P-101 - MEDICATION USE EVALUATION OF ERENUMAB (AIMOVIG) A CGRP MONOCLONAL ANTIBODY FOR MIGRAINE PROPHYLAXIS

Abstract Title:

MEDICATION USE EVALUATION OF ERENUMAB (AIMOVIG)

A CGRP MONOCLONAL ANTIBODY FOR MIGRAINE PROPHYLAXIS


Background: Calcitonin gene-related peptide (CGRP) inhibitors monoclonal antibodies (mAb) are FDA approved for migraine prophylaxis in chronic migraines and episodic migraines. The preferred CGRP mAb at the VA is Erenumab (Aimovig). Because of the cardiovascular concerns with Erenumab, VA National criteria for use requires a blood pressure check at initiation of therapy, and again within 2-4 weeks of Erenumab initiation. As CGRP mAbs have been increasingly utilized, there are also concerns about side effects . There was also a question about how many patients started on this medication were still receiving this medication.

Erenumab is a “criteria for use” medication, which means that this is the only CGRP that can be ordered without going through the non-formulary drug review process. Erenumab is reserved for use after trialing oral prophylactic agents such as beta blockers, anti-seizure medications and antidepressants for 12 weeks due to the cost and subcutaneous administration. If using a combination of a CGRP-targeted monoclonal antibody for preventative therapy and CGRP receptor antagonist for abortive therapy, patients must be evaluated and counseled on risks of concomitant therapy. There is some concern that the CFU can be bypassed, which might lead to patient safety issues as well as unwarranted costs.

Purpose/Objectives: Evaluate the efficacy and safety of Erenumab in a real-world population of migraineurs at Southeast Louisiana Heathcare System

Ensure that the national VA criteria for use for Erenumab is being followed.


Methods: Data was pulled via SQL query of the VA Central Data Warehouse for SLVHCS patients with a first release of a Erenumab from June 1, 2021 to May 31st, 2023. There were 210 patients. Patients were selected by choosing every third patient sorted alphabetically. Retrospective chart reviews were performed for 72 patients. Four of these charts did not have any documentation related to the medication started at the time in VISTA tools from a community care provider.



Patients were classified into two groups by the type of migraine (episodic or chronic). Episodic migraines are defined as having 4-14 headache days per month while chronic migraines are defined as having at least 15 headache days per month with at least 8 monthly migraines.


Results: There were 26 patients in the episodic group and 46 patients in the chronic group. Patients ranged in age from 27-63 in the episodic group and 27-72 in the chronic group. The average age was 48 and 51 respectively. Over half of the patients were prescribed Erenumab 140 mg in both the episodic and chronic migraine group (58% and 72%), most of which were initiated by a VA neurologist. There was a total of 9 community care providers. (13%). There were three patients in which the dose increased from 70mg to 140mg. A small percentage of patients were on concurrent use of CGRP antagonist, (12% in episodic and 20% in chronic) but no one had documentation of counseling of risks.



Almost all patients got an initial blood pressure reading at the start of therapy. Most patients in both groups had a blood pressure that was within the target goal of < 130/80 mmHg before initiation; around 20% in each group were slightly elevated. Less than half of the patients received a follow up blood pressure within 2-4 weeks of starting Erenumab (37% episodic and 39% chronic). It was noted that four patients had a spike in their blood pressure a few weeks after initiation, only one of these patients had a slightly elevated blood pressure at the initiation.



CFU Medication requirements were only met in 23% of the episodic group and 28% of the chronic group. Factoring in all the requirements for blood pressure documentation, initiating erenumab with slightly high blood pressures, and not documenting counseling on concurrent CGRP inhibitors, only 7% of patients met the criteria.



The discontinuation rate for Erenumab was low as most patients in both groups remained on the drug after initiation (77% episodic and 61% chronic). The only adverse reaction reported was constipation in three cases, where the medication was discontinued. (12.5%)

Conclusions/Implications for future research and/or clinical care: < ![if !supportLists] >· < ![endif] >Caution in patients with uncontrolled hypertension or high blood pressure before initiating erenumab.

