Safety of pirfenidone in patients with idiopathic pulmonary fibrosis: integrated analysis of cumulative data from 5 clinical trials.
Identifieur interne : 002350 ( PubMed/Corpus ); précédent : 002349; suivant : 002351Safety of pirfenidone in patients with idiopathic pulmonary fibrosis: integrated analysis of cumulative data from 5 clinical trials.
Auteurs : Lisa Lancaster ; Carlo Albera ; Williamson Z. Bradford ; Ulrich Costabel ; Roland M. Du Bois ; Elizabeth A. Fagan ; Robert S. Fishman ; Ian Glaspole ; Marilyn K. Glassberg ; Talmadge E. King ; David J. Lederer ; Zhengning Lin ; Steven D. Nathan ; Carlos A. Pereira ; Jeffrey J. Swigris ; Dominique Valeyre ; Paul W. NobleSource :
- BMJ open respiratory research [ 2052-4439 ] ; 2016.
Abstract
Pirfenidone is an oral antifibrotic agent that has been shown to reduce the decline in lung function in patients with idiopathic pulmonary fibrosis (IPF). We performed an integrated analysis of safety data from five clinical trials evaluating pirfenidone in patients with IPF.
DOI: 10.1136/bmjresp-2015-000105
PubMed: 26835133
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Safety of pirfenidone in patients with idiopathic pulmonary fibrosis: integrated analysis of cumulative data from 5 clinical trials.</title><author><name sortKey="Lancaster, Lisa" sort="Lancaster, Lisa" uniqKey="Lancaster L" first="Lisa" last="Lancaster">Lisa Lancaster</name><affiliation><nlm:affiliation>Department of Medicine , Vanderbilt University Medical Center , Nashville, Tennessee , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Albera, Carlo" sort="Albera, Carlo" uniqKey="Albera C" first="Carlo" last="Albera">Carlo Albera</name><affiliation><nlm:affiliation>Department of Clinical and Biological Sciences , University of Turin , Turin , Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Bradford, Williamson Z" sort="Bradford, Williamson Z" uniqKey="Bradford W" first="Williamson Z" last="Bradford">Williamson Z. Bradford</name><affiliation><nlm:affiliation>InterMune Inc , Brisbane, California , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Costabel, Ulrich" sort="Costabel, Ulrich" uniqKey="Costabel U" first="Ulrich" last="Costabel">Ulrich Costabel</name><affiliation><nlm:affiliation>Department of Pneumology and Allergy , Ruhrlandklinik, University of Duisburg-Essen , Essen , Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Du Bois, Roland M" sort="Du Bois, Roland M" uniqKey="Du Bois R" first="Roland M" last="Du Bois">Roland M. Du Bois</name><affiliation><nlm:affiliation>Emeritus Professor of Respiratory Medicine , Imperial College , London , UK.</nlm:affiliation></affiliation></author><author><name sortKey="Fagan, Elizabeth A" sort="Fagan, Elizabeth A" uniqKey="Fagan E" first="Elizabeth A" last="Fagan">Elizabeth A. Fagan</name><affiliation><nlm:affiliation>InterMune Inc , Brisbane, California , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Fishman, Robert S" sort="Fishman, Robert S" uniqKey="Fishman R" first="Robert S" last="Fishman">Robert S. Fishman</name><affiliation><nlm:affiliation>InterMune Inc , Brisbane, California , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Glaspole, Ian" sort="Glaspole, Ian" uniqKey="Glaspole I" first="Ian" last="Glaspole">Ian Glaspole</name><affiliation><nlm:affiliation>AIRMED, Alfred Hospital and Monash University , Melbourne, Victoria , Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Glassberg, Marilyn K" sort="Glassberg, Marilyn K" uniqKey="Glassberg M" first="Marilyn K" last="Glassberg">Marilyn K. Glassberg</name><affiliation><nlm:affiliation>Department of Medicine and Surgery , University of Miami Miller School of Medicine , Miami, Florida , USA.</nlm:affiliation></affiliation></author><author><name sortKey="King, Talmadge E" sort="King, Talmadge E" uniqKey="King T" first="Talmadge E" last="King">Talmadge E. King</name><affiliation><nlm:affiliation>Department of Medicine , University of California San Francisco (UCSF) , San Francisco, California , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Lederer, David J" sort="Lederer, David J" uniqKey="Lederer D" first="David J" last="Lederer">David J. Lederer</name><affiliation><nlm:affiliation>Department of Medicine , Columbia University Medical Center , New York, New York , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Lin, Zhengning" sort="Lin, Zhengning" uniqKey="Lin Z" first="Zhengning" last="Lin">Zhengning Lin</name><affiliation><nlm:affiliation>InterMune Inc , Brisbane, California , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Nathan, Steven D" sort="Nathan, Steven D" uniqKey="Nathan S" first="Steven D" last="Nathan">Steven D. Nathan</name><affiliation><nlm:affiliation>Lung Transplant Program, Inova Fairfax Hospital , Falls Church, Virginia , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Pereira, Carlos A" sort="Pereira, Carlos A" uniqKey="Pereira C" first="Carlos A" last="Pereira">Carlos A. Pereira</name><affiliation><nlm:affiliation>Lung Disease Department , Paulista School of Medicine, Federal University of São Paulo , São Paulo, Brazil.