Effects of nintedanib by inclusion criteria for progression of interstitial lung disease
The INBUILD trial investigated nintedanib placebo in patients with progressive fibrosing interstitial lung diseases (ILDs). We investigated the decline in forced vital capacity (FVC) in subgroups based on the inclusion criteria for ILD progression. Subjects had a fibrosing ILD other than idiopathic...
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| Veröffentlicht in: | The European respiratory journal 2022-02, Vol.59 (2), p.2004587 |
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| creator | Maher, Toby M Brown, Kevin K Kreuter, Michael Devaraj, Anand Walsh, Simon L F Lancaster, Lisa H Belloli, Elizabeth A Padilla, Maria Behr, Juergen Goeldner, Rainer-Georg Tetzlaff, Kay Schlenker-Herceg, Rozsa Flaherty, Kevin R |
| description | The INBUILD trial investigated nintedanib
placebo in patients with progressive fibrosing interstitial lung diseases (ILDs). We investigated the decline in forced vital capacity (FVC) in subgroups based on the inclusion criteria for ILD progression.
Subjects had a fibrosing ILD other than idiopathic pulmonary fibrosis and met the following criteria for ILD progression within the 24 months before screening despite management deemed appropriate in clinical practice: Group A, relative decline in FVC ≥10% predicted; Group B, relative decline in FVC ≥5-0.05 for heterogeneity).
The inclusion criteria used in the INBUILD trial, based on FVC decline or worsening of symptoms and extent of fibrosis on HRCT, were effective at identifying patients with progressive fibrosing ILDs. Nintedanib reduced the rate of decline in FVC across the subgroups based on the inclusion criteria related to ILD progression. |
| doi_str_mv | 10.1183/13993003.04587-2020 |
| format | Article |
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placebo in patients with progressive fibrosing interstitial lung diseases (ILDs). We investigated the decline in forced vital capacity (FVC) in subgroups based on the inclusion criteria for ILD progression.
Subjects had a fibrosing ILD other than idiopathic pulmonary fibrosis and met the following criteria for ILD progression within the 24 months before screening despite management deemed appropriate in clinical practice: Group A, relative decline in FVC ≥10% predicted; Group B, relative decline in FVC ≥5-<10% predicted with worsened respiratory symptoms and/or increased extent of fibrosis on high-resolution computed tomography (HRCT); Group C, worsened respiratory symptoms and increased extent of fibrosis on HRCT only.
In the placebo group, the rates of FVC decline over 52 weeks in Groups A, B and C, respectively, were -241.9, -133.1 and -115.3 mL per year in the overall population (p=0.0002 for subgroup-by-time interaction) and -288.9, -156.2 and -100.1 mL per year among subjects with a usual interstitial pneumonia (UIP)-like fibrotic pattern on HRCT (p=0.0005 for subgroup-by-time interaction). Nintedanib had a greater absolute effect on reducing the rate of FVC decline in Group A than in Group B or C. However, the relative effect of nintedanib
placebo was consistent across the subgroups (p>0.05 for heterogeneity).
The inclusion criteria used in the INBUILD trial, based on FVC decline or worsening of symptoms and extent of fibrosis on HRCT, were effective at identifying patients with progressive fibrosing ILDs. Nintedanib reduced the rate of decline in FVC across the subgroups based on the inclusion criteria related to ILD progression.</description><identifier>ISSN: 0903-1936</identifier><identifier>EISSN: 1399-3003</identifier><identifier>DOI: 10.1183/13993003.04587-2020</identifier><identifier>PMID: 34210788</identifier><language>eng</language><publisher>England: European Respiratory Society</publisher><subject>Original s</subject><ispartof>The European respiratory journal, 2022-02, Vol.59 (2), p.2004587</ispartof><rights>Copyright ©The authors 2022.</rights><rights>Copyright ©The authors 2022. 2022</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3200-84acae088506ef62f9c97566e9effd9a55ddff79ed612cfc93ffc83a6f0ce4583</citedby><cites>FETCH-LOGICAL-c3200-84acae088506ef62f9c97566e9effd9a55ddff79ed612cfc93ffc83a6f0ce4583</cites><orcidid>0000-0003-4402-2159</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27923,27924</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34210788$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Maher, Toby M</creatorcontrib><creatorcontrib>Brown, Kevin K</creatorcontrib><creatorcontrib>Kreuter, Michael</creatorcontrib><creatorcontrib>Devaraj, Anand</creatorcontrib><creatorcontrib>Walsh, Simon L F</creatorcontrib><creatorcontrib>Lancaster, Lisa H</creatorcontrib><creatorcontrib>Belloli, Elizabeth A</creatorcontrib><creatorcontrib>Padilla, Maria</creatorcontrib><creatorcontrib>Behr, Juergen</creatorcontrib><creatorcontrib>Goeldner, Rainer-Georg</creatorcontrib><creatorcontrib>Tetzlaff, Kay</creatorcontrib><creatorcontrib>Schlenker-Herceg, Rozsa</creatorcontrib><creatorcontrib>Flaherty, Kevin R</creatorcontrib><creatorcontrib>INBUILD trial investigators</creatorcontrib><title>Effects of nintedanib by inclusion criteria for progression of interstitial lung disease</title><title>The European respiratory journal</title><addtitle>Eur Respir J</addtitle><description>The INBUILD trial investigated nintedanib
placebo in patients with progressive fibrosing interstitial lung diseases (ILDs). We investigated the decline in forced vital capacity (FVC) in subgroups based on the inclusion criteria for ILD progression.
