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Long-term efficacy and predictors of remission following adalimumab treatment in peripheral spondyloarthritis: 3-year results from ABILITY-2.

ABSTRACT: Describe efficacy and safety of 3 years of adalimumab treatment in patients with peripheral spondyloarthritis (pSpA) and identify predictors of remission.Patients with pSpA were randomised to adalimumab 40?mg every other week or placebo for 12 weeks; a 144-week open-label extension followed (NCT01064856). Remission was assessed by the Peripheral SpA Response Criteria (PSpARC) and Ankylosing Spondylitis Disease Activity Score inactive disease (ASDAS ID). Logistic regression analyses were performed to determine predictors of remission at 1 and 3 years and sustained remission (?24?consecutive weeks).In 165 patients, ASDAS ID was achieved by 47% at 1?year and 39% at 3 years; 36% and 33% achieved PSpARC remission, respectively. Sustained ASDAS ID and PSpARC remission were achieved by 52% (86/165) and 42% (70/165) of patients, respectively. Achieving ASDAS ID at week 12 significantly predicted 1?year (OR, 8.64 (95% CI 2.97 to 25.14)), 3?year (OR, 36.12 (95% CI 2.29 to 569.08)) and sustained ASDAS ID (OR, 8.01 (95% CI 2.47 to 25.97)); achieving PSpARC remission at week 12 consistently predicted 1?year (OR, 6.47 (95% CI 1.91 to 21.95)), 3?years (OR, 15.66 (95% CI 4.19 to 58.56)) and sustained PSpARC remission (OR, 20.27 (95% CI 5.37 to 76.46)). No baseline variables consistently predicted 1-year or 3-year remission or sustained remission. The safety profile of adalimumab was consistent with observations in other SpA disease indications.In patients with pSpA, early response to adalimumab, but not baseline demographics or disease characteristics, was a better predictor of long-term remission.

SUBMITTER: Van den Bosch F

PROVIDER: S-EPMC5845429 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Long-term efficacy and predictors of remission following adalimumab treatment in peripheral spondyloarthritis: 3-year results from ABILITY-2.

Van den Bosch Filip F Mease Philip J PJ Sieper Joachim J Baeten Dominique L DL Xia Yinglin Y Chen Su S Pangan Aileen L AL Song In-Ho IH

RMD open 20180226 1

<h4>Objectives</h4>Describe efficacy and safety of 3 years of adalimumab treatment in patients with peripheral spondyloarthritis (pSpA) and identify predictors of remission.<h4>Methods</h4>Patients with pSpA were randomised to adalimumab 40 mg every other week or placebo for 12 weeks; a 144-week open-label extension followed (NCT01064856). Remission was assessed by the Peripheral SpA Response Criteria (PSpARC) and Ankylosing Spondylitis Disease Activity Score inactive disease (ASDAS ID). Logisti ...[more]

PMID: 29531780

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Project description:BACKGROUND: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. METHODS:Patients 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. RESULTS:Overall, 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. CONCLUSIONS:In 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 REGISTRATION:ClinicalTrials.gov , NCT00939003 ; registered on July 10, 2009.

Project description:To evaluate the efficacy and safety of adalimumab in patients with active nonpsoriatic peripheral spondyloarthritis (SpA).ABILITY-2 is an ongoing phase III, multicenter study of adalimumab treatment. Eligible patients age ?18 years fulfilled the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for peripheral SpA, did not have a prior diagnosis of psoriasis, psoriatic arthritis (PsA), or ankylosing spondylitis (AS), and had an inadequate response or intolerance to nonsteroidal antiinflammatory drugs (NSAIDs). Patients were randomized 1:1 to receive adalimumab 40 mg every other week or matching placebo for 12 weeks, followed by a 144-week open-label period. The primary end point was the proportion of patients achieving 40% improvement in disease activity according to the Peripheral SpA Response Criteria (PSpARC40) at week 12. This was defined as ?40% improvement from baseline (?20-mm absolute improvement on a visual analog scale) in patient's global assessments of disease activity and pain, and ?40% improvement in at least one of the following features: swollen joint and tender joint counts, total enthesitis count, or dactylitis count. Adverse events were recorded throughout the study.In total, 165 patients were randomized to a treatment group, of whom 81 were randomized to receive placebo and 84 to receive adalimumab. Baseline demographics and disease characteristics were generally similar between the 2 groups. At week 12, a greater proportion of patients receiving adalimumab achieved a PSpARC40 response compared to patients receiving placebo (39% versus 20%; P = 0.006). Overall, improvement in other outcomes was greater in the adalimumab group compared to the placebo group. The rates of adverse events were similar in both treatment groups.Treatment with adalimumab ameliorated the signs and symptoms of disease and improved physical function in patients with active nonpsoriatic peripheral SpA who exhibited an inadequate response or intolerance to NSAIDs, with a safety profile consistent with that observed in patients with AS, PsA, or other immune-mediated diseases.

Project description:PurposeTo evaluate the efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis (nr-axSpA).MethodsPatients 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.ResultsSignificantly 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.ConclusionsIn 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.

Dataset Information

Long-term efficacy and predictors of remission following adalimumab treatment in peripheral spondyloarthritis: 3-year results from ABILITY-2.

Publications

Long-term efficacy and predictors of remission following adalimumab treatment in peripheral spondyloarthritis: 3-year results from ABILITY-2.

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