Belimumab cohort (variables collected in the postmarketing surveillance study and some additional variables*) | |
Patient characteristics (at index) |
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Disease activity (at index and months 12 and 36*†) |
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Concomitant treatment (preindex (6±2 months prior to index), at index and afterwards until month 36 if changed during this period) |
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Laboratory testing (preindex if available, at index and every month until month 36) |
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Procedure |
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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 |
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Disease activity |
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Concomitant treatment |
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Laboratory testing |
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*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.