Efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis: Results of a randomised placebo-controlled trial (ABILITY-1)
Sieper, J., Van Der Heijde, D., Dougados, M., Mease, P., Maksymowych, W. P., Brown, Matthew A, Arora, V., & Pangan, A. L. (2013) Efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis: Results of a randomised placebo-controlled trial (ABILITY-1). Annals of the Rheumatic Diseases, 72(6), pp. 815-822.
Purpose: To evaluate the efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis (nr-axSpA).
Methods: Patients fulfilled Assessment of Spondyloarthritis international Society (ASAS) criteria for axial spondyloarthritis, had a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of ≥ 4, total back pain score of ≥ 4 (10 cm visual analogue scale) and inadequate response, intolerance or contraindication to non-steroidal anti-inflammatory drugs (NSAIDs); patients fulfilling modified New York criteria for ankylosing spondylitis were excluded. Patients were randomised to adalimumab (N=91) or placebo (N=94). The primary endpoint was the percentage of patients achieving ASAS40 at week 12. Efficacy assessments included BASDAI and Ankylosing Spondylitis Disease Activity Score (ASDAS). MRI was performed at baseline and week 12 and scored using the Spondyloarthritis Research Consortium of Canada (SPARCC) index.
Results: Significantly more patients in the adalimumab group achieved ASAS40 at week 12 compared with patients in the placebo group (36% vs 15%, p<0.001). Significant clinical improvements based on other ASAS responses, ASDAS and BASDAI were also detected at week 12 with adalimumab treatment, as were improvements in quality of life measures. Inflammation in the spine and sacroiliac joints on MRI significantly decreased after 12 weeks of adalimumab treatment. Shorter disease duration, younger age, elevated baseline C-reactive protein or higher SPARCC MRI sacroiliac joint scores were associated with better week 12 responses to adalimumab. The safety profile was consistent with what is known for adalimumab in ankylosing spondylitis and other diseases.
Conclusions: In patients with nr-axSpA, adalimumab treatment resulted in effective control of disease activity, decreased inflammation and improved quality of life compared with placebo. Results from ABILITY-1 suggest that adalimumab has a positive benefit-risk profile in active nr-axSpA patients with inadequate response to NSAIDs.
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|Item Type:||Journal Article|
|Additional Information:||No file attached.|
|Keywords:||adalimumab, C reactive protein, HLA B27 antigen, placebo, adult, age, Ankylosing Spondylitis Disease Activity Score, article, Assessment of Spondyloarthritis International Society 40 criteria, backache, Bath ankylosing spondylitis disease activity index, breast dysplasia, controlled study, disease activity, disease control, disease duration, double blind procedure, drug effect, drug efficacy, drug induced abortion, drug induced disease, drug induced headache, drug response, drug safety, drug tolerability, drug withdrawal, female, human, infection, major clinical study, male, malignant neoplastic disease, multicenter study, named inventories, questionnaires and rating scales, nausea, non radiographic axial spondylarthritis, nuclear magnetic resonance imaging, phase 3 clinical trial, priority journal, quality of life, randomized controlled trial, rhinopharyngitis, sacroiliitis, sensitivity analysis, spondylarthritis, Spondyloarthritis Research Consortium of Canada index, toxic hepatitis, Antibodies, Monoclonal, Humanized, Antirheumatic Agents, Double-Blind Method, Humans, Magnetic Resonance Imaging, Middle Aged, Sacroiliac Joint, Spine, Treatment Outcome|
|Divisions:||Current > Schools > School of Biomedical Sciences
Current > Institutes > Institute of Health and Biomedical Innovation
|Deposited On:||24 Sep 2015 04:06|
|Last Modified:||25 Sep 2015 02:52|
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