Whitney Palmer

Healthcare. Politics. Family.

Review: Treatment for Lupus Nephritis

Published on Nov. 10, 2016, Rheumatology Network website

By Whitney L. Jackson

Among lupus patients, lupus nephritis can be one of the most common and most severe disease manifestations — affecting 40% of lupus patients. For nearly 50 years, though, treatments have advanced, and lupus nephritis outcomes have improved.

Now, a new literature review study reveals those therapeutic steps forward have stalled. The plateau began in 2000. In fact, the risk of developing lupus nephritis-related end stage renal disease (ESRD) at 5, 10, and 15 years has stagnated at 11%, 17%, and 22% for the past decade.

According to study authors from Brigham and Women’s Hospital in Boston, this freeze isn’t related to ongoing work.

“The lack of progress in lupus nephritis outcomes is not due to lack of effort,” they wrote. “In fact, alongside government funding, private agencies have emerged as important drivers of lupus nephritis research through their own investigations and funding mechanisms.”

Still, the reasons for the stymied progress remain unclear. Researchers hypothesize poor healthcare access for some groups, limited efficacy of current treatments, and adverse effects of those treatments might be to blame.

To shed more light on this problem, the study authors reviewed existing literature. They analyzed existing incidence and outcomes data, reviewed diagnosis and treatment guidelines, and evaluated the role rheumatologists play in the therapeutic process.

Prevalence

While lupus nephritis impacts 40% of lupus patients, it is far more common in nonwhite populations and affects women more than men. According to data from a 2000-2004 Medicaid study, lupus nephritis is 3.8 times more likely in blacks, 3.7 times more in Asians, 2.3 times more in Native Americans, and 1.9 times more in Hispanics.

The incidence of lupus nephritis is also greater among patients who experience lupus onset in childhood versus as an adult – 37% versus 20%, respectively.

Barriers to Care

Regardless of ethnicity, however, existing research points to socioeconomic status as a significant contributing factor to increase lupus nephritis incidence. Based on findings from a 2010 Journal of Rheumatology study, patients in poor urban areas are less likely to have insurance, and they use emergency department services more.

In addition, these patients usually live more than 200 miles away from a rheumatologist, or immunosuppressive medications might be unavailable or cost-prohibitive. In some cases, available care could simply be substandard.

Treatment Recommendations

Overall, the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) and the European Dialysis & Transplant Association (ERA-EDTA) recommend lupus patients be closely monitored from lupus nephritis outset through routine screenings and kidney biopsies.

Authors Paul Hoover, M.D., and Karen Costenbrader, M.D., highlighted six additional, official recommendations designed to maximize lupus nephritis treatment outcomes:

1.      All lupus nephritis patients should receive adjunctive medication, including hydroxycholorquine (HCQ) that reduces systemic lupus relapses and may be associated with slowing renal damage, thrombosis, hyperglycemia, and hyperlipidemia, as well as a reno-protective agent and a lipid-lowering statin. Any woman considering pregnancy should be counseled about the effects of therapy on a fetus.

2.      EULAR/ERA-EDTA endorses low-to-moderate oral glucocorticoid doses, plus azathioprine for individuals with proteinuria >1g/day or urinary acanthocytes.

3.      Patients with Class III or IV proliferation glomerulonephritis induction therapy should receive induction therapy with moderate oral glucocorticoid doses, plus intravenous cyclophosphamide or mycophenolate mofetil (MMF) or without initial pulses of intravenous methylprednisolone.

4.      For maintenance therapy, it’s recommended that MMF or azathioprine be used with or without low-dose glucocorticoids.

5.      EULAR/ERA-EDTA recommends treatment of “active lesions” only.

6.      EULAR/ERA-EDTA recommends the continuing maintenance therapy for two years after complete remission (proteinuria <0.5mg/day – near normal glomerular filtration rates).

Poor Outcomes Due to Treatment

Historically, adherence to lupus and lupus nephritis treatment has been low with less than 25% of lupus patients having adherence rates of more than 80% over two years. This often leads to lupus relapse, kidney problems, and hospitalizations.

Existing literature shows, though, that some providers are turning to serial serum HCQ level measurements to determine whether patients are adhering to treatment regimens. HCQ levels between 500-to-2,000 ng/ml are associated with modestly-improved lupus disease activity. This type of measurement could point to treatment adherence. Behavioral therapy and patient education could also be effective, though they haven’t been tested with lupus nephritis patients yet.

Adherence isn’t the only factor that determines outcomes, however.

Recent research suggests that genetics might play a role, as well. Over the past decade, investigations have identified more than 50 lupus risk loci. Many of these focus on lupus nephritis: BLK, STAT4, TNFS4, IKZFI, IRF5, TLR9, TNFAIP3, TNIP3, ACE, KLK, FCGR2A, FCGR3A, and ITGAM. For example, APOLI1 risk alleles associated with ESRD are 60-times more likely in blacks than whites, more than doubling their risk of developing ESRD and shortening their time to developing the disease by two years.

