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1. Nintedanib in Patients With Systemic Sclerosis-Associated Interstitial Lung Disease: Subgroup Analyses by Autoantibody Status and Modified Rodnan Skin Thickness Score.

Author

Kuwana, Masataka, Allanore, Yannick, Denton, Christopher, Distler, Jörg, Steen, Virginia, Khanna, Dinesh, Matucci-Cerinic, Marco, Mayes, Maureen, Volkmann, Elizabeth, Miede, Corinna, Gahlemann, Martina, Quaresma, Manuel, Alves, Margarida, and Distler, Oliver

Subjects
Autoantibodies, Disease Progression, Female, Humans, Indoles, Lung Diseases, Interstitial, Male, Protein Kinase Inhibitors, Scleroderma, Systemic, Skin, Treatment Outcome
Abstract

OBJECTIVE: Using data from the SENSCIS trial, these analyses were undertaken to assess the effects of nintedanib versus placebo in subgroups of patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), based on characteristics previously identified as being associated with the progression of SSc-ILD. METHODS: Patients with SSc-ILD were randomized to receive either nintedanib or placebo, stratified by anti-topoisomerase I antibody (ATA) status. We assessed the rate of decline in forced vital capacity (FVC) (expressed in ml/year) over 52 weeks in subgroups based on baseline ATA status, modified Rodnan skin thickness score (MRSS) ( 0.05), indicating that there was no heterogeneity in the effect of nintedanib versus placebo between these subgroups of patients. CONCLUSION: In patients with SSc-ILD, reduction in the annual rate of decline in FVC among patients receiving nintedanib compared to those receiving placebo was not found to be heterogenous across subgroups based on ATA status, MRSS, or SSc subtype.

Published
2022

3. 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

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., Crestani, B., Criner, G., Dahlqvist, C., Danoff, S., Dematte D'Amico, J., Dilling, D., Elias, P., Ettinger, N., Falk, J., Fernández Pérez, E.R., Gamez-Dubuis, A., Giessel, G., Gifford, A., Glassberg, M., Glazer, C., Golden, J., Gómez Carrera, L., Guiot, J., Hallowell, R., Hayashi, H., Hetzel, J., Hirani, N., Homik, L., Hope-Gill, B., Hotchkin, D., Ichikado, K., Ilkovich, M., Inoue, Y., Izumi, S., Jassem, E., Jones, L., Jouneau, S., Kaner, R., Kang, J., Kawamura, T., Kessler, R., Kim, Y., Kishi, K., Kitamura, H., Kolb, M., Kondoh, Y., Kono, C., Koschel, D., Kreuter, M., Kulkarni, T., Kus, J., Lebargy, F., León Jiménez, A., Luo, Q., Mageto, Y., Maher, T.M., Makino, S., Marchand-Adam, S., Marquette, C., Martinez, R., Martínez, M., Maturana Rozas, R., Miyazaki, Y., Moiseev, S., Molina-Molina, M., Morrison, L., Morrow, L., Moua, T., Nambiar, A., Nishioka, Y., Nunes, H., Okamoto, M., Oldham, J., Otaola, M., Padilla, M., Park, J.S., Patel, N., Pesci, A., Piotrowski, W., Pitts, L., Poonyagariyagorn, H., Prasse, A., Quadrelli, S., Randerath, W., Refini, R., Reynaud-Gaubert, M., Riviere, F., Rodríguez Portal, J.A., Rosas, I., Rossman, M., Safdar, Z., Saito, T., Sakamoto, N., Salinas Fénero, 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, F., Veeraraghavan, S., Villar, A., Weigt, S., Wemeau, L., Wuyts, W., Xu, Z., Yakusevich, V., Yamada, Y., Yamauchi, H., Ziora, D., Wells, Athol U, Flaherty, Kevin R, Brown, Kevin K, Inoue, Yoshikazu, Devaraj, Anand, Richeldi, Luca, Moua, Teng, Crestani, Bruno, Wuyts, Wim A, Stowasser, Susanne, Quaresma, Manuel, Goeldner, Rainer-Georg, Schlenker-Herceg, Rozsa, and Kolb, Martin

Published
2020
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12. Efficacy and safety of spesolimab in Asian patients with a generalized pustular psoriasis flare: Results from the randomized, double‐blind, placebo‐controlled Effisayil™ 1 study

Author

Morita, Akimichi, primary, Tsai, Tsen‐Fang, additional, Yee, Evelyn Yap Wen, additional, Okubo, Yukari, additional, Imafuku, Shinichi, additional, Zheng, Min, additional, Li, Ling, additional, Quaresma, Manuel, additional, Thoma, Christian, additional, and Choon, Siew Eng, additional

