Sonia Santos Lasaosa

Background: The International Headache Society has proposed new treatment goals for migraine prevention in real world, as a way to set higher standards of care. This study provides the first assessment of the proportion of individuals achieving them after 6 months of migraine-specific treatment with anti-CGRP monoclonal antibodies (MAbs). Methods: This was a prospective, real-world, European multicenter study, including adults with migraine treated with anti-CGRP MAbs (EUREkA cohort). We assessed the proportions of individuals in each treatment goal category–migraine freedom (no monthly migraine days [MMD]); optimal control (< 4 MMD), modest control (4–6 MMD); insufficient control (>6 MMD)–after 6 months of treatment. We also assessed the proportion of individuals with ≥50% reduction in MMD in the insufficient control group. Results: Of the 5818 individuals in the EUREkA cohort, 4963 had 6 months data. Of these, 82.3% (4086/4963) were females and the median age was 48.0 [40.0–55.0] years. At baseline, the median monthly headache days [MHD] and MMD were 20.0 [13.3–28.0] and 15.0 [10.0–20.0], respectively. All participants were classified as having insufficient headache control (>6 MMD) at baseline. At month 6, 6.9% (342/4963) had migraine freedom, 22.9% (1137/4963) optimal control, 24.6% (1223/4963) modest control and 45.6% (2261/4963) insufficient control. In the insufficient control group, 27.1% (613/2261) had ≥50% reduction in MMD. Conclusions: High standards of care, defined as optimal disease control or even migraine freedom, are achieved in real-world settings with anti-CGRP MAbs in approximately 30% of individuals with a high migraine burden. These findings highlight the need to expand global access to these treatments. Future studies should explore whether initiating migraine-specific preventive treatments earlier could further reduce residual migraine days in responders, enabling a larger proportion of patients to achieve optimal disease control.

Objective: This study aimed to evaluate demographic characteristics, treatment effectiveness, and safety outcomes in patients with migraine undergoing anti‐calcitonin gene‐related peptide (CGRP) treatments regarding the presence of autoimmune diseases. Background: CGRP has an important role in migraine pathophysiology through neuronal modulation in the trigeminovascular nociceptive system and activation of neuro‐inflammatory cascades. We hypothesized that autoimmune diseases may influence treatment response and safety profiles in patients with migraine treated with anti‐CGRP treatments. Methods: This was a retrospective multicenter, age‐ and sex‐matched cohort study in headache units/headache clinics in Spain and United Kingdom between May 2024 and May 2025 including patients treated with CGRP monoclonal antibodies from prospectively collected cohorts. Patients were assessed for demographics, migraine‐related characteristics, treatment effectiveness (monthly migraine days [MMD] and/or monthly headache days [MHD]), and safety outcomes. The main outcome was the effectiveness measured by ≥50% response rate in MMD between the two groups. Secondary outcomes included other effectiveness measurements regarding the number of MMD and MHD and treatment emerging adverse events. Results: A total of 388 patients with migraine under anti‐CGRP treatments (194 with autoimmune diseases and 194 age‐ and sex‐matched controls without autoimmune diseases) were included. The proportion of patients achieving a ≥50% response rate in MMD was higher in patients without autoimmune diseases at 6 (69% vs. 53%; p = 0.006) and 9 months (74% vs. 52%; p = 0.006). Treatment emerging adverse events were comparable between the two groups (35% vs. 38%; p = 0.575). Patients with autoimmune disease had a significantly lower likelihood of achieving a ≥50% response in MMD compared with those without autoimmune disease (adjusted odds ratio, 0.61; 95% confidence interval, 0.44–0.85; p = 0.006), independent of comorbid depression and medication overuse. Conclusions: Our study shows that anti‐CGRP treatments are effective and safe for patients with migraine regardless the presence of autoimmune diseases, although an increased treatment response in patient without autoimmune disorders compared to patients with autoimmune disorders was observed. These findings highlight the need for early intervention, tailored strategies, and vigilant monitoring in patients with migraine and autoimmune disorders. Further research should explore immunomodulatory approaches to enhance outcomes. image

