Safety and efficacy of ustekinumab or golimumab in patients with chronic sarcoidosis.
Identifieur interne : 001467 ( Main/Exploration ); précédent : 001466; suivant : 001468Safety and efficacy of ustekinumab or golimumab in patients with chronic sarcoidosis.
Auteurs : Marc A. Judson [États-Unis] ; Robert P. Baughman [États-Unis] ; Ulrich Costabel [Allemagne] ; Marjolein Drent [Pays-Bas] ; Kevin F. Gibson [États-Unis] ; Ganesh Raghu [États-Unis] ; Hidenobu Shigemitsu [États-Unis] ; Joseph B. Barney [États-Unis] ; Daniel A. Culver [États-Unis] ; Nabeel Y. Hamzeh [États-Unis] ; Marlies S. Wijsenbeek [Pays-Bas] ; Carlo Albera [Pays-Bas] ; Isham Huizar [États-Unis] ; Prasheen Agarwal [États-Unis] ; Carrie Brodmerkel [États-Unis] ; Rosemary Watt [États-Unis] ; Elliot S. Barnathan [États-Unis]Source :
- The European respiratory journal [ 1399-3003 ] ; 2014.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Anticorps monoclonaux (usage thérapeutique), Anticorps monoclonaux humanisés (usage thérapeutique), Antirhumatismaux (usage thérapeutique), Facteur de nécrose tumorale alpha (antagonistes et inhibiteurs), Femelle, Humains, Interleukine-12 (antagonistes et inhibiteurs), Interleukine-23 (antagonistes et inhibiteurs), Maladie chronique, Mâle, Méthode en double aveugle, Sarcoïdose (physiopathologie), Sarcoïdose (traitement médicamenteux), Ustékinumab.
- MESH :
- antagonistes et inhibiteurs : Facteur de nécrose tumorale alpha, Interleukine-12, Interleukine-23.
- physiopathologie : Sarcoïdose.
- traitement médicamenteux : Sarcoïdose.
- usage thérapeutique : Anticorps monoclonaux, Anticorps monoclonaux humanisés, Antirhumatismaux.
- Adulte, Adulte d'âge moyen, Femelle, Humains, Maladie chronique, Mâle, Méthode en double aveugle, Ustékinumab.
English descriptors
- KwdEn :
- Adult, Antibodies, Monoclonal (therapeutic use), Antibodies, Monoclonal, Humanized (therapeutic use), Antirheumatic Agents (therapeutic use), Chronic Disease, Double-Blind Method, Female, Humans, Interleukin-12 (antagonists & inhibitors), Interleukin-23 (antagonists & inhibitors), Male, Middle Aged, Sarcoidosis (drug therapy), Sarcoidosis (physiopathology), Tumor Necrosis Factor-alpha (antagonists & inhibitors), Ustekinumab.
- MESH :
- chemical , antagonists & inhibitors : Interleukin-12, Interleukin-23, Tumor Necrosis Factor-alpha.
- chemical , therapeutic use : Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antirheumatic Agents.
- drug therapy : Sarcoidosis.
- physiopathology : Sarcoidosis.
- Adult, Chronic Disease, Double-Blind Method, Female, Humans, Male, Middle Aged, Ustekinumab.
Abstract
Sarcoidosis is characterised by non-caseating granulomas that secrete pro-inflammatory cytokines, including interleukin (IL)-12, IL-23, and tumour necrosis factor (TNF)-α. Ustekinumab and golimumab are monoclonal antibodies that specifically inhibit IL-12/IL-23 and TNF-α, respectively. Patients with chronic pulmonary sarcoidosis (lung group) and/or skin sarcoidosis (skin group) received either 180 mg ustekinumab at week 0 followed by 90 mg every 8 weeks, 200 mg golimumab at week 0 followed by 100 mg every 4 weeks, or placebo. Patients underwent corticosteroid tapering between weeks 16 and 28. The primary end-point was week 16 change in percentage predicted forced vital capacity (ΔFVC % pred) in the lung group. Major secondary end-points were: week 28 for ΔFVC % pred, 6-min walking distance, St George's Respiratory Questionnaire (lung group), and Skin Physician Global Assessment response (skin group). At week 16, no significant differences were observed in ΔFVC % pred with ustekinumab (-0.15, p = 0.13) or golimumab (1.15, p = 0.54) compared with placebo (2.02). At week 28, there were no significant improvements in the major secondary end-points, although a nonsignificant numerically greater Skin Physician Global Assessment response was observed following golimumab treatment (53%) when compared with the placebo (30%). Serious adverse events were similar in all treatment groups. Although treatment was well tolerated, neither ustekinumab nor golimumab demonstrated efficacy in pulmonary sarcoidosis. However, trends towards improvement were observed with golimumab in some dermatological end-points.
