Impact of Treatment Response on Risk of Serious Infections in Patients with Crohn's Disease: Secondary Analysis of the PYRAMID Registry.

IBD Safety biologics comparative effectiveness positioning

Journal

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
ISSN: 1542-7714
Titre abrégé: Clin Gastroenterol Hepatol
Pays: United States
ID NLM: 101160775

Informations de publication

Date de publication:
10 Jan 2024
Historique:
received: 03 11 2023
revised: 21 12 2023
accepted: 02 01 2024
medline: 13 1 2024
pubmed: 13 1 2024
entrez: 12 1 2024
Statut: aheadofprint

Résumé

Traditional risk factors for serious infections with advanced therapies in patients with Crohn's disease (CD) have been assessed at baseline prior to starting therapy. We evaluated the impact of treatment response on the risk of serious infections in adalimumab-treated patients with CD through secondary analysis of the PYRAMID registry (NCT00524537). We included patients with CD who initiated adalimumab and classified them as treatment responders (achieved steroid-free clinical remission based on patient-reported outcomes) vs. non-responders (not in steroid-free clinical remission) at 6m after treatment initiation (landmark). We compared the risk of serious infections between responders vs. non-responders between 6-36m after treatment initiation, through stabilized inverse probability of treatment weighted (IPW) Cox proportional hazards model. Of 1515 adalimumab-treated patients, 763 (50.4%) were classified as responders at 6m (37±13y, 56% female, disease duration, 9.5±8.5y). Compared with non-responders, responders were less likely to have moderate to severe symptoms (55.6% vs. 33%), require steroids (45.5% vs. 17.3%) or opiates (6.6% vs. 1.3%) at baseline, without any differences in disease location, perianal disease, and prior CD complications. During follow-up, using stabilized IPW, responders were 34% less likely to experience serious infections compared with non-responders (HR,0.66; 95% CI,0.46-0.96). Risk of gastrointestinal and extra-intestinal infections was lower in responders vs. non-responders. Patients with CD who respond to adalimumab have lower risk of developing serious infections, compared with non-responders. These findings underscore that initiation of advanced therapy for CD may lower the risk of serious infections through effective disease control and avoidance of corticosteroids.

Sections du résumé

BACKGROUND AND AIMS OBJECTIVE
Traditional risk factors for serious infections with advanced therapies in patients with Crohn's disease (CD) have been assessed at baseline prior to starting therapy. We evaluated the impact of treatment response on the risk of serious infections in adalimumab-treated patients with CD through secondary analysis of the PYRAMID registry (NCT00524537).
METHODS METHODS
We included patients with CD who initiated adalimumab and classified them as treatment responders (achieved steroid-free clinical remission based on patient-reported outcomes) vs. non-responders (not in steroid-free clinical remission) at 6m after treatment initiation (landmark). We compared the risk of serious infections between responders vs. non-responders between 6-36m after treatment initiation, through stabilized inverse probability of treatment weighted (IPW) Cox proportional hazards model.
RESULTS RESULTS
Of 1515 adalimumab-treated patients, 763 (50.4%) were classified as responders at 6m (37±13y, 56% female, disease duration, 9.5±8.5y). Compared with non-responders, responders were less likely to have moderate to severe symptoms (55.6% vs. 33%), require steroids (45.5% vs. 17.3%) or opiates (6.6% vs. 1.3%) at baseline, without any differences in disease location, perianal disease, and prior CD complications. During follow-up, using stabilized IPW, responders were 34% less likely to experience serious infections compared with non-responders (HR,0.66; 95% CI,0.46-0.96). Risk of gastrointestinal and extra-intestinal infections was lower in responders vs. non-responders.
CONCLUSIONS CONCLUSIONS
Patients with CD who respond to adalimumab have lower risk of developing serious infections, compared with non-responders. These findings underscore that initiation of advanced therapy for CD may lower the risk of serious infections through effective disease control and avoidance of corticosteroids.

Identifiants

DOI: 10.1016/j.cgh.2024.01.003 PMID: 38216022
pubmed: 38216022
pii: S1542-3565(24)00047-8
doi: 10.1016/j.cgh.2024.01.003
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT00524537']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © 2024 AGA Institute. Published by Elsevier Inc. All rights reserved.

Auteurs

Dhruv Ahuja (D)

Department of Medicine, Indira Gandhi Hospital, New Delhi, India.

Jiyu Luo (J)

Biostatistics and Bioinformatics, Herbert Wertheim School of Public Health, University of California San Diego, La Jolla, California, USA.

Yuchen Qi (Y)

Biostatistics and Bioinformatics, Herbert Wertheim School of Public Health, University of California San Diego, La Jolla, California, USA.

Gaurav Syal (G)

Division of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, California, USA.

Brigid S Boland (BS)

Division of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, California, USA.

John Chang (J)

Division of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, California, USA.

Christopher Ma (C)

Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada; Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada.

Vipul Jairath (V)

Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada; Department of Epidemiology & Biostatistics, Western University, London, Ontario, Canada.

Ronghui Xu (R)

Biostatistics and Bioinformatics, Herbert Wertheim School of Public Health, University of California San Diego, La Jolla, California, USA.

Siddharth Singh (S)

Division of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, California, USA; Division of Biomedical Informatics, Department of Medicine, University of California San Diego, La Jolla, California, USA. Electronic address: sis040@ucsd.edu.

Classifications MeSH