Direct cost and healthcare resource utilization of patients with migraine before treatment initiation with calcitonin gene-related peptide monoclonal antibodies by the number of prior preventive migraine medication classes

Aim To systematically evaluate the safety and tolerability of calcitonin-gene-related peptide binding monoclonal antibodies from the results of randomized controlled trials. Methods Online databases were searched on calcitonin-gene-related peptide binding monoclonal antibodies for the prevention of episodic migraine. Overall withdrawal, withdrawal due to adverse events, adverse events, serious adverse events and specific adverse events were extracted from the included studies. A meta-analysis was performed with Revman 5.3.0 software. Results Ten studies that investigated four drugs (galcanezumab, erenumab, fremanezumab and eptinezumab) with 5817 participants were included in this study. Serious adverse events, overall withdrawals, withdrawal due to adverse events and any adverse events were not significantly associated with monoclonal antibody treatment. Injection site pain and erythema were significantly higher in the calcitonin-gene-related peptide binding monoclonal antibodies treatment group than in the placebo group. The rates of serious adverse events were significantly higher in the galcanezumab 120 mg group. Injection site erythema was associated with galcanezumab 120 mg and 240 mg. Injection site pain and nasopharyngitis were associated with galcanezumab 150 mg and 5 mg, respectively. Overall adverse events were significantly higher with erenumab 70 mg and 140 mg. Treatment-related adverse events were significantly higher with fremanezumab 225 mg/month and 675 mg/quarter. Conclusions This study provides data on the safety and tolerability profiles of calcitonin-gene-related peptide binding monoclonal antibodies and confirms their potential use as preventive treatments for episodic migraine. In addition to the acceptable withdrawal rates, serious adverse events were rare, and the severity of most adverse events was mild to moderate. Injection site reaction may be the major adverse event associated with galcanezumab.

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How to integrate monoclonal antibodies targeting the calcitonin gene-related peptide or its receptor in daily clinical practice

The Journal of Headache and Pain ◽

10.1186/s10194-019-1000-5 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 14

Author(s):

Cindy Tiseo ◽

Raffaele Ornello ◽

Francesca Pistoia ◽

Simona Sacco

Keyword(s):

Monoclonal Antibodies ◽

Clinical Practice ◽

Calcitonin Gene Related Peptide ◽

Daily Clinical Practice ◽

Related Peptide ◽

Calcitonin Gene

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New Trends in Migraine Pharmacology: Targeting Calcitonin Gene–Related Peptide (CGRP) With Monoclonal Antibodies

Frontiers in Pharmacology ◽

10.3389/fphar.2019.00363 ◽

2019 ◽

Vol 10 ◽

Cited By ~ 19

Author(s):

Damiana Scuteri ◽

Annagrazia Adornetto ◽

Laura Rombolà ◽

Maria Diana Naturale ◽

Luigi Antonio Morrone ◽

...

Keyword(s):

Monoclonal Antibodies ◽

Calcitonin Gene Related Peptide ◽

Related Peptide ◽

Calcitonin Gene

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Calcitonin Gene-Related Peptide Antagonists for the Prevention of Migraine: Highlights From Pivotal Studies and the Clinical Relevance of This New Drug Class

Annals of Pharmacotherapy ◽

10.1177/1060028020903417 ◽

2020 ◽

Vol 54 (8) ◽

pp. 795-803

Author(s):

Karissa Arca ◽

Jenna Reynolds ◽

Kara A. Sands ◽

Harn J. Shiue

Keyword(s):

Monoclonal Antibodies ◽

Adverse Effects ◽

Adverse Events ◽

Clinical Relevance ◽

Drug Class ◽

Calcitonin Gene Related Peptide ◽

Migraine Prophylaxis ◽

Related Peptide ◽

New Drug ◽

Calcitonin Gene

Objective: To review the new drug class of calcitonin gene-related peptide antagonists (monoclonal antibodies) and their clinical relevance in migraine prophylaxis. Data Sources: A literature search was performed in PubMed (January 2009 to November 2019) using the terms migraine, calcitonin gene-related peptide (CGRP), erenumab, fremanezumab, and galcanezumab for clinical trials and studies. Study Selection and Data Extraction: Reports from human studies in English were evaluated for clinical evidence supporting pharmacology, efficacy, and adverse events. Initial pharmacokinetic and preclinical studies were excluded. Data Synthesis: In chronic and episodic migraine, prophylaxis with injections of monoclonal antibodies antagonizing CGRP reduced monthly migraine days with minimal clinically significant adverse events. In addition, there is evidence supporting efficacy in refractory migraine despite optimal prophylaxis. Relevance to Patient Care and Clinical Practice: This is the first target-specific migraine prophylaxis treatment to show efficacy with minimal adverse effects. A higher drug cost is a barrier but is balanced by improved quality of life. Current therapies have limited efficacy and tolerability because of poor side effect profiles. CGRP antagonists represent a shift to more precise migraine treatments. Conclusions: Monoclonal antibodies inhibiting CGRP are effective in migraine prophylaxis with minimal adverse effects. Targeting CGRP is a novel clinical strategy in managing migraine.

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Anti-Calcitonin Gene-Related Peptide Monoclonal Antibodies in the Treatment of Patients With Concussion

Neurology ◽

10.1212/01.wnl.0000801812.93958.f8 ◽

2021 ◽

Vol 98 (1 Supplement 1) ◽

pp. S9.1-S9

Author(s):

Jennifer McVige ◽

Megan Rooney ◽

Dylan Lis

Keyword(s):

Monoclonal Antibodies ◽

Adverse Effects ◽

Retrospective Chart Review ◽

Calcitonin Gene Related Peptide ◽

Mean Difference ◽

Related Peptide ◽

Headache Severity ◽

Calcitonin Gene ◽

Response Switching ◽

Pre Treatment

ObjectiveInvestigate the efficacy of 3 anti-Calcitonin Gene-Related Peptide monoclonal antibodies (anti-CGRP mAbs), fremanezumab, galcanezumab, and erenumab, in concussion patients with post-traumatic headache (PTH) with a migraine phenotype.BackgroundA study using monoclonal antibodies in mice with mild traumatic brain injury saw improvements in cutaneous allodynia.1 A study from Denmark using erenumab for PTH found patients had an 82% decrease in the number of headache days. This study also demonstrated that 44% of patients had a reduction in HIT-6 score = 5 after 9–12 weeks of treatment.2.Design/MethodsRetrospective chart review of patients diagnosed with PTH (n = 168) evaluated HIT-6, number of reported headache days, and the number of modifiable concussion variables (headache, dizziness, attention/concentration deficit, mood and sleep disturbance) prior to initiation of anti-CGRP mAbs and after at least 3 months of treatment were recorded.ResultsPatients saw a decrease in HIT-6 score (p < 0.0001), with a mean difference of −4.26 from pre-treatment to at least 3 months after treatment. When evaluating 5 concussion symptom categories, patients experienced x¯ = 2.35 symptoms prior to anti-CGRP mAbs treatment, and x¯ = 1.67 after at least 3 months of treatment. Patients also experienced a decrease in the number of headache days per month (<0.0001) with a mean difference of −7.25 (range 0–30) headache days per month. Seven patients experienced adverse effects (1 patient had 2 different adverse effects), including injection site rash, fatigue, constipation, and dizziness. Only one patient discontinued medication due to adverse event.ConclusionsAnti-CGRP mAbs used to treat PTH showed improved headache severity and frequency, as well as a decreased number of overall concussion symptoms. There was a subset of patients with a more robust response. Switching anti-CGRP mAbs was beneficial in some patients.

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