Table 2

Attainment of DORIS and LLDAS associated with reduced accrual of damage and severe flares in patients with active moderate-to-severe SLE (visit-by-visit analysis)

Organ damage accrualSevere flares
Person-months No of failures* Incidence rate (95% CI)†† Cox regression
HR (95% CI)
No of failures‡ Incidence rate (95% CI)†† Cox regression
HR (95% CI)
DORIS
No13 45811810.52 (8.78 to 12.60)1.00 (reference)29225.68 (22.89 to 28.80)1.00 (reference)
Yes5139307.01 (4.90 to 10.02)0.64 (0.42 to 0.97)§307.00 (4.89 to 10.01)0.34 (0.22 to 0.51)¶
 vs no LLDAS0.56 (0.37 to 0.87)**0.26 (0.17 to 0.40)¶
Time-to-target
 ≤15 months3104166.19 (3.79 to 10.10)0.57 (0.34 to 0.96)§1810.61 (6.69 to 16.85)0.20 (0.11 to 0.38)¶
 >15 months2035148.26 (4.89 to 13.94)0.69 (0.39 to 1.20)124.63 (2.63 to 8.15)0.56 (0.33 to 0.94)§
Duration of target
 ≥6 months4023216.26 (4.08 to 9.61)0.58 (0.36 to 0.93)§113.28 (1.82 to 5.92)0.14 (0.08 to 0.27)¶
 ≥12 months3891206.17 (3.98 to 9.56)0.57 (0.35 to 0.93)§113.39 (1.88 to 6.13)0.15 (0.08 to 0.28)¶
 ≥24 months3031145.54 (3.2 to 9.36)0.52 (0.29 to 0.92)§83.17 (1.58 to 6.33)0.14 (0.07 to 0.30)¶
LLDAS
No87728511.63 (9.40 to 14.38)1.00 (reference)23832.21 (28.36 to 36.57)1.00 (reference)
Yes9825637.69 (6.01 to 9.85)0.63 (0.46 to 0.89)**8410.16 (8.20 to 12.58)0.39 (0.29 to 0.51)¶
Yes (without DORIS)4686338.45 (6.01 to 11.89)0.65 (0.43 to 0.98)§5413.56 (10.38 to 17.70)0.49 (0.36 to 0.67)¶
 vs DORIS1.12 (0.68 to 1.86)1.78 (1.11 to 2.83)§
Time-to-target
 ≤9 months4672266.68 (4.55 to 9.81)0.60 (0.38 to 0.93)§399.83 (7.19 to 13.46)0.38 (0.26 to 0.55)¶
 >9 months5153378.62 (6.24 to 11.89)0.67 (0.45 to 0.99)§4510.45 (7.81 to 14.00)0.40 (0.28 to 0.56)¶
Duration of target
 ≥6 months8473537.51 (5.73 to 9.83)0.61 (0.43 to 0.86)**395.49 (4.01 to 7.52)0.19 (0.13 to 0.27)¶
 ≥12 months8152476.92 (5.20 to 9.21)0.53 (0.37 to 0.77)**355.15 (3.70 to 7.18)0.18 (0.12 to 0.26)¶
 ≥24 months6952376.39 (4.63 to 8.81)0.50 (0.33 to 0.74)**274.66 (3.20 to 6.80)0.16 (0.11 to 0.25)¶
  • *Any increase in SDI since previous visit.

  • †Multiple-failures hazard models (n=3492 visits) incorporating within-patients’ shared frailty and adjusting for gender, age and follow-up duration effects; unless specified otherwise, reference group are visits with no attainment of DORIS or LLDAS.

  • ‡Defined according to the SELENA-SLEDAI Flare Index.

  • §P<0.05.

  • ¶P<0.001.

  • **P<0.01.

  • ††Per 100 patient-years.

  • DORIS, Definition of Remission in SLE; LLDAS, Lupus Low Disease Activity State.SDI, Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index; SLE, systemic lupus erythematosus; SLEDAI, SLE Disease Activity Index;