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Publication History View all

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    ABSTRACT: Introduction: Alemtuzumab is a humanized IgG1 kappa monoclonal antibody approved for treatment of B-cell chronic lymphocytic leukemia. This cytolytic antibody is directed against CD52 and depletes lymphocytes, with monocytes, macrophages, natural killer cells and a subpopulation of granulocytes being affected to a much lesser degree. Alemtuzumab is currently under review to treat relapsing multiple sclerosis (MS) in the United States, based on positive Phase II and Phase III trials in both treatment-naïve and treated relapsing MS patients. There was excellent efficacy in suppressing both clinical and neuroimaging disease activities. In these trials, the comparator arm was not placebo, but high dose frequently dosed subcutaneous interferon beta 1a. Alemtuzumab has recently been approved by the European authorities for active relapsing MS, in essence as a first-line agent. It produces long-standing effects, consistent with an induction agent. Efficacy will have to be weighed against risk of adverse effects, which include autoimmune disorders and infection. Alemtuzumab joins an increasingly crowded market, and will add to the complexity of treating MS. Areas covered: This review will discuss alemtuzumab as a therapy for MS, reviewing PubMed for clinical trials, publications and presentations at international meetings. It will focus on a United States market perspective. Expert opinion: Alemtuzumab offers induction strategy for very active relapsing MS patients who have failed conventional therapy, and possibly selected treatment-naive patients. Alemtuzumab use is likely to be restricted to specialized MS centers, with long-term monitoring to determine the true risk for adverse effects.
    Expert opinion on biological therapy 12/2013;
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    ABSTRACT: Daily assessments can provide insight into the temporal characteristics of fatigue. They can demonstrate consistency or reveal variability, as when fatigue changes with the underlying medical condition, improves with therapy, or worsens as a medication side effect. We adapted a fatigue measure from the Patient-Reported Outcomes Measurement Information System (PROMIS(®)) for daily assessment and examined its psychometric properties in a month-long prospective study. Three groups of 100 participants each were drawn from two fatigue-related clinical disorders [osteoarthritis (OA) and premenstrual syndrome/premenstrual dysphoric disorder (PMS/PMDD)], and a general population sample (GP). They completed brief daily web-based fatigue measures at home on 28 consecutive evenings. Compliance was high for all samples, based on the percent of participants who remained in the study (98 % for GP and OA, 95 % for PMS/PMDD). The new scale performed consistently across the groups, sensitively measuring fatigue with high reliability (>0.90) especially in the average to high fatigue level range. Supporting known-groups validity, fatigue scores were elevated in the clinical groups as compared to the GP. The scale was sensitive to change, with the PMS/PMDD sample showing a linear increase in fatigue prior to menses onset, and a sharp drop off afterward. The scale was psychometrically sound across diverse clinical and general population samples, though less reliable when assessing lower levels of fatigue.
    Quality of Life Research 10/2013;
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    ABSTRACT: There are currently nine approved disease modifying therapies for relapsing forms of multiple sclerosis, with six distinct mechanisms of action. All have side effects, and none are cures. When a patient cannot tolerate therapy, or there is unacceptable breakthrough disease activity, the most common approach is to change drug. No universal guidelines exist for switching therapy. This overview will propose switch principles and suggestions.
    CNS Drugs 03/2013;
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    ABSTRACT: Parainfectious disorders of the nervous system encompass those meningo-encephalo-radiculomyelitic conditions that are temporally associated with a systemic infection, antigenic stimuli, or toxin exposure, in the absence of evidence of direct neuronal infection or invasion of the central nervous system (CNS) or peripheral nervous system (PNS). Pathogenetic mechanisms can be due to immune-mediated processes (such as bystander activation, molecular mimicy) or the inciting insult can be due to toxic factors, as in the case of botulism. A myriad of clinical manifestations can occur including headache, seizures, and mental status changes, ranging from mood and behavioral disturbances to varying levels of alteration in consciousness. Focal neurological deficits can include aphasia, hemiparesis, or paraparesis. The PNS can also be affected leading to cranial nerve involvement, focal or multifocal neuropathies, and dysfunction of the autonomic nervous system. Diagnosis is based not only on the history, examination, laboratory, and neuroimaging data but also on epidemiological factors. The parainfectious disorders covered in this review are cat scratch disease, Lyme borreliosis, legionellosis, brucellosis, botulism, pertussis, and mycoplasma. Each is associated with a distinct organism, has both systemic and neurological manifestations, and has a different epidemiological profile.
    Handbook of Clinical Neurology 01/2013; 112:1195-207.
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    ABSTRACT: Pregnancy is a major concern in multiple sclerosis (MS), because the typical patient is a young woman of childbearing age. This article reviews the impact of pregnancy on MS. Disease activity decreases, particularly during the last trimester. There is a temporary rebound of disease activity in the 3 months postpartum. Pregnancy and the postpartum period have many implications for counseling and for therapeutic decision making in MS.
