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1. Idiopathic pulmonary fibrosis: current treatment options and critical appraisal of nintedanib

Author

Bonella F, Stowasser S, and Wollin L

Subjects
Tyrosine kinase, disease progression, treatment outcome, usual interstitial pneumonia, therapeutics, Therapeutics. Pharmacology, RM1-950
Abstract

Francesco Bonella,1 Susanne Stowasser,2 Lutz Wollin3 1Interstitial and Rare Lung Disease Unit, Ruhrlandklinik, University Hospital, University of Duisburg-Essen, Essen, 2Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, 3Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany Abstract: Idiopathic pulmonary fibrosis (IPF) is the most common type of idiopathic interstitial pneumonia and is characterized by a poor prognosis, with an estimated 5-year survival of approximately 20%. Progressive and irreversible lung functional impairment leads to chronic respiratory insufficiency with a severely impaired quality of life. In the last 2 decades, novel treatments for IPF have been developed as a consequence of an increasing understanding of disease pathogenesis and pathobiology. In IPF, injured dysfunctional alveolar epithelial cells promote fibroblast recruitment and proliferation, resulting in scarring of the lung tissue. Recently, pirfenidone and nintedanib have been approved for the treatment of IPF, having shown efficacy to slow functional decline and disease progression. This article focuses on the pharmacologic characteristics and clinical evidence supporting the use of nintedanib, a potent small-molecule tyrosine kinase inhibitor, as therapy for IPF. After introducing the mechanism of action and pharmacokinetics, an overview of the safety and efficacy results from the most recent clinical trials of nintedanib in IPF is presented. Keywords: tyrosine kinase, disease progression, treatment outcome, usual interstitial pneumonia, therapeutics

Published
2015

7. Design of Phase III, Randomized, Placebo-Controlled Trials of BI 1015550 in Patients with Progressive Fibrosing Interstitial Lung Disease and Idiopathic Pulmonary Fibrosis (FIBRONEER-ILD / -IPF)

Author

Kreuter, M, additional, Maher, T, additional, Azuma, A, additional, Cottin, V, additional, Assassi, S, additional, Hoffmann-Vold, A, additional, Martinez, F, additional, Oldham, J, additional, Valenzuela, C, additional, Wijsenbeek, M, additional, Liu, Y, additional, Wachtlin, D, additional, Stowasser, S, additional, Zoz, D, additional, and Richeldi, L, additional

Published
2023
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8. Nintedanib in children and adolescents with fibrosing interstitial lung disease: the InPedILD* trial**

Author

Griese, M, additional, Deterding, R, additional, Young, L, additional, DeBoer, E, additional, Warburton, D, additional, Cunningham, S, additional, Schwerk, N, additional, Flaherty, K, additional, Brown, K, additional, Dumistracel, M, additional, Erhardt, E, additional, Bertulis, J, additional, Gahlemann, M, additional, and Stowasser, S, additional

Published
2023
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9. Sécurité d’emploi et efficacité de Bl 1015550, un inhibiteur préférentiel de la phosphodiestérase 4B (PDE4Bi), chez des patients atteints de fibrose pulmonaire idiopathique : essai de phase II

Author

Richeldi, L., primary, Azuma, A., additional, Cottin, V., additional, Hesslinger, C., additional, Stowasser, S., additional, Valenzuela, C., additional, Wijsenbeek, M., additional, Zoz, D.F., additional, Voss, F., additional, and Maher, T.M., additional

Published
2023
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11. Nintedanib in children and adolescents with fibrosing interstitial lung disease: the InPedILD trial

Author

Deterding, R, primary, Young, L R, additional, Deboer, E M, additional, Warburton, D, additional, Cunningham, S, additional, Schwerk, N, additional, Flaherty, K R, additional, Brown, K K, additional, Dumistracel, M, additional, Erhardt, E, additional, Bertulis, J, additional, Gahlemann, M, additional, Stowasser, S, additional, and Griese, M, additional

Published
2022
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12. Trial of a Preferential Phosphodiesterase 4B Inhibitor for Idiopathic Pulmonary Fibrosis

Author

Richeldi, L, Azuma, A, Cottin, V, Hesslinger, C, Stowasser, S, Valenzuela, C, Wijsenbeek, MS, Zoz, DF, Voss, F, Maher, TM, 1305-0013 Trial Investigators, Pulmonary Medicine, British Lung Foundation, National Institute for Health Research, Action for Pulmonary Fibrosis, CCA - Cancer Treatment and quality of life, and Pulmonary medicine

Subjects
Science & Technology, 1305-0013 Trial Investigators, PIRFENIDONE, General Medicine, Settore MED/10 - MALATTIE DELL'APPARATO RESPIRATORIO, STANDARDIZATION, EFFICACY, NINTEDANIB, hosphodiesterase 4 (PDE4) inhibition, Medicine, General & Internal, SDG 3 - Good Health and Well-being, General & Internal Medicine, Life Sciences & Biomedicine, 11 Medical and Health Sciences
Abstract

