Adalimumab effectively reduces the signs and symptoms of active ankylosing spondylitis in patients with total spinal ankylosis
Identifieur interne : 001437 ( Main/Exploration ); précédent : 001436; suivant : 001438Adalimumab effectively reduces the signs and symptoms of active ankylosing spondylitis in patients with total spinal ankylosis
Auteurs : D. Van Der Heijde [Pays-Bas] ; A L Pangan [États-Unis] ; M H Schiff [États-Unis] ; J. Braun [Allemagne] ; M. Borofsky [États-Unis] ; J. Torre [Espagne] ; J C Davis [États-Unis] ; R L Wong [États-Unis] ; H. Kupper [Allemagne] ; E. Collantes [Espagne]Source :
- Annals of the Rheumatic Diseases [ 0003-4967 ] ; 2007.
Abstract
To evaluate the long-term safety and efficacy of adalimumab in patients with ankylosing spondylitis (AS) and total spinal ankylosis (TSA).
Patients (n = 315) with active AS were randomised in a 2:1 ratio to receive adalimumab 40 mg every other week or placebo for 24 weeks followed by open-label adalimumab for up to 5 years. Two-year efficacy and safety data for 11 patients with investigator-defined TSA were evaluated. The primary end point was the ASsessment in AS International Working Group criteria for 20% improvement (ASAS20) at Week 12. On or after Week 12, ASAS20 non-responders could switch to open-label adalimumab. Other efficacy measurements included ASAS40, ASAS 5/6, ASAS partial remission, and 50% improvement in the Bath AS Disease Activity Index (BASDAI 50).
6 of 11 TSA patients were randomised to adalimumab and 5 to placebo. At Week 12, 50% of the adalimumab-treated patients achieved an ASAS20 response and 33% achieved an ASAS40, ASAS 5/6 and BASDAI 50. No placebo-treated patients achieved any response criteria at Week 12. 4 placebo- and 2 adalimumab-treated patients switched to open-label adalimumab before Week 24. After 1 year of adalimumab treatment, 8 of 11 patients achieved an ASAS20 response. After 2 years, 6 of the remaining 8 patients with TSA reported an ASAS20 response. There were no serious adverse events or adverse event-related study discontinuations.
In patients with TSA, adalimumab treatment resulted in rapid and clinically significant improvement in the signs and symptoms of active disease. Adalimumab effectiveness and safety were sustained for at least 2 years.
NCT00085644.
Url:
DOI: 10.1136/ard.2007.082529
PubMed: 18056755
PubMed Central: 2564805
Affiliations:
- Allemagne, Espagne, Pays-Bas, États-Unis
- Californie, Colorado, Hollande-Méridionale, Illinois, New Jersey, Pennsylvanie
- Leyde
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Le document en format XML
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Van Der Heijde</name><affiliation wicri:level="3"><nlm:aff id="aff1"><addr-line>Leiden University Medical Center, Leiden, The Netherlands</addr-line></nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Leiden University Medical Center, Leiden</wicri:regionArea><placeName><settlement type="city">Leyde</settlement><region nuts="2" type="province">Hollande-Méridionale</region></placeName></affiliation></author><author><name sortKey="Pangan, A L" sort="Pangan, A L" uniqKey="Pangan A" first="A L" last="Pangan">A L Pangan</name><affiliation wicri:level="2"><nlm:aff id="aff2"><addr-line>Abbott Laboratories, Abbott Park, Illinois, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Abbott Laboratories, Abbott Park, Illinois</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation></author><author><name sortKey="Schiff, M H" sort="Schiff, M H" uniqKey="Schiff M" first="M H" last="Schiff">M H Schiff</name><affiliation wicri:level="2"><nlm:aff id="aff3"><addr-line>Denver Arthritis Clinic Research Unit, Denver, Colorado, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Denver Arthritis Clinic Research Unit, Denver, Colorado</wicri:regionArea><placeName><region type="state">Colorado</region></placeName></affiliation></author><author><name sortKey="Braun, J" sort="Braun, J" uniqKey="Braun J" first="J" last="Braun">J. 