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Abstract
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
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
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