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  1. Article ; Online: Clinical characteristics and symptom progression of dermatomyositis subtypes: A retrospective analysis of a prospective database.

    Pandya, Rachita / Kleitsch, Julianne / Lim, Darosa / Werth, Victoria P

    Journal of the American Academy of Dermatology

    2024  

    Abstract: Background: Disease characteristics of classic dermatomyositis (DM) and clinically amyopathic DM (CADM) are well established, but there exists limited knowledge on the disease progression of these subtypes.: Objective: The objective of this study was ...

    Abstract Background: Disease characteristics of classic dermatomyositis (DM) and clinically amyopathic DM (CADM) are well established, but there exists limited knowledge on the disease progression of these subtypes.
    Objective: The objective of this study was to longitudinally track and characterize classic DM and CADM patients who experience changes in disease presentation.
    Methods: We conducted a retrospective review of prospectively collected data on 269 DM patients from a longitudinal database.
    Results: A total of 51% of the patients had classic DM and 49% had CADM. Forty percent of the classic DM patients became postmyopathic (PmDM). Median Cutaneous Dermatomyositis Disease Area and Severity Index activity (CDASI-A) score was lower in PmDM patients than in classic DM patients (13.0 vs 16.0), but 45% of the PmDM patients had CDASI-A scores > 14. Five percent of the CADM patients developed muscle involvement. Compared with CADM patients, those who developed muscle symptoms had milder skin disease before subtype conversion (median CDASI-A 12.0 vs 16.0) and at subtype conversion (median CDASI-A 9.0 vs 16.0).
    Limitations: This was a retrospective study conducted at a single tertiary-care dermatology clinic.
    Conclusions: Forty percent of the classic DM patients became PmDM. The majority continue with muscle disease, and many continue to have moderate/severe skin disease. CADM has a low risk of progressing to muscle disease, with the extent of skin disease as a potential predictive factor.
    Language English
    Publishing date 2024-02-09
    Publishing country United States
    Document type Journal Article
    ZDB-ID 603641-7
    ISSN 1097-6787 ; 0190-9622
    ISSN (online) 1097-6787
    ISSN 0190-9622
    DOI 10.1016/j.jaad.2024.02.007
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  2. Article: Evaluation of RNase therapy in systemic lupus erythematosus: a randomised phase 2a clinical trial of RSLV-132.

    Burge, Daniel J / Werth, Victoria P / Boackle, Susan A / Posada, James

    Lupus science & medicine

    2024  Volume 11, Issue 1

    Abstract: Background: Circulating, extracellular RNA is the primary trigger of type I interferon in systemic lupus erythematosus (SLE), and interferon is known to play a central pathogenic role in the disease. RSLV-132 is a catalytically active human RNase ... ...

    Abstract Background: Circulating, extracellular RNA is the primary trigger of type I interferon in systemic lupus erythematosus (SLE), and interferon is known to play a central pathogenic role in the disease. RSLV-132 is a catalytically active human RNase molecule fused to human IgG1 Fc designed to digest RNA and thereby decrease the chronic inflammation associated with SLE. The drug was evaluated in a cohort of patients with SLE with moderate-severe cutaneous disease activity and the presence of RNA immune complexes. The primary objective of the study was the assessment of the impact of 13 doses of 10 mg/kg RSLV-132 over 6 months on the mean Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) score.
    Methods: Sixty-five patients meeting the entry criteria of a baseline CLASI score of 10 or greater and positivity of at least one of five autoantibodies to RNA-binding proteins (SM/RNP, SSA/Ro, SSB/La, Sm, RNP) were randomly assigned (2:1) to receive 13 doses of RSLV-132 10 mg/kg or placebo, respectively. Participants received study drug for 24 weeks on days 1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141 and 155 with an end-of-treatment visit on day 169 and a follow-up visit at the end of the study on day 215. The primary objective was assessed on days 85 and 169. Secondary objectives included assessment of systemic disease activity using the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), the British Isles Lupus Assessment Group 2004 Index and the Physician's Global Assessment. Data from these instruments were used to calculate the SLE Responder Index 4 (SRI-4) and the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) scores.
    Results: The mean CLASI score change from baseline at day 169 was -5.7 (±7.0) in the placebo group and -6.2 (±8.5) in the RSLV-132 group. A subgroup of participants with moderate-severe systemic disease activity and high baseline SLEDAI scores (≥9) were analysed with respect to BICLA and SRI-4 responses. The RSLV-132 treated participants in the high SLEDAI subgroup had a greater percentage of BICLA responses (62% vs 44%) and SRI-4 responses (23% vs 11%) as compared with placebo. A second subgroup of participants with high baseline CLASI scores (≥21) were analysed with respect to BICLA and SRI-4 responses. The RSLV-132 treated participants in the high CLASI subgroup had a greater percentage of BICLA responses (28% vs 8%) and SRI-4 responses (39% vs 8%) as compared with placebo.
    Conclusions: Six months of RSLV-132 therapy consisting of a weekly loading dose of RSLV-132 for 1 month, followed by 5 months of biweekly administrations did not significantly improve the mean CLASI score relative to placebo in this cohort of patients with SLE. The study entry criteria selected patients with moderate-severe cutaneous disease activity and no minimum SLEDAI score, which resulted in a wide range of systemic disease activity from inactive to severe as measured by SLEDAI. When the participants with higher SLEDAI and CLASI scores were analysed, a trend towards clinical improvement favouring RSLV-132 was observed. The results warrant further evaluation of RSLV-132 in SLE and suggest that patients with more active systemic disease are most likely to benefit from RNase therapy.
    MeSH term(s) Humans ; Lupus Erythematosus, Systemic ; Antibodies, Monoclonal, Humanized/therapeutic use ; Treatment Outcome ; Ribonucleases/therapeutic use ; Immunoglobulin G/therapeutic use ; Lupus Erythematosus, Discoid/chemically induced ; Lupus Erythematosus, Discoid/drug therapy ; RNA/therapeutic use ; Recombinant Fusion Proteins
    Chemical Substances RSLV-132 (6RQ92PNH8Z) ; Antibodies, Monoclonal, Humanized ; Ribonucleases (EC 3.1.-) ; Immunoglobulin G ; RNA (63231-63-0) ; Recombinant Fusion Proteins
    Language English
    Publishing date 2024-02-07
    Publishing country England
    Document type Randomized Controlled Trial ; Clinical Trial, Phase II ; Journal Article
    ZDB-ID 2779620-6
    ISSN 2053-8790
    ISSN 2053-8790
    DOI 10.1136/lupus-2023-001113
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  3. Article ; Online: Extracellular Vesicles in the Pathogenesis, Clinical Characterization, and Management of Dermatomyositis: A Narrative Review.

