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Published Clinical Papers 2017

A selection of the latest research findings

Short-term repeat MRI scans in suspected early axial spondyloarthritis are clinically relevant only in HLA-B27-positive males 

This research investigated the natural history of magnetic resonance imaging (MRI)-determined bone marrow edema over a 12-week period.

109 MRI scans were performed on 30 patients who fulfilled the Assessment of Spondyloarthritis international Society inflammatory back pain criteria at baseline and at 4, 8, and 12 weeks.

Results indicated repeat MRI scans within a 12-week period should be considered in HLA-B27-positive males.

 

Evaluation of the impact of concomitant fibromyalgia on TNF alpha blockers effectiveness in axial spondyloarthritis

This study confirmed that fibromyalgia coexists in patients with axial spondyloarthritis and that its presence seems to have a negative impact on response to anti TNF therapy. However, researchers believed this seemed more related to the self-reported instruments used in treatment evaluation, rather than a different treatment effect of the molecule in this subgroup of patients.

 

Prevalence and clinical effect of immunogenicity of TNF-α blockers in patients with axial spondyloarthritis

This research aimed to evaluate the prevalence of immunogenicity of TNF-α blockers in axial spondyloarthritis patients and assess the effect of immunogenicity on drug levels and clinical response. The researchers concluded the some people’s failure to respond to TNF-α blockers may be at least partially related to immunogenicity. They advised measurement of anti-drug antibodies and drug levels in these patients may assist in determining further treatment strategies.

 

A truly complementary approach: A qualitative exploration of complementary and alternative medicine practitioners’ views of treating ankylosing spondylitis

There is a lack of knowledge concerning the experiences of CAM practitioners in terms of treating individuals with AS. This study aimed to explore of how UK-based CAM practitioners treat individuals with AS.
CAM practitioners emphasised the benefits of CAM to focus on providing effective symptom management when used in conjunction, rather than in opposition to, mainstream healthcare. Adoption of a more holistic approach to AS management by CAM practitioners may empower clients to become more aware of symptoms, thus potentially reducing delays in receiving a formal diagnosis of AS.

 

Patients with inflammatory bowel disease have increased risk of autoimmune and inflammatory diseases

The aim of this research was to investigate whether immune mediated diseases (including AS) are more frequent in patients with inflammatory bowel disease (IBD). It was a population based registry study, including 47,325 patients with IBD from the Danish National Patient Registry. Controls were randomly selected from the Danish Civil Registration System. Researchers discovered iImmune mediated diseases were significantly more frequent in patients with IBD. These results strengthen the hypothesis that some IMDs and IBD may have overlapping pathogenic pathways.

 

Causes of pain in patients with axial spondyloarthritis

Back pain in AS is usually either due to axial inflammation or structural changes based on new bone formation. However, there are other possible causes of pain including: vertebral fractures, degenerative spinal changes and, more rarely, subarachnoidal cysts.

The researchers therefore highlight the importance of careful evaluatation of the origin of back pain in these patients and to consider all possible differential diagnoses. The correct diagnosis is of major importance because treatments may differ considerably. In the monitoring of patients with axSpA it is especially important to consider that pain may have a different origin and it is crucial to notice changes in the nature of the reported back pain.

Accordingly, the recently updated Assessment of Spondyloarthritis international Society (ASAS)/European League Against Rheumatism (EULAR) and the treat-to-target recommendations both define improvement of symptoms, a reduction of pain and abrogation of inflammation as important targets in axSpA that can be achieved by pharmacological and nonpharmacological treatments, in rare cases including surgical methods.

 

TNF blockers inhibit spinal radiographic progression in ankylosing spondylitis by reducing disease activity: results from the Swiss Clinical Quality Management cohort

This research aimed to analyse the impact of TNF inhibitors on spinal radiographic progression in AS.

432 Patients with AS in the Swiss Clinical Quality Management cohort with up to 10 years of follow-up and radiographic assessments every 2 years were included. Radiographs were scored by two readers according to the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS).

The researchers concluded that TNF are associated with a reduction of spinal radiographic progression in patients with AS. This effect seems mediated through the inhibiting effect of TNFi on disease activity.

 

Impact of obesity on the response to tumor necrosis factor inhibitors in AS

The aim of this study was to investigate the impact of different body mass index (BMI) categories on anti TNF response in a large group of AS patients.

A total of 624 AS patients starting a first anti TNF were considered in the current study. This included 332 patients of normal weight, 204 patients who were overweight, and 88 obese patients.

