A recent phase 3 trial has confirmed that subcutaneous anifrolumab (branded as Saphnelo) offers significant treatment benefits for patients suffering from systemic lupus erythematosus (SLE) when used alongside standard therapies. The findings from the TULIP-SC trial, led by Dr. Susan Manzi, chair of the Allegheny Health Network (AHN) Medicine Institute, indicate that this new form of administration can expand access to effective treatment for a broader patient population.
Dr. Manzi emphasized the importance of these findings, stating, “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.” The trial’s results align with evolving global recommendations for lupus treatment, which now advocate for earlier use of biologics to achieve remission while minimizing the reliance on oral corticosteroids.
SLE poses serious health risks, with patients facing an increased risk of early mortality. Approximately 50% of individuals diagnosed with this condition develop irreversible organ damage within just five years, primarily due to persistent disease activity and prolonged corticosteroid use. The 2025 recommendations for SLE treatment prioritize achieving DORIS remission and advocate for the discontinuation of corticosteroids to mitigate these risks.
Anifrolumab, a fully human monoclonal antibody, works by binding to a subunit of the type 1 interferon receptor, inhibiting type I interferon activity. Previously available in the United States only through intravenous infusion, the subcutaneous formulation was approved in the EU in December 2025, allowing patients the convenience of self-administration.
The TULIP-SC trial was a multinational, double-blind, placebo-controlled study involving adults aged 18 to 70 with moderate-to-severe SLE, who were already on standard therapies like oral corticosteroids, antimalarials, or immunosuppressants. The primary endpoint, assessed in a pre-planned interim analysis of 220 participants, evaluated the treatment difference in the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response at the 52-week mark.
Results showed that the primary endpoint was met, with a response rate of 59.4% for anifrolumab compared to 43.9% for the placebo group, reflecting a significant treatment difference of 15.5% (95% confidence interval [CI], 2.3 – 28.6; P = 0.0211). The study’s secondary analysis included 367 patients, of whom 184 received anifrolumab and 183 received placebo. Notably, a greater proportion of patients on anifrolumab achieved a BICLA response while maintaining low doses of oral glucocorticoids (≤ 7.5 mg per day) through week 52 (56.2% vs. 34.0%; difference, 22.3%; 95% CI, 12.3 – 32.2; P < 0.0001). Moreover, patients treated with anifrolumab experienced a reduced time to the first sustained BICLA response, with a hazard ratio of 2.2 (95% CI, 1.5 – 3.2; P < 0.0001). At the end of the one-year period, remission based on DORIS criteria and achievement of a Low Lupus Disease Activity State were significantly higher among those receiving anifrolumab, with treatment differences of 14.2% (95% CI, 5.6 – 22.8; P = 0.0012) and 14.1% (95% CI, 4.6 – 23.6; P = 0.0038), respectively. Specifically, 29% of patients on anifrolumab achieved DORIS remission, and 40.1% reached low disease activity. While the anifrolumab group reported a slightly higher incidence of serious adverse events compared to placebo (11.9% vs. 10.4%), these safety findings were consistent with the known clinical profile of intravenous anifrolumab. Notably, herpes zoster was observed in 3.8% of patients on anifrolumab compared to 1.1% in the placebo group. Sharon Barr, executive vice president at AstraZeneca, commented on the findings, stating, “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 trial results contribute to a growing body of evidence supporting Saphnelo’s effectiveness in helping patients achieve remission and significantly diminish their reliance on oral corticosteroids, furthering AstraZeneca’s commitment to transforming lupus care.