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Van Der Heijde</name><affiliation wicri:level="3"><nlm:aff id="aff1"><addr-line>Leiden University Medical Center, Leiden, The Netherlands</addr-line></nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Leiden University Medical Center, Leiden</wicri:regionArea><placeName><settlement type="city">Leyde</settlement><region nuts="2" type="province">Hollande-Méridionale</region></placeName></affiliation></author><author><name sortKey="Pangan, A L" sort="Pangan, A L" uniqKey="Pangan A" first="A L" last="Pangan">A L Pangan</name><affiliation wicri:level="2"><nlm:aff id="aff2"><addr-line>Abbott Laboratories, Abbott Park, Illinois, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Abbott Laboratories, Abbott Park, Illinois</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation></author><author><name sortKey="Schiff, M H" sort="Schiff, M H" uniqKey="Schiff M" first="M H" last="Schiff">M H Schiff</name><affiliation wicri:level="2"><nlm:aff id="aff3"><addr-line>Denver Arthritis Clinic Research Unit, Denver, Colorado, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Denver Arthritis Clinic Research Unit, Denver, Colorado</wicri:regionArea><placeName><region type="state">Colorado</region></placeName></affiliation></author><author><name sortKey="Braun, J" sort="Braun, J" uniqKey="Braun J" first="J" last="Braun">J. Braun</name><affiliation wicri:level="1"><nlm:aff id="aff4"><addr-line>Ruhr University Bochum, Bochum, Germany</addr-line></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Ruhr University Bochum, Bochum</wicri:regionArea><wicri:noRegion>Bochum</wicri:noRegion><wicri:noRegion>Bochum</wicri:noRegion><wicri:noRegion>Bochum</wicri:noRegion></affiliation></author><author><name sortKey="Borofsky, M" sort="Borofsky, M" uniqKey="Borofsky M" first="M" last="Borofsky">M. Borofsky</name><affiliation wicri:level="2"><nlm:aff id="aff5"><addr-line>Arthritis and Osteoporosis Center, Clinical Research Center of Reading, West Reading, Pennsylvania, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Arthritis and Osteoporosis Center, Clinical Research Center of Reading, West Reading, Pennsylvania</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Torre, J" sort="Torre, J" uniqKey="Torre J" first="J" last="Torre">J. Torre</name><affiliation wicri:level="1"><nlm:aff id="aff6"><addr-line>Hospital Monte Naranco, Oviedo-Asturias, Spain</addr-line></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Hospital Monte Naranco, Oviedo-Asturias</wicri:regionArea><wicri:noRegion>Oviedo-Asturias</wicri:noRegion></affiliation></author><author><name sortKey="Davis, J C" sort="Davis, J C" uniqKey="Davis J" first="J C" last="Davis">J C Davis</name><affiliation wicri:level="2"><nlm:aff id="aff7"><addr-line>University of California, San Francisco, California, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of California, San Francisco, California</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Wong, R L" sort="Wong, R L" uniqKey="Wong R" first="R L" last="Wong">R L Wong</name><affiliation wicri:level="2"><nlm:aff id="aff8"><addr-line>Abbott Laboratories, Parsippany, New Jersey, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Abbott Laboratories, Parsippany, New Jersey</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Kupper, H" sort="Kupper, H" uniqKey="Kupper H" first="H" last="Kupper">H. Kupper</name><affiliation wicri:level="1"><nlm:aff id="aff9"><addr-line>Abbott GmbH & Co. KG, Ludwigshafen, Germany</addr-line></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Abbott GmbH & Co. KG, Ludwigshafen</wicri:regionArea><wicri:noRegion>Ludwigshafen</wicri:noRegion><wicri:noRegion>Ludwigshafen</wicri:noRegion><wicri:noRegion>Ludwigshafen</wicri:noRegion></affiliation></author><author><name sortKey="Collantes, E" sort="Collantes, E" uniqKey="Collantes E" first="E" last="Collantes">E. Collantes</name><affiliation wicri:level="1"><nlm:aff id="aff10"><addr-line>Hospital Universitario Reina Sofia, Cordova, Spain</addr-line></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Hospital Universitario Reina Sofia, Cordova</wicri:regionArea><wicri:noRegion>Cordova</wicri:noRegion></affiliation></author></analytic><series><title level="j">Annals of the Rheumatic Diseases</title><idno type="ISSN">0003-4967</idno><idno type="eISSN">1468-2060</idno><imprint><date when="2007">2007</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Objective:</title><p>To evaluate the long-term safety and efficacy of adalimumab in patients with ankylosing spondylitis (AS) and total spinal ankylosis (TSA).</p></sec><sec><title>Design:</title><p>Patients (n = 315) with active AS were randomised in a 2:1 ratio to receive adalimumab 40 mg every other week or placebo for 24 weeks followed by open-label adalimumab for up to 5 years. Two-year efficacy and safety data for 11 patients with investigator-defined TSA were evaluated. The primary end point was the ASsessment in AS International Working Group criteria for 20% improvement (ASAS20) at Week 12. On or after Week 12, ASAS20 non-responders could switch to open-label adalimumab. Other efficacy measurements included ASAS40, ASAS 5/6, ASAS partial remission, and 50% improvement in the Bath AS Disease Activity Index (BASDAI 50).