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.