Endoscopic improvement of mucosal lesions in patients with moderate to severe ileocolonic Crohn's disease following treatment with certolizumab pegol
Identifieur interne : 000400 ( Main/Exploration ); précédent : 000399; suivant : 000401Endoscopic improvement of mucosal lesions in patients with moderate to severe ileocolonic Crohn's disease following treatment with certolizumab pegol
Auteurs : Xavier Hébuterne [France] ; Marc Lémann [France] ; Yoram Bouhnik [France] ; Olivier Dewit [Belgique] ; Jean-Louis Dupas [France] ; Michael Mross [Allemagne] ; Geert D'Haens [Belgique] ; Krassimir Mitchev [Belgique] ; Étienne Ernault [Belgique] ; Séverine Vermeire [Belgique] ; Hedia Brixi-Benmansour [France] ; Tom G. Moreels [Belgique] ; Jean-Yves Mary [France] ; Philippe Marteau [France] ; Jean-Frédéric Colombel [France]Source :
- Gut [ 0017-5749 ] ; 2013-02.
Abstract
Objective To evaluate the efficacy of certolizumab pegol (CZP) in improving endoscopic lesions in patients with active ileocolonic Crohn's disease (CD). Methods This phase IIIB multicentre open-label clinical trial enrolled 89 adult patients with active endoscopic disease (ulceration in ≥2 intestinal segments with a Crohn's Disease Endoscopic Index of Severity (CDEIS) score ≥8 points). Patients received subcutaneous CZP 400 mg at weeks 0, 2 and 4 and every 4 weeks up to week 52. Endoscopic evaluations were performed at weeks 0, 10 and 54. The primary outcome was mean change in CDEIS score at week 10; secondary outcome measures included endoscopic response (decrease in CDEIS score >5 points), remission (CDEIS score <6), complete remission (CDEIS score <3) and mucosal healing (no ulcer) at weeks 10 and 54. Results In the intention-to-treat population (n=89) the mean±SD CDEIS score was 14.5±5.3 at baseline; the mean decrease in CDEIS score at week 10 was 5.7 (95% CI 4.6 to 6.8, p<0.0001). Rates of endoscopic response, endoscopic remission, complete endoscopic remission and mucosal healing at week 10 were 54%, 37%, 10% and 4%, respectively. At week 54 the corresponding rates were 49%, 27%, 14% and 8%, respectively. The safety profile was consistent with that of previous CZP trials. Conclusions Following CZP treatment in patients with active CD, endoscopic lesions were improved as shown by the decrease in mean CDEIS score and by endoscopic response and remission rates. These benefits were achieved as early as week 10 and were generally maintained through week 54. Clinical Trial Registration Number NCT00297648.
Url:
DOI: 10.1136/gutjnl-2012-302262
Affiliations:
- Allemagne, Belgique, France
- Berlin, Région de Bruxelles-Capitale
- Amiens, Berlin, Bruxelles, Lille, Nice, Paris, Reims
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Methods This phase IIIB multicentre open-label clinical trial enrolled 89 adult patients with active endoscopic disease (ulceration in ≥2 intestinal segments with a Crohn's Disease Endoscopic Index of Severity (CDEIS) score ≥8 points). Patients received subcutaneous CZP 400 mg at weeks 0, 2 and 4 and every 4 weeks up to week 52. Endoscopic evaluations were performed at weeks 0, 10 and 54. The primary outcome was mean change in CDEIS score at week 10; secondary outcome measures included endoscopic response (decrease in CDEIS score >5 points), remission (CDEIS score <6), complete remission (CDEIS score <3) and mucosal healing (no ulcer) at weeks 10 and 54. Results In the intention-to-treat population (n=89) the mean±SD