- Asthma and respiratory diseases
- Dermatology and Skin Diseases
- Allergic Rhinitis and Sensitization
- Urticaria and Related Conditions
- Sinusitis and nasal conditions
- IL-33, ST2, and ILC Pathways
- Lysosomal Storage Disorders Research
- Eosinophilic Esophagitis
- Rheumatoid Arthritis Research and Therapies
- Autoimmune Bullous Skin Diseases
- Multiple Sclerosis Research Studies
- Medicine and Dermatology Studies History
- Autoimmune and Inflammatory Disorders Research
- Respiratory and Cough-Related Research
- Glycogen Storage Diseases and Myoclonus
- Chronic Lymphocytic Leukemia Research
- Child Nutrition and Feeding Issues
- Peripheral Neuropathies and Disorders
- Systemic Lupus Erythematosus Research
- Mast cells and histamine
- Spondyloarthritis Studies and Treatments
- Chronic Obstructive Pulmonary Disease (COPD) Research
- Blood groups and transfusion
- Nasal Surgery and Airway Studies
- Psoriasis: Treatment and Pathogenesis
Sanofi (France)
2014-2024
Sanofi (Mexico)
2024
Harvard University
2024
Temple University
2024
American Academy of Otolaryngology — Head and Neck Surgery
2024
Sanofi (United States)
2020
Among patients with chronic rhinosinusitis nasal polyps (CRSwNP), randomized clinical trials (RCTs) of biologics, such as anti-interleukin-4/interleukin-13 (dupilumab) and anti-immunoglobulin E (omalizumab), have demonstrated efficacy compared intranasal corticosteroids (INCS). However, no head-to-head RCTs exist between biologics.To perform an indirect treatment comparison (ITC) the biologics plus INCS versus placebo (INCS) a common comparator.Embase, MEDLINE, Cochrane were searched for in...
Background Chronic rhinosinusitis with nasal polyps (CRSwNP) is a type 2 inflammatory disease treated sinus surgery when refractory to medical intervention. However, recurrence postsurgery common. Dupilumab, fully human monoclonal antibody, blocks the shared receptor for interleukin 4 (IL‐4) and IL‐13, key central drivers of inflammation. We report efficacy dupilumab in patients CRSwNP from SINUS‐24/SINUS‐52 trials (NCT02912468/NCT02898454), by number prior surgeries time since last surgery....
Abstract Background Chronic rhinosinusitis with nasal polyps (CRSwNP) is a predominantly type 2‐mediated inflammatory disease high symptom burden and reduced health‐related quality of life (HRQoL). This report aimed to comprehensively understand the effects dupilumab on domains HRQoL, their individual elements, health status in patients severe CRSwNP from phase 3 SINUS‐24 (NCT02912468) SINUS‐52 (NCT02898454) trials. Methods Patients were randomized ( n = 438) or placebo 286) for 24 weeks...
The ongoing "Sarcopenia and Physical fRailty IN older people: multi-componenT Treatment strategies (SPRINTT)" randomized controlled trial (RCT) is testing the efficacy of a multicomponent intervention in prevention mobility disability adults with physical frailty & sarcopenia (PF&S). Here, we describe procedures followed for PF&S case finding screening candidate participants SPRINTT RCT. We also illustrate main demographic clinical characteristics eligible screenees.The identification was...
Dupilumab has shown long-term treatment benefits in children with uncontrolled asthma. We assessed more detail the impact of dupilumab on asthma control and health-related quality life (HRQoL) their caregivers.Children aged 6-11 years moderate-to-severe type 2 (baseline blood eosinophils ≥150 cells·µL-1 or fractional exhaled nitric oxide ≥20 ppb; n=350) were treated placebo for 52 weeks VOYAGE study. Primary outcomes these analyses (change from baseline Asthma Control Questionnaire 7...
Objective The development of biomarkers to guide treatment decisions is a major research focus in rheumatoid arthritis ( RA ). Patients with have elevated interleukin‐6 IL ‐6) levels; however, the utility ‐6 as predictor response unclear. This study was undertaken investigate, by post hoc analysis, whether baseline levels are predictive sarilumab responses 2 phase III studies. Methods Serum concentrations were measured patients prior receiving 200 mg (n = 148) or adalimumab 40 152) every...
Interleukin 6 (IL-6) signaling plays a key role in the pathophysiology of rheumatoid arthritis (RA) and is inhibited by sarilumab, human monoclonal antibody blocking IL-6 receptor alpha (IL-6Rα). The effects sarilumab plus methotrexate (MTX) on serum biomarkers joint damage bone resorption were assessed two independent studies (phase II (part A) phase III B)) patients with RA history inadequate response to MTX from MOBILITY study (NCT01061736). Serum samples analyzed at baseline prespecified...
Interleukin-6 (IL-6) is a pleiotropic cytokine that plays key role in the pathogenesis of rheumatoid arthritis. Sarilumab human monoclonal antibody binds membrane-bound and soluble IL-6 receptor-α to inhibit signalling. The aim this study was compare effects sarilumab adalimumab (a tumour necrosis factor alpha inhibitor) monotherapy on levels circulating biomarkers associated with acute-phase response, bone remodelling, atherothrombosis, anaemia chronic disease markers purported reflect...
