New biologics in the form of GSK’s Benlysta and AstraZeneca’s Saphnelo have nearly doubled in use for systemic lupus erythematosus (SLE) since 2021 as rheumatologists are starting to shun traditional off-label meds for the autoimmune disease.
That’s according to analysts at Spherix Global Insights who combed through 1,011 moderate-to-severe SLE patient charts collected in collaboration with 297 U.S. rheumatologists and found “major shifts in the treatment of moderate-to-severe SLE are underway.”
There are several types of lupus, with SLE the most common. The condition is caused by an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage.
Organ damage can occur in up to 48% of people living with lupus, most within five years of diagnosis, with lupus flares also upping the risk of organ damage.
The latest report aims to “paint a real-world picture” of the current SLE landscape, according to Spherix and shows that year-over-year, GSK’s SLE drug Benlysta, which was approved by the FDA in 2011, saw “massive gains” with rheumatologists, and has now become a blockbuster medicine, making more than $1 billion last year.
They pointed to the drug’s long-standing safety profile, perceptions of efficacy, the desire to reduce the dose of steroids, as well as its 2020 indication in lupus nephritis—an advanced form of SLE that specifically attacks the kidneys—as “the most influential drivers” for the brand.
Spherix found that 37% of audited patients are currently on Benlysta for moderate-to-severe SLE, most commonly using the drug’s subcutaneous formulation of the drug, which was FDA approved back in 2017 and allows for self-injection. In 2022, 28% of audited patients were on Benlysta for moderate-to-severe SLE.
A newer drug in AstraZeneca’s Saphnelo, FDA approved in 2021, also saw gains “but significantly trails” the market leader in Benlysta. Spherix said its report found it was frequently selected in patients with “bad skin disease.”
The uptick in use of these newer biologics came at the expense in off-label use of rituximab—which has been used in SLE for years—declined for the second year in a row, according to Spherix’s figures.
Spherix also found that this new landscape “will almost certainly alter the market” for pipeline agents for SLE such as Biogen/UCB’s dapirolizumab pegol, Bristol Myers Squibb’s Sotyktu, and AbbVie’s Rinvoq, the JAK inhibitor now in phase 3 testing for SLE.
The analysts see these new agents as seeking “to steal share from established biologics and/or address unmet needs which remain amongst the patient population.”