Burden of Migraine in Patients With Preventive Treatment Failure Attending European Headache Specialist Centers: Real-World Evidence From the BECOME Study

Migraña; Fracaso del tratamiento; Productividad laboralMigraine; Treatment failure; Work productivityMigranya; Fracàs del tractament; Productivitat laboralIntroduction Migraine is consistently ranked as one of the most disabling neurological conditions in the world, often causing a substantial impairment of daily activities and quality of life. It also carries a high economic burden of direct and indirect healthcare costs. Patients with difficult-to-treat migraine often cycle through different preventive therapies, but real-world prospective evidence describing the burden of migraine in patients with prior preventive treatment failure (PPTF) in Europe is limited. In BECOME, we aimed to characterize and assess the prevalence and burden of migraine in patients with PPTF attending specialist headache centers in Europe and Israel. Furthermore, we assessed this burden in pre-specified subgroups based on the frequency of monthly migraine days (MMD) and number of PPTFs. Methods BECOME was a prospective, non-interventional study conducted in two concurrent parts across 17 countries in Europe and Israel. In part 1, patients visiting the centers over a 3-month period were screened for frequency of PPTF, MMD, and other characteristics. In part 2, patients from part 1 with ≥ 1 PPTF and ≥ 4 MMD were enrolled, and impact of migraine on patient-reported outcomes, and healthcare resource utilization (HRU) were examined. Results In part 1 (n = 20,837), 62.2% of patients reported ≥ 1 PPTF. In part 2 (n = 2419), 15.3% of patients reported ≥ 4 PPTF. In part 2, the migraine burden measured by the EuroQoL 5 dimensions 5 level (EQ-5D-5L) questionnaire indicated an impact of at least moderate severity in performing usual activities in 26.5% of patients, pain/discomfort in 51.2%, and 26.1% reported being at least moderately anxious/depressed. Most patients reported a severe impact on daily activities and disability due to migraine. Abnormal Hospital Anxiety and Depression subscale scores of ≥ 11 were observed in 29% (anxiety) and 19.8% (depression) of the population. In part 2, analysis of HRU showed 21.2% patients visited an emergency department and 8.4% were hospitalized for headache/migraine in the past year. Conclusions This study provides real-world evidence of the high personal, social, and HRU burden of migraine in Europe and Israel.This study was funded by Novartis Pharma AG, Basel, Switzerland. The study sponsor participated in the study design, data collection, data review, data analysis and writing of the report. The Rapid Service Fee was funded by Novartis Pharma AG, Basel, Switzerland

Real-world preventative drug management of Chronic Migraine among Spanish Neurologists

O42 Background: In migraine, the therapeutic preventive drug arsenal is varied. Whenprescribing both Guidelines and patient characteristics are taken intoaccount. In Spain, the use of preventive therapies seems to beheterogeneous.The objective of this study was to evaluate real-life clinical prescribingpractice amongst neurologists in Spain Methods: Observational descriptive study done with a survey by Neurologistsof the Spanish Neurological Society (SEN). Neurologists who participatedwere divided into Headache Specialists or not. The followingdata was collected: socio-demographic data, ; preventive treatmentand choices different migraine sub-types, and their personal perceptionof efficacy and tolerability to different drugs. Results: We analyzed 152 surveys from neurologists around our country.From them: 43.4% were female, 53.3% <40 years, and 34.9% were interestedin headache .In regards to preventive treatment choice; in chronic migraine topiramate(57%) amytriptiline (17.9%) and beta-blockers (14.6%), whereasin episodic migraine the preferred drugs were beta-blockers (47.7%), topiramate (21.5%) and amytriptiline (13.4%).Regarding perceived efficacy, topiramate was considered the bestoption in chronic migraine (42.7%) followed by onabotulinumtoxinA(25.5%) and amitryptiline (22.4%). In episodic migraine, neurologistpreferred topiramate (43.7%) and beta-blockers (30.3%).Regarding the duration of preventive therapy when improvementwas achieved, when treating episodic migraine 43.5% of the surveyedneurologists recommended 3 months and 39.5% preferred 6months. When they treated chronic migraine, 20.4% of neurologistsrecommended 3 months, 42.1% 6 months, 12.5% 9 months and22.4% preferred to maintain treatment during 12 months.When considering onabotulinumtoxinA treatment, the number ofprior therapeutical failures was cero in 7.2% of surveyed, one in5.9%, two in 44.1%, three in 30.9%, and four or more in 11.9%. Theincrease of OnabotulinumtoxinA dose up to 195 UI was consideredby 51% of neurologists after a first ineffective procedure, by 42.2% after two injections, and by 83% after a third infiltration. Surveyedcolleagues admitted to take into account in their decisions mainlypatient comorbidities (70.2%) rather than guidelines (13.9%). Conclusions: Initial management of Migraine among Spanish Neurologists is madewith the preventative drugs which are considered as first choices inmost of the guidelines. Management of episodic migraine differedfrom chronic migraine, both in the order or drugs and the perceptionof the most effective therapy

