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Articles by Toby Maher
Circulating Biomarkers in Subjects With Progressive Pulmonary Fibrosis: Data From the Inbuild Trial
Background: We investigated the prognostic potential of circulating biomarkers at baseline and the effects of nintedanib on changes in these biomarkers in subjects with progressive pulmonary fibrosis (PPF). Methods: In the INBUILD trial, subjects with PPF received nintedanib (n=332) or placebo (n=331).
Association of bronchoalveolar lavage cellular analysis and radiological findings in fibrotic interstitial lung diseases
Radiological patterning of ground-glass opacity (GGO) on CT in the context of interstitial lung disease (ILD) is often considered to represent inflammation and is often treated with immune suppression, despite poor outcomes in idiopathic pulmonary fibrosis and limited evidence that GGO distinguishes inflammation from fibrosis. In 316 people with fibrotic ILD, no association was found between bronchoalveolar lavage (BAL) lymphocyte counts and extent of GGO involvement.
Progressive pulmonary fibrosis: the importance of identification and intervention
Review Open access Progressive pulmonary fibrosis: the importance of identification and intervention Article Figures & Tables Info & Metrics Introduction The concept of progressive fibrosing interstitial lung disease (PF-ILD) or progressive pulmonary fibrosis (PPF) was developed to facilitate the identification of patients with an ILD other than idiopathic pulmonary fibrosis (IPF) that is worsening and requires treatment [1, 2].
From Slowing Decline to Restoring Function: Taladegib’s Promise in IPF, With Toby Maher, MD, PhD
Idiopathic pulmonary fibrosis (IPF) remains one of the most challenging and devastating chronic lung diseases, marked by progressive scarring that relentlessly limits lung function and quality of life. For years, standard of care treatment with antifibrotic therapies like pirfenidone and nintedanib has focused on slowing but not halting the decline in lung capacity. Promising new data on taladegib (ENV-101), a hedgehog (Hh) inhibitor, show potential to disrupt that standard.
Nerandomilast Approval Breaks Decade-Long Dry Spell for IPF, With Toby Maher, MD, PhD
Published on: Maher discussed the new FDA approved drug, marketed as Jascayd, and its impact for idiopathic pulmonary fibrosis.
Hypersensitivity pneumonitis
Associate Professor of Medicine Program Director, Pulmonary and Critical Care Medicine Fellowship Research Director, Pulmonary and Critical Care Medicine Corewell Health West - Michigan State University College of Human Medicine East Lansing MI Disclosures MTK received fees from InflaRx as a consultant to participate in a COVID-19 pneumonia Advisory Board. MTK received fees from Pfizer as a consultant to participate in a healthcare disparities in primary immunodeficiencies advisory board.
Nerandomilast Slows IPF & PPF Lung Function Decline: FIBRONEER
Both patients with IPF and patients with PPF treated with nerandomilast demonstrated a smaller decline in forced vital capacity over 52 weeks versus placebo.
Safety Findings on Nerandomilast for Pulmonary Fibrosis, with Toby Maher, MD, PhD
In an interview at the American Thoracic Society (ATS) International Conference, discussing the phase 3 FIBRONEER-IPF and FIBRONEER-ILD studies, Toby Maher, MD, PhD, described nerandomilast’s success in achieving its primary endpoint in both trials on patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).1 After discussing some of the most notable findings in these late-breaking data on the investigational oral phosphodiesterase 4B (PDE4B) inhibitor, the...
Significance of New Nerandomilast Findings for Pulmonary Fibrosis, with Toby Maher, MD, PhD
New phase 3 findings presented at the American Thoracic Society (ATS) International Conference, drawn from the FIBRONEER-IPF and FIBRONEER-ILD studies, indicated that nerandomilast met its primary endpoint in both studies assessing patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).1 The late-breaking data on nerandomilast, an investigational oral and preferential inhibitor of phosphodiesterase 4B (PDE4B), were previously highlighted by HCPLive.
