Unveiling the efficacy and safety of Erenumab, a monoclonal antibody targeting calcitonin gene-related peptide (CGRP) receptor, in patients with chronic and episodic migraine: a GRADE-assessed systematic review and meta-analysis of randomized clinical trials with subgroup analysis

Abstract Background Migraine is a highly prevalent and disabling disease, affecting nearly 14% of the global population. Preventive medications involve drugs like beta-adrenergic blockers, antidepressants, and anticonvulsants. However, these drugs lacked effectiveness, and patients showed poor toler...

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Main Authors: Mohamed E. Haseeb, Hazem E. Mohammed, Hatem Yaser, George Hanen, Mohamed Nasser, Shehab Yaser, Zeyad Bady
Format: Article
Language:English
Published: BMC 2025-03-01
Series:Head & Face Medicine
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Online Access:https://doi.org/10.1186/s13005-025-00494-w
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author Mohamed E. Haseeb
Hazem E. Mohammed
Hatem Yaser
George Hanen
Mohamed Nasser
Shehab Yaser
Zeyad Bady
author_facet Mohamed E. Haseeb
Hazem E. Mohammed
Hatem Yaser
George Hanen
Mohamed Nasser
Shehab Yaser
Zeyad Bady
author_sort Mohamed E. Haseeb
collection DOAJ
description Abstract Background Migraine is a highly prevalent and disabling disease, affecting nearly 14% of the global population. Preventive medications involve drugs like beta-adrenergic blockers, antidepressants, and anticonvulsants. However, these drugs lacked effectiveness, and patients showed poor tolerance and low adherence to them. Erenumab, a calcitonin gene-related peptide receptor blocker, has recently shown promising results in migraine management. In this meta-analysis, the efficacy of Erenumab is investigated by employing a subgroup analysis approach. Methods We conducted a systematic search of six electronic databases until July 2024. Review Manager 5.4 software was utilized for the analysis, based on either weighted mean difference (MD) and standard deviation (SD) for continuous outcomes or risk ratio (RR) for dichotomous outcomes, with a confidence interval (CI) of 95%. A P-value < 0.05 indicated statistical significance. The study was registered on PROSPERO with registration number CRD42024573300. Additionally, we conducted subgroup analyses and assessed the quality of evidence using GRADE. Results A total of 20 randomized controlled trials (n = 5212) were included in our analysis. At three months, Erenumab showed statistically significant improvements in monthly migraine days (MMD), monthly acute migraine-specific medication days (MSMD), Headache Impact Test (HIT-6) score, and ≥ 50% reduction from baseline in MMD (MD: -1.78, 95% CI: [-2.37 to -1.20], P < 0.00001), (MD: -1.36, 95% CI: [-1.92 to -0.81], P < 0.00001), (MD: -2.83, 95% CI: [-3.83 to -1.82], P < 0.00001), and (RR: 1.52, 95% CI: [1.31 to 1.76], P < 0.00001), respectively. Subgroup analysis revealed that Erenumab was significantly more effective in patients with prior preventive treatment failures compared to patients with no prior failure. No significant difference in Erenumab`s response existed between episodic and chronic migraine or between 140 and 70 mg, except for MSMD in dose subgrouping. Only constipation emerged as a significant adverse effect in the Erenumab group. Conclusions This meta-analysis found that Erenumab significantly reduced migraine attack frequency, medication days, and physical impairment. It was more effective for patients with prior treatment failures. The 140 mg dose showed better MSMD reduction than 70 mg. Erenumab's safety profile was similar to that of placebo, with only constipation noted as significant.
