Efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis: results of a randomised placebo-controlled trial (ABILITY-1)

Sieper, Joachim; Heijde, Desirée van der; Dougados, Maxime; Mease, Philip J.; Maksymowych, Walter P.; Brown, Matthew A.; Arora, Vipin; Pangan, Aileen L.

doi:10.1136/annrheumdis-2012-201766

Cited by 470 publications

(395 citation statements)

References 32 publications

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“…In the Ability-1 study (18), the treatment effect of adalimumab, assessed using the end point ASAS40, was similar to that observed with etanercept after 12 weeks of treatment in the present study (38). When comparing the present study with the RAPID-axial SpA trial of certolizumab pegol treatment (20), several important differences in patient inclusion criteria and baseline demographic and disease characteristics are evident.…”

Section: Discussionsupporting

confidence: 85%

“…Recently, several studies of anti-TNF therapy have been conducted in nonradiographic axial SpA, with results suggesting that these agents have efficacy similar to that seen in radiographic axial SpA (15)(16)(17)(18)(19)(20). However, to date the number of large well-controlled studies of treatment with anti-TNF or other biologic agents in nonradiographic axial SpA, including populations of patients satisfying current ASAS criteria for nonradiographic axial SpA, is limited.…”

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confidence: 99%

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Symptomatic Efficacy of Etanercept and Its Effects on Objective Signs of Inflammation in Early Nonradiographic Axial Spondyloarthritis: A Multicenter, Randomized, Double‐Blind, Placebo‐Controlled Trial

Dougados

Heijde

Sieper

et al. 2014

Arthritis & Rheumatology

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192

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Objective. To assess the efficacy of etanercept in the treatment of early active nonsteroidal antiinflammatory drug (NSAID)-refractory nonradiographic axial spondyloarthritis (SpA).Methods. The study population consisted of patients who met the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial SpA but not the modified New York radiographic criteria for ankylosing spondylitis (as assessed by a radiologist at the central trial site), had a symptom duration of >3 months but <5 years, had a score of >4 on the Bath Ankylosing Spondylitis Disease Activity Index, and had been treated unsuccessfully with >2 NSAIDs. Patients were randomized to receive etanercept 50 mg/week or placebo and continued background NSAID treatment for 12 weeks (double-blind study); ClinicalTrials.gov identifier: NCT01258738.

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Section: Discussionsupporting

confidence: 85%

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confidence: 99%

Symptomatic Efficacy of Etanercept and Its Effects on Objective Signs of Inflammation in Early Nonradiographic Axial Spondyloarthritis: A Multicenter, Randomized, Double‐Blind, Placebo‐Controlled Trial

Dougados

Heijde

Sieper

et al. 2014

Arthritis & Rheumatology

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192

135

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“…Safety results were similar to those obtained in adalimumab trials of polyarticular JIA 23, 24, 25 and adults with rheumatoid arthritis and SpA 26, 27, 39. No AEs were identified that were unique to patients with ERA.…”

Section: Discussionsupporting

confidence: 75%

“…Adalimumab has been previously demonstrated to be safe and effective in children ages 2–17 years with polyarticular JIA 23, 24, 25, in children ages 12–17 years with refractory juvenile ankylosing spondylitis having axial symptoms 19, and in adults with axial SpA 26, 27.…”

Section: Introductionmentioning

confidence: 99%

A Randomized, Double‐Blind, Placebo‐Controlled Multicenter Study of Adalimumab in Pediatric Patients With Enthesitis‐Related Arthritis

Burgos‐Vargas

Tse

Horneff

et al. 2015

Arthritis Care & Research

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ObjectiveEnthesitis‐related arthritis (ERA) is a juvenile idiopathic arthritis (JIA) category, primarily affecting entheses and peripheral joints. This study evaluated efficacy, safety, and pharmacokinetics of adalimumab versus placebo in patients with ERA.MethodsThis is a phase III, multicenter, randomized double‐blind study in patients ages ≥6 to <18 years with ERA treated with adalimumab (24 mg/m2, maximum dose 40 mg every other week) or placebo for 12 weeks, followed by up to 192 weeks of open‐label adalimumab. The primary end point was percent change from baseline in number of active joints with arthritis (AJC) at week 12. Samples were collected to determine adalimumab serum concentrations. Adverse events (AEs) were assessed throughout the study.ResultsForty‐six patients were randomized (31 adalimumab/15 placebo). At baseline, mean age was 12.9 years, mean duration of ERA symptoms was 2.6 years, mean AJC was 7.8, and mean enthesitis count was 8.1. Mean percent change from baseline in AJC at week 12 was greater in the adalimumab group versus placebo (−62.6% versus −11.6%; P = 0.039). Most secondary variables favored adalimumab versus placebo at week 12. Treatment response further increased with continued adalimumab therapy through week 52. Mean steady‐state adalimumab serum concentrations were 7.5–11.8 μg/ml, similar to patients age ≥2 years with polyarticular JIA. AE rates were similar between placebo and adalimumab: any AE (53.3% versus 67.7%), serious AEs (0% versus 3.2%), and infectious AEs (20.0% versus 29.0%).ConclusionAdalimumab reduced signs and symptoms of ERA at week 12, with improvement sustained through week 52. The safety profile was consistent with previous adalimumab studies.

