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Efficacy and continuability of 675 mg fremanezumab administration over 2 years

The Journal of Headache and Pain volume 26, Article number: 51 (2025) Cite this article

Abstract

Background

Real-world data on the long-term adherence to- and efficacy of fremanezumab 675 mg quarterly dosing remain scarce. Our study evaluated the efficacy of- and patient adherence to 675 mg fremanezumab for episodic migraine (EM) and chronic migraine (CM) over 2 years and analyzed the reasons for discontinuation.

Methods

Among patients attending our headache outpatient clinic, those aged ≥ 15 years who commenced fremanezumab 675 mg quarterly dose schedule from November 2021 to June 2022 were enrolled in this single-center observational study. The frequency and severity of headaches were recorded using a headache diary. The observation period ended for each patient at 24 months after treatment initiation. The reasons for discontinuation were documented based on follow-up medical records.

Results

Twenty-eight patients were enrolled, of whom 15 had CM and 13 had EM. One patient with CM was excluded due to withdrawal after the first injection. Of the 27 remaining patients, the treatment was effective in 70.4% (n = 19). 44.4% (n = 12) continued fremanezumab 675 mg until study termination. Among those patients who remained on fremanezumab for two years, seven updated the monthly headache calendars consistently: 2 had CM, and 5 had EM. Mean changes in MMD from the baseline were − 2.2 at 3 months,, -1.8 at 12 months, and − 1.6 (SD = 3.0) at 2 years. Treatment was discontinued because of sustained improvement in 25.9% (n = 7). 22.2% of cases (n = 6) experienced insufficient effectiveness, resulting in discontinuation. One patient (3.7%) discontinued because of injection-site erythema. One patient (3.7%) was discontinued because of pregnancy. Among the non-responders, three switched from fremanezumab to erenumab, with one returning to fremanezumab at a monthly injection of 225 mg after efficacy with erenumab waned. Two patients switched to galcanezumab. All patients who switched medication continued the new medication owing to its effectiveness. One patient was lost to follow-up.

Conclusions

Fremanezumab 675 mg quarterly dose effectively reduces headache frequency over an extended period and may facilitate medication cessation in patients who experience substantial recovery.

Peer Review reports

Background

Migraine is a common primary headache disorder characterized primarily by episodic attacks of moderate to severe throbbing pain, often accompanied by nausea, photophobia, phonophobia, sleep disturbances, and sometimes psychiatric comorbidities such as depression or panic disorder [1,2,3,4,5]. Globally, migraine has a prevalence that affects over one billion individuals, approximately 5–10% in Asia and 10–15% in the United States and Europe, having a female predominance with peak age 25–55 years [6,7,8,9,10].

A deeper understanding of migraine pathophysiology, particularly the key role of calcitonin gene-related peptide (CGRP), has facilitated the development of targeted preventive therapies [11, 12]. Monoclonal antibodies against the CGRP pathway (erenumab, galcanezumab, and fremanezumab) have demonstrated efficacy in randomized controlled trials for both chronic migraine (CM) and episodic migraine (EM) [11, 13]. Fremanezumab, galcanezumab, and erenumab are all monoclonal antibodies targeting the CGRP pathway, but they act at slightly different sites. Erenumab binds to and blocks the CGRP receptor, whereas fremanezumab and galcanezumab bind to the CGRP ligand itself, preventing it from interacting with its receptor [14,15,16]. In terms of dosing, fremanezumab can be administered subcutaneously (225 mg monthly or 675 mg quarterly) [17]; galcanezumab is generally given at 120 mg monthly (following a 240 mg loading dose) [18]; and erenumab is available in 70 mg or 140 mg monthly doses [19]. These distinct mechanisms and dosing regimens provide clinicians with tailored options for preventing migraine, depending on individual patient needs with the background of similar effectiveness and persistence among those drugs [20, 21].

Real-world evidence supporting fremanezumab’s effectiveness and safety has been increasing; however, most available data are limited to an observation period of 3–6 months [12, 22,23,24,25]. Long-term data, particularly beyond 1 year, remain scarce. Additionally, although the 675 mg quarterly regimen offers potential advantages in terms of reduced injection frequency, evidence regarding its associated long-term adherence and efficacy is still insufficient [26].

Therefore, in this single-center prospective study, we aimed to evaluate the 2-year efficacy of- and adherence to quarterly 675 mg fremanezumab administration in patients with CM and those with EM. Therefore, this study may offer valuable insights into the long-term efficacy and adherence of fremanezumab in a real-world setting.

