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Long‐Term Impact of Belimumab on Health‐Related Quality of Life and Fatigue in Patients With Systemic Lupus Erythematosus: Six Years of Treatment
Author(s) -
Strand Vibeke,
Berry Pamela,
Lin Xiwu,
Asukai Yumi,
Punwaney Rajesh,
Ramachandran Sulabha
Publication year - 2019
Publication title -
arthritis care and research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.032
H-Index - 163
eISSN - 2151-4658
pISSN - 2151-464X
DOI - 10.1002/acr.23788
Subject(s) - belimumab , medicine , quality of life (healthcare) , placebo , minimal clinically important difference , physical therapy , post hoc analysis , adverse effect , randomized controlled trial , b cell activating factor , immunology , alternative medicine , nursing , b cell , pathology , antibody
Objective To report long‐term health‐related quality of life ( HRQ oL) 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 ( BEL 112233 [ClinicalTrials.gov identifier: NCT 00724867]). 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. HRQ oL 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 ( BEL 206350) assessed clinical characteristics associated with improved HRQ oL and fatigue. Results Of the 268 patients enrolled, 140 completed the study. Patients receiving long‐term belimumab treatment reported continued improvements in HRQ oL 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 HRQ oL.