PrevenBox: Evaluation of concomitant use of preventive medications with OnabotulinumtoxinA in migraine

P114 Background: OnabotulinumtoxinA is an effective, tolerable and safepreventive treatment for chronic migraine (CM). Other than a reduc-tion in headache frequency or disability, in CM the withdrawal ofconcomitant preventive medication indicates treatment effectivenessand quality of life improvement. Objective: To characterize the change in the use of oral preventivemedication after treatment with OnabotulinumtoxinA in patientswith migraine. Methods: This is a multicentre study. We consecutively included pa-tients with migraine (ICHD-3) that were on preventive treatment withOnabotulinumtoxinA. We retrospectively collected demographic data, diagnosis of migraine, frequency and intensity changes, number ofcycle and OnabotulinumtoxinA dose. In addition, we listed the initialand current preventive treatment (number of drugs and group) andthe number and cycle of medications withdrawn. We performed aunivariate and logistic regression analysis. Results: We included 542 patients: 87.6% women, mean age 47.6 ±11.7 years. A 89.3% had chronic migraine and 10.8% had high fre-quency episodic migraine. The mean reduction in frequency aftertreatment was 13.4±8.2 headache days/month. At baseline, a 91.3%took other preventives and during treatment with Onabotulinumtox-inA a 58.6% withdrew at least one drug, 25.8% stopped completelyall oral preventive drugs. Factors associated with withdrawal were:being male, having >50% response in frequency and intensity, thenumber of infiltrations and a shorter chronification period until thefirst OnabotulinumtoxinA administration (p <0.05). The multivariateanalysis showed that a better response in intensity (OR:1.8 [1.4-2.2], p<0.001), a greater number of infiltrations (OR:1.1 [1.0-1.2], p<0.001)and a shorter chronification period (OR:0.994 [0.992-0.997], p<0.001)were predictors of withdrawal. The ROC curve, showed that 6 Onabo-tulinumtoxinA cycles was the cut-off point that better predicted oralpreventive medication withdrawal (p <0.001). Conclusions: Treatment with OnabotulinumtoxinA reduces the use ofother preventive medications for migraine. The highest probability ofwithdrawal occurs after 6 cycles of treatment

Cómo y cuándo derivar un paciente con cefalea secundaria y otros tipos de dolores craneofaciales desde Urgencias y Atención Primaria: recomendaciones del Grupo de Estudio de Cefaleas de la Sociedad Española de Neurología

Introducción: Cuando se sospecha que estamos ante una cefalea secundaria y se deriva un paciente a Urgencias o a la consulta de Neurología es importante saber qué exploraciones complementarias son oportunas hacer en cada caso, además de saber posteriormente cuál es el circuito adecuado que ha de seguir el paciente. Por este motivo, el Grupo de Estudio de Cefaleas de la Sociedad Española de Neurología (GECSEN) ha decidido crear unas recomendaciones consensuadas que establezcan un protocolo de derivación de pacientes con cefalea y/o neuralgias craneofaciales. Desarrollo: Se ha contactado con neurólogos jóvenes con interés y experiencia en cefalea y con la Junta Directiva del GECSEN han desarrollado este documento que, por razones prácticas, se ha dividido en 2 artículos. El primero centrado en las cefaleas primarias y neuralgias craneofaciales, y este centrado en las cefaleas secundarias y otros dolores craneofaciales. El enfoque es práctico, con tablas que resumen los criterios de derivación con exploraciones complementarias y otros especialistas a los que derivar, para que sea útil y facilite su uso en nuestra práctica asistencial diaria. Conclusiones: Esperamos ofrecer una guía y herramientas para mejorar la toma de decisiones ante un paciente con cefalea valorando exploraciones a priorizar y que circuitos seguir para así evitarla duplicación de consultas y retrasos en el diagnóstico y en el tratamiento