Methods

Study design and participants

We conducted a 2-year, single-center, prospective, observational study at the outpatient headache clinic of the Japanese Red Cross Society Shizuoka Hospital in Shizuoka, Japan. We enrolled patients aged ≥ 18 years with CM or EM who were eligible to receive quarterly dosing of 675 mg fremanezumab for preventive treatment, from November 2021 to June 2022.

Treatment and assessments

Each participant was instructed to maintain a headache diary to record the frequency and severity of headache attacks, as well as any adverse events. For EM, ‘effectiveness’ was defined as a ≥ 50% reduction in monthly migraine days (MMD) compared to baseline, while for CM, it was defined as a ≥ 50% reduction in moderate-to-severe headache days (MSHD) per month. We evaluated the effectiveness and adverse events every 12 weeks. The observation period ended for each patient at 24 months after treatment initiation. Among patients who discontinued fremanezumab, the reasons for discontinuation were documented based on follow-up medical records.

Outcomes

The primary outcomes were (1) the 2-year adherence, defined as the proportion of patients who continued fremanezumab for 2 years, and (2) the ‘effectiveness’, defined as the proportion of patients achieving ≥ 50% reduction in MMD for both CM and EM at the 2-year mark. The secondary outcomes included (1) mean changes in MMD and MSHD from baseline to 2 years, (2) the predictive value of being a responder at 3 months for 12-month and two-year response, and (3) the reasons for discontinuation.

Statistical analysis

Descriptive statistics were used to summarize baseline characteristics and outcome measures. Continuous variables are expressed as means (standard deviation, SD), while categorical variables are expressed as frequencies (percentage). Subgroup analyses were performed for sex (female vs. male) and migraine type (CM vs. EM). All statistical analyses were performed using Fisher’s exact test (js-STAR XR + release 2.1.3), and a p-value < 0.05 was considered statistically significant.

Results

Patient characteristics

A total of 28 patients (age range, 17–66 years; 24 females and 4 males) were enrolled. Fifteen had CM, and 12 had EM. One patient with CM was excluded from the analysis due to withdrawal after the first injection, resulting in 27 patients for the final analysis. Over the course of the study, the mean (SD) observation period was 15.6 (9.8) months. One patient experienced injection-site erythema after the initial dose, but no other severe adverse events were reported (Fig. 1; Table 1).

Fig. 1
figure 1

Study flowchart. CM, chronic migraine; EM, episodic migraine

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Table 1 Demographic and clinical characteristics of the patients
Full size table

Primary outcomes

Adherence

Among the 27 patients involved in the analysis, 12 (44.4%) continued fremanezumab treatment through 2 years, while 15 (55.5%) discontinued before the 2-year mark.

Effectiveness

Based on MMD, Ten EM patients (83.3%) met the ≥ 50% reduction criteria in MMD, while 7 CM patients (46.7%) met the ≥ 50% reduction criteria in MMD during the treatment.

Subgroup analyses

Females vs. Males

among the 23 female patients, 18 (78.3%) showed ≥ 50% improvement; 8 of these 20 patients discontinued treatment due to sustained improvement. Contrastingly, of the four male patients, only one (25.0%) achieved ≥ 50% improvement, and he discontinued treatment after sustained clinical benefit. The remaining 3 (75.0%) males were categorized as non-responders. There was no significant difference between female and male groups (p = 0.0646) (Table 2).

Table 2 Adherence and effectiveness according to types of headaches and sex
Full size table

CM vs. EM

Of the 15 patients with CM, 7 (46.7%) achieved ≥ 50% improvement in MMD, with 2 continuing due to significant improvement in severity of headache (i.e. 9 in total (60.0%) continued due to effectiveness) and with 4 (26.7%) discontinuing due to sustained improvement. Among the 12 patients with EM, 10 (83.3%) achieved ≥ 50% improvement, of whom 3 (25.0%) discontinued due to sustained improvement. Ten patients (both CM and EM) also met the criteria for medication-overuse headache; 8 (80.0%) of these patients responded and showed reduced medication use. There was no significant difference between the CM and EM subgroups (p = 0.1819) (Table 2). The recommendations of the International Headache Society, as past Japanese RCTs have evaluated CM using headache days of at least moderate severity and EM using migraine days [27, 28]. Based on these endpoints, ten EM patients (83.3%) met the ≥ 50% reduction criteria in MMD, while nine CM patients (60.0%) met the ≥ 50% reduction criteria in MSHD over the course of treatment (Appendix Fig. 1).

Secondary outcomes

Twelve patients remained on fremanezumab at the 2 years mark; seven of these, 5 EM and 2 CM, updated the monthly headache calendars consistently. Five other patients stopped updating the headache diaries after their symptoms significantly improved.

