Symptoms and General Pathology

All Conditions

Digestive System Diseases

Behaviors and Mental Disorders

Necrosis

Crohn Disease

Inflammatory Bowel Diseases

Intestinal Diseases

Gastroenteritis

Gastrointestinal Diseases

Quality of Life

Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment

Mahmut Gücük, MD

This multicenter, prospective, post marketing observational study (PMOS) was designed to demonstrate long-term effects of anti-Tumor Necrosis Factor therapies on Work Productivity and Impairment scales in participants with moderate to severe Crohn's Disease (CD) under routine conditions. Secondary objectives of this study were long-term improvement of Quality of Life (QoL), evaluation of improvement of extraintestinal symptoms and comorbidities, and evaluation of safety.

Male or female participants between 18 - 65 years of age with moderate to severe CD for whom the treating physician had recently initiated an anti-TNF treatment were included in this study. Anti-TNF treatments were administered according to the treating physician's decision and applicable product label in Turkey. No interventions were made to the treatment and the participant discontinuance or to the follow-up decisions of the treating physician. Enrolled participants were observed for one year.

Anti-Tumor Necrosis Factor (TNF) Treatments, Work Productivity and Quality of Life in Crohn's Disease

Improvement of Work Productivity and Quality of Life With Anti-TNF Therapies Used in Crohn's Disease in Routine Clinical Practice in Turkey

The Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire was used to assess impairments in both paid work and unpaid work due to symptoms of Crohn's Disease. The self-administered questionnaire consisted of 6 questions. Question 2 asked participants to indicate the number of hours missed due to health problems in the past 7 days. Question 4 asked participants to indicate the number of hours that they worked in the past 7 days. Absenteeism (work time missed) was defined as the percentage of time absent from work due to health problems in the past week and was calculated by the formula Q2/(Q2 + Q4) × 100%. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.

The Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire was used to assess impairments in both paid work and unpaid work due to symptoms of Crohn's Disease. The self-administered questionnaire consisted of 6 questions. Question 5 asked participants the degree to which their health affected productivity while working in the past 7 days, on a scale ranging from 0 to 10, with 0 indicating that health problems had no effect on their work and 10 indicating that health problems completely prevented the participant from working. Presenteeism (impairment at work) was calculated by the formula (Q5/10) × 100%. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.

The Work Productivity and Activity Impairment: General Health (WPAI:GH) self-administered questionnaire was used to assess impairments in work due to symptoms of Crohn's Disease. Q2 asked participants the number of hours missed due to health problems in the past 7 days. Q4 asked participants the number of hours that they worked in the past 7 days. Q5 asked participants the degree to which their health affected productivity while working in the past 7 days, on a scale ranging from 0 (health problems had no effect) to 10 (health problems completely prevented them from working). Total work productivity impairment (TWPI) is the combined absenteeism and presenteeism for employed participants, the percentage of overall work productivity lost due to health problems. TWPI was calculated using the formula Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4)))×(Q5/10)\] × 100%. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.

The Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire was used to assess impairments in both paid work and unpaid work due to symptoms of Crohn's Disease. The self-administered questionnaire consisted of 6 questions. Question 6 asked participants to indicate the degree to which their health affected their regular activities in the past 7 days. Total activity impairment is the percent impairment of non-work related activities due to health problems and was calculated with the formula (Q6/10) × 100%. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.

The Short Form 36 (SF-36) Health Survey was used to determine participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scores on each item were summed and averaged (range = 0 "worst" to 100 "best"). Increases from baseline indicate improvement.

The Inflammatory Bowel Disease Questionnaire (IBDQ) is a 32-item self-administered questionnaire to measure health-related quality of life in adults with Crohn's Disease. The 32 items are grouped into subscales: bowel-related symptoms (10 items), systemic symptoms (5 items), social function (5 items), and emotional function (12 items). Responses to each item within each subscale range from 1 (significant impairment) to 7 (no impairment), and mean scores ranging from 1 to 7 are calculated for each subscale. Higher scores indicate a better quality of life.

Extra-intestinal manifestations of Crohn's Disease (skeletal system \[bones and muscle\], dermatological \[skin\], hepatobiliary system \[liver, gall bladder, and bile ducts\], ocular \[eyes\] and oral \[mouth\]) were documented by the study investigators at each visit.

A serious adverse event was defined as any untoward medical occurrence in a clinical investigation participant that met at least 1 of the following criteria: death, life-threatening, hospitalization or prolongation of hospitalization, congenital anomaly, persistent or significant disability/incapacity, important medical event requiring medical or surgical intervention to prevent serious outcome, elective or spontaneous abortion.

AbbVie

Nonserious adverse events were not collected for this study.

Participants With Moderate to Severe Crohn's Disease

Age, Continuous

Sex: Female, Male

Anti-TNF Treatments

Participants lost to follow-up were not replaced. Participant selection bias and lower number of participants completing questionnaires at later study visits.

Global Medical Services

The null hypothesis was set as no difference.

Baseline

12 months

Work Productivity and Activity Index (WPAI): Absenteeism

Work Productivity and Activity Index (WPAI): Presenteeism

Total Work Productivity Impairment (TWPI)

Total Activity Impairment (TAI)

Physical Functioning Scores: the null hypothesis was set as no difference.

Role-Physical Scores: the null hypothesis was set as no difference.

Role-Emotional Scores: the null hypothesis was set as no difference.

Vitality Scores: the null hypothesis was set as no difference.

Mental Health Scores: the null hypothesis was set as no difference.

Social Functioning Scores: the null hypothesis was set as no difference.

Bodily Pain Scores: the null hypothesis was set as no difference.

General Health Scores: the null hypothesis was set as no difference.

Physical Functioning Score (Baseline)

Physical Functioning Score (12 months)

Role-Physical Score (Baseline)

Role-Physical Score (12 months)

Role-Emotional Score (Baseline)

Role-Emotional Score (12 months)

Vitality Score (Baseline)

Vitality Score (12 months)

Mental Health Score (Baseline)

Mental Health Score (12 months)

Social Functioning Score (Baseline)

Social Functioning Score (12 months)

Bodily Pain Score (Baseline)

Bodily Pain Score (12 months)

General Health Score (Baseline)

General Health Score (12 months)

Change in Short Form 36 (SF-36) Health Survey Scores

Bowel-related Symptoms Scores: The null hypothesis was set as no difference.

Systemic Symptoms Scores:The null hypothesis was set as no difference.

Emotional Function Scores: the null hypothesis was set as no difference.

Social Function Scores: The null hypothesis was set as no difference.

Spots Global Cancer Trial Database for Anti-Tumor Necrosis Factor (TNF) Treatments, Work Productivity and Quality of Life in Crohn's Disease

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