An Audit of Patients With Crohn's Disease Treated With Infliximab (P06066)

A UK Retrospective Audit of Patients With Crohn's Disease Treated With Infliximab

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00988832

Enrollment

380

Registered

2009-10-02

Start date

2010-02-28

Completion date

2010-12-31

Last updated

2015-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Brief summary

The aim of this study is to quantify how infliximab therapy is being used in the UK and the consequent impact on health care resources, which will help to inform budget holders and payers on the costs associated with the treatment of Crohn's Disease.

Detailed description

All interested hospital physicians across the UK who prescribe infliximab as part of their treatment of Crohn's Disease patients. will be included. It is assumed that the physician population will consist primarily of gastroenterologists, though general physicians (hospital-based) with an interest in Crohn's Disease may also be included.

Interventions

BIOLOGICALInfliximab

Infliximab as prescribed by a physician in normal practice for Crohn's disease

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of Crohn's Disease. * Over the age of 18 years. * Must have received the first infusion of infliximab on or after 1st January 2003 (when the maintenance therapy license was granted). * Must have received at least one infusion of infliximab. * A minimum of 12 months data prior to, and 24 months data post infliximab exposure should be available in the medical records. * Must have been under the care of the participating center for the entirety of the study period.

Exclusion criteria

* Should not have been involved in any clinical trial during the observational period (ie, a minimum of 12 months before and 24 months after first receiving infliximab). * Should not have received any biologic therapy prior to infliximab.

Design outcomes

Primary

Measure	Time frame	Description
Mean Cost Per Participant of Consultations With Health Care Providers (HCPs)	12 months prior to and 12, 18, and 24 months after the first infusion of infliximab	Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease. Costs of outpatient consultations are based on the 2009 Unit Cost of Health and Social Care published by the Personal Social Service Research Unit. Consultations with gastroenterologists, gastric/gastrointestinal surgeons, radiologists, nurses/Inflammatory Bowel Disease nurses, dieticians/nutrition specialists, psychologists/psychiatrists, pharmacists, and occupational therapists are included in the analysis.
Mean Cost Per Participant of Elective Surgical Procedures	12 months prior to and 12, 18, and 24 months after the first infusion of infliximab	Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease. Costs of elective surgical procedures were calculated as per the 2009 Healthcare Resource Group (HRG) descriptors. Costs were analyzed for elective surgeries that required participants to be admitted into a hospital.
Mean Cost Per Participant Due to Non-elective/Emergency Inpatient Admissions	12 months prior to and 12, 18, and 24 months after the first infusion of infliximab	Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease. Costs of non-elective or emergency inpatient admissions were calculated as per the 2009 Healthcare Resource Group (HRG) descriptors. Costs were analyzed for unplanned hospital admissions due to emergency surgical procedures and unplanned consultations due to complications.
Mean Cost Per Participant for Admissions for Day Case Surgery	12 months prior to and 12, 18, and 24 months after the first infusion of infliximab	Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease. Costs of day case (outpatient) surgeries were calculated as per the 2009 Healthcare Resource Group (HRG) descriptors. Costs were analyzed for any surgeries that did not require the participant to stay overnight in the hospital.
Mean Cost Per Participant for All Hospitalizations	12 months prior to and 12, 18, and 24 months after the first infusion of infliximab	Costs for all hospitalizations, including costs associated with elective and emergency (non-elective) admissions as well as outpatient procedures.
Mean Cost Per Participant of Accident and Emergency (A&E) Visits	12 months prior to and 12, 18, and 24 months after the first infusion of infliximab	Costs for visits to A&E without admission. Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease as per the 2009 Healthcare Resource Group (HRG) descriptors.
Mean Cost Per Participant for Crohns-related Medications	12 months prior to and 12, 18, and 24 months after the first infusion of infliximab	Costs of biologics were calculated by multiplying the number of vials of drug used per participant by the 2009 British National Formulary (BNF) cost per vial. Costs of other drugs with ≥10 prescriptions were calculated by multiplying the 2009 BNF daily cost of the standard/most-prescribed dose of the most-prescribed drug (reference drug) in each drug group (Anatomical Therapeutic Classification \[ATC\] Level 4) by the length of treatment. Costs for drugs in drug groups with ≤9 prescriptions were calculated using the average cost of all Crohns medications multiplied by the length of treatment.
Mean Cost Per Participant for Diagnostic Tests During Planned Outpatient Consultations	12 months prior to and 12, 18, and 24 months after the first infusion of infliximab	Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease. Costs of diagnostic tests conducted during outpatient consultations were calculated as per the 2008-2009 NHS Reference Costs. Costs for diagnostic tests during hospitalizations and A&E visits were incorporated into cost analyses for those categories and are not included here.

Participant flow

Recruitment details

No subjects were recruited for this retrospective study; participating investigators reviewed medical records of qualifying subjects and provided data to the sponsor.

Participants by arm

Arm	Count
Infliximab Infliximab as prescribed by a physician in normal practice for Crohn's disease: 5 mg/kg or 10 mg/kg infusion as either maintenance or episodic therapy.	380
Total	380

Baseline characteristics

Characteristic	Infliximab
Age, Continuous	37 years STANDARD_DEVIATION 13
Sex/Gender, Customized Female	208 participants
Sex/Gender, Customized Male	171 participants
Sex/Gender, Customized Not Specified	1 participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 380
serious Total, serious adverse events	36 / 380

Outcome results

Primary

Mean Cost Per Participant Due to Non-elective/Emergency Inpatient Admissions

Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease. Costs of non-elective or emergency inpatient admissions were calculated as per the 2009 Healthcare Resource Group (HRG) descriptors. Costs were analyzed for unplanned hospital admissions due to emergency surgical procedures and unplanned consultations due to complications.