</nlm:affiliation></affiliation></author><author><name sortKey="Swigris, Jeffrey J" sort="Swigris, Jeffrey J" uniqKey="Swigris J" first="Jeffrey J" last="Swigris">Jeffrey J. Swigris</name><affiliation><nlm:affiliation>Department of Medicine , National Jewish Health , Denver, Colorado , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Valeyre, Dominique" sort="Valeyre, Dominique" uniqKey="Valeyre D" first="Dominique" last="Valeyre">Dominique Valeyre</name><affiliation><nlm:affiliation>Pneumology Service , Assistance Publique-Hôpitaux de Paris, Avicenne University Hospital , Bobigny , France.</nlm:affiliation></affiliation></author><author><name sortKey="Noble, Paul W" sort="Noble, Paul W" uniqKey="Noble P" first="Paul W" last="Noble">Paul W. Noble</name><affiliation><nlm:affiliation>Department of Medicine , Cedars Sinai Medical Center , Los Angeles, California , USA.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2016">2016</date><idno type="RBID">pubmed:26835133</idno><idno type="pmid">26835133</idno><idno type="doi">10.1136/bmjresp-2015-000105</idno><idno type="wicri:Area/PubMed/Corpus">002350</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">002350</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Safety of pirfenidone in patients with idiopathic pulmonary fibrosis: integrated analysis of cumulative data from 5 clinical trials.</title><author><name sortKey="Lancaster, Lisa" sort="Lancaster, Lisa" uniqKey="Lancaster L" first="Lisa" last="Lancaster">Lisa Lancaster</name><affiliation><nlm:affiliation>Department of Medicine , Vanderbilt University Medical Center , Nashville, Tennessee , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Albera, Carlo" sort="Albera, Carlo" uniqKey="Albera C" first="Carlo" last="Albera">Carlo Albera</name><affiliation><nlm:affiliation>Department of Clinical and Biological Sciences , University of Turin , Turin , Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Bradford, Williamson Z" sort="Bradford, Williamson Z" uniqKey="Bradford W" first="Williamson Z" last="Bradford">Williamson Z. Bradford</name><affiliation><nlm:affiliation>InterMune Inc , Brisbane, California , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Costabel, Ulrich" sort="Costabel, Ulrich" uniqKey="Costabel U" first="Ulrich" last="Costabel">Ulrich Costabel</name><affiliation><nlm:affiliation>Department of Pneumology and Allergy , Ruhrlandklinik, University of Duisburg-Essen , Essen , Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Du Bois, Roland M" sort="Du Bois, Roland M" uniqKey="Du Bois R" first="Roland M" last="Du Bois">Roland M. Du Bois</name><affiliation><nlm:affiliation>Emeritus Professor of Respiratory Medicine , Imperial College , London , UK.</nlm:affiliation></affiliation></author><author><name sortKey="Fagan, Elizabeth A" sort="Fagan, Elizabeth A" uniqKey="Fagan E" first="Elizabeth A" last="Fagan">Elizabeth A. Fagan</name><affiliation><nlm:affiliation>InterMune Inc , Brisbane, California , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Fishman, Robert S" sort="Fishman, Robert S" uniqKey="Fishman R" first="Robert S" last="Fishman">Robert S. Fishman</name><affiliation><nlm:affiliation>InterMune Inc , Brisbane, California , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Glaspole, Ian" sort="Glaspole, Ian" uniqKey="Glaspole I" first="Ian" last="Glaspole">Ian Glaspole</name><affiliation><nlm:affiliation>AIRMED, Alfred Hospital and Monash University , Melbourne, Victoria , Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Glassberg, Marilyn K" sort="Glassberg, Marilyn K" uniqKey="Glassberg M" first="Marilyn K" last="Glassberg">Marilyn K. Glassberg</name><affiliation><nlm:affiliation>Department of Medicine and Surgery , University of Miami Miller School of Medicine , Miami, Florida , USA.</nlm:affiliation></affiliation></author><author><name sortKey="King, Talmadge E" sort="King, Talmadge E" uniqKey="King T" first="Talmadge E" last="King">Talmadge E. King</name><affiliation><nlm:affiliation>Department of Medicine , University of California San Francisco (UCSF) , San Francisco, California , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Lederer, David J" sort="Lederer, David J" uniqKey="Lederer D" first="David J" last="Lederer">David J. Lederer</name><affiliation><nlm:affiliation>Department of Medicine , Columbia University Medical Center , New York, New York , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Lin, Zhengning" sort="Lin, Zhengning" uniqKey="Lin Z" first="Zhengning" last="Lin">Zhengning Lin</name><affiliation><nlm:affiliation>InterMune Inc , Brisbane, California , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Nathan, Steven D" sort="Nathan, Steven D" uniqKey="Nathan S" first="Steven D" last="Nathan">Steven D. Nathan</name><affiliation><nlm:affiliation>Lung Transplant Program, Inova Fairfax Hospital , Falls Church, Virginia , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Pereira, Carlos A" sort="Pereira, Carlos A" uniqKey="Pereira C" first="Carlos A" last="Pereira">Carlos A. Pereira</name><affiliation><nlm:affiliation>Lung Disease Department , Paulista School of Medicine, Federal University of São Paulo , São Paulo, Brazil.