Journal article
Efficacy and Safety of Subcutaneous Anifrolumab in Systemic Lupus Erythematosus: the Randomized, Phase 3, TULIP-SC Study
Arthritis & rheumatology (Hoboken, N.J.)
29 Dec 2025
PMID: 41466456
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
The multinational, phase 3, double-blind, placebo-controlled TULIP-SC trial evaluated the efficacy and safety of subcutaneous anifrolumab in adults who have moderate-to-severe SLE activity, despite receiving standard therapy.
Adults with SLE received subcutaneous anifrolumab 120 mg or placebo once weekly for 52 weeks (1:1 randomization). Only the primary endpoint (treatment difference in BILAG-based Composite Lupus Assessment [BICLA] response at 52 weeks) was formally tested in a pre-planned interim analysis; key secondary and other endpoints were tested in the full analysis.
At the interim analysis (220 patients, anifrolumab: n=109; placebo: n=111), the primary endpoint was met (anifrolumab vs placebo: 59.4% vs 43.9%; BICLA response difference [95% confidence interval]=15.5% [2.3-28.6%], p=0.0211). The full analysis included 367 patients (anifrolumab: n=184; placebo: n=183). Versus placebo, more patients treated with anifrolumab attained a BICLA response whilst maintaining low/reduced oral glucocorticoid doses through Week 52 (56.2% vs 34.0%; difference=22.3% [12.3-32.2] p<0.0001), and the time to first sustained BICLA response was reduced (Hazard ratio=2.2 [1.5-3.2]; p<0.0001). Treatment differences in Week 52 DORIS remission and Low Lupus Disease Activity State attainment rates favored anifrolumab over placebo (14.2% [5.6-22.8%], p=0.0012, and 14.1% [4.6-23.6%], p=0.0038). The frequencies of serious adverse events were 11.9% with anifrolumab and 10.4% with placebo; the frequencies of herpes zoster were 3.8% and 1.1%, respectively.
Consistent with the well-established profile of intravenous anifrolumab, subcutaneous anifrolumab demonstrated significant, clinically meaningful treatment benefits when added to standard therapy, and an acceptable safety profile in patients with moderate to severe SLE.
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Details
- Title
- Efficacy and Safety of Subcutaneous Anifrolumab in Systemic Lupus Erythematosus: the Randomized, Phase 3, TULIP-SC Study
- Creators
- Susan Manzi - Allegheny Health NetworkIan N Bruce - Queen's University BelfastEric F Morand - Monash Medical CentreRichard Furie - Northwell HealthYoshiya Tanaka - University of Occupational and Environmental Health JapanKenneth C Kalunian - University of California SystemAnca Askanase - Columbia UniversityPatricia Puzio - AstraZeneca (United States)Emon Khan - AstraZeneca (Spain)Jenny Wissmar - AstraZeneca (Finland)Michael Song - AstraZeneca (Spain)Catharina Lindholm - AstraZeneca (Sweden)The Tulip-Sc Investigators
- Publication Details
- Arthritis & rheumatology (Hoboken, N.J.)
- Publisher
- WILEY; HOBOKEN
- Number of pages
- 10
- Grant note
- AstraZeneca
The authors would like to acknowledge Tomas Rouse of AstraZeneca as Lead Study Statistician.
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- General Internal Medicine
- Web of Science ID
- WOS:001693865000001
- Scopus ID
- 2-s2.0-105031597741
- Other Identifier
- 991022148132104721
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Rheumatology