Adverse Drug Reactions from Real-World Data in Inflammatory Bowel Disease Patients in the IBDREAM Registry
Introduction Inflammatory bowel disease (IBD) frequently requires chronic immunosuppressive treatment and active involvement from patients during treatment decision making. Information about the risk of developing adverse drug reactions (ADRs) to IBD therapies is required in this process. Objective...
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| Veröffentlicht in: | Drug safety 2021-05, Vol.44 (5), p.581-588 |
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| creator | Giraud, Eline L. Thomas, Pepijn W. A. van Lint, Jette A. van Puijenbroek, Eugene P. Römkens, Tessa E. H. West, Rachel L. Russel, Maurice G. V. M. Jansen, Jeroen M. Jessurun, Naomi T. Hoentjen, Frank |
| description | Introduction
Inflammatory bowel disease (IBD) frequently requires chronic immunosuppressive treatment and active involvement from patients during treatment decision making. Information about the risk of developing adverse drug reactions (ADRs) to IBD therapies is required in this process.
Objective
The aim of this study was to describe the ADRs reported in IBD patients from real-world data, using the Dutch nationwide IBDREAM registry, and compare the occurrence and cumulative incidences with the Summary of Product Characteristics (SmPC) of the associated drugs.
Methods
In this retrospective multicentre study, ADRs related to IBD medication were assessed. Only reports associated with the use of drugs used for the maintenance treatment of IBD were included. All ADRs were verified by healthcare professionals and coded by trained pharmacovigilance assessors.
Results
In total, 3080 ADRs were reported in 1179 patients. Twenty-three new drug–ADR associations related to the use of azathioprine, mercaptopurine, infliximab, oral mesalamine and thioguanine were reported in the IBDREAM registry that were not mentioned in the corresponding SmPCs. The most frequently reported new association was pyrexia for azathioprine (3.1%) and mercaptopurine (4.9%). In addition, there were seven ADRs with a higher cumulative incidence in IBDREAM compared with the SmPC, and included, among others, arthralgia during mercaptopurine use (2.5%), and diarrhoea (1.4%), alopecia (1.2%) and infections (1.6%) during azathioprine use.
Conclusions
Based on real-world data, ADR reporting demonstrated new ADRs and higher incidences of ADRs to IBD therapies. This information will contribute to drug safety by updating the SmPCs, allowing better risk assessment and communication towards patients. |
| doi_str_mv | 10.1007/s40264-021-01045-3 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_8053178</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2517259490</sourcerecordid><originalsourceid>FETCH-LOGICAL-c474t-5ea2dcb23d6eefa83701813482267143fe79e4ff49a13b0ba97072b368276fa13</originalsourceid><addsrcrecordid>eNp9kU1vEzEQhi1ERUPhD_RQWeJs8Neu7QtS2hSIVFRUgTha3t1xutHuuthOq_z7Ok0_4MJpNDPvPPNKL0LHjH5klKpPSVJeS0I5I5RRWRHxCs0YU4YwI_lrNKOMSVIZVh-itymtKaWa1_oNOhSiEtoYOUPreXcLMQFexM0KX4Frcx-mhH0M464dyO8Qhw4vXHa4n_By8oMbR5dD3OLTcAcDXvQJXCH8cLmHKaedLF8DXp4urs7n3wtl1acct-_QgXdDgveP9Qj9-nL-8-wbubj8ujybX5BWKplJBY53bcNFVwN4p4WiTDMhNee1YlJ4UAak99I4JhraOKOo4o2oNVe1L7Mj9HnPvdk0I3Rt8RTdYG9iP7q4tcH19t_N1F_bVbi1mlaCKV0AHx4BMfzZQMp2HTZxKp4tr5jilZGGFhXfq9oYUorgnz8wanf52H0-tuRjH_Kxohyd_O3t-eQpkCIQe0Eqq2kF8eX3f7D3wYybSw</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2517259490</pqid></control><display><type>article</type><title>Adverse Drug Reactions from Real-World Data in Inflammatory Bowel Disease Patients in the IBDREAM Registry</title><source>MEDLINE</source><source>Springer Nature - Complete Springer Journals</source><creator>Giraud, Eline L. ; Thomas, Pepijn W. A. ; van Lint, Jette A. ; van Puijenbroek, Eugene P. ; Römkens, Tessa E. H. ; West, Rachel L. ; Russel, Maurice G. V. M. ; Jansen, Jeroen M. ; Jessurun, Naomi T. ; Hoentjen, Frank</creator><creatorcontrib>Giraud, Eline L. ; Thomas, Pepijn W. A. ; van Lint, Jette A. ; van Puijenbroek, Eugene P. ; Römkens, Tessa E. H. ; West, Rachel L. ; Russel, Maurice G. V. M. ; Jansen, Jeroen M. ; Jessurun, Naomi T. ; Hoentjen, Frank ; IBDREAM registry</creatorcontrib><description>Introduction
Inflammatory bowel disease (IBD) frequently requires chronic immunosuppressive treatment and active involvement from patients during treatment decision making. Information about the risk of developing adverse drug reactions (ADRs) to IBD therapies is required in this process.
