A recent phase 3 clinical trial has confirmed that subcutaneous anifrolumab, marketed as Saphnelo, provides significant treatment benefits for patients with systemic lupus erythematosus (SLE) when used alongside standard therapies. The TULIP-SC trial revealed that this new method of administration could enhance patient outcomes, increasing access to this important medication.
Lead investigator Dr. Susan Manzi, chair of the Allegheny Health Network (AHN) Medicine Institute, emphasized the impact of these results. “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,” she stated.
SLE is a serious autoimmune condition that can lead to early mortality and irreversible organ damage in about 50% of patients within five years of diagnosis. This damage largely results from persistent disease activity and the long-term use of corticosteroids, which are commonly prescribed. The revised treatment guidelines for SLE emphasize early intervention with biologics, aiming for remission and minimizing corticosteroid use.
Anifrolumab is a first-in-class monoclonal antibody that targets the type 1 interferon receptor, effectively blocking the action of type I interferon. While it is currently available in the United States as an intravenous infusion, the subcutaneous form of the medication received approval in the European Union in December 2025, allowing patients to self-administer the treatment outside clinical settings.
The TULIP-SC trial was a multinational, double-blind, placebo-controlled study involving adults aged 18 to 70 years with moderate-to-severe SLE who were already on standard therapy—such as oral corticosteroids, antimalarials, or immunosuppressants. The primary endpoint was assessed through a pre-planned interim analysis of 220 participants, with 109 receiving anifrolumab and 111 on placebo. The results showed a treatment difference in the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response at 52 weeks.
The primary endpoint was successfully met, revealing a BICLA response of 59.4% for those treated with anifrolumab compared to 43.9% for the placebo group. This resulted in a statistically significant difference of 15.5% (95% confidence interval [CI], 2.3 – 28.6; P = 0.0211).
A further analysis expanded the participant pool to 367 individuals, including 184 on anifrolumab and 183 on placebo. Among these, a higher percentage of patients treated with anifrolumab achieved a BICLA response while maintaining low doses of oral glucocorticoids (≤ 7.5 mg per day) through week 52—56.2% compared to 34.0%, which translates to a difference of 22.3% (95% CI, 12.3 – 32.2; P < 0.0001). Additionally, anifrolumab patients experienced a significantly reduced time to first sustained BICLA response. At week 52, remission rates measured by DORIS criteria and the attainment of a Low Lupus Disease Activity State were both notably higher in the anifrolumab group, 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. Among patients receiving anifrolumab, 29% achieved DORIS remission, and 40.1% attained a low disease activity state. While the frequency of serious adverse events was slightly higher in the anifrolumab group (11.9% vs 10.4%), the safety profile was consistent with existing knowledge of intravenous anifrolumab. Notably, herpes zoster infections occurred in 3.8% of patients on anifrolumab compared to 1.1% in the placebo group. Sharon Barr, executive vice president at BioPharmaceuticals R&D 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.” She noted that the TULIP-SC trial findings contribute to the growing body of evidence supporting Saphnelo as an effective treatment option for lupus patients, helping them achieve remission and significantly reduce their reliance on oral corticosteroids.
The implications of these findings are significant, as they align with evolving treatment recommendations for SLE, underscoring the critical need for effective management strategies that prioritize patient outcomes and quality of life.
