Greater use of Benlysta, Saphnelo seen in US, EU to treat lupus
Goal to reduce long-term glucocorticoids use to prevent side effects
In both the U.S. and Europe, clinicians want to limit treatment with glucocorticoids — steroid hormones whose long-term use for autoimmune diseases is tied to serious side effects — among people with moderate to severe lupus.
To that end, healthcare professionals are increasingly prescribing biological therapies like Benlysta (belimumab) and Saphnelo (anifrolumab).
Those are the main findings of two new reports from Spherix Global Insights, a U.S. company that tracks the global pharmaceutics market. Spherix has now released two annual reports, the Patient Chart Dynamix: SLE (US) and the Patient Chart Dynamix: SLE (EU5), showing these new trends in treating lupus.
According to Spherix, the shift was driven in part by an increased number of approved therapies for lupus and lupus nephritis, one of the disorder’s most severe complications, in this decade.
“Armed with this expanded array of treatment options, healthcare providers in both the US and the EU5 have seen a notable increase in their utilization of biologics to address moderate-to-severe cases of [lupus],” Spherix stated in a press release announcing the report results.
EU treatment guidelines recommend against long-term use of glucocorticoids
Lupus is caused by the immune system accidentally launching an inflammatory attack that damages the body’s own healthy tissues.
For much of modern medical history, treatment of lupus has mainly involved glucocorticoids due to their potent anti-inflammatory and immunosuppressive effects. However, long-term use of glucocorticoids can cause substantial side effects, such as weight gain, high blood pressure, and weakened bones.
GSK’s Benlysta is an antibody-based therapy that works to reduce the inflammatory activity of immune T-cells in lupus. It’s been approved since the early 2010s for adults with active lupus in the U.S. and the European Union.
In 2020, regulatory authorities in both regions expanded the therapy’s label to include lupus nephritis, a serious complication of lupus characterized by kidney inflammation.
Meanwhile, AstraZeneca’s Saphnelo, also designed to suppress pro-inflammatory signaling pathways, was approved in 2021 in the U.S. and 2022 in the EU to treat active lupus. The therapy has not been approved for lupus nephritis, though an ongoing Phase 3 clinical trial called IRIS (NCT05138133) is testing it for that indication.
The Spherix reports analyzed data from 1,011 lupus patients in the U.S. and 1,257 lupus patients in the so-called EU5 — France, Germany, Italy, Spain, and the U.K.
The results showed that, compared with 2022, the use of both Benlysta and Saphnelo increased by 32% in both regions.
“A substantial majority of rheumatologists in both the US and EU5 regions have indicated that their prescribing decisions for Benlysta and/or Saphnelo are significantly influenced by their desire to minimize glucocorticoid dosage for their patients,” the release stated.
This is in line with recent European treatment guidelines that emphasize the role of biologic therapies in reducing glucocorticoid burden in lupus patients, Spherix noted.
While use of these therapies increased in both the U.S. and Europe, they are more widely used in the U.S. Moderate to severe lupus patients in the U.S. were about 20% more likely to be on Benlysta or Saphnelo than those in the EU5, according to Spherix.
Data suggest that the use of Benlysta for lupus patients with kidney involvement has increased in both the U.S. and Europe, regardless of disease severity.
For patients without kidney involvement, Benlysta use has expanded in the U.S., but not in Europe, “further widening the gap in biologic utilization between these two distinct SLE patient populations,” Spherix said in the release.
Spherix also noted that the use of Saphnelo “has been hindered by challenges related to access and reimbursement in the US,” and the fact that it is not authorized for treating lupus nephritis.
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