Objective
The aim of this study was to describe the ADRs reported in IBD patients from real-world data, using the Dutch nationwide IBDREAM registry, and compare the occurrence and cumulative incidences with the Summary of Product Characteristics (SmPC) of the associated drugs.
Methods
In this retrospective multicentre study, ADRs related to IBD medication were assessed. Only reports associated with the use of drugs used for the maintenance treatment of IBD were included. All ADRs were verified by healthcare professionals and coded by trained pharmacovigilance assessors.
Results
In total, 3080 ADRs were reported in 1179 patients. Twenty-three new drug–ADR associations related to the use of azathioprine, mercaptopurine, infliximab, oral mesalamine and thioguanine were reported in the IBDREAM registry that were not mentioned in the corresponding SmPCs. The most frequently reported new association was pyrexia for azathioprine (3.1%) and mercaptopurine (4.9%). In addition, there were seven ADRs with a higher cumulative incidence in IBDREAM compared with the SmPC, and included, among others, arthralgia during mercaptopurine use (2.5%), and diarrhoea (1.4%), alopecia (1.2%) and infections (1.6%) during azathioprine use.
Conclusions
Based on real-world data, ADR reporting demonstrated new ADRs and higher incidences of ADRs to IBD therapies. This information will contribute to drug safety by updating the SmPCs, allowing better risk assessment and communication towards patients.</description><identifier>ISSN: 0114-5916</identifier><identifier>EISSN: 1179-1942</identifier><identifier>DOI: 10.1007/s40264-021-01045-3</identifier><identifier>PMID: 33538994</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>6-Mercaptopurine ; Adverse Drug Reaction Reporting Systems ; Alopecia ; Arthralgia ; Azathioprine ; Clinical trials ; Data analysis ; Decision making ; Diarrhea ; Drug Safety and Pharmacovigilance ; Drug-Related Side Effects and Adverse Reactions - epidemiology ; Drug-Related Side Effects and Adverse Reactions - etiology ; Drugs ; Fever ; Health services ; Humans ; Immunosuppressive agents ; Inflammatory bowel disease ; Inflammatory bowel diseases ; Inflammatory Bowel Diseases - drug therapy ; Inflammatory Bowel Diseases - epidemiology ; Infliximab ; Intestine ; Medical treatment ; Medicine ; Medicine & Public Health ; Mercaptopurine ; Monoclonal antibodies ; Original ; Original Research Article ; Patients ; Pharmacology/Toxicology ; Pharmacovigilance ; Product safety ; Registries ; Retrospective Studies ; Risk assessment ; Risk communication ; Side effects ; Thioguanine ; Tumor necrosis factor-α</subject><ispartof>Drug safety, 2021-05, Vol.44 (5), p.581-588</ispartof><rights>The Author(s) 2021</rights><rights>Copyright Springer Nature B.V. May 2021</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c474t-5ea2dcb23d6eefa83701813482267143fe79e4ff49a13b0ba97072b368276fa13</citedby><cites>FETCH-LOGICAL-c474t-5ea2dcb23d6eefa83701813482267143fe79e4ff49a13b0ba97072b368276fa13</cites><orcidid>0000-0002-1353-4509</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s40264-021-01045-3$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s40264-021-01045-3$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,27903,27904,41467,42536,51297</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33538994$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Giraud, Eline L.</creatorcontrib><creatorcontrib>Thomas, Pepijn W. A.</creatorcontrib><creatorcontrib>van Lint, Jette A.</creatorcontrib><creatorcontrib>van Puijenbroek, Eugene P.</creatorcontrib><creatorcontrib>Römkens, Tessa E. H.</creatorcontrib><creatorcontrib>West, Rachel L.</creatorcontrib><creatorcontrib>Russel, Maurice G. V. M.</creatorcontrib><creatorcontrib>Jansen, Jeroen M.</creatorcontrib><creatorcontrib>Jessurun, Naomi T.</creatorcontrib><creatorcontrib>Hoentjen, Frank</creatorcontrib><creatorcontrib>IBDREAM registry</creatorcontrib><title>Adverse Drug Reactions from Real-World Data in Inflammatory Bowel Disease Patients in the IBDREAM Registry</title><title>Drug safety</title><addtitle>Drug Saf</addtitle><addtitle>Drug Saf</addtitle><description>Introduction
Inflammatory bowel disease (IBD) frequently requires chronic immunosuppressive treatment and active involvement from patients during treatment decision making. Information about the risk of developing adverse drug reactions (ADRs) to IBD therapies is required in this process.
