New Data Offers Vimpat Support
New data presented at AES support long-term lacosamide (Vimpat, UCB) therapy and describe quality of life improvements with therapy. Among a total of 1,054 patients who initiated open-label lacosamide treatment (2,997.8 patient-years exposure), treatment with lacosamide up to eight years was generally well tolerated and associated with a reduction in seizure frequency and maintenance of efficacy over time. Additionally, analysis of pooled data from open-label extensions of three Phase II/III trials demonstrated that long-term lacosamide therapy was associated with improvements in HRQoL. Improvements in HRQoL and reduction in seizure severity were greater in patients who achieved a 50 percent reduction in seizure frequency compared to individuals who did not respond to treatment. At Week 48, CPS responders (n=362) reported improvements in all QOLIE-31 scores with clinically meaningful improvements specifically in seizure worry (+10.81) and social functioning (+4.03). CPS non-responders (n=267) had substantially smaller improvement in seizure worry and social functioning and demonstrated worsening in all other scores. At Week 48, SGPS responders (n=183) showed clinically meaningful improvements in seizure worry (+13.34), overall quality of life (+6.75), social functioning (+7.26), and total score (+5.36). SGPS non-responders (n=99) had meaningful improvement in social functioning (+4.25), but they had smaller improvements or worsening in all other scores.
New PML Test for Tysabri
FDA in late January agreed to allow marketing of the first test to help determine the risk for the rare brain infection progressive multifocal leukoencephalopathy (PML) in people using Tysabri (natalizumab, Biogen Idec) to treat multiple sclerosis or Crohn's disease. The Stratify JCV Antibody ELISA test, when used with other clinical data from the patient, can help health care providers determine the risk for developing PML in MS and CD patients.
The test is to be used in conjunction with other risk factors:
• the presence of anti-JCV antibodies, which reflects prior exposure to JCV
• treatment with Tysabri for a significant period of time (longer than 2 years)
• treatment with certain medicines that can weaken a patient's immune system (immunosuppressants such as mitoxantrone, azathioprine, methotrexate, cyclophosphamide, and mycophenolate mofetil) before receiving Tysabri.
The risk of getting PML is greatest (about 11/1,000 patients treated) if the patient has all three of these risk factors. The FDA reviewed data for the Stratify JCV Antibody ELISA test through the de novo reclassification process, a regulatory pathway for low- to moderate-risk medical devices that are novel and not comparable to an already legally marketed device.
Sabril Data Released
Post-baseline vision data from Lundbecks Sabril (vigabatrin) patient registry were released at the annual meeting of the American Epilepsy Society. Because of the risk of Sabril-induced permanent vision loss, the FDA required a Risk Evaluation and Mitigation Strategy (REMS), which includes an ongoing patient registry that now includes 3,093 patients who enrolled in the mandatory patient registry during the two-year period between Aug. 21, 2009 and Aug. 22, 2011. Of the total patients enrolled in the registry, 1,046 had refractory complex partial seizures (CPS) and 1,880 had infantile spasms (IS).
SmartPhone Technology in
FDA approved AdaptiveStim with RestoreSensor neurostimulation by Medtronic. The system utilizes motion sensor technology found in smart phones and computer gaming systems “to provide effective pain relief and convenience by automatically adapting stimulation levels to the needs of people with chronic back and/or leg pain,” according to the company.
Data from the US RestoreSensor clinical trial showed the AdaptiveStim with RestoreSensor neurostimulator provided effective pain relief and convenience. At the end of the study, 86.5 percent of study participants with chronic pain, who were included in an intent-to-treat analysis (n=74), experienced somewhat better or much better pain relief with no loss of convenience, or somewhat more or much more convenience with no loss of pain relief, when the device's AdaptiveStim technology was turned on. This is compared to a control period when the participants manually adjusted neurostimulation settings using a patient programmer. Study participants also reported functional improvements, including improved comfort during position changes (80.3 percent).