< ![if !supportLists] >· < ![endif] >Compliance to check blood pressure 2-4 weeks after initiation of erenumab and monitor for spikes in blood pressure.

< ![if !supportLists] >· < ![endif] >Documentation of counseling on the risk of concomitant use of CGRP-targeted monoclonal antibody and CGRP receptor antagonist (gepant)

< ![if !supportLists] >· < ![endif] >Classification of migraines (episodic and chronic) based on frequency of headaches – so providers know the difference in the criteria.

< ![if !supportLists] >· < ![endif] >Preventative medications and subsequent correct dose and length of therapy that should be trialed before initiation of erenumab.

< ![if !supportLists] >· < ![endif] >Documentation of the reason for discontinuation of medication. Encourage adequate trial of CGRP mAb therapy (3 months) prior to discontinuation for lack of effectiveness.


References:

[1]	A. M. B. J. e. a. Dodick D, "ARISE: A Phase 3 randomized trial of erenumab for episodic migraine," Cephalalgia, pp. 1026-1037, 2018.
[2]	T. S. R. U. e. a. ipton RB, "Erenumab in chronic migraine: Patient-reported outcomes in a randomized double-blind study," Neurology, pp. e2250-e2260, 2019.
[3]	A. Russo, M. Silvestro and F. Clemente, "Multidimensional assessment of the effects of erenumab in chronic migraine patients with previous unsuccessful preventive treatments: a comprehensive real-world experience," J Headache Pain, vol. 21, no. 1, p. 69, 2020.
[4]	M. Cainazzo, A. Ferrari and F. Castro, "Erenumab for the preventive treatment of chronic migraine complicated with medication overuse headache: an observational, retrospective, 12-month real-life study," Neurological Sciences, vol. 42, p. 4193–4202, 2021.
[5]	A. Jakate, A. Blumenfeld and R. Boinpally, "Pharmacokinetics and safety of ubrogepant when coadministered with calcitonin gene-related peptide-targeted monoclonal antibody migraine preventives in participants with migraine: A randomized phase 1b drug-drug interaction study," Headache, vol. 61, no. 4, pp. 642-652, 2021.
[6]	C. R. K. D. e. a. Berman G, "Safety of Rimegepant, an Oral CGRP Receptor Antagonist, Plus CGRP Monoclonal Antibodies for Migraine," Headache, pp. 1734-1742, 2020 .
[7]	K. Mullin, D. Kudrow and R. Croop, "Potential for treatment benefit of small molecule CGRP receptor antagonist plus monoclonal antibody in migraine therapy," Neurology, vol. 94, no. 20, pp. e2121-e2125, 2020.
[8]	E. Loder and R. Burch, "Who Should Try New Antibody Treatments for Migraine?," JAMA Neurol, vol. 75, no. 9, pp. 1039-1040, 2018.
[9]	A. Aubdool, P. Thakore and F. Argunhan, "A Novel α-Calcitonin Gene-Related Peptide Analogue Protects Against End-Organ Damage in Experimental Hypertension, Cardiac Hypertrophy, and Heart Failure," Circulation, vol. 136, no. 4, pp. 367-383, 2017.
[10]	S. Aradi, E. Kaiser and B. Cucchiara, "Ischemic Stroke Associated With Calcitonin Gene-Related Peptide Inhibitor Therapy for Migraine: A Case Report," Journal of Stroke and Cerebrovascular Diseases, vol. 28, no. 10, 2019.
[11]	S. Kanaan, G. Hettie and E. Loder, "Real-world effectiveness and tolerability of erenumab: A retrospective cohort study," Cephalalgia, vol. 40, no. 13, pp. 1511-1522, 2020.
[12]	S. Saely, D. Croteau and L. Jawidzik, "Hypertension: A new safety risk for patients treated with erenumab," Headache, vol. 61, no. 1, pp. 202-208, 2021.
[13]	J. Robblee, K. Devick and N. Mendez, "Real-World Patient Experience With Erenumab for the Preventive Treatment of Migraine," The Journal of Head and Neck Pain, vol. 60, no. 9, pp. 2014-2025, 2020.