Evaluation of the Disease Activity Score in Twenty‐Eight Joints–Based Flare Definitions in Rheumatoid Arthritis: Data From a Three‐Year Clinical Trial
Identifieur interne : 002028 ( Main/Exploration ); précédent : 002027; suivant : 002029Evaluation of the Disease Activity Score in Twenty‐Eight Joints–Based Flare Definitions in Rheumatoid Arthritis: Data From a Three‐Year Clinical Trial
Auteurs : Maxime Dougados ; Tom W. J. Huizinga ; Ernest H. Choy ; Clifton O. Bingham ; Maher Aassi ; Corrado BernasconiSource :
- Arthritis Care & Research [ 2151-464X ] ; 2015.
Descripteurs français
- KwdFr :
- Anticorps monoclonaux humanisés (administration et posologie), Antirhumatismaux (administration et posologie), Articulations (), Articulations (anatomopathologie), Asie, Association de médicaments, Calendrier d'administration des médicaments, Europe, Facteurs temps, Humains, Indice de gravité médicale, Induction de rémission, Méthode en double aveugle, Méthotrexate (administration et posologie), Polyarthrite rhumatoïde (diagnostic), Polyarthrite rhumatoïde (traitement médicamenteux), Produits biologiques (administration et posologie), Résultat thérapeutique, Substitution de médicament, Valeur prédictive des tests, États-Unis d'Amérique, Évolution de la maladie.
- MESH :
- administration et posologie : Anticorps monoclonaux humanisés, Antirhumatismaux, Méthotrexate, Produits biologiques.
- anatomopathologie : Articulations.
- diagnostic : Polyarthrite rhumatoïde.
- traitement médicamenteux : Polyarthrite rhumatoïde.
- Articulations, Asie, Association de médicaments, Calendrier d'administration des médicaments, Europe, Facteurs temps, Humains, Indice de gravité médicale, Induction de rémission, Méthode en double aveugle, Résultat thérapeutique, Substitution de médicament, Valeur prédictive des tests, États-Unis d'Amérique, Évolution de la maladie.
English descriptors
- KwdEn :
- Antibodies, Monoclonal, Humanized (administration & dosage), Antirheumatic Agents (administration & dosage), Arthritis, Rheumatoid (diagnosis), Arthritis, Rheumatoid (drug therapy), Asia, Biological Products (administration & dosage), Disease Progression, Double-Blind Method, Drug Administration Schedule, Drug Substitution, Drug Therapy, Combination, Europe, Humans, Joints (drug effects), Joints (pathology), Methotrexate (administration & dosage), Predictive Value of Tests, Remission Induction, Severity of Illness Index, Time Factors, Treatment Outcome, United States.
- MESH :
- chemical , administration & dosage : Antibodies, Monoclonal, Humanized, Antirheumatic Agents, Biological Products, Methotrexate.
- diagnosis : Arthritis, Rheumatoid.
- drug effects : Joints.
- drug therapy : Arthritis, Rheumatoid.
- pathology : Joints.
- Asia, Disease Progression, Double-Blind Method, Drug Administration Schedule, Drug Substitution, Drug Therapy, Combination, Europe, Humans, Predictive Value of Tests, Remission Induction, Severity of Illness Index, Time Factors, Treatment Outcome, United States.
Abstract
To assess the flare rate using published criteria (Disease Activity Score in 28 joints [DAS28‐2] increase between visits of >1.2 or >0.6 if current DAS28 ≥3.2) in patients receiving constant treatment, and to compare published flare criteria to criteria used by study investigators after biologic treatment discontinuation in the ACT‐RAY study.
Patients with rheumatoid arthritis (n = 553) were randomized to add tocilizumab to ongoing methotrexate, or switch to tocilizumab plus placebo. If DAS28 ≤3.2 occurred at week 24, treatment remained constant until week 52; here we assessed the DAS28‐2 flare rate. Between weeks 52 and 104, patients in sustained remission (DAS28 <2.6 at 2 consecutive visits 12 weeks apart) discontinued tocilizumab and were assessed every 4 weeks. Per protocol, flare was defined as a worsening of disease activity that required treatment beyond the permitted therapy based on investigator opinions (investigator flare) and was compared with the DAS28‐2 definition.