Most participants were European and Asian, however, so it’s unclear if this data is accurate across ethnicities.

However, there are treatment-related factors that contribute to poor outcomes, investigators said. In fact, Hoover said, the research review revealed a surprising finding. Glucocorticoids and long-term immunosuppression – despite effectively controlling lupus activity – have significant side effects, such as infections.

Traditionally, glucocorticoid use induces successful remission within six months. However, in one Medicaid study of 33,000 lupus patients – 7,100 of which had lupus nephritis – the incidence rate of serious infection is more than 2-fold higher for lupus nephritis patients than those with lupus alone. However, the highest risk rate was among those treated with glucocorticoids followed by those treated with immunosuppressive drugs.

It is possible to minimize bad outcomes by following vaccination guidelines before beginning immunosuppressive treatment for lupus and lupus nephritis patients. Only killed infections, such as influenza, pneumococcus, hepatitis B, and HPV, are used – live vaccines are avoided.

But, in the long term, glucocorticoid use presents significant challenges to lupus nephritis treatment. Over time, continued use can cause osteoporotic fractures, avascular necrosis, diabetes mellitus, cataracts, glaucoma, and premature death.

Because of these negative effects, ACR has issued recommendations for all patients treated with glucocorticoids. Before patients begin a regimen, providers should: evaluate all patients for fall risk, counsel them on smoking cessation, encourage reduced alcohol consumption, promote modest weight loss and exercise, and encourage patients to get enough calcium and Vitamin D.

The ACR also recommends anti-osteoporotic medication for patients with prior fragility fractures. However, selecting the best anti-osteoporotic medication can be difficult. Among patients with renal insufficiency or ESRD, bisphosphonates are contraindicated for use. And, there’s no general consensus on whether these drugs can be used with women of child-bearing years.

Treatment Possibilities

Given the negative impacts of prolonged glucocorticoid usage among lupus nephritis patients, the authors wrote, the use of low-dose or glucocorticoid-free treatments are under investigation.

Although previous research with rituximab, the monoclonal antibody that targets the B-cell surface protein CD20, showed no statistical improvement in outcomes for patients who received MMF and glucocorticoids, a recent study is showing more promise. Of 50 lupus nephritis patients treated without oral glucocorticoids, 52% achieved complete renal remission at 1 year. Participants received two pulses of methylprednisolone and two 1-gram doses of rituximab, separated by two weeks, as well as MMF.

This study, the authors wrote, is setting the foundation for similar ones to determine whether lupus nephritis patients can be successfully treatment without glucocorticoids or with lower doses.

The Future

As treatment for lupus nephritis moves forward, the authors wrote, changes must be made to encourage and ensure that lower-income and nonwhite patients receive better therapies and experience improved outcomes.

Alongside creating modified therapies that change dosing levels for glucocorticoids, implementing behavioral interventions that address treatment adherence rates could be effective. Additionally, exploring personalized medicine as a method to target individuals who are genetically pre-disposed to poor outcomes can move the needle for most positive outcomes.

Ultimately, the authors said, additional steps must be taken to improve access to care overall because any delay in diagnosis and treatment inevitably leads to negative impacts on a patient’s kidneys.

To read the article at its original location: http://www.rheumatologynetwork.com/lupus/review-treatment-lupus-nephritis

 

November 16, 2016 Posted by | Healthcare | , | Leave a comment

The Assessment: Bedaquiline for TB Treatment

Published on the Nov. 11, 2016, Rheumatology Network website

By Whitney L. Jackson

The face of tuberculosis treatment is changing for the first time in 40 years, particularly when it comes to the drug-resistant forms of the disease.

Approved in 2012 by the U.S. Food and Drug Administration (FDA), bedaquiline is an antimycobacterial drug that inhibits mycobacterial ATP synthetase and drains cellular energy stores. Based on how it works, bedaquiline maintains its effectiveness against certain forms of tuberculosis that are already resisting other, existing drugs.

But, despite its benefits, initial studies revealed more patients receiving bedaquiline died than those taking a placebo therapy regimen. The question has been whether adding bedaquiline into the tuberculosis treatment regimen is worth the risk.

The Infection Problem

According to the World Health Organization (WHO), there were 8.6 million new tuberculosis cases in 2012. Incidence rates of drug-resistant tuberculosis have also been rising in the 27 most affected countries, leading the WHO to estimate there were 450,000 new drug-resistant cases globally in 2012, as well.

Overall, based on data cited in a New England Journal of Medicine editorial, tuberculosis infection carries substantial morbidity and mortality risks – among sputum-smear positive, HIV-negative patients, the 10-year fatality rate is 70%. New treatments are needed to combat this continued problem, but their use must be weighed against the likelihood they will lead to avoidable deaths.