</nlm:affiliation></affiliation></author><author><name sortKey="Swigris, Jeffrey J" sort="Swigris, Jeffrey J" uniqKey="Swigris J" first="Jeffrey J" last="Swigris">Jeffrey J. Swigris</name><affiliation><nlm:affiliation>Department of Medicine , National Jewish Health , Denver, Colorado , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Valeyre, Dominique" sort="Valeyre, Dominique" uniqKey="Valeyre D" first="Dominique" last="Valeyre">Dominique Valeyre</name><affiliation><nlm:affiliation>Pneumology Service , Assistance Publique-Hôpitaux de Paris, Avicenne University Hospital , Bobigny , France.</nlm:affiliation></affiliation></author><author><name sortKey="Noble, Paul W" sort="Noble, Paul W" uniqKey="Noble P" first="Paul W" last="Noble">Paul W. Noble</name><affiliation><nlm:affiliation>Department of Medicine , Cedars Sinai Medical Center , Los Angeles, California , USA.</nlm:affiliation></affiliation></author></analytic><series><title level="j">BMJ open respiratory research</title><idno type="ISSN">2052-4439</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Pirfenidone is an oral antifibrotic agent that has been shown to reduce the decline in lung function in patients with idiopathic pulmonary fibrosis (IPF). We performed an integrated analysis of safety data from five clinical trials evaluating pirfenidone in patients with IPF.</div></front></TEI><pubmed><MedlineCitation Status="PubMed-not-MEDLINE" Owner="NLM"><PMID Version="1">26835133</PMID><DateCreated><Year>2016</Year><Month>02</Month><Day>02</Day></DateCreated><DateCompleted><Year>2016</Year><Month>02</Month><Day>02</Day></DateCompleted><DateRevised><Year>2017</Year><Month>02</Month><Day>21</Day></DateRevised><Article PubModel="Electronic-eCollection"><Journal><ISSN IssnType="Print">2052-4439</ISSN><JournalIssue CitedMedium="Print"><Volume>3</Volume><Issue>1</Issue><PubDate><Year>2016</Year></PubDate></JournalIssue><Title>BMJ open respiratory research</Title><ISOAbbreviation>BMJ Open Respir Res</ISOAbbreviation></Journal><ArticleTitle>Safety of pirfenidone in patients with idiopathic pulmonary fibrosis: integrated analysis of cumulative data from 5 clinical trials.</ArticleTitle><Pagination><MedlinePgn>e000105</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1136/bmjresp-2015-000105</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Pirfenidone is an oral antifibrotic agent that has been shown to reduce the decline in lung function in patients with idiopathic pulmonary fibrosis (IPF). We performed an integrated analysis of safety data from five clinical trials evaluating pirfenidone in patients with IPF.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">All patients treated with pirfenidone in the three multinational Phase 3 studies (CAPACITY (studies 004 and 006), ASCEND (study 016)) and two ongoing open-label studies (study 002 and study 012 (RECAP)) were included in the analysis. Safety outcomes were assessed during the period from the first dose until 28 days after the last dose of study drug.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">A total of 1299 patients were included in the analysis. The cumulative total exposure to pirfenidone was 3160 person exposure years (PEY). The median duration of exposure was 1.7 years (range 1 week to 9.9 years), and the mean (±SD) daily dose was 2053.8 (±484.9) mg. Gastrointestinal events (nausea (37.6%), diarrhoea (28.1%), dyspepsia (18.4%), vomiting (15.9%)) and rash (25.0%) were the most common adverse events; these were generally mild to moderate in severity and without significant clinical consequence. Elevations in alanine aminotransferase or aspartate aminotransferase greater than three times the upper limit of normal occurred in 40/1299 (3.1%) patients (adjusted incidence, 2.3 per 100 PEY). Elevations were generally transient and reversible with dose modification or discontinuation.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">A comprehensive analysis of safety outcomes in a large and well-defined cohort of 1299 patients with IPF who were followed prospectively for up to 9.9 years demonstrated that long-term treatment with pirfenidone is safe and generally well tolerated.</AbstractText><AbstractText Label="TRIAL REGISTRATION NUMBERS" NlmCategory="BACKGROUND">NCT00287716, NCT00287729, NCT00662038, NCT01366209.