Fundamento. Las crisis epilépticas suelen ocurrir como episodios paroxísticos y autolimitados, por lo que frecuentemente son presenciadas y atendidas por personas no cualificadas. El objetivo de este estudio es valorar el conocimiento sobre primeros auxilios ante una crisis epiléptica en dos grupos: población general y familiares de pacientes con epilepsia. Metodología. Se realizó una encuesta estructurada a personas de la población general y a familiares sobre diferentes aspectos de manejo y maniobras a realizar ante una crisis epiléptica. Constaba de 16 preguntas: una de respuesta abierta, ocho con respuesta de opción múltiple, más siete específicas para familiares. Resultados. El 39,2% de las 434 encuestas fueron respondidas por familiares. Las maniobras adecuadas (permanecer junto al paciente, registrar duración de la crisis, limpiar secreciones) fueron significativamente más frecuentes en familiares y las inadecuadas (abrir la boca con algún objeto, sujetar al paciente) en población general, sin diferencias para la posición del paciente. La fuente de información principal para familiares era el personal sanitario, y las redes sociales y medios de comunicación para la población general. En el grupo de familiares, el 51,1% no daría medicación, pero sí llamarían a emergencias ante determinadas situaciones (62%) o si la crisis duraba más de cinco minutos (54,5%). Conclusiones. El nivel de conocimiento sobre primeros auxilios ante una crisis epiléptica fue subóptimo en ambos grupos, pero especialmente en la población general. Por tanto, se necesitan estrategias para fomentar y mejorar la formación sanitaria de población general y familiares sobre primeros auxilios ante crisis epilépticas.

Background: Preclinical evidence supports the immunoregulatory role of calcitonin gene-related peptide (CGRP) in migraine pathophysiology. The increasing use of anti-CGRP therapies in patients with migraine and other comorbidities raises the question whether the potential use of anti-CGRP monoclonal antibodies (CGRP-mAbs) therapies in combination with other immunological therapies is effective and safe. Methods: This multicenter study included patients with migraine receiving CGRP-mAbs combined with immunosuppressive and immunomodulatory treatments. Clinical and demographic data, treatment history, laboratory markers and treatment-emergent adverse events (TEAEs) were analyzed. Effectiveness outcomes included the change in monthly migraine days (MMD) and monthly headache days (MHD) at 3, 6, 9 and 12 months, alongside the > 50% response rate. Moreover, autoimmune disease progression was also evaluated. We explored differences between patients with and without autoimmune disease activation. Results: Among 89 patients, there were 80 (90%) females with a mean age of 50 years (SD: 11), who had a high prevalence of psychiatric comorbidities (anxiety 44%, depression 49%) and medication overuse (68%). Patients receiving immunological treatments experienced significant reductions in MMD and MHD, with MMD decreasing from 16 (SD: 7) at baseline to 9 (SD: 8) at 6 months, and MHD dropping from 23 (SD: 8) to 17 (SD: 11). A 50% response in MMD was achieved by 46% at 6 months. TEAEs were reported in 28%, most commonly constipation (16%) and dizziness (9%). Conclusions: CGRP-mAbs therapies combined with immunological treatments appear effective and safe in patients with autoimmune diseases. Larger prospective studies are necessary to confirm these findings and optimize management strategies.

Background: Calcitonin gene‐related peptide monoclonal antibodies (CGRP mAbs) are the first migraine‐specific prophylactic medication. Clinical data regarding patient treatment satisfaction (TS) with CGRP mAbs are limited. Methods: A multicenter prospective cohort study was conducted in patients with ≥8 headache days/month who started treatment with erenumab, galcanezumab, or fremanezumab. Monthly migraine days (MMD), monthly headache days (MHD), Migraine Disability Assessment (MIDAS), and the six‐item Headache Impact Test (HIT‐6) scores were collected. Patients’ satisfaction with treatment (effectiveness, convenience, side effects, and global satisfaction) was assessed by the Treatment Satisfaction Questionnaire for Medication, version 1.4 (TSQM‐1.4©). Results: A total of 400 patients were included. The median (interquartile range [IQR]) TS scores were high (≥70%) across all domains of the TSQM‐1.4 after 3 and 6 months of CGRP mAb therapy: 72.2 (50.0–83.3) and 83.3 (61.1–88.9) for effectiveness, 83.3 (72.2–100) and 83.3 (77.8–100) for convenience, and finally, a score of 78.6 (50.0–92.9) and 85.7 (71.4–92.9) for global satisfaction. The median (IQR) reduction in MHD and MMD was 10.0 (3.0–17.0; p < 0.001) and 8.0 (4.0–12.0; p < 0.001) days after 3 months of treatment, and 10.0 (3.0–17.0; p < 0.001) and 9.0 (5.0–17.0; p < 0.001) days after 6 months. The median (IQR) HIT‐6 score decreased from 68.0 (65.0–72.0) to 60.0 (51.0–66.0; p < 0.001) at Month 3 and to 56.0 (48.0–64.0; p < 0.001) at Month 6. Finally, the median (IQR) MIDAS score decreased from 70 (40.0–120.0) to 24 (7.8–60.0; p < 0.001) and 17 (5.0–45.0; p < 0.001) at Months 3 and 6, respectively. The median change from baseline in MMD was significantly associated with effectiveness at 3 ( β = −0.93, 95% CI −1.34 to −0.53; p < 0.001) and 6 months ( β = −1.56, 95% CI −2.15 to −0.97; p < 0.001). Similarly, reductions in MMD were significantly associated with the global satisfaction dimension of the questionnaire ( β = −0.82, 95% CI −1.27 to −0.37; p < 0.001) and ( β = −1.80, 95% CI −2.42 to −1.18; p < 0.001). Conclusions: Most patients were satisfied with CGRP mAbs’ effectiveness, tolerability, and convenience in a real‐world setting. Interestingly, increasing TS was associated with meaningful reductions in frequency, impact, and disability caused by migraine.

