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Annals of the Rheumatic Diseases May 2021MAXIMISE (Managing AXIal Manifestations in psorIatic arthritis with SEcukinumab) trial was designed to evaluate the efficacy of secukinumab in the management of axial... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVES
MAXIMISE (Managing AXIal Manifestations in psorIatic arthritis with SEcukinumab) trial was designed to evaluate the efficacy of secukinumab in the management of axial manifestations of psoriatic arthritis (PsA).
METHODS
This phase 3b, double-blind, placebo-controlled, multi-centre 52-week trial included patients (≥18 years) diagnosed with PsA and classified by ClASsification criteria for Psoriatic Arthritis (CASPAR) criteria, with spinal pain Visual Analogue Score ≥40/100 and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥4 despite use of at least two non-steroidal anti-inflammatory drugs (NSAIDs). Patients were randomised (1:1:1) to secukinumab 300 mg, secukinumab 150 mg or placebo weekly for 4 weeks and every 4 weeks thereafter. At week 12, placebo patients were re-randomised to secukinumab 300/150 mg. Primary endpoint was ASAS20 (Assessment of SpondyloArthritis international Society) response with secukinumab 300 mg at week 12.
RESULTS
Patients were randomly assigned; 167 to secukinumab 300 mg, 165 to secukinumab 150 mg and 166 to placebo. Secukinumab 300 mg and 150 mg significantly improved ASAS20 response versus placebo at week 12 (63% and 66% vs 31% placebo). The OR (95% CI) comparing secukinumab 300 mg and 150 mg versus placebo, using a logistic regression model after multiple imputation, was 3.8 (2.4 and 6.1) and 4.4 (2.7 and 7.0; p<0.0001).
CONCLUSIONS
Secukinumab 300 mg and 150 mg provided significant improvement in signs and symptoms of axial disease compared with placebo in patients with PsA and axial manifestations with inadequate response to NSAIDs.
TRIAL REGISTRATION NUMBER
NCT02721966.
Topics: Adult; Antibodies, Monoclonal, Humanized; Antirheumatic Agents; Arthritis, Psoriatic; Axis, Cervical Vertebra; Double-Blind Method; Female; Humans; Male; Middle Aged; Severity of Illness Index; Treatment Outcome
PubMed: 33334727
DOI: 10.1136/annrheumdis-2020-218808 -
The Journal of the American Academy of... Feb 2020Os odontoideum is a rare entity of the second cervical vertebra, characterized by a circumferentially corticated ossicle separated from the body of C2. The ossicle is a... (Review)
Review
Os odontoideum is a rare entity of the second cervical vertebra, characterized by a circumferentially corticated ossicle separated from the body of C2. The ossicle is a distinct entity from an odontoid fracture or a persistent ossiculum terminale. The diagnosis may be made incidentally on imaging obtained for the workup of neck pain or neurologic signs and symptoms. Diagnosis usually can be made with plain radiographs. MRI and CT can assess spinal cord integrity and C1-C2 instability. The etiology of os odontoideum is a topic of debate, with investigative studies supporting both congenital and traumatic origins. A wide clinical range of symptoms exists. Symptoms may present as nondescript pain or include occipital-cervical pain, myelopathy, or vertebrobasilar ischemia. Asymptomatic cases without evidence of radiologic instability are typically managed with periodic observation and serial imaging. The presence of atlantoaxial instability or neurological dysfunction necessitates surgical intervention with instrumentation and fusion for stability.
Topics: Axis, Cervical Vertebra; Child; Humans; Joint Instability; Spinal Fusion
PubMed: 31977608
DOI: 10.5435/JAAOS-D-18-00637 -
Annals of the Rheumatic Diseases Jan 2018Therapeutic targets have been defined for axial and peripheral spondyloarthritis (SpA) in 2012, but the evidence for these recommendations was only of indirect nature....
Treating axial spondyloarthritis and peripheral spondyloarthritis, especially psoriatic arthritis, to target: 2017 update of recommendations by an international task force.
Therapeutic targets have been defined for axial and peripheral spondyloarthritis (SpA) in 2012, but the evidence for these recommendations was only of indirect nature. These recommendations were re-evaluated in light of new insights. Based on the results of a systematic literature review and expert opinion, a task force of rheumatologists, dermatologists, patients and a health professional developed an update of the 2012 recommendations. These underwent intensive discussions, on site voting and subsequent anonymous electronic voting on levels of agreement with each item. A set of 5 overarching principles and 11 recommendations were developed and voted on. Some items were present in the previous recommendations, while others were significantly changed or newly formulated. The 2017 task force arrived at a single set of recommendations for axial and peripheral SpA, including psoriatic arthritis (PsA). The most exhaustive discussions related to whether PsA should be assessed using unidimensional composite scores for its different domains or multidimensional scores that comprise multiple domains. This question was not resolved and constitutes an important research agenda. There was broad agreement, now better supported by data than in 2012, that remission/inactive disease and, alternatively, low/minimal disease activity are the principal targets for the treatment of PsA. As instruments to assess the patients on the path to the target, the Ankylosing Spondylitis Disease Activity Score (ASDAS) for axial SpA and the Disease Activity index for PSoriatic Arthritis (DAPSA) and Minimal Disease Activity (MDA) for PsA were recommended, although not supported by all. Shared decision-making between the clinician and the patient was seen as pivotal to the process. The task force defined the treatment target for SpA as remission or low disease activity and developed a large research agenda to further advance the field.