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Lancaster</LastName><ForeName>Lisa</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Department of Medicine , Vanderbilt University Medical Center , Nashville, Tennessee , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Albera</LastName><ForeName>Carlo</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Department of Clinical and Biological Sciences , University of Turin , Turin , Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bradford</LastName><ForeName>Williamson Z</ForeName><Initials>WZ</Initials><AffiliationInfo><Affiliation>InterMune Inc , Brisbane, California , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Costabel</LastName><ForeName>Ulrich</ForeName><Initials>U</Initials><AffiliationInfo><Affiliation>Department of Pneumology and Allergy , Ruhrlandklinik, University of Duisburg-Essen , Essen , Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>du Bois</LastName><ForeName>Roland M</ForeName><Initials>RM</Initials><AffiliationInfo><Affiliation>Emeritus Professor of Respiratory Medicine , Imperial College , London , UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fagan</LastName><ForeName>Elizabeth A</ForeName><Initials>EA</Initials><AffiliationInfo><Affiliation>InterMune Inc , Brisbane, California , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fishman</LastName><ForeName>Robert S</ForeName><Initials>RS</Initials><AffiliationInfo><Affiliation>InterMune Inc , Brisbane, California , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Glaspole</LastName><ForeName>Ian</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>AIRMED, Alfred Hospital and Monash University , Melbourne, Victoria , Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Glassberg</LastName><ForeName>Marilyn K</ForeName><Initials>MK</Initials><AffiliationInfo><Affiliation>Department of Medicine and Surgery , University of Miami Miller School of Medicine , Miami, Florida , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>King</LastName><ForeName>Talmadge E</ForeName><Initials>TE</Initials><Suffix>Jr</Suffix><AffiliationInfo><Affiliation>Department of Medicine , University of California San Francisco (UCSF) , San Francisco, California , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lederer</LastName><ForeName>David J</ForeName><Initials>DJ</Initials><AffiliationInfo><Affiliation>Department of Medicine , Columbia University Medical Center , New York, New York , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lin</LastName><ForeName>Zhengning</ForeName><Initials>Z</Initials><AffiliationInfo><Affiliation>InterMune Inc , Brisbane, California , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nathan</LastName><ForeName>Steven D</ForeName><Initials>SD</Initials><AffiliationInfo><Affiliation>Lung Transplant Program, Inova Fairfax Hospital , Falls Church, Virginia , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pereira</LastName><ForeName>Carlos A</ForeName><Initials>CA</Initials><AffiliationInfo><Affiliation>Lung Disease Department , Paulista School of Medicine, Federal University of São Paulo , São Paulo, Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Swigris</LastName><ForeName>Jeffrey J</ForeName><Initials>JJ</Initials><AffiliationInfo><Affiliation>Department of Medicine , National Jewish Health , Denver, Colorado , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Valeyre</LastName><ForeName>Dominique</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Pneumology Service , Assistance Publique-Hôpitaux de Paris, Avicenne University Hospital , Bobigny , France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Noble</LastName><ForeName>Paul W</ForeName><Initials>PW</Initials><AffiliationInfo><Affiliation>Department of Medicine , Cedars Sinai Medical Center , Los Angeles, California , USA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT00287716</AccessionNumber><AccessionNumber>NCT00287729</AccessionNumber><AccessionNumber>NCT00662038</AccessionNumber><AccessionNumber>NCT01366209</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2016</Year><Month>01</Month><Day>12</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>BMJ Open Respir Res</MedlineTA><NlmUniqueID>101638061</NlmUniqueID><ISSNLinking>2052-4439</ISSNLinking></MedlineJournalInfo><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>N Engl J Med. 2014 May 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Version="1">15665326</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Respirology. 2014 Jul;19(5):740-7</RefSource><PMID Version="1">24836849</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Sarcoidosis Vasc Diffuse Lung Dis. 2014 Oct 20;31(3):198-205</RefSource><PMID Version="1">25363219</PMID></CommentsCorrections></CommentsCorrectionsList><OtherID Source="NLM">PMC4716177</OtherID><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Interstitial Fibrosis</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2015</Year><Month>08</Month><Day>14</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2015</Year><Month>10</Month><Day>08</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2016</Year><Month>2</Month><Day>3</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate 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