BACKGROUND Phosphodiesterase 4 (PDE4) inhibition is associated with antiinflammatory and antifibrotic effects that may be beneficial in patients with idiopathic pulmonary fibrosis. METHODS In this phase 2, double-blind, placebo-controlled trial, we investigated the efficacy and safety of BI 1015550, an oral preferential inhibitor of the PDE4B subtype, in patients with idiopathic pulmonary fibrosis. Patients were randomly assigned in a 2:1 ratio to receive BI 1015550 at a dose of 18 mg twice daily or placebo. The primary end point was the change from baseline in the forced vital capacity (FVC) at 12 weeks, which we analyzed with a Bayesian approach separately according to background nonuse or use of an antifibrotic agent. RESULTS A total of 147 patients were randomly assigned to receive BI 1015550 or placebo. Among patients without background antifibrotic use, the median change in the FVC was 5.7 ml (95% credible interval, -39.1 to 50.5) in the BI 1015550 group and -81.7 ml (95% credible interval, -133.5 to -44.8) in the placebo group (median difference, 88.4 ml; 95% credible interval, 29.5 to 154.2; probability that BI 1015550 was superior to placebo, 0.998). Among patients with background antifibrotic use, the median change in the FVC was 2.7 ml (95% credible interval, -32.8 to 38.2) in the BI 1015550 group and -59.2 ml (95% credible interval, -111.8 to -17.9) in the placebo group (median difference, 62.4 ml; 95% credible interval, 6.3 to 125.5; probability that BI 1015550 was superior to placebo, 0.986). A mixed model with repeated measures analysis provided results that were consistent with those of the Bayesian analysis. The most frequent adverse event was diarrhea. A total of 13 patients discontinued BI 1015550 treatment owing to adverse events. The percentages of patients with serious adverse events or severe adverse events were similar in the two trial groups. CONCLUSIONS In this placebo-controlled trial, treatment with BI 1015550, either alone or with background use of an antifibrotic agent, prevented a decrease in lung function in patients with idiopathic pulmonary fibrosis. (Funded by Boehringer Ingelheim; 1305-0013 ClinicalTrials.gov number, NCT04419506.)

Published
2022
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17. Trial of a Phosphodiesterase 4 Inhibitor for Idiopathic Pulmonary Fibrosis

Author

Richeldi, L, Stowasser, S, and Maher, TM

Subjects
Cyclic Nucleotide Phosphodiesterases, General & Internal Medicine, Medizin, Humans, Settore MED/10 - MALATTIE DELL'APPARATO RESPIRATORIO, General Medicine, Phosphodiesterase 4 Inhibitors, Type 4, 11 Medical and Health Sciences, Idiopathic Pulmonary Fibrosis, Cyclic Nucleotide Phosphodiesterases, Type 4
Published
2022

18. Efficacy and safety of nintedanib in patients with systemic sclerosis-associated interstitial lung disease treated with mycophenolate: a subgroup analysis of the SENSCIS trial

Author

Highland, K.B., Distler, O., Kuwana, M., Allanore, Y., Assassi, S., Azuma, A., Bourdin, A., Denton, C.P., Distler, J.H., Hoffmann-Vold, A.M., Khanna, D., Mayes, M.D., Raghu, G., Vonk, M.C., Gahlemann, M., Clerisme-Beaty, E., Girard, M., Stowasser, S., Zoz, D., Maher, T.M., Highland, K.B., Distler, O., Kuwana, M., Allanore, Y., Assassi, S., Azuma, A., Bourdin, A., Denton, C.P., Distler, J.H., Hoffmann-Vold, A.M., Khanna, D., Mayes, M.D., Raghu, G., Vonk, M.C., Gahlemann, M., Clerisme-Beaty, E., Girard, M., Stowasser, S., Zoz, D., and Maher, T.M.

Abstract

Item does not contain fulltext, BACKGROUND: In the Safety and Efficacy of Nintedanib in Systemic Sclerosis (SENSCIS) trial, nintedanib reduced the rate of decline in forced vital capacity (FVC) in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Patients on stable treatment with mycophenolate for at least 6 months before randomisation could participate. The aim of this subgroup analysis was to examine the efficacy and safety of nintedanib by mycophenolate use at baseline. METHODS: The SENSCIS trial was a randomised, double-blind, placebo-controlled trial, in which patients with SSc-ILD were randomly assigned (1:1) to receive 150 mg of oral nintedanib twice daily or placebo for at least 52 weeks. In a prespecified subgroup analysis, we analysed the primary endpoint of rate of decline in FVC over 52 weeks by mycophenolate use at baseline. In a post-hoc analysis, we analysed the proportion of patients with an absolute decrease in FVC of at least 3·3% predicted at week 52 (proposed minimal clinically important difference estimate for worsening of FVC in patients with SSc-ILD) in subgroups by mycophenolate use at baseline. Adverse events were reported in subgroups by mycophenolate use at baseline. Analyses were done in all participants who received at least one dose of study drug. We analysed the annual rate of decline in FVC using a random coefficient regression model (with random slopes and intercepts) including anti-topoisomerase I antibody status, age, height, sex, and baseline FVC as covariates and terms for baseline-by-time, treatment-by-subgroup, and treatment-by-subgroup-by-time interactions. SENSCIS is registered with ClinicalTrials.gov, NCT02597933, and is now complete. FINDINGS: Between Nov 30, 2015, and Oct 31, 2017, 819 participants were screened and 576 were enrolled, randomly assigned to, and treated with nintedanib (n=288) or placebo (n=288). 139 (48%) of 288 in the nintedanib group and 140 (49%) of 288 in the placebo group were taking mycophenolate at ba

Published
2021

21. Effect of nintedanib on progression of systemic sclerosis-associated interstitial lung disease (SSc-ILD) beyond 52 weeks: data from the SENSCIS trial

Author

Gläser, S, additional, Maher, T M, additional, Distler, O, additional, Allanore, Y, additional, Ogura, T, additional, Varga, J, additional, Vettori, S, additional, Crestani, B, additional, Wangenheim, U, additional, Quaresma, M, additional, Alves, M, additional, Stowasser, S, additional, and Assassi, S, additional

Published
2021
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22. Effects of nintedanib on progression of ILD in patients with fibrosing ILDs and a progressive phenotype: further analyses of the INBUILD trial

Author

Koschel, D, additional, Flaherty, K R, additional, Wells, A U, additional, Cottin, V, additional, Devaraj, A, additional, Inoue, Y, additional, Richeldi, L, additional, Walsh, S LF, additional, Kolb, M, additional, Moua, T, additional, Stowasser, S, additional, Goeldner, R G, additional, Schlenker-Herceg, R, additional, and Brown, K K, additional

