PMID- 30320964
OWN - NLM
STAT- MEDLINE
DCOM- 20200224
LR  - 20200309
IS  - 2151-4658 (Electronic)
IS  - 2151-464X (Print)
IS  - 2151-464X (Linking)
VI  - 71
IP  - 6
DP  - 2019 Jun
TI  - Long-Term Impact of Belimumab on Health-Related Quality of Life and Fatigue in 
      Patients With Systemic Lupus Erythematosus: Six Years of Treatment.
PG  - 829-838
LID - 10.1002/acr.23788 [doi]
AB  - 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.
CI  - (c) 2018, GSK. Arthritis Care & Research published by Wiley Periodicals, Inc. on 
      behalf of American College of Rheumatology.
FAU - Strand, Vibeke
AU  - Strand V
AD  - Stanford University School of Medicine, Palo Alto, California.
FAU - Berry, Pamela
AU  - Berry P
AD  - GlaxoSmithKline, Philadelphia, Pennsylvania.
FAU - Lin, Xiwu
AU  - Lin X
AD  - GlaxoSmithKline, Philadelphia, Pennsylvania.
FAU - Asukai, Yumi
AU  - Asukai Y
AD  - GlaxoSmithKline, Uxbridge, Middlesex, UK.
FAU - Punwaney, Rajesh
AU  - Punwaney R
AD  - GlaxoSmithKline, King of Prussia, Pennsylvania.
FAU - Ramachandran, Sulabha
AU  - Ramachandran S
AD  - GlaxoSmithKline, Philadelphia, Pennsylvania.
LA  - eng
SI  - ClinicalTrials.gov/NCT00724867
GR  - Human Genome Sciences/International
GR  - GlaxoSmithKline/International
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20190429
PL  - United States
TA  - Arthritis Care Res (Hoboken)
JT  - Arthritis care & research
JID - 101518086
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Immunosuppressive Agents)
RN  - 73B0K5S26A (belimumab)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal, Humanized/adverse effects/*therapeutic use
MH  - Fatigue/diagnosis/*drug therapy/immunology/psychology
MH  - Female
MH  - Humans
MH  - Immunosuppressive Agents/adverse effects/*therapeutic use
MH  - Lupus Erythematosus, Systemic/diagnosis/*drug therapy/immunology/psychology
MH  - Male
MH  - Middle Aged
MH  - *Quality of Life
MH  - Time Factors
MH  - Treatment Outcome
MH  - United States
PMC - PMC6593666
EDAT- 2018/10/16 06:00
MHDA- 2020/02/25 06:00
PMCR- 2019/06/26
CRDT- 2018/10/16 06:00
PHST- 2018/03/16 00:00 [received]
PHST- 2018/10/09 00:00 [accepted]
PHST- 2018/10/16 06:00 [pubmed]
PHST- 2020/02/25 06:00 [medline]
PHST- 2018/10/16 06:00 [entrez]
PHST- 2019/06/26 00:00 [pmc-release]
AID - ACR23788 [pii]
AID - 10.1002/acr.23788 [doi]
PST - ppublish
SO  - Arthritis Care Res (Hoboken). 2019 Jun;71(6):829-838. doi: 10.1002/acr.23788. 
      Epub 2019 Apr 29.