Use of Calcitonin Gene-Related Peptide Monoclonal Antibodies for the Treatment of Migraines in Individuals With Multiple Sclerosis.

BACKGROUND: Migraines are a common comorbidity and source of disability in patients with chronic inflammatory diseases like multiple sclerosis (MS). Recently, therapeutic agents for episodic and chronic migraine known as calcitonin gene-related peptide (CGRP) inhibitors have shown to effectively control migraine attacks and improve quality of life in the general population. This study explored the use of these novel agents in individuals with comorbid MS. METHODS: This was a retrospective, population-based cohort study at the University of South Florida's neurology clinic; it evaluated individuals with both MS and migraine. RESULTS: A total of 27 individuals with MS and chronic or episodic migraine who received treatment with a CGRP monoclonal antibody were identified. Of these, 63% reported a reduction in their migraine frequency of greater than 75%. Concurrent use of a disease-modifying therapy (DMT) for MS occurred in 82% of patients, and in 37% of these, the DMT used was also a monoclonal antibody. Adverse effects from CGRP monoclonal antibodies were mild and occurred in only 11% of patients, and no patient experienced worsening of their MS symptoms during cotreatment over the duration of the study. CONCLUSIONS: Our study showed a significant reduction in migraine frequency and a favorable adverse event profile for individuals with comorbid MS who took CGRP monoclonal antibodies and experienced no worsening of MS symptoms. In individuals with MS, CGRP monoclonal antibodies seem to be a safe and effective therapy for episodic or chronic migraine.

Assessing Barriers to Adherence with the Use of Dimethyl Fumarate in Multiple Sclerosis.

BACKGROUND: Multiple sclerosis (MS) is a chronic, inflammatory, central nervous system demyelinating disease that requires long-term use of disease-modifying therapies (DMT). Patient adherence to DMT is key in reducing the inflammation that leads to relapses and neurodegeneration. Dimethyl fumarate (DMF) poses unique challenges to adherence including being the only twice-daily dosing DMT. Previous research suggests there are direct roles that providers play on improving their patients' adherence rates, such as focusing on the patient-provider relationship, helping put the patient at ease so that they feel understood and respected. Also, route of administration affects adherence in other chronic healthcare conditions. However, the issue of adherence to DMT in MS is more complex than just route of administration, with adverse effects being the main predictor of adherence. OBJECTIVES: (1) To define various patient specific factors (e.g. fatigue and mood disorders) that affect adherence with DMF and (2) to understand how patients' perceptions of treatment satisfaction (such as effectiveness, convenience, side effects and global satisfaction) and DMFs impact on quality of life (such as social support, activities of daily living, coping) influence adherence. METHODS: Our study was a prospective, observational measurement of adherence to treatment with DMF in MS patients over 52 weeks. Twenty-five out of thirty-five patients enrolled completed the study. Adverse event (AE) data was reviewed on all participants. RESULTS: Adherence rates correlated with patient's perceived effectiveness (0.25, p < 0.023) and the level of bothersome symptoms the patient experienced (0.45, p < 0.0001). The majority of new AE onset was reported within 12 weeks of DMF initiation. This is consistent with previously published data with DMF use. CONCLUSION: Adherence rates are an important factor to be considered when starting patients on DMT. DMF creates its own barriers to adherence with our study highlighting some, including twice-daily dosing and AEs experienced following treatment initiation. Healthcare providers should be aware of these barriers prior to treatment initiation and counsel patients appropriately.

Immediate Transfer for Clot Extraction in a Young Woman With Leukemia and Asparaginase-Associated Acute Cerebral Vein Thrombosis.

We present the case of an 18-year-old woman with B-cell acute lymphoblastic leukemia (ALL) who developed hemorrhagic stroke and epilepsia partialis continua due to acute cerebral vein thrombosis (CVT). The patient had 10 risk factors for CVT (including use of asparaginase chemotherapy for the ALL) and also unfortunately had 4 biomarkers for poor prognosis for outcome post-CVT diagnosis. Immediate transfer to a Comprehensive Stroke Center allowed for hyperacute neurointerventional clot extraction with rapid restoration of the patency of the superior sagittal sinus. This resulted in an unexpectedly favorable neurological outcome and simultaneously allowed for early resumption of chemotherapy for ALL after only a 5-day hiatus. Our case highlights the importance of immediate transfer of highest risk patients with multiple biomarkers for poor prognosis to a Comprehensive Stroke Center with endovascular and neurosurgical capabilities and the possibility of overcoming the odds of a poor outcome with venous clot extraction if medical management fails. Neurological deterioration due to escalating intracranial pressure with impending herniation may occur rapidly, and treatment at such facilities can be life-saving.

Patient perceived changes in sexual dysfunction after initiation of natalizumab for multiple sclerosis.