</p></sec><sec><title>Results:</title><p>6 of 11 TSA patients were randomised to adalimumab and 5 to placebo. At Week 12, 50% of the adalimumab-treated patients achieved an ASAS20 response and 33% achieved an ASAS40, ASAS 5/6 and BASDAI 50. No placebo-treated patients achieved any response criteria at Week 12. 4 placebo- and 2 adalimumab-treated patients switched to open-label adalimumab before Week 24. After 1 year of adalimumab treatment, 8 of 11 patients achieved an ASAS20 response. After 2 years, 6 of the remaining 8 patients with TSA reported an ASAS20 response. There were no serious adverse events or adverse event-related study discontinuations.</p></sec><sec><title>Conclusion:</title><p>In patients with TSA, adalimumab treatment resulted in rapid and clinically significant improvement in the signs and symptoms of active disease. Adalimumab effectiveness and safety were sustained for at least 2 years.</p></sec><sec><title>Trial registration number:</title><p>NCT00085644.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Boonen, A" uniqKey="Boonen A">A Boonen</name></author><author><name sortKey="Van Der Linden, Sm" uniqKey="Van Der Linden S">SM van der Linden</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Braun, J" uniqKey="Braun J">J Braun</name></author><author><name sortKey="Van Der Heijde, D" uniqKey="Van Der Heijde D">D van der Heijde</name></author><author><name sortKey="Dougados, M" uniqKey="Dougados M">M Dougados</name></author><author><name sortKey="Emery, P" uniqKey="Emery P">P Emery</name></author><author><name sortKey="Khan, Ma" uniqKey="Khan M">MA Khan</name></author><author><name sortKey="Sieper, J" uniqKey="Sieper J">J Sieper</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Gran, Jt" uniqKey="Gran J">JT Gran</name></author><author><name sortKey="Skomsvoll, Jf" uniqKey="Skomsvoll J">JF Skomsvoll</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Davis, Jc" uniqKey="Davis J">JC Davis</name></author><author><name sortKey="Van Der Heijde, D" uniqKey="Van Der Heijde D">D van der Heijde</name></author><author><name sortKey="Braun, J" uniqKey="Braun J">J Braun</name></author><author><name sortKey="Dougados, M" uniqKey="Dougados M">M Dougados</name></author><author><name sortKey="Cush, J" uniqKey="Cush J">J Cush</name></author><author><name sortKey="Clegg, Do" uniqKey="Clegg D">DO Clegg</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Van Der Heijde, D" uniqKey="Van Der Heijde D">D van der Heijde</name></author><author><name sortKey="Dijkmans, B" uniqKey="Dijkmans B">B Dijkmans</name></author><author><name sortKey="Geusens, P" uniqKey="Geusens P">P Geusens</name></author><author><name sortKey="Sieper, J" uniqKey="Sieper J">J Sieper</name></author><author><name sortKey="Dewoody, K" uniqKey="Dewoody K">K DeWoody</name></author><author><name sortKey="Williamson, P" uniqKey="Williamson P">P Williamson</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Van Der Heijde, D" uniqKey="Van Der Heijde D">D van der Heijde</name></author><author><name sortKey="Kivitz, A" uniqKey="Kivitz A">A Kivitz</name></author><author><name sortKey="Schiff, Mh" uniqKey="Schiff M">MH Schiff</name></author><author><name sortKey="Sieper, J" uniqKey="Sieper J">J Sieper</name></author><author><name sortKey="Dijkmans, Ba" uniqKey="Dijkmans B">BA Dijkmans</name></author><author><name sortKey="Braun, J" uniqKey="Braun J">J Braun</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Van Der Linden, S" uniqKey="Van Der Linden S">S van der Linden</name></author><author><name sortKey="Valkenburg, Ha" uniqKey="Valkenburg H">HA Valkenburg</name></author><author><name sortKey="Cats, A" uniqKey="Cats A">A Cats</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Anderson, Jj" uniqKey="Anderson J">JJ Anderson</name></author><author><name sortKey="Baron, G" uniqKey="Baron G">G Baron</name></author><author><name sortKey="Van Der Heijde, D" uniqKey="Van Der Heijde D">D van der Heijde</name></author><author><name sortKey="Felson, Dt" uniqKey="Felson D">DT Felson</name></author><author><name sortKey="Dougados, M" uniqKey="Dougados M">M Dougados</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Jenkinson, Tr" uniqKey="Jenkinson