Bedaquiline Approval

Despite bedaquiline presenting more deaths, the FDA made a rare move. It approved the drug for use despite the risks based on the results of a two-stage, Phase 2 trialthat included sputum-positive participants who were sensitive to at least three of the five drugs used in the antimycobacterial drug regimen for multi-drug resistant pulmonary tuberculosis. The preferred background regimen included: kanamycin, ofloxacin, ethambutol, pyrazinamide, and cycloserine or terizidone.

During the first stage, 47 patients were blindly assigned to receive 8 weeks of placebo or bedaquiline, in addition to the background regimen. After 8 weeks, sputum-culture conversion was much better for bedaquiline patients (48%) than placebo (9%). In the second phase, 79 patients received bedaquiline, and 81 received placebo care. Sputum conversion, again, was much shorter for the bedaquiline group – 83 days versus 125 days.

However, the study also revealed more deaths occurred with bedaquiline. Only two placebo patients died, but 5 of 10 deaths in the bedaquiline group were attributed to disease progression. The drug’s benefit was significant enough, however, to win FDA approval.

Introducing Bedaquiline Treatment

Based on the FDA’s decision, a new study, published in PLOS, investigated different strategies for introducing bedaquiline to patients who could benefit from it. Each method was based on a patient’s resistance pattern and was designed to maximize efficacy and minimizing negative impacts. Effectively implementing antibiotic introduction strategies is important because it can affect the development of acquired resistance to new drugs, existing drugs, or both.

The new study used previously-published aggregate data to create a Markov decision model, based on a group of hypothetical patients who were beginning multi-drug resistant tuberculosis treatment. To test the various treatment methods, investigators assumed the population was mostly 30-year-old men who were susceptible to bedaquiline. They had either multi-drug resistant tuberculosis without additional resistance (67.1%), multi-drug resistant tuberculosis with resistance to at least one fluoroquinolone or at least one second-line injectable (26.2%), or multi-drug resistant tuberculosis with resistance to at least one fluoroquinolone and at least one second-line injectable (6.7%).

Investigators sampled 5,000 random parameter sets to create their decision model. They included estimating life expectancy, resistance acquisition patterns, and the number of – and outcomes – of secondary tuberculosis cases.

Given the questions around bedaquiline’s impact, researchers concentrated on mortality, resistance, and transmission outcomes.

To test effectiveness, researchers designed four treatment strategies:

  • Withholding bedaquiline from all patients
  • Providing bedaquiline to patients with extensively drug-resistant tuberculosis
  • Providing bedaquiline to patients with pre-extensively drug-resistant tuberculosis or extensively drug-resistant tuberculosis
  • Providing bedaquiline to all patients with multi-drug resistant tuberculosis

Researchers assured all multi-drug resistant tuberculosis patients received bedaquiline from baseline. For all other strategies, they assumed a 13-week lag time after treatment launch.

Results

The decision model results supported the FDA’s decision to approve bedaquiline for patients who don’t have other treatment options.

Among multi-drug resistant tuberculosis patients, using bedaquiline maximized life expectancy in 76.8% of the 5,000 parameter simulations. For all other patients, the optimal strategy seemed to be withholding bedaquiline, indicating – for this group – the bedaquiline benefit of reducing culture conversion time doesn’t outweigh the mortality risk.

When most parameters remained at fixed midpoints, the “all multi-drug resistant tuberculosis” strategy is preferred when it can reduce the median culture conversion time by at least 35 percent over what the background drug regimen only is able to produce. It’s also best when the added bedaquiline mortality risk is less than 0.00025 per week – roughly 1.3 deaths per 100 patient years.

Overall, researchers said, making bedaquiline available to all patient with multi-drug resistant tuberculosis minimizes the actual number of and expected number of lives lost to secondary tuberculosis infections. After using the best strategies for each patient, life expectancy for the hypothetical 30-year-old participants reached 36.12 years compared to 34.67 years when suboptimal therapies were used.

Data analysis also showed, based on drug-susceptibility testing, the “all multi-drug resistant tuberculosis” method provides optimal life expectancy in 69.3% of cases. Pre-extensively drug resistant tuberculosis and extensively-drug resistant tuberculosis do so in 16.9% of situations, and no bedaquiline optimizes life expectancy in only 13.7% of instances.

Limitations

The study did have limitations, however, other than presenting all participants as 30-year-old men. Investigators didn’t explore all potential bedaquiline use strategies, such as early drug substitution methods. They also held parameters unrelated to bedaquiline constant throughout the study even though reproducing those circumstances with actual study participants isn’t possible. They also assumed the background drug regimen effect would be the same for all patients even though those conditions are not reproducible in the real world.

Additionally, researchers did not consider the impact of introducing bedaquiline to HIV-positive participants.