Topics: Advisory Committees; Arthritis, Psoriatic; Axis, Cervical Vertebra; Consensus; Decision Making; Humans; Severity of Illness Index; Spondylitis, Ankylosing
PubMed: 28684559
DOI: 10.1136/annrheumdis-2017-211734 -
Italian Journal of Pediatrics Nov 2018Mucopolysaccharidoses (MPS) are a group of diseases characterized by abnormal accumulation of glycosaminoglycans (GAGs). Although there are differences among the various... (Review)
Review
Mucopolysaccharidoses (MPS) are a group of diseases characterized by abnormal accumulation of glycosaminoglycans (GAGs). Although there are differences among the various disease types, the osteoarticular system is always involved. The aim of the present study was to establish a framework for MPS-related orthopaedic manifestations and for their treatment. The authors, affiliated to three different Italian Orthopaedic Centres, report data taken from the literature reviewed in light of their accumulated professional experience. Bone alterations make up what is known as dysostosis multiplex, involving the trunk and limbs and with typical radiological findings. Joints are affected by pathological tissue infiltrations. The cervical spinal cord is involved, with stenosis and cervical and occipitocervical instability. In MPS there is a much higher incidence of scoliosis compared with healthy subjects without any particular distinctive feature. Kyphosis of the spine is more frequent and also more severe because of its possible neurological complications, and it is localized at the thoracolumbar level with a malformed vertebra at the top of the deformity. Evolving forms, and those associated with neurological damage, require anteroposterior spine fusion. The hip is invariably involved, with dysplasia affecting the femoral neck (coxa valga), the femoral epiphysis (loss of sphericity, osteonecrosis), and the femoral acetabulum which is flared. All these features explain the tendency to progressive hip migration. Genu valgum is often found (a deviation of the physiological axis with an obtuse angle opening laterally). This deformity is often localized at the proximal tibial metaphysis; it causes functional limitations and leads to an irregular erosion of the articular cartilage. In young patients who still have the growth plate, it is possible to execute a medial hemiepiphysiodesis, a temporary inhibition of cartilage growth, with progressive axis correction. In this paper, the characterisation of clinical features and the review of treatments are divided into separate sections based on the part of the body involved. The conclusions of each section are presented as a summary. One section discusses the high risk of anaesthesia-related complications requiring the collaboration of specifically trained personnel.
Topics: Bone Diseases; Humans; Mucopolysaccharidoses; Orthopedic Procedures
PubMed: 30442173
DOI: 10.1186/s13052-018-0557-y -
Pediatric Neurosurgery 2017Over 170 years ago, traumatic spondylolisthesis of the axis or hangman's fracture was described. Most descriptions of this entity have focused on adult presentations. (Review)
Review
PURPOSE
Over 170 years ago, traumatic spondylolisthesis of the axis or hangman's fracture was described. Most descriptions of this entity have focused on adult presentations.
METHODS
We review the literature on pediatric cases of hangman's fracture emphasizing the embryological as well as presentation aspects.
RESULTS
The majority of cervical spine fractures in children occur at C1 and C2 vertebrae. A normal anterolisthesis of C2 can be seen in younger children and can mimic the anterolisthesis seen after traumatic spondylolisthesis.
CONCLUSIONS
Traumatic spondylolisthesis of the axis in children requires further investigation due to the current emphasis in the literature on adult clinical findings and diagnostic challenges from the developmental immaturity of the pediatric skeleton.
Topics: Adolescent; Cervical Vertebrae; Humans; Spinal Fractures; Spondylolisthesis; Tomography, X-Ray Computed
PubMed: 28231580
DOI: 10.1159/000455923 -
Current Reviews in Musculoskeletal... Dec 2016Fractures of the second cervical vertebra (C2, axis) are common in adult spine surgery. Those fractures occurring in younger adult patients are often associated with... (Review)
Review
Fractures of the second cervical vertebra (C2, axis) are common in adult spine surgery. Those fractures occurring in younger adult patients are often associated with high-energy mechanism trauma, resulting in a "Hangman's Fracture." Management of these fractures is often successful with nonoperative means, though surgery may be needed in those fractures with greater displacement and injury to the C2-C3 disc. Older patients are more likely to sustain fractures of the odontoid process. The evidence supporting surgical management of these fractures is evolving, as there may be a mortality benefit to surgery. Regardless of treatment, longer-term mortality rates are high in this patient population, which should be discussed with the patient and family at the time of injury. Pediatric patients may suffer fractures of the axis, though differentiation of normal and pathologic findings is necessary and more difficult with the skeletally immature spine.
PubMed: 27686572
DOI: 10.1007/s12178-016-9368-1