Lupus low disease activity state (LLDAS) and remission contribute to an improved health-related quality of life (HRQOL) in patients with systemic lupus erythematosus (SLE), though this benefit is time-dependent, according to study results published in Rheumatology (Oxford).
The aim of the current post hoc analysis was to assess the effect of remission and LLDAS on HRQOL in SLE, using data from 2 double-blind randomized phase 3 clinical trials (BLISS-52 and BLISS-76; ClinicalTrials.gov Identifiers: NCT00424476 and NCT00410384, respectively)
Adult patients with active SLE, all of whom were assessed every 4 weeks for a total of 15 visits. Self-reported HRQOL was assessed using the 36-item Short Form Health Survey (SF-36), the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) scale, and the 3-level European Quality of Life 5-dimension (EQ-5D-3L) health questionnaire.
Generalized estimating equations and quantile regression were used to determine the length of time in remission/LLDAS needed to reach a significant HRQOL benefit (defined as a benefit at or above the minimal clinically important differences) during and after treatment.
A total of 1684 patients (94% women; 47% White; mean age, 38 years) were included in the analysis.
With regard to SF-36, achieving a significant benefit required 4 consecutive (β=0.66) or 4 cumulative (β=0.60) visits in remission for physical component summary scores, and 5 consecutive (β=0.49) or 6 cumulative (β=0.44) visits for mental component summary scores. A significant benefit in the ratio of these scores required either 8 consecutive (β=0.32) or 8 cumulative (β=0.30) visits in LLDAS.
With regard to EQ-5D-3L, a significant benefit required 5 consecutive (β=0.008) or 6 cumulative (β=0.007) visits in remission, and 6 consecutive (β=0.006) or 8 cumulative (β=0.005) visits in LLDAS.
With regard to FACIT-F scores, a significant benefit required 10 consecutive (β=0.39) or 12 cumulative (β=0.34) visits in remission, and 16 consecutive (β=0.25) or 17 cumulative (β=0.24) visits in LLDAS.
Limitations of the analysis included the post hoc design, limited generalizability, missing data, a short follow-up period, and lack of lupus-specific patient-reported outcome measures for HRQOL.
The study researchers concluded, “Both remission and LLDAS attainment were associated with a better [HRQOL] outcome after therapy that exceeded MCIDs in multiple domains. However, compared with LLDAS, shorter time in remission was required to achieve a clinically meaningful benefit in [HRQOL].” They further indicated that “LLDAS resulted in clinically important benefit in multiple [HRQOL] aspects also after exclusion of patients who achieved remission during follow-up, however not in fatigue.”
Disclosure: This research was supported by GlaxoSmithKline. Please see the original reference for a full list of authors’ disclosures.
Emamikia S, Oon S, Gomez A, et al. Impact of remission and low disease activity on health-related quality of life in patients with systemic lupus erythematosus. Rheumatol. Published online March 18, 2022. doi:10.1093/rheumatology/keac185