Predictors of adalimumab dose escalation in patients with crohn's disease at a tertiary referral center

Russell D. Cohen, Jeffrey R. Lewis, Hannah Turner, Laura E. H. Raffals, Stephen B. Hanauer, David T. Rubin

Research output: Contribution to journalArticle

26 Citations (Scopus)

Abstract

Background: Pivotal trials for adalimumab (ADA) demonstrated effectiveness versus placebo for induction and maintenance of remission in moderate to severely active Crohn's disease (CD). Although the approved maintenance regimen in the U.S. is 40 mg subcutaneously every 14 days, some patients require dose-escalation ([DE] either an increase in the delivered dose or decrease in the interval of treatment). Our objective was to determine which patient-, disease-, and therapy-related factors were associated with DE in CD patients treated with ADA. Methods: This retrospective medical record review of patients included all patients treated with ADA for CD at the University of Chicago Inflammatory Bowel Disease Center between 2003 and 2008. Patient-related factors, disease-related factors, and therapy-related factors were analyzed. Survival and logistic regression analyses were performed. Results: In all, 75 patients treated with ADA between December 2003 and June 2008 were identified. Thirty-one subjects (41%) required DE (32% male, median age 37.6, median disease duration 22.7 years) after a median 20 weeks of therapy (range 2-75). Patient-, clinical-, and therapy-related factors were similar between DE and non-DE. Need for DE was predicted by a family history of inflammatory bowel disease (IBD) (P = 0.0187). Time to DE was predicted by male gender, isolated colonic disease, and smoking history (all P < 0.05); however, only male gender was an independent predictor of time to DE. Conclusions: In all, 41% of CD patients required ADA DE, with shorter time to DE in smokers, men, and patients with isolated colonic disease. Patients, caregivers, and insurers should anticipate DE when utilizing ADA in CD.

Original languageEnglish (US)
Pages (from-to)10-16
Number of pages7
JournalInflammatory Bowel Diseases
Volume18
Issue number1
DOIs
StatePublished - Jan 1 2012
Externally publishedYes

Fingerprint

Tertiary Care Centers
Crohn Disease
Colonic Diseases
Inflammatory Bowel Diseases
Adalimumab
Maintenance
Therapeutics
Remission Induction
Insurance Carriers
Caregivers
Medical Records
Logistic Models
Smoking
History
Placebos
Regression Analysis
Survival

Keywords

  • adalimumab
  • anti-TNFα therapy
  • Crohn's disease
  • inflammatory bowel disease

ASJC Scopus subject areas

  • Gastroenterology
  • Immunology and Allergy

Cite this

Predictors of adalimumab dose escalation in patients with crohn's disease at a tertiary referral center. / Cohen, Russell D.; Lewis, Jeffrey R.; Turner, Hannah; Raffals, Laura E. H.; Hanauer, Stephen B.; Rubin, David T.

In: Inflammatory Bowel Diseases, Vol. 18, No. 1, 01.01.2012, p. 10-16.

Research output: Contribution to journalArticle

Cohen, Russell D. ; Lewis, Jeffrey R. ; Turner, Hannah ; Raffals, Laura E. H. ; Hanauer, Stephen B. ; Rubin, David T. / Predictors of adalimumab dose escalation in patients with crohn's disease at a tertiary referral center. In: Inflammatory Bowel Diseases. 2012 ; Vol. 18, No. 1. pp. 10-16.
@article{69d39447c6464ca1bafaac08c791fffc,
title = "Predictors of adalimumab dose escalation in patients with crohn's disease at a tertiary referral center",
abstract = "Background: Pivotal trials for adalimumab (ADA) demonstrated effectiveness versus placebo for induction and maintenance of remission in moderate to severely active Crohn's disease (CD). Although the approved maintenance regimen in the U.S. is 40 mg subcutaneously every 14 days, some patients require dose-escalation ([DE] either an increase in the delivered dose or decrease in the interval of treatment). Our objective was to determine which patient-, disease-, and therapy-related factors were associated with DE in CD patients treated with ADA. Methods: This retrospective medical record review of patients included all patients treated with ADA for CD at the University of Chicago Inflammatory Bowel Disease Center between 2003 and 2008. Patient-related factors, disease-related factors, and therapy-related factors were analyzed. Survival and logistic regression analyses were performed. Results: In all, 75 patients treated with ADA between December 2003 and June 2008 were identified. Thirty-one subjects (41{\%}) required DE (32{\%} male, median age 37.6, median disease duration 22.7 years) after a median 20 weeks of therapy (range 2-75). Patient-, clinical-, and therapy-related factors were similar between DE and non-DE. Need for DE was predicted by a family history of inflammatory bowel disease (IBD) (P = 0.0187). Time to DE was predicted by male gender, isolated colonic disease, and smoking history (all P < 0.05); however, only male gender was an independent predictor of time to DE. Conclusions: In all, 41{\%} of CD patients required ADA DE, with shorter time to DE in smokers, men, and patients with isolated colonic disease. Patients, caregivers, and insurers should anticipate DE when utilizing ADA in CD.",
keywords = "adalimumab, anti-TNFα therapy, Crohn's disease, inflammatory bowel disease",
author = "Cohen, {Russell D.} and Lewis, {Jeffrey R.} and Hannah Turner and Raffals, {Laura E. H.} and Hanauer, {Stephen B.} and Rubin, {David T.}",
year = "2012",
month = "1",
day = "1",
doi = "10.1002/ibd.21707",
language = "English (US)",
volume = "18",
pages = "10--16",
journal = "Inflammatory Bowel Diseases",
issn = "1078-0998",
publisher = "John Wiley and Sons Inc.",
number = "1",