Future Concerns

As with all drugs, acquired resistance is a concern with bedaquiline, especially because the medication is a new treatment for tuberculosis. On average, in the simulation, 5.88% of patients developed bedaquiline resistance when the drug was made available to all multi-drug resistant tuberculosis patients. When bedaquiline was only given to extensively-drug resistant tuberculosis patients, drug resistance developed in only 3.5% of cases.

There’s a hope, though, researchers said, that expanding bedaquiline use could help protect the efficacy of the existing drug regimen. By offering an additional drug to fight infection, bedaquiline could potentially limit resistance to medications already in use. So far, based on the study’s findings, that benefit does materialize. Only 2.56% of patients developed extensively-resistant tuberculosis when all patients received bedaquiline compared to the 9.82% that do so when the drug is only given to extensively-drug resistant patients.

Ultimately, researchers said, their study highlights the need to investigate bedaquiline’s impact and benefit in real-world circumstances. Continued analysis of the drug’s safety and efficacy is paramount. If the results can be duplicated, a strong case could be made – even if it leads to future bedaquiline resistance – to extend the drug’s use beyond compassionate use situations, particularly where rapid second-line drug susceptibility testing isn’t an option.

To read the article published at its original location: http://www.rheumatologynetwork.com/rheumatoid-arthritis/assessment-bedaquiline-tb-treatment

November 16, 2016 Posted by | Healthcare | , | Leave a comment

Q&A: Practice of Overdiagnosing Breast Cancer

Published on the Oct. 20, 2016, DiagnosticImaging.com website

By Whitney L. Jackson

For the past decade, screening mammography has been the widely accepted tool for identifying potential breast cancers as early as possible. But, as diagnosis rates have increased, so have the questions about whether the procedure is pinpointing the right cancers instead of simply more cancers.

In an October New England Journal of Medicine study, H. Gilbert Welch, MD, MPH, professor of medicine of Dartmouth University Geisel School of Medicine, analyzed data from 1975 to 2012 from the Surveillance, Epidemiology, and End Result (SEER) program to determine tumor size and breast cancer incidence in women age 40 and older. He and his colleagues determined the fatality rates for years before screening mammography popularity grew and after.

The number of early-detected small breast tumors spiked from 36% to 68%, while the number of large tumors dropped from 64% to 32%. Examined against the fatality rates, the specter of overdiagnosis loomed. Diagnostic Imaging spoke with Welch about the likelihood of overdiagnosis among women with potential breast cancers and what it means for screening mammography efficacy.

What are the overarching clinical implications of your study?

I think the overarching message is that, with mammography, the clear call is that most people appreciate the potential, but it benefits very few. That’s one reason we emphasize the very good news that reduced breast cancer mortality largely reflects better treatments, not screening. Mammography comes with the human cost of treating others for disease that would never have been a bother to them. That’s the overdiagnosis problem. It’s not limited to breast cancer screening. Radiologists will be familiar with it in the context of early thyroid cancer, lung cancer, or prostate cancer screening. It’s a general problem in cancer screenings.

To read the remainder of the Q&A at its original location: http://www.diagnosticimaging.com/breast-imaging/qa-practice-overdiagnosing-breast-cancer

October 26, 2016 Posted by | Healthcare | , , , , | Leave a comment

Predictive Modeling for Spine Surgeries in the MACRA Era

Published on the Sept. 26, 2016, Rheumatology Network website

By Whitney L. Jackson

For many patients – especially those facing spinal surgery – the specter of an unknown outcome can be frightening. Knowing their odds for a successful procedure versus a failed operation can help many individuals decide whether and what type of surgery they’d like to undergo.

And, having the data to determine those success percentages can also help surgeons and other providers make the right decisions when it comes to expenditures and recouping reimbursement.

Using this data is called predictive modeling. To understand how its affected spinal surgeries and payments associated with it, Rheumatology Network spoke with Joseph Osorio, M.D., Ph.D., a resident with the Department of Neurological Surgery at the University of California at San Francisco, about his study, “Predictive Modeling of Complications,” published recently in Current Reviews in Musculoskeletal Medicine.

Rheumatology Network: Why did you decide to study predictive modeling? What is the importance of this tactic?

Dr. Osorio: The importance really lies with the patients we operate on most frequently. It’s complex spine surgery. Patients are prone to having complications because their surgeries involve many levels, and there’s a high risk for complications. Patient satisfaction is something that we want to do well, and we wanted a tool where we could use all the data at our disposal in our practice in the clinic to give them a number they could understand. For example, they’ll have an 85 percent chance of success rather than telling them patients like them generally do well with this operation.

