Abstract

Background: Patients with systemic lupus erythematosus (SLE) suffer an impaired health-related quality of life (HRQoL), and the majority of them experience fatigue as a major problem. Traditionally, treatment of SLE has been symptomatic, and antimalarial agents (AMA) are considered a cornerstone of SLE treatment. In previous literature, results regarding the effect of antimalarial agents on HRQoL have been conflicting. Objectives: In this study, we aimed at investigating the potential influence of AMA on SLE patients’ self-perception of HRQoL aspects. Methods: We utilised pooled baseline data from the BLISS-52 and BLISS-76 clinical trials of belimumab (n=1684). Access to data was granted by GlaxoSmithKline. The patients’ HRQoL and fatigue were self-reported using the Medical Outcomes Study (MOS) short form 36 (SF-36) health survey, the functional assessment of chronic illness therapy (FACIT)-Fatigue scale and the three-level EuroQol- 5 Dimension (EQ-5D) questionnaire. Minimal clinically important difference (MCID) was set to ≥5.0 points for SF-36 subscales, ≥2.5 points for SF-36 component summary scores, and ≥4 points for FACIT-Fatigue scores. High disease activity was defined as a SELENA-SLEDAI score ≥10. Organ damage was assessed using the SLICC/ACR Damage Index (SDI). The non-parametric Mann-Whitney U test was used for comparisons between AMA users and non-users. Linear regression models were next used in order to adjust for possible confounding factors; these included age, sex, ethnic origin, SLE disease activity, SLE duration, organ damage, corticosteroid use and use of other immunosuppressive agents. Results: Results are presented as mean values ± standard devation. Patients receiving AMA (n=1098) performed better than patients who did not receive AMA (n=586) with regard to SF-36 physical component summary (PCS) scores (39.6 ± 9.5 versus 38.1 ± 9.9; P=0.001), physical functioning (61.1 ± 24.9 versus 55.0 ± 26.5; P Conclusion: AMA use contributes to better physical functioning in patients with SLE, independently of other factors. Acknowledgement: The authors would like to thank GlaxoSmithKline (Uxbridge, UK) for granting access to the data from the BLISS-52 and BLISS-76 trials (ClinicalTrials.gov identifiers NCT00424476 and NCT00410384, respectively) through the Clinical Study Data Request (CSDR) consortium. Disclosure of Interests: None declared

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