Effectiveness of Adjunctive High-Dose Infliximab Therapy to Improve Disability-Free Survival Among Patients With Severe Central Nervous System Tuberculosis: A Matched Retrospective Cohort Study.


Journal

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
ISSN: 1537-6591
Titre abrégé: Clin Infect Dis
Pays: United States
ID NLM: 9203213

Informations de publication

Date de publication:
17 11 2023
Historique:
received: 07 03 2023
medline: 20 11 2023
pubmed: 5 7 2023
entrez: 5 7 2023
Statut: ppublish

Résumé

Few treatment options exist for patients with severe central nervous system (CNS) tuberculosis (TB) worsening due to inflammatory lesions, despite optimal antitubercular therapy (ATT) and steroids. Data regarding the efficacy and safety of infliximab in these patients are sparse. We performed a matched retrospective cohort study based on Medical Research Council (MRC) grading system and modified Rankin Scale (mRS) scores comparing 2 groups of adults with CNS TB. Cohort A received at least 1 dose of infliximab after optimal ATT and steroids between March 2019 and July 2022. Cohort B received only ATT and steroids. Disability-free survival (mRS score ≤2) at 6 months was the primary outcome. Baseline MRC grades and mRS scores were similar between the cohorts. Median duration before initiation of infliximab therapy from start of ATT and steroids was 6 (IQR: 3.7-13) months and for neurological deficits was 4 (IQR: 2-6.2) months. Indications for infliximab were symptomatic tuberculomas (20/30; 66.7%), spinal cord involvement with paraparesis (8/30; 26.7%), and optochiasmatic arachnoiditis (3/30; 10%), worsening despite adequate ATT and steroids. Severe disability (5/30 [16.7%] and 21/60 [35%]) and all-cause mortality (2/30 [6.7%] and 13/60 [21.7%]) at 6 months were lower in cohort A versus cohort B, respectively. In the combined study population, only exposure to infliximab was positively associated (aRR: 6.2; 95% CI: 2.18-17.83; P = .001) with disability-free survival at 6 months. There were no clear infliximab-related side effects noted. Infliximab may be an effective and safe adjunctive strategy among severely disabled patients with CNS TB not improving despite optimal ATT and steroids. Adequately powered phase 3 clinical trials are required to confirm these early findings.

Sections du résumé

BACKGROUND
Few treatment options exist for patients with severe central nervous system (CNS) tuberculosis (TB) worsening due to inflammatory lesions, despite optimal antitubercular therapy (ATT) and steroids. Data regarding the efficacy and safety of infliximab in these patients are sparse.
METHODS
We performed a matched retrospective cohort study based on Medical Research Council (MRC) grading system and modified Rankin Scale (mRS) scores comparing 2 groups of adults with CNS TB. Cohort A received at least 1 dose of infliximab after optimal ATT and steroids between March 2019 and July 2022. Cohort B received only ATT and steroids. Disability-free survival (mRS score ≤2) at 6 months was the primary outcome.
RESULTS
Baseline MRC grades and mRS scores were similar between the cohorts. Median duration before initiation of infliximab therapy from start of ATT and steroids was 6 (IQR: 3.7-13) months and for neurological deficits was 4 (IQR: 2-6.2) months. Indications for infliximab were symptomatic tuberculomas (20/30; 66.7%), spinal cord involvement with paraparesis (8/30; 26.7%), and optochiasmatic arachnoiditis (3/30; 10%), worsening despite adequate ATT and steroids. Severe disability (5/30 [16.7%] and 21/60 [35%]) and all-cause mortality (2/30 [6.7%] and 13/60 [21.7%]) at 6 months were lower in cohort A versus cohort B, respectively. In the combined study population, only exposure to infliximab was positively associated (aRR: 6.2; 95% CI: 2.18-17.83; P = .001) with disability-free survival at 6 months. There were no clear infliximab-related side effects noted.
CONCLUSIONS
Infliximab may be an effective and safe adjunctive strategy among severely disabled patients with CNS TB not improving despite optimal ATT and steroids. Adequately powered phase 3 clinical trials are required to confirm these early findings.

Identifiants

pubmed: 37405816
pii: 7219699
doi: 10.1093/cid/ciad401
doi:

Substances chimiques

Antitubercular Agents 0
Infliximab B72HH48FLU
Steroids 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1460-1467

Informations de copyright

© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Déclaration de conflit d'intérêts

Potential conflicts of interest. The authors: No reported conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest.

Auteurs

Abi Manesh (A)

Department of Infectious Diseases, Christian Medical College, Vellore, Tamil Nadu, India.

Priyanka Gautam (P)

Department of Infectious Diseases, Christian Medical College, Vellore, Tamil Nadu, India.

Selwyn Selva Kumar D (SS)

Department of Infectious Diseases, Christian Medical College, Vellore, Tamil Nadu, India.

Pavithra Mannam (P)

Department of Radiology, Christian Medical College, Vellore, Tamil Nadu, India.

Anitha Jasper (A)

Department of Radiology, Christian Medical College, Vellore, Tamil Nadu, India.

Karthik Gunasekaran (K)

Department of Internal Medicine, Christian Medical College, Vellore, Tamil Nadu, India.

Naveen Cherian Thomas (NC)

Department of Physical Medicine and Rehabilitation, Christian Medical College, Vellore, Tamil Nadu, India.

Rohit Ninan Benjamin (RN)

Department of Neurology, Christian Medical College, Vellore, Tamil Nadu, India.

Leeberk Raja Inbaraj (LR)

Department of Clinical Research, ICMR-National Institute for Research in Tuberculosis, Chennai, Tamil Nadu, India.

Emily Devasagayam (E)

Department of Infectious Diseases, Christian Medical College, Vellore, Tamil Nadu, India.

Mithun Mohan George (MM)

Department of Infectious Diseases, Christian Medical College, Vellore, Tamil Nadu, India.

Rajiv Karthik (R)

Department of Infectious Diseases, Christian Medical College, Vellore, Tamil Nadu, India.

Ooriapadickal Cherian Abraham (OC)

Department of Internal Medicine, Christian Medical College, Vellore, Tamil Nadu, India.

Harshad A Vanjare (HA)

Department of Radiology, Christian Medical College, Vellore, Tamil Nadu, India.

Ajith Sivadasan (A)

Department of Neurology, Christian Medical College, Vellore, Tamil Nadu, India.

Prabhakar Thirumal Appaswamy (PT)

Department of Neurology, Christian Medical College, Vellore, Tamil Nadu, India.

Edmond Jonathan (E)

Department of Neurosurgery, Christian Medical College, Vellore, Tamil Nadu, India.

Joy S Michael (JS)

Department of Clinical Microbiology, Christian Medical College, Vellore, Tamil Nadu, India.

Prasanna Samuel (P)

Department of Biostatistics, Christian Medical College, Vellore, Tamil Nadu, India.

George M Varghese (GM)

Department of Infectious Diseases, Christian Medical College, Vellore, Tamil Nadu, India.

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