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華爾街日報AstraZeneca's Self-Injectable Lupus Drug Shines In Late-Stage Trial
On Tuesday, AstraZeneca Plc (NASDAQ:AZN) released complete results from the Phase 3 TULIP-SC trial of a subcutaneous (SC) administration of anifrolumab versus placebo in participants aged 18 to 70 years with moderately to severely active, autoantibody-positive systemic lupus erythematosus.
Topline data was shared in September 2025.
Subcutaneous (SC) administration of Saphnelo (anifrolumab) showed a statistically significant and clinically meaningful reduction in disease activity compared to placebo.
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In the TULIP-SC full analysis, 56.2% of patients who received Saphnelo achieved a reduction in disease activity at Week 52 versus 37.1% receiving placebo, which was consistent with results from previous trials.
Sharon Barr, executive vice president of BioPharmaceuticals R&D at AstraZeneca, said the latest data strengthen the case for Saphnelo’s differentiated mechanism, noting that the drug’s ability to target the type 1 interferon receptor translated into meaningful reductions in disease activity, while offering patients the added convenience of subcutaneous self-administration.
“The TULIP-SC findings build on the compelling body of evidence for Saphnelo,” Barr said, adding that the therapy has helped patients achieve remission and cut back significantly on oral corticosteroid use, underscoring AstraZeneca’s broader ambition to transform lupus care.
The safety profile observed in the TULIP-SC trial was consistent with the known clinical profile of Saphnelo administered as an intravenous (IV) infusion.
The full results confirmed the findings from the interim analysis, which was statistically significant.
In the TULIP-SC trial, Saphnelo demonstrated clinically meaningful effects across a range of outcome measures: reduction in SLE disease activity while tapering to a low dose of oral corticosteroid (OCS) (≤7.5 mg/day), and numerically delayed time to first flare.
In pre-specified secondary and exploratory endpoints, 29.0% of patients taking Saphnelo achieved DORIS remission, and 40.1% attained low-level disease activity.
Subcutaneous Saphnelo was well tolerated, and the frequency of overall adverse events was balanced between the Saphnelo and placebo treatment groups.
Saphnelo IV infusion is approved for moderate to severe SLE in more than 70 countries worldwide, including the U.S., EU, and Japan, with regulatory reviews ongoing in other countries, including China.
To date, more than 40,000 patients globally have been treated with Saphnelo. SC administration of Saphnelo is approved in the EU and is under regulatory review in several countries around the world, including the U.S. and Japan.
AstraZeneca acquired global rights to Saphnelo through an exclusive license and collaboration agreement with Medarex Inc. in 2004.
The option for Medarex to co-promote the product expired on its acquisition by Bristol-Myers Squibb Co. (NYSE:BMY) in 2009.
Under the agreement, AstraZeneca will pay Bristol-Myers a low to mid-teens royalty for sales dependent on geography.
AZN Price Action: AstraZeneca shares were up 0.58% at $91.75 during premarket trading on Tuesday, according to Benzinga Pro data.
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