ArticleArthritis and rheumatism2009
Novel evidence-based systemic lupus erythematosus responder index.
Article in Arthritis and rheumatism, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00071487 (A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of LymphoStat-B™ Antibody), which is not on this map. Cited by 181 papers, 8 of them syntheses that pooled it.
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 Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE)
Who cites it
181 citing papers in PubMed, 8 syntheses or guidelines pooled it, 472 citations in OpenAlex.
- Measurement of haemolytic anaemia in a novel treatment response measure for SLE clinical trials.Lupus science & medicine · 2026Pooled it
- CAR-based cellular therapy for refractory systemic lupus erythematosus: an overlap-controlled systematic review.Frontiers in immunology · 2026Pooled it
- Cutaneous efficacy and glucocorticoid-sparing effects of anifrolumab in systemic lupus erythematosus: a systematic review and meta-analysis of randomized controlled trials.Frontiers in immunology · 2026Pooled it
- Model-based meta-analysis using latent variable modeling to set benchmarks for new treatments of systemic lupus erythematosus.CPT: pharmacometrics & systems pharmacology · 2024Pooled it
- Exercise as adjunctive therapy for systemic lupus erythematosus.The Cochrane database of systematic reviews · 2023Pooled it
- Development and preliminary validation of the Sjögren's Tool for Assessing Response (STAR): a consensual composite score for assessing treatment effect in primary Sjögren's syndrome.Annals of the rheumatic diseases · 2022Pooled it
- Anifrolumab for the treatment of active systemic lupus erythematosus: a meta-analysis of randomized controlled trials.Zeitschrift fur Rheumatologie · 2021Pooled it
- Interventions for cutaneous disease in systemic lupus erythematosus.The Cochrane database of systematic reviews · 2021Pooled it
- Low dose IL-2 therapy restores regulatory T cells in patients with systemic lupus erythematosus in a dose-dependent manner: a phase IIb trial.Nature communications · 2026Trial
- Efficacy and safety of anifrolumab in patients with systemic lupus erythematosus without prior immunosuppressant use: post hoc analysis of phase 3 TULIP-1 and TULIP-2 trials.Lupus science & medicine · 2026Trial
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- Trial
- Telitacicept in patients with active systemic lupus erythematosus: results of a phase 2b, randomised, double-blind, placebo-controlled trial.Annals of the rheumatic diseases · 2024Trial
- Evaluation of the LFA-REAL clinician-reported outcome (ClinRO) and patient-reported outcome (PRO): prespecified analysis of the phase III ustekinumab trial in patients with SLE.Lupus science & medicine · 2023Trial
- Deucravacitinib, a Tyrosine Kinase 2 Inhibitor, in Systemic Lupus Erythematosus: A Phase II, Randomized, Double-Blind, Placebo-Controlled Trial.Arthritis & rheumatology (Hoboken, N.J.) · 2023Trial
- B Cell Kinetics upon Therapy Commencement for Active Extrarenal Systemic Lupus Erythematosus in Relation to Development of Renal Flares: Results from Three Phase III Clinical Trials of Belimumab.International journal of molecular sciences · 2022Trial
- Anifrolumab efficacy and safety by type I interferon gene signature and clinical subgroups in patients with SLE: post hoc analysis of pooled data from two phase III trials.Annals of the rheumatic diseases · 2022Trial
- Concordance and discordance in SLE clinical trial outcome measures: analysis of three anifrolumab phase 2/3 trials.Annals of the rheumatic diseases · 2022Trial
- Reductions in circulating B cell subsets and immunoglobulin G levels with long-term belimumab treatment in patients with SLE.Lupus science & medicine · 2022Trial
- Early B Cell and Plasma Cell Kinetics Upon Treatment Initiation Portend Flares in Systemic Lupus Erythematosus: AFrontiers in immunology · 2022Trial
121 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
12 authors at 9 institutions in 1 country.
Funding
Abstract
objectiveTo describe a new systemic lupus erythematosus (SLE) responder index (SRI) based on a belimumab phase II SLE trial and demonstrate its potential utility in SLE clinical trials.
methodsData from a randomized, double-blind, placebo-controlled study in 449 patients of 3 doses of belimumab (1, 4, 10 mg/kg) or placebo plus standard of care therapy (SOC) over a 56-week period were analyzed. The Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) version of the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) and British Isles Lupus Assessment Group (BILAG) SLE disease activity instruments, the Short Form 36 health survey, and biomarker analyses were used to create a novel SRI. Response to treatment in a subset of 321 serologically active SLE patients (antinuclear antibodies >/=1:80 and/or anti-double-stranded DNA antibodies >/=30 IU/ml) at baseline was retrospectively evaluated using the SRI.
resultsSRI response is defined as 1) a >/=4-point reduction in SELENA-SLEDAI score, 2) no new BILAG A or no more than 1 new BILAG B domain score, and 3) no deterioration from baseline in the physician's global assessment by >/=0.3 points. In serologically active patients, the addition of belimumab to SOC resulted in a response in 46% of patients at week 52 compared with 29% of the placebo patients (P = 0.006). SRI responses were independent of baseline autoantibody subtype.
conclusionThis evidence-based evaluation of a large randomized, placebo-controlled trial in SLE resulted in the ability to define a robust responder index based on improvement in disease activity without worsening the overall condition or the development of significant disease activity in new organ systems.
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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.