Published
2022
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17. Nintedanib in patients with autoimmune disease-related progressive fibrosing interstitial lung diseases: subgroup analysis of the INBUILD trial

Author

Matteson, Eric L; https://orcid.org/0000-0002-9866-0124, Kelly, Clive, Distler, Jörg H W; https://orcid.org/0000-0001-7408-9333, Hoffmann-Vold, Anna Maria, Seibold, James R; https://orcid.org/0000-0001-5187-3141, Mittoo, Shikha, Dellaripa, Paul F, Aringer, Martin; https://orcid.org/0000-0003-4471-8375, Pope, Janet E; https://orcid.org/0000-0003-1479-5302, Distler, Oliver; https://orcid.org/0000-0002-0546-8310, James, Alexandra, Schlenker-Herceg, Rozsa, Stowasser, Susanne, Quaresma, Manuel, Flaherty, Kevin R, Matteson, Eric L; https://orcid.org/0000-0002-9866-0124, Kelly, Clive, Distler, Jörg H W; https://orcid.org/0000-0001-7408-9333, Hoffmann-Vold, Anna Maria, Seibold, James R; https://orcid.org/0000-0001-5187-3141, Mittoo, Shikha, Dellaripa, Paul F, Aringer, Martin; https://orcid.org/0000-0003-4471-8375, Pope, Janet E; https://orcid.org/0000-0003-1479-5302, Distler, Oliver; https://orcid.org/0000-0002-0546-8310, James, Alexandra, Schlenker-Herceg, Rozsa, Stowasser, Susanne, Quaresma, Manuel, and Flaherty, Kevin R

Abstract

OBJECTIVE: To analyze the efficacy and safety of nintedanib in patients with fibrosing autoimmune disease-related interstitial lung diseases (ILDs) with a progressive phenotype. METHODS: The INBUILD trial enrolled subjects with a fibrosing ILD other than idiopathic pulmonary fibrosis, with diffuse fibrosing lung disease of >10% extent on high-resolution computed tomography, forced vital capacity (FVC) ≥45% predicted and diffusing capacity of the lungs for carbon monoxide ≥30%-<80% predicted. Subjects fulfilled protocol-defined criteria for progression of ILD within the 24 months before screening, despite management deemed appropriate in clinical practice. Subjects were randomized to receive nintedanib or placebo. We assessed the rate of decline in FVC (mL/year) and adverse events over 52 weeks in the subgroup with autoimmune disease-related ILDs. RESULTS: Among 170 subjects with autoimmune disease-related ILDs, the rate of decline in FVC over 52 weeks was -75.9 mL/year with nintedanib versus -178.6 mL/year with placebo (difference 102.7 mL/year [95% CI 23.2, 182.2]; nominal P=0.012). No heterogeneity was detected in the effect of nintedanib versus placebo across subgroups by ILD diagnosis (P=0.91). The most frequent adverse event was diarrhea, reported in 63.4% and 27.3% of subjects in the nintedanib and placebo groups, respectively. Adverse events led to permanent discontinuation of trial drug in 17.1% and 10.2% of subjects in the nintedanib and placebo groups, respectively. CONCLUSION: In the INBUILD trial, nintedanib slowed the rate of decline in FVC in subjects with progressive fibrosing autoimmune disease-related ILDs, with adverse events that were manageable for most subjects.

Published
2022

18. Nintedanib in patients with autoimmune disease-related progressive fibrosing interstitial lung diseases: subgroup analysis of the INBUILD trial

Author

Matteson, Eric L, Kelly, Clive, Distler, Jörg H W, Hoffmann-Vold, Anna Maria, Seibold, James R, Mittoo, Shikha, Dellaripa, Paul F, Aringer, Martin, Pope, Janet E, Distler, Oliver, James, Alexandra, Schlenker-Herceg, Rozsa, Stowasser, Susanne, Quaresma, Manuel, Flaherty, Kevin R, and University of Zurich

Subjects
10051 Rheumatology Clinic and Institute of Physical Medicine, 610 Medicine & health
Published
2022
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20. Efficacy and safety of spesolimab in Asian patients with a generalized pustular psoriasis flare: Results from the randomized, double‐blind, placebo‐controlled Effisayil™ 1 study.

