Article Text

Download PDFPDF

LSO-068 Association between organ-specific safety of estrogens in lupus erythematosus national assessment-systemic lupus erythematosus (SLE) disease activity index (SELENA-SLEDAI) response to belimumab and SF-36v2 and FACIT-fatigue scores in patients with SLE
  1. Regina Rendas-Baum1,
  2. Wen-Hung Chen2,
  3. Seth Anderson3,
  4. Christine Henning4,
  5. Anne Hammer3 and
  6. Mark Kosinski1
  1. 1Consulting Science, QualityMetric, USA
  2. 2Value Evidence and Outcomes, GSK, UK
  3. 3Immunology Biostatistics, GSK, USA
  4. 4Global Medical Affairs, GSK, USA


Background Limited data exist on quality of life (QoL) improvement in patients with SLE who were organ-specific responders per SELENA-SLEDAI. Here we explore the association between organ-specific SELENA-SLEDAI treatment response and 36-item Short Form Survey version 2 (SF-36v2) components and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scores in adults with SLE.

Methods This post hoc analysis (GSK Study 217382) used data from four belimumab trials (BLISS-52, NCT00424476; BLISS-76, NCT00410384; BLISS-SC, NCT01484496; EMBRACE, NCT01632241). Differences in mean changes in SF-36v2 and FACIT-Fatigue scores were compared with published group-level minimum important difference (MID; as defined in table 1) between responders (score decrease in those with baseline organ involvement) versus non-responders for each SELENA-SLEDAI organ domain. Mean score changes and change >MID were also compared between the treatment groups (belimumab [1 and 10 mg/kg intravenous and 200 mg subcutaneous] vs placebo) across SELENA-SLEDAI organ responders.

Results At baseline, BLISS-52, BLISS-76, BLISS-SC, and EMBRACE included 864, 818, 834, and 496 patients, respectively. As indicated in table 1, SELENA-SLEDAI central nervous system responders had better (defined as ≥group level MID) SF-36v2 Physical Functioning, Vitality, Mental Health, Mental Component Summary, and FACIT-Fatigue score changes than non-responders. Vascular responders had better SF-36v2 Bodily Pain, General Health Perceptions, Social Functioning, and Physical Component Summary score changes than non-responders. Hematologic responders had better SF-36v2 General Health Perceptions, Vitality, and FACIT-Fatigue score changes than non-responders. Cardiovascular and Respiratory responders had better FACIT-Fatigue score changes than non-responders. Across SELENA-SLEDAI organ systems, patients who were responders and treated with belimumab had a meaningfully better score change than placebo-treated patients on various SF-36v2 domains and/or the FACIT-Fatigue.

Conclusions Being an organ responder is associated with QoL benefits experienced by patients with SLE that were more often observed among belimumab-treated patients. Statistical significance was interpreted with caution owing to small sample sizes.

Funding GSK

Abstract LSO-068 Table 1

Summary of differences between SELENA-SLEDAI organ system responders* and non-responders in mean QoL score change (baseline to Week 52).* Responder defined as a patient with decrease from baseline in SELENA-SLEDAI score at a post-baseline visit. †BLISS-52, NCT00424476; BLISS-76, NCT00410384. ‡BLISS-52, NCT00424476; BLISS-76, NCT00410384; BLISS-SC, NCT01484496; EMBRACE, NCT01632241. Note: Differences in mean score changes ≥MID are indicated in bold; statistically significant (p<0.05) differences between organ responders and non-responders are in grey. R, responder; NR, non-responder

  • Belimumab
  • quality of life
  • systemic lupus erythematosus

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.