    Neurologic Clinics 08/2012; 30(3):877-88.
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    ABSTRACT: The goal of this study was to determine if memory would be improved by donepezil as compared to placebo in a multicenter, double-blind, randomized clinical trial (RCT). Donepezil 10 mg daily was compared to placebo to treat memory impairment. Eligibility criteria included the following: age 18-59 years, clinically definite multiple sclerosis (MS), and performance ≤ ½ SD below published norms on the Rey Auditory Verbal Learning Test (RAVLT). Neuropsychological assessments were performed at baseline and 24 weeks. Primary outcomes were change on the Selective Reminding Test (SRT) of verbal memory and the participant's impression of memory change. Secondary outcomes included changes on other neuropsychological tests and the evaluating clinician's impression of memory change. A total of 120 participants were enrolled and randomized to either donepezil or placebo. No significant treatment effects were found between groups on either primary outcome of memory or any secondary cognitive outcomes. A trend was noted for the clinician's impression of memory change in favor of donepezil (37.7%) vs placebo (23.7%) (p = 0.097). No serious or unanticipated adverse events attributed to study medication developed. Donepezil did not improve memory as compared to placebo on either of the primary outcomes in this study. This study provides Class I evidence which does not support the hypothesis that 10 mg of donepezil daily for 24 weeks is superior to placebo in improving cognition as measured by the SRT in people with MS whose baseline RAVLT score was 0.5 SD or more below average.
    Neurology 04/2011; 76(17):1500-7.
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    Frontiers in Neurology 01/2011; 2:37.
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    ABSTRACT: Knowledge of the warning signs of stroke may reduce the incidence of having a second stroke by receiving medical intervention in a timely manner. The need for stroke education is paramount to empower stroke patients to recognize the signs and symptoms of an impending stroke. The purpose of this pilot study was to develop and to evaluate the effectiveness of an educational method of providing stroke education in an acute care setting. Twenty patients were recruited and randomized to two groups. Group 1 received the standard of care: verbal and written education at the time of discharge by the discharge nurse. Group 2 received individualized protocol-driven verbal and written education with their caregiver present within the context of the Therapeutic Alliance Model using motivational interviewing techniques. Each group was sent a Stroke Knowledge Test and a patient satisfaction survey at 1 month. Results indicate that the enhanced education group received improved scores on the Stroke Knowledge Test and had better patient satisfaction scores regarding stroke education. An enhanced educational method using motivational interviewing and an individualized protocol-driven education intervention given to both the patient and a caregiver enhance stroke knowledge and patient satisfaction after discharge from the acute care setting.
    Journal of Neuroscience Nursing 12/2010; 42(6):312-22.
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    ABSTRACT: Fatigue is an extremely prevalent issue for multiple sclerosis (MS) patients. Fatigue can affect quality of life, depression, anxiety, motor function and sleep patterns. There are a number of available rating scales designed to detect and assess fatigue. However, the pathophysiology of fatigue is still not completely understood and the treatment of this symptom remains difficult. A number of clinical trials for fatigue in MS have shown some benefit with different interventions, including medication, physical activity and cognitive-behavioral therapy. Nonetheless, further research and the development of more targeted therapies are needed to improve the management of fatigue.
    Expert Review of Neurotherapeutics 09/2010; 10(9):1437-47.
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    ABSTRACT: Pediatric multiple sclerosis (MS) represents a particular MS subgroup with unique diagnostic challenges and many unanswered questions. Due to the narrow window of environmental exposures and clinical disease expression, children with MS may represent a particularly important group to study to gain a better understanding of MS pathogenesis. Acute disseminated encephalomyelitis (ADEM) is more common in children than in adults, often making the differential diagnosis of MS, particularly a clinically isolated syndrome, quite difficult. Although both disorders represent acute inflammatory disorders of the central nervous system and have overlapping symptoms, ADEM is typically (not always) self-limiting. The presence of encephalopathy is much more characteristic of ADEM and may help in distinguishing between the two. Young children (under ten years old) with MS differ the most from adults. They have a lower frequency of oligoclonal bands in their cerebrospinal fluid and are less likely to have discrete lesions on MRI. Problems of cognitive dysfunction and psychosocial adjustment have particularly serious implications in both children and teenagers with MS. Increased awareness of these difficulties and interventions are needed. While clinical research on therapies to alter the disease course is limited, the available data fortunately suggests that disease-modifying therapy is well tolerated and likely to be effective. Ultimately, multinational research studies are necessary to advance our knowledge of the causes, symptoms, and treatment of pediatric MS and such collaborations are currently underway.
    Annals of Indian Academy of Neurology 10/2009; 12(4):238-45.
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