Author

Morita, Akimichi, Tsai, Tsen‐Fang, Yee, Evelyn Yap Wen, Okubo, Yukari, Imafuku, Shinichi, Zheng, Min, Li, Ling, Quaresma, Manuel, Thoma, Christian, and Choon, Siew Eng

Abstract

Generalized pustular psoriasis is a potentially life‐threatening neutrophilic skin disease characterized by recurrent flares of widespread erythema and eruption of sterile pustules. In the Effisayil™ 1 study (NCT03782792), 53 patients with a generalized pustular psoriasis flare were treated with placebo or spesolimab, a humanized anti‐interleukin‐36 receptor monoclonal antibody, the first targeted treatment to be studied in a randomized clinical trial. Spesolimab treatment resulted in rapid pustular and skin clearance, with an acceptable safety profile. Here, we evaluate the efficacy and safety of spesolimab in 29 Asian patients in the Effisayil™ 1 study. The primary endpoint, a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation subscore of 0 (no visible pustules) at Week 1, was achieved by 10 patients (62.5%) randomized to spesolimab and one patient (7.7%) randomized to placebo (risk difference 54.8, 95% confidence interval [CI] 17.3–79.8). The key secondary endpoint, a GPPGA total score of 0 or 1 (clear or almost clear skin) at Week 1, was achieved by eight (50.0%) and two (15.4%) patients, respectively (risk difference 34.6, 95% CI −3.1–64.7). This was similar to previously published data in the overall population in whom the primary and key secondary endpoints were achieved by 54% versus 6% and 43% versus 11% of patients, respectively. The percentages of Asian patients randomized to spesolimab with a GPPGA pustulation subscore of 0 and GPPGA total score of 0 or 1 were sustained above 60% for up to 12 weeks. In these patients, patient‐reported outcomes also improved and markers of systemic inflammation were normalized. Eleven (68.8%) and eight (61.5%) of spesolimab‐ and placebo‐treated patients, respectively, experienced at least one adverse event. In conclusion, spesolimab improved outcomes in Asian patients compared with placebo, supporting its use in the treatment of generalized pustular psoriasis flares. [ABSTRACT FROM AUTHOR]

Published
2023
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21. Additional file 1 of Efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis who are elderly or have comorbidities

Author

Glaspole, Ian, Bonella, Francesco, Bargagli, Elena, Glassberg, Marilyn K., Caro, Fabian, Stansen, Wibke, Quaresma, Manuel, Orsatti, Leticia, and Bendstrup, Elisabeth

Abstract

Additional file 1: Table S1. Baseline characteristics in subgroups by age. Table S2 Most frequent comorbidities* at baseline in subgroups by number of comorbidities. Table S3 Baseline characteristics in subgroups by number of comorbidities at baseline. Table S4 Adverse events in subgroups by number of comorbidities at baseline. Table S5 Baseline characteristics in subgroups by CCI score at baseline. Table S6 Outcomes over 52 weeks in subgroups by CCI score at baseline. Table S7 Adverse events in subgroups by CCI score at baseline.

Published
2021
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22. Nintedanib in Patients With Autoimmune Disease–Related Progressive Fibrosing Interstitial Lung Diseases: Subgroup Analysis of the INBUILD Trial.

Author

Matteson, Eric L., Kelly, Clive, Distler, Jörg H. W., Hoffmann‐Vold, Anna‐Maria, Seibold, James R., Mittoo, Shikha, Dellaripa, Paul F., Aringer, Martin, Pope, Janet, Distler, Oliver, James, Alexandra, Schlenker‐Herceg, Rozsa, Stowasser, Susanne, Quaresma, Manuel, and Flaherty, Kevin R.

Subjects
ANTI-inflammatory agents, FIBROSIS, AUTOIMMUNE diseases, INTERSTITIAL lung diseases, RANDOMIZED controlled trials, VITAL capacity (Respiration), STATISTICAL sampling, PHENOTYPES
Abstract

Objective: To analyze the efficacy and safety of nintedanib in patients with fibrosing autoimmune disease–related interstitial lung diseases (ILDs) with a progressive phenotype. Methods: The INBUILD trial enrolled patients with a fibrosing ILD other than idiopathic pulmonary fibrosis, with diffuse fibrosing lung disease of >10% extent on high‐resolution computed tomography, forced vital capacity percent predicted (FVC%) ≥45%, and diffusing capacity of the lungs for carbon monoxide percent predicted ≥30% to <80%. Patients fulfilled protocol‐defined criteria for progression of ILD within the 24 months before screening, despite management deemed appropriate in clinical practice. Subjects were randomized to receive nintedanib or placebo. We assessed the rate of decline in FVC (ml/year) and adverse events (AEs) over 52 weeks in the subgroup with autoimmune disease–related ILDs. Results: Among 170 patients with autoimmune disease–related ILDs, the rate of decline in FVC over 52 weeks was −75.9 ml/year with nintedanib versus −178.6 ml/year with placebo (difference 102.7 ml/year [95% confidence interval 23.2, 182.2]; nominal P = 0.012). No heterogeneity was detected in the effect of nintedanib versus placebo across subgroups based on ILD diagnosis (P = 0.91). The most frequent AE was diarrhea, reported in 63.4% and 27.3% of subjects in the nintedanib and placebo groups, respectively. AEs led to permanent discontinuation of trial drug in 17.1% and 10.2% of subjects in the nintedanib and placebo groups, respectively. Conclusion: In the INBUILD trial, nintedanib slowed the rate of decline in FVC in patients with progressive fibrosing autoimmune disease–related ILDs, with AEs that were manageable for most patients. Video Abstract [ABSTRACT FROM AUTHOR]

