The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part I): classification of paper patients by expert opinion including uncertainty appraisal

Rudwaleit, Martín; Landewé, Robert; Heijde, Desirée van der; Listing, Joachim; Brandt, J.; Braun, J.; Burgos‐Vargas, Rubén; Collantes-Estévez, Eduardo; Davis, John C.; Dijkmans, Ben A. C.; Dougados, Maxime; Emery, Paul; Horst‐Bruinsma, Irene E. van der; Inman, Robert D.; Khan, Muhammad Asim; Leirisalo‐Repo, Marjatta; Linden, Sjef van der; Maksymowych, Walter P.; Mielants, Herman; Olivieri, Ignazio; Sturrock, R. D.; Vlam, Kurt de; Sieper, Joachim

doi:10.1136/ard.2009.108217

Cited by 773 publications

(575 citation statements)

References 19 publications

(28 reference statements)

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“…All MRIs were read by a central reader at Synarc who reported the presence of inflammation of the SI joints, which is highly suggestive of sacroiliitis 2, 7, or the absence of SI joint inflammation. All investigators, site personnel, patients, and sponsor personnel were blinded with regard to treatment allocation.…”

Section: Methodsmentioning

confidence: 99%

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A Randomized, Double‐Blind, Placebo‐Controlled, Sixteen‐Week Study of Subcutaneous Golimumab in Patients With Active Nonradiographic Axial Spondyloarthritis

Sieper

Heijde

Dougados

et al. 2015

Arthritis & Rheumatology

177

115

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ObjectiveAxial spondyloarthritis (SpA) is a chronic inflammatory disease characterized by back pain and stiffness. The objective of this study was to determine whether golimumab is superior to placebo in patients with nonradiographic axial SpA.MethodsThis phase III, double‐blind, randomized, placebo‐controlled trial was performed to evaluate subcutaneous golimumab (50 mg) versus placebo in patients ages ≥18 years to ≤45 years who had active nonradiographic axial SpA according to the Assessment of SpondyloArthritis international Society (ASAS) criteria for ≤5 years since diagnosis, high disease activity, and an inadequate response to or intolerance of nonsteroidal antiinflammatory drugs. Patients were randomized 1:1 to receive golimumab or placebo subcutaneously every 4 weeks. The primary end point was 20% improvement according to the ASAS criteria (ASAS20) at week 16. Key secondary end points were an ASAS40 response, ASAS partial remission, 50% improvement in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and change in the Spondyloarthritis Research Consortium of Canada (SPARCC) magnetic resonance imaging (MRI) index for sacroiliac (SI) joint inflammation (SPARCC score).ResultsOf the 198 patients randomized, 197 were treated (97 received golimumab, and 100 received placebo). The mean age of the patients was 31 years, and 57.1% were male. At baseline, the mean ± SD BASDAI was 6.5 ± 1.5, the mean ± SD ASDAS was 3.5 ± 0.9, and the mean ± SD SPARCC score was 11.3 ± 14.0. The primary end point, an ASAS20 response, was achieved by significantly more patients in the golimumab group compared with the placebo group (71.1% versus 40.0%; P < 0.0001). An ASAS40 response was also achieved by significantly more patients in the golimumab group compared with the placebo group (56.7% versus 23.0%; P < 0.0001). The incidence of adverse events did not differ meaningfully between groups.ConclusionPatients with active nonradiographic axial SpA treated with golimumab had significantly greater improvement in symptoms compared with patients treated with placebo. Golimumab was well tolerated and had a favorable risk/benefit profile.

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Section: Methodsmentioning

confidence: 99%

“…This latter group is described as having nonradiographic axial SpA, and nonradiographic axial SpA was recently classified by the Assessment of SpondyloArthritis international Society (ASAS) as part of axial SpA 2, 7. A late diagnosis of axial SpA frequently leads to delays in treatment 8.…”

mentioning

confidence: 99%

A Randomized, Double‐Blind, Placebo‐Controlled, Sixteen‐Week Study of Subcutaneous Golimumab in Patients With Active Nonradiographic Axial Spondyloarthritis

Sieper

Heijde

Dougados

et al. 2015

Arthritis & Rheumatology

177

115

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“…Within the last ten years, clinicians have tried to recognize and diagnose AS in the early inflammatory stage of the process that ultimately leads to bone proliferation [9,10]. The purpose of this effort was to treat AS in the early pre-radiographic stage of the disease with TNF-blockers and prevent its long-term consequences.…”

Section: Reviewmentioning

confidence: 99%

The assessment of the spondyloarthritis international society concept and criteria for the classification of axial spondyloarthritis and peripheral spondyloarthritis: A critical appraisal for the pediatric rheumatologist

