Self-Injectable Benlysta for Lupus Approved

Using Benlysta to battle lupus? You could soon be taking it at home instead of at the infusion center.

New research and technology are making it easier than ever to take medications that cannot be delivered in pill form. GSK recently announced that the FDA has approved a self-injectable, subcutaneous formulation of belimumab (Benlysta) for the treatment of autoantibody-positive systemic lupus erythematosus (SLE).

While Benlysta has been available since 2011, it needed to be administered by infusion in a hospital or clinic setting. Patients will now be able to dose themselves at home (after receiving training from their healthcare provider) because of this new approval.

Is self-injectable Benlysta a game-changer?

According to our poll about 5% of our community has tried the IV form of Benlysta. These patients now have a new option, and other patients considering the drug before, might be more open to a medication they can take at home. But does that make it a game changer?

How will self-injectable Benlysta work?

After training from their health care provider, patients will be able to administer the medicine as a once weekly injection of 200mg, from either a single-dose pre-filled syringe or from a single-dose autoinjector.

When will self-injectable Benlysta be available?

GSK hopes it will be available in specialty pharmacies in the US in late August 2017.

Is self-injectable Benlysta effective and safe?

The approval was based on an 836-person clinical trial. 556 patients were given weekly subcutaneous (SC) belimumab 200mg for 52 weeks and compared 280 patients that were given a placebo for the same time frame.

At week 52, the two groups were measured on 3 metrics. The main metric, called the primary endpoint, was the SLE Responder Index (SRI4), which is a complex measure of disease activity. The other two metrics, called secondary endpoints, were reduction in corticosteroid dosage and time to severe flare.

The study concluded: “In patients with moderate-to-severe SLE, weekly SC doses of belimumab 200 mg plus standard SLE therapy significantly improved their SRI4 response, decreased severe disease flares as compared with placebo, and had a safety profile similar to placebo plus standard SLE therapy.”  

You can see all the details and data from the study here.