Published
2022
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23. Additional file 5 of Analysis of body mass index, weight loss and progression of idiopathic pulmonary fibrosis

Author

Jouneau, Stéphane, Crestani, Bruno, Thibault, Ronan, Lederlin, Mathieu, Vernhet, Laurent, Valenzuela, Claudia, Wijsenbeek, Marlies, Kreuter, Michael, Stansen, Wibke, Quaresma, Manuel, and Cottin, Vincent

Abstract

Additional file 5: Supplemental Table 3. Annual rate of decline in FVC (mL/year) over 52 weeks in the overall trial population.

Published
2020
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24. Additional file 8 of Analysis of body mass index, weight loss and progression of idiopathic pulmonary fibrosis

Author

Jouneau, Stéphane, Crestani, Bruno, Thibault, Ronan, Lederlin, Mathieu, Vernhet, Laurent, Valenzuela, Claudia, Wijsenbeek, Marlies, Kreuter, Michael, Stansen, Wibke, Quaresma, Manuel, and Cottin, Vincent

Abstract

Additional file 8: Supplemental Figure 2. Annual rate of decline in FVC (mL/year) over 52 weeks in subgroups of patients by weight loss over 52 weeks (based on the change from baseline in weight at week 52).

Published
2020
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25. Additional file 6 of Analysis of body mass index, weight loss and progression of idiopathic pulmonary fibrosis

Author

Jouneau, Stéphane, Crestani, Bruno, Thibault, Ronan, Lederlin, Mathieu, Vernhet, Laurent, Valenzuela, Claudia, Wijsenbeek, Marlies, Kreuter, Michael, Stansen, Wibke, Quaresma, Manuel, and Cottin, Vincent

Abstract

Additional file 6: Supplemental Table 4. Baseline characteristics in subgroups of patients by weight loss ≤5 and > 5% over 52 weeks (based on the annual rate of decline in weight).

Published
2020
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26. Additional file 4 of Analysis of body mass index, weight loss and progression of idiopathic pulmonary fibrosis

Author

Jouneau, Stéphane, Crestani, Bruno, Thibault, Ronan, Lederlin, Mathieu, Vernhet, Laurent, Valenzuela, Claudia, Wijsenbeek, Marlies, Kreuter, Michael, Stansen, Wibke, Quaresma, Manuel, and Cottin, Vincent

Abstract

Additional file 4: Supplemental Table 2. Outcomes in subgroups of patients by BMI below and at least the median at baseline.

Published
2020
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30. Additional file 3 of Analysis of body mass index, weight loss and progression of idiopathic pulmonary fibrosis

Author

Jouneau, Stéphane, Crestani, Bruno, Thibault, Ronan, Lederlin, Mathieu, Vernhet, Laurent, Valenzuela, Claudia, Wijsenbeek, Marlies, Kreuter, Michael, Stansen, Wibke, Quaresma, Manuel, and Cottin, Vincent

Subjects
nutritional and metabolic diseases
Abstract

Additional file 3: Supplemental Table 1. Baseline characteristics in subgroups of patients by BMI (

Published
2020
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31. Additional file 7 of Analysis of body mass index, weight loss and progression of idiopathic pulmonary fibrosis

Author

Jouneau, Stéphane, Crestani, Bruno, Thibault, Ronan, Lederlin, Mathieu, Vernhet, Laurent, Valenzuela, Claudia, Wijsenbeek, Marlies, Kreuter, Michael, Stansen, Wibke, Quaresma, Manuel, and Cottin, Vincent

Subjects
nutritional and metabolic diseases, respiratory system, circulatory and respiratory physiology, respiratory tract diseases
Abstract

Additional file 7: Supplemental Figure 1. Scatter plots showing the correlation between BMI at baseline and FVC (mL) at baseline (A) and between BMI at baseline and the rate of decline in FVC (mL/year) assessed over 52 weeks (B).

