Introduction:There are challenges associated with the timely diagnosis of people with mild cognitive impairment (MCI) and Alzheimer's disease (AD), especially with the future introduction of amyloid-targeting therapies. This study evaluates the current diagnostic journey for MCI and dementia due to AD in Spain. Methods:This study used data from the Adelphi Real World Dementia Disease Specific Programme (DSPTM), a cross-sectional survey with retrospective data collection. The survey involved primary care physicians (PCPs) and hospital specialists with experience in managing and treating AD, along with their consulting patients, between January and July 2023 in Spain. Analyses were descriptive. Results:Physicians (N = 94; 44.7% PCPs, 38.3% neurologists) reported data for 723 patients. Most patients (78.9%) first consulted a PCP. The median (inter-quartile range) time since symptom onset to first consultation was 21.6 (6.1-48.2) weeks and, in those patients who were not diagnosed immediately, the time from first consultation to diagnosis was 13.0 (6.0-21.9) weeks if diagnosed by a PCP, or 28.9 (17.1-52.1) weeks if diagnosed by a specialist. The diagnosing physician was a specialist or a PCP for 83.2% and 16.8% of patients, respectively. In addition, the most used advanced diagnostic techniques were computed tomography scans and magnetic resonance imaging (57.2% and 43.3% of patients, respectively). CSF determination of AD biomarkers was conducted in 12.4% of patients and AD-specific blood biomarkers in 2.9%. Treatment was mostly initiated by neurologists. Conclusion:The diagnostic process for people with MCI and AD could be accelerated by increased awareness of the disease, shorter referral times, and better access to specialized diagnostic services. This study shows limited use of AD-specific biomarker testing in Spain.
Galcanezumab, a monoclonal antibody targeting calcitonin gene-related peptide, has shown efficacy in migraine prevention in clinical trials and has been included in clinical guidelines. Nonetheless, data on its real-world effectiveness are limited. TRIUMPH [Europe], an ongoing prospective study, enrolled patients ≥ 18 years old with migraine from Germany, Italy, Spain, and the UK who were initiating or switching to galcanezumab or traditional oral migraine preventive medications (TOMPs) between June 2020 and February 2023. The primary end point at 3 months was the percentage of patients achieving a response in monthly headache days (MHDs) as defined by a percentage reduction of ≥ 50
OBJECTIVE:This study assesses the 3-month effectiveness of the calcitonin gene-related peptide monoclonal antibody galcanezumab versus traditional oral migraine preventive medications. BACKGROUND:Studies comparing the effectiveness of calcitonin gene-related peptide monoclonal antibodies versus traditional oral migraine preventive medications are limited. However, such comparisons in real-world settings are useful for decision-making by patients, healthcare providers, and policymakers. METHODS:TRIUMPH is an ongoing, international, prospective observational cohort study of adult patients with migraine, initiating or switching to new preventive medication with a focus on galcanezumab versus traditional oral migraine preventive medications. Data for this analysis were collected from February 25, 2020, through February 9, 2023. All treatment decisions were at the physicians' discretion. The primary outcome was a 3-month response based on reductions in physician-recorded monthly migraine headache days: ≥50% (episodic migraine) or ≥30% (chronic migraine). The difference in the proportion of responders between treatments was assessed after adjusting for baseline cohort differences. RESULTS:Of 2813 patients, 1105 received galcanezumab and 1293 received traditional oral migraine preventive medications. The weighted response rate at 3 months was greater with galcanezumab versus traditional oral migraine preventive medications (46.6% vs. 34.5%; p < 0.001). Additional 3-month mean changes from baseline for galcanezumab versus traditional oral migraine preventive medications included a reduction in monthly migraine headache days (-5.7 [95% confidence interval (CI), -6.2 to -5.2] vs. -4.1 [95% CI, -4.5 to -3.7]), and an improvement in Migraine-Specific Quality of Life-Role Function Restrictive score (19.4 [95% CI, 17.6-21.3] vs. 10.2 [95% CI, 8.6-11.8]), respectively (both p < 0.001). CONCLUSION:Findings from this study showed that patients receiving galcanezumab had greater treatment effectiveness after 3 months than those receiving traditional oral migraine preventive medications across multiple measures, including migraine headache days, various responder rate thresholds, change in Migraine-Specific Quality of Life-Role Function Restrictive scores, and types of migraine. These findings are representative of clinical practice settings and may help physicians in making treatment decisions.
The ObserVational survey of the Epidemiology, tReatment and Care Of MigrainE (OVERCOME) European Union (EU) is part of an overarching population-based study program that also includes the United States and Japan. Here, we report data on the migraine/severe headache burden and the use of acute medication and healthcare resources in Spain and Germany. OVERCOME (EU) was an online, non-interventional, cross-sectional survey conducted in adults in Spain and Germany between October 2020 and February 2021. A total migraine cohort was established based on health survey participants who reported headache/migraine in the last 12 months AND identified as having migraine based on modified International Classification of Headache Disorders, third edition criteria OR self-reported physician diagnosis. Data were analyzed for the total migraine cohort and the subcohort with moderate to severe headache attacks, with average pain severity ≥ 5 points, pain duration ≥ 4 h, and at least moderate disability due to migraine [Migraine Disability Assessment (MIDAS) score ≥ 11] over the past 3 months. Pain of moderate or severe intensity was the most frequent symptom in the total migraine cohort (n = 19,103/20,756; 92.0
This study described, in routine clinical practice in Japan, the patient characteristics, treatment patterns, and outcomes of female patients with HR + /HER2- metastatic breast cancer (MBC) who started abemaciclib treatment. Clinical charts were reviewed for patients starting abemaciclib in 12/2018–08/2021 with a minimum of 3 months follow-up data post-abemaciclib initiation regardless of abemaciclib discontinuation. Patient characteristics, treatment patterns, and tumor response were descriptively summarized. Kaplan–Meier curves estimated progression-free survival (PFS). 200 patients from 14 institutions were included. At abemaciclib initiation, median age was 59 years, and the Eastern Cooperative Oncology Group performance status score was 0/1/2 for 102/68/5 patients (58.3/38.9/2.9%), respectively. Most had an abemaciclib starting dose of 150 mg (92.5%). The percentage of patients receiving abemaciclib as 1st, 2nd, or 3rd line treatment was 31.5%, 25.8%, and 25.2%, respectively. The most frequent endocrine therapy drugs used with abemaciclib were fulvestrant (59%) and aromatase inhibitors (40%). Evaluation of tumor response was available for 171 patients, 30.4% of whom had complete/partial response. Median PFS was 13.0 months (95% CI 10.1–15.8 months). In a routine clinical practice setting in Japan, patients with HR + , HER2- MBC appear to benefit from abemaciclib treatment in terms of treatment response and median PFS, with the results broadly reflecting the evidence demonstrated in clinical trials.
