Tocilizumab Receives Breakthrough Designation for GCA
The FDA granted the designation of breakthrough therapy to tocilizumab (Actemra) for treating GCA (Giant Cell Arteritis). This autoimmune disease causes inflammation of arteries both medium and large in size, predominantly in the head, but also in the aorta and branches of the aorta.1
To date, GCA treatment has been limited to high-dose steroids, which are used as an emergency treatment to prevent vision loss and other damage. Long-term, flare-free remission cannot always be maintained with steroids. Because of the variety of symptoms, GCA patients are usually seen by myriad specialists, including rheumatologists.
The FDA gives a breakthrough designation to expedite the development and review of treatments that show early evidence of potential clinical benefit in serious diseases to ensure patients receive access to medication as quickly as possible. Positive results of tocilizumab use in patients with GCA were seen in the Phase 3 GiACTA study. Patients treated with tocilizumab, initially as combination therapy for six months with glucocorticoids, had sustained remission though one year of treatment compared with patients who received only glucocorticoids for six to 12 months.
Comment: GCA is a serious condition and this is great news.
How much weight does wearing a fitness tracker help you lose? Next
Wearable Activity Trackers Don’t Improve Weight Loss
Dr. Jack Cush writing in Rheum now reported that an article in JAMA has reported the results of a 24-month trial showing that obese individuals on a long-term healthy diet and exercise program do not have significantly more weight loss from using a wearable device that tracks their activity.
In a randomized clinical trial conducted at the University of Pittsburgh, 471 adult participants (with a BMI between 25-40) enrolled between 2010 and 2012. All subjects were placed on a low-calorie diet, prescribed increases in physical activity, and had group counseling sessions.
Patients randomized to the intervention group were given wearable device and accompanying web interface to monitor diet and physical activity – BodyMedia Fit Core, a wearable activity tracker worn on the upper arm. The Fit Core tracks steps, hours slept and calories burned and costs about $100.
After 24 months, people who used wearable activity trackers lost 2.4 kilograms (5.29 pounds) less than a group on a similar program but using a website to track their progress.
Both groups had improved their body composition, fitness, physical activity and diet, according to the report in JAMA.
The value and impact of wearable technology remains to be proven, especially with regard to weight loss.
A commonly used medication for heart disease may have another use… next
Statins May Reduce Alzheimer’s Risk, Study Suggests
Muir reporting for ABC World News Tonight stated, “A new study shows that high use of…statins” may be associated with “a lower risk of Alzheimer’s for patients over the age of 65.” The study was published in JAMA Neurology.
Comment: It’s interesting how drugs for one disease may help another.
How bad is the opioid epidemic in the US… worse than you think… particularly for kids…next
Opioids are Like Guns in the Hands of Children
Dr. Jack Cush writing in Rheumnow reported the opioid abuse epidemic is well known and the focus of many regulators and health care personnel. The problem also affects the youngest Americans, according to a recent Washington Post article.
JAMA Pediatrics reports an analysis of pediatric hospital discharges nationwide between 1997 -2012 and found that 13,052 children were hospitalized for opioid overdoses with Oxycodone, Percocet, codeine and the like narcotics.
There were 176 pediatric deaths attributed to narcotic use. And, the data shows a doubling of opioid poisonings in children during those years. Most of the victims (73.5%) are white, and slightly more than half (53 percent) are female.
The authors draw a parallel between guns and narcotics and the need for parents and grandparents to store these safely and out of reach or access to children and adolescents.
Cush adds, mitigating these risks will require comprehensive strategies that target opioid storage, packaging, and misuse.
Comment: A terrible public health issue that requires our attention.
Reported by the Academy of Integrative Pain Management this item…
Mud-Bath Therapy in Addition to Usual Care in Bilateral Knee Osteoarthritis: Economic Evaluation
An economic evaluation of mud-bath therapy was conducted alongside a randomized controlled trial. Patients (103) were randomly assigned to receive either a 2 weeks cycle of MBT in addition to their usual treatment or to continue routine care alone. The European Quality-of-Life Questionnaire-5 Dimensions (EQ-5D) questionnaire was administered at baseline, 2 weeks, 3, 6, 9, and 12 months. Direct healthcare resource consumption data up until 12 months were derived from a daily diary given to patients and returned at prescheduled follow-up visits. The results of this cost-effectiveness analysis support the use of the mud bath therapy as mid-term complementary therapy in the management of knee OA.
What is the safest anti-inflammatory drug? Is there one? Next
Celebrex Safety Data Surprises Heart Experts
But today, Dr. Steven Nissen, chairman of the department of cardiovascular medicine at Cleveland Clinic’s Sydell and Arnold Miller Family Heart & Vascular Institute and colleagues reported findings of a major 10-year study which found no such problems with Celebrex, offering reassurance to millions of patients and potentially changing the way doctors approach treating arthritis pain.
