Treatment patterns, complications, and disease relapse in a real-world population of patients with moderate-to-severe ulcerative colitis initiating immunomodulator therapy

Edward Vincent Loftus, Jr, Keith L. Davis, Chi Chuan Wang, Homa Dastani, Allison Luo

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Background: Immunomodulator (IM) treatments in ulcerative colitis (UC) are not curative and carry increased risk of complications, sometimes leading to therapy changes, reduced treatment benefits, and eventual relapse. We assessed patterns of IM utilization and therapy changes, complications, and disease relapse in a real-world population of patients with moderate-to-severe UC. Methods: Claims data from a large commercially insured U.S. population were retrospectively analyzed. Inclusion criteria were (1) ≥ 2 UC diagnosis claims (ICD-9-CM 556.xx) between January 2005 and July 2010, (2) ≥ 1 IM claim, where first IM claim defined the index date, (3) ≥ 12 months preindex health plan enrollment (baseline), and (4) ≥ 24 months postindex plan enrollment (follow-up). Characteristics of and changes to the index IM therapy during follow-up were descriptively assessed, as were complications and disease relapses. Results: A total of 2136 patients were identified for inclusion (age, mean [SD], 46 [16] years, 54% female). Azathioprine was the most common index IM (46% of patients), followed by 6-mercaptopurine (28%). Switching from the index IM to another therapy class was common (21% of patients), with 5-ASAs (48% of switchers), oral corticosteroids (21%), and biologics (17%) being the most frequent next agents used. Augmentation was also common (25% of patients), with 5-ASA being, by far, the most frequent agent added to the index IM (72% of augmenters). Thirty percent of patients experienced a complication, and 73% of patients relapsed, with the majority of relapses occurring during index IM exposure. Conclusions: This assessment of IM treatments for UC demonstrated frequent changes to therapy and high downstream complication and relapse rates.

Original languageEnglish (US)
Pages (from-to)1361-1367
Number of pages7
JournalInflammatory Bowel Diseases
Volume20
Issue number8
DOIs
StatePublished - 2014

Fingerprint

Immunologic Factors
Ulcerative Colitis
Recurrence
Population
Therapeutics
6-Mercaptopurine
Azathioprine
International Classification of Diseases
Biological Products
Adrenal Cortex Hormones
Health

Keywords

  • Complications
  • Immunomodulators
  • Relapse
  • Treatment patterns
  • Ulcerative colitis

ASJC Scopus subject areas

  • Gastroenterology
  • Immunology and Allergy
  • Medicine(all)

Cite this

Treatment patterns, complications, and disease relapse in a real-world population of patients with moderate-to-severe ulcerative colitis initiating immunomodulator therapy. / Loftus, Jr, Edward Vincent; Davis, Keith L.; Wang, Chi Chuan; Dastani, Homa; Luo, Allison.

In: Inflammatory Bowel Diseases, Vol. 20, No. 8, 2014, p. 1361-1367.

Research output: Contribution to journalArticle

@article{3743d5d61328422093fceba722b7e2b9,
title = "Treatment patterns, complications, and disease relapse in a real-world population of patients with moderate-to-severe ulcerative colitis initiating immunomodulator therapy",
abstract = "Background: Immunomodulator (IM) treatments in ulcerative colitis (UC) are not curative and carry increased risk of complications, sometimes leading to therapy changes, reduced treatment benefits, and eventual relapse. We assessed patterns of IM utilization and therapy changes, complications, and disease relapse in a real-world population of patients with moderate-to-severe UC. Methods: Claims data from a large commercially insured U.S. population were retrospectively analyzed. Inclusion criteria were (1) ≥ 2 UC diagnosis claims (ICD-9-CM 556.xx) between January 2005 and July 2010, (2) ≥ 1 IM claim, where first IM claim defined the index date, (3) ≥ 12 months preindex health plan enrollment (baseline), and (4) ≥ 24 months postindex plan enrollment (follow-up). Characteristics of and changes to the index IM therapy during follow-up were descriptively assessed, as were complications and disease relapses. Results: A total of 2136 patients were identified for inclusion (age, mean [SD], 46 [16] years, 54{\%} female). Azathioprine was the most common index IM (46{\%} of patients), followed by 6-mercaptopurine (28{\%}). Switching from the index IM to another therapy class was common (21{\%} of patients), with 5-ASAs (48{\%} of switchers), oral corticosteroids (21{\%}), and biologics (17{\%}) being the most frequent next agents used. Augmentation was also common (25{\%} of patients), with 5-ASA being, by far, the most frequent agent added to the index IM (72{\%} of augmenters). Thirty percent of patients experienced a complication, and 73{\%} of patients relapsed, with the majority of relapses occurring during index IM exposure. Conclusions: This assessment of IM treatments for UC demonstrated frequent changes to therapy and high downstream complication and relapse rates.",
keywords = "Complications, Immunomodulators, Relapse, Treatment patterns, Ulcerative colitis",
author = "{Loftus, Jr}, {Edward Vincent} and Davis, {Keith L.} and Wang, {Chi Chuan} and Homa Dastani and Allison Luo",
year = "2014",
doi = "10.1097/MIB.0000000000000089",
language = "English (US)",
volume = "20",
pages = "1361--1367",
journal = "Inflammatory Bowel Diseases",
issn = "1078-0998",
publisher = "John Wiley and Sons Inc.",
number = "8",

