Abstract
BackgroundAdalimumab was effective in treating patients with nonradiographic axial spondyloarthritis (nr-axSpA) in the 12-week ABILITY-1 trial. We present long-term efficacy and safety results of adalimumab from the open-label ABILITY-1 extension, including the relationship between clinical and magnetic resonance imaging (MRI) remission and impact of sustained clinical remission on physical function.MethodsPatients received adalimumab 40 mg every other week or placebo for 12 weeks, then open-label adalimumab for up to 144 weeks. Clinical and safety data were collected through 3 years, and MRI data were collected until 2 years. Analyses were performed in the total population and subpopulation with positive MRI and/or elevated C-reactive protein (MRI/CRP-positive) at baseline. Clinical and MRI remission definitions included Ankylosing Spondylitis Disease Activity Score inactive disease (ASDAS ID; score < 1.3) and Spondyloarthritis Research Consortium of Canada (SPARCC) MRI score < 2 for sacroiliac joints (SIJs), spine, or both. Physical function was assessed using the Bath Ankylosing Spondylitis Functional Index.ResultsOverall, 185 patients were included in the total population and 142 in the MRI/CRP-positive subpopulation; 65% and 68%, respectively, completed 3 years. Clinical, functional, and MRI improvements were similar and equally sustainable in both populations. At year 3, the percentages of patients in ASDAS ID in the MRI/CRP-positive subpopulation were 30%/33% (nonresponder imputation) and 46%/49% (observed) for those initially receiving adalimumab/placebo. At years 1 and 2, patients in ASDAS ID vs not had significantly greater improvements in SPARCC SIJ scores from baseline (P < 0.001). Among patients with baseline MRI scores ≥ 2 who achieved ASDAS ID at year 2, 44–68% also had MRI remission. Significantly more patients with sustained ASDAS ID through year 2 or 3 vs without achieved normal physical function (100% vs 48%; 100% vs 44%; both P < 0.001). No new safety concerns were observed.ConclusionsIn the ABILITY-1 study of nr-axSpA, adalimumab therapy provided sustained clinical and functional improvements through 3 years, as well as suppression of MRI axial inflammation, which was greater in patients who achieved clinical remission. Sustained clinical remission was associated with increased attainment of normal physical function. The safety profile of adalimumab was consistent with prior studies.Trial registrationClinicalTrials.gov, NCT00939003; registered on July 10, 2009.
Highlights
Adalimumab was effective in treating patients with nonradiographic axial spondyloarthritis in the 12-week ABILITY-1 trial
In the ABILITY-1 study of nr-Axial spondyloarthritis (axSpA), adalimumab therapy provided sustained clinical and functional improvements through 3 years, as well as suppression of magnetic resonance imaging (MRI) axial inflammation, which was greater in patients who achieved clinical remission
Patient disposition and characteristics Overall, 185 patients were included in the total efficacy population, and 142 patients were included in the MRI/C-reactive protein (CRP) positive subpopulation [13]; 42 patients had confirmed absence of MRI inflammation and normal CRP at baseline (MRI- and CRP-negative subpopulation); 1 patient who had normal CRP at baseline but missing baseline MRI assessment was excluded from the MRI- and CRP-negative subpopulation analyses but was included in the baseline data (Table 1)
Summary
Adalimumab was effective in treating patients with nonradiographic axial spondyloarthritis (nr-axSpA) in the 12-week ABILITY-1 trial. We present long-term efficacy and safety results of adalimumab from the open-label ABILITY-1 extension, including the relationship between clinical and magnetic resonance imaging (MRI) remission and impact of sustained clinical remission on physical function. Clinical remission or inactive disease has been recommended as a major treatment target in the most recent updates of the Assessment of SpondyloArthritis international Society (ASAS)/European League Against Rheumatism management recommendations for axSpA and treat-to-target recommendations for spondyloarthritis [8, 9]. Once this goal is achieved, clinical remission should ideally be maintained over time. Ankylosing Spondylitis Disease Activity Score inactive disease (ASDAS ID) is the preferred definition of clinical remission [9]; more data on the long-term impact of remission status on physical function and quality of life are needed [8]
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