndrome Disease Activity Index; ITT, intent to treat ; W, week.