Publications by authors named "Patricia Coyle"

Background And Objectives: Immune checkpoint inhibitors (ICIs) are increasingly used against various cancers but are associated with immune-related adverse events (irAEs). Risk of irAEs may be higher in patients with certain preexisting autoimmune diseases, and these patients may also experience exacerbation of the underlying autoimmune disease following ICI initiation. People with multiple sclerosis (MS) have mostly been excluded from clinical trials of ICIs, so data on the safety of ICIs in MS are limited.

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AbstractThe incidence and geographic spread of Lyme disease are increasing, and more than 476,000 new cases a year are estimated to occur in the United States. Therefore, many clinicians in North America will need to consider how to approach a patient with a concern for Lyme disease. This Curbside Consult addresses common clinical considerations, including discussion of signs of early Lyme disease, available laboratory tests, when to treat and with which antibiotics.

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Background: Although certain subsets patients with multiple sclerosis (MS), an immune-mediated disorder, are at higher risk of worse acute COVID-19 outcomes compared to the general population, it is not clear whether SARS-CoV-2 infection impacts long-term outcomes compared with MS patients without COVID-19 infection.

Objectives: This study investigated MS disease activity and mortality 3.5 years post SARS-CoV-2 infection and compared with MS patients without COVID-19.

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Four sphingosine 1-phosphate (S1P) receptor modulators (fingolimod, ozanimod, ponesimod, and siponimod) are approved by the US Food and Drug Administration for the treatment of multiple sclerosis. This review summarizes efficacy and safety data on these S1P receptor modulators, with an emphasis on similarities and differences. Efficacy data from the pivotal clinical trials are generally similar for the four agents.

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Multiple sclerosis (MS) is a chronic, progressive, inflammatory disorder of the central nervous system. Relapsing-remitting MS (RRMS), the most common form of the disease, is characterized by transient neurological dysfunction with concurrent accumulation of disability. Over the past three decades, disease-modifying therapies (DMTs) capable of reducing the frequency of relapses and slowing disability worsening have been studied and approved for use in patients with RRMS.

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Background: The impact of disease-modifying treatments (DMTs) on multiple sclerosis (MS) long-term outcomes is continuously evolving. Retrospective analyses of large and long-term registries could provide information regarding general disease trajectories and risk factors that are commonly not investigated in shorter clinical trial settings.

Methods: Retrospective observational study of people with MS (pwMS) registered in New York State MS Consortium (NYSMSC) since 1996.

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Background: Patient-reported outcomes (PRO) are increasingly utilized as part of the routine clinical assessment in people with multiple sclerosis (pwMS). The long-term effect of disease modifying therapies (DMTs) and their discontinuation on PRO measures remains largely unknown.

Methods: Two pwMS groups treated with natalizumab were selected from the New York State MS Consortium (NYSMSC) database.

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Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease involving immune-mediated damage. Iron deposition in deep gray matter (DGM) structures like the thalamus and basal ganglia have been suggested to play a role in MS pathogenesis. Magnetic Resonance Imaging (MRI) imaging methods like T2 and T2* imaging, susceptibility-weighted imaging, and quantitative susceptibility mapping can track iron deposition storage in the brain primarily from ferritin and hemosiderin (paramagnetic iron storage proteins) with varying levels of tissue contrast and sensitivity.

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Background: People over age 50-55 have historically been excluded from randomized clinical trials for multiple sclerosis (MS). However, more than half of those living with an MS diagnosis are over 55.

Objective: Explore the unique considerations of treating older people with MS (PwMS) using an iterative and structured Delphi-based assessment to gather expert opinions.

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Article Synopsis
  • Relapsing multiple sclerosis (MS) is a challenging neurological disease marked by cycles of relapse and stability, and disease-modifying therapies like ofatumumab aim to manage symptoms and progression.
  • Ofatumumab is an anti-CD20 monoclonal antibody that was approved for treating relapsing forms of MS, and this study analyzes patient demographics, clinical factors, and prior treatments among those prescribed ofatumumab after its FDA approval.
  • The research used retrospective data from prescription and medical claims databases in the US, identifying over 3,600 patients, with final analysis including 2,101 patients, mainly female, at the 9-month mark after ofatumumab's approval.
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Background: Older age and longer disease duration (DD) may impact the effectiveness of disease-modifying therapies in patients with multiple sclerosis (MS). Siponimod is a sphingosine 1-phosphate receptor modulator approved for the treatment of active secondary progressive MS (SPMS) in many countries. The pivotal phase 3 EXPAND study examined siponimod versus placebo in a broad SPMS population with both active and non-active disease.

