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Interferon-γ release assay screening in biologics: safe and reliable, but not perfect

BACKGROUND: Systemic biologic agents can increase the risk of re-activation of latent tuberculosis (TB). Prior to initiation, screening for latent TB using an interferon-γ release assay (IGRA) is recommended. There is concern that false-negative IGRAs may be more likely in this context. METHODS: Thi...

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Autores principales: Cafferkey, John, Padayachee, Yorissa, Kostich, Sophia, Kumar, Kartik, Jewell, Paul, Patel, Mikin, Chavda, Aneeka, Cox, Alison, Park, Mirae, Russell, Georgina, Coleman, Meg, Martin, Laura, Kon, Onn Min
Formato: Online Artículo Texto
Lenguaje:English
Publicado: European Respiratory Society 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9703145/
https://www.ncbi.nlm.nih.gov/pubmed/36451845
http://dx.doi.org/10.1183/23120541.00193-2022
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author Cafferkey, John
Padayachee, Yorissa
Kostich, Sophia
Kumar, Kartik
Jewell, Paul
Patel, Mikin
Chavda, Aneeka
Cox, Alison
Park, Mirae
Russell, Georgina
Coleman, Meg
Martin, Laura
Kon, Onn Min
author_facet Cafferkey, John
Padayachee, Yorissa
Kostich, Sophia
Kumar, Kartik
Jewell, Paul
Patel, Mikin
Chavda, Aneeka
Cox, Alison
Park, Mirae
Russell, Georgina
Coleman, Meg
Martin, Laura
Kon, Onn Min
author_sort Cafferkey, John
collection PubMed
description BACKGROUND: Systemic biologic agents can increase the risk of re-activation of latent tuberculosis (TB). Prior to initiation, screening for latent TB using an interferon-γ release assay (IGRA) is recommended. There is concern that false-negative IGRAs may be more likely in this context. METHODS: This retrospective analysis of IGRAs, specifically T-SPOT.TB, results and outcomes of patients already on or due to start biologics identifies the rate of TB re-activation in a low TB incidence setting. Additionally, we estimate the negative predictive value (NPV) of IGRAs in this population. RESULTS: Patients on biologics were more likely to have a negative IGRA result than patients not on biologics. There was no statistically significant change in conversion or reversion rates between groups. Of 9263 patients on biologics, 19 developed active TB after starting biologics at an incidence rate of 55.1 per 100 000 patient-years. This occurred despite screening in half of the 16 patients for whom we were able to review medical records. Most drugs implicated were known to be high risk, although rituximab and natalizumab were being taken by five patients and one patient, respectively. The T-SPOT.TB NPV was 99.20% and dropped only slightly to 99.17% when we simulated an approach where all borderline IGRA results were regarded as being negative. CONCLUSIONS: Negative IGRA results confer a low risk of subsequent active TB in patients on biologics in a low TB incidence setting. However, continued awareness is needed given that a number of active TB cases will have had a prior negative result.
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spelling pubmed-97031452022-11-29 Interferon-γ release assay screening in biologics: safe and reliable, but not perfect Cafferkey, John Padayachee, Yorissa Kostich, Sophia Kumar, Kartik Jewell, Paul Patel, Mikin Chavda, Aneeka Cox, Alison Park, Mirae Russell, Georgina Coleman, Meg Martin, Laura Kon, Onn Min ERJ Open Res Original Research Articles BACKGROUND: Systemic biologic agents can increase the risk of re-activation of latent tuberculosis (TB). Prior to initiation, screening for latent TB using an interferon-γ release assay (IGRA) is recommended. There is concern that false-negative IGRAs may be more likely in this context. METHODS: This retrospective analysis of IGRAs, specifically T-SPOT.TB, results and outcomes of patients already on or due to start biologics identifies the rate of TB re-activation in a low TB incidence setting. Additionally, we estimate the negative predictive value (NPV) of IGRAs in this population. RESULTS: Patients on biologics were more likely to have a negative IGRA result than patients not on biologics. There was no statistically significant change in conversion or reversion rates between groups. Of 9263 patients on biologics, 19 developed active TB after starting biologics at an incidence rate of 55.1 per 100 000 patient-years. This occurred despite screening in half of the 16 patients for whom we were able to review medical records. Most drugs implicated were known to be high risk, although rituximab and natalizumab were being taken by five patients and one patient, respectively. The T-SPOT.TB NPV was 99.20% and dropped only slightly to 99.17% when we simulated an approach where all borderline IGRA results were regarded as being negative. CONCLUSIONS: Negative IGRA results confer a low risk of subsequent active TB in patients on biologics in a low TB incidence setting. However, continued awareness is needed given that a number of active TB cases will have had a prior negative result. European Respiratory Society 2022-11-28 /pmc/articles/PMC9703145/ /pubmed/36451845 http://dx.doi.org/10.1183/23120541.00193-2022 Text en Copyright ©The authors 2022 https://creativecommons.org/licenses/by-nc/4.0/This version is distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0. For commercial reproduction rights and permissions contact permissions@ersnet.org (mailto:permissions@ersnet.org)
spellingShingle Original Research Articles
Cafferkey, John
Padayachee, Yorissa
Kostich, Sophia
Kumar, Kartik
Jewell, Paul
Patel, Mikin
Chavda, Aneeka
Cox, Alison
Park, Mirae
Russell, Georgina
Coleman, Meg
Martin, Laura
Kon, Onn Min
Interferon-γ release assay screening in biologics: safe and reliable, but not perfect
title Interferon-γ release assay screening in biologics: safe and reliable, but not perfect
title_full Interferon-γ release assay screening in biologics: safe and reliable, but not perfect
title_fullStr Interferon-γ release assay screening in biologics: safe and reliable, but not perfect
title_full_unstemmed Interferon-γ release assay screening in biologics: safe and reliable, but not perfect
title_short Interferon-γ release assay screening in biologics: safe and reliable, but not perfect
title_sort interferon-γ release assay screening in biologics: safe and reliable, but not perfect
topic Original Research Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9703145/
https://www.ncbi.nlm.nih.gov/pubmed/36451845
http://dx.doi.org/10.1183/23120541.00193-2022
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