Journal
CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Volume 9, Issue 8, Pages 670-U84Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.cgh.2011.04.031
Keywords
Biologic; Inflammatory Bowel Disease; Inflammatory Burden
Categories
Funding
- UCB
- UCB Pharma
- Schering-Plough
- Otsuka
- Millennium
- Tillotts
- Abbott Laboratories
- Protein Design Labs
- Boehringer-Ingelheim
- Novartis
- Centocor
- Berlex
- Synta
- Schering Canada
- Elan/Biogen
- Bristol-Myers Squibb
- Procter Gamble
- Osiris
- Genentech
- AstraZeneca
- Centocor Ortho Biotech
- Essex Pharma Schering-Plough
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BACKGROUND & AIMS: Certolizumab pegol (CZP) is a pegylated-conjugated Fab' against tumor necrosis factor (TNF). Additional data are needed regarding the efficacy of induction therapy with CZP in active Crohn's disease (CD). METHODS: A placebo-controlled trial evaluated the efficacy of CZP therapy in 439 adults with moderate to severe CD naive to anti-TNF therapy. Patients were randomized to receive CZP (400 mg subcutaneously) or placebo at weeks 0, 2, and 4. The primary end point was clinical remission at week 6. RESULTS: Clinical remission rates at week 6 in the CZP and placebo groups were 32% and 25% (P = .174), respectively. Remission rates at weeks 2 and 4 in the CZP and placebo groups were 23% and 16% (P = .033) and 27% and 19% (P = .063), respectively. Clinical response rates at weeks 2, 4, and 6 in the CZP and placebo groups were 33% and 20% (P = .001), 35% and 26% (P = .024), and 41% and 34% (P = .179), respectively. There were significantly greater rates of clinical remission at week 6 for CZP in patients with increased concentrations of C-reactive protein (>= 5 mg/L) at entry. Serious adverse events developed in 5% and 4% of patients in the CZP and placebo groups, respectively. CONCLUSIONS: The primary end point did not reach statistical significance. Significant differences between CZP and placebo were observed in patients who had increased concentrations of C-reactive protein when the study began. Future clinical trials should emphasize the treatment of patients who have objective evidence of inflammation in addition to symptoms of active disease.
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