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Judicious multiple sclerosis (MS) diagnosis and early start of disease modifying therapy significantly improves long-term disability outcomes in persons with MS (pwMS). Retrospective analysis based on 25-year New York State MS Consortium (NYSMSC) data determined the effect of changes in the respective diagnostic criteria in shortening the time between symptom onset to MS diagnosis. Based on 9378 current and historical MS cases, there was a significant decrease in time to diagnosis in pwMS from 1982-2001 to >2017 periods (average 4.

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There are > 18 distinct disease-modifying therapy (DMT) options covering 10 mechanisms of action currently approved by the US Food and Drug Administration for the treatment of relapsing-remitting multiple sclerosis (RRMS). Given the multitude of available treatment options, and recent international consensus guidelines offering differing recommendations, there is broad heterogeneity in how the DMTs are used in clinical practice. Choosing a DMT for newly diagnosed patients with MS is currently a topic of significant debate in MS care.

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Article Synopsis
  • The article summarizes findings from the CLARITY and CLARITY Extension studies on the effectiveness of cladribine tablets in treating relapsing forms of multiple sclerosis (MS).
  • The studies showed that individuals taking cladribine tablets had a significantly lower risk of experiencing relapses compared to those taking a placebo, with some participants continuing to experience benefits for up to three years after initial treatment.
  • Researchers suggest that the recommended two-year dosing of cladribine tablets may provide lasting relief from relapses for up to five years in MS patients.
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Cladribine tablets (CladT) preferentially reduce B and T lymphocyte levels. As aging is associated with a decline in immune function, the effect of CladT on lymphocyte levels may differ by age. This analysis combined data from the Phase 3 CLARITY, CLARITY Extension, and ORACLE-MS studies to examine the effect of age (≤50 or >50 years) on lymphopenia following CladT 3.

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Background: Multiple sclerosis (MS) patients with stable disease course might view continued treatment as unnecessary. However, guidelines regarding treatment discontinuation are currently lacking.

Objective: To assess the clinical course after treatment discontinuation in MS patients with long disease duration.

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Multiple sclerosis (MS) is the major acquired central nervous system disease of young adults. It is a female predominant disease. Multiple aspects of MS are influenced by sex-based differences.

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People with multiple sclerosis (MS) are at risk for infections that can result in amplification of baseline symptoms and possibly trigger clinical relapses. Vaccination can prevent infection through the activation of humoral and cellular immune responses. This is particularly pertinent in the era of emerging novel vaccines against severe acute respiratory syndrome coronavirus 2, the virus that causes coronavirus disease 2019 (COVID-19).

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Article Synopsis
  • The CLARITY study demonstrated that cladribine tablets (3.5 mg/kg) significantly decrease the annualised relapse rate (ARR) in patients with relapsing-remitting multiple sclerosis compared to a placebo, with lasting effects observed in the follow-up extension period without additional treatment.
  • Over two years, patients on cladribine experienced fewer relapses and severe relapses, with statistically significant results showing improvements at multiple checkpoints.
  • The findings confirm that cladribine tablets provide durable effectiveness in managing the frequency and severity of relapses in relapsing-remitting multiple sclerosis patients.
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Background: In the Phase 3, 96-week ORACLE-MS study, cladribine tablets 10 mg (3.5 or 5.25 mg/kg cumulative dosage over two years) significantly reduced lesions associated with multiple sclerosis versus placebo in participants following a first clinical demyelinating event (FCDE).

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IL-17A and IL-22 derived from Th17 cells play a significant role in mucosal immunity and inflammation. TGF-β and IL-6 promote Th17 differentiation; however, these cytokines have multiple targets. The identification and screening of additional molecules that regulate IL-17A and IL-22 responses in certain inflammatory conditions is of great clinical significance.

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Background: Amyloid-β42 (Aβ42) is associated with plaque formation in the brain of patients with Alzheimer's disease (AD). Studies have suggested the potential utility of plasma Aβ42 levels in the diagnosis, and in longitudinal study of AD pathology. Conventional ELISAs are used to measure Aβ42 levels in plasma but are not sensitive enough to quantitate low levels.

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Article Synopsis
  • * The treatment involves two oral cycles each year for two years, potentially eliminating the need for further doses in the following years, making it a convenient option for patients with relapsing forms of MS.
  • * Clinical studies, including the significant phase III CLARITY trial, demonstrated the efficacy and safety of cladribine tablets, leading to global approval for the treatment of various types of relapsing MS.
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