Published
2021
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25. Effet du nintédanib sur la progression de la pneumopathie interstitielle diffuse associée à la sclérodermie systémique (ScS-PID) au-delà de 52 semaines : données de l’étude SENSCIS

Author

Crestani, B., primary, Maher, T.M., additional, Disler, O., additional, Allanore, Y., additional, Ogura, T., additional, Varga, J., additional, Vettori, S., additional, Von Wangenheim, U., additional, Quaresma, M., additional, Alves, M., additional, Stowasser, S., additional, and Assassi, S., additional

Published
2021
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26. Effet du nintédanib sur la progression de la pneumopathie interstitielle diffuse (PID) chez des patients atteints d’une PID associée à une maladie auto-immune : données complémentaires de l’étude INBUILD

Author

Allanore, Y., primary, Matteson, E., additional, Kelly, C., additional, Distler, J.H., additional, Hoffmann-Vold, A.M., additional, Seibold, J.R., additional, Mittoo, S., additional, Distler, O., additional, Dellaripa, P.F., additional, James, A., additional, Schlenker-Herceg, R., additional, Stowasser, S., additional, Quaresma, M., additional, and Flaherty, K.R., additional

Published
2020
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27. Nintedanib for Systemic Sclerosis-Associated Interstitial Lung Disease

Author

Distler, O, Highland, Kb, Gahlemann, M, Azuma, A, Fischer, A, Mayes, Md, Raghu, G, Sauter, W, Girard, M, Alves, M, Clerisme-Beaty, E, Stowasser, S, Tetzlaff, K, Kuwana, M, Maher, Tm, Bergna, M, Casado, G, Mannucci Walter, P, Proudman, S, Stevens, W, Thakkar, V, Troy, L, Loeffler-Ragg, J, Olschewski, H, Bondue, B, Houssiau, F, Smith, V, Wuyts, W, Johnson, S, Keystone, E, Khalidi, N, Levesque, M, Maturana Rozas, R, Silva Orellana, A, Huang, C, Li, J, Jiang, Z, Liu, Y, Xiao, W, Xu, J, Zeng, X, Zheng, Y, Zou, H, Becvar, R, Madsen, H, Søndergaard, K, Kilpeläinen, M, Myllärniemi, M, Agard, C, Allanore, Y, Bourdin, A, Cottin, V, Crestani, B, Diot, E, Dominique, S, Hachulla, E, Jouneau, S, Leroy, S, Nunes, H, Prevot, G, Wallaert, B, Wemeau, L, Aringer, M, Bewig, B, Blaas, S, Distler, J, Ehrchen, J, Ewert, R, Gläser, S, Henes, J, Hunzelmann, N, König, R, Kötter, I, Kreuter, M, Prasse, A, Schulze-Koops, H, Sfikakis, P, Vlachoyiannopoulos, P, Losonczy, G, Behera, D, Gayathri Devi HJ, Kadel, J, Kawedia, M, Kumar, D, Kumar, U, Lokhande, R, Malpani, A, Mohan, M, Nalawade, A, Parakh, U, Swarnakar, R, Shobha, V, Thangakunam, B, Udwadia, Z, Henry, M, O'Reilly, K, Balbir-Gurman, A, Kramer, M, Litinsky, I, Rosner, I, Cutolo, M, Gabrielli, A, Iaccarino, L, Pesci, A, Riccieri, V, Vettori, S, Funakubo, Y, Inoue, Y, Kawakami, A, Kawaguchi, Y, Kawamura, T, Kondoh, Y, Nanki, T, Nishioka, Y, Nozawa, K, Oguragawa, T, Okamoto, M, Sano, H, Sasai, R, Sasaki, N, Suda, T, Takahashi, H, Takeuchi, T, Tanaka, S, Yamasaki, Y, Ch'Ng, Ss, Cheah, C, Kan, S, Raja Mohamed RB, Selman, M, de Vries-Bouwstra JK, van den Toorn, L, Vonken, M, Voskuyl, Ae, Hoffmann-Vold, Am, Seip, M, Dankiewicz-Fares, I, Olesiejuk, R, Pulka, G, Szepietowski, J, Alves, J, Bernardes, M, Cordeiro, A, Costa, J, Neves, S, Salvador, Mj, Alegre Sancho, J, Carreira Delgado, P, Castellví Barranco, I, Cifrián Martínez, J, Guillén Del Castillo, A, Ovalles, Jg, López-Longo, Fj, Rivera Gallego, A, Freire Dapena MC, Román Ivorra JA, Ekwall, Ah, Maurer, B, Mihai, Cm, Müller, R, Mahakkanukrauh, A, Nantiruj, K, Siripaitoon, B, Denton, Cp, Herrick, A, Madhok, R, West, A, Bascom, R, Criner, G, Csuka, Me, Dematte D'Amico, J, Ettinger, N, Gerbino, A, Gerke, A, Glassberg, M, Glazer, C, Golden, J, Gripaldo, R, Gupta, N, Hamblin, M, Highland, K, Ho, L, Huggins, Jt, Hummers, L, Jones, L, Kahaleh, M, Khanna, D, Kim, H, Lancaster, Lh, Luckhardt, T, Mayes, M, Mendoza Ballesteros, F, Mooney, J, Mohabir, P, Morrissey, B, Moua, T, Padilla, M, Patel, N, Perez, R, Roman, J, Rossman, M, Russell, T, Saketkoo, L, Shah, A, Shlobin, O, Scholand, Mb, Simmssetts, R, Spiera, R, Steen, V, Veeraraghavan, S, Weigt, S., Distler, O, Highland, Kb, Gahlemann, M, Azuma, A, Fischer, A, Mayes, Md, Raghu, G, Sauter, W, Girard, M, Alves, M, Clerisme-Beaty, E, Stowasser, S, Tetzlaff, K, Kuwana, M, Maher, Tm, SENSCIS Trial Investigators., Bergna M, Casado, G, Mannucci Walter, P, Proudman, S, Stevens, W, Thakkar, V, Troy, L, Loeffler-Ragg, J, Olschewski, H, Bondue, B, Houssiau, F, Smith, V, Wuyts, W, Johnson, S, Keystone, E, Khalidi, N, Levesque, M, Maturana Rozas, R, Silva Orellana, A, Huang, C, Li, J, Jiang, Z, Liu, Y, Xiao, W, Xu, J, Zeng, X, Zheng, Y, Zou, H, Becvar, R, Madsen, H, Søndergaard, K, Kilpeläinen, M, Myllärniemi, M, Agard, C, Allanore, Y, Bourdin, A, Cottin, V, Crestani, B, Diot, E, Dominique, S, Hachulla, E, Jouneau, S, Leroy, S, Nunes, H, Prevot, G, Wallaert, B, Wemeau, L, Aringer, M, Bewig, B, Blaas, S, Distler, J, Ehrchen, J, Ewert, R, Gläser, S, Henes, J, Hunzelmann, N, König, R, Kötter, I, Kreuter, M, Prasse, A, Schulze-Koops, H, Sfikakis, P, Vlachoyiannopoulos, P, Losonczy, G, Behera, D, Gayathri Devi, Hj, Kadel, J, Kawedia, M, Kumar, D, Kumar, U, Lokhande, R, Malpani, A, Mohan, M, Nalawade, A, Parakh, U, Swarnakar, R, Shobha, V, Thangakunam, B, Udwadia, Z, Henry, M, O'Reilly, K, Balbir-Gurman, A, Kramer, M, Litinsky, I, Rosner, I, Cutolo, M, Gabrielli, A, Iaccarino, Laura, Pesci, A, Riccieri, V, Vettori, S, Funakubo, Y, Inoue, Y, Kawakami, A, Kawaguchi, Y, Kawamura, T, Kondoh, Y, Nanki, T, Nishioka, Y, Nozawa, K, Oguragawa, T, Okamoto, M, Sano, H, Sasai, R, Sasaki, N, Suda, T, Takahashi, H, Takeuchi, T, Tanaka, S, Yamasaki, Y, Ch'Ng, S, Cheah, C, Kan, S, Raja Mohamed, Rb, Selman, M, de Vries-Bouwstra, Jk, van den Toorn, L, Vonken, M, Voskuyl, Ae, Hoffmann-Vold, Am, Seip, M, Dankiewicz-Fares, I, Olesiejuk, R, Pulka, G, Szepietowski, J, Alves, J, Bernardes, M, Cordeiro, A, Costa, J, Neves, S, Salvador, Mj, Alegre Sancho, J, Carreira Delgado, P, Castellví Barranco, I, Cifrián Martínez, J, Guillén Del Castillo, A, Ovalles, Jg, López-Longo, Fj, Rivera Gallego, A, Freire Dapena, Mc, Román Ivorra, Ja, Ekwall, Ah, Maurer, B, Mihai, Cm, Müller, R, Mahakkanukrauh, A, Nantiruj, K, Siripaitoon, B, Denton, Cp, Herrick, A, Madhok, R, West, A, Bascom, R, Criner, G, Csuka, Me, Dematte D'Amico, J, Ettinger, N, Gerbino, A, Gerke, A, Glassberg, M, Glazer, C, Golden, J, Gripaldo, R, Gupta, N, Hamblin, M, Highland, K, Ho, L, Huggins, Jt, Hummers, L, Jones, L, Kahaleh, M, Khanna, D, Kim, H, Lancaster, Lh, Luckhardt, T, Mayes, M, Mendoza Ballesteros, F, Mooney, J, Mohabir, P, Morrissey, B, Moua, T, Padilla, M, Patel, N, Perez, R, Roman, J, Rossman, M, Russell, T, Saketkoo, L, Shah, A, Shlobin, O, Scholand, Mb, Simmssetts, R, Spiera, R, Steen, V, Veeraraghavan, S, Weigt, S., National Institute for Health Research, British Lung Foundation, University of Zurich, and Distler, Oliver