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spelling doaj-art-152576344c4f4c68848f89c2ba22f1ca2025-08-20T02:49:06ZengBMCHead & Face Medicine1746-160X2025-03-0121112410.1186/s13005-025-00494-wUnveiling the efficacy and safety of Erenumab, a monoclonal antibody targeting calcitonin gene-related peptide (CGRP) receptor, in patients with chronic and episodic migraine: a GRADE-assessed systematic review and meta-analysis of randomized clinical trials with subgroup analysisMohamed E. Haseeb0Hazem E. Mohammed1Hatem Yaser2George Hanen3Mohamed Nasser4Shehab Yaser5Zeyad Bady6Faculty of Medicine, Minia UniversityFaculty of Medicine, Assiut UniversityFaculty of Medicine, Assiut UniversityFaculty of Medicine, Minia UniversityFaculty of Medicine, Minia UniversityFaculty of Medicine, Assiut UniversityFaculty of Medicine, Assiut UniversityAbstract Background Migraine is a highly prevalent and disabling disease, affecting nearly 14% of the global population. Preventive medications involve drugs like beta-adrenergic blockers, antidepressants, and anticonvulsants. However, these drugs lacked effectiveness, and patients showed poor tolerance and low adherence to them. Erenumab, a calcitonin gene-related peptide receptor blocker, has recently shown promising results in migraine management. In this meta-analysis, the efficacy of Erenumab is investigated by employing a subgroup analysis approach. Methods We conducted a systematic search of six electronic databases until July 2024. Review Manager 5.4 software was utilized for the analysis, based on either weighted mean difference (MD) and standard deviation (SD) for continuous outcomes or risk ratio (RR) for dichotomous outcomes, with a confidence interval (CI) of 95%. A P-value < 0.05 indicated statistical significance. The study was registered on PROSPERO with registration number CRD42024573300. Additionally, we conducted subgroup analyses and assessed the quality of evidence using GRADE. Results A total of 20 randomized controlled trials (n = 5212) were included in our analysis. At three months, Erenumab showed statistically significant improvements in monthly migraine days (MMD), monthly acute migraine-specific medication days (MSMD), Headache Impact Test (HIT-6) score, and ≥ 50% reduction from baseline in MMD (MD: -1.78, 95% CI: [-2.37 to -1.20], P < 0.00001), (MD: -1.36, 95% CI: [-1.92 to -0.81], P < 0.00001), (MD: -2.83, 95% CI: [-3.83 to -1.82], P < 0.00001), and (RR: 1.52, 95% CI: [1.31 to 1.76], P < 0.00001), respectively. Subgroup analysis revealed that Erenumab was significantly more effective in patients with prior preventive treatment failures compared to patients with no prior failure. No significant difference in Erenumab`s response existed between episodic and chronic migraine or between 140 and 70 mg, except for MSMD in dose subgrouping. Only constipation emerged as a significant adverse effect in the Erenumab group. Conclusions This meta-analysis found that Erenumab significantly reduced migraine attack frequency, medication days, and physical impairment. It was more effective for patients with prior treatment failures. The 140 mg dose showed better MSMD reduction than 70 mg. Erenumab's safety profile was similar to that of placebo, with only constipation noted as significant.https://doi.org/10.1186/s13005-025-00494-wErenumabCGRPMigraineEfficacySafetySystematic review
spellingShingle Mohamed E. Haseeb
Hazem E. Mohammed
Hatem Yaser
George Hanen
Mohamed Nasser
Shehab Yaser
Zeyad Bady
Unveiling the efficacy and safety of Erenumab, a monoclonal antibody targeting calcitonin gene-related peptide (CGRP) receptor, in patients with chronic and episodic migraine: a GRADE-assessed systematic review and meta-analysis of randomized clinical trials with subgroup analysis
Head & Face Medicine
Erenumab
CGRP
Migraine
Efficacy
Safety
Systematic review
title Unveiling the efficacy and safety of Erenumab, a monoclonal antibody targeting calcitonin gene-related peptide (CGRP) receptor, in patients with chronic and episodic migraine: a GRADE-assessed systematic review and meta-analysis of randomized clinical trials with subgroup analysis
title_full Unveiling the efficacy and safety of Erenumab, a monoclonal antibody targeting calcitonin gene-related peptide (CGRP) receptor, in patients with chronic and episodic migraine: a GRADE-assessed systematic review and meta-analysis of randomized clinical trials with subgroup analysis
title_fullStr Unveiling the efficacy and safety of Erenumab, a monoclonal antibody targeting calcitonin gene-related peptide (CGRP) receptor, in patients with chronic and episodic migraine: a GRADE-assessed systematic review and meta-analysis of randomized clinical trials with subgroup analysis
title_full_unstemmed Unveiling the efficacy and safety of Erenumab, a monoclonal antibody targeting calcitonin gene-related peptide (CGRP) receptor, in patients with chronic and episodic migraine: a GRADE-assessed systematic review and meta-analysis of randomized clinical trials with subgroup analysis
title_short Unveiling the efficacy and safety of Erenumab, a monoclonal antibody targeting calcitonin gene-related peptide (CGRP) receptor, in patients with chronic and episodic migraine: a GRADE-assessed systematic review and meta-analysis of randomized clinical trials with subgroup analysis
title_sort unveiling the efficacy and safety of erenumab a monoclonal antibody targeting calcitonin gene related peptide cgrp receptor in patients with chronic and episodic migraine a grade assessed systematic review and meta analysis of randomized clinical trials with subgroup analysis
topic Erenumab
CGRP
Migraine
Efficacy
Safety
Systematic review
url https://doi.org/10.1186/s13005-025-00494-w
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