The multicenter, prospective, open-label, randomized, crossover study enrolled 79 study participants at 10 U.S. centers. Participants were randomized to receive either stimulation from the RestoreSensor device for six weeks with the AdaptiveStim technology turned on followed by six weeks with AdaptiveStim turned off, or six weeks with AdaptiveStim turned off followed by six weeks with AdaptiveStim turned on. When AdaptiveStim was turned off, participants manually adjusted stimulation levels using a patient programmer.
“AdaptiveStim technology uses a proprietary sensor and algorithm that leverage the latest advancements in motion detection technology,” Julie Foster of Medtronic said. “Similar to the sensing mechanism used in innovative technologies like automobile airbags, smart phones and computer gaming systems, the sensing capabilities of the RestoreSensor neurostimulator involve the use of an accelerometer to sense changes in body position.” She added that once the AdaptiveStim feature is activated, programming parameters based on a patient's optimal stimulation settings are correlated to certain positions or activity. “AdaptiveStim with RestoreSensor also records and stores the frequency of posture changes, providing feedback to clinicians to help them understand how a patient's individual stimulation requirements are changing over time.”
AdaptiveStim with RestoreSensor is approved by FDA for use in MRI head scans if recommended by a physician.
CT Scans for Dizziness May Not be Cost Effective
New research says subjecting patients suffering from dizziness to CT scans in the emergency room may not be cost-effective. Henry Ford Hospital researchers presenting at the annual Triological Society's Combined Sections Meeting in late January suggest stricter guidelines for emergency room CT scans of the head and brain because less than one percent of CT scans carried out in the ED showed a more severe underlying basis for dizziness (stroke or intracranial bleeding). The researchers examined 1,681 individuals with vertigo or dizziness, between January 2008 and January 2011 in the greater Detroit area.
Hope For Detecting Amyloid Deposits
Presented at the 6th Annual Human Amyloid Imaging (HAI) meeting, data suggest that the investigational imaging agent [18F]Flutemetamol could add value to current diagnostic tools used by physicians to evaluate neurodegenerative conditions like Alzheimer's Disease (AD). [18F]Flutemetamol is a PET imaging agent in Phase III development for the detection of beta amyloid.
Data presented in two abstracts from a clinical trial of [18F]Flutemetamol in patients with suspected Normal Pressure Hydrocephalus (NPH), a progressive condition associated with dementia, gait abnormalities and urinary incontinence, undergoing shunt placement correlated [18F]Flutemetamol uptake with histopathological tissue biopsies for beta amyloid in vivo. In a third abstract from another study, researchers correlated [18F]Flutemetamol uptake and structural MRI in healthy volunteers and patients with a clinical diagnosis of AD or Mild Cognitive Impairment (MCI). Specifically:
[18F]Flutemetamol uptake demonstrated a strong concordance with histopathology in subjects with NPH independent of timing and sequence of examinations.
[18F]Flutemetamol PET uptake showed 100 percent sensitivity and specificity with histopathology in a selected subset of subjects with NPH.
In a subset of patients with MCI, increased [18F]Flutemetamol uptake and decreased hippocampal volume were seen in those with progressive MCI versus those with stable MCI.
Foundation Reaching Out to Kids with Epilepsy
The CeCe Bear Initiative from the CeCe Cares Pediatric Epilepsy Foundation has launched in conjunction with the nation's leading pediatric epilepsy centers and the North American Bear Company to address the emotional trauma and financial burden associated with pediatric epilepsy. Chicago parents Peter and Sarah Cunningham envisioned the program after losing their daughter Cecelia to Dravet Syndrome. Donors to CeCe cares sponsor a teddy bear (CeCe) for $39.99. The 22-inch CeCe Bear provides comfort to a child being treated in one of the leading pediatric epilepsy centers across the country, while the balance of the proceeds is applied to help families burdened with the high cost of medical care through financial grants and related programs. cececares.org n