One of the benefits we have is the professional societies are collecting data the way we’ve been doing here at UCSF and at other centers that focus on adult spinal deformities. We have a repository of data and collect large volumes, prospectively, on patients that fall within the adult degenerative and scoliosis parameters set out in the literature. We put that information into a database and go back, retrospectively, and analyze it. There’s a huge wealth of information there to benefit us. Part of the nuts and bolts of predictive modeling is having quality data and having large volumes of it. If you don’t have quality data, then it is a limitation to the predictive model. If you do, you can apply these techniques to other conditions and settings, and achieve the same success that we have.

Rheumatology Network: How impactful has the modeling been on spinal surgery?

Dr. Osorio: I think it’s been extremely useful with aging individuals and those undergoing revision surgery. Some of them want to know because they have many options for surgery. Do they go with the larger surgery that may address the bigger problem of global spinal balance, or do they choose a less invasive one that might have a likelihood for needing another spine surgery because the bigger problem was not addressed? Are they someone who doesn’t want to take the risk of undergoing such a big operation? With this data, we can relay possible outcomes to the patient.

Rheumatology Network: What were your main findings? Why are they important?

Dr. Osorio: Some of the main findings started with one of our initial pieces of work. The first one looked at surgical complications in the adult spinal deformity patients. Those were patients we did large segment fusions on, and they returned with adjacent level disease. They come back with new pain or new neurological indications, and they need another operation. In some sense, they’ve failed the surgery and are in need of a revision operation. We were able to take 500 or so patients and look at those we had two-year follow-up data on. We look at X-rays and clinical information and we’re able to say which of all those patients — if we throw in a series of variables — are going to come back with a failed surgery. We added in variables that were strong predictors — some were based on radiographic parameters that are commonly used in the clinic to assess adult spinal deformity patients. From previous studies, we predicted that these parameters, including being over age 64, being sagittally imbalanced, and having flat back syndrome where patients develop much of their back pain by overuse of compensatory muscles, are important ones to monitor.

Rheumatology Network: Did you find anything unexpected?

Dr. Osorio: It wasn’t unexpected, but it is something that gets discussed in the literature a great deal. It’s where do we stop — at what level do we end? Do we go to the pelvis or the sacrum? Does it make a difference or not? Surgeons want to know. It seems that it does make a difference, but we need to do more studies to get a better sense of it all. At our institution, we commonly end our large spine surgeries at the pelvis. That’s something that seems to be coming out in the predictive model.

Rheumatology Network: Are there any challenges to spinal surgeries that were revealed?

Dr. Osorio: I think the biggest challenge with studies like this is that when we see patients in our clinic, we really do have an algorithm for the way we analyze each patient. Everyone receives a standing 36-inch long X-ray. We’ve essentially designed our clinic that way – we don’t see patients until they get that X-ray, so that might be a challenge for other providers who are not using this film as one of their tools in understanding a patient’s global alignment. If you start reading the literature now, you get the sense that all of us are using 36-inch X-rays to identify parameters that are important for choosing whom to operate on. In many cases, when we receive referrals from the community to see patients who have had a failed surgery, there often isn’t a record of having had a 36-inch X-ray acquired. Providers often obtain a CT scan, or an MRI of the lower back, but overlook the global alignment. We’re looking at global alignments, but the challenge in moving forward is that providers aren’t looking at the problem in a global way. We’re trying to move the field in that direction — to get providers to understand that patients often have problems that could impact more than one region. They need to think about the patient and the spine as a whole.

Rheumatology Network: How does this work fit in with MACRA?

Dr. Osorio: I would say as we move forward with this wealth of information, we’re moving toward having an abundance of information from our use of electronic heath records. Having access to this data, we’re going to have a better understanding as to what parameters most impact surgical outcomes. We can better justify an expected outcome. Are providers, when they’re offering surgeries, looking at other providers’ outcomes to get a sense as to how the field is adapting/improving? Are they actually at the mean or are they below average? Are more of the patients they’re providing surgeries to, patients they would’ve know might have failed if they’d looked at a set of high risk targets? We can provide them with these targets. We can educate providers that are going to be doing do this level of spine surgery, to pay close attention to these targets. Counsel them that it will impact their success. I think overall, MACRA is going to really try to differentiate providers that are given that kind of data and incentivize them to provide high value care. Those that are below the mean are going to suffer. This will provide them with a tool and give them a better understanding of what success is in this field.

Rheumatology Network: How can this work be used to promote better care and outcomes?

Dr. Osorio: One of the challenges we fall into, is justifying and providing large scale operations at tertiary and quarternary care centers. Operations are expensive. Smaller spine surgeries can offer immediate improvement, but if you don’t think about addressing the larger scale problem, the patient will suffer and they might be back within a year with a failed operation. This will result in the patient requiring another operation, which is something we see very often. So, in order to justify doing a larger cost operation up front, it helps to be able to look out several years in advance and predict outcomes. If you tell someone justifying cost that reimbursement for an operation is X dollars more than a smaller-scale operation, they will likely want evidence through data about why spending that much more can be justified. If they are looking at larger operations that are chosen based on the correct indications, they’ll realize over the long term that most patients aren’t returning for an initial failed surgery. In this ideal scenario, the cost is better justified for the larger operations because you need fewer surgeries overall. Ultimately, through these kinds of examples you can get an understanding how these large scale operations are justified.