Migraine is a common disabling primary headache disorder characterized by attacks of severe pain, sometimes accompanied by symptoms including nausea and photo-/phono-phobia. Real-world data of patients with migraine who sufficiently (responders) and insufficiently (insufficient responders) respond to acute treatment (AT) are limited in China. This analysis explored whether responders to AT differ from insufficient responders in terms of clinical characteristics, treatment patterns, and patient-reported outcomes in China. Data were drawn from the Adelphi Migraine Disease Specific Programme™, a point-in-time survey of internists/neurologists and their consulting patients with migraine, conducted in a real-world setting in China, January–June 2014. Responders and insufficient responders to prescribed AT were patients who typically achieved headache pain freedom within 2 h of AT in ≥ 4 and ≤ 3 of five migraine attacks, respectively. Responders were compared with insufficient responders; logistic regression was used to identify factors associated with insufficient response. Of 777 patients currently receiving AT, 44.0
INTRODUCTION:This analysis aimed to evaluate demographics, migraine-related disability, symptoms, diagnosis and healthcare consultation, work productivity, and treatment patterns according to headache frequency in adults with migraine in the OVERCOME (ObserVational survey of the Epidemiology, tReatment and Care Of MigrainE) (Spain) study.METHODS:Data were obtained from an observational, cross-sectional, web-based survey conducted between October 2020-February 2021 in Spain. Eligible participants were adult members of online survey panels living in Spain who were able to read and write Spanish and fulfilled the International Classification of Headache Disorders, third edition (ICHD-3) criteria for migraine or had a self-reported physician diagnosis.RESULTS:In total, 10,229 patients comprised the Spanish sample. Only 56.2% of respondents had a confirmed healthcare professional (HCP) diagnosis of migraine, despite almost all meeting modified ICHD-3 criteria. Pain severity, migraine-related disability, and interictal burden increased with increasing number of headache days per month. Migraine impacted on respondents' work productivity, with increases in presenteeism, work productivity loss, and daily activity impairment at higher headache frequencies. Over the past year, 66.2% of all HCP visits were specifically due to migraine, most commonly with a general practitioner or pharmacist. A subgroup of 1277 patients (12.5% of the total survey population) met eligibility criteria for migraine preventive medications, of whom only 36.6% were currently taking a preventive.CONCLUSIONS:Results of the OVERCOME (Spain) survey reveal the substantial burden of migraine, which is directly linked to headache frequency. However, most patients experiencing frequent headaches and eligible for migraine preventives are currently not taking them. Findings highlight the importance of addressing unmet needs for people with migraine in Spain.
Background Insights into the burden, needs and treatment of migraine from internet-based surveys in diverse real-world migraine populations are needed, especially at a time when novel preventive migraine medications are becoming part of the therapeutic armamentarium. The objectives of this analysis are to describe traditional preventive (orals and onabotulinum toxin A) treatment patterns in the OVERCOME (EU) study migraine cohort, as well as treatment patterns and patient satisfaction with current treatment in a subgroup of respondents eligible for migraine preventive medication. Methods The cross-sectional non-interventional OVERCOME (EU) study was conducted (October 2020–February 2021) via an online survey among adults (aged ≥ 18 years) resident in Germany or Spain. Participants, registered in existing online panels, who were willing to provide consent were considered. The migraine cohort included participants reporting headache/migraine in the past year, identified based on a validated migraine diagnostic questionnaire and/or self-reported physician diagnosis. A subgroup of survey respondents defined as eligible for migraine preventive medication at the point in time the cross-sectional survey was taken was also analysed. Variables assessed included sociodemographic and migraine-related clinical characteristics, preventive (traditional and calcitonin gene-related peptide monoclonal antibodies) treatment patterns and patient satisfaction with current treatment. Results are descriptive only. Results Of the 20,756 participants in the migraine cohort, 78.5% sought professional medical care, 50.8% received a migraine diagnosis and only 17.7% had ever used preventive medication. Half (53.3%) of participants currently using preventives took their most recent medication for six months or less. Most patients (73.9%) classified as eligible for preventive medication (based on headache frequency and/or at least moderate disability due to migraine) reported not using traditional preventives and many of those who did (66.8%) were not satisfied with their current standard of care. Conclusions Our findings highlight the low proportion of people diagnosed with migraine despite a higher rate of consultation and suggest the need for better access to treatment for people with migraine and new preventive therapies with improved efficacy and safety profiles to improve adherence and patient satisfaction.