    Ricco, Cristina / Eldaboush, Ahmed / Liu, Ming-Lin / Werth, Victoria P

    International journal of molecular sciences

    2024  Volume 25, Issue 4

    Abstract: Extracellular vesicles (EVs) are lipid-bilayer particles secreted from cells that primarily assist in cell-to-cell communication through the content of their cargo, such as proteins and RNA. EVs have been implicated in the pathogenesis of various ... ...

    Abstract Extracellular vesicles (EVs) are lipid-bilayer particles secreted from cells that primarily assist in cell-to-cell communication through the content of their cargo, such as proteins and RNA. EVs have been implicated in the pathogenesis of various autoimmune diseases, including dermatomyositis (DM), an inflammatory autoimmune disease characterized by distinct cutaneous manifestations, myopathy, and lung disease. We sought to review the role of EVs in DM and understand how they contribute to the pathogenesis and clinical characterization of the disease. We summarized the research progress on EVs in dermatomyositis based on recent publications. EV cargoes, such as double-stranded DNA, microRNA, and proteins, contribute to DM pathogenesis and mediate the proinflammatory response and cytokine release through signaling pathways such as the stimulator of interferon genes (STING) pathway. These nucleic acids and proteins have been proposed as disease-specific, stable biomarkers to monitor disease activity and responses to therapy. They also correlate with clinical parameters, inflammatory markers, and disease severity scores. Furthermore, some markers show an association with morbidities of DM, such as muscle weakness and interstitial lung disease. The continued study of EVs will help us to further elucidate our understanding of dermatomyositis.
    MeSH term(s) Humans ; Dermatomyositis/diagnosis ; Dermatomyositis/therapy ; Dermatomyositis/metabolism ; Extracellular Vesicles/metabolism ; MicroRNAs/genetics ; MicroRNAs/metabolism ; Lung Diseases, Interstitial/diagnosis ; Lung Diseases, Interstitial/etiology ; Lung Diseases, Interstitial/therapy ; Nucleic Acids/metabolism ; Proteins/metabolism ; Exosomes/metabolism
    Chemical Substances MicroRNAs ; Nucleic Acids ; Proteins
    Language English
    Publishing date 2024-02-06
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 2019364-6
    ISSN 1422-0067 ; 1422-0067 ; 1661-6596
    ISSN (online) 1422-0067
    ISSN 1422-0067 ; 1661-6596
    DOI 10.3390/ijms25041967
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  4. Book: Medical dermatology

    Werth, Victoria P.

