Trial reportThe Journal of clinical investigation2019
Monoclonal antibody targeting BDCA2 ameliorates skin lesions in systemic lupus erythematosus.
Trial report in The Journal of clinical investigation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02106897 (A Single-Ascending-Dose and Multiple-Ascending-Dose Study of BIIB059 in Healthy Volunteers and Subjects With Systemic Lupus Erythematosus), which is not on this map. Cited by 149 papers, 5 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 Single-Ascending-Dose and Multiple-Ascending-Dose Study of BIIB059 in Healthy Volunteers and Subjects With Systemic Lupus Erythematosus
Who cites it
149 citing papers in PubMed, 5 syntheses or guidelines pooled it, 289 citations in OpenAlex.
- Placebo Response in Randomised Controlled Trials of Systemic Therapies for Cutaneous Lupus Erythematosus: A Systematic Review and Meta-Analysis.Pharmaceutical medicine · 2026Pooled it
- Targeted therapies against type I interferon and TNF-alpha in cutaneous lupus erythematosus: A systematic review of randomized trials.Dermatology online journal · 2026Pooled it
- Pooled it
- Pooled it
- Interventions for cutaneous disease in systemic lupus erythematosus.The Cochrane database of systematic reviews · 2021Pooled it
- Litifilimab efficacy on skin outcomes in cutaneous lupus erythematosus in the Phase 2 LILAC study.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026Trial
- Pharmacodynamic Effects of Litifilimab in Lupus in a Randomized, Placebo-Controlled Phase 2 Study: Rapid and Sustained Reductions in Type I Interferon-Associated Gene Expression and Cytokines.Arthritis & rheumatology (Hoboken, N.J.) · 2025Trial
- Filgotinib or lanraplenib in moderate to severe cutaneous lupus erythematosus: a phase 2, randomized, double-blind, placebo-controlled study.Rheumatology (Oxford, England) · 2022Trial
- Phase 1 double-blind randomized safety trial of the Janus kinase inhibitor tofacitinib in systemic lupus erythematosus.Nature communications · 2021Trial
- A clinical population pharmacokinetic/pharmacodynamic model for BIIB059, a monoclonal antibody for the treatment of systemic and cutaneous lupus erythematosus.Journal of pharmacokinetics and pharmacodynamics · 2020Trial
- Reactive oxygen species and metabolic checkpoints shape plasmacytoid dendritic cell fate in infection and autoimmunity.Redox biology · 2026Review
- Persistent cutaneous lupus erythematosus: A pathway toward systemic disease?Journal of translational autoimmunity · 2026Review
- Genetic Polymorphisms in Systemic Lupus Erythematosus and Their Clinical Implications: A Narrative Review.International journal of molecular sciences · 2026Review
- Recommendations for the use of CLASI as an outcome measure in cutaneous lupus erythematosus clinical trials.Nature reviews. Rheumatology · 2026Review
- Targeting the pDC/IFN-I axis in HIV-1 immunotherapy.Current opinion in HIV and AIDS · 2026Review
- Treatment strategies for rituximab-resistant primary membranous nephropathy: from resistance mechanisms to emerging therapies.Frontiers in immunology · 2026Review
- Plasmacytoid dendritic cells in systemic and cutaneous lupus erythematosus: an evolving understanding.Frontiers in immunology · 2026Review
- TLR7 and TLR9 have overlapping but distinct roles in systemic lupus erythematosus and Sjögren's disease.Frontiers in immunology · 2026Review
- BDCA2 plays a central role in the binding, internalization and response of plasmacytoid dendritic cells to vidutolimod.Frontiers in immunology · 2026Article
- Regulation and Mechanism of Deleted in Breast Cancer-1 on Dendritic Cell Function in Systemic Lupus Erythematosus.MedComm · 2026Article
89 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
16 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPlasmacytoid DCs (pDC) produce large amounts of type I IFN (IFN-I), cytokines convincingly linked to systemic lupus erythematosus (SLE) pathogenesis. BIIB059 is a humanized mAb that binds blood DC antigen 2 (BDCA2), a pDC-specific receptor that inhibits the production of IFN-I and other inflammatory mediators when ligated. A first-in-human study was conducted to assess safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) effects of single BIIB059 doses in healthy volunteers (HV) and patients with SLE with active cutaneous disease as well as proof of biological activity and preliminary clinical response in the SLE cohort.
methodsA randomized, double-blind, placebo-controlled clinical trial was conducted in HV (n = 54) and patients with SLE (n = 12). All subjects were monitored for adverse events. Serum BIIB059 concentrations, BDCA2 levels on pDCs, and IFN-responsive biomarkers in whole blood and skin biopsies were measured. Skin disease activity was determined using the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A).
resultsSingle doses of BIIB059 were associated with favorable safety and PK profiles. BIIB059 administration led to BDCA2 internalization on pDCs, which correlated with circulating BIIB059 levels. BIIB059 administration in patients with SLE decreased expression of IFN response genes in blood, normalized MxA expression, reduced immune infiltrates in skin lesions, and decreased CLASI-A score.
conclusionsSingle doses of BIIB059 were associated with favorable safety and PK/PD profiles and robust target engagement and biological activity, supporting further development of BIIB059 in SLE. The data suggest that targeting pDCs may be beneficial for patients with SLE, especially those with cutaneous manifestations.
trial registrationClinicalTrials.gov NCT02106897.
fundingBiogen Inc.
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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.