Subjects
Male, Vital capacity, Indoles, Vital Capacity, Administration, Oral, 2700 General Medicine, 030204 cardiovascular system & hematology, Pulmonary function testing, law.invention, oral, Idiopathic pulmonary fibrosis, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, law, SENSCIS Trial Investigators, CYCLOPHOSPHAMIDE, Clinical endpoint, scleroderma, 030212 general & internal medicine, Enzyme Inhibitors, 11 Medical and Health Sciences, lung diseases, Lung Diseases, Interstitial -- drug therapy -- etiology -- physiopathology, 10051 Rheumatology Clinic and Institute of Physical Medicine, General Medicine, respiratory system, Sciences bio-médicales et agricoles, Middle Aged, Protein-Tyrosine Kinases, MANIFESTATIONS, Disease Progression, Nintedanib, Female, TYROSINE KINASE INHIBITOR, Life Sciences & Biomedicine, CLINICAL-TRIALS, Adult, Diarrhea, medicine.medical_specialty, FIBROBLASTS, 610 Medicine & health, Placebo, administration, behavioral disciplines and activities, 03 medical and health sciences, FEV1/FVC ratio, Medicine, General & Internal, Double-Blind Method, Internal medicine, General & Internal Medicine, Enzyme Inhibitors -- adverse effects -- therapeutic use, SCORE, medicine, Humans, Indoles -- adverse effects -- therapeutic use, Scleroderma, Systemic -- complications -- drug therapy, Science & Technology, Scleroderma, Systemic, Protein-Tyrosine Kinases -- antagonists & inhibitors, business.industry, MORTALITY, interstitial, PULMONARY-FUNCTION, systemic, STANDARDIZATION, medicine.disease, EFFICACY, respiratory tract diseases, body regions, chemistry, adult, diarrhea, disease progression, double-blind method, enzyme inhibitors, female, humans, indoles, lung diseases, interstitial, male, middle aged, protein-tyrosine kinases, scleroderma, systemic, vital capacity, business, Lung Diseases, Interstitial, Diarrhea -- chemically induced
Abstract