Published
2020
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32. Nintedanib plus Sildenafil in Patients with Idiopathic Pulmonary Fibrosis

Author

Kolb, Martin, Raghu, Ganesh, Wells, Athol U, Behr, Jürgen, Richeldi, Luca, Schinzel, Birgit, Quaresma, Manuel, Stowasser, Susanne, INSTAGE Trial Investigators, Benjamin Bondue, Bondue, Benjamin, and Martinez, Fernando J

Subjects
Adult, Male, medicine.medical_specialty, Indoles, Sildenafil, Subgroup analysis, Settore MED/10 - MALATTIE DELL'APPARATO RESPIRATORIO, Placebo, Gastroenterology, Sildenafil Citrate, law.invention, 03 medical and health sciences, Idiopathic pulmonary fibrosis, chemistry.chemical_compound, 0302 clinical medicine, Double-Blind Method, Drug Therapy, Randomized controlled trial, DLCO, law, Internal medicine, medicine, Clinical endpoint, Humans, 030212 general & internal medicine, Enzyme Inhibitors, Aged, Pulmonary Gas Exchange, business.industry, General Medicine, Middle Aged, Phosphodiesterase 5 Inhibitors, Protein-Tyrosine Kinases, Sciences bio-médicales et agricoles, respiratory system, medicine.disease, Idiopathic Pulmonary Fibrosis, respiratory tract diseases, Dyspnea, Treatment Outcome, 030228 respiratory system, chemistry, Combination, Quality of Life, Drug Therapy, Combination, Female, Nintedanib, business
Abstract

Background 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 of the lungs for carbon monoxide (DlCO), symptoms, and quality of life in patients with IPF and severely decreased DlCO. That idea was tested in this trial. Methods We randomly assigned, in a 1:1 ratio, patients with IPF and a DlCO of 35% or less of the predicted value to receive nintedanib at a dose of 150 mg twice daily plus sildenafil at a dose of 20 mg three times daily (nintedanib-plus-sildenafil group) or nintedanib at a dose of 150 mg twice daily plus placebo three times daily (nintedanib group) for 24 weeks. The primary end point was the change from baseline in the total score on the St. George’s Respiratory Questionnaire (SGRQ) at week 12 (the total score ranges from 0 to 100, with higher scores indicating worse health-related qual...

Published
2018

33. 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, Athol U, Flaherty, Kevin R, Brown, Keith, Inoue, Yoshikazu, Devaraj, Anand, Richeldi, Luca, Moua, Teng, Crestani, Bruno, Wuyts, Wim, Stowasser, Susanne, Quaresma, Manuel, Goeldner, Rainer Georg, Schlenker-Herceg, Rozsa, Bondue, Benjamin, INBUILD trial investigators, Kolb, Martin, Wells, Athol U, Flaherty, Kevin R, Brown, Keith, Inoue, Yoshikazu, Devaraj, Anand, Richeldi, Luca, Moua, Teng, Crestani, Bruno, Wuyts, Wim, Stowasser, Susanne, Quaresma, Manuel, Goeldner, Rainer Georg, Schlenker-Herceg, Rozsa, Bondue, Benjamin, INBUILD trial investigators, and Kolb, Martin

Abstract

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., info:eu-repo/semantics/published

Published
2020

34. Home spirometry in patients with idiopathic pulmonary fibrosis: data from the INMARK trial

Author

Noth, Imre, primary, Cottin, Vincent, additional, Chaudhuri, Nazia, additional, Corte, Tamera J., additional, Johannson, Kerri A., additional, Wijsenbeek, Marlies, additional, Jouneau, Stephane, additional, Michael, Andreas, additional, Quaresma, Manuel, additional, Rohr, Klaus B., additional, Russell, Anne-Marie, additional, Stowasser, Susanne, additional, and Maher, Toby M., additional

Published
2021
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35. Does nintedanib have the same effect on FVC decline in patients with progressive fibrosing ILDs treated with DMARDs or glucocorticoids?

