Magazine article Drug Topics

FDA Approves Benlysta for SLE, Horizant for RLS

Magazine article Drug Topics

FDA Approves Benlysta for SLE, Horizant for RLS

Article excerpt


Belimumab intravenous injection

(Benlysta, Human Genome Sciences)

Systemic lupus erythematosus (SLE) is a serious, potentially fatal autoimmune disease that affects between 300,000 to 1.5 million Americans of all races; for African- American women, the incidence is 3 -fold higher. On March 9, 201 1, FDA approved belimumab intravenous injection for the treatment of adult patients with active, autoantibody-positive SLE who are currently receiving standard therapy.

Efficacy. Belimumab's efficacy was evaluated in 3 randomized controlled studies involving patients with SLE who were receiving standard treatment with corticosteroids, antimalarials, nonsteroidal anti-inflammatory drugs, and immunosuppressive agents. The studies exduded patients who had received previous B -cell targeted therapy or intravenous cydophosphamide, as well as those with active lupus involving the kidneys or central nervous system.

The first of the 3 studies was integral in identifying the target population of autoantibody-positive SLE patients. The 2 subsequent studies randomly assigned a total of 1,684 patients with autoantibody-positive, active disease (defined as a SELENASLEDIA score >6) to receive belimumab 1 mg/kg or 10 mg/ kg plus standard therapy or placebo plus standard therapy. In both trials the proportion of patients responding to therapy was significantly higher in the belimumab 10 mg/kg group than in the placebo group. There was no statically significant difference in response rate between patients receiving belimumab 1 mg/ kg and placebo.

Safety. The most commonly reported adverse reactions (occurring in >5% of patients) were nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, and pharyngitis, In these studies, a greater number of deaths were reported with belimumab (11) than with placebo (3), with a total of 14 deaths occurring during the treatment periods. Explanations for these deaths included infection, cardiovascular disease, and suicide; however, no single cause predominated. Patients being treated for a chronic infection should not begin therapy with belimumab, as serious infections have been reported.

Dosing. The recommended dose of belimumab is 10 mg/kg every 2 weeks for the first 3 doses and every 4 weeks thereafter. Belimumab should be administered over the course of 1 hour. Premedication for prophylaxis against infusion and hypersensitivity reactions should be considered.

Gabapentin enacarbil extended-release tablets

(Horizant, GlaxoSmithKline and Xenoport)

Restless legs syndrome (RLS) is a disruptive neurologic disorder that affects up to 10% of Americans, On April 6, 2011, FDA approved gabapentin enacarbil extended-release tablets for the treatment of moderate -to- severe RLS in adults, Gabapentin enacarbil is not recommended for patients who are required to sleep during the daytime and remain awake at night. …

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