PURPOSE: Sexual dysfunction is a common but often overlooked secondary symptom of multiple sclerosis (MS) and can be associated with a decreased health-related quality of life (HRQoL). Natalizumab is a disease-modifying therapy approved for the treatment of relapsing forms of MS. In addition to its efficacy, those using natalizumab have shown improvement in HRQoL parameters, including fatigue and cognition. The idea that improvement in fatigue may also correlate with improvement in sexual dysfunction is the impetus for this study. METHODS: A single-center, open-label, single-arm, 24-week study was performed to evaluate perceived change in sexual dysfunction in MS patients treated with natalizumab. Adults with relapsing MS initiating natalizumab treatment and had a baseline level of sexual dysfunction were enrolled. The primary endpoint was change in the MS Intimacy and Sexuality Questionnaire-19 (MSISQ-19) score from baseline to week 24. Mean age of patients was 41 years, median disease duration was 7 years, and 73% of patients used at least one prior MS disease-modifying therapy. RESULTS: Natalizumab-treated patients experienced improvement in sexual dysfunction within the first 24 weeks of starting therapy, as demonstrated by the primary subscale of the MSISQ-19 questionnaire (-0.6976, p = 0.02). CONCLUSIONS: Given the high prevalence of sexual dysfunction in MS patients and the significant impact it has on HRQoL, more research on this often overlooked symptom of MS could be very informative for patients that are deciding to initiate a new disease modifying therapy.

Tolerability and efficacy of colestipol hydrochloride for accelerated elimination of teriflunomide.

BACKGROUND: Teriflunomide is an oral disease modifying therapy approved for the treatment of relapsing forms of multiple sclerosis. Teriflunomide' s pharmacokinetics (PK) contribute to its slow elimination, on average taking 6-8 months, though it can take up to 2 years in some instances. This slow elimination can become problematic in certain clinical situations - such as during pregnancy, when teriflunomide has potential teratogenic effects. In such scenarios, an accelerated elimination procedure (AEP) is recommended. Currently, AEPs with oral cholestyramine or activated charcoal are available but are restricted by adverse effects, limited administration routes, and dosing frequencies. METHODS: A single-center, PK interaction study was performed in a total of 14 healthy volunteers, to investigate colestipol hydrochloride (HCl) as an alternative to cholestyramine for the elimination of teriflunomide. Participants received teriflunomide for 14 days, followed by an AEP with colestipol HCl for 15 days. RESULTS AND CONCLUSIONS: The administration of colestipol HCl for 15 days was sufficient to reduce plasma teriflunomide concentrations by greater than 96%. Although colestipol HCl did not completely eliminate teriflunomide with the same effectiveness as cholestyramine, it may offer an alternative method for accelerated elimination of teriflunomide with potentially improved tolerability and more favorable dosing and administration options.

Disease-Modifying Therapies in Multiple Sclerosis: Overview and Treatment Considerations.

Controlling symptoms can slow the physical and emotional disabilities associated with multiple sclerosis and help patients attain the highest quality of life possible for as long as possible.

Are we prepared for Affordable Care Act provisions of care coordination? Case managers' self-assessments and views on physicians' roles.

PURPOSE OF STUDY: Care coordination, traditionally the purview of the case management field, is recognized as a national priority for improving health care delivery and patient outcomes. With reforms of the Affordable Care Act (ACA) of 2010, case managers face new challenges and opportunities in providing care coordination services. The evolving roles of case managers as members of interprofessional care teams will be influenced by new policies that enable physicians to be reimbursed for care coordination. This qualitative study aimed to evaluate case managers' self-assessed readiness for ACA reforms of care coordination and their perceptions of physicians' understanding of case management and ability to lead care coordination efforts in evolving models. PRIMARY PRACTICE SETTINGS: Provisions of care coordination in the ACA affect case managers in all practice settings. The majority of this study's participants represented hospital and managed care settings. METHODOLOGY AND SAMPLE: An invitation to complete an 11-item online survey was sent by e-mail to 8,110 case managers in an opt-in database maintained by a health care continuing education company. Survey questions were designed to assess respondents' (1) self-reported levels of knowledge and preparation for ACA care coordination provisions and (2) beliefs about the readiness and abilities of physicians to administer care coordination services. In addition, demographic data and open-ended comments regarding physicians' roles in conducting care coordination were collected. Over a restricted 9-day period, 834 case managers representing various health care settings responded to the survey. RESULTS: The majority of respondents (63%) indicated that more than 50% of their day is dedicated to performing care coordination activities. However, 80% of all respondents reported being "not at all knowledgeable" or only "somewhat knowledgeable" about the new care coordination provisions in the ACA. Only 8% admitted to being "very prepared" to implement ACA changes. The majority of respondents (68%) perceive their case management departments to be at least "somewhat prepared" to implement necessary changes. Whereas 67% of respondents expect physicians to have at least a "moderate role" in implementing care coordination services, only 12% believe that physicians have more than "some" understanding of the processes of care coordination and case managers' roles. IMPLICATIONS FOR CASE MANAGEMENT PRACTICE: These qualitative study findings suggest that case managers from multiple practice settings perceive a lack of preparedness, knowledge, and understanding among themselves and physicians regarding ACA reforms that may significantly affect the delivery of care coordination services. The findings call for new initiatives in interprofessional education to address the knowledge gaps and enhance understanding of the collaborative roles among case managers and physicians.