Browsing by Subject "migraine"

Erenumab (Aimovig®) is a first-in-class calcitonin gene-related peptide (CGRP) inhibitor approved for the preventive treatment of migraine by the FDA in May 2018 and by European Commission (EC) in July 2018. It is a human monoclonal antibody (mAb) binding to the CGRP receptor, antagonizing the effect of CGRP. The marketing authorization of Aimovig® was based on two phase II and two phase III clinical trials. In all trials, erenumab with doses 70 mg/mL and 140 mg/mL was found to have a significantly superior effect compared to placebo, with a similar safety profile between all groups. These conclusions are mainly in line with studies conducted post marketing authorization. However, questions about the optimal dose, and the frequency and types of adverse events in larger patient populations remain to be studied. A European Public Assessment Report (EPAR) and Summary of Product Characteristics (SmPC) are required by the European Commission for each human medicine with a marketing authorization within the European Union. The SmPC is produced by the applicant and it should contain all relevant information of the medicinal product as distilled during the assessment process. The SmPC can thus be viewed as a kind of summarized version of the EPAR. The aim of this study was to investigate the post-marketing efficacy and safety information of erenumab from three perspectives: 1) the EPAR was compared with recent systematic reviews and meta-analyses assessing the efficacy and safety of erenumab, 2) all existing literature on the efficacy and safety of erenumab on different subgroups of migraine patients was assessed and summarized, and 3) the efficacy and safety information of the EPAR was compared to those of the SmPC, to resolve whether important information is missing. This review found several points regarding the efficacy and safety of erenumab. First, the status of erenumab was further established as a safe and effective treatment for the prevention of migraine. Second, meta-analyses (n=3) with more extensive cohorts compared to those of the EPAR and SmPC, present a further case for the superiority of the 140 mg dose compared to the 70 mg dose. The difference in dose effect is addressed in the EPAR but its assessment may be based on limited information. Third, different subgroups seem to respond differently to erenumab treatment. This aspect should be further investigated by head-to-head studies. Lastly, the safety information of the SmPC seems insufficient due to lack of mention of upper respiratory infections. This adverse event was among the most common in all of the four clinical trials and has since been observed in a real-world study. Based on these findings, neither the EPAR nor the SmPC of erenumab seem to be fully up to date and information related to the dose and upper respiratory infections as a risk should be reconsidered.

Migraine was ranked as the second largest cause of disability in 2016 in the Global Burden of Disease (GBD) study. People with migraine have a greater disability and a lower health-related quality of life than those of the general population. Many migraine patients experience functional and emotional impairment due to their disease. Migraine can limit their daily activities and impact their private, professional and social life. Migraine affects the patient also in between the attacks and can impact their education, career and their family and loved ones. Comorbid diseases and failed treatment lines add to the burden of migraine. Furthermore, migraine also imposes an economic burden. Stigma is described as the hidden burden of disease. Chronic migraine patients have been found to have higher stigma than episodic migraine patients. Even though migraine is one of the most common disabling headache disorders, it is still both under-recognised, under-diagnosed and under-treated. The objectives of this study were to determine the extent of the burden and the stigma of migraine in adult Finnish migraine patients. This study aimed to produce comprehensive and current information about migraine and its severity in Finland, highlighting the burden it poses on the migraine patients as well as on society. Migraine is most prevalent among the working aged population, which increases the societal burden of the disease. This study was conducted as a cross-sectional electronic survey amongst adult Finnish migraine patients. The participants were contacted through the Finnish Migraine Patient Advocacy Group. The questionnaire consisted of the already existing and validated Migraine Disability Assessment (MIDAS) Questionnaire and of measures developed by the author. The final data consisted of 608 responses. Of all respondents with 8 or more headache days a month, over 90% were categorised in the severe disability group (MIDAS grade IV), thus having similar disability to those with 15 or more headache days a month (i.e. respondents with probable chronic migraine). The proportion of respondents with severe disability (MIDAS grade IV) was greater in the present study (65.0%) than in a study conducted in Finland in 2000 (47%), indicating that migraine disability in Finland might have become more severe during the past two decades. The mean level of headache pain in the present study was 6.2 (on a scale of 0-10) and pain was the aspect that most respondents viewed as the worst aspect of migraine. This highlights the importance of proper pain management in migraine care. Many of the respondents were also at risk for medication overuse, which highlights the importance of monitoring medication use and informing the patients about possible risks. Stress was reported as the most common migraine trigger, and reducing stress at the workplace was also reported as the most important way of how migraine could better be managed at the workplace. Almost half (44.4%) of all respondents felt stigmatised due to their migraine. Reasons for this stigma and suggested solutions on how to reduce/manage the stigma were quite similar. The ignorance of others was the most reported reason for their migraine stigma, and increasing awareness and correct information about migraine was the most reported way of reducing the stigma. Many of the respondents had faced, due to their migraine, belittlement at work, from family and friend and from healthcare professionals. Facing belittlement from healthcare professionals was reported to have happened often by 11.5% and sometimes by 34.7% of all respondents. Of all respondents, 55.6% worried often and 29.8% worried sometimes about the onset of the next migraine attack. The majority of the respondents had severe disability based on their MIDAS grades. Many other aspect of the burden were reported as well, inculding stigma, reported by almost half of the respondents. Further and future studies need to be conducted to get an even better understanding of the burden and stigma of migraine experienced by adult Finnish migraine patients. This includes further and more intricate quantitative and qualitative analyses of the data from this study, as´well as studies with new perspectives based on the results found in this study.