Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: Predicting which SLE patients are at increased risk for clinically meaningful flares may be useful in making management decisions. The purpose of this analysis was to identify demographic and disease-related predictors of flares.
Methods: Baseline demographic and SLE-related disease activity characteristics were evaluated for their ability to predict new SLE flares by treatment wk 52 in the combined dataset of 562 patients receiving placebo + standard SLE therapy from the phase 3 belimumab BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) trials. Flare was defined as the development of 1 new British Isles Lupus Assessment Group (BILAG) A or 2 new B organ domain scores; any BILAG A score; or according to the modified severe SLE Flare Index (SFI). Baseline variables included race, age, gender, BMI, SELENA-SLEDAI (mean score, range, and 24 items with ≥30/group), PGA, BILAG A−E scores, ACR diagnostic criteria, Systemic Lupus International Collaborating Clinics Damage Index, SLE duration, and concurrent medications. Baseline disease characteristics associated with a ≥10% absolute difference (% flare – % no flare) or ≥50% increase ([% flare – % no flare]/ % no flare) in flare rate were considered predictors of flare.
Results: By wk 52, 180 patients (32%) receiving placebo had 1 new BILAG A or 2 new B scores; 130 (23%) had a BILAG A score; and 133 (24%) had a severe SFI flare. By all 3 flare indices, SELENA-SLEDAI ≥12, and moderate−severe disease activity involving renal and hematologic domains were predictors of flare (see table). Serologic markers were predictors of severe SFI flare and 1 BILAG A or 2 B scores. Use of corticosteroids, immunosuppressives, antimalarials, and other concomitant medications did not predict flare.
Conclusion: SLE patients on standard therapy alone with moderate−severe renal, vasculitic, hematologic, or serologic disease activity, or SELENA-SLEDAI ≥12 were at increased risk of having a clinically meaningful flare over 52 wk.
Predictors of Flare |
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|
|
% 1 New BILAG A or 2 New B Scores |
% Any BILAG A Score |
% Severe SFI Flare |
|||
|
Characteristic |
With |
Without |
With (n = 130) |
Without (n = 432) |
With (n = 133) |
Without (n = 429) |
|
SS ≥12 |
38.9# |
24.1 |
39.2+ |
25.7 |
41.4# |
24.9 |
|
SS proteinuria |
20.0+ |
11.3 |
20.8* |
12.0 |
21.1+ |
11.9 |
|
SS vasculitis |
10.0* |
5.0 |
10.0 |
5.6 |
9.0 |
5.8 |
|
SS low complement |
70.0+ |
56.8 |
67.7 |
59.0 |
72.2+ |
57.6 |
|
SS DNA binding |
75.0+ |
64.1 |
73.1 |
66.0 |
77.4+ |
64.6 |
|
BILAG renal (A−C) |
53.3# |
31.7 |
56.9# |
33.1 |
54.9# |
33.6 |
|
BILAG vasculitis (A/B) |
14.4+ |
6.8 |
14.6* |
7.6 |
15.0* |
7.5 |
|
BILAG hematologic (A/B) |
22.8+ |
12.3 |
27.7# |
12.0 |
25.6+ |
12.6 |
|
Nominal p values for pairwise comparison (likelihood ratio test). SS, SELENA-SLEDAI. #p <0.001; +p <0.01; *p <0.05. |
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Disclosure:
R. F. van Vollenhoven,
Abbott, BMS, GSK, HGS, MSD, Pfizer, Roche, UCB,
2,
Abbott, BMS, GSK, HGS, MSD, Pfizer, Roche, UCB,
5;
M. Petri,
HGS, GSK,
5;
R. A. Levy,
HGS,GSK,
8;
S. V. Navarra,
HGS, GSK,
8;
J. P. Buyon,
HGS,
2,
HGS, GSK,
5;
Z. J. Zhong,
HGS,
1,
HGS,
3;
W. W. Freimuth,
HGS,
1,
HGS,
3;
R. Cervera,
HGS, GSK,
2,
HGS, GSK,
5.
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