Interstitial lung disease (ILD) is a common manifestation of systemic sclerosis and a leading cause of systemic sclerosis-related death. Nintedanib, a tyrosine kinase inhibitor, has been shown to have antifibrotic and antiinflammatory effects in preclinical models of systemic sclerosis and ILD., info:eu-repo/semantics/published

Published
2019

28. THU0363 EFFECTS OF NINTEDANIB IN PATIENTS WITH SYSTEMIC SCLEROSIS-ASSOCIATED ILD (SSC-ILD) AND NORMAL VERSUS ELEVATED C-REACTIVE PROTEIN (CRP) AT BASELINE: ANALYSES FROM THE SENSCIS TRIAL

Author

Riemekasten, G., primary, Carreira, P., additional, Saketkoo, L. A., additional, Aringer, M., additional, Chung, L., additional, Pope, J., additional, Miede, C., additional, Stowasser, S., additional, Gahlemann, M., additional, Alves, M., additional, and Khanna, D., additional

Published
2020
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29. OP0115 EFFECT OF NINTEDANIB ON PROGRESSION OF INTERSTITIAL LUNG DISEASE (ILD) IN PATIENTS WITH AUTOIMMUNE DISEASE-RELATED ILDS: FURTHER DATA FROM THE INBUILD TRIAL

Author

Matteson, E., primary, Kelly, C., additional, Distler, J., additional, Hoffmann-Vold, A. M., additional, Seibold, J., additional, Mittoo, S., additional, Distler, O., additional, Dellaripa, P. F., additional, James, A., additional, Schlenker-Herceg, R., additional, Stowasser, S., additional, Quaresma, M., additional, and Flaherty, K. R., additional

Published
2020
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30. Gene Expression Profiling in Patients with Idiopathic Pulmonary Fibrosis (IPF) in the INMARK Trial

Author

Selman, M., primary, Jenkins, R.G.G., additional, White, E.S., additional, Cottin, V., additional, Nishioka, Y., additional, Noth, I., additional, Prasse, A., additional, Song, J.W., additional, Strobel, B., additional, Leparc, G., additional, Ittrich, C., additional, Diefenbach, C., additional, Rohr, K., additional, Stowasser, S., additional, and Maher, T.M., additional

Published
2020
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31. Study Design of a Phase III, Randomized, Placebo-Controlled Trial of Nintedanib in Children and Adolescents with Clinically Significant Fibrosing Interstitial Lung Disease (ILD)

Author

Young, L., primary, Brown, K.K., additional, Griese, M., additional, Deutsch, G., additional, Warburton, D., additional, DeBoer, E., additional, Cunningham, S., additional, Clement, A.F., additional, Schwerk, N., additional, Flaherty, K.R., additional, Voss, F., additional, Schmid, U., additional, Schlenker-Herceg, R., additional, Verri, D., additional, Stowasser, S., additional, Clerisme-Beaty, E.M., additional, and Deterding, R.R., additional

Published
2020
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32. Nintedanib in patients with progressive fibrosing interstitial lung diseases - subgroup analyses by interstitial lung disease diagnosis in the INBUILD trial: a randomised, double-blind, placebo-controlled, parallel-group trial

Author

Wells, A.U., Flaherty, K.R., Brown, K.K., Inoue, Y., Devaraj, A., Richeldi, L., Moua, T., Crestani, B., Wuyts, W.A., Stowasser, S., Quaresma, M., Goeldner, R.-G., Schlenker-Herceg, R., Kolb, M., Abe, S., Aburto, M., Acosta, O., Andrews, C., Antin-Ozerkis, D., Arce, G., Arias, M., Avdeev, S., Barczyk, A., Bascom, R., Bazdyrev, E., Beirne, P., Belloli, E., Bergna, M.A., Bergot, E., Bhatt, N., and Publica

Abstract

Background: The INBUILD trial investigated the efficacy and safety of nintedanib versus placebo in patients with progressive fibrosing interstitial lung diseases (ILDs) other than idiopathic pulmonary fibrosis (IPF). We aimed to establish the effects of nintedanib in subgroups based on ILD diagnosis. Methods: The INBUILD trial was a randomised, double-blind, placebo-controlled, parallel group trial done at 153 sites in 15 countries. Participants had an investigator-diagnosed fibrosing ILD other than IPF, with chest imaging features of fibrosis of more than 10% extent on high resolution CT (HRCT), forced vital capacity (FVC) of 45% or more predicted, and diffusing capacity of the lung for carbon monoxide (DLco) of at least 30% and less than 80% predicted. Participants fulfilled protocol-defined criteria for ILD progression in the 24 months before screening, despite management considered appropriate in clinical practice for the individual ILD. Participants were randomly assigned 1:1 by means of a pseudo-random number generator to receive nintedanib 150 mg twice daily or placebo for at least 52 weeks. Participants, investigators, and other personnel involved in the trial and analysis were masked to treatment assignment until after database lock. In this subgroup analysis, we assessed the rate of decline in FVC (mL/year) over 52 weeks in patients who received at least one dose of nintedanib or placebo in five prespecified subgroups based on the ILD diagnoses documented by the investigators: hypersensitivity pneumonitis, autoimmune ILDs, idiopathic non-specific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs. The trial has been completed and is registered with ClinicalTrials.gov, number NCT02999178. Findings: Participants were recruited between Feb 23, 2017, and April 27, 2018. Of 663 participants who received at least one dose of nintedanib or placebo, 173 (26%) had chronic hypersensitivity pneumonitis, 170 (26%) an autoimmune ILD, 125 (19%) idiopathic non-specific interstitial pneumonia, 114 (17%) unclassifiable idiopathic interstitial pneumonia, and 81 (12%) other ILDs. The effect of nintedanib versus placebo on reducing the rate of FVC decline (mL/year) was consistent across the five subgroups by ILD diagnosis in the overall population (hypersensitivity pneumonitis 73·1 [95% CI −8·6 to 154·8]; autoimmune ILDs 104·0 [21·1 to 186·9]; idiopathic non-specific interstitial pneumonia 141·6 [46·0 to 237·2]; unclassifiable idiopathic interstitial pneumonia 68·3 [−31·4 to 168·1]; and other ILDs 197·1 [77·6 to 316·7]; p=0·41 for treatment by subgroup by time interaction). Adverse events reported in the subgroups were consistent with those reported in the overall population. Interpretation: The INBUILD trial was not designed or powered to provide evidence for a benefit of nintedanib in specific diagnostic subgroups. However, its results suggest that nintedanib reduces the rate of ILD progression, as measured by FVC decline, in patients who have a chronic fibrosing ILD and progressive phenotype, irrespective of the underlying ILD diagnosis. Funding: Boehringer Ingelheim.