After tocilizumab discontinuation, DAS28‐2 was sensitive (88–100%), but not specific (57–65%), for detecting investigator flare. Under constant treatment, DAS28‐2 criteria were met in 136 cases per 100 patient‐years despite stable disease activity. Sustained flares were infrequent. Other DAS28‐based criteria led to similar conclusions.
DAS28‐based flare occurred more often than investigator‐defined flares after biologic agent discontinuation. More stringent criteria may be more appropriate for clinical practice.
Url:
DOI: 10.1002/acr.22633
PubMed: 26037777
PubMed Central: 5132117
Affiliations:
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Le document en format XML
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(diagnosis)</term><term>Arthritis, Rheumatoid (drug therapy)</term><term>Asia</term><term>Biological Products (administration & dosage)</term><term>Disease Progression</term><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Drug Substitution</term><term>Drug Therapy, Combination</term><term>Europe</term><term>Humans</term><term>Joints (drug effects)</term><term>Joints (pathology)</term><term>Methotrexate (administration & dosage)</term><term>Predictive Value of Tests</term><term>Remission Induction</term><term>Severity of Illness Index</term><term>Time Factors</term><term>Treatment Outcome</term><term>United States</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Anticorps monoclonaux humanisés (administration et posologie)</term><term>Antirhumatismaux (administration et posologie)</term><term>Articulations ()</term><term>Articulations (anatomopathologie)</term><term>Asie</term><term>Association de médicaments</term><term>Calendrier 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id="acr22633-sec-0001"><title>Objective</title><p>To assess the flare rate using published criteria (Disease Activity Score in 28 joints [DAS28‐2] increase between visits of >1.2 or >0.6 if current DAS28 ≥3.2) in patients receiving constant treatment, and to compare published flare criteria to criteria used by study investigators after biologic treatment discontinuation in the ACT‐RAY study.</p></sec><sec id="acr22633-sec-0002"><title>Methods</title><p>Patients with rheumatoid arthritis (n = 553) were randomized to add tocilizumab to ongoing methotrexate, or switch to tocilizumab plus placebo. If DAS28 ≤3.2 occurred at week 24, treatment remained constant until week 52; here we assessed the DAS28‐2 flare rate. Between weeks 52 and 104, patients in sustained remission (DAS28 <2.6 at 2 consecutive visits 12 weeks apart) discontinued tocilizumab and were assessed every 4 weeks. Per protocol, flare was defined as a worsening of disease activity that required treatment beyond the permitted therapy based on investigator opinions (investigator flare) and was compared with the DAS28‐2 definition.</p></sec><sec id="acr22633-sec-0003"><title>Results</title><p>After tocilizumab discontinuation, DAS28‐2 was sensitive (88–100%), but not specific (57–65%), for detecting investigator flare. Under constant treatment, DAS28‐2 criteria were met in 136 cases per 100 patient‐years despite stable disease activity. Sustained flares were infrequent. Other DAS28‐based criteria led to similar conclusions.</p></sec><sec id="acr22633-sec-0004"><title>Conclusion</title><p>DAS28‐based flare occurred more often than investigator‐defined flares after biologic agent discontinuation. More stringent criteria may be more appropriate for clinical practice.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><affiliations><list></list><tree><noCountry><name sortKey="Aassi, Maher" sort="Aassi, Maher" uniqKey="Aassi M" first="Maher" last="Aassi">Maher Aassi</name><name sortKey="Bernasconi, Corrado" sort="Bernasconi, Corrado" uniqKey="Bernasconi C" first="Corrado" last="Bernasconi">Corrado Bernasconi</name><name sortKey="Bingham, Clifton O" sort="Bingham, Clifton O" uniqKey="Bingham C" first="Clifton O." last="Bingham">Clifton O. Bingham</name><name sortKey="Choy, Ernest H" sort="Choy, Ernest H" uniqKey="Choy E" first="Ernest H." last="Choy">Ernest H. Choy</name><name sortKey="Dougados, Maxime" sort="Dougados, Maxime" uniqKey="Dougados M" first="Maxime" last="Dougados">Maxime Dougados</name><name sortKey="Huizinga, Tom W J" sort="Huizinga, Tom W J" uniqKey="Huizinga T" first="Tom W. J." last="Huizinga">Tom W. J. Huizinga</name></noCountry></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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