Evidence map›Paper›PMID 21681507›Full record

Trial reportDigestive diseases and sciences2011

Postoperative infliximab is not associated with an increase in adverse events in Crohn's disease.

Miguel Regueiro, Sandra El-Hachem, Kevin E Kip, Wolfgang Schraut, Leonard Baidoo, Andrew Watson, Jason Swoger, Marc Schwartz, Arthur Barrie, Marilyn Pesci and 1 more

Abstract readComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Digestive diseases and sciences, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
3.8field-weighted citation impact, top 7% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 48 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Review
  5. Medical therapies for postoperative Crohn's disease.Therapeutic advances in gastroenterology · 2021
    Review
  6. Review
  7. Article
  8. Surgery in the age of biologics.Gastroenterology report · 2019
    Review
  9. Pediatric Crohn's Disease.Clinics in colon and rectal surgery · 2018
    Review
  10. Review
  11. Article
  12. Review
  13. Article
  14. Biologic therapy and surgery for crohn disease.Clinics in colon and rectal surgery · 2013
    Review
  15. Surgical management of IBD--from an open to a laparoscopic approach.Nature reviews. Gastroenterology & hepatology · 2013
    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

11 authors at 3 institutions in 1 country.

Miguel RegueiroDivision of Gastroenterology, Hepatology and Nutrition, Inflammatory Bowel Disease Center, University of Pittsburgh School of Medicine, 200 Lothrop Street, PUH-C Wing Mezzanine Level, Pittsburgh, PA 15213, USA. mdr7@pitt.edu
Sandra El-Hachem
Kevin E Kip
Wolfgang Schraut
Leonard Baidoo
Andrew Watson
Jason Swoger
Marc Schwartz
Arthur Barrie
Marilyn Pesci
David Binion
University of Pittsburgh · USUniversity of Pittsburgh Medical Center · USUniversity of South Florida · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInfliximab is effective treatment for Crohn's disease and has been associated with rare, but serious infectious complications. Emerging data suggest a benefit of infliximab in preventing postoperative Crohn's disease recurrence. It is not known whether administration of infliximab shortly after resective surgery for Crohn's disease increases postoperative complications.

aimsTo evaluate the risk of developing postoperative complications among Crohn's disease patients receiving infliximab within 4 weeks of intestinal resection.

methodsAs part of a randomized placebo-controlled infliximab postoperative prevention study, adverse events were prospectively monitored. Crohn's disease patients undergoing intestinal resection were randomized to placebo or infliximab 2-4 weeks after surgery. Study infusions were administered at 0, 2, and 6 weeks then every 8 weeks for 1 year. To evaluate whether infliximab increased postoperative complications, we analyzed all adverse events for 1 year after surgery.

resultsTwenty-four patients were randomized to infliximab or placebo after intestinal resection for Crohn's disease. Mean time to first postoperative infusion was 20 days (range 14-25 days). Over the course of 1 year, there were 22 total adverse events, but no difference between infliximab and placebo patients (12 versus 10, respectively, P = 1.0). In the immediate postoperative period, within 8 weeks of surgery, the number of adverse events was also similar between the two groups (3 infliximab and 5 placebo patients, P = 0.68). There were no serious adverse events and no complications related to wound healing or infection.

conclusionsInitiation of infliximab within 4 weeks of intestinal resection was not associated with postoperative complications.

Indexed as

AdultAntibodies, MonoclonalColectomyColonoscopyCrohn DiseaseDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleFollow-Up StudiesGastrointestinal AgentsHumansIncidenceInfliximabInfusions, IntravenousMaleAntibodies, MonoclonalGastrointestinal AgentsInfliximabTumor Necrosis Factor-alpha

Identifiers

PMID21681507
OpenAlexW2087088049

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.