We studied the duration and consecutiveness of remission or lupus low disease activity state (LLDAS) throughout 52 weeks of therapy in relation to health-related quality of life (HRQoL) in systemic lupus erythematosus.
We analysed data from the BLISS-52 and BLISS-76 trials (N=1684). Remission/LLDAS required clinical (c)SLEDAI-2K=0/SLEDAI-2K≤4, PhGA<0.5/≤1 (0–3), and prednisone≤5/≤7.5 mg/day, respectively. HRQoL was measured using SF-36 physical/mental component summary (PCS/MCS) and EQ-5D-3L. Minimal clinically important difference (MCID) at week 52 was defined as PCS/MCS=2.5 and EQ-5D-3L=0.040. Quantile regression analysis was performed. Adjustments for patient characteristics, including organ damage, were incorporated.
The minimum cumulative attainment of remission to achieve a benefit in PCS≥MCID at week 52 was four visits (β=0.63), while 7 visits were required for MCS differences ≥MCID (β=0.37). Correspondingly, 9 visits in LLDAS were required for achieving differences ≥MCID in both PCS (b=0.28) and MCS (β=0.29). Four consecutive visits in remission were required for PCS≥MCID (b=0.70), whereas six visits were required for MCS≥MCID (b=0.46). Sustained LLDAS for nine consecutive visits was needed for PCS/MCS≥MCID (b=0.31 for both). For EQ-5D-3L≥MCID to be reached, a cumulative total of seven visits in remission (b=0.006) or eight visits in LLDAS (b=0.005) was required, while if sustained, remission for six visits (b=0.008) or LLDAS for seven visits (b=0.006) was sufficient.
Longer time in remission was required to achieve clinically important differences in mental versus physical aspects of HRQoL, and longer time in LLDAS versus remission was required for multiple HRQoL aspects. Shorter time was required if the state was sustained.