Evidence map›Paper›PMID 24328939›Full record

ArticleThe British journal of dermatology2014

Melanoma associated with tumour necrosis factor-α inhibitors: a Research on Adverse Drug events And Reports (RADAR) project.

B Nardone, J A Hammel, D W Raisch, L L Weaver, D Schneider, D P West

Open access · greenAbstract read
In one paragraph

Article in The British journal of dermatology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
3.3field-weighted citation impact, top 8% 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

19 citing papers in PubMed, 52 citations in OpenAlex.

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  11. Malignancy Rates in Brodalumab Clinical Studies for Psoriasis.American journal of clinical dermatology · 2020
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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

6 authors at 2 institutions in 1 country.

B NardoneDepartment of Dermatology, Northwestern University, 676 N. Saint Clair Street, Suite 1600, Chicago, IL, 60611, U.S.A.
J A Hammel
D W Raisch
L L Weaver
D Schneider
D P West
Northwestern University · USUniversity of New Mexico · US

Funding

MULTIDISCIPLINARY CLINICAL AND TRANSLATIONAL SCIENCE (MCTS) PROGRAM (UL1)UL1RR025741 · NCRR · NORTHWESTERN UNIVERSITY AT CHICAGO · PI GREENLAND, PHILIP · 2008 to 2011
$24.7M
Multidisciplinary Clinical and Translational Science (MCTS) Program (UL1)UL1TR000150 · NCATS · NORTHWESTERN UNIVERSITY AT CHICAGO · PI LLOYD-JONES, DONALD M · 2012 to 2013
$10.1M
Research on Adverse Drug Events and Reports: Novel Multiple Myeloma DrugsR01CA125077 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI WEST, DENNIS PAUL · 2007 to 2009
$1.7M
NCATS NIH HHS UL1 TR000150NCI NIH HHS 5-R01-CA125077-03NCI NIH HHS R01 CA125077NCRR NIH HHS UL1 RR025741NCRR NIH HHS UL1RR025741
6 · The paper itself

Abstract

backgroundTumour necrosis factor-α inhibitors (TNFαIs) are used for treatment of inflammatory disorders. There is evidence linking these agents with occurrence of malignancies. For four out of five TNFαIs the Food and Drug Administration (FDA) label states, 'melanoma has been reported in patients treated with these agents'.

objectivesTo determine whether a statistically significant association exists between administration of TNFαIs and development of malignant melanoma.

methodsWe searched the FDA Adverse Event Reporting System (FAERS) database for terms related to melanoma and TNFαIs for detection of safety signals. We also searched a large urban academic electronic medical record (EMR) database for which we calculated the relative risk (RR) of melanoma in subjects exposed to TNFαIs vs. nonexposed subjects.

resultsThere were 972 reports of melanoma associated with a TNFαI identified in the FAERS database, with 69 reports among individuals using more than one TNFαI. A safety signal was detected for infliximab, golimumab, etanercept and adalimumab, but not certolizumab pegol. For TNFαIs as a class of drugs, a safety signal was detectable in the FAERS database, and RR was significant in the EMR database. For the EMR cohort, 6045 patients were exposed to TNFαIs and 35 cases of melanoma were detected. Significance for RR was detected for adalimumab (RR 1·8, P = 0·02) and etanercept (RR 2·35, P = 0·0004 < 0·001).

conclusionsWe identified a significant association between exposure to TNFαIs and malignant melanoma in two different analyses. Our findings add to existing evidence linking these agents with the occurrence of malignant melanoma. Additional investigations are required to explore this association further along with the risk of melanoma with TNFαI therapy.

Indexed as

Adverse Drug Reaction Reporting SystemsHumansMelanomaRisk FactorsSkin NeoplasmsTumor Necrosis Factor-alphaTumor Necrosis Factor-alpha

Identifiers

PMID24328939
PMCPMC4029918
OpenAlexW2036601710

What OpenQuestion holds

Textmetadata
LicenceTDM
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.