Published
2020

33. Consistent Effect of Nintedanib in Patients with IPF and Degrees of Impairment in Gas Exchange

Author

Richeldi, L., Kolb, M., Jouneau, S., Wuyts, W. A., Tschoepe, I., Stowasser, S., Quaresma, M., Raghu, G., Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS), McMaster University [Hamilton, Ontario], Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), University of Washington [Seattle], Boehringer Ingelheim, Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), and Jonchère, Laurent

Subjects
[SDV] Life Sciences [q-bio], [SDV]Life Sciences [q-bio], ComputingMilieux_MISCELLANEOUS
Abstract

International audience

Published
2019

35. Health-related quality of life and symptoms in patients with IPF treated with nintedanib: analyses of patient-reported outcomes from the INPULSIS® trials

Author

Kreuter, M. (Michael), Wuyts, W.A. (Wim A.), Wijsenbeek-Lourens, M.S. (Marlies), Bajwah, S. (Sabrina), Maher, T.M. (Toby M.), Stowasser, S. (Susanne), Male, N. (Natalia), Stansen, W. (Wibke), Schoof, N. (Nils), Orsatti, L. (Leticia), Swigris, J. (Jeffrey), Kreuter, M. (Michael), Wuyts, W.A. (Wim A.), Wijsenbeek-Lourens, M.S. (Marlies), Bajwah, S. (Sabrina), Maher, T.M. (Toby M.), Stowasser, S. (Susanne), Male, N. (Natalia), Stansen, W. (Wibke), Schoof, N. (Nils), Orsatti, L. (Leticia), and Swigris, J. (Jeffrey)

Abstract

BACKGROUND: In the Phase III INPULSIS® trials, treatment of patients with idiopathic pulmonary fibrosis (IPF) with nintedanib significantly reduced the annual rate of decline in forced vital capacity (FVC) versus placebo, consistent with slowing disease progression. However, nintedanib was not associated with a benefit in health-related quality of life (HRQoL) assessed using the St George's respiratory questionnaire (SGRQ). We aimed to

Published
2020
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36. Efficacy and safety of nintedanib in patients with advanced idiopathic pulmonary fibrosis

Author

Richeldi, Luca, Kolb, M., Jouneau, S., Wuyts, W. A., Schinzel, B., Stowasser, S., Quaresma, M., Raghu, G., Richeldi L. (ORCID:0000-0001-8594-1448), Richeldi, Luca, Kolb, M., Jouneau, S., Wuyts, W. A., Schinzel, B., Stowasser, S., Quaresma, M., Raghu, G., and Richeldi L. (ORCID:0000-0001-8594-1448)

Abstract

Background: The two 52-week INPULSIS trials investigated nintedanib versus placebo in patients with IPF, FVC ≥50% predicted and DLco 30-79% predicted. The 24-week INSTAGE trial investigated nintedanib plus sildenafil versus nintedanib alone in patients with IPF and DLco ≤35% predicted. We used data from INPULSIS and INSTAGE to compare the effects of nintedanib in patients with IPF with less versus more severe impairment in gas exchange at baseline. Methods: Analyses were conducted in patients treated with nintedanib alone in the INPULSIS and INSTAGE trials and in patients treated with placebo in the INPULSIS trials. Outcomes included the rate of decline in FVC over 24 weeks, the proportions of patients who had a confirmed or suspected idiopathic acute exacerbation over 24 weeks, deaths over 24 weeks, and adverse events. Analyses were descriptive. Results: In total, 638 and 136 patients received nintedanib alone in the INPULSIS and INSTAGE trials, respectively, and 423 patients received placebo in the INPULSIS trials. Rates of FVC decline were - 52.3 and - 66.7 mL/24 weeks in patients treated with nintedanib alone in INPULSIS and INSTAGE, respectively, and - 102.8 mL/24 weeks in patients treated with placebo in INPULSIS. Confirmed or suspected idiopathic acute exacerbations were reported in 0.6 and 3.7% of patients treated with nintedanib alone in INPULSIS and INSTAGE, respectively, and 2.1% of patients treated with placebo in INPULSIS. Deaths occurred in 2.0, 11.0 and 1.9% of patients in these groups, respectively. Diarrhoea adverse events were reported in 52.5 and 48.5% of patients treated with nintedanib alone in INPULSIS and INSTAGE, respectively, and 16.1% of patients treated with placebo in INPULSIS. Conclusions: Based on data from the INSTAGE and INPULSIS trials, nintedanib had a similar effect on FVC decline over 24 weeks, and a similar safety and tolerability profile, in patients with IPF and more versus less severe impairment in gas exchange. These data sup