Nerandomilast in Patients with Progressive Pulmonary Fibrosis | NEJM
Affiliations 1Department of Pulmonary, Critical Care, and Sleep Medicine, Keck School of Medicine, University of Southern California, Los Angeles 2Section of Inflammation, Repair, and Development, National Heart and Lung Institute, Imperial College London, London 3Division of Rheumatology, McGovern Medical School, UTHealth Houston, Houston 4Clinical Research Center, Mihara General Hospital, Saitama, Japan 5Nippon Medical School, Tokyo 6National Reference Center for Rare Pulmonary Diseases,...
Publisher Correction: Fibrosis: cross-organ biology and pathways to development of innovative drugs - Nature Reviews Drug Discovery
Correction to: Nature Reviews Drug Discovery https://doi.org/10.1038/s41573-025-01158-9, published online 18 March 2025. In the version of the article initially published, only Florian Rieder and Marco Prunotto were listed as equal contributors. This has now been corrected in the HTML and PDF versions of the article so that all authors are listed as having contributed equally. About this article Rieder, F., Nagy, L.E., Maher, T.M. et al.
Fibrosis: cross-organ biology and pathways to development of innovative drugs - Nature Reviews Drug Discovery
Abstract Fibrosis is a pathophysiological mechanism involved in chronic and progressive diseases that results in excessive tissue scarring. Diseases associated with fibrosis include metabolic dysfunction-associated steatohepatitis (MASH), inflammatory bowel diseases (IBDs), chronic kidney disease (CKD), idiopathic pulmonary fibrosis (IPF) and systemic sclerosis (SSc), which are collectively responsible for substantial morbidity and mortality.
Design of a Phase III, Double-Blind, Randomised, Placebo-Controlled Trial of Bi 1015550 in Patients With Progressive Pulmonary Fibrosis (Fibroneer-Ild)
INTRODUCTION: Progressive pulmonary fibrosis (PPF) includes any diagnosis of progressive fibrotic interstitial lung disease (ILD) other than idiopathic pulmonary fibrosis (IPF). However, disease progression appears comparable between PPF and IPF, suggesting a similar underlying pathology relating to pulmonary fibrosis. Following positive results in a phase II study in IPF, this phase III study will investigate the efficacy and safety of BI 1015550 in patients with PPF (FIBRONEER-ILD).
Pirfenidone in patients with unclassifiable progressive fibrosing interstitial lung disease: design of a double-blind, randomised, placebo-controlled phase II trial
Discussion This study will be the first randomised controlled trial of an antifibrotic agent specifically in patients with uILD and aims to establish whether pirfenidone reduces the rate of FVC decline in this population. A study of nintedanib is underway in patients with progressive, ‘physician-diagnosed fibrosing ILD’ including unclassifiable IIP25; however, the study of pirfenidone is unique in that only patients with uILD will be included.
Rationale, design and objectives of two phase III, randomised, placebo-controlled studies of GLPG1690, a novel autotaxin inhibitor, in idiopathic pulmonary fibrosis (ISABELA 1 and 2)
Interstitial lung disease Rationale, design and objectives of two phase III, randomised, placebo-controlled studies of GLPG1690, a novel autotaxin inhibitor, in idiopathic pulmonary fibrosis (ISABELA 1 and 2) Statistics from Altmetric.com Request Permissions If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service.
Design of a phase III, double-blind, randomised, placebo-controlled trial of BI 1015550 in patients with progressive pulmonary fibrosis (FIBRONEER-ILD)
Interstitial lung disease Design of a phase III, double-blind, randomised, placebo-controlled trial of BI 1015550 in patients with progressive pulmonary fibrosis (FIBRONEER-ILD) Statistics from Altmetric.com Request Permissions If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.
Interstitial Lung Disease
Abstract Importance Interstitial lung disease (ILD) consists of a group of pulmonary disorders characterized by inflammation and/or fibrosis of the lung parenchyma associated with progressive dyspnea that frequently results in end-stage respiratory failure. In the US, ILD affects approximately 650 000 people and causes approximately 25 000 to 30 000 deaths per year.
