THE SAFETY PROFILE OF BENLYSTA HAS BEEN STUDIED
ACROSS A DIVERSE PATIENT POPULATION1-7

  • Adults with lupus
  • Adults of Black race with lupus
  • Adults with lupus nephritis
  • Children 5 years and older with lupus
  • Post-marketing safety trial in adults with lupus

 

7000+

patients with lupus have been included in trials of BENLYSTA, including a clinical trial in patients with lupus nephritis (N=448)8

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LUPUS SAFETY PROFILE

 

The safety profile of BENLYSTA has demonstrated consistency across trials, including
trials in IV, subcutaneous, and a long-term extension study.

  • IV FORMULATION

    Incidence of adverse reactions in IV trials (Adult Phase II, BLISS-52, and BLISS-76)

    In ≥3% of patients treated with BENLYSTA IV 10 mg/kg + ST and ≥1% more
    frequently than in patients receiving placebo + ST in the 52-week Phase II trial,
    BLISS-52, and BLISS-76 

    Incidence of AEs in adult IV Trials (Phase II trial, BLISS-52, and BLISS-76) infographic
    Incidence of AEs in adult IV Trials (Phase II trial, BLISS-52, and BLISS-76)infographic

    Adverse reactions in EMBRACE, PLUTO, and BLISS-LN were consistent with those in adult
    IV trials.

    BASE (post-marketing trial of 4003 adult patients) demonstrated rates of AEs consistent with the pivotal trials and higher rates of serious infusion/hypersensitivity reactions, fatal reactions, and serious psychiatric events.

    AE = adverse event; BASE = Belimumab Assessment of Safety in SLE; IV = intravenous; PLUTO = Pediatric Lupus Trial of BENLYSTA; ST = standard therapy; EMBRACE = Efficacy and safety of belimumab in adult subjects of Black Race.

  • SC FORMULATION

        
    • The safety profile was consistent with the known safety profile of BENLYSTA IV + ST, with the exception of local injection site reactions
      • Injection site reactions in BENLYSTA + ST group: 6.1%
      • Injection site reactions in Placebo + ST group: 2.5%
      • Most common injection site reactions: pain, erythema, hematoma, pruritus, and induration

    SC = subcutaneous; ST = standard therapy.

LONG-TERM SAFETY

  • SAFETY DATA OBSERVED OVER 7 YEARS9

    Long-term safety was assessed
    in the open-label BLISS-76 LTE
    (US Participants Only)

    Safety data observed over 7 years infographic
    Safety data observed over 7 years infographic

    Over the 7-year follow-up, the rate of treatment-emergent AEs remained stable or
    declined.

    Results are descriptive. Exploratory results should be interpreted with additional care.
    See study design for data limitations.

    AE = adverse event; LTE = long-term extension; SAE = serious adverse event; ST = standard therapy.

LUPUS NEPHRITIS SAFETY PROFILE

Adverse events observed in BLISS-LN were consistent with the known safety profile of
BENLYSTA IV in patients with lupus.

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