Long‐Term Impact of Belimumab on Health‐Related Quality of Life and Fatigue in Patients With Systemic Lupus Erythematosus: Six Years of Treatment

Abstract

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 Study of Belimumab in Subjects with SLE 76‐week trial (BLISS‐76) were enrolled in this continuation study (BEL112233 [ClinicalTrials.gov identifier: NCT00724867]). The belimumab groups continued to receive the same dose (1 mg/kg or 10 mg/kg) intravenously. After March 2011, all patients received belimumab 10 mg/kg every 28 days plus standard therapy. The placebo group switched to belimumab 10 mg/kg. HRQoL and fatigue assessments included the Short Form 36 (SF‐36) health survey and the Functional Assessment of Chronic Illness Therapy (FACIT)–Fatigue subscale. Post hoc subgroup analyses (BEL206350) assessed clinical characteristics associated with improved HRQoL and fatigue. Results Of the 268 patients enrolled, 140 completed the study. Patients receiving long‐term belimumab treatment reported continued improvements in HRQoL and fatigue. At study year 6, the mean ± SD SF‐36 physical component summary (PCS) score and the mental component summary (MCS) score increased from 37.0 ± 9.9 at baseline to 41.7 ± 10.0 (mean ± SD change 4.8 ± 9.4) and from 44.3 ± 11.3 to 47.0 ± 11.6 (mean ± SD change 2.7 ± 11.3) for the PCS and MCS, respectively, exceeding the minimum clinically important difference (MCID) for improvement (2.5 units). The mean ± SD FACIT–Fatigue score exceeded the MCID of 4 at study years 1–5; at study year 6, the mean ± SD 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 SLE disease activity with belimumab plus standard therapy translates into meaningful improvements in patient‐reported fatigue and HRQoL.

Treating systemic lupus erythematosus in the 21st century: new drugs and new perspectives on old drugs

“…Clinical response rates [defined according to the 4-point Systemic Lupus Erythematosus Responder Index (SRI-4) composite index] were 50.6% in belimumab-treated vs 38.6% in placebo-treated patients, and the respective frequencies of a low disease activity state were 13.4% vs 6.8% [ 73 ]. Importantly, the addition of belimumab led to a significant reduction of severe flares, lower cumulative exposure to GCs [ 74 ], lower accrual of irreversible organ damage [ 75 , 76 ] and improved health-related quality of life [ 77 ], which are all important aspects in the treating-to-target context [ 78 ]. These effects are maintained or even enhanced during prolonged use of the drug, although disease exacerbations can occur [ 79 , 80 ].…”

The patient’s perspective: are quality of life and disease burden a possible treatment target in systemic lupus erythematosus?

“…A similar improvement of fatigue was reported by data analysing the effect of subcutaneous blisibimod and sifalimumab [ 40 , 41 ]. Six-year follow-up data for belimumab confirmed the positive effect on QoL and fatigue, but exhibited clearly the significant effect on the physical component of SF-36 [ 42 ].…”

The problem of fatigue in patients with systemic lupus erythematosus according to the data on a Russian RENAISSANCE cohort

“…Ухудшение КЖСЗ по всем шкалам опросника значимо коррелировало с усталостью (r от -0,50 до -0,82). Существенное ухудшение КЖСЗ у пациентов с СКВ на фоне усталости отмечено и другими авторами [9,[21][22][23]. У пациентов в нашем исследовании снижение КЖСЗ в большей степени повлияло на шкалы «Физическое здоровье», «Планирование», «Зависимость от других людей», «Эмоциональное здоровье» и «Образ тела».…”

“…Она характерна для многих хронических заболеваний -ревматических, инфекционных, неврологических, психических и онкологических. Усталость при СКВ имеет важные последствия для повседневной деятельности и существенно ухудшает качество жизни, связанное со здоровьем (КЖСЗ) [6][7][8][9]. К.…”

“…Усталость может существенно ухудшать повседневную жизнь больных СКВ. Она связана с нарушениями сна, болью, депрессией и тревогой [1][2][3][4][5][6][7][8][9][10].…”