Session Information
Date: Wednesday, October 24, 2018
Title: 6W010 ACR Abstract: SLE–Clinical V: Biomarkers, Criteria, & Outcomes (2928–2933)
Session Type: ACR Concurrent Abstract Session
Session Time: 9:00AM-10:30AM
Background/Purpose: Outcome measures that combine control of SLE activity and prednisone reduction are clinically relevant. A clinical goal in SLE is to reduce risk of long-term organ damage. We assessed whether two recently proposed disease activity outcomes were predictive of future damage.
Methods: For each month of follow-up in a large SLE cohort, we determined whether the patient was in Clinical Remission (as defined by the DORIS working group) or lupus low disease activity state (LLDAS) (as defined by Franklyn et al). Clinical Remission was defined as a PGA<0.5, clinical SLEDAI=0 and no prednisone or immunosuppressants. Clinical Remission on Treatment allowed for prednisone<=5mg/day and immunosuppressant use. LLDAS was defined as a SLEDAI <=4, PGA <=1.0, no major organ activity, and no new activity. LLDAS on treatment allowed for prednisone use <= 7.5 mg/d and immunosuppressants. Damage was defined using the SLICC/ACR Damage index.
Results: There were 81,118 person-months observed among 2,026 patients (92% female, 53% Caucasian, 39% African-American). Table 1 shows the rates of damage, per person month, in subgroups defined by Remission or LLDAS.
Table 1. Rates of new damage, in subgroups defined by past levels of disease activity
|
Percentage of Prior Months in: |
Number of person-months observed |
Number of months with an increase in SLICC/ACR Damage Index |
Rate of damage per 100 person months |
Rate Ratios |
P-values |
|
Clinical Remission None Not none, but < 25% 25% to 50% 50% to 75% 75%+ |
– 35,772 14,358 6573 3845 1,641 |
– 406 102 50 27 10 |
– 1.13 0.71 0.76 0.70 0.61 |
– 1.0 (Ref) 0.60 (0.48,0.75) 0.66 (0.46,0.94) 0.63 (0.42,0.97) 0.58 (0.30,1.15) |
– – <0.0001 0.023 0.035 0.12 |
|
Clinical Remission on Treatment None Not none, but < 25% 25% to 50% 50% to 75% 75%+ |
– 16,491 20,169 14,344 8396 2,789 |
– 250 170 103 54 18 |
– 1.52 0.84 0.72 0.64 0.65 |
– 1.0 (Ref) 0.54 (0.44,0.67) 0.46 (0.36,0.60) 0.43 (0.30,0.60) 0.45 (0.27,0.75) |
– – <0.0001 <0.0001 <0.0001 0.0019 |
|
LLDAS None Not none, but < 25% 25% to 50% 50% to 75% 75%+ |
– 30,366 10,880 5012 8494 7,527 |
– 343 106 40 60 46 |
– 1.13 0.97 0.80 0.71 0.61 |
– 1.0 (Ref) 0.86 (0.69,1.07) 0.70 (0.51,0.98) 0.63 (0.48,0.83) 0.54 (0.40,0.73) |
– – 0.18 0.037 0.0010 <0.0001 |
|
LLDAS on Treatment None Not none, but < 25% 25% to 50% 50% to 75% 75%+ |
– 7,656 10,555 12,686 18,151 13,141 |
– 117 134 129 133 82 |
– 1.53 1.27 1.02 0.73 0.62 |
– 1.0 (Ref) 0.83 (0.65,1.06) 0.66 (0.51,0.85) 0.48 (0.37,0.61) 0.40 (0.30,0.54) |
– – 0.14 0.0013 0.0010 <0.0001 |
Damage rates were relatively low when LLDAS was achieved at least 50% of the time. These rates were similar to those experienced by patients who met a more stringent treatment restriction with Remission on Treatment at least 50% of the time.
Conclusion: Percent time in LLDAS had a clear dose response for rate ratios of organ damage. The equivalence of LLDAS and DORIS remission on treatment is welcome news, as LLDAS on treatment > 50% of the time is an easier goal to achieve (3 times more person-months observed in our cohort) and more realistic as a clinical trial outcome.
To cite this abstract in AMA style:
Petri M, Goldman D, Magder LS. Validation of Remission and Lupus Low Disease Activity State As Predictors of Organ Damage in SLE [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/validation-of-remission-and-lupus-low-disease-activity-state-as-predictors-of-organ-damage-in-sle-2/. Accessed .ACR Meeting Abstracts - https://acrabstracts.org/abstract/validation-of-remission-and-lupus-low-disease-activity-state-as-predictors-of-organ-damage-in-sle-2/