The researchers concluded obesity is associated with significantly lower response rates to anti TNF in AS patients.

 

Treating axial spondyloarthritis and peripheral spondyloarthritis to target: 2017 update of recommendations by an international task force

Therapeutic targets have been defined for axial and peripheral spondyloarthritis, but the evidence for these recommendations was only of indirect nature. 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.  The 2017 task force arrived at a single set of recommendations for axial and peripheral spondyloarthritis. The task force defined the treatment target for spondyloarthritis as remission or low disease activity and developed a large research agenda to further advance the field.

 

The co-occurrence and characteristics of patients with axial spondyloarthritis who meet criteria for fibromyalgia: Results from a UK national register (BSRBR-AS)

The objective of this research was to estimate the proportion of AS patients who also meet the criteria for fibromyalgia and to try to chacterise them.

The BSRBR-AS register was used to assess 1504 patients (68% male). One in five (20.7%) met the criteria for fibromyalgia.  Patients who met the criteria reported significantly worse disease activity, function, global severity scores, quality of life and were more likely to have moderate/severe levels of mood disorder and clinically important fatigue. They reported work impairment around half the time.

 

Are AS, psoriatic arthritis and undifferentiated spondyloarthritis associated with an increased risk of cardiovascular events? 

Researchers investigated investigate the risk of first-time acute coronary syndrome (ACS), stroke and venous thromboembolism (VTE) in patients with AS, PsA and undifferentiated spondyloarthritis (uSpA), compared to each other and to the general population. They concluded patients with AS, PsA and uSpA are at increased risk for ACS and stroke events, which emphasises the importance of identification of and intervention against cardiovascular risk factors in SpA patients. Increased alertness for VTE is warranted in patients with SpA.

 

Long-term effects of interleukin-17A inhibition with secukinumab in active AS

This study found ecukinumab provided sustained efficacy in signs, symptoms and physical function in subjects with AS over 3 years. No new safety signals were observed.

 

Sustained efficacy, safety and patient-reported outcomes of certolizumab pegol

The aim of this study was to assess the long-term safety and efficacy of certolizumab pegol over 4 years of continuous treatment in patients with axial spondyloarthritis (axSpA), including both AS and non-radiographic (nr-) axSpA. Researchers found that improvements in clinical and patient-reported outcomes at 24 and 96 weeks were sustained through 4 years of treatment, with no new safety signals.

 

Anti TNF inhibitor treatment and occurrence of anterior uveitis in ankylosing spondylitis

This research aimed to compare the effect of adalimumab, etanercept and infliximab on anterior uveitis occurrence in AS, using data from the Swedish Biologics Registry.

Patients with AS starting adalimumab, etanercept or infliximab as their first anti TNF from January 2003 to December 2010 were extracted from the Swedish Rheumatology Quality Register. Anterior uveitis rates, based on visits to an ophthalmologist, were obtained by linkage to the Swedish National Patient Register.

For each anti TNF, anterior uveitis rates for 2 years before anti TNF was started and for the first 2 years on anti TNF treatment were compared. In the subgroup of patients who were anterior uveitis free during the 2 years before starting anti TNF, the researchers also compared the risk of a first anterior uveitis event.

1365 patients with AS were included (406 on adalimumab, 354 on etanercept and 605 on infliximab).

The results suggest differences in effect on anterior uveitis risk between adalimumab, etanercept and infliximab, with a clear advantage for adalimumab and infliximab over etanercept.

 

Exploring the relationship between demographic and disease-related variables and perceived effect of health status on sexual activity 

This research explores the relationship between demographic and disease-related variables and the perceived effect of health status on sexual activity in patients with axial spondyloarthritis (ax-SpA).

Researchers found approximately 20% of ax-SpA patients reported a large negative effect on their sexual activity. Female gender, high BMI, current smoking, and reduced HRQoL were associated with health status having a large effect on sexual activity, whereas no measures reflecting ax-SpA disease showed an independent association.

 

Efficacy and safety of non-pharmacological and non-biological pharmacological treatment 

This systematic literature review informed the 2016 update of the ASAS/EULAR recommendations for the management of axial spondyloarthritis. Key points included: regular exercise may improve several outcomes; efficacy and safety of NSAIDs are confirmed; glucocorticoids are not proven to be effective and no new data DMARDs was found.