Objective
The aim of this study was to describe the ADRs reported in IBD patients from real-world data, using the Dutch nationwide IBDREAM registry, and compare the occurrence and cumulative incidences with the Summary of Product Characteristics (SmPC) of the associated drugs.
Methods
In this retrospective multicentre study, ADRs related to IBD medication were assessed. Only reports associated with the use of drugs used for the maintenance treatment of IBD were included. All ADRs were verified by healthcare professionals and coded by trained pharmacovigilance assessors.
Results
In total, 3080 ADRs were reported in 1179 patients. Twenty-three new drug–ADR associations related to the use of azathioprine, mercaptopurine, infliximab, oral mesalamine and thioguanine were reported in the IBDREAM registry that were not mentioned in the corresponding SmPCs. The most frequently reported new association was pyrexia for azathioprine (3.1%) and mercaptopurine (4.9%). In addition, there were seven ADRs with a higher cumulative incidence in IBDREAM compared with the SmPC, and included, among others, arthralgia during mercaptopurine use (2.5%), and diarrhoea (1.4%), alopecia (1.2%) and infections (1.6%) during azathioprine use.
Conclusions
Based on real-world data, ADR reporting demonstrated new ADRs and higher incidences of ADRs to IBD therapies. This information will contribute to drug safety by updating the SmPCs, allowing better risk assessment and communication towards patients.</description><subject>6-Mercaptopurine</subject><subject>Adverse Drug Reaction Reporting Systems</subject><subject>Alopecia</subject><subject>Arthralgia</subject><subject>Azathioprine</subject><subject>Clinical trials</subject><subject>Data analysis</subject><subject>Decision making</subject><subject>Diarrhea</subject><subject>Drug Safety and Pharmacovigilance</subject><subject>Drug-Related Side Effects and Adverse Reactions - epidemiology</subject><subject>Drug-Related Side Effects and Adverse Reactions - etiology</subject><subject>Drugs</subject><subject>Fever</subject><subject>Health services</subject><subject>Humans</subject><subject>Immunosuppressive agents</subject><subject>Inflammatory bowel disease</subject><subject>Inflammatory bowel diseases</subject><subject>Inflammatory Bowel Diseases - drug therapy</subject><subject>Inflammatory Bowel Diseases - epidemiology</subject><subject>Infliximab</subject><subject>Intestine</subject><subject>Medical treatment</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Mercaptopurine</subject><subject>Monoclonal antibodies</subject><subject>Original</subject><subject>Original Research Article</subject><subject>Patients</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacovigilance</subject><subject>Product safety</subject><subject>Registries</subject><subject>Retrospective Studies</subject><subject>Risk assessment</subject><subject>Risk communication</subject><subject>Side effects</subject><subject>Thioguanine</subject><subject>Tumor necrosis factor-α</subject><issn>0114-5916</issn><issn>1179-1942</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp9kU1vEzEQhi1ERUPhD_RQWeJs8Neu7QtS2hSIVFRUgTha3t1xutHuuthOq_z7Ok0_4MJpNDPvPPNKL0LHjH5klKpPSVJeS0I5I5RRWRHxCs0YU4YwI_lrNKOMSVIZVh-itymtKaWa1_oNOhSiEtoYOUPreXcLMQFexM0KX4Frcx-mhH0M464dyO8Qhw4vXHa4n_By8oMbR5dD3OLTcAcDXvQJXCH8cLmHKaedLF8DXp4urs7n3wtl1acct-_QgXdDgveP9Qj9-nL-8-wbubj8ujybX5BWKplJBY53bcNFVwN4p4WiTDMhNee1YlJ4UAak99I4JhraOKOo4o2oNVe1L7Mj9HnPvdk0I3Rt8RTdYG9iP7q4tcH19t_N1F_bVbi1mlaCKV0AHx4BMfzZQMp2HTZxKp4tr5jilZGGFhXfq9oYUorgnz8wanf52H0-tuRjH_Kxohyd_O3t-eQpkCIQe0Eqq2kF8eX3f7D3wYybSw</recordid><startdate>20210501</startdate><enddate>20210501</enddate><creator>Giraud, Eline L.