Biogen’s litifilimab “stands out as an especially strong competitor” to Benlysta and Saphnelo, according to Spherix Global Insights analysts.
New biologics such as GSK’s Benlysta and AstraZeneca’s Saphnelo, along with off-label drugs, have been the mainstay for systemic lupus erythematosus (SLE) treatment for many years. However, the landscape may be about to change with the introduction of new medicines and indications from other approved treatments.
That’s according to Spherix Global Insights analysts who spoke to 101 U.S. rheumatologists about current and future treatments for SLE, a landscape they see as “poised for evolution.”
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.
GSK’s SLE drug Benlysta, which was approved by the FDA in 2011, has now become a blockbuster medicine, while AstraZeneca’s new challenger Saphnelo, FDA-approved in 2021, remains some way behind the market leader in Benlysta in terms of sales.
Doctors have also relied on off-label use of other older medicines, including rituximab. However, Spherix found in a 2023 report, this use has begun to lose favor among rheumatologists as they turn to newer biologics.
Now, Spherix has found that an experimental drug from Biogen, litifilimab, “stands out as an especially strong competitor” to Benlysta and Saphnelo, according to its report.
Talking to rheumatologists, Spherix analysts said that they believe litifilimab’s latest midstage data, notably its 26% improvement in SRI-4 response (a measurement on how well a patient responds to treatment) over placebo, “demonstrates a superior treatment profile compared to existing biologics and other promising therapies.”
There is also hope from new indications from already-approved drugs in the form of AbbVie’s blockbuster immunology drug Rinvoq, which is in phase 3 testing for SLE, and Bristol Myers Squibb’s Sotyktu, which presented positive data in SLE at the start of the year.
Spherix found that these oral therapies “offer convenience for patients and may appeal to rheumatologists seeking alternative treatment options.”
Getting patients to stay on them, however, can be a “challenge,” while black box warnings on JAKs (i.e., Rinvoq) “may prevent use in earlier lines of SLE treatment,” according to Spherix. Despite that, rheumatologists “are most eager to see Rinvoq approved for SLE, followed by Sotyktu and litifilimab, all of which are believed to be potentially effective for skin manifestations,” the report found.
There are also other investigational contenders in the form of UCB Pharma’s dapirolizumab pegol and Idorsia’s cenerimod.
All new entrants must, however, be mindful of the “dominance” of Benlysta, the analysts conclude, which “remains a preferred choice” in both SLE and lupus nephritis.
Source: Fierce Pharma- https://www.fiercepharma.com/marketing/lupus-landscape-poised-evolution-us-docs-eagerly-await-new-entrants?utm_medium=email&utm_source=nl&utm_campaign=LS-NL-FiercePharma&oly_enc_id=9784E2147445A5D
