Efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis: results of a randomised placebo-controlled trial (ABILITY-1)
Identifieur interne : 001F68 ( Pmc/Checkpoint ); précédent : 001F67; suivant : 001F69Efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis: results of a randomised placebo-controlled trial (ABILITY-1)
Auteurs : Joachim Sieper [Allemagne] ; Désirée Van Der Heijde [Pays-Bas] ; Maxime Dougados [France] ; Philip J. Mease [États-Unis] ; Walter P. Maksymowych [Canada] ; Matthew A. Brown [Australie] ; Vipin Arora [États-Unis] ; Aileen L. Pangan [États-Unis]Source :
- Annals of the Rheumatic Diseases [ 0003-4967 ] ; 2012.
Abstract
To evaluate the efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis (nr-axSpA).
Patients fulfilled Assessment of Spondyloarthritis international Society (ASAS) criteria for axial spondyloarthritis, had a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of ≥ 4, total back pain score of ≥ 4 (10 cm visual analogue scale) and inadequate response, intolerance or contraindication to non-steroidal anti-inflammatory drugs (NSAIDs); patients fulfilling modified New York criteria for ankylosing spondylitis were excluded. Patients were randomised to adalimumab (N=91) or placebo (N=94). The primary endpoint was the percentage of patients achieving ASAS40 at week 12. Efficacy assessments included BASDAI and Ankylosing Spondylitis Disease Activity Score (ASDAS). MRI was performed at baseline and week 12 and scored using the Spondyloarthritis Research Consortium of Canada (SPARCC) index.
Significantly more patients in the adalimumab group achieved ASAS40 at week 12 compared with patients in the placebo group (36% vs 15%, p<0.001). Significant clinical improvements based on other ASAS responses, ASDAS and BASDAI were also detected at week 12 with adalimumab treatment, as were improvements in quality of life measures. Inflammation in the spine and sacroiliac joints on MRI significantly decreased after 12 weeks of adalimumab treatment. Shorter disease duration, younger age, elevated baseline C-reactive protein or higher SPARCC MRI sacroiliac joint scores were associated with better week 12 responses to adalimumab. The safety profile was consistent with what is known for adalimumab in ankylosing spondylitis and other diseases.
In patients with nr-axSpA, adalimumab treatment resulted in effective control of disease activity, decreased inflammation and improved quality of life compared with placebo. Results from ABILITY-1 suggest that adalimumab has a positive benefit–risk profile in active nr-axSpA patients with inadequate response to NSAIDs.
Url:
DOI: 10.1136/annrheumdis-2012-201766
PubMed: 22772328
PubMed Central: 3664374
Affiliations:
- Allemagne, Australie, Canada, France, Pays-Bas, États-Unis
- Berlin, Hollande-Méridionale, Illinois, Washington (État), Île-de-France
- Berlin, Leyde, Paris, Seattle
- Université de Washington
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<front><div type="abstract" xml:lang="en"><sec><title>Purpose</title>
<p>To evaluate the efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis (nr-axSpA).</p>
</sec>
<sec><title>Methods</title>
<p>Patients fulfilled Assessment of Spondyloarthritis international Society (ASAS) criteria for axial spondyloarthritis, had a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of ≥ 4, total back pain score of ≥ 4 (10 cm visual analogue scale) and inadequate response, intolerance or contraindication to non-steroidal anti-inflammatory drugs (NSAIDs); patients fulfilling modified New York criteria for ankylosing spondylitis were excluded. Patients were randomised to adalimumab (N=91) or placebo (N=94). The primary endpoint was the percentage of patients achieving ASAS40 at week 12. Efficacy assessments included BASDAI and Ankylosing Spondylitis Disease Activity Score (ASDAS). MRI was performed at baseline and week 12 and scored using the Spondyloarthritis Research Consortium of Canada (SPARCC) index.</p>
</sec>
<sec><title>Results</title>
<p>Significantly more patients in the adalimumab group achieved ASAS40 at week 12 compared with patients in the placebo group (36% vs 15%, p<0.001). Significant clinical improvements based on other ASAS responses, ASDAS and BASDAI were also detected at week 12 with adalimumab treatment, as were improvements in quality of life measures. Inflammation in the spine and sacroiliac joints on MRI significantly decreased after 12 weeks of adalimumab treatment. Shorter disease duration, younger age, elevated baseline C-reactive protein or higher SPARCC MRI sacroiliac joint scores were associated with better week 12 responses to adalimumab. The safety profile was consistent with what is known for adalimumab in ankylosing spondylitis and other diseases.</p>
