"HER-MES is the first study that directly compared the therapeutic effects of an antibody and a small molecule in migraine prevention," said
In this head-to-head Phase IV study, patients in the Aimovig arm demonstrated a significantly lower discontinuation rate due to adverse events versus patients in the topiramate arm (10.6% versus 38.9%). Additionally, significantly more patients in the Aimovig arm achieved at least a 50% reduction from baseline in their MMDs than those in the topiramate group (55.4% versus 31.2%). In the topiramate group, the most frequent adverse events that led to discontinuation of the study medication were paraesthesia, disturbance in attention, fatigue, and nausea. In the Aimovig group, these were fatigue, nausea, disturbance in attention and dizziness. Additional study treatment-related adverse events reported by ≥2% in any trial group included constipation, decreased appetite, taste disorder, vertigo, dysgeusia, weight loss, dry mouth, irritability, mood swings, diarrhea, depression, sleep disorder, depressed mood, hypoesthesia, upper abdominal pain, aphasia, insomnia, memory impairment, dyspepsia, dysesthesia and headache.3
"We're extremely encouraged by these new results, which demonstrate lower discontinuation rates due to adverse events and superior efficacy versus topiramate in migraine prevention and strengthen our confidence that Aimovig has significant potential to help many more patients living with migraine," said
Migraine is a highly debilitating disease that has a significant impact on people's lives, including time spent with family and friends, or at work.4,5 Aimovig is the first FDA-approved migraine preventive treatment that targets the CGRP receptor.6 It is self-administered once monthly subcutaneously via the SureClick® autoinjector, does not require a loading dose and is easy to use.6,7
HER-MES (NCT03828539) is the first randomized, double-blind, double-dummy, active-controlled, parallel-group Phase IV study to assess tolerability (as assessed by the discontinuation rates due to adverse events) and efficacy of Aimovig versus topiramate in a patient-centered setting.3 The primary endpoint was treatment discontinuation rate due to adverse events of 70 mg and 140 mg Aimovig monthly compared with 50 to 100 mg topiramate daily during the double-blind treatment phase of the study.3 The secondary endpoint was efficacy of 70 mg and 140 mg Aimovig monthly versus 50 to 100 mg topiramate daily in terms of at least a 50% reduction in monthly migraine days from baseline in the last three months (months 4, 5 and 6) of the double-blind, 24-week treatment phase.3 The HER-MES study enrolled 777 adult patients with episodic or chronic migraine (≥4 migraine days per month) who had not previously received migraine prevention treatment or had failed up to three previous therapies with propranolol/metoprolol, amitriptyline and/or flunarizine.3 After the 2-week screening and 4-week baseline phase, patients received either Aimovig subcutaneously and topiramate placebo orally or topiramate orally and Aimovig placebo subcutaneously. In the double-blind, 24-week treatment phase, patients in the Aimovig arm received either 70 mg or 140 mg directly after the baseline phase, as estimated by the investigator.3 An increase in dose from 70 mg to 140 mg was possible at any time during the study. Patients in the topiramate arm were given topiramate at the highest tolerated dose (50-100 mg daily), starting with a 6-week titration phase.3 The study was conducted by Novartis at 82 study sites in
About Aimovig® (erenumab-aooe)
Aimovig is the first FDA-approved migraine preventive treatment that targets the calcitonin gene-related peptide (CGRP) receptor, which is associated with migraine.6 Aimovig has been studied in several large, global, randomized, double-blind, placebo-controlled studies to assess its efficacy and safety in migraine prevention.8,9 Aimovig is self-administered once monthly via the easy-to-use SureClick® autoinjector, without a required loading dose.6,7 More than 3,000 patients participated in registrational trials of Aimovig across four placebo-controlled Phase 2 and Phase 3 clinical studies and their open-label extensions.8-13
Aimovig is also being evaluated through CATALYST, a comprehensive evidence generation program initiated by
Aimovig® (erenumab-aooe) is indicated for the preventive treatment of migraine in adults.
IMPORTANT SAFETY INFORMATION
Contraindication: Aimovig® is contraindicated in patients with serious hypersensitivity to erenumab-aooe or to any of the excipients. Reactions have included anaphylaxis and angioedema.
Hypersensitivity Reactions: Hypersensitivity reactions, including rash, angioedema, and anaphylaxis, have been reported with Aimovig® in postmarketing experience. Most reactions were not serious and occurred within hours of administration, although some occurred more than one week after administration. If a serious or severe reaction occurs, discontinue Aimovig® and initiate appropriate therapy.
Constipation with Serious Complications: Constipation with serious complications has been reported following the use of Aimovig® in the postmarketing setting. There were cases that required hospitalization, including cases where surgery was necessary. The onset of constipation was reported after the first dose in a majority of these cases, but patients also reported later on in treatment. Aimovig® was discontinued in most reported cases. Constipation was one of the most common (up to 3%) adverse reactions reported in clinical studies.
Monitor patients treated with Aimovig® for severe constipation and manage as clinically appropriate. Concurrent use of medications associated with decreased gastrointestinal motility may increase the risk for more severe constipation and the potential for constipation-related complications.
Hypertension: Development of hypertension and worsening of pre-existing hypertension have been reported following the use of Aimovig® in the postmarketing setting. Many of the patients had pre-existing hypertension or risk factors for hypertension. There were cases requiring pharmacological treatment and, in some cases, hospitalization. Hypertension may occur at any time during treatment but was most frequently reported within seven days of dose administration. In the majority of the cases, the onset or worsening of hypertension was reported after the first dose. Aimovig® was discontinued in many of the reported cases.
Monitor patients treated with Aimovig® for new-onset hypertension, or worsening of pre-existing hypertension, and consider whether discontinuation of Aimovig® is warranted if evaluation fails to establish an alternative etiology.
Adverse Reactions: The most common adverse reactions in clinical studies (≥ 3% of Aimovig®-treated patients and more often than placebo) were injection site reactions and constipation.
Please see Aimovig® full Prescribing Information.
People with frequent migraine attacks may lose more than half their life to migraine.17,16 They endure debilitating pain, physical impairment, and can live in constant dread of the next attack – all of which is compounded by a widespread misperception of the disease.5,17 The 2019 Global Burden of Disease Study ranks migraine among the top 10 causes of years lived with disability worldwide.18 Migraine is associated with personal and societal burdens of pain, disability and financial cost, and it remains under-recognized and under-treated.5,19
This news release contains forward-looking statements that are based on the current expectations and beliefs of
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.
Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the
Any scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the
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