FRI0377 Early response to treatment is a surrogate marker of flare recurrence in acute gouty arthritis
Identifieur interne : 004A63 ( Main/Exploration ); précédent : 004A62; suivant : 004A64FRI0377 Early response to treatment is a surrogate marker of flare recurrence in acute gouty arthritis
Auteurs : A. So [Suisse] ; T. Bardin [France] ; M. Bloch [Australie] ; A. Shpilsky [États-Unis] ; T. Kiechle [Suisse] ; N. Schlesinger [États-Unis]Source :
- Annals of the Rheumatic Diseases [ 0003-4967 ] ; 2013-06.
Descripteurs français
- Wicri :
- topic : Vitamine.
English descriptors
- KwdEn :
- Academic rheumatology, Clinical characteristics, Clinical practice, Commonest site, Dosing acceleration, Family history, Family practitioners, Fracture, Gout, Gout management, Gout patients, Gouty patients, Health sciences research institute, Kingdom background, Knee injury, Knee involvement, Knee radiographs, Lifestyle study, National sample, Novartis, Osteogenesis imperfecta, Other joints, Overall prevalence, Pain reduction, Pharmaceutical, Practitioner, Primary care providers, Provider, Pubis, Radiograph, Risk factors, Serum urate level, Shorter disease duration, Soft drinks, Speakers bureau, States background, Surrogate marker, Symphysis, Symphysis pubis, Takeda, Takeda pharmaceuticals, Tophaceous gout, Total number, Treatment practices, Vast majority, Vitamin, Waist circumference.
- Teeft :
- Academic rheumatology, Clinical characteristics, Clinical practice, Commonest site, Dosing acceleration, Family history, Family practitioners, Fracture, Gout, Gout management, Gout patients, Gouty patients, Health sciences research institute, Kingdom background, Knee injury, Knee involvement, Knee radiographs, Lifestyle study, National sample, Novartis, Osteogenesis imperfecta, Other joints, Overall prevalence, Pain reduction, Pharmaceutical, Practitioner, Primary care providers, Provider, Pubis, Radiograph, Risk factors, Serum urate level, Shorter disease duration, Soft drinks, Speakers bureau, States background, Surrogate marker, Symphysis, Symphysis pubis, Takeda, Takeda pharmaceuticals, Tophaceous gout, Total number, Treatment practices, Vast majority, Vitamin, Waist circumference.
Abstract
Background Canakinumab, a fully human anti-IL-1β monoclonal antibody, selectively targets IL-1β and may be an alternative treatment to NSAIDs or colchicine in patients (pts) presenting with acute gouty arthritis (GA), in whom standard care is inappropriate or ineffective. The ideal qualities of such a treatment should include fast and potent pain relief and reduction of the risk of a new flare. When treating pts with biologic therapy, it is important to develop criteria for response-guided retreatment decisions to reduce risk of futile treatment and potential exposure to an unnecessary safety risk. Objectives To explore the rapidity of response to treatment, defined as ≥50% pain reduction within 7 days, as a potential surrogate marker of time to new flare. Methods A good concordance between prevention of flare and 50% pain reduction on a 0-100 mm visual analogue scale (VAS) was detected in a retrospective pooled analysis of two 12-week studies (β-RELIEVED, N=230; β-RELIEVED-II, N=226) in pts treated with a single dose of canakinumab 150mg sc or triamcinolone acetonide (TA) 40 mg im. The 12-week extension studies allowed evaluation of early pain response as a predictor of delay to new flare. The predictive value of the response was studied using a Cox model with response as a time-dependent covariate and the number of flares in the previous year as baseline predictor. Results 50% pain reduction within 7 days of treatment was confirmed to be a highly significant predictor of time to new flare (p<0.0001). The hazard ratio for responders vs non-responders was 0.47 (95% CI, 0.32 – 0.67). The baseline number of flares was also significant (p=0.0011) confirming the temporal aspect of disease severity as intensity of recurrent disease. A