T">TR Jenkinson</name></author><author><name sortKey="Mallorie, Pa" uniqKey="Mallorie P">PA Mallorie</name></author><author><name sortKey="Whitelock, Hc" uniqKey="Whitelock H">HC Whitelock</name></author><author><name sortKey="Kennedy, Lg" uniqKey="Kennedy L">LG Kennedy</name></author><author><name sortKey="Garrett, Sl" uniqKey="Garrett S">SL Garrett</name></author><author><name sortKey="Calin, A" uniqKey="Calin A">A Calin</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Van Der Heijde, D" uniqKey="Van Der Heijde D">D van der Heijde</name></author><author><name sortKey="Dougados, M" uniqKey="Dougados M">M Dougados</name></author><author><name sortKey="Davis, J" uniqKey="Davis J">J Davis</name></author><author><name sortKey="Weisman, Mh" uniqKey="Weisman M">MH Weisman</name></author><author><name sortKey="Maksymowych, W" uniqKey="Maksymowych W">W Maksymowych</name></author><author><name sortKey="Braun, J" uniqKey="Braun J">J Braun</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Calin, A" uniqKey="Calin A">A Calin</name></author><author><name sortKey="Garrett, S" uniqKey="Garrett S">S Garrett</name></author><author><name sortKey="Whitelock, H" uniqKey="Whitelock H">H Whitelock</name></author><author><name sortKey="Kennedy, Lg" uniqKey="Kennedy L">LG Kennedy</name></author><author><name sortKey="O Ea, J" uniqKey="O Ea J">J O’Hea</name></author><author><name sortKey="Mallorie, P" uniqKey="Mallorie P">P Mallorie</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Garrett, S" uniqKey="Garrett S">S Garrett</name></author><author><name sortKey="Jenkinson, T" uniqKey="Jenkinson T">T Jenkinson</name></author><author><name sortKey="Kennedy, Lg" uniqKey="Kennedy L">LG Kennedy</name></author><author><name sortKey="Whitelock, H" uniqKey="Whitelock H">H Whitelock</name></author><author><name sortKey="Gaisford, P" uniqKey="Gaisford P">P Gaisford</name></author><author><name sortKey="Calin, A" uniqKey="Calin A">A Calin</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Van Der Heijde, D" uniqKey="Van Der Heijde D">D van der Heijde</name></author><author><name sortKey="Schiff, M" uniqKey="Schiff M">M Schiff</name></author><author><name sortKey="Sieper, J" uniqKey="Sieper J">J Sieper</name></author><author><name sortKey="Kivitz, A" uniqKey="Kivitz A">A Kivitz</name></author><author><name sortKey="Dijkmans, B" uniqKey="Dijkmans B">B Dijkmans</name></author><author><name sortKey="Mease, P" uniqKey="Mease P">P Mease</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Allemagne</li><li>Espagne</li><li>Pays-Bas</li><li>États-Unis</li></country><region><li>Californie</li><li>Colorado</li><li>Hollande-Méridionale</li><li>Illinois</li><li>New Jersey</li><li>Pennsylvanie</li></region><settlement><li>Leyde</li></settlement></list><tree><country name="Pays-Bas"><region name="Hollande-Méridionale"><name sortKey="Van Der Heijde, D" sort="Van Der Heijde, D" uniqKey="Van Der Heijde D" first="D" last="Van Der Heijde">D. Van Der Heijde</name></region></country><country name="États-Unis"><region name="Illinois"><name sortKey="Pangan, A L" sort="Pangan, A L" uniqKey="Pangan A" first="A L" last="Pangan">A L Pangan</name></region><name sortKey="Borofsky, M" sort="Borofsky, M" uniqKey="Borofsky M" first="M" last="Borofsky">M. Borofsky</name><name sortKey="Davis, J C" sort="Davis, J C" uniqKey="Davis J" first="J C" last="Davis">J C Davis</name><name sortKey="Schiff, M H" sort="Schiff, M H" uniqKey="Schiff M" first="M H" last="Schiff">M H Schiff</name><name sortKey="Wong, R L" sort="Wong, R L" uniqKey="Wong R" first="R L" last="Wong">R L Wong</name></country><country name="Allemagne"><noRegion><name sortKey="Braun, J" sort="Braun, J" uniqKey="Braun J" first="J" last="Braun">J. Braun</name></noRegion><name sortKey="Kupper, H" sort="Kupper, H" uniqKey="Kupper H" first="H" last="Kupper">H. Kupper</name></country><country name="Espagne"><noRegion><name sortKey="Torre, J" sort="Torre, J" uniqKey="Torre J" first="J" last="Torre">J. Torre</name></noRegion><name sortKey="Collantes, E" sort="Collantes, E" uniqKey="Collantes E" first="E" last="Collantes">E. Collantes</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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HfdIndexSelect -h $EXPLOR_AREA/Data/Main/Exploration/RBID.i -Sk "pubmed:18056755" \
| HfdSelect -Kh $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd \
| NlmPubMed2Wicri -a OpenAccessBelV2
| This area was generated with Dilib version V0.6.25. |  |