Dupilumab is approved as first-line systemic treatment for adults/adolescents with moderate-to-severe atopic dermatitis (AD) in Europe and elsewhere owing to its favourable benefit-risk profile. However, non-steroidal immunosuppressants (NSISS) are often used therapy clinical practice. Impact of prior NSISS on dupilumab's effect vs. control has not been described previously. This study assessed efficacy patients AD, comparing with/without therapy, four phase 3 trials.This post hoc analysis...
Chronic rhinosinusitis with nasal polyps (CRSwNP) is a predominantly type 2 inflammatory disease high symptom burden. Data are lacking on the comparative health status of patients CRSwNP. This analysis compared baseline physical and mental health-related quality life (HRQoL) overall severe CRSwNP enrolled in Phase 3 clinical trial general population norms other chronic diseases.In this post hoc cross-sectional data from SINUS-24 study (NCT02912468), HRQoL was measured using 36-item Short...
Abstract Objectives To assess the severity of top 5 22‐item Sino‐Nasal Outcome Test (SNOT‐22) items ranked most important by patients with chronic rhinosinusitis nasal polyps (CRSwNP), effect dupilumab on these items, and their association objective disease measures. Study Design Post hoc analysis SINUS‐24 (NCT02912468) SINUS‐52 (NCT02898454) clinical trials. Setting Multinational, multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group studies. Methods Patients SNOT‐22...
Introduction Interleukin-6 (IL-6) orchestrates formation of an inflammatory pannus, leading to joint damage in rheumatoid arthritis (RA). Sarilumab is a human monoclonal antibody blocking the IL-6Rα. In TARGET ( NCT01709578 ), phase 3 study adults with moderate-to-severe RA and inadequate response or intolerance tumour necrosis factor inhibitors, subcutaneous sarilumab 200 mg 150 every 2 weeks (q2w) plus conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) significantly...
Currently, five biologic treatment options are available for use in patients with uncontrolled persistent asthma: three interleukin (IL)-5 antagonists, which either bind to the anti-IL-5 ligand (mepolizumab, reslizumab) or IL-5 receptor (benralizumab); one anti-immunoglobulin E (anti-IgE) therapy (omalizumab); and anti-IL-4/IL-13 (dupilumab). To date, no comparative data from head-to-head clinical trials these biologics.An indirect comparison (ITC) of dupilumab versus each anti-IgE therapies...
Glucagon-like peptide-1 (GLP-1) receptor agonists improve blood glucose control by enhancing glucose-sensitive insulin release, delaying gastric emptying and reducing postprandial glucagon secretion. The studies reported here investigated the response to an intravenous (iv) challenge after injection of lixisenatide (LIXI) 20 µg or placebo.Two single-centre, double-blind, randomized, placebo-controlled, single-dose, crossover were performed in healthy subjects (HS) people with type 2 diabetes...
Abstract: Patients with asthma frequently have comorbid chronic rhinosinusitis (CRS) or without nasal polyps, increasing disease burden and complicating treatment. These post hoc analyses investigated disease-specific health-related quality of life (HRQoL) general health status in the randomized, placebo-controlled QUEST study (NCT02414854) patients treated dupilumab for moderate-to-severe CRS. received 300 mg placebo every 2 weeks 52 weeks. CRS HRQoL was assessed by 22-item Sino-Nasal...
Abstract Objectives To evaluate within‐patient symptom improvement in the dupilumab SINUS‐24/‐52 studies patients with severe chronic rhinosinusitis nasal polyps (CRSwNP) (NCT02912468/NCT02898454). Methods Patients received 300 mg or placebo every 2 weeks for 24 (SINUS‐24) 52 (SINUS‐52) on background intranasal corticosteroids. daily reported symptoms of congestion (NC), loss smell (LoS) and rhinorrhoea a scale 0–3 (0 – no symptoms, 1 mild, moderate, 3 symptoms). The proportions...
The Phase 3 COMET trial (NCT02782741) comparing avalglucosidase alfa and alglucosidase included health-related quality of life (HRQoL) assessments in treatment-naïve patients with late-onset Pompe disease (LOPD). Here, we further characterize results from disease-specific general patient-reported outcome (PRO) measures. Adults who participated the receiving or (both 20 mg/kg biweekly) during 49-week double-blind treatment period were analysis. Proportions exceeding meaningful change...
Abstract Background Prurigo nodularis (PN) is characterized by intensely itchy nodules/lesions and skin pain, which can have a substantial impact on health‐related quality of life (HRQoL). Treatment benefits such symptoms impacts are best assessed in trials using patient‐reported outcome (PROs) instruments as Skin Pain Numerical Rating Scale (NRS), Sleep‐NRS Dermatology Life Quality Index (DLQI). However, no guidance exists for interpreting meaningful changes scores these PROs patients with...