Mean changes from baselines

Mean changes in MMD from the baseline were − 2.2 (SD = 2.0) at 3 months, -1.6 (SD = 3.0) at 6 months, -0.7 (SD = 2.8) at 9 months, -1.8 (SD = 3.6) at 12 months, -2.4 (SD = 1.7) at 15 months, -1.8 (SD = 3.0) at 18 months, -1.2 (SD = 3.0) at 21 months, and − 1.6 (SD = 3.0) at 2 years (Fig. 2A). Mean changes in MSHD from the baseline were − 2.9 (SD = 9.8) at 3 months, -3.9 (SD = 11.0) at 6 months, -1.7 (SD = 8.4) at 9 months, -3.2 (SD = 9.5) at 12 months, -3.9 (SD = 9.2) at 15 months, -2.8 (SD = 7.8) at 18 months, -2.9 (SD = 6.1) at 1 months, and − 2.9 (SD = 7.7) at 2 years (Fig. 2B).

Predictive value of being a responder at 3 months for two-year response

Of these 7 patients being recorded for two years constantly, 3 patients (0 CM and 3 EM) were ≧ 50% responders of MMD at 3 months. Among them, all patient remain the responder at 12 months timepoint, while one patient became out of responder criteria at 2 years. On the contrary, one EM patient who did not met criteria of ≧ 50% responder of MMD at 3 months became the responder at 12 months timepoint and remains the responder at 2years (‘late responder’).

Reasons for discontinuation

There are seven (25.9%) patients who discontinued treatment due to sustained improvement (‘recovery’). Those seven patients had a mean (SD) treatment duration of 7.8 (7.9) months. After the recovery, four of them ceased the follow-up at our outpatient clinic, while three others continued the follow-up without preventive medications. Conversely, 6 (22.2%) patients experienced insufficient effectiveness (mean treatment duration, 4.5 [3.6] months) and 1 (3.7%) patient experienced adverse effect (injection-site erythema) after the initial dose, both resulting in discontinuation. Another one (3.7%) patient discontinued treatment due to pregnancy. Among the non-responders (n = 6), 3 (50.0%), including one due to adverse effect, switched to erenumab, 2 (33.3%) switched to galcanezumab, and 1 (16.7%) was lost to follow-up. Of the three patients who switched to erenumab, two remained on erenumab at the end of this study, while one returned to fremanezumab at a monthly injection of 225 mg after efficacy with erenumab waned. Both patients who switched to galcanezumab continued therapy with favorable responses.

Fig. 2
figure 2

Changes of headache days among patients who continuously followed headache dairy for two years. A: MMD in CM and EM. B: MSHD in CM and EM. CM: chronic migraine. EM: episodic migraine. MMD: monthly headache days. MSHD: moderate-to-severe headache days

Full size image

Discussion

Real-world evidence supporting the effectiveness of fremanezumab has been accumulating worldwide, particularly for both the 225 mg monthly and 675 mg quarterly dosing schedules. However, fewer studies have focused on the 675 mg quarterly regimen specifically. For instance, in the HALO-CM trial, the mean change in MSHDs at 3 months was reported to be -4.3 ± 0.3, with a 50% responder rate of 37.6% [13]. Similarly, the HALO-EM study showed a -3.4 reduction in MMDs at 3 months and a 50% responder rate of 44.4% [11]. In Japan, Suzuki et al. documented mean reductions in MMDs: -6.5 ± 2.7 at 3 months and − 6.9 ± 2.3 at 6 months for EM and − 8.5 ± 5.1 at 3 months and − 9.7 ± 5.3 at 6 months for CM, without significant differences between monthly and quarterly dosing groups [23].

Although these findings highlight the short-term efficacy of fremanezumab, particularly over 3–6 months, data on its longer-term effectiveness and adherence—especially for the 675 mg quarterly regimen—are scarce. To our knowledge, only two real-world studies in Japan have analyzed quarterly dosing schedules, one of which was by Ohtani et al. They examined 43 patients over 3 months, where 10 received the 675 mg quarterly dose (5 with EM and 5 with CM), showing a reduction in MMDs up to 8.4 days with a 50% responder rate of 55.6% (22). In Europe, Grazzi et al. reported 12-month changes of monthly headache from the baselines for 12 months among patients receiving anti-CGRP antibody, including fremanezumab (dosing unclear), galcanezumab and erenumab, comparing its efficacy with Onabotulinum toxin A [29]. They showed reduction of monthly headache days from the baseline: -11.5 at 6 months and − 11.9 at 12 months. The 50% responder rate of monthly headache days were 76.8% and 71.0%, respectively, both of which are superior to those who received Onabotulinum toxin A. In Australia, Ray et al. also showed the 12-month efficacy and adherence of anti-CGRP antibody, including fremanezumab (dosing unclear) and galcanezumab, in the real-world settings [10]. 58.1% continued treatment during 12-month follow-up period. They showed ≧ 50% response of 52.4% at 3 months and achieved 80% at 12 months of the treatment with no significant difference in efficacy and adherence between fremanezumab and galcanezumab. They showed that there is no statistical agreement of 3-month responder as a predictive value for long-term efficiency. On the other hand, multicenter cohort study was produced by Barbanti et al., showing that half of non-responders of anti-CGRP antibodies including erenumab, galcanezumab, and fremanezumab became late responders after 24 weeks of continuation [30]. Our study not only shows that the responders at 3 months are keeps the responsiveness at 2 years, but also suggests that late-responders within two years may also exist.

