Biosimilar Switch Succeeds in Single Center

Biologics are medicines created in cells that are used primarily to treat autoimmune illnesses. You see a lot of ads for them these days for illnesses like rheumatoid arthritis, psoriasis, irritable bowel syndrome. They are very expensive, and there is a kind of generic version of a biologic called a biosimilar. There have been concerns about how effective biosimilars will be compared with the original biologic. This study says that at least for this biosimilar, moving everybody from the biologic to the biosimilar resulted in better symptom reduction that what patients got with the original biologic. Good news!

Switching from etanercept (Enbrel) to its biosimilar Benepali was successfully implemented in a single-center study of patients with rheumatoid arthritis, investigators reported here.

The switch program took place during 2017, and resulted in a cost saving of approximately £500,000 ($680,000) annually at current prices. Patients were sent a letter before the program began from the clinic's pharmacist, explaining the switch, and also received a telephone call to answer any questions they might have. Participants then attended an education session and were seen in a dedicated clinic staffed by a rheumatology consultant and specialist pharmacist.

Participants also completed an 11-part questionnaire that asked about tolerability and adverse events associated with the biosimilar. As to the ease of using the injector pen, there was an 11% increase after the switch to Benepali, from 7.8 to 8.6 on a scale, with 1 representing "very difficult" and 10 being "very easy."

"The Benepali pen was preferred to Enbrel, and patients commented on the easier technique and less manual dexterity required," the investigators noted.

Oral Steroid

When asked how patients felt their rheumatoid arthritis was responding, 75% said it was no different, 11% said it had improved, and 17% felt it was worse. And when asked "how pleased" they felt about the switch, 43% of patients said they were pleased and 23% were not pleased, while the remainder were indifferent or not sure.

A total of eight patients ultimately switched back to the originator etanercept. In five patients, this was because of adverse events including rash and diarrhea, and in three, it was because of difficulty with the autoinjector pen. In addition, there were two disease flares after the switch.

"The reassuring results of this switching program should positively encourage clinicians and patients to switch to the biosimilar in order to optimize the cost saving to the National Health Service," Shah and colleagues concluded.

New Long-Term Care Medicare Benefit Proposed

A newly proposed Medicare benefit would extend services to eligible beneficiaries for long-term care. The proposal was within a discussion draft of a bill by Representative Frank Pallone (D-NJ), released at a Wednesday roundtable discussion with aging and disability advocates.

The proposal, The Medicare Long-Term Care Services and Supports Act of 2018, would establish a cash benefit within Medicare for beneficiaries that could be used toward all long-term services and supports, including nursing facility care, adult day care programs, home health aide services, personal care services, transportation and assistance provided by a family caregiver.

“The growing need for long-term care is one of the greatest threats to retirement security for American seniors, and the adult children who care for them,” Pallone said in a statement. “It’s time to expand Medicare to include a long-term care benefit so that millions of seniors and individuals with disabilities no longer have to face financial ruin before they get assistance. I’m hoping that this proposal will begin an important discussion, and look forward to getting feedback from interested stakeholders.”

The proposal, if introduced and enacted, would be the first new Medicare benefit since Part D, which was approved in 2003 and implemented in 2006.

The discussion draft of the bill aims to help families pay for long-term care, which can cost a senior an average of $140,000 out of pocket. More than 15% of seniors will incur costs in excess of $250,000, according to Pallone. Furthermore, more than 70% of seniors older than 65 will need some long-term care services and supports in their lifetime.

The reach would extend beyond the narrow limits of many Medicare services, including those of home health care, and it would incentivize people to seek care at home, “the setting where most people want to be,” according to Pallone.

EEG Analytics for Early Detection of Autism Spectrum Disorder: A data-driven approach

This is a pretty technical article, but the idea of being able to use Artificial Intelligence to do deep analysis of such a simple test as the EEG was striking and apparently very accurate....

Autism spectrum disorder (ASD) is a complex and heterogeneous disorder, diagnosed on the basis of behavioral symptoms during the second year of life or later. Finding scalable biomarkers for early detection is challenging because of the variability in presentation of the disorder and the need for simple measurements that could be implemented routinely during well-baby checkups. 

EEG is a relatively easy-to-use, low cost brain measurement tool that is being increasingly explored as a potential clinical tool for monitoring atypical brain development. 

EEG measurements were collected from 99 infants with an older sibling diagnosed with ASD, and 89 low risk controls, beginning at 3 months of age and continuing until 36 months of age. Nonlinear features were computed from EEG signals and used as input to statistical learning methods. 

