Relevance of MCII tentative cut-offs for ESSDAI and ESSPRI
| MCII thresholds | Decrease of ESSDAI Among patients with baseline ESSDAI≥5 | Decrease of ESSPRI Among patients with baseline ESSPRI≥5 | |||||
|---|---|---|---|---|---|---|---|
| Clinical trials | ≥2 | ≥3 | ≥4 | ≥0.67 | ≥1 | ≥10% | ≥15% |
| TRIPPS11 | |||||||
| Placebo arm | NA | NA | NA | 14/45 (31.1%) | 12/45 (26.7%) | 13/45 (28.9%) | 11/45 (24.4%) |
| Infliximab arm | 17/53 (32.18%) | 9/53 (17.0%) | 15/53 (28.3%) | 12/53 (22.6%) | |||
| Rituximab trial (the Netherlands)14 | |||||||
| Placebo arm | 3/7 (42.9%) | 1/7 (14.3%) | 1/7 (14.3%) | NA | NA | NA | NA |
| Rituximab arm | 10/13 (76.9%) | 10/13 (76.9%) | 9/13 (69.2%) | ||||
| TEARS12 | |||||||
| Placebo arm | 19/40 (47.5%) | 13/40 (32.5%) | 12/40 (30.0%) | 20/43 (46.5%) | 16/43 (37.2%) | 20/43 (46.5%) | 17/43 (39.5%) |
| Rituximab arm | 21/47 (44.7%) | 15/47 (31.9%) | 14/47 (29.8%) | 26/45 (57.8%) | 21/45 (46.7%) | 25/45 (55.6%) | 21/45 (46.7%) |
| JOQUER13 | |||||||
| Placebo arm | 12/18 (66.7%) | 10/18 (55.6%) | 10/18 (55.6%) | 15/35 (42.9%) | 13/35 (37.1%) | 14/35 (40.0%) | 12/35 (34.3%) |
| Hydroxychloroquine arm | 11/14 (78.6%) | 7/14 (50.0%) | 4/14 (28.6%) | 15/35 (42.9%) | 13/35 (37.1%) | 14/35 (40.0%) | 10/35 (28.6%) |
| BELISS16 | |||||||
| Belimumab arm | 15/18 (83.3%) | 12/18 (66.7%) | 10/18 (55.6%) | 16/28 (57.1%) | 12/28 (42.9%) | 15/28 (53.6%) | 11/28 (39.3%) |
| ASAP15 | |||||||
| Abatacept arm | 13/14 (92.9%) | 12/14 (85.7%) | 12/14 (85.7%) | 6/12 (50.0%) | 6/12 (50.0%) | 6/12 (50%) | 6/12 (50%) |
EULAR, European League Against Rheumatism; ESSDAI, EULAR Sjögren's syndrome disease activity index; ESSPRI, EULAR Sjögren's syndrome patient-reported index; NA, not available.