ArticleArthritis & rheumatology (Hoboken, N.J.)2017
The Biomarkers of Lupus Disease Study: A Bold Approach May Mitigate Interference of Background Immunosuppressants in Clinical Trials.
Article in Arthritis & rheumatology (Hoboken, N.J.), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 2 of them syntheses that pooled it.
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
26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 41 citations in OpenAlex.
- Pooled it
- Pooled it
- 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
- Relationship of anifrolumab pharmacokinetics with efficacy and safety in patients with systemic lupus erythematosus.Rheumatology (Oxford, England) · 2022Trial
- Brief Report: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multiple-Dose Study to Evaluate AMG 557 in Patients With Systemic Lupus Erythematosus and Active Lupus Arthritis.Arthritis & rheumatology (Hoboken, N.J.) · 2018Trial
- Real-world treatment patterns and clinical characteristics in patients with moderate-to-severe systemic lupus erythematosus: an analysis of the SLE Prospective Observational Cohort Study (SPOCS).Lupus science & medicine · 2025Observational
- Systemic lupus erythematosus: pathogenesis and targeted therapy.Molecular biomedicine · 2024Review
- Genetic polymorphisms in genes involved in the type I interferon system (STAT4 and IRF5): association with Asian SLE patients.Clinical rheumatology · 2024Review
- The promise of precision medicine in rheumatology.Nature medicine · 2022Review
- Pre-Clinical Autoimmunity in Lupus Relatives: Self-Reported Questionnaires and Immune Dysregulation Distinguish Relatives Who Develop Incomplete or Classified Lupus From Clinically Unaffected Relatives and Unaffected, Unrelated Individuals.Frontiers in immunology · 2022Article
- Targeting type I interferons in systemic lupus erythematous.Frontiers in pharmacology · 2022Review
- The Pathogenesis, Molecular Mechanisms, and Therapeutic Potential of the Interferon Pathway in Systemic Lupus Erythematosus and Other Autoimmune Diseases.International journal of molecular sciences · 2021Review
- Clinical disease activity and flare in SLE: Current concepts and novel biomarkers.Journal of autoimmunity · 2021Review
- Potential for Antigen-Specific Tolerizing Immunotherapy in Systematic Lupus Erythematosus.Frontiers in immunology · 2021Review
- Quantitative planar array screen of 1000 proteins uncovers novel urinary protein biomarkers of lupus nephritis.Annals of the rheumatic diseases · 2020Article
- Adults with systemic lupus exhibit distinct molecular phenotypes in a cross-sectional study.EClinicalMedicine · 2020Article
- Type I Interferon Predicts an Alternate Immune System Phenotype in Systemic Lupus Erythematosus.ACR open rheumatology · 2019Article
- Immunologic findings precede rapid lupus flare after transient steroid therapy.Scientific reports · 2019Article
- Pathogenesis and treatment of autoimmune rheumatic diseases.Current opinion in rheumatology · 2019Review
- New therapeutic strategies in systemic lupus erythematosus management.Nature reviews. Rheumatology · 2019Review
Corrections and comments
- Commented on by
Authors and funding
13 authors at 3 institutions in 1 country.
Funding
Abstract
objectiveMolecular medicine raised expectations for strategically targeted biologic agents in systemic lupus erythematosus (SLE), but clinical trial results have been disappointing and difficult to interpret. Most studies add investigational agents to various, often effective, standard therapy immunosuppressants used at baseline, with unknown treatment interactions. Eliminating polypharmacy in trials of active lupus remains controversial. We undertook the Biomarkers of Lupus Disease study to test withdrawal of immunosuppressants as a novel approach to rendering SLE trials interpretable.
methodsIn 41 patients with active, non-organ-threatening SLE flare (group A), temporary steroids were given while background immunosuppressants were withdrawn. Time to loss of disease suppression (time to disease flare) and safety were evaluated; standard therapy was immediately resumed when symptoms recurred. Immunologic impacts of standard therapy were studied at baseline by multiplex assay, enzyme-linked immunosorbent assay, and messenger RNA array in group A patients plus 62 additional patients donating a single sample (group B).
resultsPatients with lower or higher baseline disease activity had median times to flare of 71 or 45 days, respectively; 40 of 41 patients (98%) had disease flares by 6 months. All flares were treated and resolved within 6 weeks. No serious adverse events occurred from flare or infection. Type I interferon (IFN), Th17, and B lymphocyte stimulator pathways tracked together. Baseline immunosuppressants had distinct impacts on Th17 and B lymphocyte stimulator, depending on IFN signature.
conclusionTrials in active, non-organ-threatening SLE can safely withdraw background treatments if patients who have disease flares are designated nonresponders and returned to standard therapy. Immunologic effects of standard therapy vary between IFN-defined subsets. These findings provide a strategy for minimizing or optimizing treatment combinations in lupus trials and clinical care.
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.