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“…In a randomized controlled trial of adalimumab in 82 predominantly male AS patients, a significant decrease of 52.9% (9.3 units) in SPARCC scores of the SI joints was observed in adalimumab-treated patients after 12 weeks of therapy, whereas a decrease of only 12.7% (1.3 units) was observed in placebo-treated patients (15). In the Ability-1 Trial of adalimumab in nonradiographic axial SpA, a mean decrease of 62.7% (3.2 units) in SPARCC score for the SI joint was reported, while the placebo responses showed a decrease of 12.8% (0.6 units) (16). However, the participants in those studies were older, had a longer disease duration, and had substantially lower mean baseline SPARCC scores than the patients in the present study.…”

Section: Discussionmentioning

confidence: 95%

Brief Report: Six‐Week Treatment of Axial Spondyloarthritis Patients With an Optimal Dose of Nonsteroidal Antiinflammatory Drugs: Early Response to Treatment in Signal Intensity on Magnetic Resonance Imaging of the Sacroiliac Joints

Varkas

Jans

Cypers

et al. 2016

Arthritis & Rheumatology

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Objective. To evaluate the early effect of full-dose nonsteroidal antiinflammatory drugs (NSAIDs) on the extent and intensity of bone marrow edema of the sacroiliac (SI) joints on magnetic resonance imaging (MRI) in axial spondyloarthritis (SpA).Methods. A single-center, 6-week study of a cohort of consecutive patients with clinically suspected axial SpA was conducted. A total of 117 patients were screened. Forty patients who were diagnosed as having axial SpA and had presented with a positive MRI of the SI joints as defined by the Assessment of SpondyloArthritis international Society (ASAS) criteria were considered for a followup MRI after 6 weeks of an optimal dose of NSAIDs. Twenty patients completed the study. Disease activity was monitored by determining the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score every 2 weeks and the Bath Ankylosing Spondylitis Functional Index score at baseline and week 6. NSAID intake was assessed by the ASAS NSAID index. Primary end points were improvement in bone marrow edema of the SI joints on MRI and BASDAI response at week 6.Results. Approximately one-third of eligible patients newly diagnosed as having axial SpA were unable to continue the full-dose NSAID schedule. The median NSAID index was 97% in patients who completed the study. There was a reduction of 1.1 units (10.5%) in mean SpondyloarthritisResearch Consortium of Canada (SPARCC) scores at week 6 in comparison to baseline (P 5 0.032). Overall, only 30% of the patients (6 of 20) had a minimal clinically important difference of ‡2.5 in SPARCC score. However, 80% of the patients displayed high-intensity lesions on STIR images at baseline, which decreased significantly at week 6 (P 5 0.011). There was a significant decrease in the relative intensity of the region of interest (P 5 0.007) and a mean decrease of 0.6 in the BASDAI score per 2 weeks of therapy (P 5 0.001). Only 29.4% of the patients met the BASDAI criteria for 50% improvement (BASDAI50) at week 6.Conclusion. Our findings indicate a high level of dropout among patients receiving full-dose NSAID therapy in daily practice. In those who tolerated NSAID therapy, there was no clinically relevant decrease in SPARCC scores and low BASDAI50 response. However, we found a decrease in signal intensity of bone marrow edema of the SI joints as an early response to 6 weeks of optimal NSAID therapy in patients newly presenting with axial SpA.

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Efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis: results of a randomised placebo-controlled trial (ABILITY-1)

Cited by 470 publications

References 32 publications

Symptomatic Efficacy of Etanercept and Its Effects on Objective Signs of Inflammation in Early Nonradiographic Axial Spondyloarthritis: A Multicenter, Randomized, Double‐Blind, Placebo‐Controlled Trial

Symptomatic Efficacy of Etanercept and Its Effects on Objective Signs of Inflammation in Early Nonradiographic Axial Spondyloarthritis: A Multicenter, Randomized, Double‐Blind, Placebo‐Controlled Trial

A Randomized, Double‐Blind, Placebo‐Controlled Multicenter Study of Adalimumab in Pediatric Patients With Enthesitis‐Related Arthritis

Brief Report: Six‐Week Treatment of Axial Spondyloarthritis Patients With an Optimal Dose of Nonsteroidal Antiinflammatory Drugs: Early Response to Treatment in Signal Intensity on Magnetic Resonance Imaging of the Sacroiliac Joints

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