I think, overall, predictive modeling and analyzing is something that’s used in the business and government worldwide. We’re simply applying it to healthcare now. We’ve been stuck in this more traditional statistical model, that is hindered because of the fundamentals that require hypotheses and assumptions. They answer a single question, but really now that we’re having an abundance of data, we’re able to better answer any questions that are patient specific and individualized to a particular problem. We can provide a number that’s easier for a patient to interpret. It’s hard to interpret an odds ratio when making a decision as to what surgery to have, but if I say you have a 96 percent chance of doing well from this surgery, that number is something that makes sense.

To read the article at its original location: http://www.rheumatologynetwork.com/news/predictive-modeling-spine-surgeries-macra-era

September 28, 2016 Posted by | Healthcare | , , | Leave a comment

Romosozumab Shows Promise for Post-Menopausal Osteoporosis

Published on the Sept. 21, 2016, Rheumatology Network website

By Whitney L. Jackson

Treating post-menopausal osteoporosis patients with romosozumab could improve their long-term bone density and decrease the risk of spine and hip fractures, according to a randomized, multi-center, double-blind, placebo-controlled study.

Currently, there’s a gap in how best to treat post-menopausal women who suffer low bone density thanks to osteoporosis. Using romosozumab could help them ward off both vertebral and all other clinical fractures into older age. Romosozumab is an investigational, bone-forming, monoclonal antibody that binds sclerostin and increases bone formation and decreases bone resportion.

In a Sept. 18 presentation at the American Society of Bone Mineral Research annual conference in Atlanta, lead study author Helen Hayes Hospital rheumatologist Felicia Cosman, M.D., revealed FRAME study investigators wanted to identify a medication that could reverse bone loss and offer preventive care for the future.

The results of this study present “a unique opportunity for patients with osteoporosis who are at high risk for fractures and might be at imminent risk for future fractures. If they have a medication that rapidly increases bone strength and reduces fracture risk, it puts them in a better position for the next year and beyond,” she said.

Participants were post-menopausal women between ages 55 and 90 with osteoporosis. They had bone mineral density T-scores of <­ -2.5 at total hip or femoral neck. Co-primary endpoints were subject incidence of new vertebral fractures through M12 and M24. Secondary endpoint included clinical (nonvertebral plus symptomatic vertebral) and nonvertebral fracture, and bone mass density.

Of the 7,180 women, 89 percent completed the entire study. They were divided into a placebo group and one that received monthly 210 mg injections of romosozumab. Both groups received 60 mg of denosumab monthly for a year.

According to results, the romosozumab group experienced a 13-percent and 6.8-percent increase in bone density in the spine and hips, respectively, after one year. At the second year, the increase was 17.9 percent for spine and 8.8 percent for hips. Overall, romosozumab decreased new vertebral fracture risk by 73 percent and new clinical fractures by 36 percent.

To read the article at its original location: http://www.rheumatologynetwork.com/news/romosozumab-shows-promise-post-menopausal-osteoporosis

September 28, 2016 Posted by | Healthcare | , , , , | Leave a comment

Low Protein and Osteoporosis in Men?

Published on the Sept. 21, 2016, Rheumatology Network website

By Whitney L. Jackson

Low protein intake may be responsible for fractures in older men, according to an observational study that analyzed data from the 2000-2002 Osteoporotic Fractures in Men Study.

Dietary protein is a potentially modifiable risk factor for controlling fractures among older men.

In a Sept. 18 presentation at the American Society of Bone Mineral Research annual conference in Atlanta, lead study author Lisa Langsetmo, M.D., from the University of Minnesota, discussed the investigators’ hypothesis that lower-to-moderate protein intake was associated with an increased fracture risk while high protein intake was not.

“Increased dietary protein intake may be feasible as a low-risk intervention to reduce the risk of hip fracture among older men,” she said.

The study, which included 5,875 men — average age 73.6 years — had two objectives: to assess the association of protein intake with low trauma (trauma < fall from standing height) fracture risk and to assess whether the association between protein intake and fracture risk was mediated by falls, body mass index, bone mineral density, appendicular lean mass or gait speed.

Researchers took baseline protein assessment and excluded men with < 500 kcal/d total energy intake or missing ­­> 10 items. The median was 15.9 percent total energy intake with a range from 14.2 percent to 17.8 percent. They defined low protein intake as the bottom quartile and high intake at the top quartile, Dr. Langsetmo said.

According to the analysis, there were 808 low trauma fractures, excluding head, hands, and feet, over 15 years. Results showed a 16-percent lower hip fracture risk, and an 8-percent lower major osteoporotic fracture risk.

