Trial reportAnnals of the rheumatic diseases2023
Lupus low disease activity state attainment in the phase 3 TULIP trials of anifrolumab in active systemic lupus erythematosus.
Trial report in Annals of the rheumatic diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 26 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus
A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus
Who cites it
26 citing papers in PubMed, 61 citations in OpenAlex.
- Real-world outcomes after anifrolumab initiation in systemic lupus erythematosus: a pragmatic treat-to-target analysis.Clinical rheumatology · 2026Article
- Real-world treatment patterns and outcomes in moderate-to-severe SLE: findings from the Spanish SPOCS cohort.Lupus science & medicine · 2026Observational
- Comparison of BAFF and type I IFN activity in blood and placenta in SLE and healthy pregnancies.Lupus science & medicine · 2026Article
- Real-world experience of anifrolumab treatment in patients with moderate-to-severe SLE: a retrospective study of patients in early access programmes.Lupus science & medicine · 2026Observational
- Reduction in Renal Relapse and Preservation of Long-Term Kidney Function After Lupus Low Disease Activity in Patients With Lupus Nephritis.Arthritis care & research · 2026Article
- Targeting STAT3 in systemic lupus erythematosus and lupus nephritis: mechanisms, therapeutic advances, and structure-informed perspectives.Frontiers in pharmacology · 2026Review
- Advances in the treatment of systemic lupus erythematosus.Nature reviews. Drug discovery · 2025Review
- Impact of glucocorticoid dose threshold in definition of lupus low disease activity state: a multinational observational cohort study.Lupus science & medicine · 2025Observational
- Anifrolumab for Nonsystemic Cutaneous Lupus Erythematosus: Clinical Experience, Immunologic Insights, and Review of the Literature.Journal of clinical medicine · 2025Article
- Prevalence and outcomes of a pilot definition of severe refractory systemic lupus erythematosus: observations from a multinational Asia-Pacific cohort.Arthritis research & therapy · 2025Article
- Immune cell aberrations in Systemic Lupus Erythematosus: navigating the targeted therapies toward precision management.Cellular & molecular biology letters · 2025Review
- Observational
- Characteristics and clinical outcomes of patients with systemic lupus erythematosus initiating anifrolumab in a real-world setting in Spain (AZAHAR study): an observational study protocol.Lupus science & medicine · 2025Article
- Advances in Targeted Therapy for Systemic Lupus Erythematosus: Current Treatments and Novel Approaches.International journal of molecular sciences · 2025Review
- Type I interferon signature: a quantitative standardized method for clinical application.Clinical and experimental immunology · 2025Article
- Immunotargets and Therapy for Systemic Lupus Erythematosus.ImmunoTargets and therapy · 2025Review
- Patients achieving low lupus disease activity state, systemic lupus erythematosus disease control or remission showed lower rates of organ damage during longitudinal follow-up: analysis of the Hopkins Lupus Cohort.Lupus science & medicine · 2024Article
- Characterisation and outcomes of different subsets of low disease activity states in patients with systemic lupus erythematosus.Lupus science & medicine · 2024Article
- Challenges and opportunities in access to care for systemic lupus erythematosus patients across Europe and worldwide.Rheumatology (Oxford, England) · 2024Review
- The NYMERIA Study: A Real-World, Multicentre Contemporary Assessment of Disease- and Patient-Related Burden and Treatment Strategies in Patients with Systemic Lupus Erythematosus.Mediterranean journal of rheumatology · 2024Article
Corrections and comments
- Erratum issuedCorrection:2024
Authors and funding
5 authors at 4 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesIn patients with systemic lupus erythematosus (SLE), lupus low disease activity state (LLDAS) attainment is associated with improved outcomes. We investigated LLDAS attainment in anifrolumab-treated patients.
methodsWe performed post hoc analysis of pooled Treatment of Uncontrolled Lupus via the Interferon Pathway (TULIP-1) (NCT02446912) and TULIP-2 (NCT02446899) anifrolumab phase 3 trial data in patients with moderate to severe SLE receiving standard therapy. LLDAS was defined as: SLE Disease Activity Index 2000 ≤4 without major organ activity, no new disease activity, Physician's Global Assessment ≤1, prednisone ≤7.5 mg/day and no non-standard immunosuppressant dosing. Time to first LLDAS attainment was compared between groups using Cox regression modelling; responses were compared using logistic regression.
resultsAgnostic to treatment, 205/819 (25.0%) patients attained LLDAS at week 52; 186/205 (90.7%) were also British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA)-responders. Among BICLA-responders at week 52, 186/318 (58.5%) attained LLDAS; 203/380 (53.4%) SLE Responder Index-4 (SRI(4)) responders attained LLDAS. Improvements from baseline in patient global assessment scores at week 52 were threefold greater in LLDAS-attainers. At week 52, 30.0% of anifrolumab-treated patients and 19.6% of placebo were in LLDAS (OR 1.8, 95% CI 1.3 to 2.5, p=0.0011). Compared with placebo, anifrolumab treatment was associated with earlier LLDAS attainment (time to first LLDAS, HR 1.76, 95% CI 1.35 to 2.30, p<0.0001), increased cumulative time in LLDAS (p<0.0001) and higher likelihood of sustained LLDAS (p<0.001). Anifrolumab treatment was also associated with higher rates of Definition of Remission in SLE remission at week 52 (15.3% vs 7.6%; OR 2.2, 95% CI 1.4 to 3.6, p=0.0013).
conclusionsLLDAS attainment was highly associated with, but more stringent than, BICLA and SRI(4) responses. Compared with placebo, anifrolumab treatment was associated with earlier, more frequent, and more prolonged and sustained LLDAS. TRIAL REGISTRATION NUMBERS: NCT02446912 and NCT02446899.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.