TocilizumabV1, PubMed, Checkpoint, bibRecord, 000458

Health-related quality of life in patients with giant cell arteritis treated with tocilizumab in a phase 3 randomised controlled trial.

Identifieur interne : 000458 ( PubMed/Checkpoint ); précédent : 000457; suivant : 000459

Health-related quality of life in patients with giant cell arteritis treated with tocilizumab in a phase 3 randomised controlled trial.

Auteurs : Vibeke Strand [États-Unis] ; Sophie Dimonaco [Royaume-Uni] ; Katie Tuckwell [États-Unis] ; Micki Klearman [États-Unis] ; Neil Collinson [Royaume-Uni] ; John H. Stone [États-Unis]

Source :

Arthritis research & therapy [ 1478-6362 ] ; 2019.

RBID : pubmed:30786937

Descripteurs français

KwdFr :
- Adulte d'âge moyen, Anti-inflammatoires (usage thérapeutique), Anticorps monoclonaux humanisés (administration et posologie), Anticorps monoclonaux humanisés (usage thérapeutique), Artérite à cellules géantes (physiopathologie), Artérite à cellules géantes (psychologie), Artérite à cellules géantes (traitement médicamenteux), Association de médicaments, Enquêtes et questionnaires, Fatigue (physiopathologie), Fatigue (psychologie), Fatigue (traitement médicamenteux), Femelle, Humains, Mâle, Méthode en double aveugle, Prednisone (administration et posologie), Prednisone (usage thérapeutique), Qualité de vie, Résultat thérapeutique, Sujet âgé, État de santé.
MESH :
- administration et posologie : Anticorps monoclonaux humanisés, Prednisone.
- physiopathologie : Artérite à cellules géantes, Fatigue.
- psychologie : Artérite à cellules géantes, Fatigue.
- traitement médicamenteux : Artérite à cellules géantes, Fatigue.
- usage thérapeutique : Anti-inflammatoires, Anticorps monoclonaux humanisés, Prednisone.
- Adulte d'âge moyen, Association de médicaments, Enquêtes et questionnaires, Femelle, Humains, Mâle, Méthode en double aveugle, Qualité de vie, Résultat thérapeutique, Sujet âgé, État de santé.

English descriptors

KwdEn :
- Aged, Anti-Inflammatory Agents (therapeutic use), Antibodies, Monoclonal, Humanized (administration & dosage), Antibodies, Monoclonal, Humanized (therapeutic use), Double-Blind Method, Drug Therapy, Combination, Fatigue (drug therapy), Fatigue (physiopathology), Fatigue (psychology), Female, Giant Cell Arteritis (drug therapy), Giant Cell Arteritis (physiopathology), Giant Cell Arteritis (psychology), Health Status, Humans, Male, Middle Aged, Prednisone (administration & dosage), Prednisone (therapeutic use), Quality of Life, Surveys and Questionnaires, Treatment Outcome.
MESH :
- chemical , administration & dosage : Antibodies, Monoclonal, Humanized, Prednisone.
- chemical , therapeutic use : Anti-Inflammatory Agents, Antibodies, Monoclonal, Humanized, Prednisone.
- drug therapy : Fatigue, Giant Cell Arteritis.
- physiopathology : Fatigue, Giant Cell Arteritis.
- psychology : Fatigue, Giant Cell Arteritis.
- Aged, Double-Blind Method, Drug Therapy, Combination, Female, Health Status, Humans, Male, Middle Aged, Quality of Life, Surveys and Questionnaires, Treatment Outcome.

Abstract

Patients with giant cell arteritis (GCA) treated with tocilizumab (TCZ) every week or every other week and prednisone tapering achieved superior rates of sustained remission to patients treated with placebo and prednisone tapering in a randomised controlled trial. Health-related quality of life (HRQOL) in patients from this trial is now reported.

DOI: 10.1186/s13075-019-1837-7
PubMed: 30786937

Affiliations:

Links toward previous steps (curation, corpus...)

to stream PubMed, to step Corpus: 000490
to stream PubMed, to step Curation: 000490