</sec>
<sec><title>Conclusions</title>
<p>In patients with nr-axSpA, adalimumab treatment resulted in effective control of disease activity, decreased inflammation and improved quality of life compared with placebo. Results from ABILITY-1 suggest that adalimumab has a positive benefit–risk profile in active nr-axSpA patients with inadequate response to NSAIDs.</p>
</sec>
</div>
</front>
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<pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Ann Rheum Dis</journal-id>
<journal-id journal-id-type="iso-abbrev">Ann. Rheum. Dis</journal-id>
<journal-id journal-id-type="hwp">annrheumdis</journal-id>
<journal-id journal-id-type="publisher-id">ard</journal-id>
<journal-title-group><journal-title>Annals of the Rheumatic Diseases</journal-title>
</journal-title-group>
<issn pub-type="ppub">0003-4967</issn>
<issn pub-type="epub">1468-2060</issn>
<publisher><publisher-name>BMJ Group</publisher-name>
<publisher-loc>BMA House, Tavistock Square, London, WC1H 9JR</publisher-loc>
</publisher>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">22772328</article-id>
<article-id pub-id-type="pmc">3664374</article-id>
<article-id pub-id-type="publisher-id">annrheumdis-2012-201766</article-id>
<article-id pub-id-type="doi">10.1136/annrheumdis-2012-201766</article-id>
<article-categories><subj-group subj-group-type="hwp-journal-coll"><subject>1506</subject>
<subject>1507</subject>
</subj-group>
<subj-group subj-group-type="heading"><subject>Clinical and Epidemiological Research</subject>
</subj-group>
<series-title>Extended report</series-title>
</article-categories>
<title-group><article-title>Efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis: results of a randomised placebo-controlled trial (ABILITY-1)</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Sieper</surname>
<given-names>Joachim</given-names>
</name>
<xref ref-type="aff" rid="af1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>van der Heijde</surname>
<given-names>Désirée</given-names>
</name>
<xref ref-type="aff" rid="af2">2</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Dougados</surname>
<given-names>Maxime</given-names>
</name>
<xref ref-type="aff" rid="af3">3</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Mease</surname>
<given-names>Philip J</given-names>
</name>
<xref ref-type="aff" rid="af4">4</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Maksymowych</surname>
<given-names>Walter P</given-names>
</name>
<xref ref-type="aff" rid="af5">5</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Brown</surname>
<given-names>Matthew A</given-names>
</name>
<xref ref-type="aff" rid="af6">6</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Arora</surname>
<given-names>Vipin</given-names>
</name>
<xref ref-type="aff" rid="af7">7</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Pangan</surname>
<given-names>Aileen L</given-names>
</name>
<xref ref-type="aff" rid="af7">7</xref>
</contrib>
</contrib-group>
<aff id="af1"><label>1</label>
Department of Gastroenterology and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany</aff>
<aff id="af2"><label>2</label>
Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands</aff>
<aff id="af3"><label>3</label>
Rheumatology B Department, Paris-Descartes University, Medicine Faculty, Cochin Hospital, Paris, France</aff>
<aff id="af4"><label>4</label>
Division of Rheumatology Research, Swedish Medical Center, University of Washington, Seattle, Washington, USA</aff>
<aff id="af5"><label>5</label>
Department of Medicine, University of Alberta, Edmonton, Canada</aff>
<aff id="af6"><label>6</label>
Human Genetics Group, University of Queensland Diamantina Institute, Princess Alexandra Hospital, Brisbane, Australia</aff>
<aff id="af7"><label>7</label>
Abbott Laboratories, Abbott Park, Illinois, USA</aff>
<author-notes><corresp id="cor1"><label>Correspondence to</label>
Professor Joachim Sieper, Medical Department I, Rheumatology, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Hindenburgdamm 30, Berlin 12203, Germany; <email>joachim.sieper@charite.de</email>
</corresp>
</author-notes>
<pub-date pub-type="ppub"><month>6</month>
<year>2013</year>
</pub-date>
<pub-date pub-type="epub"><day>7</day>
<month>7</month>
<year>2012</year>
</pub-date>
<volume>72</volume>
<issue>6</issue>