Study design of BI 1015550 for idiopathic pulmonary fibrosis and progressive pulmonary fibrosis: a plain language summary
This is an abstract of the Plain Language Summary of Publication article. To read the full Plain Language Summary of this article, click here to view the PDF. Link to original articles here Link to original articles here Acknowledgments The authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors (ICMJE). The authors did not receive payment related to the development of the manuscript.
Effects of nintedanib on symptoms in patients with progressive pulmonary fibrosis
Introduction Symptoms of dyspnoea and cough, as well as fatigue, can have a profound impact on the lives of patients with pulmonary fibrosis [1–3]. Current approaches to the management of pulmonary fibrosis aim to slow disease progression, minimise symptoms and preserve patients’ health-related quality of life (HRQoL). Reliable, valid and responsive patient-reported outcomes are needed to evaluate the impact of disease on patients’ lives and the effects of interventions [4, 5].
An adjudication algorithm for respiratory-related hospitalisation in idiopathic pulmonary fibrosis
Introduction Idiopathic pulmonary fibrosis (IPF) is a chronic progressive lung disease that places a high burden on patients, with excessive mortality and increasing prevalence [1, 2]. Pirfenidone and nintedanib are approved for the treatment of IPF [3, 4], but neither reverse existing pathology [5–7]. Novel therapeutic agents are under development [8], leading to a pressing need to optimise and standardise clinical trial end-points [9].
Association study of human leukocyte antigen variants and idiopathic pulmonary fibrosis
Introduction Idiopathic pulmonary fibrosis (IPF) is a lung disease characterised by progressive scarring of the alveoli leading to impaired gas exchange. The median survival after IPF diagnosis is 2–5 years and there are limited drug treatments for patients [1]. Several studies have reported both environmental and genetic risk factors related to IPF [2]. However, the cause of IPF development remains unclear.
Effects of nintedanib on symptoms in patients with progressive pulmonary fibrosis
Footnotes This manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.
Gastrointestinal pirfenidone adverse events in idiopathic pulmonary fibrosis depending on diet: the MADIET clinical trial
To the Editor: Idiopathic pulmonary fibrosis (IPF) is a chronic and lethal interstitial lung disease (ILD) [1, 2]. Antifibrotic medications such as pirfenidone have been a turning point in the management of IPF, slowing of disease progression and improving survival [1–5]. However, mild-to-moderate gastrointestinal (GI) adverse events (AEs), including nausea and vomiting, have been reported in clinical trials and real-world practice as the most frequent challenge for drug adherence in IPF [1, 3–7].
Ziritaxestat and Lung Function in Idiopathic Pulmonary Fibrosis-Reply
Ziritaxestat and Lung Function in Idiopathic Pulmonary Fibrosis—Reply Ziritaxestat, a Novel Autotaxin Inhibitor, and Lung Function in Idiopathic Pulmonary Fibrosis Toby M. Maher, MD, PhD; Paul Ford, MD, PhD; Kevin K. Brown, MD; Ulrich Costabel, MD, PhD; Vincent Cottin, MD, PhD; Sonye K. Danoff, MD, PhD; Irene Groenveld, MSc; Eric Helmer, PharmD; R. Gisli Jenkins, MD, PhD; Julie Milner, PhD; Geert Molenberghs, PhD; Bjorn Penninckx, MD; Matthew J.
Now Unfolding: The Future of Idiopathic Pulmonary Fibrosis
close Please confirm that you would like to log out of Medscape. If you log out, you will be required to enter your username and password the next time you visit. Log out Cancel This transcript has been edited for clarity. For more episodes, download the Medscape app or subscribe to the podcast on Apple Podcasts, Spotify, or your preferred podcast provider. Jeffrey J. Swigris, DO: Welcome to Medscape InDiscussion on the topic of idiopathic pulmonary fibrosis, or IPF.
