Galcanezumab for the Management of Migraine: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials

Abu‐Zaid, Ahmed; AlBatati, Saud K; AlHossan, Abdullah M; AlMatrody, Rayan A; AlGzi, Ayman; Al-Sharief, Rayan A; Alsobyani, Faris M; Almubarak, Amena Faiq; Alatiyah, Nadeen S

doi:10.7759/cureus.11621

Cited by 7 publications

(6 citation statements)

References 28 publications

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“…In patients with chronic migraine who have only had a partial response to Botox, adjunctive preventative therapy with a CGRP-mAb drug is safe and effective. The CGRP-mAbs considerably decreased the number of headache days and pain severity, according to the researchers, with adverse event rates comparable to those seen in prior studies of these drugs [15].…”

Section: Botox Vs Anti-cgrpsupporting

confidence: 71%

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Long-Term Management of Migraine With OnabotulinumtoxinA (Botox) vs Calcitonin Gene-Related Peptide Antibodies (Anti-CGRP)

Pallapothu,

Quintana Mariñez,

Chakkera

et al. 2023

Cureus

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In this literature review, we will evaluate the effectiveness of OnabotulinumtoxinA (Botox) and anticalcitonin gene-related peptide (anti-CGRP) in the treatment of migraine headaches. Both therapies are frequently prescribed for managing and preventing migraines and have received Food and Drug Administration (FDA) approval. The mechanism of action, side effects, compliance, cost-effectiveness, and migraine treatment provided by these two medicines were compared in the analysis of several studies. Many studies found that as Botox was administered by a doctor every three months and had fewer side effects than anti-CGRP, which is self-administered every month, it was more compliant than anti-CGRP. After examining the data, Botox is believed to be the most effective therapy. Although both therapies are efficient, this article compares them to determine which is the best management strategy.

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Section: Botox Vs Anti-cgrpsupporting

confidence: 71%

“…About 61% of participants in the 240mg group reported a 50 percent decrease in headaches [1]. It has appeared to be valuable in the anticipation and treatment of migraines [15]. In expansion, 62.3% of those given 120mg detailed the same.…”

Section: Anti-cgrp Mechanism Of Actionmentioning

confidence: 99%

Long-Term Management of Migraine With OnabotulinumtoxinA (Botox) vs Calcitonin Gene-Related Peptide Antibodies (Anti-CGRP)

Pallapothu,

Quintana Mariñez,

Chakkera

et al. 2023

Cureus

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“…In a meta-analysis of EM studies, the frequency of these events in antibody-treated patients (nasopharyngitis, 6.3%; upper respiratory tract infection, 6.9%) was comparable to that of placebo patients (nasopharyngitis, 6.7%; upper respiratory tract infection, 5.9%) [ 6 ]. However, other recent meta-analyses have suggested a possible association between upper respiratory infections and erenumab [ 25 ] and galcanezumab [ 26 , 27 ]. In the present pooled analysis of eptinezumab studies, the rates of nasopharyngitis (eptinezumab, 6.7%; placebo, 5.2%) and upper respiratory tract infection (eptinezumab, 7.6%; placebo, 6.1%) were similar to the EM meta-analysis [ 6 ].…”

Section: Discussionmentioning

confidence: 99%

Safety and tolerability of eptinezumab in patients with migraine: a pooled analysis of 5 clinical trials

