Findings
At week 52, the primary end point was met, with 60.3% of patients who received anifrolumab-fnia achieving a BICLA response compared with 43.9% of patients who received placebo (difference [95% CI] = 16.5% [3.3–29.6%]; P=0.014). Also at week 52, the proportion of BICLA responders who met the oral corticosteroid dosing criteria and the proportion who achieved the SLE Responder Index response were greater numerically in the anifrolumab-fnia-treated group than in the placebo-treated group. Additionally, patients who received anifrolumab were also about two times more likely than those who received placebo to achieve a BICLA response sustained through week 52.
No new safety signals were identified in the study.
The study also includes an open-label extension period of 52 weeks for participants who completed the 52-week treatment period.
Conclusion
This clinical trial indicated that the subcutaneous administration of anifrolumab-fnia led to a statistically significant and clinically meaningful reduction in disease activity in patients with moderate to severe, active, autoantibody-positive SLE compared with placebo.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
References
- Highlights of prescribing information: Saphnelo (anifrolumab-fnia) injection. U.S. Food & Drug Administration. 2021 Jul.
- Biologics license application approval letter: Saphnelo (anifrolumab-fnia). U.S. Food & Drug Administration. 2021 Jul 30.
- Saphnelo subcutaneous self-administration recommended for approval in E.U. by CHMP for systemic lupus erythematosus [news release]. AstraZeneca PLC. 2025 Oct 17.
- Subcutaneous anifrolumab in adult patients with systemic lupus erythematosus (Tulip SC) [NCT04877691]. ClinicalTrials.gov. 2025 Oct 23.
- Manzi S, Bruce I, Morand E, et al. Efficacy and safety of subcutaneous anifrolumab in systemic lupus erythematosus: Interim analysis of a phase 3 randomized placebo-controlled study [abstract 1545]. Arthritis Rheumatol. 2025;77(suppl 9).