DOI: 10.1183/09031936.00000914
PubMed: 25034562
Affiliations:
- Allemagne, Pays-Bas, États-Unis
- Alabama, Colorado, Hollande-Méridionale, Nevada, Ohio, Pennsylvanie, Texas, Washington (État), État de New York
- Los Angeles, Pittsburgh, Rotterdam, Seattle
- Université de Californie du Sud, Université de Pittsburgh, Université de Washington
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Le document en format XML
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Judson</name><affiliation wicri:level="2"><nlm:affiliation>Dept of Medicine, Albany Medical College, Albany, NY, USA judsonm@mail.amc.edu.</nlm:affiliation><country wicri:rule="url">États-Unis</country><wicri:regionArea>Dept of Medicine, Albany Medical College, Albany, NY</wicri:regionArea><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Baughman, Robert P" sort="Baughman, Robert P" uniqKey="Baughman R" first="Robert P" last="Baughman">Robert P. Baughman</name><affiliation wicri:level="2"><nlm:affiliation>Dept of Internal Medicine, University of Cincinnati Medical Center, Cincinnati, OH, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Dept of Internal Medicine, University of Cincinnati Medical Center, Cincinnati, OH</wicri:regionArea><placeName><region type="state">Ohio</region></placeName></affiliation></author><author><name sortKey="Costabel, Ulrich" sort="Costabel, Ulrich" uniqKey="Costabel U" first="Ulrich" last="Costabel">Ulrich Costabel</name><affiliation wicri:level="1"><nlm:affiliation>Ruhrlandklinik and University of Duisburg-Essen, Essen, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Ruhrlandklinik and University of Duisburg-Essen, Essen</wicri:regionArea><wicri:noRegion>Essen</wicri:noRegion><wicri:noRegion>Essen</wicri:noRegion><wicri:noRegion>Essen</wicri:noRegion></affiliation></author><author><name sortKey="Drent, Marjolein" sort="Drent, Marjolein" uniqKey="Drent M" first="Marjolein" last="Drent">Marjolein Drent</name><affiliation wicri:level="1"><nlm:affiliation>Dept of Interstitial Lung Diseases, Gelderse Vallei Hospital, Ede, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Dept of Interstitial Lung Diseases, Gelderse Vallei Hospital, Ede</wicri:regionArea><wicri:noRegion>Ede</wicri:noRegion></affiliation></author><author><name sortKey="Gibson, Kevin F" sort="Gibson, Kevin F" uniqKey="Gibson K" first="Kevin F" last="Gibson">Kevin F. Gibson</name><affiliation wicri:level="4"><nlm:affiliation>Division of Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh, Pittsburgh, PA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Division of Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh, Pittsburgh, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region><settlement type="city">Pittsburgh</settlement></placeName><orgName type="university">Université de Pittsburgh</orgName></affiliation></author><author><name sortKey="Raghu, Ganesh" sort="Raghu, Ganesh" uniqKey="Raghu G" first="Ganesh" last="Raghu">Ganesh Raghu</name><affiliation wicri:level="4"><nlm:affiliation>Division of Pulmonary and Critical Care Medicine, University of Washington, Seattle, WA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Division of Pulmonary and Critical Care Medicine, University of Washington, Seattle, WA</wicri:regionArea><placeName><region type="state">Washington (État)</region><settlement type="city">Seattle</settlement></placeName><orgName type="university">Université de Washington</orgName></affiliation></author><author><name sortKey="Shigemitsu, Hidenobu" sort="Shigemitsu, Hidenobu" uniqKey="Shigemitsu H" first="Hidenobu" last="Shigemitsu">Hidenobu Shigemitsu</name><affiliation wicri:level="4"><nlm:affiliation>University of Southern California, Los Angeles, CA, USA Division of Pulmonary and Critical Care Medicine, University of Nevada School of Medicine, Las Vegas, NV, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Southern California, Los Angeles, CA, USA Division of Pulmonary and Critical Care Medicine, University of Nevada School of Medicine, Las Vegas, NV</wicri:regionArea><placeName><region type="state">Nevada</region><settlement