Improvements in health-related quality of life with belimumab, a B-lymphocyte stimulator-specific inhibitor, in patients with autoantibody-positive systemic lupus erythematosus from the randomised controlled BLISS trials

Abstract

Objective: Assess the effects of belimumab treatment plus standard systemic lupus erythematosus (SLE) therapy on health-related quality of life (HRQOL) in patients with active, autoantibody-positive SLE.

Methods: Patients received standard therapy plus placebo or belimumab 1 or 10 mg/kg in two multicentre, randomised controlled trials of 52 (BLISS-52; N=865) and 76 (BLISS-76; N=819) weeks' duration. Responders were evaluated by SLE Responder Index at week 52. Patient-reported outcome assessments included SF-36, Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, and EQ-5D.

Results: Mean SF-36 Physical Component Summary (PCS) scores at week 24 was a major secondary endpoint. Baseline SF-36 scores were 1.5 SDs below age-/sex-matched US norms with similar improvement at week 24 across treatment groups. Mean changes from baseline in PCS scores were significantly (p<0.05) greater with belimumab 1 mg/kg (4.20) and 10 mg/kg (4.18) versus placebo (2.96) in BLISS-52, week 52. In BLISS-76, significantly (p<0.05) greater improvements were seen with belimumab 1 mg/kg in PCS (belimumab 1 mg/kg=4.37, 10 mg/kg=3.41 vs placebo=2.85) and Mental Component Summary (MCS) scores (belimumab 1 mg/kg=3.14, 10 mg/kg=2.70 vs placebo=1.40) at week 52, and in MCS score at week 76 (belimumab 1 mg/kg=3.05, 10 mg/kg=2.28 vs placebo=1.36). In pooled analysis, significantly greater improvements in PCS, SF-36 vitality domain, and FACIT-Fatigue scores at week 52 were evident with both belimumab doses.

Conclusions: The clinically meaningful improvements in HRQOL in autoantibody-positive patients with active SLE treated with belimumab and standard therapy are consistent with the reductions in disease activity observed in these trials.

Clinicaltrialsgov number: NCT00424476, NCT00410384.

Keywords: Autoimmune Diseases; Systemic Lupus Erythematosus; Treatment.

Figures

Figure 1

Last observation carried forward analysis of mean changes in (A) SF-36 Physical Component Summary and (B) Mental Component Summary scores for weeks 24 and 52 in BLISS-52 and pooled phase 3 studies, and weeks 24, 52 and 76 in BLISS-76. *p†p<0.01. MCID, minimum clinically important difference.

Figure 2

Spydergrams of composited baseline (BL) and week-52 SF-36 domain scores by treatment group versus US age-/gender (A/G)-matched norms in (A) BLISS-52, (B) BLISS-76, and (C) pooled analysis. Inner polygon (deep purple) represents weighted mean BL SF-36 domain scores across all three treatment groups; outer polygon (yellow) represents A/G norms as a benchmark comparison; mean changes with placebo, and belimumab 1 and 10 mg/kg shown as intermediate polygons (grey, blue, and light purple, respectively). BP, bodily pain; GH, general health; MH, mental health; PF, physical functioning; RE, role-emotional; RP, role-physical; SF, social functioning; VT, vitality.

Figure 3

Last observation carried forward analysis of mean changes from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue and SF-36 vitality domain scores for (A) BLISS-52 at week 52, (B) BLISS-76 at weeks 52 and 76, and (C) pooled phase 3 data at week 52. Higher scores indicate less fatigue and increased vitality. *p†p<0.05; ‡p<0.001. The p values were obtained from an ANCOVA model for the comparison between each belimumab treatment group and the placebo group. ANCOVA, analysis of covariance; MCID, minimum clinically important difference.