Real-world effectiveness of fremanezumab for the preventive treatment of migraine: Interim analysis of the pan-European, prospective, observational, phase 4 PEARL study.

BACKGROUND: The ongoing Pan-European Real Life (PEARL) phase 4 study is evaluating fremanezumab effectiveness and safety for the prevention of episodic and chronic migraine. This interim analysis reports primary, secondary and exploratory endpoints from when 500 participants completed at least six months of treatment. METHODS: Adults with episodic migraine or chronic migraine maintaining daily headache diaries were enrolled upon initiation of fremanezumab. Primary endpoint: proportion of participants with ≥50% reduction in monthly migraine days during the six-month period after fremanezumab initiation. Secondary endpoints: mean change from baseline across months 1-12 in monthly migraine days, acute migraine medication use, and headache-related disability. Exploratory endpoint: mean change in headache severity from baseline across months 1-12. Safety was assessed through adverse events reported. RESULTS: Overall, 897 participants were enrolled and 574 included in the effectiveness analyses (episodic migraine, 25.8%; chronic migraine, 74.2%). Of participants with data available, 175/313 (55.9%) achieved ≥50% monthly migraine days reduction during the six-month period post-initiation. Across months 1-12, there were sustained reductions in mean monthly migraine days, acute medication use, disability scores, and headache severity. Few adverse events were reported. CONCLUSION: PEARL interim results support the effectiveness and safety of fremanezumab for migraine prevention in a real-world population across several European countries.Trial registration: encepp.eu: EUPAS35111.

Relevant factors for neurologists to define effectiveness of migraine preventive drugs and take decisions on treatment. My-LIFE European Delphi survey.

BACKGROUND: Clinical guidelines agree that preventive treatment should be considered in patients with uncontrolled migraine despite acute medications or patients with ≥4 migraine days per month. However, the criteria to define the effectiveness of treatment and the factors that inform the decision to (dis)continue it are not clearly defined in clinical practice. METHODS: Overall, 148 healthcare practitioners from five European countries completed a two-wave questionnaire. The Steering Committee defined a simulated set of 108 migraine patient profiles based on the combination of five factors (frequency of the attacks, intensity of the attacks, use of acute migraine medications, patient perception and presence/absence of tolerable side effects). These profiles were used in a Delphi survey among European neurologists to identify the criteria that should be used to decide treatment response and continuation using a conjoint analysis approach. RESULTS: Consensus was reached for 82/108 (76%) of profiles regarding treatment response, and for 86/108 (80%) regarding treatment continuation. Multivariable logistic regression analysis showed that a ≥50% reduction in the use of acute migraine medications and positive patient's perception of treatment were the most important factors that lead to the decision of continuing (combined factors, OR = 18.3, 95% CI 13.4-25.05). CONCLUSIONS: This survey identifies two relevant outcome measures: one objective (use of acute migraine treatment medications) and one subjective (positive patient perception) that guide the clinician decision to continue preventive treatment in migraine patients. SIGNIFICANCE: In clinical practice, criteria to define the effectiveness of migraine preventive treatment and factors that guide treatment stop or continuation are not clearly defined. In this simulated clinical setting study, a reduction in the use of acute migraine medications was the factor associated with preventive treatment effectiveness definition. This study also revealed that factors strongly associated with the decision of treatment continuation in real life are the acute migraine medications use and a positive patient's perception of treatment effectiveness.

Risk perception, beliefs about medicines and medical adherence among pregnant and breastfeeding women with migraine: findings from a cross-sectional study in Norway.

OBJECTIVES: To examine risk perception, beliefs about migraine medications and medical adherence among pregnant and breastfeeding women with migraine. DESIGN AND SETTING: Cross-sectional study conducted in Norway from October 2013 to February 2014. Data were collected via an anonymous, electronic questionnaire. PARTICIPANTS: Women with migraine, either pregnant or having delivered within the previous 18 months. MAIN OUTCOMES: Women's perception of teratogenic risk (numeric rating scale 0-10) was obtained for 14 different drugs/substances, including medications commonly used in the acute treatment of migraine. Women's perspectives on migraine drug therapy were assessed by 10 statements from the Beliefs about Medicines Questionnaire (BMQ-Specific) and six pregnancy/breastfeeding-specific statements. Adherence to migraine treatment during pregnancy and breastfeeding period was assessed by maternal self-report. RESULTS: The study population included 401 women with migraine, of which 140 were pregnant and 261 were new mothers. More than 70% of the women reported use of migraine medications during pregnancy. Still, the majority severely overestimated the risk associated with migraine medications and were concerned about using medications to manage their migraine during pregnancy and breastfeeding. Almost 9 out of 10 women had at some point deliberately avoided using migraine medications during their pregnancy. Women reporting use of migraine medications, however, were more positive and overestimated to a lesser extent the risks of using such medications in pregnancy compared with their counterparts. CONCLUSIONS: Women with migraine severely overestimated the risk associated with migraine pharmacotherapy in pregnancy. The majority of women were concerned about use of migraine medications during pregnancy and breastfeeding and reported non-adherence to needed treatment. More attention should be focused on women's beliefs and concerns regarding migraine pharmacotherapy during pregnancy and breastfeeding in order to improve management of disease, reduce unfounded concerns and enhance adherence to needed treatment.

Use of antimigraine medications and information needs during pregnancy and breastfeeding: a cross-sectional study among 401 Norwegian women.

PURPOSE: Migraine is highly prevalent among women of fertile age. The main objectives of this study were to describe the prevalence and patterns of use of antimigraine medications during pregnancy and breastfeeding and to identify maternal and migraine-related factors associated with medication use during pregnancy. METHODS: The study is a cross-sectional internet-based survey among pregnant women and new mothers with migraine conducted in Norway from October 1, 2013 to February 1, 2014. Descriptive statistics were used to explore patterns of medication use, and logistic regression analysis was performed to examine the association between maternal socio-demographic and migraine-related factors and use of antimigraine medications during pregnancy. RESULTS: Of the total 401 respondents, 34.9 % were pregnant and 65.1 % had delivered within the last 18 months. The majority reported use of antimigraine medications during pregnancy (73.3 %) and postpartum (64.8 %), yet less than a third considered their migraine to be optimally treated during pregnancy (31.7 %) and the breastfeeding period (27.2 %). The patterns of medication use markedly changed during pregnancy and postpartum. Women with moderate or severe migraine were more likely to use antimigraine medications during pregnancy compared to women with mild migraine. CONCLUSIONS: Despite the fact that antimigraine medications were commonly used, the majority of the women felt that their migraine was suboptimally treated during pregnancy and postpartum. There was a decline in the use of medicines in pregnancy and postpartum, and the patterns of use markedly changed. Efforts to improve treatment of women with migraine during pregnancy and breastfeeding should be undertaken.