Multicountry Post-Marketing Observational Study on Maintenance of Effectiveness of Adalimumab in Patients With Ankylosing Spondylitis and Psoriatic Arthritis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ankylosing Spondylitis
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Enrollment
- 566
- Primary Endpoint
- Percentage of Participants With Active Axial Symptoms in Remission
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This 12-month postmarketing observational study (PMOS) was a prospective, single-arm, multicenter, multi-country study, with follow-up visits at 3, 6, 9, and 12 months after the initial baseline visit. The study was conducted to determine the long-term effectiveness of treatment with adalimumab in routine clinical use in participants with Ankylosing Spondylitis (AS) and Psoriatic Arthritis (PsA) in Central and Eastern European Countries.
Detailed Description
Additional study objectives were to evaluate AS and PsA with regard to extra-articular manifestations (EAMs), functional status, the use of concomitant nonsteroidal anti-inflammatory medication, and work productivity impairment. In addition, the Ankylosing Spondylitis Disease Activity Score (ASDAS), a new disease activity index in AS, was measured in parallel with the standard Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score to assess the effectiveness of adalimumab in treating axial symptoms.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients will be enrolled in this Postmarketing observational study PMOS if they fulfill all of the below criteria:
- •Adult patients with diagnosis of Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA).
- •Eligible for adalimumab therapy according to the local product label and prescription/reimbursement guidelines.
- •Have been prescribed adalimumab within a maximum of one (1) month prior to the study enrolment.
- •Have negative result of Tuberculosis (TB) screening test or TB prophylaxis as per local guidelines.
- •Are willing to provide Authorization to the investigator to use and/or disclose personal and/or health data, or to provide Informed Consent if requested by the Local Regulations, before entry into the study.
Exclusion Criteria
- •Patients fulfilling below exclusion criteria will not be eligible for this Postmarketing study (PMOS):
- •Meet contraindications for treatment with adalimumab as outlined in the latest version of the local Summary of Product Characteristics (SmPC)
Outcomes
Primary Outcomes
Percentage of Participants With Active Axial Symptoms in Remission
Time Frame: Baseline (Visit 0) to 12 months
The Ankylosing Spondylitis Disease Score (ASDAS) tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Remission was defined as ASDAS \<1.3 at 12 months.
Percentage of Participants With Peripheral Symptoms in Remission
Time Frame: Baseline (Visit 0) to 12 months
The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission. Remission was defined as DAS28 ≤2.6 at 12 months.
Percentage of Participants With a 50% or More Decrease in Bath Ankylosing Spondylitis Daily Activity Index (BASDAI) Score at 12 Months Relative to Baseline
Time Frame: Baseline (Visit 0) to 12 months
The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline.
Percentage of Participants With a Disease Activity Score 28 (DAS28) Decrease ≥1.2 at 12 Months Relative to Baseline
Time Frame: Baseline (Visit 0) to 12 months
The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Secondary Outcomes
- Mean Change in Ankylosing Spondylitis Disease Activity Score (ASDAS)(Baseline (Visit 0) to 12 months)
- Percentage of Participants Whose Co-medication With Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Was Stopped During the Study(Baseline (Visit 0) to 12 months)
- Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Psoriatic Arthritis(Baseline (Visit 0) to 12 months)
- Mean Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (in Case of Axial Symptoms) and/or Disease Activity Score/28 Joints (DAS28) (in Case of Peripheral Symptoms) in Participants With Ankylosing Spondylitis(Baseline (Visit 0) to 12 months)
- Correlation Between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis(Baseline (Visit 0) to 12 months)
- Mean Frequency of Extra-articular Manifestations (EAMs)(Baseline (Visit 0) to 12 months)
- Predictors of Maintained Treatment Response and Remission in Participants With Psoriatic Arthritis(Baseline (Visit 0) to 12 months)
- Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Ankylosing Spondylitis(Baseline (Visit 0) to 12 months)
- Change in the Percentage of Ankylosing Spondylitis Participants Who Have Paid Work(Baseline (Visit 0) to 12 months)
- Correlation Between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Psoriatic Arthritis(Baseline (Visit 0) to 12 months)
- Change in the Percentage of Psoriatic Arthritis Participants Who Have Paid Work(Baseline (Visit 0) to 12 months)
- Duration of Treatment With Adalimumab(Baseline (Visit 0) to 12 months)
- Predictors of Maintained Treatment Response and Remission in Participants With Ankylosing Spondylitis(Baseline (Visit 0) to 12 months)
- Mean Change in Health Assessment Questionnaire Disability Index (HAQ-DI) Score (in Case of Peripheral Symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) Score (in Case of Axial Symptoms) in Participants With Ankylosing Spondylitis(Baseline (Visit 0) to 12 months)
- Mean Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (in Case of Axial Symptoms) and/or Disease Activity Score/28 Joints (DAS28) (in Case of Peripheral Symptoms) in Participants With Psoriatic Arthritis(Baseline (Visit 0) to 12 months)
- Mean Change in Health Assessment Questionnaire Disability Index ( HAQ-DI) Score (in Case of Peripheral Symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) Score (in Case of Axial Symptoms) in Participants With Psoriatic Arthritis(Baseline (Visit 0) to 12 months)