Background and Aims Outcome measures that combine control of SLE activity and prednisone reduction are clinically relevant. A clinical goal in SLE is to reduce risk of long-term organ damage. We assessed whether two recently proposed disease activity outcomes were predictive of future damage.
Methods For each month of follow-up, we determined whether the patient was in Clinical Remission (as defined by the DORIS work group) or low lupus disease activity state (LLDAS) (as defined by Franklyn et al.). Clinical Remission was defined as a PGA <0.5, clinical SLEDAI=0 and no prednisone or immunosuppressants. Clinical Remission on Treatment allowed for prednisone<=5 mg/day and immunosuppressant use. LLDAS was defined as a SLEDAI<=4, PGA<=1.0, no major organ activity, and no new activity. LLDAS on treatment allowed for prednisone use<=7.5 mg/d and immunosuppressants. Damage was defined using the SLICC/ACR index.
Results There were 81 118 person-months observed among 2026 patients (92% female, 53% Caucasian, 39% African-American). Table 1 shows the rates of damage, per person month, in subgroups defined by Remission or LLDAS.
Damage rates were relatively low when LLDA was achieved at least 50% of the time. These rates were similar to those experienced by patients who met a more stringent treatment restriction with Remission on Treatment at least 50% of the time.
Conclusions The equivalence of LLDAS and DORIS remission on treatment is welcome news, as LLDAS on treatment >50% of the time is an easier goal to achieve (3 times more person-months observed in our cohort) and more realistic as a clinical trial outcome.
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