For the study involving 24,081 heart patients and people at an increased risk for cardiovascular disease, the researchers compared celecoxib with the nonsteroidal anti-inflammatory drugs Naproxyn and Ibuprofen and found celecoxib no more dangerous to the heart than the two NSAIDs, which have been prescribed for decades. Celebrex was even safer when it came to certain side effects, like serious gastrointestinal problems.
Nissen said it’s important for the public to understand that the researchers weren’t studying the occasional use of these drugs — instead they focused on patients with osteoarthritis or rheumatoid arthritis who take the drugs every day to control pain.
Nissen said it was “very striking” that when it came to side effects, there was about a 50 percent lower risk of having a serious gastrointestinal complication from Celebrex compared to ibuprofen or naproxen.
“Celebrex, unlike the other agents, does not have anti-platelet effects so is safer to combine with other blood thinners and can be taken peri-operatively — and even before the operation without increasing bleeding — to reduce post-operative pain, and also does not block the potent anti-platelet effects of aspirin.
A treatment for ankylosing spondylitis bites the dust… next
Otezla Fails In Ankylosing Spondylitis Study
Dr. Jack Cush writing in RheumNow reported that ClinicalTrials.gov has listed the results of the POSTURE study, a large randomized placebo-controlled trial wherein apremilast (Otezla) was found to yield no benefit (compared to placebo) in treating ankylosing spondylitis (AS) (32.5% vs. 36.6% ASAS20 at week 16) patients. These findings make it unlikely that Celgene will pursue AS as an indication for apremilast.
Comment: I’m not surprised. Otezla’s effects are modest.
Study Shows Potential for Early Diagnosis of Arthritis
Pat Anson writing for Pain News Network reported a new study by British researchers has demonstrated the potential for an experimental blood test that can diagnose arthritis in its earliest stages. Such a test could lead to earlier treatment of osteoarthritis (OA) and rheumatoid arthritis (RA), years before joint damage and physical symptoms begin.
Researchers at Warwick Medical School recruited 225 people with early or advanced OA, RA or another inflammatory joint disease, along with a control group of healthy volunteers with no joint problems. Their blood and fluid from affected knee joints were then analyzed with mass spectrometry.
The test found patterns in blood plasma amino acids that were damaged by oxygen, nitrogen and sugar molecules. The damage was highest in the blood samples of patients with OA or RA, and markedly lower in the blood of healthy volunteers — giving researchers identifiable biomarkers that could be used for an early diagnosis.
“This is a big step forward for early-stage detection of arthritis that will help start treatment early and prevent painful and debilitating disease,” said Naila Rabbani, PhD, of Warwick Medical School. “Damage to proteins in the arthritic joint have been known for many years but this is the first time it has been exploited for early-stage diagnosis.
“For the first time we measured small fragments from damaged proteins that leak from the joint into blood. The combination of changes in oxidised, nitrated and sugar-modified amino acids in blood enabled early stage detection and classification of arthritis – osteoarthritis, rheumatoid arthritis or other self-resolving inflammatory joint disease.”
When Cheap Generic Drugs Morph Into Expensive Prescriptions
Dr. Jack Cush writing in Rheumnow reported The Wall Street Journal has issued an alarming trend in generic drug pricing that affects many, especially the elderly and those with arthrtis.
Pharmaceutical companies have developed a growing number of combined generic products whose sum is far more than the cost of the individual generics. For example, the migraine medication Treximet has two active ingredients—sumatriptan and naproxen. As generics these two drugs may result in a copay of zero dollars for the average patient.
A box of nine tablets of Treximet costs $728.67, according to Truven Health Analytics. But the average actual cost for a box is about $353, and the cost of its two constituents, sumatriptan and naproxen, would cost around $19, according to GoodRx.
Others combo agents in this category include acne cream Acanya, Duexis and Vimovo for arthritis pain and the weight-loss pill Qsymia.
Comment: Pharmaceutical companies can be sneaky I think.
So… you need knee replacement. Should you get them done one at a time or both at once… next
Simultaneous Versus Staged Bilateral Total Knee Arthroplasty
Dr. Jack Cush writing in Rheumnow reported on a metanalysis from 2013 that identified 18 articles which included over 65,000 patients and compared those undergoing single as opposed to simultaneous total knee replacements.
The incidence of mortality was significantly higher in the simultaneous group at 30 days (RR 3.67, 95% CI 1.68–8.02), 3 months (RR 2.45, 95% CI 2.15–2.79) and 1 year (RR 1.85, 95% CI 1.66–2.06) after surgery.
On the other hand there were no significant differences between the two groups with regard to in-hospital mortality R 1.18, 95% CI 0.74–1.88), post-operative deep vein thrombosis, cardiac complications, and pulmonary embolism or infection rates
Thus the higher mortality rate associated with bilateral total knee arthroplasty should impact patient selection for this surgical option. The good news is that there is no differences in other common complications associated with arthroplasty – infection, thrombotic events, etc.