Table 1

Data source and collection

Belimumab cohort (variables collected in the postmarketing surveillance study and some additional variables*)
Patient characteristics (at index)
  • Patient demographics and clinical characteristics

Disease activity (at index and months 12 and 36*†)

  • PGA score

  • Occurrence of SLE flares

  • SDI score

  • BILAG category A/B*†

Concomitant treatment (preindex (6±2 months prior to index), at index and afterwards until month 36 if changed during this period)
  • Corticosteroids

  • Immunosuppressants

  • Antimalarials (dosage and route of administration)*

  • ACE inhibitors*

  • Angiotensin receptor blockers*

  • Anticoagulants*

  • Non-steroidal anti-inflammatories*

Laboratory testing (preindex if available, at index and every month until month 36)
  • Anti-dsDNA Ab

  • C3/C4 and total complement activity (CH50)

  • uPCR (preindex if available, at index and monthly afterwards)

  • Urine sediment*

  • Renal biopsy (preindex and after index if records existed)*

  • Dialysis/transplant (if records existed)*

  • Hospitalisations (if records existed)*

Comparison cohort (variables collected through the LUNA registry at baseline and every 12 months thereafter, ongoing, and some variables collected as a LUNA registry expansion)
Patient characteristics
  • Patient demographics, date of disease onset, comorbidities and concomitant treatments, smoking and drinking habits, medical and reproductive history and blood pressure

Disease activity

  • PGA score

  • SDI score

  • BILAG category A/B‡

Concomitant treatment
  • Corticosteroid dose

  • Immunosuppressant use

Laboratory testing
  • Complete blood count

  • Biochemical examination

  • Urinalysis

  • C3/C4 levels

  • Anti-dsDNA Ab

  • Antiphospholipid antibody

  • *Variables will be abstracted from patients’ medical records after obtaining patient consent.

  • †BILAG category based on the occurrence of a prescription change related to category A/B, with or without renal involvement and collected during the follow-up period (months 1–36).

  • ‡Variables (BILAG category and monthly laboratory data) will be collected from medical charts as a LUNA registry expansion.

  • BILAG, British Isles Lupus Assessment Group; C3/C4, complement C3/C4; dsDNA Ab, double-stranded DNA antibody; LUNA, Lupus Registry of Nationwide Institutions; PGA, Physician Global Assessment; SDI, Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index; SELENA-SLEDAI, Safety of Estrogens in Lupus Erythematosus National Assessment–SLE Disease Activity Index; uPCR, urine protein:creatinine ratio.