Patients with headaches caused by idiopathic intracranial hypertension (IIH) are undergoing treatment with anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies in a small, ongoing clinical trial, researchers reported at the virtual annual scientific meeting of the American Headache Society.
In the small study, Lindsay Frerichs, MD, clinical headache medicine fellow at the University of Texas Southwestern School of Medicine in Dallas, recruited 24 patients diagnosed with migraine—23 of whom are women. She wanted to determine whether treatment with an anti-CGRP monoclonal antibody improves headache frequency, severity, and disability in patients with persistent headaches following IIH.
"The predilection for IIH to occur in women and the rise in prevalence around puberty suggests a hormonal component," Dr. Frerichs told Neurology Today At the Meetings. "However, no specific female hormones have been identified. Genetic analysis that was performed in the Idiopathic Intracranial Hypertension Treatment Trial also did not identify any specific genes known to be associated with hormonal disorders or obesity."
"IIH often causes new daily persistent headache," she said. "The headache is frequently associated with blurred or double vision, episodes of brief transient visual loss in one or both eyes, and pulsatile tinnitus. It is treated differently than migraine and there is a risk of permanent visual loss with IIH."
In the trial, 11 patients are being treated with galcanezumab, five with fremanezumab, and eight with erenumab, she reported in her poster presentation.
The patients were identified through a retrospective chart review, including individuals seen from March 2018 to January 2020. They were diagnosed with IIH and have used or are currently using anti-CGRP monoclonal antibodies. The researchers are analyzing the data to see if these patients can achieve at least a 50 percent decrease in mean headache days a month. They expect to report outcomes in October.
Dr. Frerichs, who will take an appointment in August as assistant professor of neurology at Washington University School of Medicine in St. Louis, also noted that there are also medications that can cause IIH, such as tetracyclines, vitamin A, and other retinoids. In addition, corticosteroid withdrawal, growth hormone supplementation in children, and lithium, among others factors, may play a role."
The incidence of IIH is 1.9 per 100,000 in the general population and 20 to 25 per 100,000 in obese women of childbearing age, Dr. Frerichs said.
Commenting on the study, Amaal Starling, MD, FAHS, assistant professor of neurology at the Mayo Clinic in Phoenix, AZ, said: "With a number of 24 patients, this study would be considered a pilot trial. Larger numbers of patients will be needed for definitive results."
Dr. Starling noted that clinicians do not know the mechanism of action that would allow the anti-CGRP agents to impact the headaches caused by IIH. "What we do know is that headaches in the setting of IIH, even after the pressures have been normalized, have migraine features and typically meet the diagnostic criteria for migraine," she said. "Based on that, we can hypothesize that some migraine pathophysiology may be occurring leading to migraine-like symptoms in the setting of IIH. If CGRP physiology is involved in migraine, it may also be involved in the migraine-like symptoms in IIH."
Currently, treatment for IIH is an unmet need in medicine. "We have no evidence-based treatment options specifically for the headache in IIH," Dr. Starling said. "At this time, the recommended treatment of IIH is acetazolamide mainly to normalize the increase intracranial pressure, however, it does not always address the headache. For the IIH headache, we typically use migraine preventives and acute medications, devices, and procedures off label."
Disclosures: Drs. Frerichs and Staarling had no relevant disclosures.
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AHS Abstract: Cohen F, Armand C, Vollbracht S. Efficacy and tolerability of CGRP monoclonal antibody medications in patients with chronic migraine undergoing treatment with onabotulinumtoxinA.