type="city">Los Angeles</settlement></placeName><orgName type="university">Université de Californie du Sud</orgName></affiliation></author><author><name sortKey="Barney, Joseph B" sort="Barney, Joseph B" uniqKey="Barney J" first="Joseph B" last="Barney">Joseph B. Barney</name><affiliation wicri:level="2"><nlm:affiliation>Pulmonary and Critical Care Medicine, University of Alabama, Birmingham, AL, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Pulmonary and Critical Care Medicine, University of Alabama, Birmingham, AL</wicri:regionArea><placeName><region type="state">Alabama</region></placeName></affiliation></author><author><name sortKey="Culver, Daniel A" sort="Culver, Daniel A" uniqKey="Culver D" first="Daniel A" last="Culver">Daniel A. Culver</name><affiliation wicri:level="2"><nlm:affiliation>Pulmonary, Allergy and Critical Care Medicine, Cleveland Clinic Foundation, Cleveland, OH, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Pulmonary, Allergy and Critical Care Medicine, Cleveland Clinic Foundation, Cleveland, OH</wicri:regionArea><placeName><region type="state">Ohio</region></placeName></affiliation></author><author><name sortKey="Hamzeh, Nabeel Y" sort="Hamzeh, Nabeel Y" uniqKey="Hamzeh N" first="Nabeel Y" last="Hamzeh">Nabeel Y. Hamzeh</name><affiliation wicri:level="2"><nlm:affiliation>Dept of Medicine, National Jewish Health, Denver, CO, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Dept of Medicine, National Jewish Health, Denver, CO</wicri:regionArea><placeName><region type="state">Colorado</region></placeName></affiliation></author><author><name sortKey="Wijsenbeek, Marlies S" sort="Wijsenbeek, Marlies S" uniqKey="Wijsenbeek M" first="Marlies S" last="Wijsenbeek">Marlies S. Wijsenbeek</name><affiliation wicri:level="3"><nlm:affiliation>Dept of Pulmonary Disease, Erasmus MC, University Hospital Rotterdam, Rotterdam, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Dept of Pulmonary Disease, Erasmus MC, University Hospital Rotterdam, Rotterdam</wicri:regionArea><placeName><settlement type="city">Rotterdam</settlement><region nuts="2" type="province">Hollande-Méridionale</region></placeName></affiliation></author><author><name sortKey="Albera, Carlo" sort="Albera, Carlo" uniqKey="Albera C" first="Carlo" last="Albera">Carlo Albera</name><affiliation wicri:level="3"><nlm:affiliation>Dept of Pulmonary Medicine, Erasmus Medical Centre, University Hospital Rotterdam, Rotterdam, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Dept of Pulmonary Medicine, Erasmus Medical Centre, University Hospital Rotterdam, Rotterdam</wicri:regionArea><placeName><settlement type="city">Rotterdam</settlement><region nuts="2" type="province">Hollande-Méridionale</region></placeName></affiliation></author><author><name sortKey="Huizar, Isham" sort="Huizar, Isham" uniqKey="Huizar I" first="Isham" last="Huizar">Isham Huizar</name><affiliation wicri:level="2"><nlm:affiliation>Dept of Medicine, Texas Tech University Health Science Center, Lubbock, TX, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Dept of Medicine, Texas Tech University Health Science Center, Lubbock, TX</wicri:regionArea><placeName><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Agarwal, Prasheen" sort="Agarwal, Prasheen" uniqKey="Agarwal P" first="Prasheen" last="Agarwal">Prasheen Agarwal</name><affiliation wicri:level="2"><nlm:affiliation>Biostatistics, Janssen Research and Development, LLC, Spring House, PA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Biostatistics, Janssen Research and Development, LLC, Spring House, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Brodmerkel, Carrie" sort="Brodmerkel, Carrie" uniqKey="Brodmerkel C" first="Carrie" last="Brodmerkel">Carrie Brodmerkel</name><affiliation wicri:level="2"><nlm:affiliation>Immunology Biomarkers, Janssen Research and Development, LLC, Spring House, PA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Immunology Biomarkers, Janssen Research and Development, LLC, Spring House, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Watt, Rosemary" sort="Watt, Rosemary" uniqKey="Watt