    (Dermatologic clinics ; 19,4)

    2001  

    Author's details Victoria P. Werth ..., guest ed
    Series title Dermatologic clinics ; 19,4
    Collection
    Language English
    Size X S., S. 583 - 815 : zahlr. Ill.
    Publisher Saunders
    Publishing place Philadelphia u.a.
    Publishing country United States
    Document type Book
    HBZ-ID HT013203758
    Database Catalogue ZB MED Medicine, Health

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    Shelf markLoan statusLocation
    Se 851 -19,4- verfügbar in Königswinter Königswinter

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  5. Article ; Online: Trial of intravenous immunoglobulin in dermatomyositis: a critically appraised research paper.

    Pandya, Rachita / Kleitsch, Julianne / Werth, Victoria P

    The British journal of dermatology

    2023  Volume 188, Issue 6, Page(s) 738–739

    MeSH term(s) Humans ; Dermatomyositis/drug therapy ; Immunoglobulins, Intravenous/therapeutic use
    Chemical Substances Immunoglobulins, Intravenous
    Language English
    Publishing date 2023-03-20
    Publishing country England
    Document type Clinical Trial ; Journal Article
    ZDB-ID 80076-4
    ISSN 1365-2133 ; 0007-0963
    ISSN (online) 1365-2133
    ISSN 0007-0963
    DOI 10.1093/bjd/ljad044
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  6. Article ; Online: Emerging immunotherapeutic strategies for cutaneous lupus erythematosus: an overview of recent phase 2 and 3 clinical trials.

    Lim, Darosa / Kleitsch, Julianne / Werth, Victoria P

    Expert opinion on emerging drugs

    2023  Volume 28, Issue 4, Page(s) 257–273

    Abstract: Introduction: Cutaneous lupus erythematosus (CLE) is an autoimmune disease that is clinically heterogenous and may occur with or without the presence of systemic lupus erythematosus (SLE). While existing on a spectrum, CLE and SLE present differences in ...

    Abstract Introduction: Cutaneous lupus erythematosus (CLE) is an autoimmune disease that is clinically heterogenous and may occur with or without the presence of systemic lupus erythematosus (SLE). While existing on a spectrum, CLE and SLE present differences in their underlying pathogenesis and therapeutic responses. No new therapies have been approved in recent decades by the U.S. Food and Drug Administration for CLE, although frequently refractory to conventional therapies. There is an unmet need to develop effective drugs for CLE as it significantly impacts patients' quality of life and may leave irreversible disfiguring damage.
    Areas covered: This review provides an update on the latest phase 2 and 3 clinical trials performed in CLE or SLE using skin-specific outcome measures. Emergent therapies are presented alongside their mechanism of action as recent translational studies have permitted identification of critical targets among immune cells and/or pathways involved in CLE.
    Expert opinion: While the recent literature has few trials for CLE, drugs targeting type I interferon, its downstream signaling and plasmacytoid dendritic cells have shown promising results. Further research is required to develop long-awaited effective therapies, and this review highlights the importance of implementing trials dedicated to CLE to fill the current gap in CLE therapeutics.
    MeSH term(s) Humans ; Quality of Life ; Lupus Erythematosus, Cutaneous/drug therapy ; Lupus Erythematosus, Cutaneous/etiology ; Skin/pathology ; Lupus Erythematosus, Systemic/drug therapy ; Lupus Erythematosus, Systemic/complications ; Immunotherapy
    Language English
    Publishing date 2023-12-26
    Publishing country England
    Document type Journal Article ; Review ; Research Support, N.I.H., Extramural ; Research Support, U.S. Gov't, Non-P.H.S.
    ZDB-ID 2061369-6
    ISSN 1744-7623 ; 1472-8214
    ISSN (online) 1744-7623
    ISSN 1472-8214
    DOI 10.1080/14728214.2023.2273536
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  7. Article ; Online: Litifilimab (BIIB059), a promising investigational drug for cutaneous lupus erythematosus.

    Cho, Sung Kyung / Vazquez, Thomas / Werth, Victoria P

    Expert opinion on investigational drugs

    2023  Volume 32, Issue 5, Page(s) 345–353

    Abstract: Introduction: There are no U.S. Food and Drug Administration (FDA) approved therapies for cutaneous lupus erythematosus (CLE). Litifilimab is a monoclonal antibody against BDCA2, a plasmacytoid dendritic cell-specific antigen, currently under ... ...