Low protein intake was associated with increased fracture risk (HR=1.28, 95 percent CI, 1.08-1.51) compared to those with moderate intake. High protein intake was not associated (HR=1.00, 95 percent CI, 0.84-1.19). There was a two point change in estimates when they were adjusted for falls, body mass index, appendicular lean mass and gait speed.

The protein intake-fracture risk association was dependent on skeletal site, Dr. Langsetmo said. In addition, while the hip fracture association was strong, there was no such association with vertebral fractures.

To read the article at its original location: http://www.rheumatologynetwork.com/news/low-protein-and-osteoporosis-men

 

September 28, 2016 Posted by | Healthcare | , , , | Leave a comment

Growth of Interventional Radiology

Published on the Sept. 22, 2016, DiagnosticImaging.com website

By Whitney L. Jackson

Historically, mention of interventional radiology conjured up thoughts of vascular techniques. Today, this area of radiology encompasses much more – in fact, according to industry experts, it’s growing quickly and is expanding heavily throughout health care as a whole.

But, what’s behind this extension, and how has it – and will it – affect diagnostic radiology?

These changes, said Matt Hawkins, MD, director of pediatric interventional radiology (IR) at Emory University School of Medicine, will likely change the health care landscape in the years to come.

“Interventional radiology will play a bigger role moving forward,” he said. “As we measure the overall cost and value, we can do a lot in interventional radiology that costs less and positively impacts patients.”

Interventional Radiology’s Changing Face
For many years, IR was used mainly to make cardiovascular procedures less invasive, but in recent years, these techniques have been applied to other specialty areas, as well, according to the Advisory Board. In addition to medical oncology and pediatrics, IR is gaining ground in neurology, gastroenterology, and urology.

A Transparency Market Research report indicated the most common IR procedures include angioplasty, venous access, biopsy, fibroid embolization, stents, arteriograms, and embolization.

Providers are using IR more frequently in these ways because the techniques are more cost effective, less disruptive to the body, and can be done in the outpatient setting. Based on the Advisory Board analysis, increased use of IR in research is strengthening the quantitative data to support IR’s value in radiology as a whole.

To read the remainder of the article at its original location: http://www.diagnosticimaging.com/interventional-radiology/growth-interventional-radiology

September 23, 2016 Posted by | Healthcare | , , , | Leave a comment

Fracture Assessment Tools Underutilized, Study Shows

Published on the Sept. 19, 2016, RheumatologyNetwork.com Website

By Whitney L. Jackson

Using the fracture assessment tool with older, community-dwelling women can help reduce their risk of hip fracture over time, according to a randomized controlled trial.

Currently, although the cost of fractures is high for both society and individuals, the use of fracture risk tools to identify at-risk patients — and potentially stave off future fractures — is relatively low. The FRAX assessment tool identifies high-risk individuals in primary care environments in an effort to reduce fracture incidence.

The FRAX study was developed by the World Health Organization to evaluate fracture risk based on individual patient models that integrate risk associated with clinical risk factors, as well as bone mineral density at the femoral neck. The FRAX algorithms provide a 10-year fracture probability.

In fact, according to a 2010 study, the National Osteoporosis Foundation Guide recommends treating patients who have a FRAX 10-year score of ≥3 percent for hip fractures or ≥ 20 percent for major osteoporotic fractures to reduce future fracture risks.

In a Sept. 19, presentation at the 2016 American Society of Bone Mineral Research conference, lead author E.V. McCloskey, M.D., from the University of Sheffield in the United Kingdom, discussed a five-year, two-arm study into the efficacy of using the FRAX tool to pinpoint women with osteoporosis who are also at high fracture risk in the community.

Of the 12,483 women identified in primary care environments, 6,233 were randomized into the study’s screening arm. In that group, 898 women (14.4 percent) were identified as high risk using the FRAX tool. By the end of the first year, exposure to osteoporosis medication was higher in the screening group compared to the control group – 15.3 percent versus 4.5 percent, respectively. High treatment uptake occurred in the high-risk group (78.3 percent) at six months.

Results showed the incidence of major osteoporosis fractures – comprising hip, waist, humerus, and clinical vertebral fractures — reduced by 12 percent (2 percent to 21 percent, p=0.018). Screening was associated with a significant reduction in hip fractures (RRR 27 percent, 10 percent – 41 percent, p=0.003).

Based on these findings, researchers wrote, a systematic, community-based screening fracture risk program that uses the FRAX tool in older women can be both feasible and effective in lowering hip fracture risk.

To read the article at its original location: http://www.rheumatologynetwork.com/news/fracture-assessment-tools-underutilized-study-shows

September 20, 2016 Posted by | Healthcare | , , | Leave a comment

Hip Fractures No Longer on a Downward Trend in the U.S.

