ABSTRACT
Background and aims: Erenumab proved to be safe and well tolerated in a 5-year continuation of a 1-year double-blind, placebo-controlled study. Aim: to assess >48-week erenumab tolerability and safety in a real-world setting. Methods: In this long term (>48-week), multicenter (n = 15), longitudinal cohort real life study, we monitored all the adverse events emerged in consecutive adult patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) treated with monthly erenumab 70 mg or 140 mg from 20 December 2018 to 15 December 2020. Results: 442 patients (HFEM: 115;CM: 327) were treated with erenumab for >48 weeks: 209 (47.3%) patients were treated for 49–60 weeks, 132 (29.9%) for 61–72 weeks;73 (16.5%) for 73–84 weeks;21 (4.7%) for 85–100 weeks. Overall, >1 treatment emergent adverse event (TEAE) was reported by 136 (30.8%) [HFEM: 43 (37.4%);CM: 93 (28.4%)]. Most common TEAE were constipation (n = 66;14.9%), injection site erythema (n = 15;3.4%), and influenza (n = 7;1.6%). Serious adverse events (SAE) were reported by 8 patients (1.8%) and led to treatment discontinuation: severe constipation (n = 3), abdominal pain (n = 1), NSTEMI (n = 3), Covid-19 infection (n = 1). Only severe constipation was considered treatment-related SAE (0.45%). Conclusions: Conclusion: Erenumab is safe and well tolerated also in long-term treatment (>48 weeks) in real life.
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Background and aims: The present Italian multicenter study aimed at investigating whether the course of primary headache disorders in children and adolescents was changed during the lockdown necessary to contain the COVID-19 emergency in Italy. Methods: During the lockdown, we submitted an online questionnaire to patients already diagnosed with primary headache disorders. Questions explored the course of headache, daily habits, psychological factors related to COVID- 19, general mood and school stress. Answers were transformed into data for statistical analysis. Through a bivariate analysis, the main variables affecting the subjective trend of headache, and intensity and frequency of the attacks were selected. The significant variables were then used for the multivariate analysis. Results: We collected the answers of 707 patients. In the multivariate analysis, we found that reduction of school effort and anxiety was the main factor explaining the improvement in the subjective trend of headache and the intensity and frequency of the attacks (p<0.001). The greater the severity of headache, the larger was the clinical improvement (p<0.001). Disease duration was negatively associated with the improvement (p<0.001). It is noteworthy that clinical improvement was independent of prophylaxis (p>0.05), presence of chronic headache disorders (p>0.05) and geo- graphical area (p>0.05). Conclusions: Our study showed that lifestyle modification represents the main factor impacting the course of primary headache disorders in children and adolescents. In particular, reduction in school-related stress during the lockdown was the main factor explaining the general headache improvement in our population. (Figure Presented).
ABSTRACT
Objective: To assess 1) the impact of online mindfulness on psychological distress, 2) altruistic efforts, and 3) the quantity, quality, and availability of online mindfulness resources during the COVID-19 pandemic. Methods: 233 participants (203 U.S.;20 international;10 unknown) participated in this prospective, single-arm, nonrandomized clinical trial of a single online mindfulness meditation session with pre- and post-surveys. Main outcome measures: (a) Mindfulness session helpfulness, online platform effectiveness, and immediate pre- to post-session changes in momentary stress, anxiety, and COVID-19 concern;(b) qualitative themes representing how people are helping others during the pandemic;(c) absolute changes in quantity of mindfulness-oriented web content and free online mindfulness resource availability from May to August 2020. Results: Most participants felt the online mindfulness session was helpful and the electronic platform effective for practicing mindfulness (89%, 95% CI: [82 to 93%]), with decreased momentary anxiety (76%;95% CI: [69 to 83%]), stress (80%;[72 to 86%]), and COVID-19 concern (55%;[46 to 63%]), (p<0.001 for each measure). Participants reported helping others in a variety of ways during the pandemic, including following public health guidelines, conducting acts of service and connection, and engaging in self-renewing and self-care activities to be able to better help others. Mindfulness+COVID search results increased by 52% from May to August 2020. Most (73%) Academic Consortium for Integrative Medicine and Health member websites offer free online mindfulness resources, with 56% of them offering online classes. Conclusion: Virtual mindfulness is an increasingly accessible intervention available world-wide that may reduce psychological distress during this isolating public health crisis. Kindness and altruism are being demonstrated during the pandemic. The consolidated online mindfulness resources provided may help guide clinicians and patients.
ABSTRACT
BACKGROUND: Lombardy was severely hit by the COVID-19 pandemic since February 2020 and the Health System underwent rapid reorganization. Outpatient clinics were stopped for non-urgent patients: it became a priority to manage hundreds of fragile neurological patients who suddenly had less reference points. In Italy, before the pandemic, Televisits were neither recognized nor priced. METHODS: At the Fondazione IRCCS Istituto Neurologico C. Besta, we reorganized outpatient clinics to deliver Neuro-telemedicine services, including Televisits and Teleneurorehabilitation, since March 2020. A dedicated Working Group prepared the procedure, tested the system, and designed satisfaction questionnaires for adults and children. RESULTS: After a pilot phase, we prepared a procedure for Telemedicine outpatient clinics which was approved by hospital directions. It included prescription, booking, consenting, privacy and data protection, secure connection with patients (Teams Microsoft 365), electronic report preparation and delivery, reporting, and accountability of the services. During the March-September 2020 period, we delivered 3167 Telemedicine services, including 1618 Televisits, to 1694 patients (972 adults, 722 children) with a wide range of chronic neurological disorders. We successfully administered different clinical assessment and scales. Satisfaction among patients and caregivers was very high. CONCLUSIONS: During the dramatic emergency, we were able to take care of more than 1600 patients by organizing Neuro-telehealth in a few weeks, lessening the impact of the pandemic on fragile patients with chronic neurological disorders;this strategy is now stably embedded in our care pathways. In Italy, Telehealth is at present recognized and priced and is becoming a stable pillar of the health system.