Burgos‐Vargas

2012

Pediatr Rheumatol

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This review refers to the origin and current state of the assessment of the SpondyloArthritis International Society (ASAS) criteria for the classification of axial and peripheral spondyloarthritis (SpA) and the possible implications in the pediatric population. The ASAS criteria evolved from the idea that the earlier the recognition of patients with ankylosing spondylitis, the better the efficacy of tumor necrosis factor blockers. Strategies included the development of new concepts, definitions, and techniques for the study of clinical signs and symptoms. Of relevance, the new definition of inflammatory back pain (IBP) and the introduction of sacroiliitis by magnetic resonance imaging represented the most important advance in the early identification of AS in the “pre-radiographic stage” of the disease. AS is considered in this paper as a disease continuum with symptoms depending on age at onset. The application of those specific strategies in children and adolescents with SpA seems limited because the most important manifestation in the early stage of disease is not IBP, but peripheral arthritis and enthesitis. In this instance, the logical approach to juvenile onset SpA according to ASAS criteria should not be through the axial criteria but rather the peripheral set of criteria.

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“…Axial SpA includes patients with or without definitive radiographic changes in the sacroiliac joints. These subpopulations are known, respectively, as ankylosing spondylitis (AS) 1 and nonradiographic axial SpA 2, 3.…”

Section: Introductionmentioning

confidence: 99%

Impact of Certolizumab Pegol on Patient‐Reported Outcomes in Patients With Axial Spondyloarthritis

Sieper

Kivitz

Tubergen

et al. 2015

Arthritis Care & Research

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ObjectivePatient‐reported outcomes (PROs) provide an opportunity to collect important information relating to patient well‐being, which is often difficult for physicians to measure (e.g., quality of life, pain, fatigue, and sleep). Here we evaluate the effects of certolizumab pegol (CZP) on PROs during the 24‐week, double‐blind phase of the RAPID axial spondyloarthritis (SpA) trial, a phase 3 trial of axial SpA patients, including both ankylosing spondylitis (AS) and nonradiographic axial SpA patients.MethodsA total of 325 patients with active axial SpA were randomized 1:1:1 to placebo, CZP 200 mg every 2 weeks, or CZP 400 mg every 4 weeks. The primary end point was the Assessment of SpondyloArthritis International Society criteria for 20% improvement in disease activity response at week 12, and has been reported previously. PROs included total back pain, nocturnal back pain, a daily pain diary, the Sleep Problems Index II (SPI) domain of the Medical Outcomes Study (MOS) Sleep Scale, fatigue, the Ankylosing Spondylitis Quality of Life (ASQOL) measure, and the Short Form 36‐item (SF‐36) health survey physical component summary (PCS), mental component summary (MCS), and domains.ResultsPatients treated with CZP reported significant improvements from week 1 for nocturnal back pain (placebo −0.6, CZP 200 mg every 2 weeks −1.9, and CZP 400 mg every 4 weeks −1.6; P < 0.001) and ASQOL (placebo −1.0, CZP 200 mg every 2 weeks −2.3, and CZP 400 mg every 4 weeks −1.9; P < 0.05) compared with placebo, while significant improvements in total back pain were seen from day 2. Patients treated with both CZP dosing regimens also had significantly greater improvements in fatigue, MOS‐SPI, SF‐36 PCS, MCS, and domains compared with placebo. Improvements were similar in both AS and nonradiographic axial SpA patients.ConclusionBoth CZP dosing schedules rapidly improved patient well‐being, as measured by PROs, including pain, fatigue, sleep, SF‐36, and ASQOL in both AS and nonradiographic axial SpA patients.

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The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part I): classification of paper patients by expert opinion including uncertainty appraisal

Abstract: The ASAS group has developed candidate criteria for the classification of axial SpA that include patients without radiographic sacroiliitis. The candidate criteria need to be validated in an independent international study.

Cited by 773 publications

References 19 publications

A Randomized, Double‐Blind, Placebo‐Controlled, Sixteen‐Week Study of Subcutaneous Golimumab in Patients With Active Nonradiographic Axial Spondyloarthritis

A Randomized, Double‐Blind, Placebo‐Controlled, Sixteen‐Week Study of Subcutaneous Golimumab in Patients With Active Nonradiographic Axial Spondyloarthritis

The assessment of the spondyloarthritis international society concept and criteria for the classification of axial spondyloarthritis and peripheral spondyloarthritis: A critical appraisal for the pediatric rheumatologist

Impact of Certolizumab Pegol on Patient‐Reported Outcomes in Patients With Axial Spondyloarthritis

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