Migraine prevention is an area of a large unmet medical need, with existing therapies often having modest efficacy and poor tolerability. Calcitonin gene‐related peptide (CGRP) receptor antagonism is a novel approach to migraine preventive therapy. Erenumab is a human monoclonal antibody against canonical CGRP receptor. The present study is a phase 3 trial intended to assess the efficacy and safety of erenumab for prevention of migraine in Japanese adults with episodic migraine (EM) and chronic migraine (CM). The study consists of a screening period (up to 7 weeks, including a 4‐week baseline period), a 24‐week double‐blind treatment period (DBTP), a 28‐week open‐label treatment period (OLTP), and an 8‐week safety follow‐up period (12 weeks after the last dose of investigational product).

The main purpose of this study is to evaluate the efficacy of erenumab in participants with chronic cluster headache.

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BACKGROUND:

Therapeutic monoclonal antibodies against the calcitonin gene-related peptide (CGRP) receptor or its ligand have changed the landscape of treatment options for migraine. Erenumab is the first and only fully human monoclonal antibody designed to target and block the CGRP receptor. It is approved by the Food and Drug Administration for preventive treatment of migraine in adults. The recommended dose of erenumab is 70 mg monthly, with guidance that some patients may benefit from the 140 mg monthly dose. There is a need for information to guide clinical practice on the comparative efficacy and safety of these two dosing options.

OBJECTIVE:

To evaluate therapeutic and tolerability differences between erenumab 70 and 140 mg based on evidence from published literature.

METHODS:

This narrative review evaluates therapeutic and tolerability differences between erenumab 70 and 140 mg based on a literature search using PubMed interface, Embase and Ovid MEDLINE(R) databases. The key search terms included migraine, AMG 334, AMG334, erenumab, erenumab-aooe, and Aimovig. The search was limited to English language articles or conference abstracts published up to May 2021.

RESULTS:

From the literature search, we retrieved 23 relevant articles/conference abstracts (19 articles [5 randomized, double-blind studies] and 4 conference abstracts) for inclusion in this narrative review. Although the recommended starting dosage of erenumab is 70 mg, this narrative review of the literature indicates that some patients may benefit from a dosage of 140 mg erenumab once monthly-especially those with difficult-to-treat disease and prior treatment failures. The evidence indicates that erenumab at 140 mg has a numerically better efficacy than 70 mg across a broad spectrum of migraine outcomes, including preventing progression to chronic migraine.

CONCLUSION:

Cumulative data from the literature support a therapeutic gain with an increase from erenumab 70 to 140 mg and a rationale for initiating 140 mg in selected patients.

Objective To systematically evaluate the clinical efficacy and safety of erenumab in the preventive treatment of migraine in adults. Methods Taking Erenumab or AMG334 AND Migraine as search terms, retrieve in databases such as PubMed, Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang Data and VIP, and search engines such as Google Scholar, in order to collect randomized controlled trials (RCTs) of erenumab in the preventive treatment of adult migraine from January 1, 2001 to August 1, 2018. Jadad Scale was used to evaluate the quality of literatures. Results A total of 68 English articles were enrolled after preliminary searching, and 4 high-quality RCTs (Jadad score ≥ 4) with a total of 2682 cases (1626 cases in erenumab group and 1056 cases in placebo group) were finally included after excluding duplicates and those not meeting the inclusion criteria. The results were as follows: 1) compared with placebo, erenumab (70 mg/4 weeks or per month, 140 mg/4 weeks) was more effective (effective defined as ≥ 50% reduction from baseline migraine days per month) and showed significantly higher efficacy in reducing migraine days per month, the use of migraine-specific medication, Migraine Physical Function Impact Diary on Everyday Activities and Physical Impairment (MPFID-EA and MPFID-PI) in treating migraine patients. 2) The incidence of adverse reactions was low and mild, and there was no significant difference compared with placebo. Common adverse reactions included injection site pain, upper respiratory tract infection, nasopharyngitis, etc. There were very few patients who discontinued treatment due to adverse drug reactions. Conclusions Erenumab is safe and effective in the preventive treatment of migraine in adults.

Objective: To systematically evaluate the clinical efficacy and safety of erenumab in the preventive treatment of migraine in adults. Methods: Taking Erenumab or AMG334 AND Migraine as search terms, retrieve in databases such as PubMed, Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang Data and VIP, and search engines such as Google Scholar, in order to collect randomized controlled trials (RCTs) of erenumab in the preventive treatment of adult migraine from January 1, 2001 to August 1, 2018. Jadad Scale was used to evaluate the quality of literatures. Results: A total of 68 English articles were enrolled after preliminary searching, and 4 high-quality RCTs (Jadad score ≥ 4) with a total of 2682 cases (1626 cases in erenumab group and 1056 cases in placebo group) were finally included after excluding duplicates and those not meeting the inclusion criteria. The results were as follows: 1) compared with placebo, erenumab (70 mg/4 weeks or per month, 140 mg/4 weeks) was more effective (effective defined as ≥ 50% reduction from baseline migraine days per month) and showed significantly higher efficacy in reducing migraine days per month, the use of migraine-specific medication, Migraine Physical Function Impact Diary on Everyday Activities and Physical Impairment (MPFID -EA and MPFID-PI) in treating migraine patients. 2) The incidence of adverse reactions was low and mild, and there was no significant difference compared with placebo. Common adverse reactions included injection site pain, upper respiratory tract infection, nasopharyngitis, etc. There were very few patients who discontinued treatment due to adverse drug reactions. Conclusions: Erenumab is safe and effective in the preventive treatment of migraine in adults.