Airway soluble CSF1R predicts progression in patients with idiopathic pulmonary fibrosis
ERJ Open Research 9: 00690-2022; DOI: 10.1183/23120541.00690-2022 Tweetable abstract This study provides the first evidence for a role of airway sCSF1R in IPF https://bit.ly/3KTBrCA To the Editor: Idiopathic pulmonary fibrosis (IPF) is a chronic debilitating lung disease, characterised by progressive deposition of excessive extracellular matrix in the lung parenchyma [1]. Though rare, IPF has a median untreated survival of 3 years from diagnosis, making it more deadly than many cancers [2, 3].
The causal relationship between gastro-oesophageal reflux disease and idiopathic pulmonary fibrosis: a bidirectional two-sample Mendelian randomisation study
Introduction Idiopathic pulmonary fibrosis (IPF) is a progressive fibrotic lung disease characterised by a usual interstitial pneumonia pattern on thorax computed tomography or biopsy in the absence of a recognised cause [1]. The incidence in Europe and North America is 3–9 per 100 000 person-years [2] and the prognosis is poor, with a median survival of 3 years [3, 4].
The Future of Clinical Trials in Idiopathic Pulmonary Fibrosis
The Future of Clinical Trials in Idiopathic Pulmonary Fibrosis Ziritaxestat, a Novel Autotaxin Inhibitor, and Lung Function in Idiopathic Pulmonary Fibrosis Toby M. Maher, MD, PhD; Paul Ford, MD, PhD; Kevin K. Brown, MD; Ulrich Costabel, MD, PhD; Vincent Cottin, MD, PhD; Sonye K. Danoff, MD, PhD; Irene Groenveld, MSc; Eric Helmer, PharmD; R. Gisli Jenkins, MD, PhD; Julie Milner, PhD; Geert Molenberghs, PhD; Bjorn Penninckx, MD; Matthew J.
Ziritaxestat, a Novel Autotaxin Inhibitor, and Lung Function in Idiopathic Pulmonary Fibrosis
Key Points Question Does the autotaxin inhibitor ziritaxestat improve outcomes, compared with placebo, in patients with idiopathic pulmonary fibrosis who continue to receive standard of care with pirfenidone, nintedanib, or neither standard of care treatment?
Health Disparities in the Diagnosis and Treatment of Interstitial Lung Disease
close Please confirm that you would like to log out of Medscape. If you log out, you will be required to enter your username and password the next time you visit. Log out Cancel Perspective > Medscape > MDAngle Toby M. Maher, MD, discusses health disparities faced by patients with interstitial lung disease (ILD). One major challenge is the delayed diagnosis of ILD due to overlapping symptoms with other conditions like heart disease, asthma, or chronic obstructive pulmonary disease.
In Retrospect: The Evolution of Understanding of Interstitial Lung Disease
close Please confirm that you would like to log out of Medscape. If you log out, you will be required to enter your username and password the next time you visit. Log out Cancel Perspective > Medscape > MDAngle Toby M. Maher, MD, recounts an early encounter with a patient with an acute exacerbation of undiagnosed idiopathic pulmonary fibrosis whose condition deteriorated over 5 weeks and eventually led to his death.
The causal relationship between gastro-esophageal reflux disease and idiopathic pulmonary fibrosis: A bidirectional two-sample Mendelian randomization study
European Respiratory Journal DOI: 10.1183/13993003.01585-2022 Abstract Background Gastro-esophageal reflux disease (GERD) is associated with idiopathic pulmonary fibrosis (IPF) in observational studies. It is not known if this association arises because GERD causes IPF, or IPF causes GERD, or because of confounding by factors, such as smoking, associated with both GERD and IPF.
Clinical trial simulations in pulmonary fibrosis: patient-focused insights and adaptations
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GLPG1205 for idiopathic pulmonary fibrosis: a phase 2 randomised placebo-controlled trial
Abstract Background GLPG1205 is a selective functional antagonist of G-protein-coupled receptor 84, which plays an important role in fibrotic processes. This study assessed the efficacy, safety and tolerability of GLPG1205 for treatment of idiopathic pulmonary fibrosis (IPF). Methods PINTA (ClinicalTrials.gov: NCT03725852) was a phase 2, randomised, double-blind, placebo-controlled, proof-of-concept trial.