Prediction of the clinical diagnostic outcome of ASD or not ASD was highly accurate when using EEG measurements from as early as 3 months of age. Specificity, sensitivity and PPV were high, exceeding 95% at some ages. Prediction of ADOS calibrated severity scores for all infants in the study using only EEG data taken as early as 3 months of age was strongly correlated with the actual measured scores. This suggests that useful digital biomarkers might be extracted from EEG measurements.

Peter Pan Housing 

"Peter Pan Housing" is the idea that you choose a house you won't be able to use if you develop a mobility or other disability. You make your housing choice because you think, "I'll never grow up". This is a collection of articles about the concept....

Music activates regions of the brain spared by Alzheimer's disease

Ever get chills listening to a particularly moving piece of music? You can thank the salience network of the brain for that emotional joint. Surprisingly, this region also remains an island of remembrance that is spared from the ravages of Alzheimer's disease. Researchers at the University of Utah Health are looking to this region of the brain to develop music-based treatments to help alleviate anxiety in patients with dementia. Their research will appear in the April online issue of The Journal of Prevention of Alzheimer's Disease.

"People with dementia are confronted by a world that is unfamiliar to them, which causes disorientation and anxiety" said Jeff Anderson, M.D., Ph.D., associate professor in Radiology at U of U Health and contributing author on the study. "We believe music will tap into the salience network of the brain that is still relatively functioning."

"When you put headphones on dementia patients and play familiar music, they come alive," said Jace King, a graduate student in the Brain Network Lab and first author on the paper. "Music is like an anchor, grounding the patient back in reality."

Biologics May Chip Away at Clogged Arteries After Just 1 Year

This is interesting.....

Biologic drugs for psoriasis were associated not only with improved skin condition but, as an added bonus, reduced atherosclerotic plaque burden, according to late-breaking data presented here.

Biologic therapy was associated with regressing coronary plaque burden over 1 year, Elnabawi told the audience, concluding that it may be of benefit to target proinflammatory cytokines related to cardiovascular disease.

"To see a reduction in coronary plaque after just 1 year of biologic therapy alone is incredible and very assuring. It's the first time we're seeing treatment of a skin disease with biologic therapy have an impact specifically on plaque in the coronary," according to principal investigator Nehal Mehta, MD, MSCE, of the National Heart, Lung, and Blood Institute, in a press release.

"Our study results further emphasize the importance of patients maintaining and treating psoriasis to decrease the risks of adverse cardiovascular events occurring. This also opens the door for us to look at other disease states and see how anti-inflammatory therapy options could impact coronary plaque over time."

Common Class of Drugs Linked to Dementia, Even When Taken 20 Years Before Diagnosis

Anticholinergic effects from OTC and prescribed medications have a powerful effect on cognition and it becomes more powerful as you get older. I've posted on this before, but we all need reminders that many, many drugs have anticholinergic effects....

The largest and most detailed study of the long-term impact of anticholinergic drugs, a class of drugs commonly prescribed in the United States and United Kingdom as antidepressants and incontinence medications, has found that their use is associated with increased risk of dementia, even when taken 20 years before diagnosis of cognitive impairment.

An international research team from the US, UK and Ireland analyzed more than 27 million prescriptions as recorded in the medical records of 40,770 patients over age 65 diagnosed with dementia compared to the records of 283,933 older adults without dementia.

The researchers found greater incidence of dementia among patients prescribed anticholinergic antidepressants, anticholinergic bladder medications and anticholinergic Parkinson’s disease medications than among older adults who were not prescribed these drugs.

Dementia increased with greater exposure to anticholinergic medications.

“Anticholinergic Medication and Risk of Dementia: Case-control Study” is published in BMJ (formerly the British Medical Journal) an international peer-reviewed medical journal.

“Anticholinergics, medications that block acetylcholine, a nervous system neurotransmitter, have previously been implicated as a potential cause of cognitive impairment,” 

Drug Could Make Progeria Manageable, Not Fatal

The disease is Hutchinson-Gilford Progeria, an ultra-rare condition – occurring in just 1 in 4 million births and characterized by premature aging.

The natural history of progeria is death, usually due to cardiac causes, in the early to mid-teen years. Until recently, there have been no known therapies.

Enter lonafarnib, an obscure little farnesyl transferase inhibitor that has seen some use in hepatitis delta virus infection and is being investigated for its anti-cancer properties.

