Effectiveness and Safety of CGRP-mAbs in Menstrual-Related Migraine: A Real-World Experience

Silvestro, Marcello; Orologio, Ilaria; Bonavita, Simona; Clemente, Fabrizio; Fasano, Carla; Tessitore, Alessandro; Tedeschi, Gioacchino; Russo, Antonio

doi:10.1007/s40122-021-00273-w

Cited by 12 publications

(8 citation statements)

References 34 publications

(53 reference statements)

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“…However, the treatment of menstrual migraine still poses specific challenges, being a more resistant subtype that is less responsive to prophylactic pharmacological treatments [ 147 ]. Results of a recent study on the effect of CGRP(−receptor) monoclonal antibodies in 40 patients with menstrual-related migraine and three or more previous treatment failures further confirmed this [ 148 ]. Besides a significant reduction of median menstrual migraine frequency, pain intensity, and attack duration, they showed that menstrual migraine episodes had a slightly less treatment response compared to the non-menstrual migraine episodes (72.4% reduction vs. 60% reduction) [ 148 ].…”

Section: Expert Opinionmentioning

confidence: 65%

Considerations for hormonal therapy in migraine patients: a critical review of current practice

van Lohuizen,

Paungarttner,

Lampl

et al. 2023

Expert Review of Neurotherapeutics

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Introduction Migraine, a neurovascular headache disorder, is a leading cause of disability worldwide. Within the multifaceted pathophysiology of migraine, hormonal fluctuations play an evident triggering and exacerbating role, pointing toward the need for identification and proper usage of both existing and new hormonal targets in migraine treatment. Areas covered With a threefold higher incidence of migraine in women than in men, the authors delve into sex hormone-related events in migraine patients. A comprehensive overview is given of existing hormonal therapies, including oral contraceptives, intrauterine devices, transdermal and subcutaneous estradiol patches, gnRH-agonists, oral testosterone, and 5α reductase inhibitors. The authors discuss their effectiveness and risks, noting their suitability for different patient profiles. Next, novel evolving hormonal treatments, such as oxytocin and prolactin, are explored. Lastly, the authors cover hormonal conditions associated with migraine, such as polycystic ovary syndrome, endometriosis, and transgender persons receiving gender affirming hormone therapy, aiming to provide more personalized and effective solutions for migraine management. Expert opinion Rigorous research into both existing and new hormonal targets, as well as the underlying pathophysiology, is needed to support a tailored approach in migraine treatment, in an ongoing effort to alleviate the impact of migraine on individuals and society.

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Section: Expert Opinionmentioning

confidence: 65%

Considerations for hormonal therapy in migraine patients: a critical review of current practice

van Lohuizen,

Paungarttner,

Lampl

et al. 2023

Expert Review of Neurotherapeutics

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“…A post hoc analysis of data from a phase 3 randomized trial indicated that erenumab reduced monthly migraine headache days compared with placebo in women with a history of menstrual migraine; however, unlike our study, the analysis did not specifically investigate migraine headaches occurring during menstrual periods separately from migraine headaches occurring outside of the 5-day perimenstrual window [ 34 ]. A real-world observational study conducted at a single center in Italy reported that CGRP/CGRP receptor antibodies, including galcanezumab, reduced the frequency, intensity, and duration of menstrual-related migraines occurring during the 5-day perimenstrual window in 40 women with ≥ three previous treatment failures [ 35 ]. Together, these results suggest that galcanezumab may be an effective preventive treatment for women experiencing migraine during menstrual periods.…”

Section: Discussionmentioning

confidence: 99%

Galcanezumab Effects on Migraine Severity and Symptoms in Japanese Patients with Episodic Migraine: Secondary Analysis of a Phase 2 Randomized Trial

