ArticleArthritis & rheumatology (Hoboken, N.J.)2018
Efficacy of Epratuzumab, an Anti-CD22 Monoclonal IgG Antibody, in Systemic Lupus Erythematosus Patients With Associated Sjögren's Syndrome: Post Hoc Analyses From the EMBODY Trials.
Article in Arthritis & rheumatology (Hoboken, N.J.), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 35 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.
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease
Who cites it
35 citing papers in PubMed, 1 synthesis or guideline pooled it, 70 citations in OpenAlex.
- British Society for Rheumatology guideline on management of adult and juvenile onset Sjögren disease.Rheumatology (Oxford, England) · 2025Guideline
- Inflammasomes in Sjögren's Disease: Exploring the Therapeutic Value.International journal of molecular sciences · 2026Review
- Identification of gene modules associated with B cell activation and tissue remodeling in primary Sjögren's syndrome.BMC immunology · 2025Article
- Sjögren's Syndrome: Epidemiology, Classification Criteria, Molecular Pathogenesis, Diagnosis, and Treatment.MedComm · 2025Review
- 2023 International Rome consensus for the nomenclature of Sjögren disease.Nature reviews. Rheumatology · 2025Article
- Salivary gland transcriptomic analysis and immunophenotyping in the IL-14α transgenic mouse model of Sjögren's disease.Frontiers in dental medicine · 2025Article
- Review
- Update on the pathophysiology and treatment of primary Sjögren syndrome.Nature reviews. Rheumatology · 2024Review
- Concomitant Sjögren's disease as a biomarker for treatment effectiveness in rheumatoid arthritis - results from the Swiss clinical quality management cohort.Arthritis research & therapy · 2024Observational
- Emerging biologic frontiers for Sjogren's syndrome: Unveiling novel approaches with emphasis on extra glandular pathology.Frontiers in pharmacology · 2024Review
- Investigative biological therapies for primary Sjögren's syndrome.Archives of medical science : AMS · 2024Article
- Current Treatment Approach, Emerging Therapies and New Horizons in Systemic Lupus Erythematosus.Life (Basel, Switzerland) · 2023Review
- The Role of Regulatory T Cells in the Onset and Progression of Primary Sjögren's Syndrome.Cells · 2023Review
- Xerostomia: From Pharmacological Treatments to Traditional Medicine-An Overview on the Possible Clinical Management and Prevention Using Systemic Approaches.Current oncology (Toronto, Ont.) · 2023Review
- Impact of Siglecs on autoimmune diseases.Molecular aspects of medicine · 2023Review
- Heterogeneity of antibody-secreting cells infiltrating autoimmune tissues.Frontiers in immunology · 2023Review
- Promising Experimental Treatments for Lupus Nephritis: Key Talking Points and Potential Opportunities.Research and reports in urology · 2023Review
- Conformationally Constrained Sialyl Analogues as New Potential Binders of h-CD22.Chembiochem : a European journal of chemical biology · 2022Article
- The full range of ophthalmological clinical manifestations in systemic lupus erythematosus.Frontiers in ophthalmology · 2022Article
- New developments in Sjogren's syndrome.Rheumatology (Oxford, England) · 2021Review
Corrections and comments
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Authors and funding
17 authors at 10 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveEMBODY 1 (ClinicalTrials.gov identifier: NCT01262365) and EMBODY 2 (ClinicalTrials.gov identifier: NCT01261793) investigated the efficacy and safety of epratuzumab, a CD22-targeted humanized monoclonal IgG antibody, in patients with systemic lupus erythematosus (SLE). The studies showed no significant difference from placebo in primary or secondary clinical outcome measures but did demonstrate B cell-specific immunologic activity. The aim of this post hoc analysis was to determine whether epratuzumab had a different clinical efficacy profile in SLE patients with versus those without an associated diagnosis of Sjögren's syndrome (SS).
methodsThe efficacy and safety of epratuzumab were compared between 2 patient subpopulations randomized in EMBODY 1 and 2: SLE patients with and those without a diagnosis of associated SS. British Isles Lupus Assessment Group (BILAG) total score, BILAG-based Combined Lupus Assessment (BICLA) clinical response to treatment, biologic markers (including B cells, IgG, IgM, and IgA), and safety were assessed.
resultsA total of 1,584 patients were randomized in the EMBODY 1 and EMBODY 2 trials; 113 patients were anti-SSA positive and had a diagnosis of associated SS, and 1,375 patients (86.8%) had no diagnosis of associated SS (918 patients were randomized to receive epratuzumab and 457 to receive placebo). For patients with associated SS, but not those without associated SS, a higher proportion of patients receiving epratuzumab achieved a BICLA response and a reduction from baseline in BILAG total score. B cell reduction was faster in patients with associated SS. The sensitivity of B cells to epratuzumab as measured by the mean concentration producing 50% of the maximum B cell count depletion was lower for patients with associated SS (9.5 μg/ml) versus the total EMBODY population (87.1 μg/ml). No difference in the frequency of adverse events in those receiving placebo was reported.
conclusionPatients with SLE and associated SS treated with epratuzumab showed improvement in SLE disease activity, which was associated with bioactivity, such as decreases in B cell number and IgM level.
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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.