R" first="Rosemary" last="Watt">Rosemary Watt</name><affiliation wicri:level="2"><nlm:affiliation>Immunology, Janssen Research and Development, LLC, Spring House, PA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Immunology, Janssen Research and Development, LLC, Spring House, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Barnathan, Elliot S" sort="Barnathan, Elliot S" uniqKey="Barnathan E" first="Elliot S" last="Barnathan">Elliot S. Barnathan</name><affiliation wicri:level="2"><nlm:affiliation>Immunology, Janssen Research and Development, LLC, Spring House, PA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Immunology, Janssen Research and Development, LLC, Spring House, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author></analytic><series><title level="j">The European respiratory journal</title><idno type="eISSN">1399-3003</idno><imprint><date when="2014" type="published">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Antibodies, Monoclonal (therapeutic use)</term><term>Antibodies, Monoclonal, Humanized (therapeutic use)</term><term>Antirheumatic Agents (therapeutic use)</term><term>Chronic Disease</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Interleukin-12 (antagonists & inhibitors)</term><term>Interleukin-23 (antagonists & inhibitors)</term><term>Male</term><term>Middle Aged</term><term>Sarcoidosis (drug therapy)</term><term>Sarcoidosis (physiopathology)</term><term>Tumor Necrosis Factor-alpha (antagonists & inhibitors)</term><term>Ustekinumab</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Anticorps monoclonaux (usage thérapeutique)</term><term>Anticorps monoclonaux humanisés (usage thérapeutique)</term><term>Antirhumatismaux (usage thérapeutique)</term><term>Facteur de nécrose tumorale alpha (antagonistes et inhibiteurs)</term><term>Femelle</term><term>Humains</term><term>Interleukine-12 (antagonistes et inhibiteurs)</term><term>Interleukine-23 (antagonistes et inhibiteurs)</term><term>Maladie chronique</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Sarcoïdose (physiopathologie)</term><term>Sarcoïdose (traitement médicamenteux)</term><term>Ustékinumab</term></keywords><keywords scheme="MESH" type="chemical" qualifier="antagonists & inhibitors" xml:lang="en"><term>Interleukin-12</term><term>Interleukin-23</term><term>Tumor Necrosis Factor-alpha</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antibodies, Monoclonal</term><term>Antibodies, Monoclonal, Humanized</term><term>Antirheumatic Agents</term></keywords><keywords scheme="MESH" qualifier="antagonistes et inhibiteurs" xml:lang="fr"><term>Facteur de nécrose tumorale alpha</term><term>Interleukine-12</term><term>Interleukine-23</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Sarcoidosis</term></keywords><keywords scheme="MESH" qualifier="physiopathologie" xml:lang="fr"><term>Sarcoïdose</term></keywords><keywords scheme="MESH" qualifier="physiopathology" xml:lang="en"><term>Sarcoidosis</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Sarcoïdose</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Anticorps monoclonaux</term><term>Anticorps monoclonaux humanisés</term><term>Antirhumatismaux</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Chronic Disease</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Ustekinumab</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Femelle</term><term>Humains</term><term>Maladie chronique</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Ustékinumab</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Sarcoidosis is characterised by non-caseating granulomas that secrete pro-inflammatory cytokines, including interleukin (IL)-12, IL-23, and tumour necrosis factor (TNF)-α. Ustekinumab and golimumab are monoclonal antibodies that specifically inhibit IL-12/IL-23 and TNF-α, respectively. Patients with chronic pulmonary sarcoidosis (lung group) and/or skin sarcoidosis (skin group) received either 180 mg ustekinumab at week 0 followed by 90 mg every 8 weeks, 200 mg golimumab at week 0 followed by 100 