title: Response to belimumab among patients with systemic lupus erythematosus in clinical practice settings: 24-month results from the OBSErve study in the USA.
abstract: OBJECTIVE
  To examine disease activity and clinical outcomes, and describe overall patterns of systemic lupus erythematosus (SLE) care in patients who received belimumab in a real-world clinical setting.
  
  
  METHODS
  This observational cohort study was conducted in US clinical practices. Rheumatologists (n=92) identified adults with SLE who had received ≥8 infusions of belimumab plus standard of care (SoC). Physicians assessed disease outcomes at 6-month intervals using patient medical charts, for up to 24 months. The primary outcome was physician-assessed change in SLE disease. Other outcomes included change in steroid use, laboratory tests and healthcare resource utilisation (HCRU).
  
  
  RESULTS
  Of 501 patients (intent-to-treat population (ITT)), 446 were female, mean age was 43.3 years and 98% had moderate/severe disease activity at baseline (first dose of belimumab). Data for 277 patients who completed 24 months of belimumab treatment were available. Among the ITT, a ≥50% improvement in overall clinical response between baseline and month 6 was reported for 48.7% of patients; continued improvement was seen at all subsequent 6-month intervals relative to the previous timepoint. The percentage of patients with moderate/severe disease also decreased at each timepoint. At baseline, 77.0% of patients received steroids at a mean (SD) prednisone equivalent dose of 19.9 (14.39) mg/day, which decreased to 8.4 (7.35) mg/day at month 6 and 6.1 (9.31) mg/day at month 24. Abnormal laboratory values typically associated with SLE also demonstrated improvements at month 6, which continued through 24 months. HCRU decreased over the duration of the study.
  
  
  CONCLUSIONS
  Patients with SLE who received belimumab plus SoC for up to 24 months demonstrated improvements in disease severity and laboratory values and a reduction in steroid use and HCRU as early as month 6. Improvements continued through 24 months, providing evidence of reduced disease activity among patients taking belimumab in real-world clinical practice.
authors.affiliation: MedStar Washington Hospital Center , Washington DC , USA.
authors.forename: C E
authors.initials: CE
authors.lastname: Collins
authors.affiliation: University of California , San Francisco, California , USA.
authors.forename: M
authors.initials: M
authors.lastname: Dall'Era
authors.affiliation: GlaxoSmithKline, Research Triangle Park, North Carolina , USA.
authors.forename: H
authors.initials: H
authors.lastname: Kan
authors.affiliation: Medical Data Analytics , Parsippany, New Jersey , USA.
authors.forename: C
authors.initials: C
authors.lastname: Macahilig
authors.affiliation: GlaxoSmithKline , Philadelphia, Pennsylvania , USA.
authors.forename: C
authors.initials: C
authors.lastname: Molta
authors.affiliation: GlaxoSmithKline , Middlesex, Uxbridge , UK.
authors.forename: V
authors.initials: V
authors.lastname: Koscielny
authors.affiliation: GlaxoSmithKline , Philadelphia, Pennsylvania , USA.
authors.forename: D J
authors.initials: DJ
authors.lastname: Chang
keywords: Belimumab; Biologics; Real-world effectiveness; Systemic Lupus Erythematosus
references.citation: Lancet. 2011 Feb 26;377(9767):721-31
references.pmid: 21296403
references.citation: Lupus. 2013 Jan;22(1):63-72
references.pmid: 23263865
references.citation: N Engl J Med. 1993 Dec 30;329(27):2029-32
references.pmid: 8018139
references.citation: Arthritis Rheum. 2011 Dec;63(12):3918-30
references.pmid: 22127708
references.citation: Arthritis Rheum. 2003 Nov;48(11):3253-65
references.pmid: 14613291
references.citation: J Am Soc Nephrol. 1999 Feb;10(2):413-24
references.pmid: 10215343
references.citation: Ann Rheum Dis. 2012 Aug;71(8):1343-9
references.pmid: 22337213
references.citation: Arthritis Rheum. 2000 Aug;43(8):1801-8
references.pmid: 10943870
references.citation: Lupus. 2001;10(3):140-7
references.pmid: 11315342