Trial testing under-the-skin Saphnelo in SLE hits main goal
Self-administered version of therapy reduced disease severity in adults
A self-administered, under-the-skin injection version of AstraZeneca’s Saphnelo (anifrolumab-fnia) was effective for reducing disease severity in adults with systemic lupus erythematosus (SLE), according to results from an interim analysis of a Phase 3 clinical trial.
“Today’s news takes us one step closer in making the clinically meaningful benefits of Saphnelo accessible for more patients with systemic lupus erythematosus,” Sharon Barr, PhD, executive vice president of biopharmaceuticals research and development at AstraZeneca, said in a company press release.
Injectable Saphnelo aimed at making treatment more convenient
SLE, the most common form of lupus, is marked by the immune system attacking the body’s healthy tissues.
Saphnelo is an antibody-based therapy designed to bind to subunit 1 of the type I interferon receptor, inhibiting the activity of interferons — pro-inflammatory signaling molecules involved in the autoimmune attack that drives SLE. According to AstraZeneca, an intravenous, or into-the-vein, infusion version of the therapy is approved to treat moderate to severe SLE in more than 70 countries worldwide, including the U.S.
Although the approved version of Saphnelo has been proven effective for reducing SLE disease activity, infusion therapies can be burdensome for patients because they require people to go to a medical center for treatment. Aiming to make treatment more convenient, AstraZeneca is developing a subcutaneous, or under-the-skin, injection version of Saphnelo designed to be administered at home.
“With Saphnelo, we hope to establish remission as an achievable treatment goal for more patients, and we are actively working with regulatory authorities to bring this new administration option to patients as soon as possible,” Barr said.
Subcutaneous Saphnelo could help patients reduce corticosteroid use
The Phase 3 TULIP-SC clinical trial (NCT04877691) enrolled 367 adults with SLE who were experiencing substantial disease activity despite being on standard lupus treatments, including corticosteroids, antimalarials, and/or immunosuppressants.
Participants were randomly assigned to receive subcutaneous Saphnelo or a placebo once weekly for 52 weeks, or about a year. Those who completed this initial part of the study could then enroll in an open-label extension to continue receiving Saphnelo for another year.
The study aimed to show that significantly more patients given the under-the-skin formulation of Saphnelo would be considered responders on the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at week 52. A BICLA response basically means there has been a reduction of disease severity in all affected organs and no signs of disease worsening in other measures.
Today’s results for subcutaneous [Saphnelo] reinforce the efficacy and safety of this therapy and provide the opportunity for this important biologic to reach a wider group of patients in a more flexible and convenient way.
A prespecified interim analysis showed that the study has already met this goal, with significantly higher BICLA response rates seen among patients given subcutaneous Saphnelo than in those treated with a placebo, according to AstraZeneca. The company didn’t provide further information, noting that data from the analysis are under regulatory review and will be presented in detail at a scientific meeting next month.
“Today’s results for subcutaneous [Saphnelo] reinforce the efficacy and safety of this therapy and provide the opportunity for this important biologic to reach a wider group of patients in a more flexible and convenient way,” said Susan Manzi, MD, professor of medicine at Drexel University College in Philadelphia and principal investigator of the TULIP-SC trial.
Manzi noted that subcutaneous Saphnelo could help patients reduce their use of corticosteroids, powerful anti-inflammatory therapies. Corticosteroids are a cornerstone treatment for managing SLE and other inflammatory disorders, but long-term use can lead to serious side effects, so modern guidelines emphasize the importance of minimizing their use wherever possible.
“Despite guidelines recommending earlier intervention and biologic treatments, too many people with systemic lupus erythematosus rely on oral corticosteroids, which contribute to irreversible organ damage,” Manzi said.
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