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 accrual | Severe 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 | |||||||
| No | 13 458 | 118 | 10.52 (8.78 to 12.60) | 1.00 (reference) | 292 | 25.68 (22.89 to 28.80) | 1.00 (reference) |
| Yes | 5139 | 30 | 7.01 (4.90 to 10.02) | 0.64 (0.42 to 0.97)§ | 30 | 7.00 (4.89 to 10.01) | 0.34 (0.22 to 0.51)¶ |
| vs no LLDAS | 0.56 (0.37 to 0.87)** | 0.26 (0.17 to 0.40)¶ | |||||
| Time-to-target | |||||||
| ≤15 months | 3104 | 16 | 6.19 (3.79 to 10.10) | 0.57 (0.34 to 0.96)§ | 18 | 10.61 (6.69 to 16.85) | 0.20 (0.11 to 0.38)¶ |
| >15 months | 2035 | 14 | 8.26 (4.89 to 13.94) | 0.69 (0.39 to 1.20) | 12 | 4.63 (2.63 to 8.15) | 0.56 (0.33 to 0.94)§ |
| Duration of target | |||||||
| ≥6 months | 4023 | 21 | 6.26 (4.08 to 9.61) | 0.58 (0.36 to 0.93)§ | 11 | 3.28 (1.82 to 5.92) | 0.14 (0.08 to 0.27)¶ |
| ≥12 months | 3891 | 20 | 6.17 (3.98 to 9.56) | 0.57 (0.35 to 0.93)§ | 11 | 3.39 (1.88 to 6.13) | 0.15 (0.08 to 0.28)¶ |
| ≥24 months | 3031 | 14 | 5.54 (3.2 to 9.36) | 0.52 (0.29 to 0.92)§ | 8 | 3.17 (1.58 to 6.33) | 0.14 (0.07 to 0.30)¶ |
| LLDAS | |||||||
| No | 8772 | 85 | 11.63 (9.40 to 14.38) | 1.00 (reference) | 238 | 32.21 (28.36 to 36.57) | 1.00 (reference) |
| Yes | 9825 | 63 | 7.69 (6.01 to 9.85) | 0.63 (0.46 to 0.89)** | 84 | 10.16 (8.20 to 12.58) | 0.39 (0.29 to 0.51)¶ |
| Yes (without DORIS) | 4686 | 33 | 8.45 (6.01 to 11.89) | 0.65 (0.43 to 0.98)§ | 54 | 13.56 (10.38 to 17.70) | 0.49 (0.36 to 0.67)¶ |
| vs DORIS | 1.12 (0.68 to 1.86) | 1.78 (1.11 to 2.83)§ | |||||
| Time-to-target | |||||||
| ≤9 months | 4672 | 26 | 6.68 (4.55 to 9.81) | 0.60 (0.38 to 0.93)§ | 39 | 9.83 (7.19 to 13.46) | 0.38 (0.26 to 0.55)¶ |
| >9 months | 5153 | 37 | 8.62 (6.24 to 11.89) | 0.67 (0.45 to 0.99)§ | 45 | 10.45 (7.81 to 14.00) | 0.40 (0.28 to 0.56)¶ |
| Duration of target | |||||||
| ≥6 months | 8473 | 53 | 7.51 (5.73 to 9.83) | 0.61 (0.43 to 0.86)** | 39 | 5.49 (4.01 to 7.52) | 0.19 (0.13 to 0.27)¶ |
| ≥12 months | 8152 | 47 | 6.92 (5.20 to 9.21) | 0.53 (0.37 to 0.77)** | 35 | 5.15 (3.70 to 7.18) | 0.18 (0.12 to 0.26)¶ |
| ≥24 months | 6952 | 37 | 6.39 (4.63 to 8.81) | 0.50 (0.33 to 0.74)** | 27 | 4.66 (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;