Published
2020

37. Nintedanib in patients with progressive fibrosing interstitial lung diseases—subgroup analyses by interstitial lung disease diagnosis in the INBUILD trial: a randomised, double-blind, placebo-controlled, parallel-group trial

Author

Wells, A. U., Flaherty, K. R., Brown, K. K., Inoue, Y., Devaraj, A., Richeldi, Luca, Moua, T., Crestani, B., Wuyts, W. A., Stowasser, S., Quaresma, M., Goeldner, R. -G., Schlenker-Herceg, R., Kolb, M., Abe, S., Aburto, M., Acosta, O., Andrews, C., Antin-Ozerkis, D., Arce, G., Arias, M., Avdeev, S., Barczyk, A., Bascom, R., Bazdyrev, E., Beirne, P., Belloli, E., Bergna, M. A., Bergot, E., Bhatt, N., Blaas, S., Bondue, B., Bonella, F., Britt, E., Buch, K., Burk, J., Cai, H., Cantin, A., Castillo Villegas, D. M., Cazaux, A., Cerri, S., Chaaban, S., Chaudhuri, N., Cottin, V., Criner, G., Dahlqvist, C., Danoff, S., Dematte D'Amico, J., Dilling, D., Elias, P., Ettinger, N., Falk, J., Fernandez Perez, E. R., Gamez-Dubuis, A., Giessel, G., Gifford, A., Glassberg, M., Glazer, C., Golden, J., Gomez Carrera, L., Guiot, J., Hallowell, R., Hayashi, H., Hetzel, J., Hirani, N., Homik, L., Hope-Gill, B., Hotchkin, D., Ichikado, K., Ilkovich, M., Izumi, S., Jassem, E., Jones, L., Jouneau, S., Kaner, R., Kang, J., Kawamura, T., Kessler, R., Kim, Y., Kishi, K., Kitamura, H., Kondoh, Y., Kono, C., Koschel, D., Kreuter, M., Kulkarni, T., Kus, J., Lebargy, F., Leon Jimenez, A., Luo, Q., Mageto, Y., Maher, T. M., Makino, S., Marchand-Adam, S., Marquette, C., Martinez, Sara, Martinez, M., Maturana Rozas, R., Miyazaki, Y., Moiseev, S., Molina-Molina, M., Malcolm, Joan Morrison, Morrow, L., Nambiar, A., Nishioka, Y., Nunes, H., Okamoto, M., Oldham, J., Otaola, M., Padilla, M., Park, J. S., Patel, N., Pesci, Riccardo, Piotrowski, W., Pitts, L., Poonyagariyagorn, H., Prasse, A., Quadrelli, S., Randerath, W., Refini, R., Reynaud-Gaubert, M., Riviere, F., Rodriguez Portal, J. A., Rosas, I., Rossman, M., Safdar, Z., Saito, T., Sakamoto, N., Salinas Fenero, M., Sauleda, J., Schmidt, S., Scholand, M. B., Schwartz, M., Shapera, S., Shlobin, O., Sigal, B., Silva Orellana, A., Skowasch, D., Song, J. W., Stieglitz, S., Stone, H., Strek, M., Suda, T., Sugiura, H., Takahashi, H., Takaya, H., Takeuchi, T., Thavarajah, K., Tolle, L., Tomassetti, S., Tomii, K., Valenzuela, C., Vancheri, C., Varone, Francesco, Veeraraghavan, S., Villar, A., Weigt, S., Wemeau, L., Wuyts, W., Xu, Z., Yakusevich, V., Yamada, Y., Yamauchi, H., Ziora, D., Richeldi L. (ORCID:0000-0001-8594-1448), Martinez R., Morrison L., Pesci A., Varone F., Wells, A. U., Flaherty, K. R., Brown, K. K., Inoue, Y., Devaraj, A., Richeldi, Luca, Moua, T., Crestani, B., Wuyts, W. A., Stowasser, S., Quaresma, M., Goeldner, R. -G., Schlenker-Herceg, R., Kolb, M., Abe, S., Aburto, M., Acosta, O., Andrews, C., Antin-Ozerkis, D., Arce, G., Arias, M., Avdeev, S., Barczyk, A., Bascom, R., Bazdyrev, E., Beirne, P., Belloli, E., Bergna, M. A., Bergot, E., Bhatt, N., Blaas, S., Bondue, B., Bonella, F., Britt, E., Buch, K., Burk, J., Cai, H., Cantin, A., Castillo Villegas, D. M., Cazaux, A., Cerri, S., Chaaban, S., Chaudhuri, N., Cottin, V., Criner, G., Dahlqvist, C., Danoff, S., Dematte D'Amico, J., Dilling, D., Elias, P., Ettinger, N., Falk, J., Fernandez Perez, E. R., Gamez-Dubuis, A., Giessel, G., Gifford, A., Glassberg, M., Glazer, C., Golden, J., Gomez Carrera, L., Guiot, J., Hallowell, R., Hayashi, H., Hetzel, J., Hirani, N., Homik, L., Hope-Gill, B., Hotchkin, D., Ichikado, K., Ilkovich, M., Izumi, S., Jassem, E., Jones, L., Jouneau, S., Kaner, R., Kang, J., Kawamura, T., Kessler, R., Kim, Y., Kishi, K., Kitamura, H., Kondoh, Y., Kono, C., Koschel, D., Kreuter, M., Kulkarni, T., Kus, J., Lebargy, F., Leon Jimenez, A., Luo, Q., Mageto, Y., Maher, T. M., Makino, S., Marchand-Adam, S., Marquette, C., Martinez, Sara, Martinez, M., Maturana Rozas, R., Miyazaki, Y., Moiseev, S., Molina-Molina, M., Malcolm, Joan Morrison, Morrow, L., Nambiar, A., Nishioka, Y., Nunes, H., Okamoto, M., Oldham, J., Otaola, M., Padilla, M., Park, J. S., Patel, N., Pesci, Riccardo, Piotrowski, W., Pitts, L., Poonyagariyagorn, H., Prasse, A., Quadrelli, S., Randerath, W., Refini, R., Reynaud-Gaubert, M., Riviere, F., Rodriguez Portal, J. A., Rosas, I., Rossman, M., Safdar, Z., Saito, T., Sakamoto, N., Salinas Fenero, M., Sauleda, J., Schmidt, S., Scholand, M. B., Schwartz, M., Shapera, S., Shlobin, O., Sigal, B., Silva Orellana, A., Skowasch, D., Song, J. W., Stieglitz, S., Stone, H., Strek, M., Suda, T., Sugiura, H., Takahashi, H., Takaya, H., Takeuchi, T., Thavarajah, K., Tolle, L., Tomassetti, S., Tomii, K., Valenzuela, C., Vancheri, C., Varone, Francesco, Veeraraghavan, S., Villar, A., Weigt, S., Wemeau, L., Wuyts, W., Xu, Z., Yakusevich, V., Yamada, Y., Yamauchi, H., Ziora, D., Richeldi L. (ORCID:0000-0001-8594-1448), Martinez R., Morrison L., Pesci A., and Varone F.

