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Headache Disorders
Published in Sahar Swidan, Matthew Bennett, Advanced Therapeutics in Pain Medicine, 2020
In recent years, four monoclonal antibodies targeting CGRP or the CGRP receptor have been tested in humans for the prevention of migraine: galcanezumab, eptinezumab, erenumab, and fremanezumab.31 High-quality RCTs have demonstrated the efficacy of these antibodies in decreasing migraine days in episodic migraine as well as chronic migraine. Fremanezumab showed efficacy in reducing monthly migraines in a phase III trial of 1130 patients with chronic migraine.32 Erenumab—the only monoclonal antibody that targets the CGRP receptor—demonstrated similar efficacy for episodic migraine in addition to chronic migraine.33 The reported reduction in monthly migraine has been approximately three to six episodes per month and significantly greater than placebo. Of note, patients with chronic migraine were excluded from the previously cited studies if they had failed preventative treatment with two to three prophylactic medications. Despite the promising results of these positive trials, additional studies are needed to determine the long-term efficacy, safety, and cost-effectiveness of monoclonal antibodies. An analysis of a 5-year study of erenumab revealed sustained treatment effect and safety at week 64, with 25% of patients reporting 100% reduction in monthly migraine days.34 Erenumab, galcanezumab, and fremanezumab are all currently FDA-approved for migraine prevention. The long-term safety is still questioned, as well as the role of these agents as first-line treatments or only after multiple medications failures. As CGRP is an essential vasodilatory protein for cerebral and coronary arteries, its potential contraindication in patients with coronary artery disease, past stroke, or uncontrolled hypertension for example has not been well-studied but should be taken into consideration when there is a thought of prescribing these agents.
Recently approved and emerging drug options for migraine prophylaxis
Published in Expert Opinion on Pharmacotherapy, 2022
Enrico Bentivegna, Michelangelo Luciani, Valeria Ferrari, Silvia Galastri, Francesco Baldari, Francesco Scarso, Piera A. Lamberti, Paolo Martelletti
The first conducted study is HALO EM [47] that enrolled 875 patients aged from 18 to 70 with an established diagnosis of episodic migraine. The cluster of patients was randomly divided into three groups: placebo, 225 mg regimen, and 675 mg. The second one is HALO CM [48]. This trial enrolled 1.130 patients, aged from 18 to 70 with an established diagnosis of chronic migraine. The cluster of patients was randomly divided into three groups, being treated with the same regimen of HALO EM trial. In both studies, Fremanezumab has demonstrated to be effective in reducing both the number of migraine pain days and the number of monthly headaches, at least to a moderate severity. The limitation of those studies is that several categories of patients, such as pregnant women and those affected by ischemic conditions, such as coronary disease or stroke, were not included. Another study, HALO TS [49], assessed the efficacy of Fremanezumab, by enrolling 1.890 participants completing the 12-week HALO studies and new participants. The cluster was composed of adults with chronic migraine or episodic migraine, and it was either randomized, placebo controlled or using two different dosing regimens. The observation was performed for 52 weeks. The results showed 12 months of sustained improvements in terms of number of episodes, severity of episodes, usage of symptomatic medications and disability. Moreover, Fremanezumab showed a very low incidence of side effects [50].
Safety and tolerability of preventive treatment options for chronic migraine
Published in Expert Opinion on Drug Safety, 2021
Amanda Tinsley, John Farr Rothrock
There are no controlled studies of the anti-CGRP mabs involving pregnant or lactating women. Although pregnancy was an exclusion criterion in a 52 week long term efficacy and safety trial for fremanezumab for CM prevention, 6 patients discontinued due to a positive pregnancy test. The reported outcomes of these pregnancies include one spontaneous abortion, one premature separation of the placenta (placental abruption) with no fetal loss, one premature birth, and one fetal death. These events were assessed to be unrelated to fremanezumab by the investigator [53]. There is one published case report documenting no adverse events during pregnancy, delivery and a period of breastfeeding in a migraine patient exposed to erenumab during pregnancy and lactation [69]. A limited number of safety reports (n = 94) from Vigibase, a World Health Organization global database of individual case safety reports, have indicated no specific maternal toxicities, patterns of major birth defects, or increased reporting of spontaneous abortions with the SC CGRP mabs administered during pregnancy (90%), exposure shortly prior to pregnancy (5%) or breast-feeding (1%) [70]. Registries to collect data for these populations exist for all four anti-CGRP mabs. .
Fremanezumab for the preventive treatment of migraine in adults
Published in Expert Review of Clinical Pharmacology, 2019
Luana Lionetto, Martina Curto, Giusy Ylenia Cisale, Matilde Capi, Fabiola Cipolla, Martina Guglielmetti, Paolo Martelletti
Fremanezumab, a humanized monoclonal antibody, inhibits the interaction of CGRP with its receptor. FDA and EMA approved its clinical use for migraine prevention in adults. The available results from two Phase II and two Phase III randomized clinical trials showed a good efficacy of treatment with subcutaneous fremanezumab for episodic and chronic migraine with respect to placebo. Adverse events were mild or moderate and related to the injection-site reactions (erythema, pain or induration), but they occurred relatively frequently. Vital signs, laboratory findings, and other clinical parameters did not show relevant changes. Several other clinical trials are actually ongoing with the aims of evaluating fremanezumab efficacy for prevention of episodic and chronic cluster headache and post-traumatic headache. Although long-term safety is still being evaluated in an ongoing trial, fremanezumab represents a potentially useful option for the management of migraine disease.