Author

Chaudhuri, Nazia, primary, Cottin, Vincent, additional, Cerri, Stefania, additional, Kreuter, Michael, additional, Otaola, Maria, additional, Castillo Villegas, Diego, additional, Glazer, Craig, additional, Müller, Heiko, additional, Coeck, Carl, additional, Quaresma, Manuel, additional, and Maher, Toby M, additional

Published
2020
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39. Effects of nintedanib in patients with progressive fibrosing ILDs and differing baseline FVC: further analyses of the INBUILD trial

Author

Valenzuela, Claudia, primary, Maher, Toby M, additional, Bonella, Francesco, additional, Pesci, Alberto, additional, Jouneau, Stephane, additional, Patel, Nina M, additional, Fernández Pérez, Evans R, additional, Goeldner, Rainer-Georg, additional, Stowasser, Susanne, additional, Schlenker-Herceg, Rozsa, additional, Quaresma, Manuel, additional, and Cottin, Vincent, additional

Published
2020
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42. 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, Athol U, primary, Flaherty, Kevin R, additional, Brown, Kevin K, additional, Inoue, Yoshikazu, additional, Devaraj, Anand, additional, Richeldi, Luca, additional, Moua, Teng, additional, Crestani, Bruno, additional, Wuyts, Wim A, additional, Stowasser, Susanne, additional, Quaresma, Manuel, additional, Goeldner, Rainer-Georg, additional, Schlenker-Herceg, Rozsa, additional, Kolb, Martin, additional, Abe, S., additional, Aburto, M., additional, Acosta, O., additional, Andrews, C., additional, Antin-Ozerkis, D., additional, Arce, G., additional, Arias, M., additional, Avdeev, S., additional, Barczyk, A., additional, Bascom, R., additional, Bazdyrev, E., additional, Beirne, P., additional, Belloli, E., additional, Bergna, M.A., additional, Bergot, E., additional, Bhatt, N., additional, Blaas, S., additional, Bondue, B., additional, Bonella, F., additional, Britt, E., additional, Buch, K., additional, Burk, J., additional, Cai, H., additional, Cantin, A., additional, Castillo Villegas, D.M., additional, Cazaux, A., additional, Cerri, S., additional, Chaaban, S., additional, Chaudhuri, N., additional, Cottin, V., additional, Crestani, B., additional, Criner, G., additional, Dahlqvist, C., additional, Danoff, S., additional, Dematte D'Amico, J., additional, Dilling, D., additional, Elias, P., additional, Ettinger, N., additional, Falk, J., additional, Fernández Pérez, E.R., additional, Gamez-Dubuis, A., additional, Giessel, G., additional, Gifford, A., additional, Glassberg, M., additional, Glazer, C., additional, Golden, J., additional, Gómez Carrera, L., additional, Guiot, J., additional, Hallowell, R., additional, Hayashi, H., additional, Hetzel, J., additional, Hirani, N., additional, Homik, L., additional, Hope-Gill, B., additional, Hotchkin, D., additional, Ichikado, K., additional, Ilkovich, M., additional, Inoue, Y., additional, Izumi, S., additional, Jassem, E., additional, Jones, L., additional, Jouneau, S., additional, Kaner, R., additional, Kang, J., additional, Kawamura, T., additional, Kessler, R., additional, Kim, Y., additional, Kishi, K., additional, Kitamura, H., additional, Kolb, M., additional, Kondoh, Y., additional, Kono, C., additional, Koschel, D., additional, Kreuter, M., additional, Kulkarni, T., additional, Kus, J., additional, Lebargy, F., additional, León Jiménez, A., additional, Luo, Q., additional, Mageto, Y., additional, Maher, T.M., additional, Makino, S., additional, Marchand-Adam, S., additional, Marquette, C., additional, Martinez, R., additional, Martínez, M., additional, Maturana Rozas, R., additional, Miyazaki, Y., additional, Moiseev, S., additional, Molina-Molina, M., additional, Morrison, L., additional, Morrow, L., additional, Moua, T., additional, Nambiar, A., additional, Nishioka, Y., additional, Nunes, H., additional, Okamoto, M., additional, Oldham, J., additional, Otaola, M., additional, Padilla, M., additional, Park, J.S., additional, Patel, N., additional, Pesci, A., additional, Piotrowski, W., additional, Pitts, L., additional, Poonyagariyagorn, H., additional, Prasse, A., additional, Quadrelli, S., additional, Randerath, W., additional, Refini, R., additional, Reynaud-Gaubert, M., additional, Riviere, F., additional, Rodríguez Portal, J.A., additional, Rosas, I., additional, Rossman, M., additional, Safdar, Z., additional, Saito, T., additional, Sakamoto, N., additional, Salinas Fénero, M., additional, Sauleda, J., additional, Schmidt, S., additional, Scholand, M.B., additional, Schwartz, M., additional, Shapera, S., additional, Shlobin, O., additional, Sigal, B., additional, Silva Orellana, A., additional, Skowasch, D., additional, Song, J.W., additional, Stieglitz, S., additional, Stone, H., additional, Strek, M., additional, Suda, T., additional, Sugiura, H., additional, Takahashi, H., additional, Takaya, H., additional, Takeuchi, T., additional, Thavarajah, K., additional, Tolle, L., additional, Tomassetti, S., additional, Tomii, K., additional, Valenzuela, C., additional, Vancheri, C., additional, Varone, F., additional, Veeraraghavan, S., additional, Villar, A., additional, Weigt, S., additional, Wemeau, L., additional, Wuyts, W., additional, Xu, Z., additional, Yakusevich, V., additional, Yamada, Y., additional, Yamauchi, H., additional, and Ziora, D., additional

