Trial reportAnnals of the rheumatic diseases2018
Lupus Low Disease Activity State (LLDAS) attainment discriminates responders in a systemic lupus erythematosus trial:
Trial report in Annals of the rheumatic diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
39 citing papers in PubMed.
- Lupus low disease activity state attainment in the phase 3 TULIP trials of anifrolumab in active systemic lupus erythematosus.Annals of the rheumatic diseases · 2023Trial
- What Does It Mean to Be a British Isles Lupus Assessment Group-Based Composite Lupus Assessment Responder? Post Hoc Analysis of Two Phase III Trials.Arthritis & rheumatology (Hoboken, N.J.) · 2021Trial
- Safety and efficacy of low-dose intravenous arsenic trioxide in systemic lupus erythematosus: an open-label phase IIa trial (Lupsenic).Arthritis research & therapy · 2021Trial
- Attainment of treat-to-target endpoints in SLE patients with high disease activity in the atacicept phase 2b ADDRESS II study.Rheumatology (Oxford, England) · 2020Trial
- Real-world treatment patterns and outcomes in moderate-to-severe SLE: findings from the Spanish SPOCS cohort.Lupus science & medicine · 2026Observational
- Type I interferons enhance B cell activation and promote differentiation of double negative 2 cells in SLE.Lupus science & medicine · 2026Article
- 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
- Impact of glucocorticoid dose threshold in definition of lupus low disease activity state: a multinational observational cohort study.Lupus science & medicine · 2025Observational
- 2025 Chinese guidelines for the diagnosis and treatment of systemic lupus erythematosus.Rheumatology and immunology research · 2025Article
- Patient-reported outcomes and healthcare resource utilization in systemic lupus erythematosus: impact of disease activity.BMC rheumatology · 2024Article
- Review
- Association of systemic lupus erythematosus standard of care immunosuppressants with glucocorticoid use and disease outcomes: a multicentre cohort study.Advances in rheumatology (London, England) · 2024Article
- Pragmatic targets for moderate/severe SLE and their implications for clinical care and trial design: sustained DORIS or LLDAS for at least 6 months is sufficient while their attainment for at least 24 months ensures high specificity for damage-free progression.Annals of the rheumatic diseases · 2024Article
- Targeting DORIS Remission and LLDAS in SLE: A Review.Rheumatology and therapy · 2023Review
- Viewpoint on anifrolumab in patients with systemic lupus erythematosus and a high unmet need in clinical practice.RMD open · 2023Article
- Current Treatment Approach, Emerging Therapies and New Horizons in Systemic Lupus Erythematosus.Life (Basel, Switzerland) · 2023Review
- Meeting report: the ALPHA project: a stakeholder meeting on lupus clinical trial outcome measures and the patient perspective.Lupus science & medicine · 2023Article
- Expansion of extrafollicular B and T cell subsets in childhood-onset systemic lupus erythematosus.Frontiers in immunology · 2023Article
- Biological therapy in systemic lupus erythematosus, antiphospholipid syndrome, and Sjögren's syndrome: evidence- and practice-based guidance.Frontiers in immunology · 2023Review
- Impact of remission and low disease activity on health-related quality of life in patients with systemic lupus erythematosus.Rheumatology (Oxford, England) · 2022Article
Corrections and comments
- Commented on by
- Commented on by
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesIn a
methodsPatients received intravenous placebo (n=102) or anifrolumab (300 mg, n=99; 1,000 mg, n=104) Q4W plus standard of care for 48 weeks. LLDAS attainment (SLE Disease Activity Index 2000 ≤4 without major organ activity, no new disease activity, Physician's Global Assessment ≤1, prednisolone ≤7.5 mg/d and standard immunosuppressant dosage tolerance) was assessed. Associations with endpoints and LLDAS attainment differences between treatments were explored.
resultsLLDAS attainment at Week 52 was associated with SLE Responder Index 4 (SRI[4]) and British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) (74/85[87%] and 62/84[74%] were also SRI[4] and BICLA responders, respectively; both nominal p<0.001). Only 74/159 (47%) of SRI(4) and 62/121 (51%) of BICLA responders reached LLDAS.Anifrolumab-treated patients achieved earlier LLDAS, and more spent at least half their observed time in LLDAS (OR vs. placebo; 300 mg: 3.04, 95% CI 1.34 to 6.92, nominal p=0.008; 1,000 mg: 2.17, 95% CI 0.93 to 5.03, nominal p=0.072) vs placebo-treated patients. At Week 52, 17/102 (17%), 39/99 (39%) and 29/104 (28%) of patients on placebo, anifrolumab 300 and 1,000 mg, respectively, attained LLDAS (OR vs. placebo; 300 mg: 3.41, 95% CI 1.73 to 6.76, p<0.001; 1,000 mg: 2.03, 95% CI 1.01 to 4.07, nominal p=0.046).
conclusionsLLDAS attainment represents a clinically meaningful SLE outcome measure, and anifrolumab is associated with more patients who met LLDAS criteria versus placebo. These data support LLDAS as an SLE RCT endpoint. TRIAL REGISTRATION NUMBER: NCT1438489; Post-results.
Indexed as
Identifiers
What OpenQuestion holds
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.