Background/Purpose: The Medical Outcome Survey Short Form 36 (SF-36) is one of the most widely used tools for measuring patient reported outcomes. In cross-sectional studies, there has been no correlation between QoL and disease activity or damage. The aim of this study is to assess QoL over time in the first 5 years of a multinational multicenter cohort.

Methods: An inception cohort of SLE patients from 31 centres in 12 countries has been assembled according to a standardized protocol between 2000 and 2013 to study the risk factors for atherosclerosis. Patients enter the cohort within 15 months of SLE diagnosis (≥4 ACR criteria). Clinical and laboratory features of SLE and comorbidities are gathered in a standardized protocol at yearly intervals. In addition patients complete the SF-36 at yearly intervals.  Only patients who had 5 years of follow up and who had a minimum of 5 completed questionnaires were included in this analysis. The outcomes assessed include the 8 health domains of SF-36, in addition to physical component scores (PSC) and mental component scores (MCS) for each patient. In order to test for change in SF-36 domains over the 5 year period, GEE models were run separately for each of the 8 domains and the 2 composite scores. Each model adjusted for repeated measures by patients. Domains were also compared for gender, age, ethnicity and active disease (SLEDAI-2K ≥ 6) at enrolment.

Results: 485 patients (90.1% female) with 5 or more SF-36 evaluations were included. The disease duration at enrolment was 5.3 ± 4.1 months and the mean age at diagnosis was 35.8 ± 13.2 years. The race/ethnicity distribution was as follows: 57% Caucasian, 15% Black, 16% Asian, 8% Hispanic and 4% other. All 8 domains, in addition to MCS and PCS showed improvement that was statistically significant in the first 2 years of follow-up. No significant improvement was noted in any of the 8 domains or composite scores from years 3-5. 

Baseline domain scores range from 44.2-70.7 and PCS and MCS scores were 39.4 and 44.9. In year 2 domain scores range from 52.4-71.6 and PCS and MCS scores were 42.8 and 47.7.

Generally higher values of SF-36 scores are associated with male gender, younger age and Hispanic and Asian ethnicities. Levels of disease activity were not associated with SF-36.

Conclusion: Unlike late stage lupus where QoL is stable, in patients with early disease (within the first 2 years) all domains improve. Therefore SF-36 may be used as an outcome measure for improvement in the first two years of SLE.