Published
2020
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44. Nintedanib in Progressive Fibrosing Interstitial Lung Diseases

Author

Flaherty, Kevin R, Wells, Athol U, Cottin, Vincent, Devaraj, Anand, Walsh, Simon L F, Inoue, Yoshikazu, Richeldi, Luca, Kolb, Martin, Tetzlaff, Kay, Stowasser, Susanne, Coeck, Carl, Clerisme-Beaty, Emmanuelle, Rosenstock, Bernd, Quaresma, Manuel, Haeufel, Thomas, Goeldner, Rainer-Georg, Schlenker-Herceg, Rozsa, Brown, Kevin K, INBUILD Trial Investigators, Dahlqvist, Caroline, UCL - SSS/IREC/MONT - Pôle Mont Godinne, and UCL - (MGD) Service de pneumologie

Subjects
Diarrhea, Male, Indoles, Aged, Disease Progression, Double-Blind Method, Female, Humans, Idiopathic Pulmonary Fibrosis, Middle Aged, Protein Kinase Inhibitors, Vital Capacity, Settore MED/10 - MALATTIE DELL'APPARATO RESPIRATORIO, 030204 cardiovascular system & hematology, 03 medical and health sciences, chemistry.chemical_compound, Idiopathic pulmonary fibrosis, 0302 clinical medicine, Vital Capacity -- drug effects, Pulmonary fibrosis, medicine, Indoles -- adverse effects -- therapeutic use, 030212 general & internal medicine, Lung, Idiopathic Pulmonary Fibrosis -- drug therapy -- physiopathology, Protein Kinase Inhibitors -- adverse effects -- therapeutic use, business.industry, Lung fibrosis, General Medicine, respiratory system, Sciences bio-médicales et agricoles, medicine.disease, Preclinical data, medicine.anatomical_structure, chemistry, Cancer research, Nintedanib, business, Tyrosine kinase, Intracellular, Diarrhea -- chemically induced
Abstract

Preclinical data have suggested that nintedanib, an intracellular inhibitor of tyrosine kinases, inhibits processes involved in the progression of lung fibrosis. Although the efficacy of nintedanib has been shown in idiopathic pulmonary fibrosis, its efficacy across a broad range of fibrosing lung diseases is unknown., info:eu-repo/semantics/published

Published
2019

45. Safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis in Brazil

Author

Pereira, Carlos Alberto de Castro, Baddini-Martinez, José Antonio, Baldi, Bruno Guedes, Jezler, Sérgio Fernandes de Oliveira, Rubin, Adalberto Sperb, Alves, Rogerio Lopes Rufino, Zonzin, Gilmar Alves, Quaresma, Manuel, Trampisch, Matthias, and Rabahi, Marcelo Fouad

Subjects
Inibidor de tirosina quinase, Indoles, Expanded access program, Tyrosine kinase inhibitor, Humans, Original Article, Interstitial lung disease, Doença pulmonar intersticial, Drug tolerance, Fibrose pulmonar idiopática, Brazil, Idiopathic Pulmonary Fibrosis, Programa de acesso expandido
Abstract

Objective Clinical trials have shown that nintedanib 150 mg twice daily (bid) reduces disease progression in patients with idiopathic pulmonary fibrosis (IPF), with an adverse event profile that is manageable for most patients. Prior to the approval of nintedanib as a treatment for IPF in Brazil, an expanded access program (EAP) was initiated to provide early access to treatment and to evaluate the safety and tolerability of nintedanib in this patient population. Methods Patients with a diagnosis of IPF within the previous five years, forced vital capacity (FVC) ≥ 50% predicted and diffusing capacity of the lungs for carbon monoxide (DLco) 30% to 79% predicted were eligible to participate in the EAP. Patients received nintedanib 150 mg bid open-label. Safety assessments included adverse events leading to permanent discontinuation of nintedanib and serious adverse events. Results The EAP involved 57 patients at eight centers. Most patients were male (77.2%) and white (87.7%). At baseline, mean (SD) age was 70.7 (7.5) years and FVC was 70.7 (12.5) % predicted. Mean (SD) exposure to nintedanib was 14.4 (6.2) months; maximum exposure was 22.0 months. The most frequently reported adverse events considered by the investigator to be related to nintedanib treatment were diarrhea (45 patients, 78.9%) and nausea (25 patients, 43.9%). Adverse events led to permanent discontinuation of nintedanib in 16 patients (28.1%). Sixteen patients (28.1%) had a serious adverse event. Conclusion In the Brazilian EAP, nintedanib had an acceptable safety and tolerability profile in patients with IPF, consistent with data from clinical trials.

