BENLYSTA (belimumab) - Systemic lupus erythematosus (SLE)

The clinical benefit of BENLYSTA 120 mg and 400 mg (belimumab) powder for concentrate for solution for infusion and BENLYSTA 200 mg (belimumab) solution for injection in pre-filled pen remains substantial as add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g. positive anti-dsDNA and low complement) despite well-managed standard therapy with synthetic anti-malarials, NSAIDs, corticosteroids and, potentially, immunosuppressives, depending on specific organ involvement.

The new data are not of a nature to modify the previous conclusions of the Committee (opinions of 25/06/2014 and 04/04/2018):

• BENLYSTA 120 mg and 400 mg (belimumab) powder for concentrate for solution for infusion provide a minor clinical added value (CAV IV) in the care pathway for adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity despite treatment with synthetic anti-malarials, NSAIDs, corticosteroids and/or immunosuppressives, depending on specific organ
  

BENLYSTA 200 mg solution for injection in pre-filled pen is a range supplement that does not provide any clinical added value (CAV V) compared to BENLYSTA 120 mg and 400 mg powder for concentrate for solution for infusion.