Sustained Clinical, Functional Improvements With Adalimumab in Axial Spondyloarthritis
Adalimumab therapy provided sustained clinical and functional improvements in nonradiographic axial spondyloarthritis.
Adalimumab provided sustained clinical remission and functional improvements in patients with nonradiographic axial spondyloarthritis (axSpA) through 3 years of therapy, according to results of the ABILITY-1 trial (ClinicalTrials.gov identifier: NCT00939003) published in Arthritis Research & Therapy.
Desiree van der Heijde, MD, PhD, from the Leiden University Medical Center in the Netherlands, and colleagues reported long-term efficacy and safety results from the open-label, 3-year ABILITY-1 trial. Study participants received adalimumab 40 mg every other week or placebo for 12 weeks and then open-label adalimumab for up to 144 weeks. The investigators collected clinical and safety data over the course of 3 years and magnetic resonance imaging (MRI) data over the course of 2 years.
Researchers performed analyses of data from the total population and subpopulation with positive MRI or elevated C-reactive protein (MRI/CRP-positive) at baseline. Clinical and MRI remission definitions included Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease score <13 and Spondyloarthritis Research Consortium of Canada (SPARCC) MRI score <2 for sacroiliac joints, spine, or both. They assessed physical function using the Bath Ankylosing Spondylitis Functional Index (BASDAI).
The total study population included 185 patients, and the MRI/CRP-positive subpopulation included 142 patients; 65% and 68%, respectively, completed the 3-year study. Clinical, functional, and MRI improvements were similar and equally sustainable in both populations.
At 156 weeks, the mean ASDAS was 1.9 and BASDAI was 3.3 in the MRI/CRP-positive subpopulation. The mean changes from baseline to 156 weeks were −1.4 for ASDAS and −3.1 for BASDAI. Similar improvements in ASDAS and BASDAI were observed in the MRI/CRP-negative subpopulation. In addition, there was a significant reduction in SPARCC MRI sacroiliac joint and spinal inflammation scores from baseline to 1 and 2 years in the MRI/CRP-positive subpopulation and in the total efficacy population (P <.001).
Sustained clinical remission was achieved by 24% of patients at year 2, 23% of patients at year 3, and 18% of patients through 2 and 3 years in the MRI/CRP-positive group. Among the 142 patients who were MRI/CRP-positive at baseline, 102 had abnormal physical function. Of these, normal function was achieved by 62% of participants at year 2, and by 59% of participants at year 3. Among all patients with abnormal physical function at baseline, participants who achieved sustained clinical remission during year 2 or year 3 or through both years achieved normal function. In comparison, less than half the patients with abnormal function at baseline who did not enter sustained clinical remission achieved normal function. All patients with normal physical function at baseline retained normal function at years 2 and 3, regardless of remission status. The safety profile of adalimumab was consistent with prior studies.
The authors note that clinical remission and remission based on MRI were only partly concordant. They add that along with the safety data from the ABILITY-1 study, their findings support the favorable benefit-risk profile of adalimumab therapy in patients with nonradiographic axial spondyloarthritis.
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Van der Heijde D, Sieper J, Maksymowych WP, et al. Clinical and MRI remission in patients with nonradiographic axial spondyloarthritis who received long-term open-label adalimumab treatment: 3-year results of the ABILITY-1 trial [published online March 27, 2018]. Arthritis Res Ther. doi: 10.1186/s13075-018-1556-5