Background The objective of this study was to assess whether migraine-related outcomes changed during intelligent lockdown when compared with the prior period. Methods This was a cohort study evaluating the first month of intelligent lockdown in the Netherlands (12 March to 8 April 2020) compared with one baseline month (13 February to 11 March 2020). We identified 870 migraine patients treated at the Leiden Headache Center with headache e-diaries during the period of interest. Adherence to the e-diary had to be ≥80%, yielding 592 enrolled patients. Results Intelligent lockdown led to a decrease in monthly migraine days (−0.48; 95% CI: −0078 to −0.18, p = 0.002) and acute medication days (−0.48; 95% CI: −0.76 to −0.20, p < 0.001), and an increase in general well-being (0.11; 95% CI: 0.06 to 0.17, p < 0.001). No differences in non-migrainous headache days and pain coping were observed. Consistent results were found in a subset that was followed for 4 months. Conclusions Our findings imply that intelligent lockdown measures can improve migraine disability despite of the potential negative effects of COVID-19 and lockdown. We hypothesise that this effect is a combined result of working from home, scaling down demanding social lives, and freedom to choose how to organise one’s time.
Aim To determine whether our E-diary can be used to diagnose migraine and provide more reliable migraine-related frequency numbers compared to patients’ self-reported estimates. Methods We introduced a self-developed E-diary including automated algorithms differentiating headache and migraine days, indicating whether a patient has migraine. Reliability of the E-diary diagnosis in combination with two previously validated E-questionnaires was compared to a physician’s diagnosis as gold standard in headache patients referred to the Leiden Headache Clinic (n = 596). In a subset of patients with migraine (n = 484), self-estimated migraine-related frequencies were compared to diary-based results. Results The first migraine screening approach including an E-headache questionnaire, and the E-diary revealed a sensitivity of 98% and specificity of 17%. In the second approach, an E-migraine questionnaire was added, resulting in a sensitivity of 79% and specificity of 69%. Mean self-estimated monthly migraine days, non-migrainous headache days and days with acute medication use were different from E-diary-based results (absolute mean difference ± standard deviation respectively 4.7 ± 5.0, 6.2 ± 6.6 and 4.3 ± 4.8). Conclusion The E-diary including algorithms differentiating headache and migraine days showed usefulness in diagnosing migraine. The use emphasised the need for E-diaries to obtain reliable information, as patients do not reliably recall numbers of migraine days and acute medication intake. Adding E-diaries will be helpful in future headache telemedicine.
Background and purpose: New prophylactics for migraine, targeting calcitonin generelated peptide (CGRP), have recently emerged. Real-world data are important for a comprehensive understanding of treatment response. We assessed the consistency of response to erenumab, a monoclonal CGRP receptor antibody, in a real-world setting, in order to determine which patients may be considered responders in clinical practice.Methods: All erenumab-treated patients (n = 100) completed a time-locked daily electronic diary, and an automated algorithm was used to monitor treatment response.Monthly migraine days (MMD), non-migrainous headache days, days of acute medication use (MAMD), well-being and coping with pain were assessed for a 6-month period. The primary outcome was reduction in MMD compared to baseline. Results:The numbers of MMD and MAMD decreased in all months, in both episodic and chronic migraine patients, compared to baseline (p < 0.001), while general well-being (p < 0.001) and coping with pain (p < 0.001) also improved. Of all patients, 36% had an MMD reduction of ≥50% in ≥3/6 months, and 6% had such a reduction in all 6 months.For a ≥30% MMD reduction, the figures were 60% and 24%, respectively. Almost 90% of patients with an average MMD reduction of ≥30% over the first 3 months had a sustained response in the last 3 months. In addition, 20% of patients without an initial response (average <30%), had a delayed response (average ≥30%) in the last 3 months. Conclusion:Erenumab was effective in migraine patients who were highly refractory to previous prophylactics. As a practical guideline, we propose that treatment be continued for at least 6 months and that patients with a ≥30% MMD reduction in at least half of the treatment period should be considered to be responders.
Background and Objectives:Anti-CGRP (receptor) antibodies are approved as preventive treatment for migraine. Recent concerns have been raised after a retrospective analysis of post-marketing case reports of elevated BP associated with erenumab. In this prospective follow-up study we aimed to assess the safety regarding blood pressure (BP) in a real world setting.Methods:All people with migraine that were treated with erenumab and fremanezumab at the Leiden Headache Center between January 2019 and January 2021 were included. BP measurements were collected from baseline (T0) until 12 months follow-up, with a three-month interval (T1–T4). Mixed linear models were fitted with time as a fixed effect and the patient as a random effect.Results:Both systolic and diastolic BP were increased at all time points T1-T4 compared to T0 (p<0.001). The maximum estimated increase in mean systolic BP was 5.2 mmHg (95% CI: 3.1-7.5). The maximum estimated increase in mean diastolic BP was 3.5 mmHg (95% CI: 2.0-4.9). In the erenumab group (n = 109), both systolic and diastolic BP were increased all time points compared to T0 (all p<0.001). For fremanezumab (n = 87), systolic but not diastolic BP was increased compared to T0 at T1 (p=0.006) and T2 (p=0.004). Four patients (3.7%) with normal BP at T0 required antihypertensive treatment after erenumab was started.Discussion:The mean systolic and diastolic BP increased after anti-CGRP (receptor) antibodies were started. The majority of patients remained within the normal blood pressure limits, but some patients required antihypertensive treatment. Physicians should be aware that people with migraine may be at risk to develop hypertension when treated with anti-CGRP (receptor) antibodies and this should be added to (inter)national treatment guidelines.Classification of Evidence:This study provides Class III evidence that anti-CGRP (receptor) antibodies increase blood pressure when used to treat patients with migraine.
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