Migraine is a highly debilitating disease that is still both underdiagnosed and undertreated. However, the preventative treatment options for migraine has evolved from the first introduction of beta blockers in the 1960’s1 to the recent emergence of small molecule antagonists and monoclonal antibodies blocking the calcitonin gene-related peptide(CGRP)2. As part of the Teva Satellite Symposium titled “Optimism and opportunities with anti-CGRP biologics in migraine – where are we today?” at the 5th Congress of the European Academy of Neurology (EAN), Prof. Zaza Katsarava (University of Essen-Duisburg, Germany) discussed current preventative migraine treatment options and presented data from recent phase III clinical trials of anti-CGRP biologics.

“The new anti-CGRP migraine treatments will change the life of many migraine sufferers.”

Zaza Katsarava (University of Essen-Duisburg, Germany)

Prof. Katsarava began his presentation by giving an overview of the existing monoclonal antibodies targeting CGRP or its receptor for migraine prevention. Currently there are three anti-CGRP (ligand or receptor) antibodies approved for the treatment of migraine: fremanezumab3, erenumab4 and galcanezumab.5 These antibodies have demonstrated efficacy in both episodic migraine (EM) and chronic migraine (CM), and are generally well tolerated.3,4,5 A fourth one, eprinezumab6, is under development, but is not yet approved.

Prof. Katsarava continued by showing data from recent phase III studies of fremanezumab. He stated that in all the placebo-controlled trials, the incidence of adverse events in patients receiving fremanezumab was comparable with placebo-treated patients.7

HALO EM and HALO CM

The HALO EM study assessed the efficacy of fremanezumab compared with placebo in EM prevention.8 The results show that fremanezumab significantly reduced the number of migraine days per month compared with placebo over 3 months.8 The proportion of patients achieving ≥50% reduction from baseline in migraine days per month over 3 months was also significantly higher with fremanezumab.8 In HALO CM, fremanezumab treatment led to significantly fewer headache days per month over 3 months in patients with CM.9

HALO Long-Term Study

The HALO Long-term study evaluated the long-term efficacy and safety of fremanezumab.10 The results showed that the reduction in monthly migraine days with fremanezumab was maintained over 12 months in patients with EM.10 Likewise, the reduction in monthly headache days in patients with CM taking fremanezumab was maintained over 12 months.12 The proportion of patients with ≥50% reduction from baseline in monthly migraine days (patients with EM) or monthly headache days (patients with CM) were further sustained during the 12-month study period.11

FOCUS

The FOCUS study evaluated fremanezumab in patients with EM or CM who had failed prior preventative treatments.12 The study included patients with documented inadequate response to 2–4 classes of prior preventative migraine treatments. The findings showed that fremanezumab significantly reduced monthly migraine days vs placebo over 12 weeks in patients with either EM and CM.12 Furthermore, use of any acute headache medication was significantly reduced in patients with EM or CM taking fremanezumab vs placebo.12

To conclude his presentation, Prof. Katsarava summarized the positive features of anti-CGRP treatments for migraine: reduction in migraine days, rapid onset of effect, favorable safety and tolerability, as well as reduction of use of abortive drugs. In Prof. Katsavara’s opinion, there may be cause for optimism for migraine sufferers today.

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  2. Edvinsson L, et al. CGRP as the target of new migraine therapies – successful translation from bench to clinic. Nat Rev Neurol. 2018;14:338–50.
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  5. https://www.ema.europa.eu/en/medicines/human/EPAR/emgality. Last accessed July 2019.
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  7. Teva. Ajovy Prescribing Information, 2019.
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  11. Newman LC, et al. Presented at the 13th European Headache Congress, Athens, Greece, 2019.
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