Effectiveness of three calcitonin gene-related peptide monoclonal antibodies for migraine: A 12-month, single-center, observational real-world study in Japan

Suzuki, Keisuke; Suzuki, Shigeaki; Shiina, Tomohiko; Tatsumoto, Muneto; Fujita, Hiroaki; Haruyama, Yasuo; Hirata, Koichi

doi:10.1177/03331024231177649

Cited by 14 publications

(5 citation statements)

References 40 publications

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“…Similar results were found in a single-center Japanese real-life study, where no difference in monthly reduction in migraine days over 12 months was found between three CGRP mAbs [22]. Another study of 152 patients compared anti-CGRP mAbs that target the CGRP itself (68 patients; 49 galcanezumab, 19 fremanezumab) to erenumab (84 patients), which targets the CGRP receptor.…”

Section: Discussionsupporting

confidence: 72%

Comparative Study of the Efficacy of Anti-CGRP mAbs on Migraineurs: Analysis of the First Year of Therapy, 1-Month Suspension Period, and Reprisal

Tereshko,

Dal Bello,

Pez

et al. 2023

JCM

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Background: Few studies compare the clinical effectiveness of the three anti-CGRP mAbs. Moreover, no studies compare their efficacy during suspension and reprisal. Our study aimed to compare the efficacy of migraine frequency, intensity, and symptomatic medication intake during the first year of therapy, a 1-month suspension period, and a 3-month drug reprisal. Methods: A total of 160 migraineurs (chronic and high-frequency episodic) were treated with anti-CGRP mAbs (49 with fremanezumab, 55 with erenumab, and 55 with galcanezumab) for 12 months. They discontinued the therapy for 1 month and then reprised the therapy. In the three groups, we analyzed and compared the migraine days per month, migraine intensity, and symptomatic medication intake per month at baseline, 3-month, 6-month, and 12-month follow-up. We also compared these variables during the 1-month suspension and 3 months after the reprisal of the therapy. We compared the data and evaluated the response rate (>50% reduction in migraine days per month) at different follow-ups. This comparison was also performed separately for chronic and high-frequency episodic migraineurs. Results: There was no statistical difference in monthly migraine days, intensity, or symptomatic medication intake per month at the different follow-ups. Moreover, there was no difference in the response rate overall. However, in chronic migraineurs treated with galcanezumab, the response rate was higher during the 1-month suspension when compared to fremanezumab and erenumab. In high-frequency episodic migraineurs, fremanezumab had a higher response rate at 12-month follow-up when compared to galcanezumab and erenumab. Conclusions: In our study, the three anti-CGRP mAbs presented a similar response, with no significant differences, during the first year of therapy, the suspension period, and 3 months after the drug reprisal. The response rate during the 1-month suspension period in chronic migraineurs may be higher with galcanezumab.

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Section: Discussionsupporting

confidence: 72%

Comparative Study of the Efficacy of Anti-CGRP mAbs on Migraineurs: Analysis of the First Year of Therapy, 1-Month Suspension Period, and Reprisal

Tereshko,

Dal Bello,

Pez

et al. 2023

JCM

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“…With more patients, the results with erenumab would also have been statistically significant. The comparison of efficacy in reducing MMDs among CGRP mAbs is a clinically relevant topic, which should be explored with a much larger population [ 25 , 27 – 29 ].…”

Section: Discussionmentioning

confidence: 99%

“…However, age, disease duration, baseline MMDs, and baseline HIT-6 were not relevant to 50% RR at V3. Although previous studies found these clinical parameters to be predictors of clinical efficacy, it should be pointed out that there are clear discrepancies among such data in terms of age [ 24 , 31 , 46 ] and baseline MMDs [ 25 , 46 , 47 ]. Hence, there is the possibility that the effectiveness of these parameters as therapeutic predictors is influenced by the difference in study populations.…”

Section: Discussionmentioning

confidence: 99%

“…Third, we did not collect detailed information about the clinical features of migraine attacks, such as the nature of the headaches and their laterality and the presence of accompanying symptoms. Unilaterality, pulsatile nature, vomiting, cranial autonomic symptoms, allodynia, osmophobia, and good response to triptans have been identified as predictive factors for therapeutic response [ 25 , 43 , 53 , 54 ]. Conversely, concomitant depression and obesity are known to predict poor outcomes [ 43 , 53 ].…”

Section: Discussionmentioning

confidence: 99%

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Real-world experience with calcitonin gene-related peptide-targeted antibodies for migraine prevention: a retrospective observational cohort study at two Japanese headache centers

