Trial reportClinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association2010
Continuous therapy with certolizumab pegol maintains remission of patients with Crohn's disease for up to 18 months.
Trial report in Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 34 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase III Multi-national, Multi-centre, Double-blind Placebo-controlled Parallel Group, 26 Week Study to Assess the Maintenance of Clinical Response to Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc, (Dosed 4-weekly From Weeks 8 to 24), in the Treatment of Patients With Active Crohn's Disease Who Have Responded to Open Induction Therapy (Dosed at Weeks 0, 2 and 4) With CDP870
A Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed 4-weekly), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Completed Studies CDP870-031 or CDP870-032
Who cites it
34 citing papers in PubMed, 3 syntheses or guidelines pooled it, 109 citations in OpenAlex.
- Certolizumab pegol for maintenance of medically induced remission in Crohn's disease.The Cochrane database of systematic reviews · 2022Pooled it
- Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2017Pooled it
- Safety Profile of Biologic Drugs in the Treatment of Inflammatory Bowel Diseases: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials.Clinical drug investigation · 2017Pooled it
- Longitudinal Safety Outcomes of Anti-tumor Necrosis Factor Alpha Therapy in the Treatment of Inflammatory Bowel Disease.Digestive diseases and sciences · 2026Article
- Celastrol Activates HSF1 to Enhance Regulatory T Cells Function and Ameliorate Intestinal Inflammation.Biomolecules · 2025Article
- Heat shock factor 1 drives regulatory T-cell induction to limit murine intestinal inflammation.Mucosal immunology · 2024Article
- Landscape of new drugs and targets in inflammatory bowel disease.United European gastroenterology journal · 2022Review
- Tumor Necrosis Factor's Pathway in Crohn's Disease: Potential for Intervention.International journal of molecular sciences · 2021Review
- Therapeutic Drug Monitoring of Certolizumab Pegol: Can Real-World Data Translate to Clinical Practice?Crohn's & colitis 360 · 2021Article
- Positioning of old and new biologicals and small molecules in the treatment of inflammatory bowel diseases.World journal of gastroenterology · 2018Review
- Anti-TNF Therapy in Crohn's Disease.International journal of molecular sciences · 2018Review
- Exposure-response relationship of certolizumab pegol induction and maintenance therapy in patients with Crohn's disease.Alimentary pharmacology & therapeutics · 2018Article
- Immunogenicity of biologics in inflammatory bowel disease.Therapeutic advances in gastroenterology · 2018Article
- Accounting for Pharmacokinetic Variability of Certolizumab Pegol in Patients with Crohn's Disease.Clinical pharmacokinetics · 2017Article
- Review
- Approach to the Patient with Mild Crohn's Disease: a 2016 Update.Current gastroenterology reports · 2016Review
- Rate and Predictors of Endoscopic Mucosal Healing in Biologic Naive Patients with Inflammatory Bowel Disease by Azathioprine Treatment: A Real World, 10 Years' Experience from a Single Centre in Turkey.Journal of gastrointestinal & digestive system · 2016Article
- Approach to Optimize Anti-TNF-α Therapy in Patients With IBD.Current treatment options in gastroenterology · 2016Article
- Targeting Antigens to Dec-205 on Dendritic Cells Induces Immune Protection in Experimental Colitis in Mice.European journal of microbiology & immunology · 2016Article
- Biologic agents for IBD: practical insights.Nature reviews. Gastroenterology & hepatology · 2015Review
Corrections and comments
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Authors and funding
8 authors at 7 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND &
aimsThe safety and efficacy of maintenance therapy with the anti-tumor necrosis factor certolizumab pegol has not been reported beyond 6 months. We assessed the long-term efficacy, safety, and immunogenicity of continuous versus interrupted maintenance therapy with subcutaneous certolizumab pegol in patients with Crohn's disease.
methodsPatients who responded to induction therapy at week 6 of the PEGylated Antibody Fragment Evaluation in Crohn's Disease: Safety and Efficacy (PRECiSE) 2 trial were assigned randomly to groups given certolizumab pegol (continuous) or placebo (drug-interruption) during weeks 6 to 26. Patients who completed PRECiSE 2 were eligible to enter PRECiSE 3, an ongoing, prospective, open-label extension trial in which patients have received certolizumab pegol (400 mg) every 4 weeks for 54 weeks to date, and were not offered the option to increase their dose. Disease activity was measured by the Harvey-Bradshaw Index.
resultsHarvey-Bradshaw Index responses at week 26 for the continuous and drug-interruption groups were 56.3% and 37.6%, respectively; corresponding remission rates were 47.9% and 32.4%, respectively. Of patients responding at week 26, response rates at week 80 after the start of PRECiSE 2 in the continuous and drug-interruption groups were 66.1% and 63.3%, respectively; among patients in remission at week 26, week 80 remission rates were 62.1% and 63.2%, respectively. More patients in the drug-interruption group developed antibodies against certolizumab pegol (and had lower plasma concentrations of certolizumab pegol) than the continuously treated group.
conclusionsCertolizumab pegol effectively maintains remission of Crohn's disease for up to 18 months. Continuous therapy is more effective than interrupted therapy.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.