Novartis presents new migraine data demonstrating sustained efficacy of Aimovig®▼ (erenumab) to 52 weeks
May 03, 2019
New data presented at the American Academy of Neurology show continued treatment benefit with Aimovig through one year of follow up1,2
At 52-weeks, two-thirds (72%) of those with chronic migraine had converted to episodic migraine, in addition to evidence of sustained reductions in monthly migraine days for those with episodic migraine1,2
Safety data demonstrate a similar adverse event rate to placebo, consistent with previous Aimovig clinical trials1,2,3,4,5,6
Frimley, UK, May 02, 2019– Novartis today announcedthat new data from two follow-up studies of Aimovig® (erenumab) will be presented at the 71st Annual Meeting of the American Academy of Neurology (AAN) in Philadelphia. These data reinforce the established safety and efficacy profile of Aimovig in long-term use across both chronic and episodic migraine patient populations1,2.
Aimovig is the first and only licensed treatment specifically designed to prevent migraine by blocking the CGRP receptor, which is involved in the physiological processes associated with migraine7. These new data show the potential for Aimovig to reduce the burden of disease for people living with migraine, while also demonstrating sustained benefits over time.
Chronic migraine is defined as 15 or more headache days per month of which eight or more involve migraine symptoms8, while episodic migraine is defined as less than 15 headache days per month9. A one-year open-label extension (OLE) study looked at the percentage of people with chronic migraine who converted to episodic migraine following treatment with Aimovig. More than two-thirds (72%) of chronic migraine patients converted to episodic migraine, with numerically higher conversion rates at the 140 mg versus 70 mg dosing (76% and 69%, respectively). The conversion is clinically meaningful as evidenced by greater reductions from parent study baseline to week 52 in mean monthly migraine days (MMD) (-12.5 and -10.6 for 140 mg and 70 mg, respectively vs 18.1 at baseline) and higher ≥50% response rates for converters (82% and 71% for 140 mg and 70 mg, respectively)1.
“Aimovig has previously been shown to reduce the number of migraine days in patients with chronic migraine. This follow up data is important as it shows a sustained response at 12 months,” said Dr Alex Sinclair, Consultant Neurologist at University Hospitals Birmingham NHS Foundation Trust (UHB). “Importantly, the safety data is very reassuring over this prolonged time period. Migraine is a highly debilitating and often neglected disease. Targeted migraine therapies are now emerging, marking a step changing advance for the care of migraine patients.”
In a one-year extension of the Phase 3 STRIVE study, data show Aimovig provided sustained efficacy in the prevention of episodic migraine, with 65% (140 mg) and 61% (70 mg) of patients experiencing a 50% or more reduction in MMD. The safety profile was comparable to that observed in prior studies with no new relevant safety findings2.
“People living with migraine have been waiting years for a treatment specifically designed to meet their needs, and with Aimovig we start to see the potential of what can be achieved with such a treatment,” said Dr Mark Toms, Chief Scientific Officer at Novartis UK. “We’re proud of the work we’ve done, in collaboration with the neurology community, to revolutionise the treatment of complex, debilitating conditions such as migraine.”
Aimovig is the first and only licensed treatment specifically designed to prevent migraine by blocking the CGRP receptor, which is involved in the physiological processes associated with migraine. Aimovig has been studied in several large global, randomised, double-blind, placebo-controlled studies to assess its safety and efficacy in migraine prevention. More than 2,500 adult migraine patients have participated in our clinical trial programme across the four placebo-controlled Phase II and Phase III clinical studies of between 12 weeks and six months in duration and their open-label extensions3,4,5,6. The safety data for Aimovig to date are consistent, demonstrating a similar adverse event rate to placebo in clinical trials in patients with both episodic and chronic migraine3,4,5,6. The most common adverse events observed were injection site reactions, constipation, muscle spasms and pruritus. Aimovig can be self-administered at home, or by another trained individual, once every four weeks via the SureClick® auto-injector pen, with no additional therapeutic monitoring required.
About the Open-Label Extension Study in Chronic Migraine
The open-label extension of the pivotal parent study (NCT02066415) is a randomised 52-week, double-blind, placebo-controlled study (OLE, NCT02174861) evaluating the long-term efficacy of Aimovig in chronic migraine prevention in patients taking Aimovig 70 mg and 140 mg1. Proportions of episodic migraine converters/nonconverters based on observed data were summarised throughout the OLE (overall population) and by last dose received (70 mg or 140 mg)1. Efficacy data were collected at Weeks 1–12, 21–24, 37–40, and 49–52; endpoints included change from parent study baseline in monthly migraine days (MMD) and proportion of patients with ≥50% reduction in MMD1.
About the STRIVE Study in Episodic Migraine
STRIVE (NCT02456740) is a global Phase 3, multicentre, randomised 24-week, double-blind, placebo-controlled study evaluating the safety and efficacy of Aimovig in episodic migraine prevention2. In the study, 955 patients were randomised to Aimovig 70 mg or 140 mg or placebo2. At Week 24 (active treatment phase [ATP] baseline), 845 patients were re-randomized to Aimovig 70 mg or 140 mg2. Assessments included MMD; monthly acute migraine specific medication treatment days (MSMD); proportion of patients achieving a ≥50%, ≥75%, and 100% reduction in MMD (responder rates: RR); and safety2.
Migraine is a common and disabling neurological condition that causes a wide variety of painful and debilitating symptoms, including but not limited to severe headache10. Latest research shows that around 10 million people in the UK (aged 15-69) experience migraine11, with estimates showing there are over 190,000 migraine attacks every day12. Migraine is more prevalent than diabetes, epilepsy and asthma combined12 and classified as the highest cause of years lived with disability amongst those aged 15-4911. Despite this, migraine remains undiagnosed and undertreated in at least 50% of patients13. An estimated £9.7 billion a year is lost in the UK alone due to migraine through direct and indirect costs: in treating patients and in lost productivity11.
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach more than 750 million people globally and we are finding innovative ways to expand access to our latest treatments. About 105 000 people of more than 140 nationalities work at Novartis around the world. Find out more at www.novartis.com.
In the UK, we employ approximately 1,500 people to serve healthcare needs across the whole of the UK, as well as supporting the global operations of Novartis. Since 2014, Novartis has invested over £200 million in R&D and is a leading sponsor of clinical trials, in the UK. For more information, please visit www.novartis.co.uk
1 Lipton R, Tepper S, Silberstein S, et al. Presented at the 71st Annual Meeting of the American Academy of Neurology; May 4-10, 2019; Philadelphia, PA.
2 Chou D, Goadsby P, Reuter U, et al. Presented at the 71st Annual Meeting of the American Academy of Neurology; May 4-10, 2019; Philadelphia, PA
3 Dodick DW et al. ARISE: A Phase 3 randomised trial of erenumab for episodic migraine. Cephalalgia. 2018 Jan 1:333102418759786.
4 Goadsby P et al. A controlled trial of erenumab for episodic migraine. NEJM. 2017 Nov.
5 Reuter U, et al. Efficacy and tolerability of erenumab in patients with episodic migraine in whom two-to-four previous preventive treatments were unsuccessful: a randomised, double-blind, placebo-controlled, phase 3b study. Lancet. 2018;392(10161):2280-2287.
6 Tepper S,et al. Safety and efficacy of erenumab for preventative treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2017 Jun;16(6):425-434.