similar result was obtained for time from response (or Day 7 for non-responders) to new flare using Kaplan-Meier technique (log-rank test, p<0.0001) with median time 100 days for non-responder and non-estimable yet for responders within 6 month study (Figure). Figure 1. Time to first new flare (Kaplan-Meier estimate). Conclusions These results demonstrate that a 50% pain reduction by VAS within 7 days of treatment in acute GA pts is associated with delay of new flare and can be used as a surrogate marker of time to new flare. Disclosure of Interest A. So Grant/Research support from: Novartis, Consultant for: Novartis, Ardea, Speakers Bureau: Novartis, Ardea, Menarini, T. Bardin Grant/Research support from: Menarini, Consultant for: Novartis, Ipsen, Menarini, Ardea, Biocryst, M. Bloch Grant/Research support from: Novartis, A. Shpilsky Shareholder of: Novartis, Employee of: Novartis, T. Kiechle Shareholder of: Novartis, Employee of: Novartis, N. Schlesinger Grant/Research support from: Novartis, Consultant for: Novartis, URL Pharma, Savient, Takeda, Rx Ensyme, Speakers Bureau: Takeda, Savient, Novartis
Url:
DOI: 10.1136/annrheumdis-2012-eular.2834
Affiliations:
- Australie, France, Suisse, États-Unis
- Canton de Vaud, New Jersey, Nouvelle-Galles du Sud, Île-de-France
- Lausanne, Paris, Sydney
Links toward previous steps (curation, corpus...)
- to stream Istex, to step Corpus: 002C66
- to stream Istex, to step Curation: 002C66
- to stream Istex, to step Checkpoint: 000373
- to stream Main, to step Merge: 004B87
- to stream Main, to step Curation: 004A63
Le document en format XML
<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">FRI0377 Early response to treatment is a surrogate marker of flare recurrence in acute gouty arthritis</title>
<author><name sortKey="So, A" sort="So, A" uniqKey="So A" first="A." last="So">A. So</name>
</author>
<author><name sortKey="Bardin, T" sort="Bardin, T" uniqKey="Bardin T" first="T." last="Bardin">T. Bardin</name>
</author>
<author><name sortKey="Bloch, M" sort="Bloch, M" uniqKey="Bloch M" first="M." last="Bloch">M. Bloch</name>
</author>
<author><name sortKey="Shpilsky, A" sort="Shpilsky, A" uniqKey="Shpilsky A" first="A." last="Shpilsky">A. Shpilsky</name>
</author>
<author><name sortKey="Kiechle, T" sort="Kiechle, T" uniqKey="Kiechle T" first="T." last="Kiechle">T. Kiechle</name>
</author>
<author><name sortKey="Schlesinger, N" sort="Schlesinger, N" uniqKey="Schlesinger N" first="N." last="Schlesinger">N. Schlesinger</name>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">ISTEX</idno>
<idno type="RBID">ISTEX:EC878942AF999586A4CCCC1C215D1D54D815D647</idno>
<date when="2013" year="2013">2013</date>
<idno type="doi">10.1136/annrheumdis-2012-eular.2834</idno>
<idno type="url">https://api.istex.fr/document/EC878942AF999586A4CCCC1C215D1D54D815D647/fulltext/pdf</idno>
<idno type="wicri:Area/Istex/Corpus">002C66</idno>
<idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Corpus" wicri:corpus="ISTEX">002C66</idno>
<idno type="wicri:Area/Istex/Curation">002C66</idno>
<idno type="wicri:Area/Istex/Checkpoint">000373</idno>
<idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Checkpoint">000373</idno>
<idno type="wicri:doubleKey">0003-4967:2013:So A:fri:early:response</idno>
<idno type="wicri:Area/Main/Merge">004B87</idno>
<idno type="wicri:Area/Main/Curation">004A63</idno>
<idno type="wicri:Area/Main/Exploration">004A63</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">FRI0377 Early response to treatment is a surrogate marker of flare recurrence in acute gouty arthritis</title>
<author><name sortKey="So, A" sort="So, A" uniqKey="So A" first="A." last="So">A. So</name>
<affiliation wicri:level="3"><country xml:lang="fr">Suisse</country>
<wicri:regionArea>CHUV, University of Lausanne, Lausanne</wicri:regionArea>
<placeName><settlement type="city">Lausanne</settlement>
<region nuts="3" type="region">Canton de Vaud</region>
</placeName>
</affiliation>