et al. 2022

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Introduction Galcanezumab, a humanized monoclonal antibody against calcitonin gene-related peptide, is a preventive migraine treatment. In global, randomized, placebo-controlled trials, galcanezumab reduced migraine headache severity and the frequency of migraine headaches associated with nausea and/or vomiting, photophobia and phonophobia, prodromal symptoms, or aura. We report secondary analyses from a Japanese phase 2 trial that assessed the effect of galcanezumab on migraine headache severity, frequency of migraine-associated symptoms, and frequency of migraine headaches during menstrual periods in Japanese patients with episodic migraine. Methods Adults with migraine (International Classification of Headache Disorders, 3rd edition; 4–14 migraine headache days/month) were randomized (2:1:1) to a monthly placebo ( n = 230), 120 mg galcanezumab (240 mg loading dose; n = 115), or 240 mg galcanezumab ( n = 114) for 6 months (double-blind). Patients recorded migraine headache days, severity, and symptoms in an electronic diary. Changes from baseline were analyzed (mixed model for repeated measures). Results Both galcanezumab doses significantly reduced the number of monthly moderate-to-severe and severe migraine headache days compared with placebo, overall (difference in least-squares mean change from baseline, 120 mg/240 mg versus placebo: moderate-to-severe, −1.9/−1.8 days; severe: −0.4/−0.4 days) and in each month; mean severity score was significantly reduced in the 240 mg group. Both galcanezumab doses significantly reduced the number of migraine headache days with nausea/vomiting (−1.1/−1.0 days), photophobia/phonophobia (−2.3/−1.7 days), prodromal symptoms (−0.7/−0.8 days), and aura (−0.7/−0.7 days). In most cases, the proportion of migraine headache days with these symptoms was reduced by galcanezumab. Both galcanezumab doses reduced the number of migraine headache days occurring during menstrual periods ( n = 269; −0.8/−0.9 days). Conclusion Once-monthly galcanezumab significantly reduced the frequency of migraine headache days with moderate-to-severe or severe headache, migraine headache days with migraine-associated symptoms, and migraine headache days during menstrual periods in Japanese patients with episodic migraine, consistent with results from global studies. Trial Registration: ClinicalTrials.gov (NCT02959177). Supplementary Information The online version contains supplementary material available at 10.1007/s40120-022-00410-3.

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“…Other preventive therapies include vitamin E, magnesium, and phytoestrogens. A recent study has also shown that administration of calcitonin gene‐related peptide (CGRP)‐associated antibodies once a month six times reduced the frequency, severity, and duration of menstruation‐associated migraine and improved response to analgesics [36].…”

Section: Migrainementioning

confidence: 99%

Recent applications of Kampo treatment for neurological diseases

Muramatsu

Tamada

Harada

et al. 2023

Traditional & Kampo Medicine

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Background: Although various new drugs have been developed for neurological diseases, many diseases have no effective treatment or only inadequate efficacy. Here we introduce some examples of effective Kampo treatment. Key Findings: (1) Parasomnia in the elderly is preceded by the onset of diffuse Lewy body disease, with symptoms such as nightmares and loud screaming in the middle of the night. Keishikaryukotsuboreito (KSTRB), indicated in the classics for treating parasomnia, was effective in alleviating the symptoms. KSTRB is also used for enuresis that persists into adulthood.(2) Chronic subdural hematomas (CSDHs), treated by hematoma removal with burr-hole surgery, recur at a rate of up to 20%. Goreisan (GRS) reduces hematoma volume and prevents postoperative CSDH recurrence. Homogeneous CSDH was most responsive to GRS in preventing recurrence. (3) Migraine frequently interferes with daily life. Keishibukuryogan (KBG), which alleviates blood stasis, was effective for patients with both menstruation-associated migraine and scintillating scotomas. (4) Many traditional herbal medicines are listed in the Korean Medicine Clinical Practice Guideline for Stroke in Korea. Chunghyuldan, a related formula of Orengedokuto (OGT), is mainly used to prevent stroke. Conclusion: Kampo medicine is being applied in new and effective ways to treat various neurological diseases. Hopefully, more clinicians will recognize the usefulness of such Kampo medicines and utilize them in their daily practice.

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Effectiveness and Safety of CGRP-mAbs in Menstrual-Related Migraine: A Real-World Experience

Cited by 12 publications

References 34 publications

Considerations for hormonal therapy in migraine patients: a critical review of current practice

Considerations for hormonal therapy in migraine patients: a critical review of current practice

Galcanezumab Effects on Migraine Severity and Symptoms in Japanese Patients with Episodic Migraine: Secondary Analysis of a Phase 2 Randomized Trial

Recent applications of Kampo treatment for neurological diseases

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