A5055135931- Asthma and respiratory diseases
- Bone health and osteoporosis research
- Bone health and treatments
- IL-33, ST2, and ILC Pathways
- Eosinophilic Esophagitis
- Multiple Sclerosis Research Studies
- Bone Metabolism and Diseases
- CNS Lymphoma Diagnosis and Treatment
- Polyomavirus and related diseases
- Systemic Lupus Erythematosus Research
- Allergic Rhinitis and Sensitization
- Rheumatoid Arthritis Research and Therapies
- Sinusitis and nasal conditions
- Health Systems, Economic Evaluations, Quality of Life
- Cytomegalovirus and herpesvirus research
- Hip and Femur Fractures
- Glioma Diagnosis and Treatment
- Biosimilars and Bioanalytical Methods
- Pediatric health and respiratory diseases
- Peripheral Neuropathies and Disorders
- Orthopaedic implants and arthroplasty
- Bone and Joint Diseases
- Statistical Methods in Clinical Trials
- Respiratory and Cough-Related Research
- Pregnancy and Medication Impact
Novartis (United States)
2024-2025
Sanofi (United States)
2018-2023
Nationwide Children's Hospital
2023
Novartis (France)
2023
Sanofi (France)
2018-2022
AVEO Oncology (United States)
2018-2022
GlaxoSmithKline (Netherlands)
2022
Novartis (Switzerland)
2022
Regeneron (United States)
2022
Napp Pharmaceuticals (United Kingdom)
2022
Abstract The 3-year FREEDOM trial assessed the efficacy and safety of 60 mg denosumab every 6 months for treatment postmenopausal women with osteoporosis. Participants who completed were eligible to enter an extension continue evaluation up 10 years. For results presented here, from group had 2 more years (long-term group) those placebo exposure (cross-over group). We report bone turnover markers (BTMs), mineral density (BMD), fracture rates, safety. A total 4550 enrolled in (2343 long-term;...
The FREEDOM study and its Extension provide long-term information about the effects of denosumab for treatment postmenopausal osteoporosis. Treatment up to 8 years was associated with persistent reduction bone turnover, continued increases in mineral density, low fracture incidence, a favorable benefit/risk profile.This aims report results through year 5 study, representing women osteoporosis.Women who completed 3-year were eligible enter 7-year open-label which all participants are...
The Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) extension is evaluating the long-term efficacy and safety denosumab for up to 10 years.The objective study was report results from first 3 years extension, representing exposure.This a multicenter, international, open-label 4550 women.Women FREEDOM group received more total (long-term) women placebo (crossover).Bone turnover markers (BTMs), bone mineral density (BMD), fracture, data are...
Transient increases in blood eosinophil counts have been observed dupilumab clinical trials.To assess and eosinophilia-related treatment-emergent adverse events (TEAEs) across 11 trials, comparing adult adolescent patients with asthma chronic rhinosinusitis nasal polyps (CRSwNP), atopic dermatitis, eosinophilic esophagitis.Eosinophil counts, rates of TEAEs or eosinophilia (>1,500 cells/μL), discontinuations, symptoms, efficacy CRSwNP are presented.Transient mean were dupilumab-treated (mean...
ABSTRACT Atherosclerosis and osteoporosis are chronic diseases that progress with age, studies suggest aortic calcification, an indicator of atherosclerosis, is inversely associated bone mineral density (BMD). The osteoprotegerin (OPG)/receptor activator NF-κB (RANK)/RANK ligand (RANKL) system has been proposed as a shared regulatory for vasculature. Denosumab (DMAb), monoclonal antibody against RANKL, improved BMD reduced fracture risk in the Fracture Reduction Evaluation Osteoporosis Every...
BackgroundLoss of smell (LoS) is one the most troublesome and difficult-to-treat symptoms severe chronic rhinosinusitis with nasal polyps (CRSwNP).ObjectiveTo assess impact dupilumab on sense in CRSwNP.MethodsIn randomized SINUS-24 SINUS-52 studies, adults CRSwNP received 300 mg subcutaneously or matching placebo every 2 weeks for 24 52 weeks, respectively. Smell was assessed using daily patient-reported LoS score (0–3) University Pennsylvania Identification Test (UPSIT; 0–40). Data from...
About one-tenth of patients with difficult-to-treat chronic rhinosinusitis nasal polyps (CRSwNP) have comorbid non-steroidal anti-inflammatory drug-exacerbated respiratory disease (NSAID-ERD). Dupilumab, a fully human monoclonal antibody that blocks the shared interleukin (IL)-4/IL-13 receptor component, is an approved add-on treatment in severe CRSwNP. This post hoc analysis evaluated dupilumab efficacy and safety CRSwNP with/without NSAID-ERD.Data were pooled from phase 3 SINUS-24 SINUS-52...
FeNO may have a role as both prognostic and predictive biomarker in combination with eosinophils for assessing responsiveness to some biological therapies.We evaluated the value of baseline FeNO, adjusted blood eosinophil levels other clinical characteristics, an independent predictor treatment response dupilumab patients uncontrolled moderate-to-severe asthma.We performed post hoc analysis LIBERTY ASTHMA QUEST (NCT02414854), phase 3, double-blind study aged 12 years older asthma, who...
