N/A
N=4,681
Basic Documentation of Adalimumab (Humira) in Patients With Ankylosing Spondylitis (AS)
Ankylosing Spondylitis
Bottom Line
View on ClinicalTrials.gov: NCT01079182 ↗Enrolled (actual)
4,681
Serious AEs
3.0%
Results posted
Jun 2015
Primary outcome: Primary: Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score — 5.5; -2.0; -2.1; -2.2 BASDAI score
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score |
5.5; -2.0; -2.1; -2.2; -2.3; -2.3 | — |
| PRIMARY Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score |
4.9; -1.4; -1.5; -1.6; -1.6; -1.7 | — |
| PRIMARY Number of Participants With Drug-Related Adverse Events (AEs) |
1099 | — |
| SECONDARY Mean Number of Involved Peripheral Joints |
3.1; 1.8; 1.6; 1.6; 1.5; 1.5 | — |
| SECONDARY Percentage of Participants With Extraspinal Manifestations |
13.6; 5.6; 3.7; 4.1; 4.5; 3.5 | — |
| SECONDARY Mean Erythrocyte Sedimentation Rate (ESR) |
26.8; 12.9; 13.3; 13.6; 13.3; 13.3 | — |
| SECONDARY Mean Plasma Concentrations of C-Reactive Protein (CRP) |
17.1; 6.2; 6.5; 6.3; 6.0; 5.5 | — |
| SECONDARY Mean Bath Ankylosing Spondylitis-Global (BAS-G) Score |
6.7; 4.8; 4.1; 3.8; 3.6; 3.5 | — |
| SECONDARY Mean Global Assessment of Disease Activity Score |
6.5; 3.1; 2.8; 2.6; 2.4; 2.3 | — |
| SECONDARY Mean Participant Fatigue Score |
5.9; 4.3; 4.2; 4.0; 3.9; 3.8 | — |
| SECONDARY Mean Participant Pain Score |
6.7; 4.0; 3.9; 3.8; 3.7; 3.5 | — |
| SECONDARY Percentage of Participants With Morning Stiffness |
95.4; 81.8; 79.9; 78.8; 77.6; 77.6 | — |
| SECONDARY Mean Duration of Morning Stiffness |
56.7; 33.5; 31.3; 29.6; 28.6; 27.7 | — |
| SECONDARY Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) Improvement Criteria |
57.9; 63.0; 64.3; 65.6; 66.9; 67.2 | — |
| SECONDARY Percentage of Participants Achieving ASAS Partial Remission Criteria |
1.1; 17.7; 21.5; 23.3; 23.9; 24.9 | — |
| SECONDARY Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks |
23.0; 47.2; 52.6; 55.9; 57.1; 60.2 | — |
| SECONDARY Percentage of Participants Who Missed Work Days Due to Ankylosing Spondylitis (AS) in the Previous 12 Months |
45.7; 39.3; 32.2; 26.3; 21.3; 17.2 | — |
| SECONDARY Mean Missed Work Days Due to Ankylosing Spondylitis in the Previous 12 Months |
48.0; 52.2; 56.0; 50.5; 48.0; 35.3 | — |
| SECONDARY Percentage of Participants With In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months |
20.6; 18.9; 16.9; 12.9; 8.4; 4.7 | — |
| SECONDARY Mean Days of In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months |
16.0; 15.1; 16.3; 17.2; 18.8; 17.7 | — |
| SECONDARY Percentage of Participants on Adalimumab Monotherapy |
78.8; 81.6; 82.8; 83.2; 83.6; 83.7 | — |
| SECONDARY Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs) |
13.0; 11.9; 11.9; 11.6; 11.5; 11.6 | — |
| SECONDARY Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents |
17.5; 12.4; 11.8; 11.1; 11.2; 10.1 | — |
| SECONDARY Mean Equivalent Dose of Prednisolone |
10.5; 6.6; 6.8; 6.4; 7.2; 6.0 | — |
Summary
The research question explored in this study was whether the effectiveness and safety of adalimumab in participants with ankylosing spondylitis was maintained during long-term therapy in routine clinical practice in Germany.
Eligibility Criteria
Inclusion Criteria
- Participants with active, AS for at least 4 weeks (BASDAI greater than or equal to 4).
- Participants who failed treatment with two non-steroidal anti-inflammatory drugs (NSAIDs).
- No contraindications for anti-tumor necrosis factors (TNF) therapy.
Exclusion Criteria
- Participants who do not meet the above listed inclusion criteria.
Data sourced from ClinicalTrials.gov (NCT01079182). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.