A5007804440- Interstitial Lung Diseases and Idiopathic Pulmonary Fibrosis
- Systemic Sclerosis and Related Diseases
- Sarcoidosis and Beryllium Toxicity Research
- Eosinophilic Disorders and Syndromes
- Pulmonary Hypertension Research and Treatments
- Psoriasis: Treatment and Pathogenesis
- Chronic Obstructive Pulmonary Disease (COPD) Research
- Chronic Myeloid Leukemia Treatments
- Respiratory and Cough-Related Research
- Occupational and environmental lung diseases
- Inhalation and Respiratory Drug Delivery
- Lung Cancer Treatments and Mutations
- Medical Imaging and Pathology Studies
- Atrial Fibrillation Management and Outcomes
- Inflammatory Myopathies and Dermatomyositis
- Peptidase Inhibition and Analysis
- Dermatology and Skin Diseases
- Occupational exposure and asthma
- Eosinophilic Esophagitis
- Myeloproliferative Neoplasms: Diagnosis and Treatment
- Asthma and respiratory diseases
- Gastroesophageal reflux and treatments
- Fungal Plant Pathogen Control
- Pharmaceutical studies and practices
- Chronic Lymphocytic Leukemia Research
Boehringer Ingelheim (Germany)
2015-2023
Boehringer Ingelheim (China)
2018-2021
German Center for Lung Research
2016-2019
Heidelberg University
2016-2019
Boehringer Ingelheim (Finland)
2015-2018
Boehringer Ingelheim (Taiwan)
2018
Medical University of South Carolina
2017
Boehringer Ingelheim (Australia)
2017
Boehringer Ingelheim (India)
2015-2016
Preclinical data have suggested that nintedanib, an intracellular inhibitor of tyrosine kinases, inhibits processes involved in the progression lung fibrosis. Although efficacy nintedanib has been shown idiopathic pulmonary fibrosis, its across a broad range fibrosing diseases is unknown.
Rationale: Nintedanib and pirfenidone slow the progression of idiopathic pulmonary fibrosis (IPF), but disease continues to progress. More data are needed on safety efficacy combination therapy with nintedanib add-on pirfenidone.Objectives: To investigate safety, tolerability, pharmacokinetic exploratory endpoints in patients treated versus alone.Methods: Patients IPF FVC greater than or equal 50% predicted at screening who completed a 4- 5-week run-in 150 mg twice daily without dose...
Nintedanib is an approved treatment for idiopathic pulmonary fibrosis (IPF). A subgroup analysis of a previously published trial suggested that sildenafil may provide benefits regarding oxygenation, gas exchange as measured by the diffusion capacity lungs carbon monoxide (DlCO), symptoms, and quality life in patients with IPF severely decreased DlCO. That idea was tested this trial.We randomly assigned, 1:1 ratio, DlCO 35% or less predicted value to receive nintedanib at dose 150 mg twice...
Objective: Some patients with interstitial lung diseases (ILDs) other than idiopathic pulmonary fibrosis (IPF) develop a progressive fibrosing phenotype. We investigated the diagnosis and management of non-IPF ILDs using data from survey physicians US insurance claims. Methods: Pulmonologists, rheumatologists internists in France, Germany, Italy, Japan, Spain, UK who had managed ≥10 past year, including those ILDs, completed an online survey. Data on prescription claims were obtained...
Introduction Nintedanib slows disease progression in patients with idiopathic pulmonary fibrosis (IPF) by reducing the rate of decline forced vital capacity, an adverse event profile that is manageable for most patients. We used data from six clinical trials to characterise safety and tolerability nintedanib investigate its effects on survival. Methods Data treated ≥1 dose 150 mg two times per day or placebo 52-week TOMORROW trial and/or open-label extension; INPULSIS their extension,...
To analyze the efficacy and safety of nintedanib in patients with fibrosing autoimmune disease-related interstitial lung diseases (ILDs) a progressive phenotype.The INBUILD trial enrolled ILD other than idiopathic pulmonary fibrosis, diffuse disease >10% extent on high-resolution computed tomography, forced vital capacity percent predicted (FVC%) ≥45%, diffusing lungs for carbon monoxide ≥30% to <80%. Patients fulfilled protocol-defined criteria progression within 24 months before screening,...
Abstract Background The two 52-week INPULSIS trials investigated nintedanib versus placebo in patients with IPF, FVC ≥50% predicted and DLco 30–79% predicted. 24-week INSTAGE trial plus sildenafil alone IPF ≤35% We used data from to compare the effects of less more severe impairment gas exchange at baseline. Methods Analyses were conducted treated trials. Outcomes included rate decline over 24 weeks, proportions who had a confirmed or suspected idiopathic acute exacerbation deaths adverse...