Abstract

Background: The INBUILD trial investigated the efficacy and safety of nintedanib versus placebo in patients with progressive fibrosing interstitial lung diseases (ILDs) other than idiopathic pulmonary fibrosis (IPF). We aimed to establish the effects of nintedanib in subgroups based on ILD diagnosis. Methods: The INBUILD trial was a randomised, double-blind, placebo-controlled, parallel group trial done at 153 sites in 15 countries. Participants had an investigator-diagnosed fibrosing ILD other than IPF, with chest imaging features of fibrosis of more than 10% extent on high resolution CT (HRCT), forced vital capacity (FVC) of 45% or more predicted, and diffusing capacity of the lung for carbon monoxide (DLco) of at least 30% and less than 80% predicted. Participants fulfilled protocol-defined criteria for ILD progression in the 24 months before screening, despite management considered appropriate in clinical practice for the individual ILD. Participants were randomly assigned 1:1 by means of a pseudo-random number generator to receive nintedanib 150 mg twice daily or placebo for at least 52 weeks. Participants, investigators, and other personnel involved in the trial and analysis were masked to treatment assignment until after database lock. In this subgroup analysis, we assessed the rate of decline in FVC (mL/year) over 52 weeks in patients who received at least one dose of nintedanib or placebo in five prespecified subgroups based on the ILD diagnoses documented by the investigators: hypersensitivity pneumonitis, autoimmune ILDs, idiopathic non-specific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs. The trial has been completed and is registered with ClinicalTrials.gov, number NCT02999178. Findings: Participants were recruited between Feb 23, 2017, and April 27, 2018. Of 663 participants who received at least one dose of nintedanib or placebo, 173 (26%) had chronic hypersensitivity pneumonitis, 170 (26%) an autoimmune IL

Published
2020

41. Nintedanib in patients with chronic fibrosing Interstitial lung diseases with progressive phenotype: the INBUILD trial*

Author

Koschel, D, additional, Flaherty, KR, additional, Wells, AU, additional, Cottin, V, additional, Devaraj, A, additional, Inoue, Y, additional, Richeldi, L, additional, Walsh, S, additional, Stowasser, S, additional, Coeck, C, additional, Goeldner, RG, additional, Clerisme-Beaty, E, additional, Schlenker-Herceg, R, additional, and Brown, KK, additional

Published
2020
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43. Effect of nintedanib on biomarkers of extracellular matrix (ECM) turnover and FVC decline in patients with IPF: results from the INMARK study*

Author

Pfeifer, M, additional, Maher, TM, additional, Stowasser, S, additional, Nishioka, Y, additional, White, ES, additional, Cottin, V, additional, Noth, I, additional, Selman, M, additional, Rohr, KB, additional, Wachtlin, D, additional, Ittrich, C, additional, Diefenbach, C, additional, and Jenkins, RG, additional

Published
2020
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46. The INBUILD Trial of Nintedanib in Patients with Progressive Fibrosing Instititial Lung Diseases: Subgroup with Autoimmune Diseases*

Author

Bonella, F, additional, Matteson, E, additional, Kelly, C, additional, Distler, JHW, additional, Hoffmann-Vold, A, additional, Seibold, JR, additional, Mittoo, S, additional, Distler, O, additional, Goeldner, RG, additional, Schlenker-Herceg, R, additional, Stowasser, S, additional, Quaresma, M, additional, and Flaherty, KR, additional

Published
2020
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48. Nintédanib chez les patients atteints de pneumopathie interstitielle diffuse (PID) chroniques avec un phénotype de fibrose progressive : essai INBUILD

Author

Cottin, V., primary, Flaherty, K.R., additional, Wells, A.U., additional, Devaraj, A., additional, Inoue, Y., additional, Richeldi, L., additional, Walsh, S., additional, Stowasser, S., additional, Coeck, C., additional, Goeldner, R.G., additional, Clerisme-Beaty, E., additional, Schlenker-Herceg, R., additional, and Brown, K.K., additional

Published
2020
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49. Le Nintédanib réduit le déclin de la capacité vitale forcée dans les sous-groupes de patients atteints de pneumopathie interstitielle diffuse associée à la sclérodermie systémique (ScS-PID) : résultats de l’étude SENSCIS

Author

Cottin, V., primary, Distler, O., additional, Highland, K., additional, Gahlemann, M., additional, Azuma, A., additional, Mayes, M., additional, Raghu, G., additional, Sauter, W., additional, Girard, M., additional, Alves, M., additional, Clerisme-Beaty, E., additional, Stowasser, S., additional, Kuwana, M., additional, and Maher, T., additional

Published
2020
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