"Migraine is a disabling disease for many patients. It disrupts daily living and the ability to function and participate in activities with loved ones," said
Excessive use of acute pain-relief medications is common among people who suffer from migraine as they desperately try to control the symptoms. Among the patients experiencing 15 or more headache days a month in the erenumab Phase 2 study (n=667), 41 percent met strict criteria for medication overuse. Compared to a 3.5-day reduction in placebo, both dosages of erenumab reduced mean monthly migraine days by 6.6 by the end of the study (both p<0.001 versus placebo). Furthermore, days requiring acute pain-relief medications were also significantly reduced in both dosage arms (2.1-day reduction for placebo, compared to 5.4 days for erenumab 70 mg and 4.9 for erenumab 140 mg; both p<0.001 versus placebo).
Detailed results from the positive six-month STRIVE study of erenumab 70 mg and 140 mg, and the positive three-month ARISE study of erenumab 70 mg will also be presented at the meeting. These data include both primary and secondary endpoints, evaluating the reduction in monthly migraine days and the percentage of patients who responded to erenumab. Results from STRIVE have been submitted for peer-reviewed publication.
The safety profile of erenumab was similar to placebo across all treatment arms in the Phase 2 and Phase 3 studies. The most common adverse events across the studies were upper respiratory tract infection, injection site pain, nausea and nasopharyngitis.
Erenumab is a human monoclonal antibody specifically designed for the prevention of migraine. Erenumab specifically inhibits the CGRP receptor, believed to play a critical role in mediating the incapacitating pain of migraine. Across the four placebo-controlled Phase 2 and Phase 3 clinical studies, more than 2,600 patients have been exposed to erenumab.
These data support the first submissions in the
Global Health Economics
About the 20120295 Study
The 20120295 study is a global Phase 2, randomized, 12-week, double-blind, placebo-controlled study evaluating the safety and efficacy of erenumab in chronic migraine prevention. In the study, 667 patients were randomized to receive once-monthly subcutaneous placebo or erenumab (70 mg or 140 mg) in a 3:2:2 ratio, respectively. The primary endpoint was change in monthly migraine days from baseline to the last four weeks of the 12-week treatment phase in patients with chronic migraine (the number of migraine days between weeks nine and 12). Secondary study endpoints included reduction of at least 50 percent from baseline in monthly migraine days, change from baseline in monthly acute migraine-specific medication days and change from baseline in cumulative monthly headache hours.
About Erenumab Phase 3 Studies
STRIVE (STudy to evaluate the efficacy and safety of erenumab in migRaIne preVEntion, 20120296) is a global Phase 3, multicenter, randomized six-month, double-blind, placebo-controlled study evaluating the safety and efficacy of erenumab in episodic migraine prevention. In the study, 955 patients were randomized to receive once-monthly subcutaneous placebo or erenumab (70 mg or 140 mg) in a 1:1:1 ratio. Patients enrolled in STRIVE were experiencing an average of 8.3 migraine days per month at baseline. The primary endpoint was change from baseline in mean monthly migraine days over the last three months of the double-blind treatment phase of the study (months 4, 5, 6). Secondary study endpoints included reduction of at least 50 percent from baseline in mean monthly migraine days, change from baseline in mean monthly acute migraine-specific medication days, and reductions from baseline in both mean impact on everyday activities domain and mean physical impairment domain scores on the Migraine Physical Function Impact Diary (MPFID).
ARISE (A Phase 3, RandomIzed, double-blind, placebo-controlled Study to Evaluate the efficacy and safety of erenumab in migraine prevention, 20120297) is a global Phase 3, multicenter, randomized, three-month, double-blind, placebo-controlled study evaluating the safety and efficacy of erenumab in episodic migraine prevention. In the study, 577 patients were randomized to receive once-monthly subcutaneous placebo or erenumab (70 mg) in a 1:1 ratio. Study participants who completed the double-blinded portion had the option to continue in a long-term safety extension. Patients enrolled in ARISE were experiencing an average 8.3 migraine days each month at baseline. The primary endpoint was change from baseline in monthly migraine days from baseline to the last four weeks of the three-month treatment phase (the number of migraine days between weeks 9 and 12). Secondary study endpoints included reduction of at least 50 percent from baseline in monthly migraine days and change from baseline in monthly acute migraine-specific medication treatment days. The MPFID assessed two other secondary endpoints.
Erenumab is a human monoclonal antibody specifically designed for the prevention of migraine. Erenumab specifically inhibits the receptor of the calcitonin gene-related peptide (CGRP) which is thought to play a causal role in migraine pathophysiology. Erenumab has been studied in several large global, randomized, double-blind, placebo-controlled trials to assess its safety and efficacy in migraine prevention.
Migraine is a distinct neurological disease.1 People with migraine lose a substantial portion of their lives to this illness, experiencing significant physical impairment, frequently accompanied by head pain, nausea, vomiting and meaningful disruption of daily activities.1
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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1Lipton RB, et al. Migraine prevalence, disease burden, and the need for preventative therapy. Neurology. 2007; 68(5):343-9.
2Headache disorders - Fact sheets.
3Marketscan data on file.
4Hepp Z et al. Adherence to oral migraine-preventive medications among patients with chronic migraine. Cephalalgia. 2015; 35(6):478-88.
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