Rationale: In the INSTAGE trial in patients with idiopathic pulmonary fibrosis (IPF) and severely impaired gas exchange, nintedanib plus sildenafil was associated numerical benefits on St. George's Respiratory Questionnaire (SGRQ) total score, brain natriuretic peptide (BNP), FVC decline versus alone. Exploratory analyses of STEP-IPF (Sildenafil Trial Exercise Performance IPF) suggested that may have a greater effect SGRQ score IPF who right heart dysfunction (RHD).Objectives: Assess whether...
Nintedanib is an approved therapy for idiopathic pulmonary fibrosis (IPF). Some patients treated with nintedanib experience weight loss. Exploratory data suggest that low body mass index or loss are associated worse outcomes in IPF. We investigated whether BMI at baseline over 52 weeks was FVC decline, influenced the effect of nintedanib, IPF.Using pooled from two INPULSIS trials, we analysed rate decline (mL/yr) and placebo subgroups by (< 25; ≥25 to < 30; ≥30 kg/m2) (≤5; > 5%) using random...
Data from the INMARK trial were used to investigate feasibility and validity of home spirometry as a measure lung function decline in patients with idiopathic pulmonary fibrosis (IPF).Subjects IPF preserved forced vital capacity (FVC) randomised receive nintedanib or placebo for 12 weeks followed by open-label 40 weeks. Clinic was conducted at baseline 4, 8, 12, 16, 20, 24, 36 52. Subjects asked perform least once week ideally daily. Correlations between home- clinic-measured FVC rates...
Abstract Effisayil 1 was a multicentre, randomized, double‐blind, placebo‐controlled study of the anti‐interleukin (IL)‐36 receptor monoclonal antibody, spesolimab, in patients presenting with generalized pustular psoriasis (GPP) flare. Previously published data from this revealed that within week, rapid and skin clearance were observed receiving spesolimab versus placebo. In pre‐specified subgroup analysis, efficacy evaluated according to patient demographic clinical characteristics at...
Generalized pustular psoriasis (GPP) is a rare, neutrophilic skin disease that can become life-threatening if flares are untreated. There limited data describing the characteristics and clinical course of GPP with current treatment options.The aim study was to describe outcomes using historical medical information from patients enrolled in Effisayil™ 1 trial.Investigators collected retrospective characterizing patients' prior trial enrollment. Data on overall were collected, as well typical,...
Using data from the SENSCIS trial, these analyses were undertaken to assess effects of nintedanib versus placebo in subgroups patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), based on characteristics previously identified as being associated progression SSc-ILD.Patients SSc-ILD randomized receive either or placebo, stratified by anti-topoisomerase I antibody (ATA) status. We assessed rate decline forced vital capacity (FVC) (expressed ml/year) over 52 weeks...
Abstract Background Idiopathic pulmonary fibrosis (IPF) predominantly affects individuals aged > 60 years who have several comorbidities. Nintedanib is an approved treatment for IPF, which reduces the rate of decline in forced vital capacity (FVC). We assessed efficacy and safety nintedanib patients with IPF were elderly had multiple Methods Data pooled from five clinical trials randomised to receive 150 mg twice daily or placebo. outcomes subgroups by age < 75 versus ≥ years, 5...
ABSTRACT Background and objective The efficacy safety of nintedanib in patients with idiopathic pulmonary fibrosis (IPF) were investigated the placebo‐controlled INPULSIS® trials. All who completed an trial could receive open‐label extension INPULSIS®‐ON. Methods We assessed long‐term Asian race treated Analyses descriptive. Results A total 215 INPULSIS®‐ON, whom 121 continued INPULSIS®‐ON 94 initiated having received placebo trial. At baseline mean (SD) age was 66.3 (7.5) years, 80.5% males...
Abstract Generalized pustular psoriasis is a potentially life‐threatening neutrophilic skin disease characterized by recurrent flares of widespread erythema and eruption sterile pustules. In the Effisayil™ 1 study (NCT03782792), 53 patients with generalized flare were treated placebo or spesolimab, humanized anti‐interleukin‐36 receptor monoclonal antibody, first targeted treatment to be studied in randomized clinical trial. Spesolimab resulted rapid clearance, an acceptable safety profile....
Idiopathic pulmonary fibrosis (IPF) is the classic progressive fibrosing interstitial lung disease (ILD), but some patients with ILDs other than IPF also develop a phenotype (PF-ILD). Information on use and cost of healthcare resources in PF-ILD limited. We used USA-based medical insurance claims (2014–2016) to assess PF-ILD. Patients at least two ILD one pulmonologist visit were considered have ILD. Pulmonologist frequency was as proxy identify (at four visits 2016, or three more 2016 vs....