Assessment of enthesitis in ankylosing spondylitis

Heuft-Dorenbosch, L; Spoorenberg, A.; Tubergen, Astrid van; Landewé, Robert; Tempel, Hille van der; Mielants, Herman; Dougados, Maxime; Heijde, Desirée van der

doi:10.1136/ard.62.2.127

Cited by 590 publications

(377 citation statements)

References 11 publications

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“…The presence and severity of dactylitis were scored on a scale of 0-3, where 0 ϭ no dactylitis and 3 ϭ severe dactylitis, in each digit of the hands and feet. Enthesitis was assessed using the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) index (15), modified for PsA to include plantar fascia, with scores of 0-15.…”

Section: Methodsmentioning

confidence: 99%

Golimumab, a new human tumor necrosis factor α antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: Twenty‐four–week efficacy and safety results of a randomized, placebo‐controlled study

Kavanaugh¹,

McInnes²,

Mease³

et al. 2009

Arthritis & Rheumatism

564

489

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Objective. To assess the efficacy and safety of golimumab in patients with active psoriatic arthritis (PsA). Methods. Adult patients withPsA who had at least 3 swollen and 3 tender joints and active psoriasis were randomly assigned to receive subcutaneous injections of placebo (n ‫؍‬ 113), golimumab 50 mg (n ‫؍‬ 146), or golimumab 100 mg (n ‫؍‬ 146) every 4 weeks through week 20. Efficacy assessments through week 24 included the American College of Rheumatology 20% improvement criteria (ACR20), the Psoriasis Area and Severity Index (PASI) in patients in whom at least 3% of the body surface area was affected by psoriasis at baseline, the Short Form 36 Health Survey (SF-36), the disability index of the Health Assessment Questionnaire (HAQ), the Nail Psoriasis Severity Index (NAPSI), the physician's global assessment of psoriatic nail disease, and enthesitis (using the PsA-modified Maastricht Ankylosing Spondylitis Enthesitis Score [MASES] index).Results. At week 14, 48% of all patients receiving golimumab, 51% of patients receiving golimumab 50 mg, and 45% of patients receiving golimumab 100 mg achieved an ACR20 response (the primary end point), compared with 9% of patients receiving placebo (P < 0.001 for all comparisons). Among the 74% of patients in whom at least 3% of the body surface area was affected by psoriasis at baseline, 40% of those in the golimumab 50 mg group and 58% of those in the golimumab 100 mg group had at least 75% improvement in the PASI at week 14 (major secondary end point), compared with 3% of placebo-treated patients (P < 0.001 for both doses). Significant improvement was observed for other major secondary end points (the HAQ and the SF-36), the NAPSI, the physician's global assessment of psoriatric nail disease, and the PsAClinicalTrials.gov identifier: NCT00265096.

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Section: Methodsmentioning

confidence: 99%

Golimumab, a new human tumor necrosis factor α antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: Twenty‐four–week efficacy and safety results of a randomized, placebo‐controlled study

Kavanaugh¹,

McInnes²,

Mease³

et al. 2009

Arthritis & Rheumatism

564

489

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“…There was great variability in assessing these domains, with 12 and 6 different instruments used to assess enthesitis and dactylitis, respectively. The simple evaluation for the presence of enthesitis or entheseal pain was the most utilized instrument for assessing enthesitis (n ϭ 6 [10.3%]), followed by the Maastricht Ankylosing Spondylitis Enthesitis Score (97) and the presence of enthesitis in the feet and heels, both reported in 5 articles (8.6%).…”

Section: Resultsmentioning

confidence: 99%

Clinical outcomes in psoriatic arthritis: A systematic literature review

Palominos¹,

Gaujoux-Viala²,

Fautrel³

et al. 2012

Arthritis Care & Research

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Objective. Many outcomes have been proposed in the assessment of psoriatic arthritis (PsA). The Outcome Measures in Rheumatology (OMERACT) core set for PsA evaluation comprises 6 domains: joints, skin, function, pain, patient's global assessment, and quality of life. The objective of this work was to assess reporting of outcomes in PsA, including patient-reported outcomes (PROs) in recent publications. Methods. A systematic literature search of clinical trials related to PsA and reporting at least 1 clinical outcome between 2006 and 2010 was performed in PubMed, i.e., just before to just after publication of the OMERACT core set. All clinical outcomes were noted and subdivided into domains of health. Data analysis was descriptive. Results. Fifty-eight articles (12,405 patients) were included in the analysis: 17 (29%) were randomized clinical trials; the patients' mean ؎ SD age was 48.2 ؎ 5.4 years and the mean ؎ SD disease duration was 9.0 ؎ 3.1 years. Eighty-four different outcomes were reported, with a mean ؎ SD of 6.9 ؎ 4.3 per study. Patients were mainly assessed using the 6 core set domains, reported in 37.9% (quality of life) to 55.2% (skin) of articles; however, the core set was rarely completely reported since only 10.3% of the studies reported all 6 core domains. PROs were heterogeneous and in particular there was no consensus regarding the number of joints to assess and instruments for dactylitis and enthesitis. PROs were assessed in more than 75% of publications using 28 different instruments. Conclusion. There is great heterogeneity in PsA assessment, even since publication of the OMERACT core set. Better consensus on instruments to assess each domain of health and better insight into which outcomes are important for patients is needed.

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“…Secondary variables analyzed at week 12 and through week 52 included total enthesitis count (0–35), the Maastricht Ankylosing Spondylitis Enthesitis Score (0–13) 28, the Spondyloarthritis Canadian Research Consortium Enthesitis Index (0–16) 29, tender joint count (TJC; 0–72), swollen joint count (SJC; 0–68), number of joints with LOM (0–66), presence of dactylitis (0–20), patient's assessment of total back pain (0–100 mm visual analog scale [VAS]), parent's assessment of patient's pain (0–100 mm VAS), physician's global assessment of disease activity (PGA, 0–100 mm VAS), 50% improvement in the Bath Ankylosing Spondylitis Disease Activity Index 30, and American College of Rheumatology (ACR) Pediatric 30 (Pedi 30), 50, 70, and 90 responses 31. The percent change in AJC from baseline through week 52 was also analyzed.…”

Section: Methodsmentioning

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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Assessment of enthesitis in ankylosing spondylitis

Cited by 590 publications

References 11 publications

Golimumab, a new human tumor necrosis factor α antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: Twenty‐four–week efficacy and safety results of a randomized, placebo‐controlled study

Golimumab, a new human tumor necrosis factor α antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: Twenty‐four–week efficacy and safety results of a randomized, placebo‐controlled study

Clinical outcomes in psoriatic arthritis: A systematic literature review

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

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