Publications by authors named "Ghaith Noaiseh"

Background: Sjögren's disease is a chronic autoimmune disease with an unmet need for targeted therapies. The aim of the TWINSS study is to evaluate the safety and efficacy of iscalimab, a monoclonal antibody against CD40, in patients with active Sjögren's disease.

Methods: This randomised, double-blind, placebo-controlled, phase 2b study, conducted at 71 sites in 23 countries, enrolled patients aged 18 years or older fulfilling the American College of Rheumatology/European Alliance of Associations for Rheumatology (EULAR) 2016 criteria.

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Article Synopsis
  • Sjögren's disease (SjD) is an autoimmune disorder without approved therapies, and Dazodalibep (DAZ) is a promising new treatment that targets costimulatory signals in immune cells.
  • A clinical trial tested DAZ on two groups of SjD patients: one with moderate-to-severe disease and another with severe symptoms but less organ involvement, measuring changes in disease activity and patient-reported outcomes at day 169.
  • Both groups showed significant improvement with DAZ compared to placebo, and the drug was generally safe, though some common adverse events included COVID-19, headaches, and respiratory infections.
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Sjögren's syndrome is a systemic autoimmune disease defined by its targeted inflammation of the salivary and lacrimal glands, resulting in dry mouth and eyes in the majority and persistent or recurrent salivary gland enlargement in a minority of those affected. Involvement of major organs, an increased risk of lymphoma, and autoantibodies against ubiquitous cellular ribonucleoproteins define some of its systemic features. Those affected have a high symptom burden and the development of disease-modifying therapies is thus an urgent need.

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Objective: To address heterogeneity complicating primary SS (pSS) clinical trials, research and care by characterizing and clustering patients by their molecular phenotypes.

Methods: pSS patients met American-European Consensus Group classification criteria and had at least one systemic manifestation and stimulated salivary flow of ⩾0.1 ml/min.

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Objective: To evaluate the clinical efficacy and safety of baminercept, a lymphotoxin β receptor IgG fusion protein (LTβR-Ig), for the treatment of primary Sjögren's syndrome (SS), and to explore the possible mechanisms of action of this treatment.

Methods: In this multicenter trial, 52 patients with primary SS were randomized in a 2:1 ratio to receive subcutaneous injections of 100 mg of baminercept every week for 24 weeks or matching placebo. The primary end point was the change between screening and week 24 in the stimulated whole salivary flow (SWSF) rate.

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Objectives: There are currently no head-to-head comparisons of sialagogues for Primary Sjögren's syndrome (pSS). We compared the tolerability and side effect profile of pilocarpine and cevimeline in patients with pSS and determined clinical, laboratory and pathological variables associated with therapeutic failure.

Methods: We retrospectively reviewed the use of pilocarpine and cevimeline in 118 patients with pSS who fulfilled the 2002 American European Consensus Group criteria in a University-based setting.

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Objective: To quantify muscle outcomes, independent of fat mass, in rheumatoid arthritis (RA) patients compared to healthy controls.

Methods: Quantitative computed tomography scans measured calf muscle and fat cross-sectional area (CSA) and muscle density (an index of intramuscular adipose tissue), and isometric dynamometry was used to measure ankle muscle strength in 50 participants with RA ages 18-70 years and 500 healthy controls. Multivariable linear regression models assessed muscle deficits in RA after adjusting for group differences in adiposity and assessing for an altered muscle-fat association.

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