<affiliation wicri:level="3"><country xml:lang="fr">Suisse</country>
<wicri:regionArea>CHUV, University of Lausanne, Lausanne</wicri:regionArea>
<placeName><settlement type="city">Lausanne</settlement>
<region nuts="3" type="region">Canton de Vaud</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Bardin, T" sort="Bardin, T" uniqKey="Bardin T" first="T." last="Bardin">T. Bardin</name>
<affiliation wicri:level="3"><country xml:lang="fr">France</country>
<wicri:regionArea>Hôpital Lariboisière, Paris</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="3"><country xml:lang="fr">France</country>
<wicri:regionArea>Hôpital Lariboisière, Paris</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Bloch, M" sort="Bloch, M" uniqKey="Bloch M" first="M." last="Bloch">M. Bloch</name>
<affiliation wicri:level="3"><country xml:lang="fr">Australie</country>
<wicri:regionArea>Holdsworth House Medical Practice, Sydney</wicri:regionArea>
<placeName><settlement type="city">Sydney</settlement>
<region type="état">Nouvelle-Galles du Sud</region>
</placeName>
</affiliation>
<affiliation wicri:level="3"><country xml:lang="fr">Australie</country>
<wicri:regionArea>Holdsworth House Medical Practice, Sydney</wicri:regionArea>
<placeName><settlement type="city">Sydney</settlement>
<region type="état">Nouvelle-Galles du Sud</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Shpilsky, A" sort="Shpilsky, A" uniqKey="Shpilsky A" first="A." last="Shpilsky">A. Shpilsky</name>
<affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Novartis Pharmaceuticals Corporation, New Jersey</wicri:regionArea>
<placeName><region type="state">New Jersey</region>
</placeName>
</affiliation>
<affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Novartis Pharmaceuticals Corporation, New Jersey</wicri:regionArea>
<placeName><region type="state">New Jersey</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Kiechle, T" sort="Kiechle, T" uniqKey="Kiechle T" first="T." last="Kiechle">T. Kiechle</name>
<affiliation wicri:level="1"><country xml:lang="fr">Suisse</country>
<wicri:regionArea>Novartis Pharma AG, Basel</wicri:regionArea>
<wicri:noRegion>Basel</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><country xml:lang="fr">Suisse</country>
<wicri:regionArea>Novartis Pharma AG, Basel</wicri:regionArea>
<wicri:noRegion>Basel</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Schlesinger, N" sort="Schlesinger, N" uniqKey="Schlesinger N" first="N." last="Schlesinger">N. Schlesinger</name>
<affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Umdnj-Rwjms, New Jersey</wicri:regionArea>
<placeName><region type="state">New Jersey</region>
</placeName>
</affiliation>
<affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Umdnj-Rwjms, New Jersey</wicri:regionArea>
<placeName><region type="state">New Jersey</region>
</placeName>
</affiliation>
</author>
</analytic>
<monogr></monogr>
<series><title level="j">Annals of the Rheumatic Diseases</title>
<title level="j" type="abbrev">Ann Rheum Dis</title>
<idno type="ISSN">0003-4967</idno>
<idno type="eISSN">1468-2060</idno>
<imprint><publisher>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher>
<date type="published" when="2013-06">2013-06</date>
<biblScope unit="volume">71</biblScope>
<biblScope unit="issue">Suppl 3</biblScope>
<biblScope unit="page" from="441">441</biblScope>
</imprint>
<idno type="ISSN">0003-4967</idno>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><idno type="ISSN">0003-4967</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Academic rheumatology</term>
<term>Clinical characteristics</term>
<term>Clinical practice</term>
<term>Commonest site</term>
<term>Dosing acceleration</term>
<term>Family history</term>
<term>Family practitioners</term>
<term>Fracture</term>
<term>Gout</term>
<term>Gout management</term>
<term>Gout patients</term>
<term>Gouty patients</term>
<term>Health sciences research institute</term>
<term>Kingdom background</term>