Phosphodiesterase 4B inhibition: a potential novel strategy for treating pulmonary fibrosis
Clinical evidence for targeting PDE4B Phase I trials with BI 1015550 in healthy male volunteers (n=42) and patients with IPF (n=15) found most adverse events to be either mild or moderate [74]. Gastrointestinal adverse events were the most common events and were more frequent in patients treated with BI 1015550 than placebo (80% versus 40%, respectively) [74].
Rituximab versus intravenous cyclophosphamide in patients with connective tissue disease-associated interstitial lung disease in the UK (RECITAL): a double-blind, double-dummy, randomised, controlled, phase 2b trial
Statistical analysis A sample size of 104 participants was planned to give 90% power to detect a 5% difference in 24-week rate of change in FVC between treatment groups at a two-tailed significance level of 5%. We originally planned to aim for 10% over-recruitment to account for patient dropouts before week 24; however, because of the COVID-19 pandemic and an anticipated prolonged interruption to recruitment, study enrolment was halted in March, 2020, after randomisation of 101 participants.
GLPG1205 for idiopathic pulmonary fibrosis: a Phase 2 randomised placebo-controlled trial
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The role of precision medicine in interstitial lung disease
Abstract The management of interstitial lung disease (ILD) may benefit from a conceptual shift. Increased understanding of this complex and heterogeneous group of disorders over the past 20 years has highlighted the need for individualised treatment strategies that encompass diagnostic classification and disease behaviour. Biomarker-based approaches to precision medicine hold the greatest promise.
Interstitial lung diseases
1. Travis WD Costabel U Hansell DM et al. An official American Thoracic Society/European Respiratory Society statement: update of the international multidisciplinary classification of the idiopathic interstitial pneumonias. Am J Respir Crit Care Med. 2013; 188: 733-748 2. Spectrum of fibrotic lung diseases. N Engl J Med. 2020; 383: 958-968 3. Harari S Spagnolo P Cocconcelli E Luisi F Cottin V Recent advances in the pathobiology and clinical management of lymphangioleiomyomatosis. Curr Opin Pulm Med.
Lung function trajectory in progressive fibrosing interstitial lung disease
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Cluster analysis of transcriptomic datasets to identify endotypes of idiopathic pulmonary fibrosis
Discussion By applying new statistical methods for data co-normalisation and machine learning to multiple publicly available datasets, we identified three clusters of patients with IPF with statistically significant differences in lung function and survival.
Biomarker signatures for progressive idiopathic pulmonary fibrosis
Britt Clynick, Tamera J. Corte, Helen E. Jo, Iain Stewart, Ian N. Glaspole, Christopher Grainge, Toby M. Maher, Vidya Navaratnam, Richard Hubbard, Peter M.A. Hopkins, Paul N. Reynolds, Sally Chapman, Christopher Zappala, Gregory J. Keir, Wendy A. Cooper, Annabelle M. Mahar, Samantha Ellis, Nicole S. Goh, Emma De Jong, Lilian Cha, Dino B.A. Tan, Lucy Leigh, Christopher Oldmeadow, E. Haydn Walters, R.
Effects of nintedanib by inclusion criteria for progression of interstitial lung disease
Toby M. Maher, Kevin K. Brown, Michael Kreuter, Anand Devaraj, Simon L.F. Walsh, Lisa H. Lancaster, Elizabeth A. Belloli, Maria Padilla, Juergen Behr, Rainer-Georg Goeldner, Kay Tetzlaff, Rozsa Schlenker-Herceg, Kevin R. Flaherty on behalf of the INBUILD trial investigators European Respiratory Journal 2022 59: 2004587; DOI: 10.1183/13993003.04587-2020 Abstract Background The INBUILD trial investigated nintedanib versus placebo in patients with progressive fibrosing interstitial lung diseases (ILDs).