Smith

Spierings²,

Cady

et al. 2021

J Headache Pain

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Background The humanized anti-CGRP monoclonal antibody eptinezumab has been evaluated in five large-scale clinical trials conducted in patients with migraine. This integrated analysis was conducted to evaluate the comprehensive safety and tolerability of eptinezumab in patients with migraine across these studies. Methods Data were pooled from four randomized, double-blind, placebo-controlled studies and the first year of one open-label study. Results The pooled population comprised 2867 adults with migraine: eptinezumab, n = 2076 (4797 infusions); placebo, n = 791 (1675 infusions). A total of 1137/2076 (54.8%) patients who received eptinezumab and 414/791 (52.3%) patients who received placebo experienced ≥1 treatment-emergent adverse event (TEAE); rates were similar across eptinezumab dose groups (10–1000 mg). For most patients with TEAEs, the events were mild or moderate in severity and considered unrelated to study drug by the investigators. Thirty infusion-site AEs occurred in 27/2076 (1.3%) patients who received eptinezumab and 7 in 7/791 (0.9%) patients who received placebo. Infusion-site AEs led to infusion interruption in 19/2076 (0.9%) and 5/791 (0.6%) patients in the eptinezumab and placebo groups, respectively. Nasopharyngitis occurred in ≥2% of patients in the eptinezumab 300-mg group and with an incidence of at least 2 percentage points greater than in the placebo group; however, in most patients (eptinezumab, 139/140; placebo 40/41), its occurrence was considered not related to study treatment. Adverse events coded to hypersensitivity occurred for 23/2076 (1.1%) patients treated with eptinezumab and no patients in the placebo group. If additional TEAE terms that could indicate hypersensitivity are considered (e.g., urticaria, flushing/hot flush, rash, and pruritus), hypersensitivity reactions in the two pivotal placebo-controlled phase 3 studies occurred in ≥2% of patients in the eptinezumab 100-mg and 300-mg groups, and the incidence was at least 2 percentage points greater in either of these groups than in the placebo group. Most hypersensitivity reactions were not serious and resolved with standard medical treatment or observation without treatment, usually within 1 day. Conclusions In adults with migraine, the intravenous administration of eptinezumab every 12 weeks demonstrated a favorable safety and tolerability profile. Trial registration ClinicalTrials.gov (Identifiers: NCT01772524, NCT02275117, NCT02559895, NCT02974153, NCT02985398).

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“…In their meta-analysis, Abu-Zaid et al [40] found that 120 and 240 mg galcanezumab decreased the MHDs, MHDs with acute medication use, and severity score. Quality-of-life and disability scores were significantly better with the 240 mg galcanezumab only.…”

Section: Discussionmentioning

confidence: 99%

Safety and efficacy of galcanezumab in chronic and episodic migraine patients: a systematic review and meta-analysis of randomized controlled trials

Zaazouee,

Ebrahim,

Al-araj

et al. 2024

Egypt J Neurol Psychiatry Neurosurg

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Background The humanized monoclonal antibody galcanezumab is an anti-calcitonin-gene-related-peptide (CGRP) and frequently used for migraine prevention. However, the literature revealed limited data with conflicting results. This study aims to assess the safety and efficacy of galcanezumab in treating patients with episodic or chronic migraine. Methods We searched for randomized controlled trials till September 2022 from six databases (Cochrane library, Embase, PubMed, Web of Science, Scopus, and Clinicaltrials.gov registry). Our primary outcomes were the change in the number of monthly migraine headache days (MHDs) and adverse events. We extracted the data and analyzed it by RevMan (5.4) software. Results Eight studies with 4964 patients were included. Galcanezumab (≥ 120 mg) significantly reduced the MHDs for six months in migraine patients compared to placebo. The monthly risk ratio (RR) ranged from − 2.33 to − 1.62 for episodic migraine and − 2.86 to − 2.44 for chronic migraine. The response rate of ≥ 50%, ≥ 75% and 100% were higher with galcanezumab groups. The rate ranged from 1.72 to 4.19 for episodic migraine and 1.84 to 2.47 for chronic migraine. It is generally safe except for injection site safety outcomes (erythema, reaction, pruritis, and swelling), the results were significantly higher with galcanezumab groups. It appears dose independent except for injection site reaction, which showed higher with galcanezumab 120 mg only. Furthermore, any adverse events, serious adverse events (SAE) and that led to discontinuation were higher with galcanezumab 240 mg. Conclusion Galcanezumab is effective in patients with episodic or chronic migraine after one to six months use. It reduced MHDs and had an effective response rate. Moreover, it is generally safe except for injection site adverse events, and SAE, especially with galcanezumab 240mg.

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Galcanezumab for the Management of Migraine: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials

Abstract: Abu-Zaid et al. This is an open access article distributed under the terms of the Creative Commons Attribution License CC-BY 4.0., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Cited by 7 publications

References 28 publications

Long-Term Management of Migraine With OnabotulinumtoxinA (Botox) vs Calcitonin Gene-Related Peptide Antibodies (Anti-CGRP)

Long-Term Management of Migraine With OnabotulinumtoxinA (Botox) vs Calcitonin Gene-Related Peptide Antibodies (Anti-CGRP)

Safety and tolerability of eptinezumab in patients with migraine: a pooled analysis of 5 clinical trials

Safety and efficacy of galcanezumab in chronic and episodic migraine patients: a systematic review and meta-analysis of randomized controlled trials

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