SABLE: A 5-Year Prospective Observational Registry to Assess Adverse Events of Interest and Effectiveness in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Treated With or Without Benlysta (Belimumab) (116543)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Multi-center, prospectiv, observational cohort study

Study drug and medical condition

• Name of medicine:
  BENLYSTA
• Study drug International non-proprietary name (INN) or common name:
  BELIMUMAB
• Medical condition to be studied:
  Systemic lupus erythematosus

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  Evaluate the incidence of following AESI over 5 years in adults with active auto antibody positive SLE treated with/without BENLYSTA: Malignancies, Mortality, Opportunistic infections & other infections of interest, Non-melanoma skin cancer, Selected serious psychiatric event, Serious infections.
• Outcomes:
  Incidence of the following adverse events of special interest (AESI):; - Malignancies (excluding non-melanoma skin cancers); - Mortality; - Opportunistic infections and other infections of interest (Appendix 1); - Non-melanoma skin cancers (NMSC); - Selected serious psychiatric events (Appendix 2); - Serious infections; ; Evaluate the effectiveness measures in adults with active autoantibody-positive SLE treated with/without BENLYSTA:; - Organ damage assessed by SLICC/ACR Damage Index; - Concomitant SLE meds including steroids; - Hospitalization; - Quality of life assessed by SF-12v2 Health Survey; - Fatigue assessed by FACIT-Fatigue Scale; - SLE disease activity assessed by SLEDAI 2000; - Severe Flare derived by SLE Flare Index
• Data analysis plan:
  Estimate AESI via incidence rates & compared between cohorts using binomial regression and/or Cox models / Kaplan-Meier plots based on one or more exposure strategies as described: ; (1, 2) patients contribute data until their first treatment switch, or a pre-specified landmark timepoint, ; (3) Ever-taken Benlysta strategy, an event will be attributed to BENLYSTA if the patient was ever exposed to BENLYSTA prior to the event, & to non-Benlysta otherwise, ; (4) patient profile approach, patients are characterized by the switch patterns, ; (5) the as-exposed analysis or marginal structural methods may be used to model treatment switch and explore the long-term treatment effect. Safety analysis may employ a lagged risk window since an AE may be attributed to a treatment after discontinuation. Similar methods will be applied to the effectiveness endpoints. Propensity score methods and/or multivariate regression methods will be used to adjust for potential confounding factors & selection bias.