Self-injected Saphnelo offers new flexibility for lupus treatment
At-home formulation significantly reduces disease activity, organ damage in trial
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An under-the-skin, self-administered version of Saphnelo (anifrolumab-fnia) could soon allow people with systemic lupus erythematosus (SLE) to manage their condition at home with the same effectiveness as clinical infusions.
According to AstraZeneca, the new subcutaneous formulation provides efficacy comparable to the approved intravenous formulation while significantly reducing the “burden of care” for patients who currently travel long distances for treatment.
The subcutaneous version was approved in the European Union last month, and applications are currently under review in the U.S. and Japan. These filings are backed by data from the Phase 3 TULIP-SC clinical trial (NCT04877691), which showed that the at-home injection helps more than half of patients achieve a meaningful reduction in disease severity.
“Subcutaneous, self-administered Saphnelo puts optimal care within reach for more patients, allowing healthcare providers to offer the medicine’s clinically meaningful benefits to more patients and empower patients with an at-home, flexible and convenient way to receive treatment,” Rob Fogel, MD, vice president of global medical affairs, respiratory and immunology at AstraZeneca, which markets Saphnelo.
Targeting the drivers of inflammation in SLE
Saphnelo is designed to block the activity of interferons, which are signaling molecules that drive inflammation in SLE. An intravenous (into-the-vein) infusion version has been approved in the U.S. since 2021 for adults with moderate to severe SLE who are on standard therapy.
“Evidence across clinical trials and real-world studies has shown that treatment with [intravenous] Saphnelo can reduce SLE disease activity and long-term organ damage compared to standard of care,” Fogel said. “This new era of biologic treatment has helped reimagine what living well with lupus can look like for patients, who for so long faced suboptimal treatments.”
The TULIP-SC clinical trial enrolled 367 adults with SLE who had significant disease activity despite standard lupus therapies. Participants were randomly assigned to take subcutaneous Saphnelo or a placebo once weekly for a year. Full results were published last month in Arthritis & Rheumatology, in a paper titled “Efficacy and Safety of Subcutaneous Anifrolumab in Systemic Lupus Erythematosus: the Randomized, Phase 3, TULIP-SC Study.”
The study’s main goal was to determine whether patients given Saphnelo were more likely to achieve a British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response, meaning reduced disease severity across all affected organs without worsening in other measures or organs. This goal was met, with more than half (56.2%) of patients given Saphnelo achieving a BICLA response, compared with about a third (37.1%) of those on the placebo. A similar difference was observed in the proportion of patients who attained a BICLA response while maintaining low or reduced oral corticosteroid doses through one year of treatment.
Other measures also favored subcutaneous Saphnelo over the placebo. Of particular note, DORIS remission rates were significantly higher with the therapy (29% vs 14.7%).
“We also saw nearly twice as many patients on subcutaneous Saphnelo achieve DORIS remission compared to those on placebo,” said Susan Manzi, MD, principal investigator of the TULIP-SC trial at Drexel University in Philadelphia, and medical director for the Lupus Foundation of America. “DORIS remission is the definition of remission in SLE that is recommended for use in clinical care, meaning that the disease is not active, with no signs of inflammation or damage to the body.”
Consistent safety with added flexibility
A key benefit observed in the study was a reduced need for oral corticosteroids, anti-inflammatory medicines commonly used in SLE.
“Although [corticosteroids] offer relief from symptoms of SLE, they do not target the underlying drivers of the disease and are associated with adverse events and long-term harm to the body,” Manzi said, noting that reducing these doses is a primary goal in lupus care.
The TULIP-SC trial found that patients on subcutaneous Saphnelo could maintain a BICLA response while lowering their steroid intake.
Safety outcomes were similar in patients given subcutaneous Saphnelo or the placebo. Overall, trial data suggest that the safety and effectiveness of this Saphnelo formulation are similar to those of the original intravenous formulation.
“Since its approval, [intravenous] Saphnelo has provided an important treatment option for adults with moderate-to-severe SLE, showing that remission is possible as a treatment outcome,” Manzi said, adding, “The efficacy and safety data in the TULIP-SC trial are consistent with the known clinical profile of [intravenous Saphnelo]. What sets subcutaneous Saphnelo apart is not a change in therapeutic effect, but the flexibility it may offer patients in how they receive care. “