}

TY - JOUR

T1 - Treatment patterns, complications, and disease relapse in a real-world population of patients with moderate-to-severe ulcerative colitis initiating immunomodulator therapy

AU - Loftus, Jr, Edward Vincent

AU - Davis, Keith L.

AU - Wang, Chi Chuan

AU - Dastani, Homa

AU - Luo, Allison

PY - 2014

Y1 - 2014

N2 - Background: Immunomodulator (IM) treatments in ulcerative colitis (UC) are not curative and carry increased risk of complications, sometimes leading to therapy changes, reduced treatment benefits, and eventual relapse. We assessed patterns of IM utilization and therapy changes, complications, and disease relapse in a real-world population of patients with moderate-to-severe UC. Methods: Claims data from a large commercially insured U.S. population were retrospectively analyzed. Inclusion criteria were (1) ≥ 2 UC diagnosis claims (ICD-9-CM 556.xx) between January 2005 and July 2010, (2) ≥ 1 IM claim, where first IM claim defined the index date, (3) ≥ 12 months preindex health plan enrollment (baseline), and (4) ≥ 24 months postindex plan enrollment (follow-up). Characteristics of and changes to the index IM therapy during follow-up were descriptively assessed, as were complications and disease relapses. Results: A total of 2136 patients were identified for inclusion (age, mean [SD], 46 [16] years, 54% female). Azathioprine was the most common index IM (46% of patients), followed by 6-mercaptopurine (28%). Switching from the index IM to another therapy class was common (21% of patients), with 5-ASAs (48% of switchers), oral corticosteroids (21%), and biologics (17%) being the most frequent next agents used. Augmentation was also common (25% of patients), with 5-ASA being, by far, the most frequent agent added to the index IM (72% of augmenters). Thirty percent of patients experienced a complication, and 73% of patients relapsed, with the majority of relapses occurring during index IM exposure. Conclusions: This assessment of IM treatments for UC demonstrated frequent changes to therapy and high downstream complication and relapse rates.

AB - Background: Immunomodulator (IM) treatments in ulcerative colitis (UC) are not curative and carry increased risk of complications, sometimes leading to therapy changes, reduced treatment benefits, and eventual relapse. We assessed patterns of IM utilization and therapy changes, complications, and disease relapse in a real-world population of patients with moderate-to-severe UC. Methods: Claims data from a large commercially insured U.S. population were retrospectively analyzed. Inclusion criteria were (1) ≥ 2 UC diagnosis claims (ICD-9-CM 556.xx) between January 2005 and July 2010, (2) ≥ 1 IM claim, where first IM claim defined the index date, (3) ≥ 12 months preindex health plan enrollment (baseline), and (4) ≥ 24 months postindex plan enrollment (follow-up). Characteristics of and changes to the index IM therapy during follow-up were descriptively assessed, as were complications and disease relapses. Results: A total of 2136 patients were identified for inclusion (age, mean [SD], 46 [16] years, 54% female). Azathioprine was the most common index IM (46% of patients), followed by 6-mercaptopurine (28%). Switching from the index IM to another therapy class was common (21% of patients), with 5-ASAs (48% of switchers), oral corticosteroids (21%), and biologics (17%) being the most frequent next agents used. Augmentation was also common (25% of patients), with 5-ASA being, by far, the most frequent agent added to the index IM (72% of augmenters). Thirty percent of patients experienced a complication, and 73% of patients relapsed, with the majority of relapses occurring during index IM exposure. Conclusions: This assessment of IM treatments for UC demonstrated frequent changes to therapy and high downstream complication and relapse rates.

KW - Complications

KW - Immunomodulators

KW - Relapse

KW - Treatment patterns

KW - Ulcerative colitis

UR - http://www.scopus.com/inward/record.url?scp=84905496700&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84905496700&partnerID=8YFLogxK

U2 - 10.1097/MIB.0000000000000089

DO - 10.1097/MIB.0000000000000089

M3 - Article

C2 - 24918320

AN - SCOPUS:84905496700

VL - 20

SP - 1361

EP - 1367

JO - Inflammatory Bowel Diseases

JF - Inflammatory Bowel Diseases

SN - 1078-0998

IS - 8

ER -