Headache: What to ask, how to examine, and which scales to use. Recommendationsof the Spanish Society of Neurology’s Headache Study Group

Introducción: La cefalea es el motivo de consulta neurológico más prevalente en los distintos niveles asistenciales, donde la anamnesis y exploración son primordiales para realizar un diagnóstico y tratamiento adecuados. Con la intención de unificar la atención de esta patología, el Grupo de Estudio de Cefalea de la Sociedad Española de Neurología (GECSEN) ha decidido elaborar unas recomendaciones consensuadas para mejorar y garantizar una adecuada asistencia en atención primaria, urgencias y neurología. Metodología: El documento es práctico, sigue el orden de la dinámica de actuación durante una consulta: anamnesis, escalas que cuantifican el impacto y la discapacidad y exploración. Además, finaliza con pautas para realizar un seguimiento adecuado y un manejo de las expectativas del paciente con el tratamiento pautado.Conclusiones: Esperamos ofrecer una herramienta que mejore la atención al paciente con cefalea para garantizar una asistencia adecuada y homogénea a nivel nacional.Introduction: Headache is the most common neurological complaint at the different levelsof the healthcare system, and clinical history and physical examination are essential in thediagnosis and treatment of these patients. With the objective of unifying the care given topatients with headache, the Spanish Society of Neurology’s Headache Study Group (GECSEN)has decided to establish a series of consensus recommendations to improve and guaranteeadequate care in primary care, emergency services, and neurology departments.Methods: With the aim of creating a practical document, the recommendations follow thedynamics of a medical consultation: clinical history, physical examination, and scales quantif-ying headache impact and disability. In addition, we provide recommendations for follow-upand managing patients’ expectations of the treatment.Conclusions: With this tool, we aim to improve the care given to patients with headache inorder to guarantee adequate, homogeneous care across Spain

Excellent Response to OnabotulinumtoxinA: Different Definitions, Different Predictors

The identification of patients who can benefit the most from the available preventive treatments is important in chronic migraine. We explored the rate of excellent responders to onabotulinumtoxinA in a multicenter European study and explored the predictors of such response, according to different definitions. A pooled analysis on chronic migraineurs treated with onabotulinumtoxinA and followed-up for, at least, 9 months was performed. Excellent responders were defined either as patients with a ≥75% decrease in monthly headache days (percent-based excellent responders) or as patients with &lt;4 monthly headache days (frequency-based excellent responders). The characteristics of excellent responders at the baseline were compared with the ones of patients with a &lt;30% decrease in monthly headache days. Percent-based excellent responders represented about 10% of the sample, whilst frequency-based excellent responders were about 5% of the sample. Compared with non-responders, percent-based excellent responders had a higher prevalence of medication overuse and a higher excellent response rate even after the 1st and the 2nd injection. Females were less like to be frequency-based excellent responders. Chronic migraine sufferers without medication overuse and of female sex may find fewer benefits with onabotulinumtoxinA. Additionally, the excellent response status is identifiable after the first cycle

Cómo y cuándo derivar un paciente con cefalea secundaria y otros tipos de dolores craneofaciales desde Urgencias y Atención Primaria: recomendaciones del Grupo de Estudio de Cefaleas de la Sociedad Española de Neurología