    Abstract Introduction: There are no U.S. Food and Drug Administration (FDA) approved therapies for cutaneous lupus erythematosus (CLE). Litifilimab is a monoclonal antibody against BDCA2, a plasmacytoid dendritic cell-specific antigen, currently under investigation for systemic lupus erythematosus (SLE) and CLE. The LILAC study, published in the New England Journal of Medicine, is a phase II randomized controlled trial for CLE which demonstrated superiority of Litifilimab over placebo using a skin directed outcome measure.
    Areas covered: This review identifies challenges that have hindered the development of any approved treatments for CLE, recent SLE trials that include skin disease data, and the pharmacological properties of litifilimab. We review the clinical efficacy and safety of litifilimab for both SLE and CLE in the phase I and II clinical trials. This review aims to highlight the need for more CLE-specific clinical trials and examine the potential of litifilimab as the first FDA approved therapy for CLE. (Clinical trial registration: www.clinicaltrials.gov identifier is NCT02847598.).
    Expert opinion: Litifilimab demonstrated efficacy in a randomized phase II clinical trial as a standalone CLE trial using validated skin-specific outcome measures, making it the first successful clinical trial for a CLE targeted therapy. If approved, litifilimab will be a pivotal change in the landscape of CLE management especially for severe and refractory disease.
    MeSH term(s) Humans ; Drugs, Investigational/therapeutic use ; Lupus Erythematosus, Cutaneous/drug therapy ; Skin ; Antibodies, Monoclonal ; Lupus Erythematosus, Systemic/drug therapy ; Randomized Controlled Trials as Topic ; Clinical Trials, Phase II as Topic
    Chemical Substances Drugs, Investigational ; Antibodies, Monoclonal
    Language English
    Publishing date 2023-05-15
    Publishing country England
    Document type Review ; Journal Article
    ZDB-ID 1182884-5
    ISSN 1744-7658 ; 0967-8298 ; 1354-3784
    ISSN (online) 1744-7658
    ISSN 0967-8298 ; 1354-3784
    DOI 10.1080/13543784.2023.2212154
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  8. Article ; Online: Characterizing primary hospitalizations for systemic lupus erythematosus in the United States.

    Desai, Amar D / Werth, Victoria P / Elman, Scott A

    Rheumatology (Oxford, England)

    2023  Volume 62, Issue 12, Page(s) e335–e337

    MeSH term(s) Humans ; United States/epidemiology ; Hospitalization ; Lupus Erythematosus, Systemic/epidemiology
    Language English
    Publishing date 2023-06-12
    Publishing country England
    Document type Journal Article
    ZDB-ID 1464822-2
    ISSN 1462-0332 ; 1462-0324
    ISSN (online) 1462-0332
    ISSN 1462-0324
    DOI 10.1093/rheumatology/kead290
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  9. Article ; Online: Trial of Intravenous Immune Globulin in Dermatomyositis.

    Werth, Victoria P / Fiorentino, David F / Vleugels, Ruth Ann

    The New England journal of medicine

    2023  Volume 388, Issue 1, Page(s) 94

    MeSH term(s) Humans ; Immunoglobulins, Intravenous/therapeutic use ; Dermatomyositis/drug therapy ; Dermatomyositis/immunology
    Chemical Substances Immunoglobulins, Intravenous
    Language English
    Publishing date 2023-01-11
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMc2214285
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  10. Article ; Online: A Multidisciplinary Collaborative Approach to Retinal Toxic Effects Screening for Dermatology Patients Taking Antimalarials.

    Fett, Nicole / Werth, Victoria P

    JAMA dermatology

    2021  Volume 157, Issue 9, Page(s) 1112–1113

    Abstract: Clinical question: What are the roles of antimalarial therapy prescribers and eye care specialists in regard to antimalarial dosing, screening for retinal toxic effects, and antimalarial treatment cessation?: Bottom line: Antimalarial prescribers ... ...

    Abstract Clinical question: What are the roles of antimalarial therapy prescribers and eye care specialists in regard to antimalarial dosing, screening for retinal toxic effects, and antimalarial treatment cessation?
    Bottom line: Antimalarial prescribers should prescribe antimalarial dosages at 5 mg/kg/d or less of actual body weight. A baseline retinal examination with optical coherence tomography should be performed within 6 months of starting antimalarial therapy to rule out confounding disease. Patients at low risk for retinopathy do not require annual screening until 5 years of antimalarial use. Eye care clinicians should not stop treatment with antimalarials because of equivocal findings, as retinopathy occurs slowly, and therefore there is time for repeated testing. Antimalarial treatment cessation should be a collaborative decision that involves the patient, the prescriber, and the eye care clinician and that focuses on patient values, the severity of the underlying disease, and the estimated risk of visual loss if treatment with the drug is continued.
    MeSH term(s) Antimalarials/adverse effects ; Dermatology ; Humans ; Hydroxychloroquine/adverse effects ; Retinal Diseases/chemically induced ; Retinal Diseases/diagnosis ; Tomography, Optical Coherence/methods
    Chemical Substances Antimalarials ; Hydroxychloroquine (4QWG6N8QKH)
    Language English
    Publishing date 2021-07-28
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2701761-8
    ISSN 2168-6084 ; 2168-6068
    ISSN (online) 2168-6084
    ISSN 2168-6068
    DOI 10.1001/jamadermatol.2021.2699
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