Whitney Palmer

Healthcare. Politics. Family.

Study: This Corticosteroid Reduces OA Pain

Published on the April 4, 2016, Rheumatology Network website

By Whitney L.J. Howell

The extended-release corticosteroid FX006 (Zilretta) has been shown to have a maximal analgesic effect in patients with knee osteoarthritis (OA) over the standard TCA 40 mg suspension after an intra-articular injection.  However, the dose response rate for FX006 between 20mg and 40mg has, to-date, been unknown.

In an April 2 presentation entitled, “Sustained and Profound Analgesic Benefits in People With Osteoporosis of the Knee Using FX006, an Intra-Articular Extended-Release Formulation of Triamcinolone Acetonide: Results From a Double-Blind, Randomized, Parallel-Group, Dose-Ranging Study,” Philip Conaghan, from the University of Leeds in the United Kingdom discussed FX006 effectiveness over other options.

A total of 306 patients, with documented knee OA with Kellgren-Lawrence grade 2 or 3 and pain intensities from 5-to-9 on a scale of 1-to-10, were treated with either a single IA injection of 20mg or 40mg FX006 or a saline placebo. Baseline age, race, body mass index, and knee characteristics were similar across groups. Researchers monitored participants over 24 weeks for efficacy and safety. The primary endpoint was a change from baseline measures at week 12.

According to the results, Mixed Model Repeat Measures FX006 20mg demonstrated significant improvement in daily pain levels from weeks 1 through 9. FX006 also offered improvement from weeks 1 to 13. In the LOCF/BOCF analysis, FX006 20mg from weeks 1 through 8, and FX006 showed improvement from weeks 1 to 13. In a secondary analysis, FX006 performed better than the placebo for each week.

For all patients with OA, FX006 demonstrated higher efficacy than a placebo. FX006 20mg and 40mg reach maximum performance at week 5, and a phase 3 trial is underway to compare FX006 40mg with standard TCA suspension 40mg and placebo.

To read the article at its original location: http://www.rheumatologynetwork.com/osteoarthritis/study-corticosteroid-reduces-oa-pain


April 13, 2016 Posted by | Healthcare | , , , | Leave a comment

OA Progression as Seen in a Biomarker Panel

Published on the Apr. 4, 2016, Rheumatology Network website

By Whitney L.J. Howell

There are better ways to predict knee osteoarthritis (OA) progression, according to a Duke University physician scientist reporting at OARSI 2016 World Congress.

Currently, most physicians rely on poor predictors, such as age, sex, body mass index, knee pain, general bone mineral content and joint space width, but osteoarthritis comes in phases, reported Virginia Kraus, M.D., Ph.D., of the Duke Molecular Physiology Institute.

Osteoarthritis is a disease associated with periods of inactivity with no more than 30 percent of individuals affected by the progression of knee OA at any one time. These periods of quiescence effect clinical trials — the majority of which in OA suffer from “low power” due to an inability to identify progressors, Dr. Kraus reported.

During an April 1 presentation at OARSI 2016 in Amsterdam earlier this month, Dr. Kraus reported that serum biomarkers may offer a more accurate measure of osteoarthritis progression.

“We developed a method of predicting OA progression based on a panel of mass spectrometry and ELISA based biomarkers. Markers predicting osteophyte progression were distinctly different from those predicting JSN progression. These results suggest that a select set of biomarkers identified from targeted and non-targeted analyses could significantly improve prediction of knee OA progression and could be useful for enriching knee OA clinical trials for progressors,” she reported.

The Kraus study pulled participant data from the Prediction of Osteoarthritis Progression cohort and Genetics of Generalized OA studies. Kraus’s team ran a mass spectrometry analysis to create a Multiple Reaction Monitoring (MRM) panel on 146 peptides (99 proteins) in serum that included synovial fluid (n=23), urine (n=45), and serum (n=40) from knee osteoarthritis radiographic progressors and non-progressors.

Dr. Kraus and colleagues found that MRM or ELISA-based biomarkers, in combination with clinical parameters, significantly improved the prediction of OA progression (all definitions) over clinical variables alone achieving AUCs ranging from 0.84-0.97.

Of the subject population, 82 percent were female with a mean age of 64 and mean BMI of 28. The percentage of each sample meeting the knee OA progress definition was:  75 percent ANY, 52 percent JSN, 66 percent osteophyte, and 29 percent KL progression. Age, gender, and BMI were only significant in predicting osteophyte progression.

Knee osteoarthritis progression was defined as any knee osteoarthritis  progression or osteophyte, joint space narrowing (JSN) or Kellgren Lawrence (KL) grade progression within four years. Any progression was predicted by 10 MRM markers; osteophyte progression by 7 MRM markers; JSN progression by 6 ELISA markers; and KL progression by 1 ELISA marker.

To read the article at its original location: http://www.rheumatologynetwork.com/osteoarthritis/oa-progression-seen-biomarker-panel

April 13, 2016 Posted by | Healthcare | , , | Leave a comment

Study Reveals a Link between Heart Disease and Knee OA

Published on the April 5, 2016, Rheumatology Network website

By Whitney L.J. Howell

Severe knee osteoarthritis is modestly associated with an increased risk of all-cause and cardiovascular disease specific mortality, shows a study presented at the OARSI 2016 World Congress held in Amsterdam this month.

Individuals with cardiovascular disease (CVD) have increased odds of having knee osteoarthritis, as well as a higher likelihood of premature death. Study results suggested, however, other factors besides co-morbidities that could link osteoarthritis and mortality risk.

In an April 1 presentation titled, “Individuals with Severe Knee OA Are At Increased Risk of All-Cause and Cardiovascular Disease-Specific Mortality: The Johnston County Osteoarthritis Project,” Rebecca Cleveland, Ph.D., from the University of North Carolina at Chapel Hill, discussed how these associations were independent of comorbidities and socio-demographic measures linked to higher mortality.

Data on 4,403 participants, age 45 and older, in the Johnston County Osteoarthritis Project were analyzed to examine the association between baseline radiographic knee osteoarthritis measures and all-cause, cardiovascular disease-specific death. The original study enrollment included 3,185 individuals; an additional 1,218 joined as a cohort enrichment.

Researchers used the National Death Index date and cause-of-death records to assess vital status. They used the Kellgren-Lawrence (KL) grade of 2 in either knee to define knee ROA. Severe and symptomatic (sxOA) ROA received a KL grade 3. All models were adjusted for age, cohort (original or enrichment), gender, education, smoking, and self-reported high blood pressure, cancer, and diabetes, as well as heart disease and stroke.

Among participants, average age was 61, 63.5 percent were women, 35.2 percent were black, 36.1 percent didn’t complete high school, and 21.2 percent were smokers. Nearly 13.3 percent had diabetes, 10.1 percent had heart disease, slightly more than 1 percent had stroke and cancer each, and 39 percent had hypertension.

After follow-up at 14. 5 years, investigators determined that participants with knee radiographic osteoarthritis had significantly lower survival than those without it – 61.9 percent and 73.6 percent, respectively. After 24 years, severe, symptomatic knee osteoarthritis was modestly associated with an increased risk of all-cause and CVD-specific mortality.

“Our results suggest there may be mechanisms beyond comorbidities in the link between knee rOA and mortality risk that merit further investigation. Future studies should focus on potential interactions with comorbidities,” the authors wrote.

To read the article at its original location: http://www.rheumatologynetwork.com/OARSI2016/study-reveals-link-between-heart-disease-and-knee-oa

April 13, 2016 Posted by | Healthcare | , , | Leave a comment


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