title: Efficacy and safety of tabalumab plus standard of care in Japanese patients with active systemic lupus erythematosus: Subgroup analyses of the ILLUMINATE-1 study.
abstract: OBJECTIVE
  To assess the efficacy and safety of tabalumab, an anti-B cell activating factor (BAFF) antibody, in combination with standard of care (SoC) therapy in Japanese patients with active systemic lupus erythematosus (SLE).
  
  
  METHODS
  A subgroup analysis was conducted in Japanese patients (n = 45) enrolled in ILLUMINATE-1, a phase III global trial in SLE patients (N = 1164). Patients received SoC plus tabalumab or placebo, starting with a loading dose (240 mg) at week 0, followed by 120 mg every 4 weeks (120 Q4W, n = 15), 120 mg every 2 weeks (120 Q2W, n = 15), or placebo Q2W (n = 15). The primary endpoint was proportion achieving SLE Responder Index-5 (SRI-5) improvement at week 52.
  
  
  RESULTS
  A numerically greater SRI-5 response rate was achieved with 120 Q2W (46.7%; p = 0.059 vs. placebo) compared with 120 Q4W (20.0%) and placebo Q2W (13.3%). The proportion of patients with severe SLE flare was lower for 120 Q2W (0%) and 120 Q4W (6.7%) than for placebo (26.7%). The rates of serious adverse events (AEs) and treatment-emergent AEs were similar across treatments.
  
  
  CONCLUSIONS
  In Japanese SLE patients, tabalumab 120 Q2W improved SRI-5 response rate and reduced the frequency of severe flares compared with placebo. Safety profiles were similar with tabalumab and placebo.
authors.affiliation: a The First Department of Internal Medicine , School of Medicine, University of Occupational and Environmental Health , Kitakyushu , Japan.
authors.forename: Yoshiya
authors.initials: Y
authors.lastname: Tanaka
authors.affiliation: b Division of Rheumatology, Department of Internal Medicine , Keio University School of Medicine , Tokyo , Japan.
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Takeuchi
authors.affiliation: c Eli Lilly Japan K.K. , Kobe , Japan , and.
authors.forename: Naotsugu
authors.initials: N
authors.lastname: Akashi
authors.affiliation: c Eli Lilly Japan K.K. , Kobe , Japan , and.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Takita
authors.affiliation: d Eli Lilly and Company , Indianapolis , IN , USA.
authors.forename: Birgit
authors.initials: B
authors.lastname: Kovacs
authors.affiliation: c Eli Lilly Japan K.K. , Kobe , Japan , and.
authors.forename: Sawako
authors.initials: S
authors.lastname: Kariyasu
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D005260:Female; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D059039:Standard of Care
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C575974:tabalumab
keywords: BAFF; Japanese; SRI; Safety; Systemic lupus erythematosus