Our study thus provides the first real-world, single-center evidence of yearly adherence to- and effectiveness of the 675 mg quarterly regimen. Notably, we observed that treatment was discontinued not only due to ineffectiveness but also due to patient-reported “recovery,” underscoring a potential benefit whereby some patients may achieve sufficient improvement to warrant cessation. Additionally, several patients who discontinued fremanezumab due to insufficient effect transitioned successfully to other CGRP-targeted antibodies (erenumab or galcanezumab), suggesting that switching agents may be a viable strategy in refractory cases, as suggested in previous studies [31, 32].

Nevertheless, there are several limitations of this study. There are limited number of patients who continuously recorded the monthly headache days, along with the painkiller usage details, including type of medications and frequency of usage. Since only two CM patients existed to be followed up for two years constantly, it was insufficient to employ the continuous variables including t-test or Mann-Whitney U-test to evaluate if reductions of MHD and MSHD were statistically significant. Further evaluation is warranted to clarify long-term outcomes, including the impact on medication-overuse headache, accompanying symptoms (e.g., prodrome or aura), and health-related quality of life. Direct comparisons between the 675 mg quarterly- and 225 mg monthly schedules in a larger, multicenter setting will also be essential to establish optimal treatment strategies for CM and EM.

Conclusions

This single-center observational study demonstrated that fremanezumab at a 675 mg quarterly dose effectively reduces headache frequency over an extended period and may facilitate medication cessation in patients who experience substantial recovery. These real-world findings underscore the potential of quarterly fremanezumab as a long-term prophylactic option for both CM and EM, although further research is needed to confirm these results in larger, multicenter populations.

Data availability

No datasets were generated or analysed during the current study.

Abbreviations

CGRP:

calcitonin gene-related peptide

CM:

chronic migraine

EM:

episodic migraine

MMD:

monthly migraine days

MSHD:

moderate-to-severe headache days

SD:

standard deviation

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Authors and Affiliations

  1. Japanese Red Cross Society Shizuoka Hospital, Shizuoka, Japan

    Shohei Yoshida, Noboru Imai, Masato Keicho, Jun Kamimura, Asami Moriya, Nobuyasu Yagi, Rieko Suzuki, Takashi Konishi & Masahiro Serizawa

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  1. Shohei Yoshida
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  2. Noboru Imai
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  3. Masato Keicho
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  4. Jun Kamimura
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Contributions

Noboru Imai designed and conceptualized this study. Shohei Yoshida acquired data. Masato Keicho, Jun Kamimura, Asami Moriya, Nobuyasu Yagi, Rieko Suzuki, Takashi Konishi, Masahiro Serizawa revised the manuscript for intellectual content. The authors have read and approved the final manuscript.

Corresponding author

Correspondence to Shohei Yoshida.

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Ethics approval and consent to participate

This study was approved by Ethics Committee of Japanese Red Cross Society Shizuoka Hospital (approval number: 2018-21). Patients were informed about this observational study via the questionnaire of the headache outpatient clinic, and they could opt out of this study. The need for informed consent was waived by Japanese Red Cross Society Shizuoka hospital in accordance with national regulations (Ethical Guidelines for Medical and Biological Research Involving Human Subjects). All methods were carried out in accordance with relevant guidelines and regulations.

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Competing interests

Noboru Imai reports being an advisor for Sawai and received speaker fees from Daiichi Sankyo, Eli Lilly, Otsuka, and Amgen; however, these companies had no relation to the study.

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Yoshida, S., Imai, N., Keicho, M. et al. Efficacy and continuability of 675 mg fremanezumab administration over 2 years. J Headache Pain 26, 51 (2025). https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s10194-025-01994-5

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  • DOI: https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s10194-025-01994-5

Keywords

The Journal of Headache and Pain

ISSN: 1129-2377

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