CDEIS score was 14.5±5.3 at baseline; the mean decrease in CDEIS score at week 10 was 5.7 (95% CI 4.6 to 6.8, p<0.0001). Rates of endoscopic response, endoscopic remission, complete endoscopic remission and mucosal healing at week 10 were 54%, 37%, 10% and 4%, respectively. At week 54 the corresponding rates were 49%, 27%, 14% and 8%, respectively. The safety profile was consistent with that of previous CZP trials. Conclusions Following CZP treatment in patients with active CD, endoscopic lesions were improved as shown by the decrease in mean CDEIS score and by endoscopic response and remission rates. These benefits were achieved as early as week 10 and were generally maintained through week 54. Clinical Trial Registration Number NCT00297648.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Belgique</li><li>France</li></country><region><li>Berlin</li><li>Région de Bruxelles-Capitale</li></region><settlement><li>Amiens</li><li>Berlin</li><li>Bruxelles</li><li>Lille</li><li>Nice</li><li>Paris</li><li>Reims</li></settlement></list><tree><country name="France"><noRegion><name sortKey="Hebuterne, Xavier" sort="Hebuterne, Xavier" uniqKey="Hebuterne X" first="Xavier" last="Hébuterne">Xavier Hébuterne</name></noRegion><name sortKey="Bouhnik, Yoram" sort="Bouhnik, Yoram" uniqKey="Bouhnik Y" first="Yoram" last="Bouhnik">Yoram Bouhnik</name><name sortKey="Brixi Benmansour, Hedia" sort="Brixi Benmansour, Hedia" uniqKey="Brixi Benmansour H" first="Hedia" last="Brixi-Benmansour">Hedia Brixi-Benmansour</name><name sortKey="Colombel, Jean Frederic" sort="Colombel, Jean Frederic" uniqKey="Colombel J" first="Jean-Frédéric" last="Colombel">Jean-Frédéric Colombel</name><name sortKey="Dupas, Jean Louis" sort="Dupas, Jean Louis" uniqKey="Dupas J" first="Jean-Louis" last="Dupas">Jean-Louis Dupas</name><name sortKey="Hebuterne, Xavier" sort="Hebuterne, Xavier" uniqKey="Hebuterne X" first="Xavier" last="Hébuterne">Xavier Hébuterne</name><name sortKey="Lemann, Marc" sort="Lemann, Marc" uniqKey="Lemann M" first="Marc" last="Lémann">Marc Lémann</name><name sortKey="Marteau, Philippe" sort="Marteau, Philippe" uniqKey="Marteau P" first="Philippe" last="Marteau">Philippe Marteau</name><name sortKey="Mary, Jean Yves" sort="Mary, Jean Yves" uniqKey="Mary J" first="Jean-Yves" last="Mary">Jean-Yves Mary</name></country><country name="Belgique"><region name="Région de Bruxelles-Capitale"><name sortKey="Dewit, Olivier" sort="Dewit, Olivier" uniqKey="Dewit O" first="Olivier" last="Dewit">Olivier Dewit</name></region><name sortKey="D Haens, Geert" sort="D Haens, Geert" uniqKey="D Haens G" first="Geert" last="D'Haens">Geert D'Haens</name><name sortKey="Ernault, Etienne" sort="Ernault, Etienne" uniqKey="Ernault E" first="Étienne" last="Ernault">Étienne Ernault</name><name sortKey="Mitchev, Krassimir" sort="Mitchev, Krassimir" uniqKey="Mitchev K" first="Krassimir" last="Mitchev">Krassimir Mitchev</name><name sortKey="Moreels, Tom G" sort="Moreels, Tom G" uniqKey="Moreels T" first="Tom G" last="Moreels">Tom G. Moreels</name><name sortKey="Vermeire, Severine" sort="Vermeire, Severine" uniqKey="Vermeire S" first="Séverine" last="Vermeire">Séverine Vermeire</name></country><country name="Allemagne"><region name="Berlin"><name sortKey="Mross, Michael" sort="Mross, Michael" uniqKey="Mross M" first="Michael" last="Mross">Michael Mross</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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