Published
2019

49. Nintedanib and sildenafil in patients with idiopathic pulmonary fibrosis and right heart dysfunction: A prespecified subgroup analysis of a double-blind randomized clinical trial (instage)

Author

Behr, J, Kolb, M, Song, J, Luppi, F, Schinzel, B, Stowasser, S, Quaresma, M, Martinez, F, Behr, Jürgen, Kolb, Martin, Song, Jin Woo, Luppi, Fabrizio, Schinzel, Birgit, Stowasser, Susanne, Quaresma, Manuel, Martinez, Fernando J, Behr, J, Kolb, M, Song, J, Luppi, F, Schinzel, B, Stowasser, S, Quaresma, M, Martinez, F, Behr, Jürgen, Kolb, Martin, Song, Jin Woo, Luppi, Fabrizio, Schinzel, Birgit, Stowasser, Susanne, Quaresma, Manuel, and Martinez, Fernando J

Abstract

Rationale: In the INSTAGE trial in patients with idiopathic pulmonary fibrosis (IPF) and severely impaired gas exchange, nintedanib plus sildenafil was associated with numerical benefits on St. George's Respiratory Questionnaire (SGRQ) total score, brain natriuretic peptide (BNP), and FVC decline versus nintedanib alone. Exploratory analyses of the STEP-IPF (Sildenafil Trial of Exercise Performance in IPF) trial suggested that sildenafil may have a greater effect on SGRQ score in patients with IPF who have right heart dysfunction (RHD). Objectives: Assess whether RHD influenced the effects of nintedanib plus sildenafil versus nintedanib alone in the INSTAGE trial. Methods: Subgroup analyses of patients with (n = 117) versus those without (n = 156) echocardiographic signs of RHD at baseline. Measurements and Main Results: There was no heterogeneity between subgroups by presence of RHD in the effect of nintedanib plus sildenafil versus nintedanib alone on change in SGRQ total score at Week 12 (P = 0.74) or Week 24 (P = 0.90), or change in FVC at Week 12 (P = 0.58) or Week 24 (P = 0.55). In both subgroups, nintedanib plus sildenafil had a numerically greater effect on reducing FVC decline versus nintedanib alone. Between-group differences in change in BNP at Week 24 were 2119.9 ng/L (95% confidence interval = 2171.3 to 268.5) and 23.6 ng/L (95% confidence interval = 247.2 to 40.0) in patients with and without signs of RHD at baseline, respectively (P, 0.01). Conclusions: In the INSTAGE trial, there were no significant differences in the effects of nintedanib plus sildenafil versus nintedanib alone on changes in SGRQ and FVC between patients with or without echocardiographic signs of RHD at baseline. The benefit of combination therapy on stabilizing BNP was more pronounced in patients with RHD at baseline.

Published
2019

50. Utility of nintedanib for severe idiopathic pulmonary fibrosis: a single-center retrospective study [Letter]

Author

Orsatti,Leticia, Fortea,Josep, Quaresma,Manuel, Orsatti,Leticia, Fortea,Josep, and Quaresma,Manuel

Abstract

Leticia Orsatti, Josep Fortea, Manuel Quaresma Boehringer Ingelheim International GmbH, Ingelheim, GermanyWe read with interest the study by Abe et al on the clinical utility of nintedanib in patients with severe idiopathic pulmonary fibrosis (IPF).1 Based on the retrospective follow-up of 51 patients, the authors concluded that the survival benefit from nintedanib is reduced among patients with severe IPF (n=17) compared with those with mild-to-moderate IPF (n=34), but that the prognosis for patients with severe IPF is significantly better in those who remain on nintedanib for more than 3 months.In our opinion, the study design does not allow conclusions to be drawn about the treatment effect of nintedanib on survival in patients with severe versus mild-tomoderate IPF.View the original paper by Abe and colleaguesA Letter to the Editor has been received and published for this article.

Published
2019

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