Impact of Adalimumab (Humira®) Therapy on Selected Health Care Resource Utilization and Sick Leave in Patients With Ankylosing Spondylitis in Clinical Practice (IDEA)

Participants with Ankylosing Spondylitis (AS)

Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.

Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Month 12

The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity. Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms). The BASDAI 50 score captures patients with 50% reduction in the BASDAI score compared to baseline as observed.

Percentage of Participants Achieving BASDAI 50

The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity. Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms). The BASDAI 50 score captures patients with 50% reduction in the BASDAI score compared to baseline.

Percentage of Participants Achieving At Least 2.0 Score Decrease in Ankylosing Spondylitis Disease Activity (ASDAS) Score From Baseline

The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, and peripheral pain/swelling assessed on a visual analogue scale (from 0 (normal) to 10 (extreme pain or disability) cm) and duration of morning stiffness on a numerical rating scale (from 0 to 10, with 0 being none and 10 representing a duration of 2 hours or longer). The laboratory parameter is a measurement of C-reactive protein (mg/L) (CRP) or erythrocyte sedimentation rate (mm/h) (ESR). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and either CRP or ESR values) are combined to yield a score ranging from 0 to no defined upper limit. Higher scores indicate higher disease activity. Clinically important improvement is defined as a change >= 1.1 units, and major improvement is defined as a change >= 2.0 units.

Mean Change in the Number of Hospital Inpatient Days

Difference in the number of hospital inpatient days during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy.

Mean Change in the Number of Hospitalizations

Difference in the number of hospitalizations during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy.

Mean Change in the Number of Sick Leave Days

Difference in the number of sick leave days during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy (in employed subjects only)

Mean Change in the Number of Sick Leaves

Difference in the number of sick leaves during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy (in employed subjects only).

Mean Change in the Number of Outpatient Visits to Each Kind of Health Care Provider

Difference in the number of outpatient visits to each kind of health care provider which includes general practitioner, rheumatologist, other specialists (ophthalmologist, gastroenterologist, dermatologist, physiatrist), physiotherapist and rheumatology nurse, during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy.

Mean Change From Baseline in BASDAI Score

The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity. Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms).

Mean Change From Baseline in Ankylosing Spondylitis Disease Activity (ASDAS) Score

The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, and peripheral pain/swelling assessed on a visual analogue scale (from 0 (normal) to 10 (extreme pain or disability) cm) and duration of morning stiffness on a numerical rating scale (from 0 to 10, with 0 being none and 10 representing a duration of 2 hours or longer). The laboratory parameter is a measurement of C-reactive protein (mg/L) (CRP) or erythrocyte sedimentation rate (mm/h) (ESR). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and either CRP or ESR values) are combined to yield a score ranging from 0 to no defined upper limit. Higher scores indicate higher disease activity. Remission is defined as ASDAS score <1.3. Clinically important improvement is defined as a change >= 1.1 units, and major improvement is defined as a change >= 2.0 units.

Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score

The BASFI is a numeric rating scale that uses self-reported patient evaluations to measure physical function impairment caused by AS. It is a ten questions, each question was scored on a numerical rating scale that ranged from 0 (no functional impairment) to 10 (maximal impairment). The mean of the ten questions was the total BASFI score. A higher score indicates more severe impairment of functioning.