Session Type: Abstract Submissions (ACR)
Background/Purpose: In patients with active disease, physicians look for an early signal in response to treatment to guide their therapeutic decisions.
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) measures disease activity in 24 descriptors, generates a total score describing disease activity overall. SLEDAI-2K records descriptors of disease activity as present or absent. In the SLEDAI-2K Responder Index 50 (S2K RI-50), each of the 24 descriptors has a definition for a ≥ 50% improvement resulting in an appropriate 50% score for the corresponding descriptor and a total score describing disease activity overall.
We aimed to determine if a signal of improvement in disease activity at 3 months predicts further improvement at 6 months.
Methods: Consecutive active lupus patients who attended the clinic between 2012 and 2014 were screened for inclusion. Patients were included if they: 1) had at least 1 of the following 5 SLEDAI-2K clinical organ systems active (vascular, renal, musculoskeletal, serosal or skin); central nervous system was excluded and 2) started or increased prednisone therapy and/or immunosuppressants. All patients had to have a follow-up visits at 3 and 6 months.
Outcome measures: Disease activity was measured by SLEDAI-2K at all visits and by S2K RI-50 at 3 months.
Study definitions: Signal of improvement by SLEDAI-2K is defined as a decrease by ≥1 in SLEDAI-2K score at 3 months. Signal of improvement by S2K RI-50 is defined as a decrease by ≥1 in S2K RI-50 score at 3 months.
Based on the change in the total SLEDAI-2K score (baseline – last visit), each of the patients at last visit were grouped as: 1) improved (SLEDAI-2K decreased by ≥4) and not improved (SLEDAI-2K decreased <4).
First, we identified the patients with SLEDAI-2K signal at 3 months and those who did not have a SLEDAI-2K signal were further evaluated for possible S2K RI-50 signal. Patients with signals were reevaluated at 6 months to determine if they had further improvement.
Results: 87 patients with mean SLEDAI-2K at baseline visit was 8.9±5.1 were studied. 90% were female, age at baseline visit was 40.0±12.4 and disease duration was 13.2±9.6years.
Signals of improvement: Of the 87 patients, 54 (62%) had a SLEDAI-2K signal at 3 months. Of the 33 patients who did not have a SLEDAI-2K signal, a S2K RI-50 signal was identified in 11 (33%) patients.
Study endpoints: Of the 54 patients with SLEDAI-2K signal at 3 months, 28 (52%) patients improved at 6 months. Of the 11 patients with S2K RI-50 signal at 3 months, 5 (46%) improved at 6 months.
Conclusion: A signal of improvement at 3 months predicts further improvement in disease activity at 6 months. S2K RI-50 signal at 3 months, which is not discern by SLEDAI-2K, predicts improvement in half of the patients at 6 months. S2KRI-50 can identify non responders at 3 months who will respond at 6 months
D. D. Gladman,
M. B. Urowitz,
« Back to 2014 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/a-signal-of-improvement-in-lupus-disease-activity-at-3-months-predicts-further-valid-improvement-at-6-months/