Long-term impact of belimumab on health-related quality of life and fatigue in patients with systemic lupus erythematosus: 6 years of treatment.

OBJECTIVE: To report long-term health-related quality of life (HRQoL) and fatigue outcomes in patients with systemic lupus erythematosus (SLE) receiving belimumab.

METHODS: Patients with SLE who completed the BLISS-76 trial were enrolled into this continuation study (BEL112233, NCT00724867). The belimumab groups continued to receive the same dose (1 mg/kg or 10 mg/kg intravenously; post-March 2011 all patients received 10 mg/kg) every 28 days, plus standard of care (SoC). The placebo group switched to belimumab 10 mg/kg. HRQoL and fatigue assessments included the Short Form-36 (SF-36) Health Survey and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale. Post hoc subgroup analyses (BEL206350) assessed clinical characteristics associated with improved HRQoL and fatigue.

RESULTS: 268 patients enrolled; 140 completed the study. Patients receiving long-term belimumab reported continued improvements in HRQoL and fatigue. At Study Year 6, mean (standard deviation [SD]) Physical Component Summary (PCS) and Mental Component Summary (MCS) SF-36 scores increased from baseline 37.0 (9.9) to 41.7 (10.0; mean change, 4.8 [9.4]) for PCS and from 44.3 (11.3) to 47.0 (11.6; mean change, 2.7 [11.3]) for MCS, exceeding the minimum clinically important difference (MCID) for improvement (2.5 units). Mean (SD) FACIT-Fatigue score exceeded the MCID of 4 at Study Years 1-5; at Study Year 6 the mean change was 3.7 (11.8). Statistically significant associations were observed between parent trial treatment groups and change from baseline in PCS, MCS, and FACIT-Fatigue scores (p<0.01).

CONCLUSION: Long-term control of disease activity with belimumab plus SoC translates into meaningful improvements in patient-reported fatigue and HRQoL.