PMID- 29409143
OWN - NLM
STAT- MEDLINE
DCOM- 20190708
LR  - 20240327
IS  - 2326-5205 (Electronic)
IS  - 2326-5191 (Print)
IS  - 2326-5191 (Linking)
VI  - 70
IP  - 6
DP  - 2018 Jun
TI  - Long-Term Safety and Efficacy of Belimumab in Patients With Systemic Lupus 
      Erythematosus: A Continuation of a Seventy-Six-Week Phase III Parent Study in the 
      United States.
PG  - 868-877
LID - 10.1002/art.40439 [doi]
AB  - OBJECTIVE: We undertook this US multicenter continuation study (GlaxoSmithKline 
      study BEL112233; ClinicalTrials.gov identifier: NCT00724867) to assess long-term 
      safety and efficacy of belimumab in patients with systemic lupus erythematosus 
      (SLE) who completed the Study of Belimumab in Subjects with SLE 76-week trial 
      (ClinicalTrials.gov identifier: NCT00410384). METHODS: Patients continued to 
      receive the same belimumab dose plus standard therapy; patients previously 
      receiving placebo received 10 mg/kg belimumab. The primary outcome measure was 
      long-term safety of belimumab (frequency of adverse events [AEs] and damage 
      assessed using the Systemic Lupus International Collaborating Clinics/American 
      College of Rheumatology Damage Index [SDI], evaluated every 48 weeks [1 study 
      year]). Other assessments included the SLE Responder Index (SRI), flare rates 
      (using the modified SLE Flare Index [SFI]), prednisone use, and B cell levels. 
      RESULTS: Of 268 patients, 140 completed the study and 128 withdrew. The mean +/- SD 
      score on the Safety of Estrogens in Lupus Erythematosus National Assessment 
      version of the SLE Disease Activity Index (SELENA-SLEDAI) at baseline was 7.8 +/- 
      3.86. The mean +/- SD SDI score increased by 0.4 +/- 0.68 from its value at baseline 
      (1.2 +/- 1.51). The overall incidence of treatment-related and serious AEs remained 
      stable or declined through study year 7. An SRI response was achieved by 41.9% 
      and 75.6% of patients at the study year 1 and study year 7 midpoints, 
      respectively. At the study year 7 midpoint, relative to baseline, 78.2% had 
      achieved a >/=4-point reduction in the SELENA-SLEDAI score, 98.4% had no new 
      British Isles Lupus Assessment Group (BILAG) A organ domain score and no more 
      than 1 new BILAG B organ domain score, 93.7% had no worsening in the physician's 
      global assessment of disease activity, 20.6% had experienced >/=1 severe SFI flare, 
      the mean decrease in prednisone dose was 31.4%, and the median change in CD20+ B 
      cell numbers was -83.2%. CONCLUSION: These long-term exposure results confirm the 
      previously observed safety and efficacy profiles of belimumab in patients with 
      SLE.
CI  - (c) 2018 The Authors. Arthritis & Rheumatology published by Wiley Periodicals, Inc. 
      on behalf of American College of Rheumatology.
FAU - Furie, Richard A
AU  - Furie RA
AD  - Northwell Health, Great Neck, New York.
FAU - Wallace, Daniel J
AU  - Wallace DJ
AD  - Cedars-Sinai Medical Center, University of California, Los Angeles.
FAU - Aranow, Cynthia
AU  - Aranow C
AD  - The Feinstein Institute for Medical Research, Manhasset, New York.
FAU - Fettiplace, James
AU  - Fettiplace J
AD  - GlaxoSmithKline, Uxbridge, UK.
FAU - Wilson, Barbara
AU  - Wilson B
AD  - GlaxoSmithKline, Research Triangle Park, North Carolina.
FAU - Mistry, Prafull
AU  - Mistry P
AD  - GlaxoSmithKline, Stevenage, UK.
FAU - Roth, David A
AU  - Roth DA
AD  - GlaxoSmithKline, Philadelphia, Pennsylvania.
FAU - Gordon, David
AU  - Gordon D
AD  - GlaxoSmithKline, Philadelphia, Pennsylvania.
LA  - eng
SI  - ClinicalTrials.gov/NCT00724867
SI  - ClinicalTrials.gov/NCT00410384
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20180425
PL  - United States
TA  - Arthritis Rheumatol
JT  - Arthritis & rheumatology (Hoboken, N.J.)
JID - 101623795
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Immunosuppressive Agents)
RN  - 73B0K5S26A (belimumab)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal, Humanized/*administration & dosage
MH  - Female
MH  - Humans
MH  - Immunosuppressive Agents/*administration & dosage
MH  - Intention to Treat Analysis
MH  - Lupus Erythematosus, Systemic/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Quality of Life
MH  - Single-Blind Method
MH  - Time Factors
MH  - Treatment Outcome
MH  - United States
PMC - PMC6001779
EDAT- 2018/02/07 06:00
MHDA- 2019/07/10 06:00
PMCR- 2018/06/14
CRDT- 2018/02/07 06:00
PHST- 2016/09/22 00:00 [received]
PHST- 2018/01/30 00:00 [accepted]
PHST- 2018/02/07 06:00 [pubmed]
PHST- 2019/07/10 06:00 [medline]
PHST- 2018/02/07 06:00 [entrez]
PHST- 2018/06/14 00:00 [pmc-release]
AID - ART40439 [pii]
AID - 10.1002/art.40439 [doi]
PST - ppublish
SO  - Arthritis Rheumatol. 2018 Jun;70(6):868-877. doi: 10.1002/art.40439. Epub 2018 
      Apr 25.