Belimumab on health-related quality of life and fatigue in patients with systemic lupus erythematosus: 6 years of treatment
A study has reported long-term health-related quality of life ( HRQoL ) and fatigue outcomes in patients with systemic lupus erythematosus ( SLE ) receiving Belimumab ( Belysta ).
Patients with systemic lupus erythematosus who completed the BLISS-76 trial were enrolled into continuation study ( BEL112233 ).
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.
268 patients were enrolled; 140 completed the study.
Patients receiving long-term Belimumab reported continued improvements in HRQoL and fatigue.
At Study Year 6, mean Physical Component Summary ( PCS ) and Mental Component Summary ( MCS ) SF-36 scores increased from baseline 37.0 to 41.7 ( 10.0; mean change, 4.8 ) for PCS and from 44.3 to 47.0 ( 11.6; mean change, 2.7 ) for MCS, exceeding the minimum clinically important difference ( MCID ) for improvement ( 2.5 units ).
Mean FACIT-Fatigue score exceeded the MCID of 4 at Study Years 1-5; at Study Year 6 the mean change was 3.7.
Statistically significant associations were observed between parent trial treatment groups and change from baseline in PCS, MCS, and FACIT-Fatigue scores ( p less than 0.01 ).
In conclusion, long-term control of disease activity with Belimumab plus standard of care translates into meaningful improvements in patient-reported fatigue and HRQoL. ( Xagena )
Strand V et al, Arthritis Care Res 2018; Epub ahead of print
XagenaMedicine_2018