資料來源:https://www.pharmatimes.com/news/final_nice_nod_for_gsks_lupus_drug_benlysta_1047608

In line with draft recommendations, the National Institute for Health and Care Excellence has recommended use of Benlysta (belimumab) to treat systemic lupus erythematosus (SLE), but only under a managed access agreement between GSK and NHS England, which will provide the drug at a discounted price, and on the condition that data is collected to help address remaining questions over its efficacy.

Benlysta was actually cleared by European regulators back in 2011 for autoantibody-positive SLE but, until now, NICE had barred patients from accessing it on the NHS because on the belief that it did not represent a cost-effective use of resources.

The drug is the first in a new class of drugs called BLyS-specific inhibitors, which work by targeting a naturally occurring protein believed to play a role in the production of antibodies which attack and destroy the body's own healthy tissues.

Lupus - a chronic autoimmune disease that, if uncontrolled, can lead to severe, debilitating symptoms, long-term organ damage and premature death - affects more than 20,000 people in England and Wales, and some patients with advanced disease fail to respond to current therapy.

Earlier this year, a long-term analysis demonstrated low rates of organ damage progression in patients with moderate-to-severe SLE taking the drug for five years, regardless of their level of damage at the start of the trial.

Interim analysis of data from two pooled, open-label, continuation studies (BLISS-52 and BLISS-76) showed that 85.1 percent of patients taking Benlysta plus the standard of care showed no organ damage at study years five-six, as measured by change in SLICC Damage Index from baseline, a validated score to quantify organ damage.