Real-world evidence of fremanezumab for treating migraine in Japan: a retrospective study.
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ABSTRACT: Background
There have been very few real-world studies reported in the literature solely focusing on fremanezumab in Asia. This study aimed to evaluate the efficacy and safety of fremanezumab in a real-world setting in Japan.Method
This single-centered, observational, retrospective study examined patients with migraines who received four doses of fremanezumab between December 2021 and August 2022 at Keio University Hospital. We assessed the changes in monthly migraine days, responder rates, and migraine-associated symptoms, as well as injection site reactions and adverse events.Result
Twenty-nine patients were enrolled, wherein 79.3% were women. Compared with those at baseline, the monthly migraine days decreased by 5.9 days at 4 months. The 50% responder rate was 55.2% at 4 months. A total of 57.9%, 47.8%, and 65.0% of patients showed improvement in the severity of photophobia, phonophobia, and nausea/vomiting, respectively. Moreover, injection site reactions were the most common adverse events (55.2%).Conclusion
Fremanezumab is effective and safe for migraine prevention in Japan. Fremanezumab also improved migraine-associated symptoms in half of the patients.
SUBMITTER: Ohtani S
PROVIDER: S-EPMC10644569 | biostudies-literature | 2023 Nov
REPOSITORIES: biostudies-literature
Publications
Real-world evidence of fremanezumab for treating migraine in Japan: a retrospective study.
Ohtani Seiya S Watanabe Narumi N Ihara Keiko K Takahashi Nobuyuki N Miyazaki Naoki N Ishizuchi Kei K Takemura Ryo R Hori Satoko S Nakahara Jin J Takizawa Tsubasa T
BMC neurology 20231114 1
<h4>Background</h4>There have been very few real-world studies reported in the literature solely focusing on fremanezumab in Asia. This study aimed to evaluate the efficacy and safety of fremanezumab in a real-world setting in Japan.<h4>Method</h4>This single-centered, observational, retrospective study examined patients with migraines who received four doses of fremanezumab between December 2021 and August 2022 at Keio University Hospital. We assessed the changes in monthly migraine days, respo ...[more]
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Project description:BackgroundThe efficacy and tolerability of fremanezumab, a fully humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP) and is approved for the preventive treatment of migraine in adults, have been demonstrated in randomized, double-blind, placebo-controlled trials. Real-world data can further support those clinical trial data and demonstrate the full clinical benefits of fremanezumab. This chart review assessed the effectiveness of fremanezumab for improving clinical outcomes in adult patients with migraine treated according to real-world clinical practice.MethodsThis retrospective, panel-based, online physician chart review study used electronic case report forms with US physicians. Patient inclusion criteria were a physician diagnosis of migraine, fremanezumab treatment initiation at ≥ 18 years of age after US Food and Drug Administration approval, ≥ 1 dose of fremanezumab treatment, and ≥ 2 assessments of monthly migraine days (MMD; 1 within 30 days before treatment initiation and ≥ 1 after initiation). Changes from baseline in MMD, monthly headache days (MHD), and Migraine Disability Assessment (MIDAS) and 6-item Headache Impact Test (HIT-6) scores were assessed over 6 months. These endpoints were evaluated in the overall population and subgroups divided by dosing schedule and number of prior migraine preventive treatment failures.ResultsThis study included data from 421 clinicians and 1003 patients. Mean age at fremanezumab initiation was 39.7 years, and most patients were female (75.8%). In the overall population, mean baseline MMD and MHD were 12.7 and 14.0, respectively. Mean (percent) reductions from baseline in MMD and MHD, respectively, were - 4.6 (36.2%) and - 4.7 (33.6%) at Month 1, - 6.7 (52.8%) and - 6.8 (48.6%) at Month 3, and - 9.2 (72.4%) and - 9.8 (70.0%) at Month 6. Mean (percent) reductions from baseline in MIDAS and HIT-6 scores also increased over the 6-month study period, from - 6.2 (21.6%) and - 8.4 (14.0%) at Month 1 to - 18.1 (63.1%) and - 16.2 (27.0%) at Month 6, respectively. Improvements in these outcomes over 6 months were observed across all evaluated subgroups.ConclusionsThis real-world study demonstrated effectiveness of fremanezumab treatment for up to 6 months, irrespective of dosing regimen or number of prior migraine preventive treatment failures, reflecting ongoing, clinically meaningful improvements in patient outcomes.
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Project description:BackgroundThe effectiveness of fremanezumab in treating migraine has been demonstrated in randomized controlled trials. However, real-world study results are still limited.MethodsWe conducted a single-center, observational study that included patients with episodic migraine (EM) and chronic migraine (CM) who received fremanezumab monthly or quarterly over 6-month periods. The primary outcome of this study was to evaluate changes in monthly migraine days (MMD) and responder achievement after treatment with fremanezumab. The secondary aim was to characterize the predictors of responder at 6 months. We also evaluated the effectiveness of fremanezumab in the patients who switched from other calcitonin gene-related peptide (CGRP) monoclonal antibodies, and compared the effectiveness of fremanezumab between the monthly and quarterly dosing groups. One hundred twenty-seven patients with migraine (age, 45.2 ± 12.6 years; 96 women) who received at least one dose of fremanezumab with ≥3 months of follow-up were included. The number of MMD was assessed by headache diary.ResultsThe changes in MMD from baseline at 1, 3, and 6 months were -6.1 ± 4.7, -7.7 ± 4.4, and - 8.5 ± 4.5 days in the total cohort, respectively (p < 0.001). The ≥50%, ≥ 75 and 100% responder rates at 6 months were 67.6, 22.5, and 5.4% in the total cohort, 90.4, 36.5, and 9.6% in the EM group, and 52.2, 14.9, and 1.5% in the CM group, respectively. Fremanezumab was also effective in 35 patients who switched from other CGRP monoclonal antibodies. Quarterly and monthly fremanezumab doses were equally effective in MMD reduction in the EM and CM groups. In the CM group, 65.1% experienced remission to EM after 6 months. Adverse reactions were mild and occurred in 9.5% of total patients. An at least ≥50% reduction in MMD from months 1 to 3 better predicted a ≥ 50% reduction in MMD at 6 months with 90.5% sensitivity and 80.6% specificity (p < 0.001).ConclusionIn our real-world study, quarterly and monthly fremanezumab dosing showed both favorable effectiveness and tolerability in patients with migraine.
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