PMID- 31883702
OWN - NLM
STAT- MEDLINE
DCOM- 20200918
LR  - 20200918
IS  - 1879-114X (Electronic)
IS  - 0149-2918 (Linking)
VI  - 42
IP  - 1
DP  - 2020 Jan
TI  - Rate of Adverse Events and Associated Health Care Costs for the Management of 
      Inflammatory Bowel Disease in Germany.
PG  - 130-143.e3
LID - S0149-2918(19)30574-0 [pii]
LID - 10.1016/j.clinthera.2019.11.012 [doi]
AB  - PURPOSE: Therapeutic management of inflammatory bowel disease (IBD) is 
      challenging, and available therapies are associated with adverse events (AEs) 
      that may lead to treatment discontinuation. This study evaluated the rate of 
      drug-related AEs of special interest (AESIs) associated with IBD therapies and 
      compare health care costs among patients with IBD who did and did not experience 
      AESIs. METHODS: A retrospective cohort analysis was conducted using claims data 
      from a German Sickness Fund (Allgemeine Ortskrankenkasse PLUS). Patients were 
      diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) and newly 
      initiating treatment with immunosuppressant, anti-tumor necrosis factor alpha, or 
      anti-integrin therapies from January 1, 2011, to December 31, 2015. Patients were 
      required to have continuous insurance coverage and no evidence of use of these 
      IBD therapies for 12 months before the date of newly initiating therapy (index 
      date). Rates of AESIs were based on 28 different events or chronic conditions 
      associated with IBD treatment. Direct health care costs were reported separately 
      for patients who did or did not experience AESIs. Only treatment periods lasting 
      >/=60 days were considered. AESI rates related to all possible treatment patterns 
      were calculated and reported as the number of events per 10,000 patient-years. 
      Health care costs were calculated based on IBD-related health care resource use. 
      FINDINGS: A total of 1126 (CD, n = 676; UC, n = 450) patients met the inclusion 
      criteria. Mean age was 36.5 years for patients with CD and 42.5 years for 
      patients with UC; 60.5% and 47.6% were female, respectively. Median observed time 
      since the index date was 1460 and 1552 days, for patients with CD and UC. The 
      overall rate for any AESI was 1392.4 and 1917.9 events per 10,000 patient-years 
      in patients with CD and those with UC. Severe infections and diabetes mellitus 
      were the most common AESIs. Significant differences in mean total direct health 
      care costs were found for CD patients with AESIs versus those without (euro8920.08 
      and euro6004.86; P < 0.001). A similar trend was observed with mean drug costs and 
      mean medical costs. In UC, total direct health care costs, although generally 
      higher in patients with AESIs, were not significantly different; however, medical 
      costs were (euro1946.93 vs euro971.28; P < 0.001). IMPLICATIONS: AEs are common in 
      patients with IBD treated with current therapies and associated with substantial 
      health care costs. An urgent need exists for development of IBD treatments that 
      are associated with lower rates of AEs.
CI  - Copyright (c) 2020 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Wilke, Thomas
AU  - Wilke T
AD  - Ingress-Health, Wismar, Germany.
FAU - Groth, Antje
AU  - Groth A
AD  - IPAM e.V., Wismar, Germany.
FAU - Long, Grainne H
AU  - Long GH
AD  - Roche Products Ltd, Welwyn Garden City, United Kingdom.
FAU - Tatro, Amanda R
AU  - Tatro AR
AD  - Genentech, Inc, South San Francisco, CA, United States.
FAU - Sun, Diana
AU  - Sun D
AD  - Genentech, Inc, South San Francisco, CA, United States. Electronic address: 
      sun.diana@gene.com.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20191226
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Immunosuppressive Agents)
RN  - 0 (Integrins)
RN  - 0 (Tumor Necrosis Factor-alpha)
SB  - IM
MH  - Adult
MH  - Cohort Studies
MH  - Colitis, Ulcerative/*drug therapy/*economics
MH  - Crohn Disease/*drug therapy/*economics
MH  - Drug Costs
MH  - Female
MH  - Germany
MH  - Health Care Costs
MH  - Humans
MH  - Immunosuppressive Agents/*adverse effects/*economics
MH  - Integrins/antagonists & inhibitors
MH  - Male
MH  - Middle Aged
MH  - Tumor Necrosis Factor-alpha/antagonists & inhibitors
MH  - Young Adult
OTO - NOTNLM
OT  - Adverse event
OT  - Crohn's disease
OT  - Germany
OT  - Health care resource utilization
OT  - Inflammatory bowel disease
OT  - Ulcerative colitis
EDAT- 2019/12/31 06:00
MHDA- 2020/09/20 06:00
CRDT- 2019/12/30 06:00
PHST- 2019/05/06 00:00 [received]
PHST- 2019/09/04 00:00 [revised]
PHST- 2019/11/14 00:00 [accepted]
PHST- 2019/12/31 06:00 [pubmed]
PHST- 2020/09/20 06:00 [medline]
PHST- 2019/12/30 06:00 [entrez]
AID - S0149-2918(19)30574-0 [pii]
AID - 10.1016/j.clinthera.2019.11.012 [doi]
PST - ppublish
SO  - Clin Ther. 2020 Jan;42(1):130-143.e3. doi: 10.1016/j.clinthera.2019.11.012. Epub 
      2019 Dec 26.