</creator><creator>Thomas, Pepijn W. A.</creator><creator>van Lint, Jette A.</creator><creator>van Puijenbroek, Eugene P.</creator><creator>Römkens, Tessa E. H.</creator><creator>West, Rachel L.</creator><creator>Russel, Maurice G. V. M.</creator><creator>Jansen, Jeroen M.</creator><creator>Jessurun, Naomi T.</creator><creator>Hoentjen, Frank</creator><general>Springer International Publishing</general><general>Springer Nature B.V</general><scope>C6C</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>4T-</scope><scope>7RV</scope><scope>7T2</scope><scope>7TK</scope><scope>7U7</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-1353-4509</orcidid></search><sort><creationdate>20210501</creationdate><title>Adverse Drug Reactions from Real-World Data in Inflammatory Bowel Disease Patients in the IBDREAM Registry</title><author>Giraud, Eline L. ; Thomas, Pepijn W. A. ; van Lint, Jette A. ; van Puijenbroek, Eugene P. ; Römkens, Tessa E. H. ; West, Rachel L. ; Russel, Maurice G. V. M. ; Jansen, Jeroen M. ; Jessurun, Naomi T. ; Hoentjen, Frank</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c474t-5ea2dcb23d6eefa83701813482267143fe79e4ff49a13b0ba97072b368276fa13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>6-Mercaptopurine</topic><topic>Adverse Drug Reaction Reporting Systems</topic><topic>Alopecia</topic><topic>Arthralgia</topic><topic>Azathioprine</topic><topic>Clinical trials</topic><topic>Data analysis</topic><topic>Decision making</topic><topic>Diarrhea</topic><topic>Drug Safety and Pharmacovigilance</topic><topic>Drug-Related Side Effects and Adverse Reactions - epidemiology</topic><topic>Drug-Related Side Effects and Adverse Reactions - etiology</topic><topic>Drugs</topic><topic>Fever</topic><topic>Health services</topic><topic>Humans</topic><topic>Immunosuppressive agents</topic><topic>Inflammatory bowel disease</topic><topic>Inflammatory bowel diseases</topic><topic>Inflammatory Bowel Diseases - drug therapy</topic><topic>Inflammatory Bowel Diseases - epidemiology</topic><topic>Infliximab</topic><topic>Intestine</topic><topic>Medical treatment</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Mercaptopurine</topic><topic>Monoclonal antibodies</topic><topic>Original</topic><topic>Original Research Article</topic><topic>Patients</topic><topic>Pharmacology/Toxicology</topic><topic>Pharmacovigilance</topic><topic>Product safety</topic><topic>Registries</topic><topic>Retrospective Studies</topic><topic>Risk assessment</topic><topic>Risk communication</topic><topic>Side effects</topic><topic>Thioguanine</topic><topic>Tumor necrosis factor-α</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Giraud, Eline L.</creatorcontrib><creatorcontrib>Thomas, Pepijn W. A.</creatorcontrib><creatorcontrib>van Lint, Jette A.</creatorcontrib><creatorcontrib>van Puijenbroek, Eugene P.</creatorcontrib><creatorcontrib>Römkens, Tessa E. H.</creatorcontrib><creatorcontrib>West, Rachel L.</creatorcontrib><creatorcontrib>Russel, Maurice G. V. M.</creatorcontrib><creatorcontrib>Jansen, Jeroen M.</creatorcontrib><creatorcontrib>Jessurun, Naomi T.</creatorcontrib><creatorcontrib>Hoentjen, Frank</creatorcontrib><creatorcontrib>IBDREAM registry</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Docstoc</collection><collection>Proquest Nursing & Allied Health Source</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Drug safety</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Giraud, Eline L.</au><au>Thomas, Pepijn W. A.</au><au>van Lint, Jette A.</au><au>van Puijenbroek, Eugene P.</au><au>Römkens, Tessa E. H.</au><au>West, Rachel L.</au><au>Russel, Maurice G. V. M.</au><au>Jansen, Jeroen M.</au><au>Jessurun, Naomi T.</au><au>Hoentjen, Frank</au><aucorp>IBDREAM registry</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Adverse Drug Reactions from Real-World Data in Inflammatory Bowel Disease Patients in the IBDREAM Registry</atitle><jtitle>Drug safety</jtitle><stitle>Drug Saf</stitle><addtitle>Drug Saf</addtitle><date>2021-05-01</date><risdate>2021</risdate><volume>44</volume><issue>5</issue><spage>581</spage><epage>588</epage><pages>581-588</pages><issn>0114-5916</issn><eissn>1179-1942</eissn><abstract>Introduction
