End of Induction Patient-reported Outcomes Predict Clinical Remission but Not Endoscopic Remission in Crohn's Disease.
Crohn’s disease
inflammatory bowel disease
patient-reported outcomes
Journal
Journal of Crohn's & colitis
ISSN: 1876-4479
Titre abrégé: J Crohns Colitis
Pays: England
ID NLM: 101318676
Informations de publication
Date de publication:
05 Jul 2021
05 Jul 2021
Historique:
pubmed:
28
11
2020
medline:
15
12
2021
entrez:
27
11
2020
Statut:
ppublish
Résumé
It is unclear whether early symptom improvement in Crohn's disease [CD] provides any prognostic information for patients long-term. This paper aims to investigate the relationship between early patient-reported outcomes [PROs] after completion of induction of infliximab, and their relationship with long-term clinical remission [CR] and endoscopic remission [ER]. This post-hoc analysis [Clinicaltrials.gov: NCT02096861] used data from 220 CD patients to evaluate the relationship of Weeks 6 and 14 PRO variables and Week 54 clinical remission (Crohn's Disease Activity Index [CDAI <150), PRO2 remission (mean score abdominal pain [AP] ≤1 and stool frequency [SF] ≤1.5), and endoscopic remission (Simple Endoscopic Score-CD [SES-CD <3). Multivariable logistic regression models adjusted for confounders were used to assess the relationships between post-induction PROs and outcomes of interest. Patients with moderate or severe AP after induction had reduced odds of achieving 1-year CR and PRO2 remission compared with those with mild AP (adjusted odds ratio [aOR] for CR 0.31, 95% confidence interval [CI] 0.17-0.57, p = 0.0002). Similarly, patients with moderately to severely elevated SF after induction had reduced odds of 1-year CR and PRO2 remission compared with patients with less SF [aOR for CR 0.31, 95% CI 0.16-0.58, p = 0.0003]. No significant differences were found when comparing higher Weeks 6 or 14 PRO scores of AP and/or SF with lower PRO scores in the odds of achieving 1-year ER. Post-induction PROs of AP and SF strongly predict likelihood of 1-year CR but are not associated with 1-year ER. Clinical symptoms alone should not be relied upon when assessing response to therapies for CD.
Sections du résumé
BACKGROUND AND AIMS
OBJECTIVE
It is unclear whether early symptom improvement in Crohn's disease [CD] provides any prognostic information for patients long-term. This paper aims to investigate the relationship between early patient-reported outcomes [PROs] after completion of induction of infliximab, and their relationship with long-term clinical remission [CR] and endoscopic remission [ER].
METHODS
METHODS
This post-hoc analysis [Clinicaltrials.gov: NCT02096861] used data from 220 CD patients to evaluate the relationship of Weeks 6 and 14 PRO variables and Week 54 clinical remission (Crohn's Disease Activity Index [CDAI <150), PRO2 remission (mean score abdominal pain [AP] ≤1 and stool frequency [SF] ≤1.5), and endoscopic remission (Simple Endoscopic Score-CD [SES-CD <3). Multivariable logistic regression models adjusted for confounders were used to assess the relationships between post-induction PROs and outcomes of interest.
RESULTS
RESULTS
Patients with moderate or severe AP after induction had reduced odds of achieving 1-year CR and PRO2 remission compared with those with mild AP (adjusted odds ratio [aOR] for CR 0.31, 95% confidence interval [CI] 0.17-0.57, p = 0.0002). Similarly, patients with moderately to severely elevated SF after induction had reduced odds of 1-year CR and PRO2 remission compared with patients with less SF [aOR for CR 0.31, 95% CI 0.16-0.58, p = 0.0003]. No significant differences were found when comparing higher Weeks 6 or 14 PRO scores of AP and/or SF with lower PRO scores in the odds of achieving 1-year ER.
CONCLUSIONS
CONCLUSIONS
Post-induction PROs of AP and SF strongly predict likelihood of 1-year CR but are not associated with 1-year ER. Clinical symptoms alone should not be relied upon when assessing response to therapies for CD.
Identifiants
pubmed: 33245751
pii: 6007629
doi: 10.1093/ecco-jcc/jjaa242
pmc: PMC8491840
doi:
Substances chimiques
Gastrointestinal Agents
0
Infliximab
B72HH48FLU
Banques de données
ClinicalTrials.gov
['NCT02096861']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1114-1119Subventions
Organisme : NIDDK NIH HHS
ID : P30 DK120515
Pays : United States
Organisme : NIH HHS
ID : DK120515
Pays : United States
Organisme : Digestive Diseases Research Center
Organisme : American Gastroenterology Association
Commentaires et corrections
Type : CommentIn
Informations de copyright
© The Author(s) 2020. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.
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