Background: Cluster headache (CH) is the most prevalent trigeminal‐autonomic cephalalgia. Research evidence supports the hypothesized involvement of the posterior hypothalamus, the trigeminal‐vascular system, and other central pain‐processing regions in the pathogenesis of pain. Because of the role of the hypothalamus, CH patients should be at greater risk of developing an altered emotional response. Impulsivity is associated with depression, bipolar disorders, suicide attempts, and addictive disorders, which can be frequent in CH. Objective: Our objective is to evaluate the prevalence of impulsivity in CH patients. Methods: This is a cross‐sectional observational study. Barratt Impulsiveness Scale (BIS‐11) was administered to evaluate impulsivity. Results: Fifty CH patients outside the bout and 60 matched controls were included. Patients were recruited from an outpatient headache unit. The percentage of episodic CH patients with a diagnosis of impulsivity (BIS‐11 ≥ 73) was 14.2% compared to 1.6% in the control group ( p = 0.02). The mean score on the BIS‐11 was 58.5 (SD: 14.3) in the case group and 57.1 (SD: 9.2) in the control group. Although the global score on the scale did not differ between both groups, there were differences in cognitive (16.2 [SD: 4.4] vs. 14.5 [SD: 3.5]; p = 0.01) but not in motor and nonplanning impulsivity. Conclusion: Our findings suggest that CH patients have greater cognitive impulsivity. If impulsivity plays an important role in the risk of suicide and substance use disorders, early detection and an effective multidisciplinary management could reduce CH‐related burden and impact.

Background/Objectives: Chronic migraine (CM) is a neurological disorder that causes significant disability, loss of productivity, and economic burden. Preventive treatments, including pharmacological and educational interventions, are crucial for managing CM effectively. The aim of this study was to analyze whether adding a therapeutic telehealth education program (TTEP) to pharmacological treatment achieved a greater reduction in the number of headache days experienced by patients with CM. Methods: A randomized, double-blind, controlled pilot study with two parallel groups was performed. Patients with a diagnosis of CM and who were being treated with Botulinum Toxin were randomly assigned to either the EG (therapeutic education program about the neuroscience of pain, migraine, pain strategies, sleep habits, exercise, nutrition, postural habits, and relaxation strategies) or CG (general health recommendations with no specific content about migraine). The intervention lasted a total of eight weeks and was delivered via a telehealth application (APP). Headache frequency, migraine frequency, pain intensity, headache impact, allodynia, fear of movement, pain catastrophizing, chronic pain self-efficacy, anxiety and depression, sleep quality, and sedentary lifestyle were measured at baseline (M0), one month after the intervention started (M1), at the end of the intervention (M2), and one month after the intervention was completed for follow-up (M3). Results: In total, 48 patients participated. There were differences between the groups in the following outcomes in favor of EG for headache frequency at the one-month follow-up (p = 0.03; d = 0.681); chronic pain self-efficacy at post-treatment (p = 0.007; d = 0.885) and at the one-month follow-up (p < 0.001; d = 0.998); and sleep quality at post-treatment (p = 0.013; d = 0.786) and at the one-month follow-up (p < 0.001; d = 1.086). No differences existed between the groups for the other outcomes examined (p < 0.05). Conclusions: The use of TTEP reduced the number of headache days, improved sleep quality, and increased self-efficacy in managing pain. This pilot study suggests that the addition of a specialized TTPE to pharmacological treatments may be more effective than a general health recommendation program for migraine.