}

TY - JOUR

T1 - Predictors of adalimumab dose escalation in patients with crohn's disease at a tertiary referral center

AU - Cohen, Russell D.

AU - Lewis, Jeffrey R.

AU - Turner, Hannah

AU - Raffals, Laura E. H.

AU - Hanauer, Stephen B.

AU - Rubin, David T.

PY - 2012/1/1

Y1 - 2012/1/1

N2 - Background: Pivotal trials for adalimumab (ADA) demonstrated effectiveness versus placebo for induction and maintenance of remission in moderate to severely active Crohn's disease (CD). Although the approved maintenance regimen in the U.S. is 40 mg subcutaneously every 14 days, some patients require dose-escalation ([DE] either an increase in the delivered dose or decrease in the interval of treatment). Our objective was to determine which patient-, disease-, and therapy-related factors were associated with DE in CD patients treated with ADA. Methods: This retrospective medical record review of patients included all patients treated with ADA for CD at the University of Chicago Inflammatory Bowel Disease Center between 2003 and 2008. Patient-related factors, disease-related factors, and therapy-related factors were analyzed. Survival and logistic regression analyses were performed. Results: In all, 75 patients treated with ADA between December 2003 and June 2008 were identified. Thirty-one subjects (41%) required DE (32% male, median age 37.6, median disease duration 22.7 years) after a median 20 weeks of therapy (range 2-75). Patient-, clinical-, and therapy-related factors were similar between DE and non-DE. Need for DE was predicted by a family history of inflammatory bowel disease (IBD) (P = 0.0187). Time to DE was predicted by male gender, isolated colonic disease, and smoking history (all P < 0.05); however, only male gender was an independent predictor of time to DE. Conclusions: In all, 41% of CD patients required ADA DE, with shorter time to DE in smokers, men, and patients with isolated colonic disease. Patients, caregivers, and insurers should anticipate DE when utilizing ADA in CD.

AB - Background: Pivotal trials for adalimumab (ADA) demonstrated effectiveness versus placebo for induction and maintenance of remission in moderate to severely active Crohn's disease (CD). Although the approved maintenance regimen in the U.S. is 40 mg subcutaneously every 14 days, some patients require dose-escalation ([DE] either an increase in the delivered dose or decrease in the interval of treatment). Our objective was to determine which patient-, disease-, and therapy-related factors were associated with DE in CD patients treated with ADA. Methods: This retrospective medical record review of patients included all patients treated with ADA for CD at the University of Chicago Inflammatory Bowel Disease Center between 2003 and 2008. Patient-related factors, disease-related factors, and therapy-related factors were analyzed. Survival and logistic regression analyses were performed. Results: In all, 75 patients treated with ADA between December 2003 and June 2008 were identified. Thirty-one subjects (41%) required DE (32% male, median age 37.6, median disease duration 22.7 years) after a median 20 weeks of therapy (range 2-75). Patient-, clinical-, and therapy-related factors were similar between DE and non-DE. Need for DE was predicted by a family history of inflammatory bowel disease (IBD) (P = 0.0187). Time to DE was predicted by male gender, isolated colonic disease, and smoking history (all P < 0.05); however, only male gender was an independent predictor of time to DE. Conclusions: In all, 41% of CD patients required ADA DE, with shorter time to DE in smokers, men, and patients with isolated colonic disease. Patients, caregivers, and insurers should anticipate DE when utilizing ADA in CD.

KW - adalimumab

KW - anti-TNFα therapy

KW - Crohn's disease

KW - inflammatory bowel disease

UR - http://www.scopus.com/inward/record.url?scp=83555172398&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=83555172398&partnerID=8YFLogxK

U2 - 10.1002/ibd.21707

DO - 10.1002/ibd.21707

M3 - Article

VL - 18

SP - 10

EP - 16

JO - Inflammatory Bowel Diseases

JF - Inflammatory Bowel Diseases

SN - 1078-0998

IS - 1

ER -