Session Information
Date: Monday, November 6, 2017
Title: Systemic Lupus Erythematosus – Clinical Aspects and Treatment Poster II: Damage and Comorbidities
Session Type: ACR Poster Session B
Session Time: 9:00AM-11:00AM
Background/Purpose: Lupus low disease activity state (LLDAS) is a systemic lupus erythematosus (SLE) outcome measure that combines low disease activity and a 7.5 mg limit on prednisone. We have previously shown that there is a dose-response reduction in SLICC/ACR organ damage by percentage of time spent in LLDAS. We now show which components of LLDAS are most important.
Methods: Lupus low disease activity state (LLDAS) was defined by Franklyn et al as a SLEDAI <=4, PGA <=1.0, no major organ activity, and no new activity and prednisone use <= 7.5 mg/d. Using a large clinical cohort, we looked at the risk of organ damage among those who satisfied this definition 75% of the time. Then we looked at the risk of organ damage (by SLICC/ACR Damage Index) among those who satisfied modifications of this definition.
Results: Table 1 shows the risk of damage if LLDAS is present at 75% of previous visits, if some of the requirements for LLDAS are relaxed. If we define LLDAS in the standard way and patients satisfy this definition 75% of the time, damage is experienced in 0.62% of subsequent months. If we use the same definition but allow a prednisone dose of up to 10 mg/day, we still observed a relatively low risk of damage (0.59% per month) among those who achieve that standard 75% of the time.
Table 1: Risk of new damage in a person month in subgroups defined by LLDAS on treatment, after relaxing some of the requirements. The percentages refer to the risk of damage for months that meet the criterion in 75% of preceding follow-up.
|
Criterion |
Number of months and instances of damage among those who satisfy the criterion to the left at least 75% of the person-time. |
||
|
Number of person-months observed |
Number of months with an increase in damage |
Percentage of months in which damage occurred |
|
|
LLDAS (original definition) |
13,141 |
82 |
0.62% |
|
LLDAS, but allow SLEDAI up to 5 |
13,198 |
82 |
0.62% |
|
LLDAS, but allow SLEDAI up to 6 |
13,382 |
84 |
0.63% |
|
LLDAS, but no SLEDAI requirement |
13,382 |
84 |
0.63% |
|
LLDAS, but allow Prednisone up to 10 mg/d |
14,561 |
86 |
0.59% |
|
LLDAS, but allow Prednisone up to 15 mg/d |
15,721 |
97 |
0.64% |
|
LLDAS, but allow Prednisone up to 20 mg/d |
15,928 |
108 |
0.68% |
|
LLDAS, but no limit on Prednisone |
16,399 |
111 |
0.68% |
|
LLDAS, but allow PGA up to 1.5 |
14,641 |
100 |
0.68% |
|
LLDAS, but no PGA requirement |
15,334 |
107 |
0.70% |
Table 2 shows the risk of damage if some of the requirements for LLDAS are made more stringent. A more stringent SLEDAI or lower dose of prednisone did not result in a lower damage risk and reduced the number of patients who achieved those stricter goals. The lowest risk was seen if LLDAS was modified to require a PGA of 0 (risk=51%), but this stringent standard was only achieved for a small percentage of the follow-up.
Table 2: Risk of new damage in a person month in subgroups defined by LLDAS on treatment, after making some of the requirements more stringent. The percentages refer to the risk of damage for months that meet the criterion in 75% of preceding follow-up.
|
Criterion |
Number of months and instances of damage among those who satisfy the criterion to the left at least 75% of the person-time. |
||
|
Number of person-months observed |
Number of months with an increase in damage |
Percentage of months in which damage occurred |
|
|
LLDAS (original definition) |
13,141 |
82 |
0.62% |
|
|
|
|
|
|
LLDAS, but require PGA <= 0.5 |
8,221 |
46 |
0.56% |
|
LLDAS, but require PGA<=0.2 |
1,922 |
12 |
0.62% |
|
LLDAS, but require PGA=0 |
1,753 |
9 |
0.51% |
|
|
|
|
|
|
LLDAS, but require SLEDAI <=3 |
12,115 |
72 |
0.59% |
|
LLDAS, but require SLEDAI<=2 |
11,815 |
69 |
0.58% |
|
LLDAS, but require SLEDAI<=1 |
7,943 |
46 |
0.58% |
|
LLDAS, but require SLEDAI=0 |
7,624 |
45 |
0.59% |
|
|
|
|
|
|
LLDAS, but require Prednisone<=5 |
12,482 |
76 |
0.61% |
|
LLDAS, but require Prednisone=0 |
8,661 |
55 |
0.64% |
Conclusion: Our findings suggest that a relaxed definition of LLDAS (allowing for greater levels of SLEDAI and higher doses of prednisone) might still be a realistic target for clinical care, if the goal is to reduce the risk of later organ damage.
To cite this abstract in AMA style:
Petri M, Goldman D, Magder LS. Lupus Low Disease Activity State: Can We Relax the Definition and Still Achieve Low Risk of SLE-Related Damage? [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/lupus-low-disease-activity-state-can-we-relax-the-definition-and-still-achieve-low-risk-of-sle-related-damage/. Accessed .« Back to 2017 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/lupus-low-disease-activity-state-can-we-relax-the-definition-and-still-achieve-low-risk-of-sle-related-damage/