Published on the Sept. 19, 2016, RheumatologyNetwork.com Website

By Whitney L. Jackson

The 15-year trend of decreasing hip fractures due to osteoporosis is coming to a close in the United States, according to an observational study of Medicare claims data. A drop in reimbursement for a common screening technique could be to blame.

Since 2001, hip fracture rates have dropped thanks to improvements in osteoporosis evaluation and fracture predictions via dual-energy X-Ray absorptiometry (DXA), as well as new drugs, such as oral bisphosphate. DXA uses to X-ray beams to measure bone mineral density and diagnose osteoporosis.

In a Sept. 17, presentation at the 2016 American Society of Bone Mineral Research conference, lead study author E. Michael Lewiecki, M.D., of the New Mexico Clinical Research and Osteoporosis Center, discussed investigators’ analysis of hip fracture rates to determine if the downward trend still existed.

Researchers used Medicare claims and enrollment data from 2002-2014, approximately 900,000 annually, for the analysis. It was five percent sample of Medicare’s fee-for-service beneficiaries who had at least one Medicare-paid DXA scan per year. DXA providers were either office-based, free-standing or hospital-based. Analysts identified hip fractures with ICD-9 codes 820.0x, 820.2x, and 820.8x, excluding trauma-associated fractures.

While the analysis showed a downward trend in osteoporosis-caused hip fractures from 2002-2012, the data revealed a reversal, beginning in 2013. The uptick coincides with a drop in Medicare reimbursement for DXA screening. Reimbursement levels dropped to below cost, Dr. Lewiecki said in an interview with Rheumatology Network.

“The analysis suggests the downward trend for hip fractures in the United States could be over,” he said. “We can’t say that declines in DXA reimbursement are directly responsible for the higher than expected hip fractures, but it makes sense when you look at other contributing factors.”

To combat the drop in screening and, potentially, provide better treatment for osteoporosis, Dr. Lewiecki said patients should educate themselves about the benefits and risk of DXA screening. In addition, he said, patients and providers should support a bill in the U.S. Congress that would create a reimbursement floor for DXA payments that would make providing screening more profitable – or at least less costly – for doctors who have offered the service.

To read the article at its original location: http://www.rheumatologynetwork.com/news/hip-fractures-no-longer-downward-trend-us

 

September 20, 2016 Posted by | Healthcare | , , , , , | Leave a comment

How One Class of Bisphosphonates Could Predict Vertebral Fractures

Published on the Sept. 19, 2016, RheumatologyNetwork.com Website

By Whitney L. Jackson

Using biomarkers to assess the efficacy of existing bisphosphonate drugs in predicting fracture risk could pave the way for improved osteoporosis treatment, according to a new study.

Currently, little analysis exists into how bisphosphonate drugs can relate bone turnover markers to fracture reduction. With the cost of drug development so high — and with the time to get new drugs approved so long — researchers looked into how available drugs can help reduce fracture risk.

In a Sept. 19 presentation at the America Society of Bone Mineral Research conference, lead study author Douglas Bauer, M.D., from the University of California-San Francisco, discussed how biomarkers, such as blood and urine, can help identify how one class of bisphosphonates can predict vertebral — but not non-vertebral — fractures.

Based on the National Institutes of Health Bone Quality project, investigators analyzed data on more than 120,000 participants from 11 clinical trials, including bone turnover markers, dual-energy X-Ray absorptiometry and fracture outcomes. They recorded baseline data from 2,268 individuals with vertebral fractures, 3,286 with non-spine fractures (including 514 hip fractures), and 6,729 N-telopeptide of type 1 collagen fractures.

Researchers compared the mean effect of the bisphosphonate to the placebo over a three-to-four-year period. Results indicate there’s a high statistically-significant relationship between short-term change and bone markers for vertebral fractures compared to the placebo group (p=0.005, r=0.84). However, no such strong relationship exists for non-vertebral fractures. The findings suggest that non-fragile factors, such as falling, come into play for non-vertebral fractures.

For instance, for two hypothetical bisphosphonates with 10 percent versus 30 percent reductions in bone-specific alkaline phosphatase, the model predicted a 19 percent versus 66 percent reduction in vertebral fractures (r2-0.84, p=0.001). The relationship is weaker and not significant for non-vertebral fractures. The comparable risk reductions were 12 percent versus 21 percent (r2=0.06, p=0.27).

Ultimately, Dr. Bauer told Rheumatology Network, the study results can, hopefully, be useful in developing medications for the same bisphosphonate classes and extending the effects to other populations.

“The hope is that this overall effect can be observed in all anti-absorptive medications that will be developed in the future,” Dr. Bauer said. “Hopefully, all this data will be used to fill in predictive efficacy.”

To read the article at its original location: http://www.rheumatologynetwork.com/news/how-one-class-bisphosphonates-could-predict-vertebral-fractures

September 20, 2016 Posted by | Healthcare | , , , , | Leave a comment

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