<fpage>815</fpage>
<lpage>822</lpage>
<history><date date-type="accepted"><day>31</day>
<month>5</month>
<year>2012</year>
</date>
</history>
<permissions><copyright-statement>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</copyright-statement>
<copyright-year>2013</copyright-year>
<license license-type="open-access"><license-p>This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc/3.0/">http://creativecommons.org/licenses/by-nc/3.0/</ext-link>
and <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc/3.0/legalcode">http://creativecommons.org/licenses/by-nc/3.0/legalcode</ext-link>
</license-p>
</license>
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<self-uri xlink:title="pdf" xlink:type="simple" xlink:href="annrheumdis-2012-201766.pdf"></self-uri>
<related-article id="d35e186" related-article-type="companion" ext-link-type="doi" xlink:href="10.1136/annrheumdis-2012-202389"></related-article>
<related-article id="d35e187" related-article-type="companion" ext-link-type="doi" xlink:href="10.1136/annrheumdis-2012-202908"></related-article>
<abstract><sec><title>Purpose</title>
<p>To evaluate the efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis (nr-axSpA).</p>
</sec>
<sec><title>Methods</title>
<p>Patients fulfilled Assessment of Spondyloarthritis international Society (ASAS) criteria for axial spondyloarthritis, had a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of ≥ 4, total back pain score of ≥ 4 (10 cm visual analogue scale) and inadequate response, intolerance or contraindication to non-steroidal anti-inflammatory drugs (NSAIDs); patients fulfilling modified New York criteria for ankylosing spondylitis were excluded. Patients were randomised to adalimumab (N=91) or placebo (N=94). The primary endpoint was the percentage of patients achieving ASAS40 at week 12. Efficacy assessments included BASDAI and Ankylosing Spondylitis Disease Activity Score (ASDAS). MRI was performed at baseline and week 12 and scored using the Spondyloarthritis Research Consortium of Canada (SPARCC) index.</p>
</sec>
<sec><title>Results</title>
<p>Significantly more patients in the adalimumab group achieved ASAS40 at week 12 compared with patients in the placebo group (36% vs 15%, p<0.001). Significant clinical improvements based on other ASAS responses, ASDAS and BASDAI were also detected at week 12 with adalimumab treatment, as were improvements in quality of life measures. Inflammation in the spine and sacroiliac joints on MRI significantly decreased after 12 weeks of adalimumab treatment. Shorter disease duration, younger age, elevated baseline C-reactive protein or higher SPARCC MRI sacroiliac joint scores were associated with better week 12 responses to adalimumab. The safety profile was consistent with what is known for adalimumab in ankylosing spondylitis and other diseases.</p>
</sec>
<sec><title>Conclusions</title>
<p>In patients with nr-axSpA, adalimumab treatment resulted in effective control of disease activity, decreased inflammation and improved quality of life compared with placebo. Results from ABILITY-1 suggest that adalimumab has a positive benefit–risk profile in active nr-axSpA patients with inadequate response to NSAIDs.</p>
</sec>
</abstract>
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<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Canada</li>
<li>France</li>
<li>Pays-Bas</li>
<li>États-Unis</li>
</country>
<region><li>Berlin</li>
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<li>Illinois</li>
<li>Washington (État)</li>
<li>Île-de-France</li>
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<tree><country name="Allemagne"><region name="Berlin"><name sortKey="Sieper, Joachim" sort="Sieper, Joachim" uniqKey="Sieper J" first="Joachim" last="Sieper">Joachim Sieper</name>
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<country name="France"><region name="Île-de-France"><name sortKey="Dougados, Maxime" sort="Dougados, Maxime" uniqKey="Dougados M" first="Maxime" last="Dougados">Maxime Dougados</name>
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<country name="Canada"><noRegion><name sortKey="Maksymowych, Walter P" sort="Maksymowych, Walter P" uniqKey="Maksymowych W" first="Walter P" last="Maksymowych">Walter P. Maksymowych</name>
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<country name="Australie"><noRegion><name sortKey="Brown, Matthew A" sort="Brown, Matthew A" uniqKey="Brown M" first="Matthew A" last="Brown">Matthew A. Brown</name>
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