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16 Articles in Volume 19, Issue #2
Analgesics of the Future: Inside the Potential of Glial Cell Modulators
APPs as Leaders in Pain Management
Cases in Urine Drug Monitoring Interpretation: How to Stay in Control
Complex Chronic Pain Disorders
Efficacy of Chiropractic Care for Back Pain: A Clinical Summary
Hydrodissection for the Treatment of Abdominal Pain Caused by Post-Operative Adhesions
Letters: The Word "Catastrophizing;" AIPM Ceases Operations; Patient Questions
Management of Severe Radiculopathy in a Pregnant Patient
Managing Pain in Adults with Intellectual Disabilities
Pain in the Courtroom: An Excerpt
Q&A with Howard L. Fields: How Patients’ Expectations May Control Pain
Special Report: CGRP Monoclonal Antibodies for Chronic Migraine
The Management of Chronic Overlapping Pain Conditions
Vibration for Chronic Pain
What are the dangers of loperamide abuse?
When Patient Education Fails to Improve Outcomes: A Low Back Pain Case

Special Report: CGRP Monoclonal Antibodies for Chronic Migraine

A retrospective review of early clinical experience with the CGRP inhibitor erenumab (Aimovig) for the prevention of migraine.
Pages 45-52
Page 1 of 5

Migraine is a relatively common illness, known to affect 12% of the population. Chronic migraine (CM) is a frequently encountered subset of migraine, and presents certain difficulties in treatment. Those with CM often report at least 15 headache days per month, with at least 8 days being migrainous in nature; medication overuse headache (MOH) cannot be a major contributing factor to the headache pattern.

Many individuals suffering from CM do not do well with the usual preventive approaches. For instance, oral medications – such as antidepressants, anticonvulsants, and those used for hypertension – tend to have limited efficacy in patients with CM or come with too many side effects. In some cases, onabotulinumtoxinA (Botox) may be more effective than oral preventives and tends to have few side effects. As a result, many patients with CM end up with refractory chronic migraine (RCM), defined as failing on at least three types of prophylactic medications. Thus, new preventive approaches are needed for chronic migraineurs. The calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) may help to fill this role.

Enter the CGRPs Inhibitors

Calcitonin gene-related peptide is an important neuropeptide involved in the migraine process. CGRP receptors are ubiquitous in the sites that are involved in migraine pathogenesis. CGRP is involved in mast cell degranulation, neurogenic inflammation, and the subsequent vasodilation. During a migraine, CGRP levels usually rise. For those with migraine, infusions of CGRP may precipitate an attack.1 During a migraine, trigeminal nerves that are activated may release CGRP, as well as other inflammatory compounds.1 The mAbs that inhibit CGRP have been shown to be effective for a number of patients with chronic migraine.2

Erenumab-aooe (referred to as erenumab in this article) was the first CGRP mAb to become commercially available in May 2018. It is manufactured by Amgen and Novartis and branded as Aimovig. Erenumab is a subcutaneously administered once-per-month injection. There are currently two other mAbs available: fremanezumab (Teva Pharmaceuticals, Ajovy) and galcanezumab (Emgality, Eli Lilly). These are all large-molecule mAbs, with little penetration through the blood-brain barrier (BBB). Erenumab targets the CGRP receptor, while the others in this class affect the CGRP ligand. These large molecule mAbs have several major advantages, including little or no drug interactions. In addition, they are cleared through the reticuloendothelial system and do not irritate the liver or kidneys.3 Demand for these newer preventives has been brisk, as there has been a paucity of effective therapies for those with chronic migraine.

Clinical Data on the First CGRP: Erenumab

The erenumab pivotal trial (n = 667) for chronic migraine resulted in reasonable efficacy over 3 months. The mean age was 40 years old. Patients received either placebo (70 mg or 140 mg) per month. A safety extension study was also conducted, in which approximately 40% of subjects achieved at least a 50% reduction in monthly migraine days, while placebo reduced migraine days only by 23%. The side effects in this pivotal trial were very few, with no serious adverse events reported.4

Erenumab was also studied in two Phase 3 pivotal trials for the prevention of episodic migraine. In the STRIVE trial (n = 955), a 50% or greater responder rate, for mean monthly migraine days per month, was achieved in 43.3% of the patients who received 70 mg monthly, and in 50% of those who received 140 mg monthly.5 Few side effects were noted in both episodic trials. In the ARISE pivotal episodic trial with erenumab (efficacy analysis n = 570), 40% of those receiving 70 mg monthly reported 50% or greater relief.6 The erenumab LIBERTY trial assessed episodic patients who had failed two to four previous preventive treatments. The erenumab 140 mg group had a 30.3% responder rate (50% or great response in monthly migraine days). A number of patients in the episodic migraine trials were able to continue erenumab for as long as 5 years. It was reported that 383 patients continued in the extension with reasonable and sustained efficacy.7 There were scant side effects.

In addition, there was an erenumab and angina trial. Erenumab was used in patients with stable angina. No safety concerns were identified.8 One further study of erenumab and blood pressure concluded that erenumab did not tend to increase blood pressure.9

(Source: 123RF)

Retrospective Evaluation: Use of Erenumab in Patients with Chronic Migraine

This paper provides an evaluation of the author’s in-clinic experience using erenumab in patients with chronic migraine over a period of six months. Data were collected retrospectively and divided into three reports. In the first, efficacy and side effects were categorized for an initial 220 patients placed on erenumab. Results were assessed after three months of treatment. In the second report, the poor responders versus the excellent responders were compared. The third report focuses on patients who completed six months of treatment with erenumab.

Methods

Study Design: This retrospective study was conducted during November and December 2018. Data were collected exclusively for this study. The patients were seen at the Robbins Headache Clinic in Illinois. This clinic is an urban, tertiary, referral center featuring a socioeconomically diverse population. The study was designed to evaluate the early results with one CGRP monoclonal antibody: erenumab. IntegReview IRB approved the study protocol. All patients gave informed consent. As noted, this paper includes three distinct sets of data, described in the following sections.

Data Collection & Analysis: The two headache specialists in the clinic, Lawrence Robbins, MD, and Brooke Phenicie, NP-C, interviewed patients during their return office visits. Robbins also reviewed the patients’ paper charts. Most, but not all, of the patients kept paper or electronic records of their headache days. The collected database was free of patient identifiers and names. Each mini study, or report, had its own set of data, including reported differences in age and gender. For reporting purposes, subjects were divided into three age groups: 18 to 40; 41 to 60; and 61 and over.

Last updated on: March 15, 2019
Continue Reading:
At Stake: The Possible Long-Term Side Effects of CGRP Antagonists
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