The first trial of lonafarnib led to promising results -- kids treated with the drug had improved weight gain and less skeletal rigidity. But only now was there enough data collected to look at a hard outcome – all-cause mortality.

The researchers compared 63 patients treated with lonafarnib to 63 patients who were not treated with the drug. Again, this wasn't randomized. I think there's a good argument here that randomization would be unethical. That said, the researchers matched treated and untreated patients on a variety of factors to minimize bias. And the results were dramatic.

Among the treated patients, just four died over the two years of study, compared to 17 deaths in the untreated group. These results are unheard of in this disease. Results this strong are rarely seen in most diseases, actually.

Now most of these kids started taking the medication at around 9 or 10 years of age, and it didn't seem to have much effect on their physical appearance. But one wonders if earlier treatment would lead to even more dramatic results.

Praxbind Gains Full FDA Approval as Pradaxa Reversal Agent

If you are on Pradaxa, this is worth reading....

Final Phase 3 study data had demonstrated that Praxbind immediately reversed the anticoagulant effect of Pradaxa

Boehringer Ingelheim announced that the Food and Drug Administration (FDA) has granted full approval for Praxbind (idarucizumab) for use in patients treated with Pradaxa (dabigatran etexilate mesylate) when reversal of anticoagulant effects is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding. 

Praxbind was initially granted accelerated approval by the FDA in October 2015; continued approval was pending results from the Phase 3 RE-VERSE AD trial (N=503). The latest analysis included findings from patients requiring urgent procedures/emergency surgery (eg, surgery for an open fracture after a fall) or patients with either uncontrolled or life-threatening bleeding complications (eg, intracranial hemorrhage, severe trauma after car accident). The primary endpoint was the degree of reversal of the anticoagulant effect of Pradaxa achieved by Praxbind within 4 hours. 

The final study data, published in July 2017, demonstrated that Praxbind immediately reversed the anticoagulant effect of Pradaxa. Complete reversal was seen within 4 hours in the majority of patients, as measured by ecarin clotting time (ECT 82%) or diluted thrombin time (dTT 99%). In addition, there was a low rate of thrombotic events and no new safety events were reported. 

Innovative, Affordable Home Care Model Boosts Cantata’s Bottom Line

Real, thoughtful coordination is less expensive and more effective.....

Cantata, a Chicago-area senior housing and care provider, is achieving success with its Take2 home care model, increasing margins even as clients are paying less for services.

Take2 was piloted in 2014, rolled out on a wider scale in 2016, and now serves about 60 people after a record month for new sign-ups in March, Cantata CEO John Larson said last week at the LeadingAge Illinois annual meeting and expo near Chicago. Cantata is a not-for-profit organization that offers an array of senior services; its campus-based housing, located about 15 miles southwest of downtown Chicago, includes independent living, assisted living and enhanced care.

The cost of personal care is already steep for consumers, and rates are only going up as tightening labor markets and changing laws increase costs for providers. At the same time, turnover is rampant in home care and a worker shortage is set to get worse as the baby boomer generation ages.

Take2 is a neighborhood-based system, in which caregivers drive around a designated area for the duration of their shifts, dropping in on clients to provide services in short bursts of about 20 minutes. Some of these drop-ins are scheduled and others are done on-demand, as clients have needs that arise and they alert the Take2 staff.

Currently, the service area is roughly six square miles around the Cantata campus. The organization has two people handling the program logistics and six to eight roving caregivers. They work regularly scheduled shifts, around the clock.

Take2 provides a wide array of services, including bathing and dressing assistance, light housekeeping, medication reminders, home maintenance and pet care. It does not provide companion care, given that the caregivers come in to perform specific tasks and then leave, moving on to the next house.

At the outset, the Cantata team had some doubts about the model. For instance, some people feared that clients would constantly be calling for help, and caregivers would be frantically trying to field requests and get from house to house.

“Our team said, it’ll be like a video game,” Larson said.

Those fears did not come to pass. In fact, clients request on-demand services infrequently, and the care team has been able to keep visits brief while maintaining 95% customer satisfaction and good health outcomes. For instance, as of October 2016, with 125 clients served, there had been only three falls with injury and two 30-day hospital readmissions.

There is a learning curve, however. Explaining the system and setting client expectations are important.

“We rarely if ever say, you’ll have a bath at 9:30,” Larson said. “We say … you’ll get hygiene in the morning.”

Similarly, there was skepticism about helping people with toileting on a schedule, but that has also not been a stumbling block. It is not unusual to have a toileting schedule in an assisted living setting, Larson noted.