mg every 4 weeks, or placebo. Patients underwent corticosteroid tapering between weeks 16 and 28. The primary end-point was week 16 change in percentage predicted forced vital capacity (ΔFVC % pred) in the lung group. Major secondary end-points were: week 28 for ΔFVC % pred, 6-min walking distance, St George's Respiratory Questionnaire (lung group), and Skin Physician Global Assessment response (skin group). At week 16, no significant differences were observed in ΔFVC % pred with ustekinumab (-0.15, p = 0.13) or golimumab (1.15, p = 0.54) compared with placebo (2.02). At week 28, there were no significant improvements in the major secondary end-points, although a nonsignificant numerically greater Skin Physician Global Assessment response was observed following golimumab treatment (53%) when compared with the placebo (30%). Serious adverse events were similar in all treatment groups. Although treatment was well tolerated, neither ustekinumab nor golimumab demonstrated efficacy in pulmonary sarcoidosis. However, trends towards improvement were observed with golimumab in some dermatological end-points.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Pays-Bas</li><li>États-Unis</li></country><region><li>Alabama</li><li>Colorado</li><li>Hollande-Méridionale</li><li>Nevada</li><li>Ohio</li><li>Pennsylvanie</li><li>Texas</li><li>Washington (État)</li><li>État de New York</li></region><settlement><li>Los Angeles</li><li>Pittsburgh</li><li>Rotterdam</li><li>Seattle</li></settlement><orgName><li>Université de Californie du Sud</li><li>Université de Pittsburgh</li><li>Université de Washington</li></orgName></list><tree><country name="États-Unis"><region name="État de New York"><name sortKey="Judson, Marc A" sort="Judson, Marc A" uniqKey="Judson M" first="Marc A" last="Judson">Marc A. Judson</name></region><name sortKey="Agarwal, Prasheen" sort="Agarwal, Prasheen" uniqKey="Agarwal P" first="Prasheen" last="Agarwal">Prasheen Agarwal</name><name sortKey="Barnathan, Elliot S" sort="Barnathan, Elliot S" uniqKey="Barnathan E" first="Elliot S" last="Barnathan">Elliot S. Barnathan</name><name sortKey="Barney, Joseph B" sort="Barney, Joseph B" uniqKey="Barney J" first="Joseph B" last="Barney">Joseph B. Barney</name><name sortKey="Baughman, Robert P" sort="Baughman, Robert P" uniqKey="Baughman R" first="Robert P" last="Baughman">Robert P. Baughman</name><name sortKey="Brodmerkel, Carrie" sort="Brodmerkel, Carrie" uniqKey="Brodmerkel C" first="Carrie" last="Brodmerkel">Carrie Brodmerkel</name><name sortKey="Culver, Daniel A" sort="Culver, Daniel A" uniqKey="Culver D" first="Daniel A" last="Culver">Daniel A. Culver</name><name sortKey="Gibson, Kevin F" sort="Gibson, Kevin F" uniqKey="Gibson K" first="Kevin F" last="Gibson">Kevin F. Gibson</name><name sortKey="Hamzeh, Nabeel Y" sort="Hamzeh, Nabeel Y" uniqKey="Hamzeh N" first="Nabeel Y" last="Hamzeh">Nabeel Y. Hamzeh</name><name sortKey="Huizar, Isham" sort="Huizar, Isham" uniqKey="Huizar I" first="Isham" last="Huizar">Isham Huizar</name><name sortKey="Raghu, Ganesh" sort="Raghu, Ganesh" uniqKey="Raghu G" first="Ganesh" last="Raghu">Ganesh Raghu</name><name sortKey="Shigemitsu, Hidenobu" sort="Shigemitsu, Hidenobu" uniqKey="Shigemitsu H" first="Hidenobu" last="Shigemitsu">Hidenobu Shigemitsu</name><name sortKey="Watt, Rosemary" sort="Watt, Rosemary" uniqKey="Watt R" first="Rosemary" last="Watt">Rosemary Watt</name></country><country name="Allemagne"><noRegion><name sortKey="Costabel, Ulrich" sort="Costabel, Ulrich" uniqKey="Costabel U" first="Ulrich" last="Costabel">Ulrich Costabel</name></noRegion></country><country name="Pays-Bas"><noRegion><name sortKey="Drent, Marjolein" sort="Drent, Marjolein" uniqKey="Drent M" first="Marjolein" last="Drent">Marjolein Drent</name></noRegion><name sortKey="Albera, Carlo" sort="Albera, Carlo" uniqKey="Albera C" first="Carlo" last="Albera">Carlo Albera</name><name sortKey="Wijsenbeek, Marlies S" sort="Wijsenbeek, Marlies S" uniqKey="Wijsenbeek M" first="Marlies S" last="Wijsenbeek">Marlies S. 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