Subjects had a fibrosing ILD other than idiopathic pulmonary fibrosis and met the following criteria for ILD progression within the 24 months before screening despite management deemed appropriate in clinical practice: Group A, relative decline in FVC ≥10% predicted; Group B, relative decline in FVC ≥5-<10% predicted with worsened respiratory symptoms and/or increased extent of fibrosis on high-resolution computed tomography (HRCT); Group C, worsened respiratory symptoms and increased extent of fibrosis on HRCT only.
In the placebo group, the rates of FVC decline over 52 weeks in Groups A, B and C, respectively, were -241.9, -133.1 and -115.3 mL per year in the overall population (p=0.0002 for subgroup-by-time interaction) and -288.9, -156.2 and -100.1 mL per year among subjects with a usual interstitial pneumonia (UIP)-like fibrotic pattern on HRCT (p=0.0005 for subgroup-by-time interaction). Nintedanib had a greater absolute effect on reducing the rate of FVC decline in Group A than in Group B or C. However, the relative effect of nintedanib
placebo was consistent across the subgroups (p>0.05 for heterogeneity).
The inclusion criteria used in the INBUILD trial, based on FVC decline or worsening of symptoms and extent of fibrosis on HRCT, were effective at identifying patients with progressive fibrosing ILDs. Nintedanib reduced the rate of decline in FVC across the subgroups based on the inclusion criteria related to ILD progression.</description><subject>Original s</subject><issn>0903-1936</issn><issn>1399-3003</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><recordid>eNpVkU1LxDAQhoMo7vrxCwTJ0Ut10rTZ5CKI-AULXhS8hWw6WSPdZE1awX9vq-6ip4GZ931nhoeQEwbnjEl-wbhSHICfQ1XLWVFCCTtkOnaLsb1LpqCAF0xxMSEHOb8BMFFxtk8mvCoZzKSckpcb59B2mUZHgw8dNib4BV18Uh9s22cfA7XJd5i8oS4muk5xmTB_DwbPaEm58503LW37sKSNz2gyHpE9Z9qMx7_1kDzf3jxd3xfzx7uH66t5YXkJUMjKWIMgZQ0CnSidsmpWC4EKnWuUqeumcW6msBGstM4q7pyV3AgHFoe_-SG5_Mld94sVNhZDl0yr18mvTPrU0Xj9fxL8q17GDy0lKyuhhoCz34AU33vMnV75bLFtTcDYZ13WlazYoIVByn-kNsWcE7rtGgZ6ZKI3TPQ3Ez0yGVynfy_cejYQ-BfdWYpd</recordid><startdate>20220201</startdate><enddate>20220201</enddate><creator>Maher, Toby M</creator><creator>Brown, Kevin K</creator><creator>Kreuter, Michael</creator><creator>Devaraj, Anand</creator><creator>Walsh, Simon L F</creator><creator>Lancaster, Lisa H</creator><creator>Belloli, Elizabeth A</creator><creator>Padilla, Maria</creator><creator>Behr, Juergen</creator><creator>Goeldner, Rainer-Georg</creator><creator>Tetzlaff, Kay</creator><creator>Schlenker-Herceg, Rozsa</creator><creator>Flaherty, Kevin R</creator><general>European Respiratory Society</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0003-4402-2159</orcidid></search><sort><creationdate>20220201</creationdate><title>Effects of nintedanib by inclusion criteria for progression of interstitial lung disease</title><author>Maher, Toby M ; Brown, Kevin K ; Kreuter, Michael ; Devaraj, Anand ; Walsh, Simon L F ; Lancaster, Lisa H ; Belloli, Elizabeth A ; Padilla, Maria ; Behr, Juergen ; Goeldner, Rainer-Georg ; Tetzlaff, Kay ; Schlenker-Herceg, Rozsa ; Flaherty, Kevin R</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3200-84acae088506ef62f9c97566e9effd9a55ddff79ed612cfc93ffc83a6f0ce4583</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Original s</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Maher, Toby M</creatorcontrib><creatorcontrib>Brown, Kevin K</creatorcontrib><creatorcontrib>Kreuter, Michael</creatorcontrib><creatorcontrib>Devaraj, Anand</creatorcontrib><creatorcontrib>Walsh, Simon