Results for primary and secondary endpoints at 52 weeks
| Maintenance group (n=61) | Withdrawal group (n=63) | Relative risk (95% CI) | P value* | |
| Primary endpoint: any flare according to SFI | 4 (7) | 17 (27) | 0.2 (0.1 to 0.7) | 0.003 |
| Secondary endpoints: | ||||
| Detail of SFI flares | ||||
| No flare | 57 (93) | 46 (73) | 1 (Ref.) | Ref. |
| Mild/moderate | 3 (5) | 12 (19) | 0.2 (0.1 to 0.8)† | 0.012 |
| Severe | 1 (2) | 5 (8) | 0.2 (0.1 to 1.5)† | 0.096 |
| Any flare according to BILAG index | 4 (7) | 17 (27) | 0.2 (0.1 to 0.7) | 0.003 |
| Detail of BILAG index flares | ||||
| No flare | 57 (93) | 46 (73) | 1 (Ref.) | Ref. |
| Mild | 3 (5) | 9 (14) | 0.3 (0.1 to 1.1)† | 0.066 |
| Moderate | 0 (0) | 3 (5) | NA† | 0.096 |
| Severe | 1 (2) | 5 (8) | 0.2 (0.1 to 1.5)† | 0.096 |
| Moderate/severe | 1 (2) | 8 (13) | 0.1 (0.1 to 0.9) | 0.013 |
| Patients experiencing an increase in the SDI | 0 (0) | 3 (5) | NA | 0.244 |
Values are the number (%) of patients.
*Using Fisher’s exact test.
†Compared with patients in the ‘no flare’ group as the reference.
BILAG, British Isles Lupus Assessment Group; NA, not available; SDI, SLICC damage index; SFI, SELENA-SLEDAI flare index; SLICC, Systemic Lupus International Collaborating Clinics.