Evidence map›Paper›PMID 23155441›Full record

SynthesisPloS one2012

Cancer risk of anti-TNF-α at recommended doses in adult rheumatoid arthritis: a meta-analysis with intention to treat and per protocol analyses.

Guillaume Moulis, Agnès Sommet, Johana Béné, François Montastruc, Laurent Sailler, Jean-Louis Montastruc, Maryse Lapeyre-Mestre

Open access · goldAbstract readMeta-Analysis
In one paragraph

Synthesis in PloS one, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 3 pooled it
9.5field-weighted citation impact, top 1% 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

23 citing papers in PubMed, 3 syntheses or guidelines pooled it, 81 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Article
  6. Article
  7. Golimumab (anti-TNF monoclonal antibody): where we stand today.Human vaccines & immunotherapeutics · 2021
    Review
  8. Article
  9. TNF-α inhibitors in the treatment of hidradenitis suppurativa.Therapeutic advances in chronic disease · 2019
    Review
  10. Review
  11. Article
  12. Cancer and autoimmunity: Harnessing longitudinal cohorts to probe the link.Best practice & research. Clinical rheumatology · 2016
    Review
  13. Article
  14. Article
  15. Inflammation and cancer: advances and new agents.Nature reviews. Clinical oncology · 2015
    Review
  16. Article
  17. Review
  18. Article
  19. Tumor necrosis factor inhibitors - state of knowledge.Archives of medical science : AMS · 2014
    Article
  20. Skin cancer in organ transplant recipients: more than the immune system.Journal of the American Academy of Dermatology · 2014
    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 at 4 institutions in 1 country.

Guillaume MoulisCHU Toulouse, Service de Médecine Interne, Toulouse, France. guillaume.moulis@univ-tlse3.fr
Agnès Sommet
Johana Béné
François Montastruc
Laurent Sailler
Jean-Louis Montastruc
Maryse Lapeyre-Mestre
Observatoire Midi-Pyrénées · FRUniversité Toulouse III - Paul Sabatier · FRUniversité de Lille · FRUniversité Fédérale de Toulouse Midi-Pyrénées · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe risk of malignancies on TNF-α antagonists is controversial. The aim of this survey was to assess cancer risk on TNF-α antagonists in adult rheumatoid arthritis patients, including the five marketed drugs (infliximab, etanercept, adalimumab, golimumab and certolizumab) used in line with the New Drug Application. Furthermore, the relative interest of modified intention to treat or per protocol analyses to assess such sparse events remains unknown. METHODOLOGY/PRINCIPAL

findingsData sources were MEDLINE, CENTRAL, ISI Web of Science, ACR and EULAR meeting abstracts, scientific evaluation of the drugs leading to their marketing approval, and clinicaltrials.gov, until 31 December 2012.We selected double-blind randomized controlled trials in adult rheumatoid arthritis patients, including at least one treatment arm in line with New Drug Application. We performed random effect meta-analysis, with modified intention to treat and per protocol analyses. Thirty-three trials were included. There was no excess risk of malignancies on anti-TNF-α administered in line with New Drug Application in the per protocol model (OR, 0.93 95%CI[0.59-1.44]), as well as in the modified intention to treat model (OR, 1.27 95%CI[0.82-1.98]). There was a non-significant tendency for an excess non-melanoma skin cancer risk in both models (respectively, 1.37 [0.71-2.66] and 1.90 [0.98-3.67]). With fixed effect Peto model restricting to trials during at least 52 weeks, the overall cancer risk was respectively 1.60 [0.97-2.64] and 1.22 [0.72-2.08]. Whatever the model, modified intention to treat analysis led to higher estimations than per protocol analysis. The later may underestimate the treatment effect when assessing very sparse events and when many patients dropped out in placebo arms. In metaregression, there was no differential risk among the five drugs. CONCLUSIONS/SIGNIFICANCE: This study did not find any evidence for an excess cancer risk on TNF-α antagonists in adult rheumatoid arthritis patients, but an excess cancer risk after several years of exposure cannot be ruled out. Both modified intention to treat and per protocol analyses should be presented in such safety analyses.

Indexed as

Antibodies, MonoclonalAntirheumatic AgentsArthritis, RheumatoidHumansNeoplasmsRiskTumor Necrosis Factor-alphaAntibodies, MonoclonalAntirheumatic AgentsTumor Necrosis Factor-alpha

Identifiers

PMID23155441
PMCPMC3498371
OpenAlexW1973460930

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.