Global pharma powerhouse AstraZeneca’s Saphnelo (anifrolumab) delivered a statistically significant and clinically meaningful reduction in disease activity when administered subcutaneously, according to full Phase III results from the TULIP-SC trial published in Arthritis & Rheumatology.
The study met its primary endpoint, with 56.2% of patients with systemic lupus erythematosus (SLE) treated with subcutaneous Saphnelo achieving a reduction in disease activity at Week 52, compared with 37.1% of patients receiving placebo. The difference of 19.1 percentage points, measured using the BICLA composite endpoint, was highly statistically significant (p=0.0002) and consistent with earlier anifrolumab trials.
The full analysis confirmed findings from the interim readout and showed a safety profile in line with the established intravenous formulation of Saphnelo. Rates of adverse events were balanced between treatment and placebo groups.
SLE remains a life-threatening autoimmune disease, with patients facing an elevated risk of early mortality and long-term organ damage. Around half of patients develop irreversible organ damage within five years of diagnosis, often driven by ongoing disease activity and prolonged use of oral corticosteroids. Reducing disease activity while limiting steroid exposure is increasingly recognised as critical to improving long-term outcomes.
Susan Manzi, chair of the Allegheny Health Network Medicine Institute and principal investigator of the TULIP-SC trial, said: “These meaningful results from the TULIP-SC trial provide confidence that the efficacy and DORIS-defined remission rates that we’ve seen with anifrolumab can be achieved in a new subcutaneous administration, allowing even more patients to benefit from this effective treatment.
"The results align with important changes in global lupus treatment recommendations, which now emphasise earlier intervention with biologics, driving remission and reduced use of oral corticosteroids as key treatment goals.”
In secondary and exploratory analyses, subcutaneous Saphnelo showed benefits across multiple clinically relevant measures, including greater reductions in disease activity while tapering oral corticosteroids to ≤7.5 mg/day, faster achievement of BICLA responses, and a numerically delayed time to first disease flare. Nearly one-third of treated patients achieved DORIS-defined remission, while 40.1% reached low-level disease activity as measured by LLDAS.
Sharon Barr, Executive Vice President, BioPharmaceuticals R&D at AstraZeneca, said: “These results reinforce Saphnelo’s unique approach of targeting the type 1 interferon receptor to reduce disease activity, with the added convenience of subcutaneous self-administration.
"The TULIP-SC findings build on the compelling body of evidence for Saphnelo, which has helped patients achieve remission and significantly reduce reliance on oral corticosteroids – further reinforcing our ambition to transform lupus care.”
Saphnelo is currently approved as an intravenous infusion for the treatment of moderate to severe SLE in more than 70 countries, including the US, EU and Japan, and has been used by more than 40,000 patients worldwide.