Shibata,

Fujita,

Hoshino

et al. 2024

BMC Neurol

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Background Although randomized controlled trials (RCTs) have shown that calcitonin gene-related peptide (CGRP)-targeted monoclonal antibodies (CGRP mAbs) are an efficacious and safe therapeutic modality for migraine prevention, their clinical benefits have not been well validated in Japanese patients in the real-world setting. The present study aimed to evaluate the real-world efficacy and safety of galcanezumab, fremanezumab, and erenumab in Japanese patients with migraine. Methods This observational retrospective cohort study was conducted at two headache centers in Japan. Patients with migraine who had experienced treatment failure with at least one traditional oral migraine preventive agent were treated with a CGRP mAb de novo. The primary efficacy endpoints were the changes from baseline in monthly migraine days (MMDs) and Headache Impact Test-6 (HIT-6) score after 3 dosing intervals (V3). We explored whether demographic and clinical characteristics predicted therapeutic outcomes at V3. Results Sixty-eight patients who completed three doses of a CGRP mAb (85.3% female [58/68], mean age: 46.2 ± 13.1 years) were included in the analysis. There were 19 patients with chronic migraine. The baseline MMDs were 13.4 ± 6.0. After 3 doses, the MMDs significantly decreased to 7.4 ± 5.5 (p < 0.0001), and the 50% response rate was 50.0%. HIT-6 score was significantly reduced from 66.7 ± 5.4 to 56.2 ± 8.7 after 3 doses (P = 0.0001). There was a positive correlation between the changes in MMDs and HIT-6 score from baseline after 2 doses (p = 0.0189). Those who achieved a ≥ 50% therapeutic response after the first and second doses were significantly more likely to do so at V3 (crude odds ratio: 3.474 [95% CI: 1.037 to 10.4], p = 0.0467). The most frequent adverse event was constipation (7.4%). None of the adverse events were serious, and there was no need for treatment discontinuation. Conclusions This real-world study demonstrated that CGRP mAbs conferred Japanese patients with efficacious and safe migraine prevention, and an initial positive therapeutic response was predictive of subsequent favorable outcomes. Concomitant measurement of MMDs and HIT-6 score was useful in evaluating the efficacy of CGRP mAbs in migraine prevention.

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“…В японское исследование K. Suzuki и соавт. [19] вошли 228 пациентов, 123 из них получали фреманезумаб, остальные -эренумаб или галканезумаб. Уменьшение числа дней с мигренью в месяц более чем на 50% на 3, 6 и 12-м месяцах лечения составило 48,2; 61,0 и 73,7% соответственно.…”

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Fremanezumab in real-life clinical practice: specialized headache center experience

Azimova,

Skorobogatikh,

Osipova

et al. 2024

RJTAO

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Anti-CGRP monoclonal antibodies (mAb) have been approved and successfully used in Russia since 2020.Objective: to investigate the efficacy and safety of fremanezumab (FRE) therapy (225 mg monthly or 675 mg quarterly) in real-life clinical practice in patients with migraine who referred to a specialized Russian headache center.Material and methods. This open-label, retrospective study involved 202 patients (mean age 39.4±12.2 years) with frequent episodic (EM) or chronic migraine (CM) who received at least three injections of FRE 225 mg or three injections with a total dose of 675 mg and regularly completed the Migrebot headache diary one month before starting therapy and throughout the course of treatment.Results. The mean number of migraine days per month decreased in the whole group from 20.1±8.2 (before treatment) to 8.5±7.9 after 12 weeks (p<0.0001), in the EM group from 10.9±4.1 to 3.6±3.7 (p<0.0001) and in the CM group - from 24.4±5.7 to 10.8±8.3 (p<0.0001). Adverse events were observed in 13 (6.4%) patients (most frequently local reactions: itching, rash, redness, induration at the injection site).Conclusion. The study showed a favourable efficacy and safety profile of FRE in the Russian population, where anti-CGRP mAbs are considered the first-line treatment for migraine.

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Effectiveness of three calcitonin gene-related peptide monoclonal antibodies for migraine: A 12-month, single-center, observational real-world study in Japan

Cited by 14 publications

References 40 publications

Comparative Study of the Efficacy of Anti-CGRP mAbs on Migraineurs: Analysis of the First Year of Therapy, 1-Month Suspension Period, and Reprisal

Comparative Study of the Efficacy of Anti-CGRP mAbs on Migraineurs: Analysis of the First Year of Therapy, 1-Month Suspension Period, and Reprisal

Real-world experience with calcitonin gene-related peptide-targeted antibodies for migraine prevention: a retrospective observational cohort study at two Japanese headache centers

Fremanezumab in real-life clinical practice: specialized headache center experience

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