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.
- Certolizumab pegol
- mucosal healing
- endoscopic response
- Crohn's disease
- anti-TNF agent
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Marc Lémann died on 26 August 2010. We remember our esteemed colleague and recognise his contributions to this manuscript and to advancing the understanding and treatment of Crohn's disease.
Funding The MUSIC study (NCT00297648) was funded by UCB Pharma.
Competing interests XH received funding from UCB Pharma, Baxter, Fresenius Kabi, Vifor for advisory activity, as a member on an advisory board and from Abbott, Nestlé, Norgine, Nutricia and Schering-Plough for educational activities. ML served as a consultant for UCB Pharma and participated in continuing medical education events supported by unrestricted educational grants from UCB Pharma. He died on 26 August 2010. YB has been reimbursed by Schering-Plough and Abbott for attending several conferences and has been paid by Schering-Plough, Abbott, Ferring, Norgine, HAC Pharma, BMS and Teva for running educational programmes. OD has received fees from MSD, Abbott and Ferring for speaking and from MSD and Abbott for educational activities. J-LD has no disclosure information or competing interests to report. MM has received payment for conducting clinical studies for Roche Pharma, MSD Pharma, Ferring, Merckle-Recordati, Shire, Merz Pharma, Viofor Pharma, Abbott, UCB Pharma, Dr. Falk Pharma and AstraZeneca and has been reimbursed for attending conferences by several of these companies. GD'H has received consulting fees from UCB Pharma and has been paid to serve on Speakers Bureau/Advisory Committees for UCB Pharma. KM was an employee of UCB Pharma during development of this manuscript. EE is an employee of UCB Pharma. SV has received fees from UCB, Abbott, Centocor and MSD for running educational programmes and has a research chair from UCB. HB-B has been reimbursed by Abbott, Schering-Plough and UCB for attending several conferences and has received fees from Abbott and Schering-Plough for speaking. TM received lecture fees, grant support and research support from UCB Pharma. PM has served as a consultant for UCB Pharma and has participated in continuing medical education events supported by unrestricted educational grants from UCB Pharma. J-YM has no competing interests to report. J-FC has received consulting fees from Abbott Laboratories, ActoGeniX, Albireo Pharma, Amgen, AstraZeneca, Bayer AG, Biogen Idec, Boehringer Ingelheim GmbH, Bristol-Myers Squibb, Cellerix, Centocor, ChemoCentryx, Cosmo Technologies, Danone Research, Elan Pharmaceuticals, Genentech, Giuliani SpA, Given Imaging, Glaxo Smith Kline, Hutchison MediPharma, MSD, Millennium Pharmaceuticals (now Takeda), Neovacs, Ocera Therapeutics, Pfizer, Shire Pharmaceuticals, Prometheus Laboratories, Sanofi-Aventis, Schering-Plough, Synta Pharmaceuticals, Teva, Therakos, UCB Pharma and Wyeth; has served on advisory committees for Abbott Laboratories, Centocor, Danone, Elan, MSD, Millennium Pharmaceuticals (now Takeda), Schering-Plough and UCB Pharma; has received speaking fees from Abbott Laboratories, Centocor, Elan Pharmaceuticals, Given Imaging, MSD, Otsuka America Pharmaceutical, Schering-Plough, Shire Pharmaceuticals, Tillotts Pharma and UCB Pharma; has received grant support from Abbott Laboratories, Astra-Zeneca, Ferring, MSD, Schering-Plough and UCB Pharma; and has stock ownership for Intestinal Biotech Development, Lille, France.
Ethics approval The protocol, all protocol amendments, and the informed consent document were reviewed and approved by an independent ethics committee or institutional review board at each site. All patients gave their informed consent to participate in the study before any study-related procedures were performed.
Provenance and peer review Not commissioned; externally peer reviewed.
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