Introducción: . Cuando se sospecha que estamos ante una cefalea secundaria y se deriva un paciente a Urgencias o a la consulta de Neurología es importante saber qué exploraciones complementarias son oportunas hacer en cada caso, además de saber posteriormente cuál es el circuito adecuado que ha de seguir el paciente.Por este motivo, el Grupo de Estudio de Cefaleas de la Sociedad Espanola ˜ de Neurología (GECSEN) ha decidido crear unas recomendaciones consensuadas que establezcan un protocolo de derivación de pacientes con cefalea y/o neuralgias craneofaciales. Desarrollo: Se ha contactado con neurólogos jóvenes con interés y experiencia en cefalea y con la Junta Directiva del GECSEN han desarrollado este documento que, por razones prácticas, se ha dividido en 2 artículos. El primero centrado en las cefaleas primarias y neuralgias craneofaciales, y este centrado en las cefaleas secundarias y otros dolores craneofaciales. El enfoque es práctico, con tablas que resumen los criterios de derivación con exploraciones complementarias y otros especialistas a los que derivar, para que sea útil y facilite su uso en nuestra práctica asistencial diaria. Conclusiones: Esperamos ofrecer una guía y herramientas para mejorar la toma de decisiones ante un paciente con cefalea valorando exploraciones a priorizar y que circuitos seguir para así evitarla duplicación de consultas y retrasos en el diagnóstico y en el tratamiento. © 2017 Publicado por Elsevier Espana, ˜ S.L.U. en nombre de Sociedad Espanola ˜ de Neurolog´ıa. Este es un art´ıculo Open Access bajo la licencia CC BY-NC-ND (http://creativecommons.org/ licenses/by-nc-nd/4.0/)

Excellent Response to OnabotulinumtoxinA : Different Definitions, Different Predictors

The identification of patients who can benefit the most from the available preventive treatments is important in chronic migraine. We explored the rate of excellent responders to onabotulinumtoxinA in a multicenter European study and explored the predictors of such response, according to different definitions. A pooled analysis on chronic migraineurs treated with onabotulinumtoxinA and followed-up for, at least, 9 months was performed. Excellent responders were defined either as patients with a ≥75% decrease in monthly headache days (percent-based excellent responders) or as patients with <4 monthly headache days (frequency-based excellent responders). The characteristics of excellent responders at the baseline were compared with the ones of patients with a <30% decrease in monthly headache days. Percent-based excellent responders represented about 10% of the sample, whilst frequency-based excellent responders were about 5% of the sample. Compared with non-responders, percent-based excellent responders had a higher prevalence of medication overuse and a higher excellent response rate even after the 1st and the 2nd injection. Females were less like to be frequency-based excellent responders. Chronic migraine sufferers without medication overuse and of female sex may find fewer benefits with onabotulinumtoxinA. Additionally, the excellent response status is identifiable after the first cycle

Encephalopathy associated with autoimmune thyroid disease in patients with Graves' disease: clinical manifestations, follow-up, and outcomes

<p>Abstract</p> <p>Background</p> <p>The encephalopathy associated with autoimmune thyroid disease (EAATD) is characterized by neurological/psychiatric symptoms, high levels of anti-thyroid antibodies, increased cerebrospinal fluid protein concentration, non-specific electroencephalogram abnormalities, and responsiveness to the corticosteroid treatment in patients with an autoimmune thyroid disease. Almost all EAATD patients are affected by Hashimoto's thyroiditis (HT), although fourteen EAATD patients with Graves' disease (GD) have been also reported.</p> <p>Methods</p> <p>We have recorded and analyzed the clinical, biological, radiological, and electrophysiological findings and the data on the therapeutic management of all GD patients with EAATD reported so far as well as the clinical outcomes in those followed-up in the long term.</p> <p>Results</p> <p>Twelve of the fourteen patients with EAATD and GD were women. The majority of GD patients with EAATD presented with mild hyperthyroidism at EAATD onset or shortly before it. Active anti-thyroid autoimmunity was detected in all cases. Most of the patients dramatically responded to corticosteroids. The long term clinical outcome was benign but EAATD can relapse, especially at the time of corticosteroid dose tapering or withdrawal. GD and HT patients with EAATD present with a similar clinical, biological, radiological, and electrophysiological picture and require an unaffected EAATD management.</p> <p>Conclusions</p> <p>GD and HT equally represent the possible background condition for the development of EAATD, which should be considered in the differential diagnosis of all patients with encephalopathy of unknown origin and an autoimmune thyroid disease, regardless of the nature of the underlying autoimmune thyroid disease.</p