Inflammatory bowel disease (IBD) frequently requires chronic immunosuppressive treatment and active involvement from patients during treatment decision making. Information about the risk of developing adverse drug reactions (ADRs) to IBD therapies is required in this process.
Objective
The aim of this study was to describe the ADRs reported in IBD patients from real-world data, using the Dutch nationwide IBDREAM registry, and compare the occurrence and cumulative incidences with the Summary of Product Characteristics (SmPC) of the associated drugs.
Methods
In this retrospective multicentre study, ADRs related to IBD medication were assessed. Only reports associated with the use of drugs used for the maintenance treatment of IBD were included. All ADRs were verified by healthcare professionals and coded by trained pharmacovigilance assessors.
Results
In total, 3080 ADRs were reported in 1179 patients. Twenty-three new drug–ADR associations related to the use of azathioprine, mercaptopurine, infliximab, oral mesalamine and thioguanine were reported in the IBDREAM registry that were not mentioned in the corresponding SmPCs. The most frequently reported new association was pyrexia for azathioprine (3.1%) and mercaptopurine (4.9%). In addition, there were seven ADRs with a higher cumulative incidence in IBDREAM compared with the SmPC, and included, among others, arthralgia during mercaptopurine use (2.5%), and diarrhoea (1.4%), alopecia (1.2%) and infections (1.6%) during azathioprine use.
Conclusions
Based on real-world data, ADR reporting demonstrated new ADRs and higher incidences of ADRs to IBD therapies. This information will contribute to drug safety by updating the SmPCs, allowing better risk assessment and communication towards patients.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>33538994</pmid><doi>10.1007/s40264-021-01045-3</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0002-1353-4509</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Drug safety, 2021-05, Vol.44 (5), p.581-588 |
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| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_8053178 |
| source | MEDLINE; Springer Nature - Complete Springer Journals |
| subjects | 6-Mercaptopurine Adverse Drug Reaction Reporting Systems Alopecia Arthralgia Azathioprine Clinical trials Data analysis Decision making Diarrhea Drug Safety and Pharmacovigilance Drug-Related Side Effects and Adverse Reactions - epidemiology Drug-Related Side Effects and Adverse Reactions - etiology Drugs Fever Health services Humans Immunosuppressive agents Inflammatory bowel disease Inflammatory bowel diseases Inflammatory Bowel Diseases - drug therapy Inflammatory Bowel Diseases - epidemiology Infliximab Intestine Medical treatment Medicine Medicine & Public Health Mercaptopurine Monoclonal antibodies Original Original Research Article Patients Pharmacology/Toxicology Pharmacovigilance Product safety Registries Retrospective Studies Risk assessment Risk communication Side effects Thioguanine Tumor necrosis factor-α |
| title | Adverse Drug Reactions from Real-World Data in Inflammatory Bowel Disease Patients in the IBDREAM Registry |
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