PMID- 29807477
OWN - NLM
STAT- MEDLINE
DCOM- 20181211
LR  - 20220408
IS  - 1477-0962 (Electronic)
IS  - 0961-2033 (Print)
IS  - 0961-2033 (Linking)
VI  - 27
IP  - 9
DP  - 2018 Aug
TI  - A 6-month open-label extension study of the safety and efficacy of subcutaneous 
      belimumab in patients with systemic lupus erythematosus.
PG  - 1489-1498
LID - 10.1177/0961203318777634 [doi]
AB  - Objective To evaluate the safety, tolerability and efficacy of subcutaneous (SC) 
      belimumab in patients with systemic lupus erythematosus (SLE) beyond 1 year. 
      Methods This was a 24-week, open-label extension following a 52-week, 
      double-blind, placebo-controlled trial of belimumab SC. Patients who completed 
      the double-blind phase were eligible to enter the open-label phase. All patients 
      received weekly belimumab 200 mg SC plus standard SLE therapy. Outcome measures 
      included safety and efficacy (SLE Response Index (SRI) and SLE Flare Index (SFI) 
      rates), and changes in biomarker and B cell levels. Results Of 677 patients who 
      completed the 52-week, double-blind phase, 662 entered the open-label phase; 206 
      had previously received placebo and 456 had previously received belimumab. 
      Despite differences in total belimumab exposure (24 weeks in the 
      placebo-to-belimumab group versus 76 weeks in the belimumab group), the 
      proportions of patients experiencing more than one adverse event (AE) or a 
      serious AE in the open-label phase were similar between groups 
      (placebo-to-belimumab: 51.5 and 6.8%; belimumab: 48.2 and 5.5%, respectively). 
      Most AEs were mild/moderate in severity. Efficacy was maintained through the 
      extension phase. An SRI response was achieved by 16.1% of patients in the 
      placebo-to-belimumab group and 76.3% patients in the belimumab group. 
      Furthermore, 1.0% of patients in the placebo-to-belimumab group and 2.6% of 
      patients in the belimumab group experienced a severe SFI flare. Conclusion 
      Belimumab SC was well tolerated and efficacy was maintained during the extension 
      phase of this study. The safety profile of belimumab SC is consistent with that 
      of previous experience with belimumab. Trial registration ClinicalTrials.gov 
      identifier: NCT01484496.
FAU - Doria, A
AU  - Doria A
AD  - 1 Rheumatology Unit, Department of Medicine, University of Padova, Padua, Italy.
FAU - Bass, D
AU  - Bass D
AD  - 2 GlaxoSmithKline R&D, Philadelphia, PA, USA.
FAU - Schwarting, A
AU  - Schwarting A
AD  - 3 Division of Rheumatology, University Hospital Mainz, Mainz, Germany.
AD  - 4 ACURA Rheumazentrum Kliniken, Bad Kreuznach, Germany.
FAU - Hammer, A
AU  - Hammer A
AD  - 2 GlaxoSmithKline R&D, Philadelphia, PA, USA.
FAU - Gordon, D
AU  - Gordon D
AD  - 2 GlaxoSmithKline R&D, Philadelphia, PA, USA.
FAU - Scheinberg, M
AU  - Scheinberg M
AD  - 5 Centro de Pesquisas Clinicas do Hospital Abreu Sodre, Sao Paulo, Brazil.
FAU - Fox, N L
AU  - Fox NL
AD  - 6 GlaxoSmithKline R&D, Rockville, MD, USA.
FAU - Groark, J
AU  - Groark J
AD  - 2 GlaxoSmithKline R&D, Philadelphia, PA, USA.
FAU - Stohl, W
AU  - Stohl W
AD  - 7 Division of Rheumatology, University of Southern California Keck School of 
      Medicine, Los Angeles, CA, USA.
FAU - Kleoudis, C
AU  - Kleoudis C
AD  - 8 Parexel Clinical Research, Raleigh-Durham, NC, USA.
FAU - Roth, D
AU  - Roth D
AD  - 2 GlaxoSmithKline R&D, Philadelphia, PA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01484496
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20180528
PL  - England
TA  - Lupus
JT  - Lupus
JID - 9204265
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Biomarkers)
RN  - 0 (Glucocorticoids)
RN  - 0 (Immunosuppressive Agents)
RN  - 73B0K5S26A (belimumab)
RN  - VB0R961HZT (Prednisone)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal, Humanized/*administration & dosage/adverse effects
MH  - Biomarkers/blood
MH  - Double-Blind Method
MH  - Female
MH  - Glucocorticoids/administration & dosage
MH  - Humans
MH  - Immunosuppressive Agents/*administration & dosage/adverse effects
MH  - Injections, Subcutaneous
MH  - Lupus Erythematosus, Systemic/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Prednisone/administration & dosage
MH  - Symptom Flare Up
MH  - Treatment Outcome
PMC - PMC6066857
OTO - NOTNLM
OT  - B-lymphocyte stimulator
OT  - Belimumab
OT  - SLE responder index
OT  - corticosteroids
OT  - open-label extension
OT  - subcutaneous
OT  - systemic lupus erythematosus
EDAT- 2018/05/29 06:00
MHDA- 2018/12/12 06:00
PMCR- 2018/07/31
CRDT- 2018/05/30 06:00
PHST- 2018/05/29 06:00 [pubmed]
PHST- 2018/12/12 06:00 [medline]
PHST- 2018/05/30 06:00 [entrez]
PHST- 2018/07/31 00:00 [pmc-release]
AID - 10.1177_0961203318777634 [pii]
AID - 10.1177/0961203318777634 [doi]
PST - ppublish
SO  - Lupus. 2018 Aug;27(9):1489-1498. doi: 10.1177/0961203318777634. Epub 2018 May 28.