<term>Knee injury</term>
<term>Knee involvement</term>
<term>Knee radiographs</term>
<term>Lifestyle study</term>
<term>National sample</term>
<term>Novartis</term>
<term>Osteogenesis imperfecta</term>
<term>Other joints</term>
<term>Overall prevalence</term>
<term>Pain reduction</term>
<term>Pharmaceutical</term>
<term>Practitioner</term>
<term>Primary care providers</term>
<term>Provider</term>
<term>Pubis</term>
<term>Radiograph</term>
<term>Risk factors</term>
<term>Serum urate level</term>
<term>Shorter disease duration</term>
<term>Soft drinks</term>
<term>Speakers bureau</term>
<term>States background</term>
<term>Surrogate marker</term>
<term>Symphysis</term>
<term>Symphysis pubis</term>
<term>Takeda</term>
<term>Takeda pharmaceuticals</term>
<term>Tophaceous gout</term>
<term>Total number</term>
<term>Treatment practices</term>
<term>Vast majority</term>
<term>Vitamin</term>
<term>Waist circumference</term>
</keywords>
<keywords scheme="Teeft" xml:lang="en"><term>Academic rheumatology</term>
<term>Clinical characteristics</term>
<term>Clinical practice</term>
<term>Commonest site</term>
<term>Dosing acceleration</term>
<term>Family history</term>
<term>Family practitioners</term>
<term>Fracture</term>
<term>Gout</term>
<term>Gout management</term>
<term>Gout patients</term>
<term>Gouty patients</term>
<term>Health sciences research institute</term>
<term>Kingdom background</term>
<term>Knee injury</term>
<term>Knee involvement</term>
<term>Knee radiographs</term>
<term>Lifestyle study</term>
<term>National sample</term>
<term>Novartis</term>
<term>Osteogenesis imperfecta</term>
<term>Other joints</term>
<term>Overall prevalence</term>
<term>Pain reduction</term>
<term>Pharmaceutical</term>
<term>Practitioner</term>
<term>Primary care providers</term>
<term>Provider</term>
<term>Pubis</term>
<term>Radiograph</term>
<term>Risk factors</term>
<term>Serum urate level</term>
<term>Shorter disease duration</term>
<term>Soft drinks</term>
<term>Speakers bureau</term>
<term>States background</term>
<term>Surrogate marker</term>
<term>Symphysis</term>
<term>Symphysis pubis</term>
<term>Takeda</term>
<term>Takeda pharmaceuticals</term>
<term>Tophaceous gout</term>
<term>Total number</term>
<term>Treatment practices</term>
<term>Vast majority</term>
<term>Vitamin</term>
<term>Waist circumference</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Vitamine</term>
</keywords>
</textClass>
<langUsage><language ident="en">en</language>
</langUsage>
</profileDesc>
</teiHeader>
<front><div type="abstract">Background Canakinumab, a fully human anti-IL-1β monoclonal antibody, selectively targets IL-1β and may be an alternative treatment to NSAIDs or colchicine in patients (pts) presenting with acute gouty arthritis (GA), in whom standard care is inappropriate or ineffective. The ideal qualities of such a treatment should include fast and potent pain relief and reduction of the risk of a new flare. When treating pts with biologic therapy, it is important to develop criteria for response-guided retreatment decisions to reduce risk of futile treatment and potential exposure to an unnecessary safety risk. Objectives To explore the rapidity of response to treatment, defined as ≥50% pain reduction within 7 days, as a potential surrogate marker of time to new flare. Methods A good concordance between prevention of flare and 50% pain reduction on a 0-100 mm visual analogue scale (VAS) was detected in a retrospective pooled analysis of two 12-week studies (β-RELIEVED, N=230; β-RELIEVED-II, N=226) in pts treated with a single dose of canakinumab 150mg sc or triamcinolone acetonide (TA) 40 mg im. The 12-week extension studies allowed evaluation of early pain response as a predictor of delay to new flare. The predictive value of the response was studied using a Cox model with response as a time-dependent covariate and the number of flares in the previous year as baseline predictor. Results 50% pain reduction within 7 days