0000000000769127

AUTHOR

Benjamin A Fisher

showing 3 related works from this author

Guidelines for biomarkers in autoimmune rheumatic diseases - evidence based analysis

2018

Autoimmune rheumatic diseases are characterised by an abnormal immune system response, complement activation, cytokines dysregulation and inflammation. In last years, despite many progresses in managing these patients, it has been shown that clinical remission is reached in less than 50% of patients and a personalised and tailored therapeutic approach is still lacking resulting in a significant gap between guidelines and real-world practice. In this context, the need for biomarkers facilitating early diagnosis and profiling those individuals at the highest risk for a poor outcome has become of crucial interest. A biomarker generally refers to a measured characteristic which may be used as a…

0301 basic medicineEvidence-based practiceImmunologyInflammationGuidelines as TopicSystemic lupus erythematosuBioinformaticsAntiphospholipid syndrome; Biomarker; Rheumatoid arthritis; Sjögren syndrome; Spondyloarthritides; Systemic lupus erythematosus; Systemic sclerosis;Autoimmune DiseaseAutoimmune DiseasesRheumatic Disease03 medical and health sciencesTherapeutic approachSystemic sclerosiEconomica0302 clinical medicineImmune systemSystemic lupus erythematosusAntiphospholipid syndromeEarly DiagnosiRheumatic DiseasesAntiphospholipid syndromemedicineImmunology and AllergyHumansRheumatoid arthritisRheumatoid arthritiAntiphospholipid syndrome; Biomarker; Rheumatoid arthritis; Sjögren syndrome; Spondyloarthritides; Systemic lupus erythematosus; Systemic sclerosis030203 arthritis & rheumatologySpondyloarthritidebusiness.industryBiomarkermedicine.diseaseClinical diseaseSjögren syndromeAntiphospholipid syndrome; Biomarker; Rheumatoid arthritis; Sjögren syndrome; Spondyloarthritides; Systemic lupus erythematosus; Systemic sclerosis; Autoimmune Diseases; Biomarkers; Early Diagnosis; Evidence-Based Practice; Guidelines as Topic; Humans; Rheumatic Diseases; Immunology and Allergy; ImmunologySettore MED/16 - Reumatologia030104 developmental biologyEarly DiagnosisRheumatoid arthritisEvidence-Based PracticeBiomarker (medicine)SpondyloarthritidesSystemic sclerosismedicine.symptombusinessBiomarkersHuman
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A phase 2 randomized, double-blind, placebo-controlled, proof-of-concept study of oral seletalisib in primary Sjögren’s syndrome

2020

Abstract Objectives This phase 2 proof-of-concept study (NCT02610543) assessed efficacy, safety and effects on salivary gland inflammation of seletalisib, a potent and selective PI3Kδ inhibitor, in patients with moderate-to-severe primary Sjögren’s syndrome (PSS). Methods Adults with PSS were randomized 1:1 to seletalisib 45 mg/day or placebo, in addition to current PSS therapy. Primary end points were safety and tolerability and change from baseline in EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) score at week 12. Secondary end points included change from baseline at week 12 in EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) score and histological features in salivary …

Male0301 basic medicineSalivamedicine.medical_specialtyPyridinesprimary Sjögren’s syndromeAdministration Oralprimary Sjogren's syndromePlaceboProof of Concept StudyGastroenterologySalivary Glandshistologyseletalisib03 medical and health sciences0302 clinical medicineDouble-Blind MethodRheumatologyInternal medicineproof-of-conceptmedicineHumansPharmacology (medical)Adverse effect030203 arthritis & rheumatologySalivary glandbiologySurrogate endpointbusiness.industryMiddle Agedmedicine.diseaseSialadenitisphosphatidylinositol 3-kinase delta (PI3K delta)primary Sjögren's syndrome3. Good healthSjogren's Syndrome030104 developmental biologymedicine.anatomical_structureTolerabilityImmunoglobulin MAntirheumatic Agentsphosphatidylinositol 3-kinase delta (PI3Kδ)Quinolinesbiology.protein[SDV.IMM]Life Sciences [q-bio]/ImmunologyFemalebusiness
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AB0458 A PHASE II RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF OF CONCEPT STUDY OF ORAL SELETALISIB IN PATIENTS WITH PRIMARY SJÖGREN’S SYNDROM…

2019

Background: Seletalisib is a potent, selective oral inhibitor of phosphoinositide-3 kinase delta (PI3Kδ). Preclinical data have shown that the PI3Kδ pathway is upregulated within salivary glands of patients with PSS and contributes to disease pathogenesis.1 Objectives: To assess the efficacy and safety of seletalisib in patients with PSS. Methods: In this Phase II, double-blind, proof of concept study (NCT02610543), patients with PSS having an EULAR Sjogren’s Syndrome Disease Activity Index (ESSDAI) score ≥5 were randomised 1:1 to seletalisib once daily or placebo (PBO) in addition to current PSS therapy for 12 weeks. The primary endpoint was change from baseline in ESSDAI at Week 12. The s…

030203 arthritis & rheumatology0301 basic medicinemedicine.medical_specialtyLymphocytic infiltrationbusiness.industryPlaceboPreclinical dataDouble blind03 medical and health sciences030104 developmental biology0302 clinical medicineTolerabilitySeletalisibInternal medicinemedicineIn patientSjogren sbusiness
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