Links to Exploration step

pubmed:30786937

Le document en format XML

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<term>Giant Cell Arteritis</term>
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<front><div type="abstract" xml:lang="en">Patients with giant cell arteritis (GCA) treated with tocilizumab (TCZ) every week or every other week and prednisone tapering achieved superior rates of sustained remission to patients treated with placebo and prednisone tapering in a randomised controlled trial. Health-related quality of life (HRQOL) in patients from this trial is now reported.</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">30786937</PMID>
<DateCompleted><Year>2020</Year>
<Month>04</Month>
<Day>06</Day>
</DateCompleted>
<DateRevised><Year>2020</Year>
<Month>04</Month>
<Day>08</Day>
</DateRevised>
<Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1478-6362</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>21</Volume>
<Issue>1</Issue>
<PubDate><Year>2019</Year>
<Month>02</Month>
<Day>20</Day>
</PubDate>
</JournalIssue>
<Title>Arthritis research & therapy</Title>
<ISOAbbreviation>Arthritis Res. Ther.</ISOAbbreviation>
</Journal>
<ArticleTitle>Health-related quality of life in patients with giant cell arteritis treated with tocilizumab in a phase 3 randomised controlled trial.</ArticleTitle>
<Pagination><MedlinePgn>64</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1186/s13075-019-1837-7</ELocationID>
<Abstract><AbstractText Label="BACKGROUND">Patients with giant cell arteritis (GCA) treated with tocilizumab (TCZ) every week or every other week and prednisone tapering achieved superior rates of sustained remission to patients treated with placebo and prednisone tapering in a randomised controlled trial. Health-related quality of life (HRQOL) in patients from this trial is now reported.</AbstractText>
<AbstractText Label="METHODS">Exploratory analyses of SF-36 PCS and MCS and domain scores, PtGA and FACIT-Fatigue were performed in patients treated with weekly subcutaneous TCZ 162 mg plus 26-week prednisone taper (TCZ-QW + Pred-26) or placebo plus 26-week or 52-week prednisone tapers (PBO + Pred-26 or PBO + Pred-52). These analyses were performed on responder and non-responder patients, including those who achieved the primary outcome and those who experienced flare and received escape prednisone doses.</AbstractText>
<AbstractText Label="RESULTS">Baseline SF-36 PCS, MCS and domain scores were low, indicating impaired HRQOL related to GCA. At week 52, least squares mean (LSM) changes in PCS scores improved with TCZ-QW + Pred-26 but worsened in both PBO + Pred groups (p <  0.001). LSM changes in MCS scores increased with TCZ-QW + Pred-26 versus PBO + Pred-52 (p < 0.001). Treatment with TCZ-QW + Pred-26 resulted in significantly greater improvement in four of eight SF-36 domains compared with PBO + Pred-26 and six of eight domains compared with PBO + Pred-52 (p < 0.01). Improvement with TCZ-QW + Pred-26 met or exceeded minimum clinically important differences (MCID) in all eight domains compared with five domains with PBO + Pred-26 and none with PBO + Pred-52. Domain scores in the TCZ-QW + Pred-26 group at week 52 met or exceeded age- and gender-matched normative values (A/G norms). LSM changes from baseline in FACIT-Fatigue scores increased significantly with TCZ-QW + Pred-26, exceeding MCID and A/G norms (p < 0.001).</AbstractText>
<AbstractText Label="CONCLUSIONS">Patients with GCA receiving TCZ-QW + Pred-26 reported statistically significant and clinically meaningful improvement in SF-36 and FACIT-Fatigue scores compared with those receiving prednisone only. Improvements in the TCZ-QW + Pred-26 group led to recovery of HRQOL to levels at least comparable to those of A/G-matched normative values at week 52 and exceeded normative values in five of eight domains.</AbstractText>
<AbstractText Label="TRIAL REGISTRATION">ClinicalTrials.gov, NCT01791153. Date of registration: February 13, 2013.</AbstractText>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Strand</LastName>
<ForeName>Vibeke</ForeName>
<Initials>V</Initials>
<AffiliationInfo><Affiliation>Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Dimonaco</LastName>
<ForeName>Sophie</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Roche Products Ltd., Welwyn Garden City, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Tuckwell</LastName>
<ForeName>Katie</ForeName>
<Initials>K</Initials>
<AffiliationInfo><Affiliation>Genentech, South San Francisco, CA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Klearman</LastName>
<ForeName>Micki</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Genentech, South San Francisco, CA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Collinson</LastName>
<ForeName>Neil</ForeName>
<Initials>N</Initials>
<AffiliationInfo><Affiliation>Roche Products Ltd., Welwyn Garden City, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Stone</LastName>
<ForeName>John H</ForeName>
<Initials>JH</Initials>
<AffiliationInfo><Affiliation>Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Yawkey 2, 55 Fruit Street, Boston, MA, 02114, USA. jhstone@mgh.harvard.edu.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName>
<AccessionNumberList><AccessionNumber>NCT01791153</AccessionNumber>
</AccessionNumberList>
</DataBank>
</DataBankList>
<GrantList CompleteYN="Y"><Grant><GrantID>N/A</GrantID>
<Agency>Roche</Agency>
<Country>International</Country>
</Grant>
</GrantList>
<PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType>
<PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016449">Randomized Controlled Trial</PublicationType>
<PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2019</Year>
<Month>02</Month>
<Day>20</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>England</Country>
<MedlineTA>Arthritis Res Ther</MedlineTA>
<NlmUniqueID>101154438</NlmUniqueID>
<ISSNLinking>1478-6354</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList><Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D000893">Anti-Inflammatory Agents</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D061067">Antibodies, Monoclonal, Humanized</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>I031V2H011</RegistryNumber>
<NameOfSubstance UI="C502936">tocilizumab</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>VB0R961HZT</RegistryNumber>
<NameOfSubstance UI="D011241">Prednisone</NameOfSubstance>
</Chemical>
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<CitationSubset>IM</CitationSubset>
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</MeshHeading>
<MeshHeading><DescriptorName UI="D000893" MajorTopicYN="N">Anti-Inflammatory Agents</DescriptorName>
<QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName>
</MeshHeading>
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<MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D004359" MajorTopicYN="N">Drug Therapy, Combination</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D005221" MajorTopicYN="N">Fatigue</DescriptorName>
<QualifierName UI="Q000188" MajorTopicYN="N">drug therapy</QualifierName>
<QualifierName UI="Q000503" MajorTopicYN="N">physiopathology</QualifierName>
<QualifierName UI="Q000523" MajorTopicYN="N">psychology</QualifierName>
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<MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName>
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<MeshHeading><DescriptorName UI="D013700" MajorTopicYN="N">Giant Cell Arteritis</DescriptorName>
<QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName>
<QualifierName UI="Q000503" MajorTopicYN="N">physiopathology</QualifierName>
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<MeshHeading><DescriptorName UI="D006304" MajorTopicYN="Y">Health Status</DescriptorName>
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<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName>
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Health-related quality of life in patients with giant cell arteritis treated with tocilizumab in a phase 3 randomised controlled trial.

Health-related quality of life in patients with giant cell arteritis treated with tocilizumab in a phase 3 randomised controlled trial.

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