Evidence map›Paper›PMID 18071721›Full record

Trial reportInternational journal of colorectal disease2008

Certolizumab pegol, a monthly subcutaneously administered Fc-free anti-TNFalpha, improves health-related quality of life in patients with moderate to severe Crohn's disease.

Paul Rutgeerts, Stefan Schreiber, Brian Feagan, Dorothy L Keininger, Liz O'Neil, Richard N Fedorak, CDP870 Crohn's Disease Study Group

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in International journal of colorectal disease, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00152490 (A Phase III Multi-national, Multi-centre, Double-blind Placebo-controlled Parallel Group, 26 Week Study to Assess the Safety and Efficacy of the Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc,), which is not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT00152490 phase3completednot on this map

A Phase III Multi-national, Multi-centre, Double-blind Placebo-controlled Parallel Group, 26 Week Study to Assess the Safety and Efficacy of the Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc, (Dosed at Weeks 0, 2, 4 Then 4-weekly to Week 24), in the Treatment of Patients With Active Crohn's Disease

TypeinterventionalSponsorUCB PharmaRan2003 to 2005Enrolled604ConditionsCrohn's DiseaseArmsCertolizumab Pegol (CDP870)
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Certolizumab pegol for induction of remission in Crohn's disease.The Cochrane database of systematic reviews · 2019
    Pooled it
  3. Review
  4. Allergic and Immunologic Perspectives of Inflammatory Bowel Disease.Clinical reviews in allergy & immunology · 2019
    Review
  5. Anti-TNF Therapy in Crohn's Disease.International journal of molecular sciences · 2018
    Review
  6. Review
  7. Review
  8. Article
  9. Inflammatory bowel disease: a Canadian burden of illness review.Canadian journal of gastroenterology = Journal canadien de gastroenterologie · 2012
    Review
  10. Review
  11. Article
  12. Review
  13. Article
  14. Crohn's disease: Adalimumab improves quality of life.Nature reviews. Gastroenterology & hepatology · 2009
    Article
  15. Article
  16. Advances in the diagnosis and management of inflammatory bowel disease: challenges and uncertainties.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Paul RutgeertsDivision of gastroenterology, University Hospital Leuven, Leuven, Belgium. paul.rutgeerts@uz.kuleuven.ac.be
Stefan Schreiber
Brian Feagan
Dorothy L Keininger
Liz O'Neil
Richard N Fedorak
CDP870 Crohn's Disease Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsCertolizumab pegol, a polyethylene glycolated Fc-free Fab' was efficacious and well tolerated in patients with moderate-to-severe Crohn's disease in a previously reported randomized, placebo-controlled study. In this paper, we report the effect of certolizumab pegol on health-related quality of life (HRQoL). MATERIALS AND

methodsPatients with moderate-to-severe active Crohn's disease (n = 292) received subcutaneous certolizumab pegol 100, 200, or 400 mg or placebo at weeks 0, 4, and 8. A post hoc analysis of the intent-to-treat population (290 patients with HRQoL data) assessed HRQoL by evaluating patients' responses to the self-administered inflammatory bowel disease questionnaire (IBDQ) at baseline and weeks 2, 4, 6, 8, 10, and 12.

resultsPatients receiving certolizumab pegol 400 mg at weeks 0, 4, and 8 demonstrated, via their IBDQ total score, significantly (P <or= 0.05) greater improvement in HRQoL from baseline to week 12 and at all other time points compared with placebo. Moreover, HRQoL improved over time in all certolizumab pegol groups, irrespective of baseline C-reactive protein levels. Emotional well-being (IBDQ Emotional Function domain) improved throughout the study for patients receiving certolizumab pegol 400 mg. This improvement was significantly (P <or= 0.05) greater than for patients receiving placebo at all time points. In addition, systemic symptoms (IBDQ Systemic Symptoms domain) improved significantly more in patients receiving certolizumab pegol 400 mg than in those receiving placebo at weeks 4, 8, 10, and 12 (P <or= 0.05) and approached statistical significance at week 2 (P = 0.054).

conclusionThis analysis suggests that certolizumab pegol 400 mg improves HRQoL in patients with moderate-to-severe Crohn's disease.

Indexed as

Quality of LifeAdultAntibodies, Monoclonal, HumanizedCertolizumab PegolCrohn DiseaseDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFollow-Up StudiesHumansImmunoglobulin Fab FragmentsInjections, SubcutaneousPolyethylene GlycolsRetrospective StudiesSeverity of Illness IndexTime FactorsAntibodies, Monoclonal, HumanizedCertolizumab PegolImmunoglobulin Fab FragmentsPolyethylene GlycolsTumor Necrosis Factor-alpha

Identifiers

PMID18071721
PMCPMC2225995

What OpenQuestion holds

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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.