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Belimumab Effective in Patients With Serologically Active Systemic Lupus Erythematosus: Presented at EULAR

By Alec O'Neill

PARIS -- June 16, 2008 -- Belimumab has significant activity against systemic lupus erythematosus (SLE), reported investigators here at EULAR 2008, the Annual Congress of the European League Against Rheumatism.

In the 3-year extension phase of a phase 2 study, roughly half of all patients with serologically active SLE had a significant improvement in symptoms as measured by the SLE Responder Index, a new validated measure of lupus activity, said Richard A. Furie, MD, Systemic Lupus Erythematosus and Autoimmune Disease Treatment Center, North Shore University Hospital, Long Island Jewish Health System, Lake Success, New York.

Belimumab is a humanised monoclonal antibody that binds to the common growth factor B-lymphocyte stimulator (BLyS), a new target for SLE therapies.

The SLE Responder Index, which recently was recognised by the US Food and Drug Administration, is composed of 3 items:

• An improvement of 4 or more points on the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) scale.
• No new 1A or 2B flares on the British Isles Lupus Assessment Group (BILAG) scale.
• No worsening on the Physicians' Global Assessment measure.

The original endpoint of the trial was an improvement in SELENA SLEDAI criteria alone, which the drug failed to meet. The investigators then applied the new SLE Responder Index criteria to the data and continued the study to gather additional data.

The study, presented on June 12, involved 449 patients with SLE and scores >=4 on the SELENA SLEDAI. Patients were entered into a 52-week, double-blind trial of belimumab at doses of 1, 4, or 10 mg/kg monthly or to placebo.

At study week 56, all patients who remained on placebo were then switched to high-dose belimumab 10 mg/kg. Patients already receiving belimumab at week 56 either had their doses increased to 10 mg/kg, or remained on their current doses, according to the best judgment of the investigator.

At week 76, all patients still in the study were given 10 mg/kg in a continuous trial.

Seropositivity was defined as an antinuclear antibodies level >1:80 or an anti-double-stranded-DNA antibodies level >30 IU.

Among all patients who were seropositive at baseline, 46% had significant improvement at week 52 (difference from placebo 29%, P < .05). Similarly, at week 56 the SLE Responder rate among patients on the belimumab was 49% (a 35% improvement over placebo, P < .05). At both 76 weeks and 160 weeks, the SLE Responder Index rate was 55%.

Belimumab is now being evaluated in 2 phase 3 studies with 810 patients in each study.

Funding for this trial was provided by Human Genome Sciences.


[Presentation title: Belimumab (Fully Human Monoclonal Antibody to BLyS) Improved or Stabilized Systemic Lupus Erythematosus (SLE) Disease Activity and Reduced Flare Rate During 3 Years of Therapy. Abstract OP-0017]

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