Evidence map›Paper›PMID 39845804›Full record

ArticleFrontiers in pharmacology2024

Analysis of the risk of oncological adverse events associated with infliximab in combination with azathioprine compared to monotherapy: insights from the FAERS database.

Qian Qiao, Jiachen Sun, Ya Zheng, Yingying Mi, Yanan Gong, Jiahui Liu, Wenyue Rui, Yumei Ma, Yongning Zhou, Min Liu

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Frontiers in pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

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

1 citing paper in PubMed.

  1. Article
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

10 authors.

Qian QiaoThe First Clinical Medical College, Lanzhou University, Lanzhou, China.
Jiachen SunThe First Clinical Medical College, Lanzhou University, Lanzhou, China.
Ya ZhengDepartment of Gastroenterology, The First Hospital of Lanzhou University, Lanzhou, China.
Yingying MiThe First Clinical Medical College, Lanzhou University, Lanzhou, China.
Yanan GongDepartment of Gastroenterology, The First Hospital of Lanzhou University, Lanzhou, China.
Jiahui LiuThe First Clinical Medical College, Lanzhou University, Lanzhou, China.
Wenyue RuiThe First Clinical Medical College, Lanzhou University, Lanzhou, China.
Yumei MaThe First Clinical Medical College, Lanzhou University, Lanzhou, China.
Yongning ZhouDepartment of Gastroenterology, The First Hospital of Lanzhou University, Lanzhou, China.
Min LiuDepartment of Gastroenterology, The First Hospital of Lanzhou University, Lanzhou, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: This study aimed to evaluate the risk of tumor formation with infliximab or azathioprine monotherapy versus their combination, using the FDA Adverse Event Reporting System (FAERS) database. Methods: Data were extracted from the FAERS database for patients treated with infliximab, azathioprine, and combination therapy from Q1 2004 to Q2 2024. Signal mining employed methods such as Reported Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Multiple Gamma-Poisson Scaling Assessment (MGPSA) and Bayesian Confidence Interval Progressive Neural Network (BCPNN). Results: Our analysis of the FAERS database revealed that the highest number of reported cases involved skin-related tumors, both individually and in combination. In terms of sex, the risk of cancer was higher in men compared to women in the infliximab-only and combination groups; however, no sex difference was observed in the azathioprine-only group. Regarding age, we noted an increasing incidence of adverse tumor events in middle-aged and elderly individuals compared to minors, except in the azathioprine group, where age was not identified as an independent risk factor. Additionally, body weight was not found to be an independent risk factor in any of the three medication groups. After controlling for age, sex, and body weight, combination therapy did not increase the risk of tumor development compared to the azathioprine group alone. In contrast, for patients using infliximab alone, combination therapy not only did not elevate the risk of tumor development but also appeared to reduce it. The results of the Weber distribution suggest a random failure-type profile for the infliximab and azathioprine-only group, while an early failure-type profile was observed for the combination therapy. Furthermore, we analyzed the median time to onset and cumulative incidence rates, revealing no significant differences in median time to tumor onset or cumulative incidence rates between the combination therapy and the single agent. Conclusion: After adjusting for age, sex, and body weight, combination therapy did not significantly increase tumor development risk compared to the azathioprine-only group. Additionally, in patients on infliximab monotherapy, combination therapy appeared to reduce the risk of tumor development.

Indexed as

adverse eventazathioprinecombined treatmentFAERSinfliximabtumor

Identifiers

PMID39845804
PMCPMC11750843

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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.