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OP0186 5-Year Organ Damage Accrual and Safety in Patients with Sle Treated with Belimumab Plus Standard of Care
  1. I.N. Bruce1,
  2. M. Urowitz2,
  3. R. van Vollenhoven3,
  4. C. Aranow4,
  5. J. Fettiplace5,
  6. M. Oldham6,
  7. E. Menius7,
  8. B. Wilson8,
  9. C. Molta9,
  10. D. Roth9,
  11. D. Gordon9
  1. 1The University of Manchester, Manchester, United Kingdom
  2. 2University of Toronto and Toronto Western Hospital, Toronto, Canada
  3. 3Karolinska Institute, Stockholm, Switzerland
  4. 4The Feinstein Institute for Medical Research, Manhasset, United States
  5. 5GSK, Uxbridge
  6. 6GSK, Stevenage, United Kingdom
  7. 7The Feinstein Institute for Medical Research
  8. 8GSK, Research Triangle Park
  9. 9GSK, Philadelphia, United States

Abstract

Background Systemic lupus erythematosus (SLE) is a chronic relapsing and remitting condition in which long-term damage can accrue over time.

Objectives To examine long-term organ damage and safety following 5 years of treatment with belimumab plus standard of care (SoC) in patients with SLE.

Methods We examined pooled interim data (GSK201223) from two open-label studies that enrolled patients who completed the BLISS-52 and BLISS-76 studies. Patients received belimumab plus SoC every 4 weeks. Baseline was defined as prior to the first dose of belimumab. SLICC Damage Index (SDI) values were assessed every 48 weeks (yearly interval).

Results 998 patients comprised the modified intent-to-treat population at baseline: 940 (94.2%) were female, with a mean (SD) age of 38.7 (11.49) years and disease duration of 6.69 (6.24) years. The mean (SD) SELENA-SLEDAI and SDI were 8.2 (4.18) and 0.7 (1.19), respectively. Reasons for study withdrawal included: subject request (16.8%), AEs (8.5%), other (7.0%), and investigator decision (4.8%). 411 (41.2%) patients had damage at baseline (SDI =1: 235 [23.5%]; SDI ≥2: 176 [17.6%]).

At 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%]). The mean (SD) change in SDI was +0.19 (0.481). Of patients with damage at baseline, 132/162 (81.5%) had no change in SDI (SDI +1: 22/162 [13.6%], SDI +2: 8/162 [4.9%], SDI +3: 0/162 [0%]), mean (SD) change in SDI was +0.23 (0.529). Of patients without baseline damage, 211/241 (87.6%) had no change in SDI (SDI +1: 24/241 [10.0%], SDI +2: 5/241 [2.1%], SDI +3: 1/241 [0.4%]), mean change (SD) in SDI was +0.15 (0.444).

Overall, 433 (43.4%) of patients had a drug-related AE. The most common drug-related AEs were infections/infestations, 282 (28%) patients, and gastrointestinal disorders, 139 (14%) patients. 23 (2%) patients had an adjudicated opportunistic infection (OI); 4 (0.4%) patients had a serious OI. 87 (8.7%) patients had herpes zoster. 88 (8.8%) patients had an AE causing belimumab discontinuation. 11 deaths occurred during the study period; 2 deaths occurred after study exit.

Conclusions Patients with moderate to severe SLE treated with belimumab plus SoC for 5 years had a low incidence of organ damage accrual and clinically manageable rates of AEs. Importantly, patients with pre-existing organ damage at study entry experienced similar rates of damage accrual compared with those with no baseline damage. As existing damage is a known risk for future damage accrual, our data suggest that belimumab may have a positive effect on risk factors for future damage that requires further evaluation.

Acknowledgements Studies funded by GlaxoSmithKline (study #201223) and Human Genome Sciences. Louisa Pettinger, PhD, Fishawack Indicia Ltd, UK, assisted with the abstract submission and was funded by GSK.

Disclosure of Interest I. Bruce Grant/research support from: UCB, GSK, Roche, Sanofi, Consultant for: UCB, Eli Lilly, GSK, Medimmune, Pfizer, Employee of: University of Manchester, Speakers bureau: UCB, GSK, Medimmune, M. Urowitz Grant/research support from: GSK, UCB, Eli Lilly, Consultant for: GSK, UCB, Eli Lilly, R. van Vollenhoven Grant/research support from: AbbVie, BMS, GSK, Pfizer, Roche, UCB, Consultant for: AbbVie, Biotest, BMS, Crescendo, Eli Lilly, GSK, Janssen, Merck, Pfizer, Roche, UCB, Vertex, C. Aranow Grant/research support from: GSK, UCB, Eli Lilly, Celgene, Janssen, Consultant for: GSK, UCB, Eli Lilly, Celgene, Janssen, J. Fettiplace Shareholder of: GSK, Employee of: GSK, M. Oldham Shareholder of: GSK, Employee of: GSK, E. Menius Shareholder of: GSK, Employee of: GSK, B. Wilson Shareholder of: GSK, Employee of: GSK, C. Molta Shareholder of: GSK, Employee of: GSK, D. Roth Shareholder of: GSK, Employee of: GSK, D. Gordon Shareholder of: GSK, Employee of: GSK

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