Table 2.
Maintenance Group (n = 102) | Withdrawal Group (n = 102) | P Value | |
---|---|---|---|
Flares at 12 months | |||
Flare (first definition)a | 30 (29.4) | 18 (17.6) | 0.023 |
Flare (second definition)b | 14 (13.7) | 11 (10.8) | 0.467 |
Flare (third definition)c | 12 (11.8) | 7 (6.9) | 0.197 |
Flares at 24 months | |||
Flare (first definition)a | 51 (50) | 34 (33.3) | 0.01 |
Flare (second definition)b | 28 (27.5) | 15 (14.7) | 0.024 |
Flare (third definition)c | 27 (26.5) | 13 (12.7) | 0.013 |
Damage accrual at 24 months | |||
Related to glucocorticosteroids | 12 (11.8) | 3 (2.9) | 0.02 |
Not related to glucocorticosteroids | 7 (6.9) | 4 (3.9) | 0.317 |
Increase in SDI | 18 (17.6) | 7 (6.9) | 0.022 |
Abbreviation: SDI, Systemic Lupus International Collaborating Clinics Damage Index; SLEDAI‐2K, Systemic Lupus Erythematosus Disease Activity Index‐2000; SMD, standardized mean difference.
Data are given as n (%).
Any increase in clinical SLEDAI‐2K (excluding serology).
Any increase in clinical SLEDAI‐2K plus treatment escalation (for glucocorticosteroids, antimalarials or immunosuppressives).
Any increase ≥4 in clinical SLEDAI‐2K.