Safety Profile

THE SAFETY PROFILE OF BENLYSTA HAS BEEN ESTABLISHED IN 8 CLINICAL TRIALS1-6*

Icon: Silhouette

Established safety profile in systemic lupus erythematosus (SLE)

Icon: Clock

Long-term safety studies in SLE

Icon: Kidneys

Safety profile in patients with lupus nephritis (LN)

BASE=Belimumab Assessment of Safety in SLE; BLISS=Belimumab International SLE Study; EMBRACE=Efficacy and Safety of Belimumab in Adult Subjects of Black Race; PLUTO=Pediatric Lupus Trial of BENLYSTA.

* Adult Phase II (Trial 1), BLISS-76 (Trial 2), BLISS-52 (Trial 3), EMBRACE (Trial 4), BLISS-LN (Trial 5), PLUTO (Trial 6), BLISS-SC (Trial 7), and BASE (post-marketing safety trial).

SLE: ESTABLISHED SAFETY ACROSS A WIDE RANGE OF PATIENTS

Icon: Intravenous Administration of BENLYSTA

Safety: IV formulation

  • Adverse reactions reported with IV infusion (Phase II, BLISS-52 and BLISS-76):
    • Most common (≥5%) in BENLYSTA + standard therapy (ST) group: nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, and pharyngitis
    • Most common (≥5%) in placebo + ST group: nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia
  • In the following SLE trials, adverse reactions were consistent with those in adult IV trials:
    • EMBRACE (adult Black patients)
    • PLUTO (pediatric patients over the age of 5)
    • 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 infections, and serious psychiatric events
Icon: Subcutaneous Administration of BENLYSTA

Safety: 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
Icon: Study Information

See the efficacy results for SLE trials

View the Trial Data

LN: SAFETY PROFILE
ADVERSE REACTIONS OBSERVED IN BLISS-LN WERE CONSISTENT WITH THE KNOWN SAFETY PROFILE OF BENLYSTA IV + ST IN PATIENTS WITH SLE6

Icon: Shield

Incidence of adverse events in the BLISS-LN trial6

An overall summary during the 104-week BLISS-LN trial.

Chart: Adverse Reactions in BLISS-LN Trial
Chart: Adverse Reactions in BLISS-LN Trial

AE=adverse event; AZA=azathioprine; CYC=cyclophosphamide; IP=investigational product; MMF=mycophenolate mofetil.

Icon: Study Information

See the efficacy results for the LN trial

View the Trial Data

Consider the safety profile of BENLYSTA when prescribing for your patients.