PT  - JOURNAL ARTICLE
AU  - Xavier Hébuterne
AU  - Marc Lémann
AU  - Yoram Bouhnik
AU  - Olivier Dewit
AU  - Jean-Louis Dupas
AU  - Michael Mross
AU  - Geert D'Haens
AU  - Krassimir Mitchev
AU  - Étienne Ernault
AU  - Séverine Vermeire
AU  - Hedia Brixi-Benmansour
AU  - Tom G Moreels
AU  - Jean-Yves Mary
AU  - Philippe Marteau
AU  - Jean-Frédéric Colombel
TI  - Endoscopic improvement of mucosal lesions in patients with moderate to severe ileocolonic Crohn's disease following treatment with certolizumab pegol
AID  - 10.1136/gutjnl-2012-302262
DP  - 2013 Feb 01
TA  - Gut
PG  - 201--208
VI  - 62
IP  - 2
4099  - http://gut.bmj.com/content/62/2/201.short
4100  - http://gut.bmj.com/content/62/2/201.full
SO  - Gut2013 Feb 01; 62
AB  - 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.