Could the New Anti-CGRP Monoclonal Antibodies Be Effective in Migraine Aura? Case Reports and Literature Review

Albanese, Maria; Mercuri, Nicola Biagio

doi:10.3390/jcm11051228

Cited by 18 publications

(18 citation statements)

References 26 publications

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“…Case reports included observation of contradictory findings, e.g., de novo appearance [116] or substantial improvement of auras [104] and de novo appearance or significant improvement [119] of headache related to sexual activity [125]. This could be explained by differential effects based on unknown co-factors or reflect the report of mere coincidences.…”

Section: Discussionmentioning

confidence: 99%

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Monoclonal Antibodies Against Calcitonin Gene-related Peptide for Migraine Prophylaxis: A Systematic Review of Real-world Data

Pavelic¹,

Wöber²,

Riederer³

et al. 2022

Preprint

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Objective: To perform a systematic review of real-world outcomes for anti-CGRP-mAbs. Methods: Following the PRISMA guidelines, we searched PubMed for real-world data of Erenumab, Galcanezumab, Fremanezumab, or Eptinezumab in patients with migraine. Results: We identified 104 publications (73 retrospective), comprising 8 pharmaco-epidemiologic and 63 clinic-based studies, 30 case reports and 3 other articles. None of the clinic-based studies provided follow-up data over more than one year in more than 200 patients. Findings suggest reductions in health insurance claims and days with sick-leave as well as better treatment adherence with anti-CGRP-mAbss. Effectiveness, reported in 59 clinic-based studies, was comparable to randomized controlled trials. A treatment pause was associated with an increase in migraine frequency and switching to another antibody resulted in a better response in some of the patients. Adverse events and safety issues were addressed in 70 papers including 22 single case reports. Conclusion: Real-world data on anti-CGRP-mAbs are limited by retrospective data collection, small patient numbers and short follow-up periods. The majority of papers seem to support good effectiveness and tolerability of anti-CGRP-mAbs in the real-world setting. There is an unmet need for large prospective real-world studies providing long-term follow-up of patients treated with anti-CGRP-mAbs.

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Section: Discussionmentioning

confidence: 99%

“…Improvement of a symptom or comorbid condition with anti-CGRP-mAbs was reported for migraine aura [104], cluster headache [114,128], headache related to sexual activity [119], sleep terrors [129], and stuttering [130]. In three patients, severe nausea induced by Erenumab led to smoking cessation [120].…”

Section: Deterioration Of Preexisting Disordermentioning

confidence: 98%

Monoclonal Antibodies Against Calcitonin Gene-related Peptide for Migraine Prophylaxis: A Systematic Review of Real-world Data

Pavelic¹,

Wöber²,

Riederer³

et al. 2022

Preprint

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“…Although fremanezumab has been reported in a phase 2 randomized trial to reduce the number of days per week with nausea/vomiting and with photophobia/phonophobia, the effect on migraine headache days with these symptoms was not assessed [ 18 ]. Interestingly, a recent case report described the disappearance of aura in a patient treated with galcanezumab and reduced duration and intensity of aura in a patient treated with erenumab [ 27 ]; another case report also reported reduced aura after erenumab treatment [ 28 ]. A physician survey conducted in Germany has reported that erenumab reduced nausea/vomiting, photophobia/phonophobia, and aura [ 29 ].…”

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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“…All monoclonal antibodies are effective in migraine prophylaxis, in randomized clinical trials as well as in real-life settings ( 9 – 17 ), in difficult-to-treat patients with chronic migraine ( 18 – 20 ), with or without medication overuse ( 19 , 21 , 22 ) and in patients with multiple comorbidities, especially psychiatric ( 23 – 25 ), and migraine with aura ( 26 ).…”

Section: Introductionmentioning

confidence: 99%

Photophobia and migraine outcome during treatment with galcanezumab

Cola

Ceccardi²,

Bolchini³

et al. 2023

Front. Neurol.

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BackgroundCalcitonin gene-related peptide (CGRP) plays a pivotal role in migraine physiology, not only regarding migraine pain but also associated symptoms such as photophobia. The aim of the present study was to assess monoclonal antibodies targeting CGRP efficacy not only in terms of headache and migraine frequency and disability but also in reducing ictal photophobia.Material and methodsThis is a retrospective observational study, conducted at the Headache Center–ASST Spedali Civili Brescia. All patients in monthly treatment with galcanezumab with at least a 6-month follow-up in September 2022 with reported severe photophobia during migraine attacks were included. Data regarding headache frequency, analgesics consumption, and migraine disability were collected quarterly. Moreover, patients were asked the following information regarding photophobia: (1) whether they noticed an improvement in photophobia during migraine attacks since galcanezumab introduction; (2) the degree of photophobia improvement (low, moderate, and high); and (3) timing photophobia improvement.ResultsForty-seven patients were enrolled in the present study as they met the inclusion criteria. Seventeen patients had a diagnosis of high-frequency episodic migraine and 30 of chronic migraine. From baseline to T3 and T6, a significant improvement in terms of headache days (19.2 ± 7.6 vs. 8.6 ± 6.8 vs. 7.7 ± 5.7; p < 0.0001), migraine days (10.4 ± 6.7 vs. 2.9 ± 4.3 vs. 3.6 ± 2.8; p < 0.0001), analgesics consumption (25.1 ± 28.2 vs. 7.6 ± 7.5 vs. 7.6 ± 8.1; p < 0.0001), MIDAS score (82.1 ± 48.4 vs. 21.6 ± 17.6 vs. 18.1 ± 20.5; p < 0.0001), and HIT-6 score (66.2 ± 6.2 vs. 57.2 ± 8.6 vs. 56.6 ± 7.6; p < 0.0001) was found. Thirty-two patients (68.1%) reported a significant improvement in ictal photophobia, with over half of the patients reporting it within the first month of treatment. Photophobia improvement was more frequent in patients with episodic migraine (p = 0.02) and triptans responders (p = 0.03).ConclusionsThe present study confirms previous reports regarding galcanezumab efficacy beyond migraine frequency. In particular, over 60% of patients, in our cohort, documented a significant improvement also in reducing ictal photophobia. This improvement was, in most patients, moderate to high, and within the first 6 months of treatment, regardless of the clinical response on migraine frequency.

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Could the New Anti-CGRP Monoclonal Antibodies Be Effective in Migraine Aura? Case Reports and Literature Review

Cited by 18 publications

References 26 publications

Monoclonal Antibodies Against Calcitonin Gene-related Peptide for Migraine Prophylaxis: A Systematic Review of Real-world Data

Monoclonal Antibodies Against Calcitonin Gene-related Peptide for Migraine Prophylaxis: A Systematic Review of Real-world Data

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

Photophobia and migraine outcome during treatment with galcanezumab

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