Special Investigation (Long-term Investigation) in Patients With Crohn's Disease

An adverse event was any untoward or unintended symptoms (including abnormal laboratory findings), condition or illness, which are not always related to Humira. Please see Adverse Event section below for more details.

The Change in Crohn's Disease Activity Index (CDAI) is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. A negative change from Baseline indicates improvement.

WPAI: CD is a questionnaire used to evaluate lost productivity due to CD; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Absenteeism (percentage of work time missed due to CD) is calculated as the number of hours of work missed due to CD / (number of hours of work missed due to CD + number of hours worked) * 100. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.

WPAI: CD is a questionnaire used to evaluate lost productivity due to CD; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Presenteeism (percentage of impairment while working due to CD ) is calculated as the patient's rating of how much CD affected productivity while working (0 = no effect; 10 = completely prevented from working) / 10 * 100. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.

WPAI: CD is a questionnaire used to evaluate lost productivity due to CD ; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Total work productivity impairment takes into account both hours missed due to CD symptoms and the patient's assessment of the degree to which CD affected their productivity while working (overall work impairment [OWI]). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.

WPAI: CD is a questionnaire used to evaluate lost productivity due to CD ; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Activity impairment (percentage of activity impairment due to CD ) is calculated as the patient's rating of how much CD affected their ability to do regular daily activities, other than working at a job (0 = no effect; 10 = completely prevented from working) / 10 * 100. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.

Endoscopic remission per endoscopy sub score.

CRP values were measured as an inflammatory parameter. Low CRP values mean less inflammation.