Objectives: Migraine affects more than 80 million people in Western Europe. The present study evaluated disability and health‐related quality of life (HRQoL) among patients with episodic migraine (EM) and chronic migraine (CM) who had failed multiple preventive treatments. Materials and Methods: This study was an analysis of cross‐sectional, web‐based survey data from adult patients with migraine (EM and CM) from the United Kingdom, France, and Spain who had self‐reported failure of two or more preventive treatments. Patient characteristics and patient‐reported HRQoL, migraine‐related disability, healthcare resource use (HCRU), and burden of migraine were evaluated by classification (CM and EM) and country (EM only). Results: In this sample of 316 patients (United Kingdom, n = 106; Spain, n = 105; France, n = 105), 76 (24.1%) patients had CM, the mean (standard deviation [SD]) age was 39.5 (12.3) years, and 164 (51.9%) patients were female. Those patients with CM reported greater migraine‐related disability based on Migraine Disability Assessment (MIDAS) scores versus those with EM (mean [SD]: 43.8 [44.7] vs. 23.2 [28.3]), as well as greater pain‐related impact on daily activities and higher HCRU. Among patients with EM, MIDAS scores indicated disability was severe in Spain (mean [SD]: 31.6 [31.1]) and France (24.3 [31.1]) and moderate in the United Kingdom (13.8 [17.9]), while HRQoL was similar across countries. Regarding the burden of EM, higher levels of pain and symptom‐related interference with many aspects of life, including occupational functioning, were reported in the United Kingdom and Spain versus France. Conclusions: Migraine is associated with substantial disability and decreased HRQoL among patients who have failed previous preventive therapies. Although migraine burden varied by country, the results suggest high unmet needs in all countries. Appropriate treatment could reduce migraine‐related burden and HCRU among patients with difficult‐to‐treat migraine.

To evaluate whether preventive treatment can modify endothelial and oxidative biomarkers of vascular disease risk in patients with high-frequency episodic and chronic migraine. In this observational, prospective pilot study, 88 prophylactic treatment-naïve patients with episodic and chronic migraine and 56 healthy sex/age matched controls underwent ultrasonography exams and blood tests at baseline, and again in the migraine patients after 3 months’ treatment with metoprolol or topiramate. Biomarkers for endothelial function and oxidative stress were analyzed. At baseline, patients with migraine in the low-frequency episodic group had differences exclusively in nitrates 17.6 versus 27.33 µM; p = 0.046 compared to the controls. However, when comparing the group comprised of patients with high-frequency episodic migraine and chronic migraine versus controls, statistically significant differences appeared in hsCRP 2.68 versus 1.64 mg/dL; p = 0.049, vWF antigen (133% vs. 110%; p = 0.020, vWF activity (111% vs. 90%; p = 0.010) and isoprostane levels (181 vs. 238 µM; p = 0.05). Only in the chronic migraine subgroup did we found statistically significant differences in CIMT (0.60 vs. 0.54 mm; p = 0.042) which were significantly greater than in the controls. After treatment, patients who respond to preventive treatment exhibited significantly higher levels of nitrates (24.2–13.8 µM; p = 0.022) and nitrites (10.4–3.43 µM; p = 0.002) compared than non-responders. Moreover, biomarker levels improved in treatment-responsive patients with migraine; hsCRP levels decreased from 2.54 to 1.69 mg/dL (p < 0.05), vWF activity levels decreased from 124 to 103 IU/dL (p = 0.003) and prothrombin activity decreased from 1.01 to 0.93 (p = 0.01). These differences were also observed in the high-frequency and chronic migraine subgroup and reach statistical significance in the case of hsCRP, which decreased from 2.12 to 0.83 mg/dL (p = 0.048). Patients with migraines have differences in biomarker levels compared to controls, suggesting endothelial and oxidative dysfunction. The greatest differences in biomarker levels compared to controls are observed in migraine patients in the high-frequency and chronic migraine subgroups. Based on our results, preventive treatment is capable of modifying markers of endothelial dysfunction and oxidative stress in migraine patients, even in cases of chronic and high-frequency migraine.

Objective: Chronic migraine (CM) is a significant public health problem that affects 2.2% of the global population. Onabotulinumtoxin A (OnabotA) is a safe and effective prophylactic treatment for patients with CM. The standard injection interval for OnabotA is 12 weeks. Nevertheless, some patients experience a wearing-off effect (WOE) in the weeks preceding the next scheduled cycle. The objectives of this study are to determine the prevalence of early WOE, to analyze variables that could be clinical predictors and to specify which interval is the most appropriate to define the existence of this phenomenon. Methods: This is a prospective single-center study of consecutive adult patients with CM who, after failing previous prophylactic therapies, started OnabotA treatment following the PREEMPT protocol between June and December of 2021. Results: A total of 59 patients (93.2% female, age 44 ± 12 years) were included. A total of 37 patients (64.9%) fulfilled medication overuse criteria. Of the total patients, 40.6% reported WOE and this was more frequent after the first cycle (35.6%). Depression and anxiety disorder was a statistically significant clinical predictor of WOE (OR 3.4; CI 95% 1.22–10.84; p = 0.028). A better cut-off point to consider WOE seems to be at 10 weeks. Conclusions: Early WOE is common in patients on OnabotA treatment for CM. Individualizing the standard 12-week injection, using total doses of 195 U, and managing psychiatric comorbidities with pharmacological and non-pharmacological strategies may improve treatment outcomes and reduce OnabotA WOE.