Toby M. Maher, Anoop M. Nambiar, Athol U. Wells European Respiratory Journal 2022; DOI: 10.1183/13993003.02146-2021 Abstract The management of interstitial lung disease (ILD) may benefit from a conceptual shift. Increased understanding of this complex and heterogeneous group of disorders over the past 20 years has highlighted the need for individualised treatment strategies that encompass diagnostic classification and disease behaviour.
Autoantibodies are present in the bronchoalveolar lavage but not circulation in patients with fibrotic interstitial lung disease
Karim Boustani, Poonam Ghai, Rachele Invernizzi, Richard J. Hewitt, Toby M. Maher, Quan-Zhen Li, Philip L. Molyneaux, James A. Harker ERJ Open Research 2022 8: 00481-2021; DOI: 10.1183/23120541.00481-2021 Abstract Background Fibrotic interstitial lung disease (fILD) has previously been associated with the presence of autoantibody. While studies have focused on systemic autoimmunity, the role of local autoantibodies in the airways remains unknown.
Lung function trajectory in progressive fibrosing interstitial lung disease
Abstract Proposed criteria for progressive fibrosing interstitial lung disease (PF-ILD) have been linked to increased mortality risk, but lung function trajectory after satisfying individual criterion remains unknown. Because survival is rarely employed as the primary endpoint in therapeutic trials, identifying PF-ILD criteria that best predict subsequent change in forced vital capacity (FVC) could improve clinical trial design.
Autoantibodies are present in the bronchoalveolar lavage but not circulation in patients with fibrotic interstitial lung disease
Karim Boustani, Poonam Ghai, Rachele Invernizzi, Richard J. Hewitt, Toby M. Maher, Quan-Zhen Li, Philip L. Molyneaux, James A. Harker ERJ Open Research 2021; DOI: 10.1183/23120541.00481-2021 Abstract Background Fibrotic interstitial lung disease (fILD) has previously been associated with the presence of autoantibody. While studies have focused on systemic autoimmunity, the role of local autoantibodies in the airways remains unknown.
Biomarker signatures for progressive idiopathic pulmonary fibrosis
Britt Clynick, Tamera J. Corte, Helen E. Jo, Iain Stewart, Ian N. Glaspole, Christopher Grainge, Toby M. Maher, Vidya Navaratnam, Richard Hubbard, Peter M. A. Hopkins, Paul N. Reynolds, Sally Chapman, Christopher Zappala, Gregory J. Keir, Wendy A. Cooper, Annabelle M. Mahar, Samantha Ellis, Nicole S. Goh, Emma De Jong, Lilian Cha, Dino B. A. Tan, Lucy Leigh, Christopher Oldmeadow, E. Haydn Walters, R.
Measurement of hypoxia in the lung in idiopathic pulmonary fibrosis: an F-MISO PET/CT study
Joanna C. Porter, Thida Win, Kjell Erlandsson, Francesco Fraioli, Alaleh Rashidnasab, Beverley Holman, Balaji Ganeshan, Nicholas J. Screaton, Toby M. Maher, Raymond Endozo, John Hoath, Robert I. Shortman, Elise Emond, Kris Thielemans, Brian F. Hutton, Pauline T. Lukey, Franklin Aigbirhio, Saif Khan, Manuel Rodriguez-Justo, Ashley M.
Measurement of hypoxia in the lung in IPF: an F-MISO PET CT study
Joanna C. Porter, Thida Win, Kjell Erlandsson, Francesco Fraioli, Alaleh Rashidnasab, Beverley Holman, Balaji Ganeshan, Nicholas J. Screaton, Toby M. Maher, Raymond Endozo, John Hoath, Robert I. Shortman, Elise Emond, Kris Thielemans, Brian F. Hutton, Pauline T. Lukey, Franklin Aigbirhio, Saif Khan, Manuel Rodriguez-Justo, Ashley M.
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