PMID- 28118533
OWN - NLM
STAT- MEDLINE
DCOM- 20170814
LR  - 20220330
IS  - 2326-5205 (Electronic)
IS  - 2326-5191 (Print)
IS  - 2326-5191 (Linking)
VI  - 69
IP  - 5
DP  - 2017 May
TI  - Efficacy and Safety of Subcutaneous Belimumab in Systemic Lupus Erythematosus: A 
      Fifty-Two-Week Randomized, Double-Blind, Placebo-Controlled Study.
PG  - 1016-1027
LID - 10.1002/art.40049 [doi]
AB  - OBJECTIVE: To assess the efficacy and safety of subcutaneous (SC) belimumab in 
      patients with systemic lupus erythematosus (SLE). METHODS: Patients with 
      moderate-to-severe SLE (score of >/=8 on the Safety of Estrogens in Lupus 
      Erythematosus National Assessment [SELENA] version of the SLE Disease Activity 
      Index [SLEDAI]) were randomized 2:1 to receive weekly SC belimumab 200 mg or 
      placebo by prefilled syringe in addition to standard SLE therapy for 52 weeks. 
      The primary end point was the SLE Responder Index (SRI4) at week 52. Secondary 
      end points were reduction in the corticosteroid dosage and time to severe flare. 
      Safety was assessed according to the adverse events (AEs) reported and the 
      laboratory test results. RESULTS: Of 839 patients randomized, 836 (556 in the 
      belimumab group and 280 in the placebo group) received treatment. A total of 159 
      patients withdrew before the end of the study. At entry, mean SELENA-SLEDAI 
      scores were 10.5 in the belimumab group and 10.3 in the placebo group. More 
      patients who received belimumab were SRI4 responders than those who received 
      placebo (61.4% versus 48.4%; odds ratio [OR] 1.68 [95% confidence interval (95% 
      CI) 1.25-2.25]; P = 0.0006). In the belimumab group, both time to and risk of 
      severe flare were improved (median 171.0 days versus 118.0 days; hazard ratio 
      0.51 [95% CI 0.35-0.74]; P = 0.0004), and more patients were able to reduce their 
      corticosteroid dosage by >/=25% (to </=7.5 mg/day) during weeks 40-52 (18.2% versus 
      11.9%; OR 1.65 [95% CI 0.95-2.84]; P = 0.0732), compared with placebo. AE 
      incidence was comparable between treatment groups; serious AEs were reported by 
      10.8% of patients taking belimumab and 15.7% of those taking placebo. A worsening 
      of IgG hypoglobulinemia by >/=2 grades occurred in 0.9% of patients taking 
      belimumab and 1.4% of those taking placebo. CONCLUSION: In patients with 
      moderate-to-severe SLE, weekly SC doses of belimumab 200 mg plus standard SLE 
      therapy significantly improved their SRI4 response, decreased severe disease 
      flares as compared with placebo, and had a safety profile similar to placebo plus 
      standard SLE therapy.
CI  - (c) 2017 The Authors. Arthritis & Rheumatology published by Wiley Periodicals, Inc. 
      on behalf of American College of Rheumatology.
FAU - Stohl, William
AU  - Stohl W
AD  - University of Southern California, Los Angeles.
FAU - Schwarting, Andreas
AU  - Schwarting A
AD  - Acura Kliniken Rheinland-Pfalz AG, Bad Kreuznach, Germany.
FAU - Okada, Masato
AU  - Okada M
AD  - St. Luke's International Hospital, Tokyo, Japan.
FAU - Scheinberg, Morton
AU  - Scheinberg M
AD  - Rheumatology Hospital Abreu Sodre, Sao Paulo, Brazil.
FAU - Doria, Andrea
AU  - Doria A
AD  - University of Padua, Padua, Italy.
FAU - Hammer, Anne E
AU  - Hammer AE
AD  - GlaxoSmithKline, Research Triangle Park, North Carolina.
FAU - Kleoudis, Christi
AU  - Kleoudis C
AD  - Parexel, Raleigh-Durham, North Carolina.
FAU - Groark, James
AU  - Groark J
AD  - GlaxoSmithKline, Philadelphia, Pennsylvania.
FAU - Bass, Damon
AU  - Bass D
AD  - GlaxoSmithKline, Philadelphia, Pennsylvania.
FAU - Fox, Norma Lynn
AU  - Fox NL
AD  - GlaxoSmithKline, Rockville, Maryland.
FAU - Roth, David
AU  - Roth D
AD  - GlaxoSmithKline, Philadelphia, Pennsylvania.
FAU - Gordon, David
AU  - Gordon D
AD  - GlaxoSmithKline, Philadelphia, Pennsylvania.
LA  - eng
SI  - ClinicalTrials.gov/NCT01484496
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20170407
PL  - United States
TA  - Arthritis Rheumatol
JT  - Arthritis & rheumatology (Hoboken, N.J.)
JID - 101623795
RN  - 0 (Adrenal Cortex Hormones)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Immunoglobulin G)
RN  - 0 (Immunosuppressive Agents)
RN  - 73B0K5S26A (belimumab)
SB  - IM
MH  - Adrenal Cortex Hormones/administration & dosage
MH  - Adult
MH  - Antibodies, Monoclonal, Humanized/*therapeutic use
MH  - Disease Progression
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Immunoglobulin G/immunology
MH  - Immunologic Deficiency Syndromes/chemically induced/immunology
MH  - Immunosuppressive Agents/*therapeutic use
MH  - Infusions, Subcutaneous
MH  - Lupus Erythematosus, Systemic/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Odds Ratio
MH  - Proportional Hazards Models
MH  - Severity of Illness Index
MH  - Therapeutics
MH  - Treatment Outcome
PMC - PMC5434872
EDAT- 2017/01/25 06:00
MHDA- 2017/08/15 06:00
PMCR- 2017/05/17
CRDT- 2017/01/25 06:00
PHST- 2016/05/23 00:00 [received]
PHST- 2017/01/12 00:00 [accepted]
PHST- 2017/01/25 06:00 [pubmed]
PHST- 2017/08/15 06:00 [medline]
PHST- 2017/01/25 06:00 [entrez]
PHST- 2017/05/17 00:00 [pmc-release]
AID - ART40049 [pii]
AID - 10.1002/art.40049 [doi]
PST - ppublish
SO  - Arthritis Rheumatol. 2017 May;69(5):1016-1027. doi: 10.1002/art.40049. Epub 2017 
      Apr 7.