One year of treatment with the latest generation drugs and migraine attacks drop by over 90 percent. AND the revolutionary promise of monoclonal antibodies to treat migraines. Their potential has been known for years in the treatment of the pathology, but has recently been further validated by an Italian study, in which 16 centers coordinated by the IRCCS San Raffaele of Rome participated. The work was published in the scientific journal Journal of Neurology.
«One year of treatment with anti-CGRP monoclonal antibodies causes the frequency of migraine attacks to collapse in almost all subjects (91.3%)» he explained Piero Barbanticoordinator of the research group and director of the Unit for Treatment and Research on Headaches and Pain of the IRCCS San Raffaele as well as responsible for the Italian Migraine Registry.
San Raffaele in Rome is a world leader in testing new molecules against headaches. The data from the study just published shows that anti-CGRP therapies will revolutionize treatments in the coming years and will drastically improve the life of migraine patients. This will also mean a clear reduction in the direct and indirect costs of the pathology. To date valued at approximately 20 billion euros.
Monoclonal antibodies: effective in almost all patients
The San Raffaele study is considered important for three reasons. First: “It demonstrates that anti-CGRP monoclonal antibodies represent a point of no return in the treatment of a devastating disease such as migraine, proving effective in practically everyone. Secondly, it documents that defining someone who does not improve after three months of treatment as non-responsive – as unfortunately currently required by the rules of the Italian Medicines Agency (Aifa) – is a serious mistake. Because it excludes 30% of patients from the benefit.”
Today, in fact, only those who do not respond to treatment after three months can continue with treatment with monoclonal antibodies under a reimbursement regime. But the study, Barbanti specifies, «shows that after about 90 days only 60.5% of patients respond. While waiting six months 75% respond and 91.3% respond after twelve months. This means that the current AIFA criteria exclude 30% of migraine sufferers treated with monoclonals from the possible benefit.” Finally, the Roman work highlights how intractable or drug-resistant migraine is a true rarity.
Treating migraines: AIFA criteria
For all these reasons, «it is urgent that the Italian Medicines Agency takes note of this evidence and reviews the criteria for the reimbursement of monoclonal antibodies. As well as those relating to prescription.” Currently, only migraine patients with at least 8 days of migraine per month can benefit from the reimbursement of monoclonal antibodies by the healthcare system. And who have failed previous treatments with antidepressants, antiepileptics and beta blockers. «Here is the first problem», underlines the neurologist. «Antiepileptic drugs can cause fetal harm (this is a recent warning from the European Medicines Agency), but the majority of migraine patients are women of reproductive age».
As data from the World Health Organization also underline, migraine is the third most frequent pathology and the second most disabling. It clearly prefers the female sex, with a female/male ratio of 3:1. Furthermore, women experience more frequent migraine episodes, of greater intensity and duration and have a greater overall number of comorbidities, with greater negative consequences on the quality of life.
How monoclonal antibodies work
Treatment with monoclonal antibodies is considered a revolution also because the disease is an alternative treated with drugs borrowed from other pathologies. For example with non-steroidal anti-inflammatories, antiepileptics, beta-blockers and antiarrhythmics. Also with botulinum toxin, which has shown good results for chronic migraines. Anti-CGRP monoclonal antibodies (acronym from the English Calcitonin Gene Related Peptide) instead represent the first specific therapy.
These molecules they block the action of a peptide that participates in the cascade process that determines the migraine attack. They are drugs to be taken as prophylaxis and monthly, with a subcutaneous injection. The duration of treatment will be evaluated by the doctors during the treatment. «Therapy with monoclonal antibodies must be interrupted for at least one month after twelve months of treatment», explains Barbanti. «One year of treatment is too short a period for the positive effects of the treatment to consolidate. It would take at least 18-24 consecutive months.”