Weekly Subcutaneous Anifrolumab Improves Disease Control in Lupus: Phase 3 TULIP-SC Trial
Written By : Medha Baranwal
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2026-02-19 15:00 GMT | Update On 2026-02-19 15:01 GMT
USA: Subcutaneous anifrolumab significantly improved disease control in adults with moderate to severe systemic lupus erythematosus (SLE) who remained active despite standard therapy, findings from the phase 3 TULIP-SC trial published in Arthritis & Rheumatology. The study was led by Susan Manzi of the Lupus Center of Excellence, Autoimmunity Institute, Allegheny Health Network, Pittsburgh, and international collaborators.
Anifrolumab, a type I interferon receptor antagonist, is already approved as an intravenous (IV) therapy for SLE. The TULIP-SC trial was designed to evaluate whether a weekly subcutaneous (SC) formulation could offer similar efficacy and safety while potentially improving convenience and access.
This multinational, randomized, double-blind, placebo-controlled phase 3 study enrolled adults with moderate to severe SLE. Participants were randomly assigned in a 1:1 ratio to receive either subcutaneous anifrolumab 120 mg or placebo once weekly for 52 weeks, in addition to their background standard-of-care therapy.
The primary endpoint was the proportion of patients achieving a BILAG-based Composite Lupus Assessment (BICLA) response at week 52.
The study led to the following findings:
- In the preplanned interim analysis of 220 patients, the primary endpoint was achieved, with nearly 60% of patients in the anifrolumab group attaining a BICLA response compared with 43.9% in the placebo group.
- In the full analysis of 367 patients, a higher proportion of patients receiving anifrolumab achieved a BICLA response while maintaining low or reduced oral glucocorticoid doses through week 52 compared with placebo.
- Patients treated with anifrolumab experienced a shorter time to first sustained BICLA response.
- Greater proportions of patients in the anifrolumab group achieved DORIS-defined remission at week 52 compared with placebo.
- Attainment of Low Lupus Disease Activity State at week 52 was also higher with anifrolumab than with placebo.
- Serious adverse events occurred at comparable rates in the anifrolumab and placebo groups.
- Herpes zoster was reported more frequently in the anifrolumab group, although overall incidence remained low.
The investigators acknowledged certain limitations. Although the primary endpoint was analyzed at an interim stage, this was prespecified in the study design, and eligibility criteria and procedures remained unchanged between interim and final analyses. Importantly, patients with severe or unstable neuropsychiatric lupus or active severe lupus nephritis were excluded, limiting the applicability of results to those populations.
Overall, weekly subcutaneous anifrolumab demonstrated meaningful clinical benefits with an acceptable safety profile when added to standard therapy in patients with moderate to severe SLE. The availability of a subcutaneous formulation may provide a practical at-home alternative to monthly intravenous infusions, potentially expanding treatment accessibility for individuals living with lupus.
Reference:
Manzi, S., Bruce, I. N., Morand, E. F., Furie, R., Tanaka, Y., Kalunian, K. C., Askanase, A., Puzio, P., Khan, E., Wissmar, J., Song, M., & Lindholm, C. Efficacy and Safety of Subcutaneous Anifrolumab in Systemic Lupus Erythematosus: A Randomized, Phase 3 Study. Arthritis & Rheumatology. https://doi.org/10.1002/art.70041
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.