Migraine is, according to the World Health Organisation Global Burden of Disease studies, the second most disabling condition worldwide, and is estimated to affect 1.3 billion people.
Key to reversing the disability of migraine is the development of safe and effective treatments to prevent migraine attacks.A group of medications that target calcitonin gene-related peptide (CGRP), are the first class of preventive treatment to be developed specifically for migraine, and the first new treatment for patients in decades.
Dr Ray said, "The CGRP molecule, however, has a wide number of other actions which we have summarised in the literature previously, and ranges from effects on bone health to controlling blood pressure." The concern, therefore, he said, is that these medications that inhibit CGRP, may have an off-target effect in addition to preventing migraine attacks.
To address this, the group developed a registry to allow clinicians to report potential adverse events related to these new medications.
"As a result of our work, we identified and published a case series of patients who developed a new or worsened inflammatory or auto-immune condition following the administration of these medications.
"We also summarised the existing evidence from pre-clinical animal models as to how this medication may exert an impact on the immune system to cause these complications. To date therefore, we have identified a potentially significant side-effect in a key class of medications used in the prevention of migraine and espoused a biologically plausible theory as to why this may occur."
In view of their clinical observations, Dr Ray said that further work is now required to either support or refute the hypothesis that inhibition of CGRP has an effect on the immune system.
"We propose to do this by collecting blood samples on patients who are started on these medications by their treating clinicians. We will then use a next-generation single molecule analyser (SIMOA) to evaluate some of the constituents of each patient's immune system (the cytokines) before, and after administration of the medication.
"From this we will be able to determine if these medications are having the effect we think they might have. The results of this work will be significant for prescribing clinicians, in order to ensure the safe use for patients with migraine, as well as for headache researchers worldwide."
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