Background/Purpose:

Systemic Lupus Erythematous Disease Activity Index-2000 (SLEDAI-2K) is a global index that describes disease activity overall in 9 systems.  The use of multiple measures is time consuming and physicians favor one measure, as long as the results are robust. We aimed to determine if SLEDAI-2K is valid in identifying patients who had a clinically important overall improvement with no worsening in other systems.

Methods:

This is an analysis of prospectively collected data on all active lupus patients who attended the Lupus Clinic from 2000-2012. Patients were included if at baseline visit: 1) SLEDAI-2K ≥6, 2) at least 1 of the 6 SLEDAI-2K clinical organ systems was active and for the renal system the presence of proteinuria was mandatory and 3) start or increase in the dose of prednisone. All patients had at least one follow-up at 9-12 months. 

Based on the change in the total SLEDAI-2K scores on follow up visits, patients were grouped as: 1) improved (SLEDAI-2K decreased by ≥4), 2) flared/worsened (SLEDAI-2K increased by ≥4) and 3) unchanged. 

Focusing on patients who improve, each organ system was defined as 1) New Organ: organ system inactive at start but active at study end 2) Same: no change in activity between start and end 3) Improved: lower activity in organ system at the end and 4) worse: higher activity in organ system at study end.

Results:

158 patients were analyzed (table 1). SLEDAI-2K was 12.25±5.27 at baseline and 6.65±4.88 at follow-up visits.

Sex F	97 (89%)
Age at diagnosis (years)	26±11
Age at 1st visit in  the study (years)	39±13
Disease Duration at 1st visit in the study (years)	12±9
Race
Caucasian	67 (61%)
Black	13 (12%)
Asian	14 (13%)
Others	15 (14%)
Medications at 1st visit in the study: patients number (%)
Steroid	109 (100%)
Anti-malarial	82 (75%)
Immunosuppressants	69 (63%)

Of the 158 patients studied 109 patients had improved on SLEDAI-2K scoring on follow-up visit, 38 stayed the same and 11 worsened.

109 patients improved with a mean SLEDAI-2K score at baseline visit of 13.1±5.7 and at follow-up visit of 4.8±4.4. In this group, no one had a new system at study end. Worsening was identified in 5 patients at study end and this resulted from abnormal laboratory results: 1) one patient developed pyuria at follow up visit in addition to existing proteinuria and hematuria that were persistent from study start and 2) 4 patients had worsening in the immunological system (either a new anti-DNA positivity or low complements). In all 5 patients, this laboratory worsening was not clinically significant and did not require a change in the management (table 2).

Table 2. Activity of SLEDAI-2K systems’ descriptors in patients who improved at

study end

 

Global disease activity	Improvement n=109
Organ systems	New organ	Same	Improved	Worsened
CNS	0	95	14	0
Vascular	0	92	17	0
MSK	0	65	44	0
Renal	0	61	47	1
Dermal	0	75	34	0
Serosal	0	105	4	0
Immunological	4	71	30	4
Constitutional	0	102	7	0
Hematologic	0	102	6	0

Conclusion:

SLEDAI-2K is valid to identify improvement in disease activity overall and we have now shown that no clinically important worsening occurs simultaneously. Therefore, SLEDAI-2K can be used as a single measure in the assessment of disease activity.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/disease-activity-does-not-improve-significantly-in-one-system-and-worsen-in-another-system/