Evidence map›Paper›PMID 34504225›Full record

ArticleScientific reports2021

Association between 9-month isoniazid prophylaxis of latent tuberculosis and severe hepatitis in patients treated with TNF inhibitors.

Edward Chia-Cheng Lai, Hsun-Yin Liang, Ya-Chun Huang, Wei-I Huang, Pi-Hui Chao, Wen-Wen Chen, Meng-Yu Weng

Erratum issuedOpen access · goldAbstract read
In one paragraph

Article in Scientific reports, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 51% 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

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Edward Chia-Cheng LaiSchool of Pharmacy, Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
Hsun-Yin LiangTaiwan Drug Relief Foundation, Taipei, Taiwan.
Ya-Chun HuangDepartment of Internal Medicine, Division of Allergy, Immunology, and Rheumatology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, No. 138 Shen-Li Rd., Tainan, 704, Taiwan.
Wei-I HuangTaiwan Drug Relief Foundation, Taipei, Taiwan.
Pi-Hui ChaoTaiwan Drug Relief Foundation, Taipei, Taiwan.
Wen-Wen ChenTaiwan Drug Relief Foundation, Taipei, Taiwan.
Meng-Yu WengDepartment of Internal Medicine, Division of Allergy, Immunology, and Rheumatology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, No. 138 Shen-Li Rd., Tainan, 704, Taiwan. maggieweng69@gmail.com.ORCID 0000-0002-0741-2134
Taiwan Food and Drug Administration · TWNational Cheng Kung University Hospital · TWNational Cheng Kung University · TW

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

To investigate associations between isoniazid for latent tuberculosis and risk of severe hepatitis, affecting patients with rheumatoid arthritis or ankylosing spondylitis whose treatment includes tumor necrosis factor inhibitors. Our self-controlled case series study analyzed Taiwan's National Health Insurance Database from 2003 to 2015 to identify RA or AS patients, aged ≥ 20 years, receiving TNF inhibitors and a 9-month single isoniazid treatment. The outcome of interest was hospitalization due to severe hepatitis. We defined risk periods by isoniazid exposure (days): 1-28, 29-56, 57-84, 85-168, 169-252, and 253-280. To compare risk of severe hepatitis in exposed and non-exposed periods, we performed conditional Poisson regressions to generate incidence rate ratios (IRR) and 95% confidence intervals, with adjustment of patients' baseline covariates including age, sex, HBV, HCV and related medication. Of 54,267 RA patients and 137,889 AS patients identified between 2000 and 2015, 11,221 (20.7%) RA and 4,208 (3.1%) AS patients underwent TNFi therapy, with 722 (5%) receiving isoniazid for latent tuberculosis. We identified 31 incident cases (4.3%) of hospitalization due to severe hepatitis. Of these hospitalization events, 5 occurred in the exposed periods, 25 occurred in the INH unexposed periods, and 1 occurred in the pre-exposure period. Compared with non-exposure, the risk of severe hepatitis was higher in exposed periods (incidence rate ratio [IRR]: 5.1, 95% CI: 1.57-16.55), especially 57-84 days (IRR: 17.29, 95% CI: 3.11-96.25) and 85-168 days (IRR:10.55, 95% CI: 1.90-58.51). The INH related fatal hepatotoxicity was not identified in our study. Our findings suggest an association between risk of severe hepatitis and exposure to isoniazid in patients with RA or AS under TNFi therapy, particularly within the exposed period 57-168 days. A close monitoring of liver function is mandatory to minimize the risk, especially within the first 6 months after initiation of 9 months isoniazid.

Indexed as

AdultAgedAntitubercular AgentsArthritis, RheumatoidFemaleHepatitisHospitalizationHumansIsoniazidLatent TuberculosisMaleMiddle AgedMycobacterium tuberculosisPost-Exposure ProphylaxisRisk AssessmentSeverity of Illness IndexAntitubercular AgentsIsoniazidTumor Necrosis Factor Inhibitors

Identifiers

PMID34504225
PMCPMC8429453
OpenAlexW3196384162

What OpenQuestion holds

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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.