of treatment was confirmed to be a highly significant predictor of time to new flare (p<0.0001). The hazard ratio for responders vs non-responders was 0.47 (95% CI, 0.32 – 0.67). The baseline number of flares was also significant (p=0.0011) confirming the temporal aspect of disease severity as intensity of recurrent disease. A similar result was obtained for time from response (or Day 7 for non-responders) to new flare using Kaplan-Meier technique (log-rank test, p<0.0001) with median time 100 days for non-responder and non-estimable yet for responders within 6 month study (Figure). Figure 1. Time to first new flare (Kaplan-Meier estimate). Conclusions These results demonstrate that a 50% pain reduction by VAS within 7 days of treatment in acute GA pts is associated with delay of new flare and can be used as a surrogate marker of time to new flare. Disclosure of Interest A. So Grant/Research support from: Novartis, Consultant for: Novartis, Ardea, Speakers Bureau: Novartis, Ardea, Menarini, T. Bardin Grant/Research support from: Menarini, Consultant for: Novartis, Ipsen, Menarini, Ardea, Biocryst, M. Bloch Grant/Research support from: Novartis, A. Shpilsky Shareholder of: Novartis, Employee of: Novartis, T. Kiechle Shareholder of: Novartis, Employee of: Novartis, N. Schlesinger Grant/Research support from: Novartis, Consultant for: Novartis, URL Pharma, Savient, Takeda, Rx Ensyme, Speakers Bureau: Takeda, Savient, Novartis</div>
</front>
</TEI>
<affiliations><list><country><li>Australie</li>
<li>France</li>
<li>Suisse</li>
<li>États-Unis</li>
</country>
<region><li>Canton de Vaud</li>
<li>New Jersey</li>
<li>Nouvelle-Galles du Sud</li>
<li>Île-de-France</li>
</region>
<settlement><li>Lausanne</li>
<li>Paris</li>
<li>Sydney</li>
</settlement>
</list>
<tree><country name="Suisse"><region name="Canton de Vaud"><name sortKey="So, A" sort="So, A" uniqKey="So A" first="A." last="So">A. So</name>
</region>
<name sortKey="Kiechle, T" sort="Kiechle, T" uniqKey="Kiechle T" first="T." last="Kiechle">T. Kiechle</name>
<name sortKey="Kiechle, T" sort="Kiechle, T" uniqKey="Kiechle T" first="T." last="Kiechle">T. Kiechle</name>
<name sortKey="So, A" sort="So, A" uniqKey="So A" first="A." last="So">A. So</name>
</country>
<country name="France"><region name="Île-de-France"><name sortKey="Bardin, T" sort="Bardin, T" uniqKey="Bardin T" first="T." last="Bardin">T. Bardin</name>
</region>
<name sortKey="Bardin, T" sort="Bardin, T" uniqKey="Bardin T" first="T." last="Bardin">T. Bardin</name>
</country>
<country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Bloch, M" sort="Bloch, M" uniqKey="Bloch M" first="M." last="Bloch">M. Bloch</name>
</region>
<name sortKey="Bloch, M" sort="Bloch, M" uniqKey="Bloch M" first="M." last="Bloch">M. Bloch</name>
</country>
<country name="États-Unis"><region name="New Jersey"><name sortKey="Shpilsky, A" sort="Shpilsky, A" uniqKey="Shpilsky A" first="A." last="Shpilsky">A. Shpilsky</name>
</region>
<name sortKey="Schlesinger, N" sort="Schlesinger, N" uniqKey="Schlesinger N" first="N." last="Schlesinger">N. Schlesinger</name>
<name sortKey="Schlesinger, N" sort="Schlesinger, N" uniqKey="Schlesinger N" first="N." last="Schlesinger">N. Schlesinger</name>
<name sortKey="Shpilsky, A" sort="Shpilsky, A" uniqKey="Shpilsky A" first="A." last="Shpilsky">A. Shpilsky</name>
</country>
</tree>
</affiliations>
</record>
Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Asie/explor/AustralieFrV1/Data/Main/Exploration
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 004A63 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 004A63 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien |wiki= Wicri/Asie |area= AustralieFrV1 |flux= Main |étape= Exploration |type= RBID |clé= ISTEX:EC878942AF999586A4CCCC1C215D1D54D815D647 |texte= FRI0377 Early response to treatment is a surrogate marker of flare recurrence in acute gouty arthritis }}
This area was generated with Dilib version V0.6.33. |