L F</creatorcontrib><creatorcontrib>Lancaster, Lisa H</creatorcontrib><creatorcontrib>Belloli, Elizabeth A</creatorcontrib><creatorcontrib>Padilla, Maria</creatorcontrib><creatorcontrib>Behr, Juergen</creatorcontrib><creatorcontrib>Goeldner, Rainer-Georg</creatorcontrib><creatorcontrib>Tetzlaff, Kay</creatorcontrib><creatorcontrib>Schlenker-Herceg, Rozsa</creatorcontrib><creatorcontrib>Flaherty, Kevin R</creatorcontrib><creatorcontrib>INBUILD trial investigators</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>The European respiratory journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Maher, Toby M</au><au>Brown, Kevin K</au><au>Kreuter, Michael</au><au>Devaraj, Anand</au><au>Walsh, Simon L F</au><au>Lancaster, Lisa H</au><au>Belloli, Elizabeth A</au><au>Padilla, Maria</au><au>Behr, Juergen</au><au>Goeldner, Rainer-Georg</au><au>Tetzlaff, Kay</au><au>Schlenker-Herceg, Rozsa</au><au>Flaherty, Kevin R</au><aucorp>INBUILD trial investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effects of nintedanib by inclusion criteria for progression of interstitial lung disease</atitle><jtitle>The European respiratory journal</jtitle><addtitle>Eur Respir J</addtitle><date>2022-02-01</date><risdate>2022</risdate><volume>59</volume><issue>2</issue><spage>2004587</spage><pages>2004587-</pages><issn>0903-1936</issn><eissn>1399-3003</eissn><abstract>The INBUILD trial investigated nintedanib
placebo in patients with progressive fibrosing interstitial lung diseases (ILDs). We investigated the decline in forced vital capacity (FVC) in subgroups based on the inclusion criteria for ILD progression.
Subjects had a fibrosing ILD other than idiopathic pulmonary fibrosis and met the following criteria for ILD progression within the 24 months before screening despite management deemed appropriate in clinical practice: Group A, relative decline in FVC ≥10% predicted; Group B, relative decline in FVC ≥5-<10% predicted with worsened respiratory symptoms and/or increased extent of fibrosis on high-resolution computed tomography (HRCT); Group C, worsened respiratory symptoms and increased extent of fibrosis on HRCT only.
In the placebo group, the rates of FVC decline over 52 weeks in Groups A, B and C, respectively, were -241.9, -133.1 and -115.3 mL per year in the overall population (p=0.0002 for subgroup-by-time interaction) and -288.9, -156.2 and -100.1 mL per year among subjects with a usual interstitial pneumonia (UIP)-like fibrotic pattern on HRCT (p=0.0005 for subgroup-by-time interaction). Nintedanib had a greater absolute effect on reducing the rate of FVC decline in Group A than in Group B or C. However, the relative effect of nintedanib
placebo was consistent across the subgroups (p>0.05 for heterogeneity).
The inclusion criteria used in the INBUILD trial, based on FVC decline or worsening of symptoms and extent of fibrosis on HRCT, were effective at identifying patients with progressive fibrosing ILDs. Nintedanib reduced the rate of decline in FVC across the subgroups based on the inclusion criteria related to ILD progression.</abstract><cop>England</cop><pub>European Respiratory Society</pub><pmid>34210788</pmid><doi>10.1183/13993003.04587-2020</doi><orcidid>https://orcid.org/0000-0003-4402-2159</orcidid><oa>free_for_read</oa></addata></record> |
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| title | Effects of nintedanib by inclusion criteria for progression of interstitial lung disease |
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