Trial reportAnnals of the rheumatic diseases2013
Lupuzor/P140 peptide in patients with systemic lupus erythematosus: a randomised, double-blind, placebo-controlled phase IIb clinical trial.
Trial report in Annals of the rheumatic diseases, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 74 papers, 1 of them a synthesis 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
74 citing papers in PubMed, 1 synthesis or guideline pooled it, 160 citations in OpenAlex.
- Model-based meta-analysis using latent variable modeling to set benchmarks for new treatments of systemic lupus erythematosus.CPT: pharmacometrics & systems pharmacology · 2024Pooled it
- The State-of-the Art of Personalized Vaccines for Non-Communicable Diseases: A Narrative Review.Vaccines · 2026Review
- Mapping organ-associated autoantigenic landscapes in systemic lupus erythematosus.Frontiers in immunology · 2026Review
- Advances in the treatment of systemic lupus erythematosus.Nature reviews. Drug discovery · 2025Review
- Citrullinated peptides as drug candidates for rheumatoid arthritis.Frontiers in immunology · 2025Review
- Immunotargets and Therapy for Systemic Lupus Erythematosus.ImmunoTargets and therapy · 2025Review
- Molecular profiling and therapeutic tailoring to address disease heterogeneity in systemic lupus erythematosus.Clinical and experimental medicine · 2024Review
- Immunotherapeutic approaches for systemic lupus erythematosus: early overview and future potential.Medical review (2021) · 2023Review
- Vaccines for immune tolerance against autoimmune disease.Advanced drug delivery reviews · 2023Review
- Safety and efficacy of biological agents in the treatment of Systemic Lupus Erythematosus (SLE).BMC rheumatology · 2023Article
- Peptide-based immunotherapy in lupus: Where are we now?Rheumatology and immunology research · 2023Review
- Review
- Current Treatment Approach, Emerging Therapies and New Horizons in Systemic Lupus Erythematosus.Life (Basel, Switzerland) · 2023Review
- The role of lysosomes in metabolic and autoimmune diseases.Nature reviews. Nephrology · 2023Review
- Immunological and translational key challenges in systemic lupus erythematosus: A symposium update.Journal of translational autoimmunity · 2023Article
- How autophagy, a potential therapeutic target, regulates intestinal inflammation.Frontiers in immunology · 2023Review
- Article
- Comparison of Responsiveness of British Isles Lupus Assessment Group 2004 Index, Systemic Lupus Erythematosus Disease Activity Index 2000, and British Isles Lupus Assessment Group 2004 Systems Tally.Arthritis care & research · 2022Article
- Therapeutic effects of peptide P140 in a mouse periodontitis model.Cellular and molecular life sciences : CMLS · 2022Article
- Neutrophil-Lymphocyte Ratio Predicting Case Severity in SARS-CoV-2 Infection: A Review.Cureus · 2022Review
14 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo evaluate treatment with the peptide-based agent, Lupuzor, in a double-blind, randomised, placebo-controlled study of patients with systemic lupus erythematosus.
methodsPatients who met ≥4 of the American College of Rheumatology criteria, had a score of ≥6 on the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) and did not have an A score on the British Isles Lupus Assessment Group (BILAG)-2004 scale were eligible. 149 intention-to-treat (ITT) patients were randomly assigned to receive Lupuzor (200 μg) subcutaneously every 4 weeks (n=49; group 1) or every 2 weeks (n=51; group 2) or placebo (n=49; group 3) in addition to standard of care (SOC). A target population (136 ITT patients) consisting of patients having a clinical SLEDAI score ≥6 at week 0 was considered. The clinical SLEDAI score is the SLEDAI-2K score obtained by omitting low complement and increased DNA binding components.
resultsIn the ITT overall population, 53.1% in group 1 (p=0.048), 45.1% in group 2 (p=0.18) and 36.2% in the placebo group achieved an SLE Responder Index (SRI) response at week 12. In the target population, the results were more impressive: 61.9% in group 1 (p=0.016), 48.0% in group 2 (p=0.18) and 38.6% in the placebo group achieved an SRI response at week 12. An interim analysis including 114 patients from the target population demonstrated an even better efficacy (according to SLEDAI score) in group 1 compared with placebo (67.6% vs 41.5% (p<0.025) at week 12 and 84.2% vs 45.8% (p<0.025) at week 24). The most common adverse event was a mild injection-site erythema.
conclusionsLupuzor/200 µg given three times at 4-week intervals during 12 weeks in addition to SOC is efficacious and generally well tolerated.
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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.