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Value Propositions - August 2016

VBCR - August 2016, Vol 5, No 4 - Value Propositions

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Portable Device Offers Easier, Cost-Effective Approach to Gout Diagnosis

Researchers at the University of California, Los Angeles (UCLA) have developed a compact, cost-effective, portable imaging system that can diagnose gout, according to a recent announcement by the institution. This new system, which uses computational microscopy to analyze uric acid crystals, could give more primary care physicians the opportunity to screen for the disease.

In an article recently published by Scientific Reports, Yibo Zhang, PhDc, Electrical Engineering Department, UCLA, and colleagues explain the research behind, and the purpose for their device. They assert that, although compensated polarized light microscopy has been the “gold standard” for diagnosing gout since the early 1960s, recent studies have shown that the procedure is not commonly performed in primary care clinics. In addition to limits regarding field of view (FOV), lack of use of the procedure is attributed to polarized light microscopes being bulky, heavy, and expensive.

The new device designed by Mr Zhang and colleagues uses holographic imaging and lens-free on-chip microscopy technology to produce high-resolution images of crystal-like objects in patient fluid samples without the need for lenses.

“With ~2 orders of magnitude larger FOV than a CPLM (compensated polarized light microscope), the presented technique has the potential to largely improve the efficiency and accuracy of gout diagnosis, while also reducing costs,” the researchers concluded in their report. “Furthermore, as the lens-free imaging set-up can be cost-effective and field-portable, the presented method is especially promising for automated diagnosis of crystal arthropathy at the point of care or in resource-limited clinical settings.”

According to the university, this technology could ultimately be used to diagnose other conditions diagnosed via conventional polarized light microscopes and that are caused by crystals forming in bodily fluids (eg, kidney stones).

Horan MS. UCLA Newsroom. July 25, 2016; Zhang Y, Lee SYC, Zhang Y, et al. Sci Rep. 2016;6:28793.

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Efficacy and Safety Maintained for Up to 5 Years with Tocilizumab Therapy

Patients with rheumatoid arthritis (RA) who inadequately responded to methotrexate monotherapy and were treated with tocilizumab plus methotrexate experienced subdued radiographic progression and maintained improvements in signs and symptoms over 5 years, according to new research data from Joel Kremer, MD, Albany Medical College, NY, and colleagues.

Seeking to report the 5-year efficacy and safety data of patients with active RA treated with tocilizumab, researchers conducted a randomized, 2-year, placebo-controlled study, and an open-label, 3-year extension of tocilizumab use in this patient population. Study participants received placebo or intravenous tocilizumab 4 mg/kg or 8 mg/kg every 4 weeks plus methotrexate; rescue with tocilizumab was receivable from week 16, and, after week 52, patients could switch to open-label tocilizumab 8 mg/kg.

Using the Genant-modified Total Sharp Score (GmTSS), Dr Kremer and colleagues analyzed radiographs of 1149 patients who had at least baseline, week 104, and post–week 104 radiographs by randomized treatment. They then combined the clinical and safety data for all patients who received ≥1 doses of tocilizumab, and presented results from the first tocilizumab dose.

Of the patients included in the study, 34% received 5 years of treatment. The mean 5-year GmTSS change demonstrated a greater inhibition of radiographic progression in tocilizumab patients compared with those who received placebo (1.34 vs 3.02). In addition, the greatest annualized progression rate occurred in year 1. The study authors reported that, overall, 53% and 35% of patients receiving tocilizumab and placebo experienced no progression (GmTSS ≤0), respectively.

Per the American College of Rheumatology improvement criteria response, Disease Activity Score 28-erythrocyte sedimentation rate, European League Against Rheumatism good/moderate response, and Boolean remission, clinical benefit was maintained. Physical function was also maintained, and the 5-year safety profile was similar to that of 2 years.

“Over 5 years, tocilizumab [plus methotrexate] inhibited radiographic progression and maintained improvements in signs and symptoms and physical function in [methotrexate]-inadequate responders with active disease,” Dr Kremer and colleagues concluded. “No new safety signals occurred.”

Kremer JM, Blanco R, Halland AM, et al. Clin Exp Rheumatol. 2016 Apr 15. Epub ahead of print.

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First Ever Treatment Guidelines for Managing Rheumatologic Manifestations of Sjögren’s Syndrome

The Sjögren’s Syndrome Foundation (SSF) has published rheumatology clinical practice guidelines featuring management recommendations designed to improve quality and consistency of care for patients with Sjögren’s syndrome.

“These first ever, standard of care guidelines for systemic Sjögren’s in the [United States] will fill a significant clinical void,” stated Steven Taylor, Chief Executive Officer, SSF, in a recent announcement by the organization. “But beyond that, the guidelines will inform healthcare coverage policy, lead to needed educational programs, and highlight opportunities for future research.”

The guidelines, which were recently published in Arthritis Care & Research, detail how these recommendations were formed and selected for inclusion.

Using input from patients and rheumatologists, members of the SSF Clinical Practice Guidelines committee posited questions regarding the management of systemic manifestations of Sjögren’s. Topic review groups were assigned these clinical questions, and charged with performing systematic reviews, extracting data, and drafting guidelines.

The resulting recommendations were reviewed by experts—including 30 to 40 academic and community practice clinicians, registered nurses, and patients—using a modified Delphi process, and rated in accordance with the American Society of Clinical Oncology’s GRADE modifications. Recommendations had to achieve an agreement level of ≥75% among the experts to be adopted as a guideline recommendation.

Notable recommendations include the use of self-care measures and exercise to reduce fatigue; a decision tree for oral disease-modifying antirheumatic drug use in cases of inflammatory musculoskeletal pain; and rituximab in select clinical settings for oral and ocular dryness, and for certain extraglandular manifestations (eg, inflammatory arthritis, pulmonary disease, and mononeuritis multiplex). The guidelines also strongly discourage the use of tumor necrosis factor-α inhibitors for sicca symptoms, and the majority of clinical contexts in primary Sjögren’s.

Carsons SE, Vivino FB, Parke A, et al. Arthritis Care Res (Hoboken). 2016 Jul 7. Epub ahead of print.

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Short-Term Use of Soft Lateral Wedge Arch Support Significantly Reduces Pain in Patients with Knee Osteoarthritis

Patients with knee osteoarthritis (OA) who, for a short term, used soft versus rigid lateral wedge arch support experienced more significant improvement in pain, physical activity, quality of life, and daily living, sports, and recreation functions, researchers behind a prospective, double-blind, randomized study have found.

Using the International Classification of Functioning, Disability and Health system, Ru-Lan Hsieh, MD, Department of Physical Medicine and Rehabilitation, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan, and Wen-Chung Lee, MD, PhD, Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, compared the efficacy of using rigid versus soft lateral wedge arch support insoles for a short term in 74 patients with knee OA. Among other scales for evaluation, they used the Knee Injury and Osteoarthritis Outcome Score to measure knee OA-related health status.

“The use of soft [lateral wedge arch support] insoles resulted in a significant short-term reduction in pain and improvements in stair ascent time, daily living function, sports and recreation function, and knee-related quality of life,” explained Drs Hsieh and Lee in their report.

They concluded by asserting the necessity for clinical trials evaluating the biomechanical and long-term efficacy of different types of insoles in patients with knee OA.

Hsieh RL, Lee WC. Medicine (Baltimore). 2016;95:e3952.

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Last modified: September 27, 2016
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