 

Clinical outcomes following spinal fracture in patients with AS

This study aimed to evaluate the outcomes of patients with AS who sustained acute vertebral fractures over a 10-year period. A retrospective review of patient records and radiographic images was performed. Mechanism of injury, fracture type, timing of diagnosis, neurological deficit, management and complications were assessed.

Twenty-four patients were included. Most (23) sustained low energy injuries. Five patients had a delayed diagnosis over 24 hours after the time of injury. Twelve patients had a neurological deficit at the time of admission and most did not recover. Eighteen patients underwent surgical stabilisation. There were 19 complications (in 15 patients) following surgery.

The authors conclude people with AS are at risk of spinal fracture and associated spinal cord injury after relatively minor trauma. Delayed diagnosis places the patient at risk of neurological compromise, and thus a high index of suspicion is needed when assessing this patient group.

 

Swiss ball exercises improve muscle strength and walking performance in AS

This research evaluated the effectiveness of a progressive muscle strengthening program using a Swiss ball. The researchers conclude progressive muscle strengthening using a Swiss ball is effective for improving muscle strength and walking performance in patients with AS.

 

Tofacitinib in patients with ankylosing spondylitis: a phase II, 16-week, randomised, placebo-controlled, dose-ranging study

The aim of this clinical study was to compare efficacy and safety of various doses of tofacitinib, an oral Janus kinase inhibitor, with placebo in patients with active AS. It was a is 16-week (12-week treatment, 4-week washout), phase II, multicentre, dose-ranging trial. The primary efficacy endpoint was Assessment of SpondyloArthritis International Society 20% improvement (ASAS20) response rate at week 12. Secondary endpoints included objective measures of disease activity, patient-reported outcomes and MRI of sacroiliac joints and spine. Safety was monitored.

The study concluded that tofacitinib 5 and 10 mg twice daily demonstrated greater clinical efficacy versus placebo in reducing signs, symptoms and objective endpoints of active AS in adult patients with a similar 12-week safety profile as reported in other indications.

 

Acute Anterior Uveitis as a Risk Factor of AS

Acute anterior uveitis (AAU) could be the first presentation of AS. This study investigates whether AAU is a risk factor in developing AS later by using National Health Insurance Research Database (NHIRD) in Taiwan. The researchers concluded AAU was a risk factor for AS. They note to identify AAU as an extra-articular manifestation is crucial for early diagnosis and treatment of AS.

 

Should axial spondyloarthritis without radiographic changes be treated with anti-TNF agents?

This clinical paper was published in Rheumatology International and was authored by members of the NASS Medical Advisory Board including Dr Andrew Keat, Dr Alex Bennett, Dr Karl Gaffney and Dr Helena Marzo-Ortega. It looks at the evidence base for managing people with non-radiographic axial spondyloarthritis (nr-axSpA). To explore whether this should be treated similarly to AS, they examined the literature on prevalence, natural history, disease burden, and treatment.

The authors conclude there is strong evidence that nr-axSpA and AS are expressions of the same disease. Approximately 10% of patients with nr-axSpA will develop radiographic disease over 2 years; after more than 20 years, the figure may exceed 80%. Nr-axSpA patients have lower CRP and less spinal inflammation on MRI than AS patients but similar disease activity, pain, and quality-of-life impairment. Most patients with nr-axSpA manage well with conservative treatment, but a minority have severe disabling symptoms. Anti-TNF therapy has demonstrated similar efficacy and safety in nr-axSpA and AS. Current evidence does not clearly indicate that anti-TNF treatment can inhibit or limit bony progression of AS, the basis of conservative and anti-TNF treatment is control of symptoms and function. For some patients with nr-axSpA, the need for powerful treatments is as great as in some with AS; thus, the authors conclude, treatment of axSpA should be consistent across the axSpA spectrum with anti-TNF agents being available, irrespective of radiographic change, according to the same criteria as those applied to AS.

 

Behaviour change intervention increases physical activity, spinal mobility and quality of life in adults with ankylosing spondylitis: a randomised trial

This article appeared in the Journal of Physiotherapy. It aimed to study whether a 3-month behaviour change intervention targeting physical activity increased habitual physical activity in adults with ankylosing spondylitis (AS). It wanted to see if the intervention improved health-related physical fitness, AS-related features, and attitude to exercise and assess whether any gains were maintained over a 3-month follow-up. The study concluded that health-enhancing physical activity, spinal mobility and quality of life were significantly improved after the intervention, and improvements were maintained at 3-month follow-up.