What question did this study set out to answer?

To evaluate the efficacy and safety of the B lymphocyte stimulator inhibitor belimumab plus standard therapy compared with placebo plus standard therapy in active systemic lupus erythematosus (SLE).

September 1, 2011Arthritis & RheumatismOpen Access

A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus

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To evaluate the efficacy and safety of the B lymphocyte stimulator inhibitor belimumab plus standard therapy compared with placebo plus standard therapy in active systemic lupus erythematosus (SLE).
Conducted a phase III, multicenter, randomized, placebo-controlled trial in 819 antinuclear antibody-positive or anti-dsDNA-positive SLE patients with SELENA-SLEDAI scores ≥6.
Patients were randomized 1:1:1 to receive intravenous belimumab (1 mg/kg or 10 mg/kg) or placebo on days 0, 14, and 28, and then every 28 days through 72 weeks alongside standard therapy.
The primary efficacy endpoint was the SLE Responder Index (SRI) response rate at week 52.
At week 52, 10 mg/kg belimumab significantly improved SRI response rate compared with placebo (43.2% vs 33.5%; P = 0.017), while the 1 mg/kg belimumab response rate was 40.6% (P = 0.089).
At week 76, SRI response rates were 38.5% with 10 mg/kg belimumab, 39.1% with 1 mg/kg belimumab, and 32.4% with placebo.
Severe flare risk over 76 weeks decreased by 34% with 1 mg/kg belimumab (P = 0.023) and 23% with 10 mg/kg belimumab (P = 0.13), with comparable serious and severe adverse event rates across all groups.

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Implication

Randomized trial demonstrates improved response rates and reduced severe flares with belimumab in active systemic lupus erythematosus, highlighting its efficacy as targeted therapy.

Cite This Study

Furie et al. (2011) studied this question.

synapsesocial.com/papers/6a7c95c665c70251ff770b88 https://doi.org/10.1002/art.30613

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Implication

Randomized trial demonstrates improved response rates and reduced severe flares with belimumab in active systemic lupus erythematosus, highlighting its efficacy as targeted therapy.

A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus

Key Points

Discussion

Implication

Cite This Study

A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus

Key Points

Discussion

Implication

Cite This Study

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