PMID- 26936891
OWN - NLM
STAT- MEDLINE
DCOM- 20170321
LR  - 20181113
IS  - 1477-0962 (Electronic)
IS  - 0961-2033 (Print)
IS  - 0961-2033 (Linking)
VI  - 25
IP  - 7
DP  - 2016 Jun
TI  - Long-term organ damage accrual and safety in patients with SLE treated with 
      belimumab plus standard of care.
PG  - 699-709
LID - 10.1177/0961203315625119 [doi]
AB  - OBJECTIVE: To examine long-term organ damage and safety following treatment with 
      belimumab plus standard of care (SoC) in patients with systemic lupus 
      erythematosus (SLE). METHODS: Pooled data were examined from two ongoing 
      open-label studies that enrolled patients who completed BLISS-52 or BLISS-76. 
      Patients received belimumab every four weeks plus SoC. SLICC Damage Index (SDI) 
      values were assessed every 48 weeks (study years) following belimumab initiation 
      (baseline). The primary endpoint was change in SDI from baseline at study years 
      5-6. Incidences of adverse events (AEs) were reported for the entire study 
      period. RESULTS: The modified intent-to-treat (MITT) population comprised 998 
      patients. At baseline, 940 (94.2%) were female, mean (SD) age was 38.7 (11.49) 
      years, and disease duration was 6.7 (6.24) years. The mean (SD) SELENA-SLEDAI and 
      SDI scores were 8.2 (4.18) and 0.7 (1.19), respectively; 411 (41.2%) patients had 
      organ damage (SDI = 1: 235 (23.5%); SDI >/= 2: 176 (17.6%)) prior to belimumab. A 
      total of 427 (42.8%) patients withdrew overall; the most common reasons were 
      patient request (16.8%) and AEs (8.5%).The mean (SD) change in SDI was +0.2 
      (0.48) at study years 5-6 (n = 403); 343 (85.1%) patients had no change from 
      baseline in SDI score (SDI +1: 46 (11.4%), SDI +2: 13 (3.2%), SDI +3: 1 (0.2%)). 
      Of patients without organ damage at baseline, 211/241 (87.6%) had no change in 
      SDI and the mean change (SD) in SDI was +0.2 (0.44). Of patients with organ 
      damage at baseline, 132/162 (81.5%) had no change in SDI and the mean (SD) change 
      in SDI was +0.2 (0.53). The probability of not having a worsening in SDI score 
      was 0.88 (95% CI: 0.85, 0.91) and 0.75 (0.67, 0.81) in those without and with 
      baseline damage, respectively (post hoc analysis).Drug-related AEs were reported 
      for 433 (43.4%) patients; infections/infestations (282, 28.3%) and 
      gastrointestinal disorders (139, 13.9%) were the most common. CONCLUSION: 
      Patients with SLE treated with long-term belimumab plus SoC had a low incidence 
      of organ damage accrual and no unexpected AEs. High-risk patients with 
      pre-existing organ damage also had low accrual, suggesting a favorable effect on 
      future damage development.
CI  - (c) The Author(s) 2016.
FAU - Bruce, I N
AU  - Bruce IN
AD  - Arthritis Research UK Centre for Epidemiology, Centre for Musculoskeletal 
      Research, Institute for Inflammation and Repair, University of Manchester, 
      Manchester Academic Health Sciences Centre, Manchester, UK The Kellgren Centre 
      for Rheumatology, NIHR Manchester Musculoskeletal Biomedical Research Unit, 
      Central Manchester University Hospitals NHS Foundation Trust, Manchester Academic 
      Health Science Centre, Manchester, UK ian.bruce@manchester.ac.uk.
FAU - Urowitz, M
AU  - Urowitz M
AD  - University of Toronto and Toronto Western Hospital, Toronto, ON, Canada.
FAU - van Vollenhoven, R
AU  - van Vollenhoven R
AD  - Karolinska Institute, Stockholm, Sweden.
FAU - Aranow, C
AU  - Aranow C
AD  - The Feinstein Institute for Medical Research, Manhasset, NY, USA.
FAU - Fettiplace, J
AU  - Fettiplace J
AD  - GSK, Uxbridge, Middlesex, UK.
FAU - Oldham, M
AU  - Oldham M
AD  - GSK, Stevenage, Hertfordshire, UK.
FAU - Wilson, B
AU  - Wilson B
AD  - GSK, Research Triangle Park, NC, USA.
FAU - Molta, C
AU  - Molta C
AD  - GSK, Philadelphia, PA, USA.
FAU - Roth, D
AU  - Roth D
AD  - GSK, Philadelphia, PA, USA.
FAU - Gordon, D
AU  - Gordon D
AD  - GSK, Philadelphia, PA, USA.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20160301
PL  - England
TA  - Lupus
JT  - Lupus
JID - 9204265
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Immunosuppressive Agents)
RN  - 73B0K5S26A (belimumab)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal, Humanized/*administration & dosage/adverse effects
MH  - Double-Blind Method
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology
MH  - Female
MH  - Gastrointestinal Diseases/chemically induced
MH  - Humans
MH  - Immunosuppressive Agents/*administration & dosage/adverse effects
MH  - Lupus Erythematosus, Systemic/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Severity of Illness Index
MH  - Standard of Care
MH  - Treatment Outcome
PMC - PMC4958991
OTO - NOTNLM
OT  - Systemic lupus erythematosus
OT  - organ damage
OT  - safety
EDAT- 2016/03/05 06:00
MHDA- 2017/03/23 06:00
PMCR- 2016/07/25
CRDT- 2016/03/04 06:00
PHST- 2015/08/25 00:00 [received]
PHST- 2015/12/01 00:00 [accepted]
PHST- 2016/03/04 06:00 [entrez]
PHST- 2016/03/05 06:00 [pubmed]
PHST- 2017/03/23 06:00 [medline]
PHST- 2016/07/25 00:00 [pmc-release]
AID - 0961203315625119 [pii]
AID - 10.1177_0961203315625119 [pii]
AID - 10.1177/0961203315625119 [doi]
PST - ppublish
SO  - Lupus. 2016 Jun;25(7):699-709. doi: 10.1177/0961203315625119. Epub 2016 Mar 1.