Session Information
Title: Systemic Lupus Erythematosus - Clinical Aspects and Treatment: Treatment and Management Studies
Session Type: Abstract Submissions (ACR)
Background/Purpose: Reduction of corticosteroid dose remains an important goal in the management of systemic lupus erythematosus (SLE). Current standard of care in SLE relies heavily on corticosteroids, despite what is known about the side effects of corticosteroids and their role in the development of new organ damage.
Methods: We used data from a longitudinal lupus cohort to understand the impact of different levels of exposure to corticosteroids on the risk of developing new irreversible organ damage, as measured by the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI). Cox proportional hazard models were used to estimate the impact of predictors, including mean prednisone dose, on the risk of developing any new organ damage or any new organ damage by organ system (e.g., ocular, musculoskeletal, cardiovascular, and renal damage) over time.
Results: At cohort entry, the average age of SLE patients was 38 years and the average disease duration was 5.1 years. Patients were followed for an average of 6.2 years. The most frequent types of organ damage, occurring over time, were ocular damage (cataract) and musculoskeletal damage (osteoporotic fractures). Mean prednisone dose, disease activity score, and immunosuppressant use during the follow-up period, as well as SDI score at cohort entry, were significant predictors of the risk of developing any new organ damage. There was a dose-response relationship between mean prednisone dose during the follow-up period and the risk of developing any new organ damage (Models 1 and 2; Table 1). A 1-mg/day increase in prednisone dose increased the risk of developing any new organ damage by 2.8% (p<0.001). The risk more than doubled when patients were exposed to a prednisone dose during follow-up of ≥20 mg/day versus <7.5 mg/day (HR=2.51, 95% CI 1.98, 3.20; p<0.001). For individual organ systems, exposure to a mean prednisone dose during follow-up of ≥7.5mg/day versus <7.5 mg/day significantly increased the risk of developing cataracts (HR=2.41, p<0.001), osteoporotic fractures (HR=2.16, p<0.001), and cardiovascular damage (HR=1.54, p=0.041), but showed no significant difference for renal damage (HR=1.44, p=0.163).
Conclusion: Organ damage in SLE is multifactorial, with both corticosteroid treatment and disease activity playing a role. However, even a minimal change in corticosteroid dose (1 mg/day of prednisone) significantly affects the accrual of organ damage over time. These findings may be offset, to some degree, by the impact that prednisone has on damage through the reduction in disease activity.
Table 1. Time-dependent Cox proportional hazard model showing the effect of mean prednisone dose on the risk of any new organ damage in systemic lupus erythematosus
|
Variable |
Model 1 |
Model 2 |
||
|
HR |
p-Value |
HR |
p-Value |
|
|
SELENA-SLEDAI score during follow-up (≥6 vs. <6) |
1.40 (1.17-1.67) |
<0.001 |
1.37 (1.15-1.64) |
<0.001 |
|
Mean prednisone dose, mg/day: |
|
|
|
|
|
(≥7.5 vs. <7.5)
|
1.74 (1.49-2.04) |
<0.001 |
NA |
|
|
(≥7.5-<15 vs. <7.5)
|
NA |
|
1.54 (1.28-1.84) |
<0.001
|
|
(≥15-<20 vs. <7.5)
|
NA |
|
1.80 (1.35-2.40) |
<0.001
|
|
(≥20 vs. <7.5)
|
NA |
|
2.51 (1.98-3.20) |
<0.001
|
|
Abbreviations: CI = confidence interval; HR = hazard ratio; NA = not applicable; SELENA-SLEDAI = Safety of Estrogens in Lupus Erythematosus National Assessment version of the SLE Disease Activity Index. |
||||
|
Note: The only difference between Models 1 and 2 is that Model 1 uses mean prednisone dose as a binary variable, while Model 2 uses mean prednisone dose as a 4-level categorical variable. All HRs presented in the table are adjusted for age, race, ethnicity, and SDI score at cohort entry; calendar year of diagnosis; and time-dependent variables, including mean prednisone dose, SELENA-SLEDAI score, immunosuppressant use, and antimalarial use during follow-up. |
||||
Disclosure:
S. Al Sawah,
Eli Lilly and Company,
3;
X. Zhang,
Eli Lilly and Company,
3;
B. Zhu,
Eli Lilly and Company,
3;
L. S. Magder,
None;
S. A. Foster,
Eli Lilly and Company,
3;
N. Iikuni,
Eli Lilly and Company,
3;
M. Petri,
None.
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