Background and aims: Recent randomised studies reported a positive effect of erenumab in migraine prevention. Aim of our study was to investigate real-life efficacy and safety of erenumab in refractory migraine patients. Methods: Patients received erenumab 70mg monthly for 3 months. At month 3 (M3), the dose of erenumab was increased to 140mg following patients' response. Changes in monthly migraine days (MMD), intake of acute medications, 50% responders rate, Headache Impact Test (HIT-6) and Allodynia Symptom Checklist (ASC-12) scores were assessed at M3 and after 6 months of treatment (M6). Results: 58 patients with a mean age of 51 were enrolled in the study. The MMD at baseline was 19 (SD 8.0). 41 patients had chronic migraine and 44 patients had medication overuse headache (MOH). Before starting erenumab, patients have tried an average of 5 preventives (range: 1-10). 17 patients received erenumab 140mg at M6. The MMD was reduced by 3.9 at M3 and by 5.0 at M6 (p<0.001). The number of days of acute medication intake was reduced by 3.6 at M3 and by 5.3 at M6 (p<0.001). At M6, a 50% or greater reduction in the MMD was achieved for 39% of patients. Mean HIT-6 and ASC-12 scores were reduced by 7.4 (p=0.002) and 2.9 (p=0.03), respectively, at M6. MOH was not confirmed in 29% of patients at M6. 25% of patients had side effects. Conclusion: 6-month treatment of Erenumab is effective in reducing migraine severity and patients' disability in refractory migraine in a daily-life setting.

BACKGROUND:

Migraine is one of the neurological diseases that have a negative impact on subjects' productivity and daily activity of patients. Introducing monoclonal antibodies as a valuable option for resolving the persistent problem of migraine is still under investigation. The current study aimed to evaluate the efficacy and safety profile related to Erenumab.

METHODS:

A prospective study for clinical data collection and analysis from recruited therapy-refractory migraine subjects were carried through 6 months for each subject. All subjects received Erenumab 70 mg monthly. Each patient provided the clinical data monthly starting from 0 months and for the next 6 months. Migraine disability assessment (MIDAS) questionnaire was used for evaluation of the Erenumab efficacy every 3 months. In addition, data regarding adverse effects, migraine triggers, and the impact of previous COVID-19 on migraine severity were collected and analyzed.

RESULTS:

Ninety subjects were recruited in the study. Erenumab injections resulted in a significant (p < 0.001) reduction in MIDAS score in the 3rd month compared with baseline, also this significance was continuous in the 6th month. In contrast, there was no significant difference in the 6th month compared with the 3rd. Previously infected COVID-19 subjects showed a higher severity of migraine attacks compared with non-infected subjects. Skin redness and local pain were the most common adverse effects 63.3%, 47.77% respectively associated with Erenumab.

CONCLUSION:

Using Erenumab therapy showed a great beneficial impact regarding the reduction of migraine-related disabilities. COVID-19 was related to the increased severity of migraine attacks.

Objective: To describe a case of ischemic colitis following initiation of erenumab for treatment of refractory migraine. Background: Antagonism of calcitonin gene-related peptide (CGRP) is a newly approved mechanism for treatment of migraine. Apart from the trigeminovascular system, CGRP is also widely distributed in the gastrointestinal tract and contributes to regulation of motility and blood flow. There have been theoretical concerns about vasoconstriction from antagonism of CGRP that were not observed in clinical trials. Design/Methods: Single patient case report of ischemic colitis with use of erenumab (antagonist of CGRP receptor). Results: A 41 year old woman with rheumatoid arthritis on tofacitinib, Raynaud's syndrome, and attention deficit hyperactivity disorder on dextroamphetamine-amphetamine experienced chronic migraine refractory to treatment with topiramate, nortriptyline, and valproate. She used rizatriptan and butalbital-acetaminophen-caffeine for abortive therapy of headaches. She was started on erenumab (Aimovig), and one month after the first injection, she had severe upper abdominal pain. Colonoscopy showed ulcers at the splenic flexure with biopsy consistent with ischemic colitis. CT angiography of the abdomen did not show any fixed obstruction of the mesenteric vasculature. No other clear secondary cause was found. Conclusions: Although a single case, the time course of ischemic colitis following initiation of erenumab suggests a possible association. Other contributing factors included concurrent use of rizatriptan and amphetamines, which are both vasoconstrictive. Prescribers should be cautious of use of CGRP antagonists in patients with vasoconstrictive disease (Raynaud's in this patient) and on multiple other vasoactive medications.

The purpose of this study is to determine if the administration of the CGRP-receptor antagonist erenumab is effective in decreasing pain and improving quality of life in patients with FMS by comparing the difference in pain scores in Fibromyalgia Impact Questionnaire, defense and veterans Pain Rating Scale and The American College of Rheumatology 2010 Preliminary Diagnostic Criteria for Fibromyalgia score over the study period.