CONSISTENT SAFETY

BENLYSTA: 7 years in-market experience1

Adverse reactions in ≥3% of patients receiving BENLYSTA 10 mg/kg + standard therapy and ≥1% more frequently than in those receiving placebo + standard therapy in the 52-week Phase II trial, BLISS-52, and BLISS-761

  Preferred Term BENLYSTA 10 mg/kg +
Standard Therapy
(n=674)
%
Placebo + Standard Therapy
(n=675)
%
 
  Nausea 15 12  
  Diarrhea 12 9  
  Pyrexia 10 8  
  Nasopharyngitis 9 7  
  Bronchitis 9 5  
  Insomnia 7 5  
  Pain in extremity 6 4  
  Depression 5 4  
  Migraine 5 4  
  Pharyngitis 5 3  
  Cystitis 4 3  
  Leukopenia 4 2  
  Gastroenteritis viral 3 1  

The safety profile for BENLYSTA SC + standard therapy was consistent with that of BENLYSTA IV + standard therapy, with the exception of local injection site reactions.

Injection site reactions occurred in 6.1% of patients receiving BENLYSTA SC + standard therapy and in 2.5% of patients receiving placebo + standard therapy, respectively. The majority (94%) did not necessitate discontinuation of treatment.

  • The proportion of patients who discontinued treatment due to any adverse reaction was 7.2% of patients receiving BENLYSTA SC + standard therapy and 8.9% of patients receiving placebo + standard therapy
  • The proportion of patients who discontinued treatment due to any adverse reaction was 6.2% for patients receiving BENLYSTA IV + standard therapy and 7.1% for patients receiving placebo + standard therapy

Adverse reaction rates observed in clinical studies may not predict those observed in clinical practice.

REFERENCES:

1. BENLYSTA [package insert]. Research Triangle Park, NC: GlaxoSmithKline, 2017.

831318R0 February 2018

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