Background Migraine is a primary headache disorder characterized by recurrent attacks that may have a significant impact on patients’ daily life. Treatment options must often be re-evaluated in light of efficacy, tolerability and compliance issues. Few data on commonly applied treatment algorithms and treatment failures have existed in Germany in 2017/2018. The PANORAMA survey was designed to explore and characterize the migraine healthcare landscape and to demonstrate the medical treatment need at that time in Germany. Methods Three different questionnaires were used to assess the profile of the 119 participating centers, characterize migraine patients at centers and evaluate qualitative aspects of the current migraine healthcare situation from a physician´s professional perspective. Data were analyzed as observed and summarized by descriptive statistics. Results The results demonstrate that once referred to a migraine specialist, the majority of patients continue to be treated at a specialist. At specialized centers, 41.6 % of migraine patients receive prophylactic treatment. 45.4 % of prophylactic treatments are initiated with a beta-blocker and 28.1 % with an anti-epileptic. Pivotal factors to initiate prophylactic treatment are migraine attack frequency and intensity (58.0 %). Treatment decisions are largely based on prior / concomitant diseases and physical constitution of the patient (52.1 %). Following an inadequate treatment, most patients either switch substance class or discontinue prophylactic treatment. Conclusions PANORAMA gives a comprehensive overview of the migraine healthcare landscape in Germany in 2017/2018, elucidates a lack of common treatment algorithms and reveals a high demand for defined therapy strategies and new prophylactic treatment going forwards.
BackgroundNeuroinflammation and microglial activation play a role in AD as shown pathologically and by microglial PET imaging (Zhou et al, Front Immunol 2021). We found that nasal anti‐CD3 mAb induced IL‐10‐secreting T cells in the cervical lymph node that migrate to the brain, suppress microglial inflammation and ameliorate disease in a model of progressive MS (Mayo et a,l Brain 2016). In humans we found that nasal anti‐CD3 (Foralumab) decreased inflammation and accelerated resolution of lung inflammation in patients with mild COVID‐19 (Moreira et al, Front Immunol 2021) and modulated microglial activation in progressive MS as measured by microglial PET imaging (Chitnis et al, unpublished). We thus tested nasal anti‐CD3 in animal models of AD.MethodWe treated AD mice (3xTg and APP/PS1) with nasal anti‐CD3, isotype control antibody or PBS 3x/week for 6 months (3xTg) or 3x/week for 2 months (APP/PS1) and investigated cognitive behavior (Morris water maze and Y‐maze), microglia gene profile using a Nanostring myeloid codeset and T cell infiltration in the brain by immunofluorescence.ResultWe found that microglia lose their homeostatic (M0) signature and acquire a neurodegenerative (MGnD) signature in animal models of AD. In 3xTg mice, we found that nasal anti‐CD3 restored the M0 signature by increasing the expression of Cx3cr1, Mafb, and Jun, and lessened the MGnD signature by decreasing the expression of Trem2, Nos2 and Ccl5. Nasal anti‐CD3 improved cognition in 3xTg mice as measured by the Y‐maze and Morris water maze tests and in APP/PS1 mice as measured by the Y‐maze test. Nasal anti‐CD3 induced migration of T cells to the brain which interacted with microglia.ConclusionNasal anti‐CD3 restores the microglial M0 signature and improves behavior in animal models of AD. Based on these results and the successful administration of nasal anti‐CD3 to subjects with progressive MS and COVID‐19, phase 1 trials of nasal Foralumab are planned in subjects with mild AD to assess safety, clinical effects and microglial activation as measured by microglial PET imaging. Nasal anti‐CD3 is a novel approach to treat AD by targeting microglial inflammation.
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