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Migraine, the results of ‘real world’ studies are becoming increasingly relevant

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On the occasion of the 52nd Congress of the Italian Society of Neurology in Milan, new studies on ‘real world’ clinical practice were presented that provide more information about the treatment of migraine

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On the occasion of the symposium “Fremanezumab: What has changed in a year”, held at the 52nd Congress of the Italian Society of Neurology in Milan, scheduled from December 3 to 6, new studies on the clinical practice of “real world” that provide more information about migraine treatment. In particular, the pharmaceutical company Teva presented the new evidence from the Pearl study, Pan-European Real World, involving 354 patients from 30 different centers in Italy. According to a previous study by Teva, there are 41 million people living with migraine in Europe: Migraine, which mainly affects the population aged between 35 and 45, can affect both work performance and the ability to be a partner or parent. That’s why migraine is considered the number one cause of disability in young women, and the second in the world. Fremanezumab, protagonist of the symposium, is a drug used to prevent migraines.

Word to the experts

“The Pearl study is one of those studies that are technically defined as ‘real life’: it means that the patient is treated normally, as it would be by his or her general practitioner or specialist doctor, the difference is that data is collected in a capillary This is important because controlled clinical trials include patients with selected characteristics and who are treated according to a precise protocol; ‘real life’ studies instead give us more useful information for the management of these patients in the real world’, explains l Professor of Neurology at the University of Pavia Cristina Tassorelli For the expert, it is “essential that pharmaceutical companies carry out these studies, because by collecting information in different centers we can build an important case study and we can get indications that are getting stronger and stronger” .

The other statements

According to Antonio Russo, Head of the Headache Center of the University of Campania ‘Luigi Vanvitelli’, who also spoke during the day, ‘The wealth data that real life studies give us stems from the fact that we have patients that we meet in our clinical practice, with their difficulties and their history of failures with previous drugs. What we observe is as close as possible to the experience of the clinical neurologist in his daily activities”. In migraine, there are several criteria for assessing disability, which can indicate how severe the disease is in the individual patient. “Midas, the assessment of migraine disability, gives us extensive information about the impact of the disease on the patient: it is a good indicator, simple and very intuitive, it can be used by the patient, by the general practitioner or by the specialist, and tells us how serious the disease is and to what extent it prevents the patient from living different aspects of his life, such as studying, going to work or having hobbies. But it may also be useful to consider the number of migraine days per month: preliminary data suggest that using both, in addition to or as an alternative, could tell us a little more to better understand the impact of the disease on the patient.” , concludes Tassorelli.


According to Aifa, in order to be prescribed and reimbursed for the antibody, patients must have at least 8 migraine days per month and a Midas score equal to or greater than 11. According to Professor Russo, future research will reveal the role of monoclonal antibodies. This “will aim not only at identifying the possible changes in neuronal plasticity and thus in the functioning of the brains of patients who perform therapies with monoclonal antibodies, but above all at identifying biomarkers that allow us to understand whether there is are types of patients who respond better, and at what time points, to antibodies. The data we have to date suggests that the faster we act with monoclonal antibodies, the better the expectation of treatment efficacy will be,” concludes the expert.

Source: TG 24 Sky

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