Type 2 inflammatory diseases often coexist in patients. Dupilumab targets type inflammation and has demonstrated treatment benefits patients with atopic dermatitis (AD), asthma, chronic rhinosinusitis nasal polyps (CRSwNP) an acceptable safety profile.This post hoc analysis across five phase 3 studies moderate to severe AD or CRSwNP, evaluated time of onset duration the response.Patients received subcutaneous dupilumab 200/300 mg placebo. Assessments included Eczema Area Severity Index, Peak...
Limited data exist on the efficacy of long-term therapies for osteoporosis. In osteoporotic postmenopausal women receiving denosumab 7 years, nonvertebral fracture rates significantly decreased in years 4-7 versus 1-3. This is first demonstration a further benefit outcomes with therapy osteoporosis.This study aimed to evaluate whether treatment continued beyond 3 associated reduction rates.Participants who completed 3-year placebo-controlled Fracture REduction Evaluation Denosumab...
Background: Reduced MS disease activity with alemtuzumab versus subcutaneous interferon beta-1a (SC IFNB-1a) in core phase 2/3 studies was accompanied by increased incidence of infections that were mainly nonserious and responsive to treatment. Alemtuzumab efficacy durable over 6 years. Objective: To evaluate years alemtuzumab-treated patients. Methods: Three randomized trials (CAMMS223, Comparison Rebif Efficacy Multiple Sclerosis (CARE-MS) I, CARE-MS II) compared two courses 12 mg SC...
Romosozumab is a bone-forming antibody that increases bone formation and decreases resorption. We conducted double-blinded, randomized, phase-2, dose-finding trial to evaluate the effect of romosozumab on clinical outcomes open reduction internal fixation intertrochanteric or femoral neck hip fractures.Patients (55 94 years old) were randomized 2:3:3:3 receive 3 subcutaneous injections (70, 140, 210 mg) placebo postoperatively day 1 weeks 2, 6, 12. The primary end point was difference in...
Conjunctivitis is a known comorbidity of atopic dermatitis. Dupilumab clinical trials for moderate-to-severe dermatitis in adults showed higher conjunctivitis incidence dupilumab-treated patients than placebo-treated patients, whereas uncontrolled asthma reported lower rates both dupilumab and placebo. The objective this study was to evaluate the severity adolescents with or asthma. We evaluated (aged 12 < 18 years) three phase III trials. Ocular events were diagnosed treated based on...
Background: In the 2-year CARE-MS I and II trials, alemtuzumab 12 mg administered on 5 consecutive days at core study baseline 3 months later significantly improved outcomes versus subcutaneous interferon beta-1a (SC IFNB-1a) in relapsing–remitting multiple sclerosis patients. Here, we present final 6-year extension trial results (CAMMS03409), compare over 6 years patients randomized to both treatment groups baseline. Methods: Over a 4-year extension, (alemtuzumab-only) received as-needed...
ABSTRACT Denosumab reduced bone resorption, increased mineral density (BMD), and decreased new vertebral, hip, nonvertebral fracture risk in postmenopausal women with osteoporosis the FREEDOM trial. Consistent its mechanism of action, transiliac crest biopsies from subjects treated denosumab for 1 to 3 years demonstrated turnover that was reversible upon treatment cessation. Long-term up 6 extension provides sustained reduction continued low incidence. Here, we evaluate 5 on remodeling at...
Alemtuzumab efficacy versus subcutaneous interferon-β-1a (SC IFNB-1a) was demonstrated over 2 years in patients with relapsing-remitting multiple sclerosis, continued 7 additional years. is included as a recommended treatment for highly active disease (HAD) by the American Academy of Neurology Practice Guidelines, and label indication Europe recently restricted to HAD patients. There currently no consensus definition HAD, alemtuzumab across various definitions has not been explored...
Romosozumab is an antibody that binds and inhibits sclerostin, thereby increasing bone formation decreasing resorption. A double-blinded, randomized, phase-2, dose-finding trial was performed to evaluate the effect of romosozumab on radiographic clinical outcomes surgical fixation tibial diaphyseal fractures.Patients (18 82 years old) were randomized 3:1:1:1:1:1:1:1:1:1 a placebo or 1 9 treatment groups. Patients received subcutaneous injections postoperatively day weeks 2, 6, 12. The...
Abstract Background In the phase 2 CAMMS223 trial (NCT00050778), alemtuzumab significantly improved clinical and MRI outcomes versus subcutaneous interferon beta-1a over 3 years in treatment-naive patients with relapsing–remitting MS. Here, we assess efficacy safety of 12 who enrolled CAMMS03409 extension (NCT00930553), available follow-up through subsequent TOPAZ (NCT02255656). Methods CAMMS223, received courses (12 mg/day; baseline: 5 days; months later: days); 22% a third course....
Cytokines, such as interleukins (IL)-4/5/13, play a key role in multiple type 2 inflammatory diseases, including allergic asthma. Dupilumab, human monoclonal antibody, blocks the shared receptor component for IL-4/IL-13, inhibiting signaling. In this post hoc analysis of VOYAGE (NCT02948959), dupilumab efficacy was evaluated patients aged 6-11 years with asthma or without evidence (baseline serum total IgE ≥30 IU/mL and ≥1 perennial aeroallergen-specific ≥0.35kU/L).