The anti-CGRP agent showed sustained benefit in reducing migraine frequency as well as good safety over 4 or more years of treatment in a cohort of more than 200 patients.
Messoud Ashina, MD, PhD, DMSc
An interim analysis of long-term treatment with erenumab (Aimoig; Novartis) suggests that the anti-calcitonin gene-related peptide (CGRP) therapy can provide sustained benefit in reducing migraine frequency while being well-tolerated and safe throughout 4 years of treatment.1
Conducted by Messoud Ashina, MD, PhD, DMSc, professor of neurology, Faculty of Health and Medical Sciences, University of Copenhagen, and colleagues, the study included 221 patients who initially received 70-mg erenumab monthly and later switched to 140-mg monthly after about 2 years of treatment. The data, which were accepted to the American Academy of Neurology (AAN) 2020 Annual Meeting
for presentation, showed that the mean change in monthly migraine days (MMD) from baseline (8.7 days [standard deviation (SD), 2.7]) was a reduction of 5.8 days (SD, 3.8).
Additionally, 77% (n = 170), 56% (n = 124), and 33% (n = 73) of the cohort had response rates of ≥50%, ≥75%, and 100%, respectively.
“Efficacy (1 year) and safety (3 years) of erenumab results from a comprehensive clinical development program resulted in approval for migraine prevention in over 40 countries to date. Longer-term efficacy and safety data are important for patients and clinicians,” Ashina and colleagues wrote.
Among those who were using acute migraine-specific medications (AMSM), at baseline, the mean use was 6.1 treatment days (SD, 2.7), which was reduced by 4.6 days (SD, 3.3). The median exposure from those receiving at least 1 dose of erenumab (n = 383) was 58.5 months (interquartile range [IQR], 17.0–62.2).
When adjusting adverse event (AE) and serious AE incidence rates for exposure, the respective rates were 124.9 per 100-patient-years and 3.8 per 100-patient-years. The most frequently occurring AEs were nasopharyngitis (10.9 per 100-patient-years), upper respiratory tract infection (6.8 per 100-patient-years), and influenza (4.7 per 100-patient-years). In total, 19 patients (5.0%) discontinued due to AEs. There were no new safety signals nor increases in AE or SAE incidence over 4+ years of exposure vs the double-blind treatment phase.
Notably, constipation did not increase with long-term treatment—occurring at a rate of 1.3 per 100-patient-years (9 of 383 patients) for the 70-mg group and 2.6 per 100-patient-years (15 of 250 patients) for the 140-mg group during 4+ years. In the randomized controlled trials, those rates were 4.3, 5.6, and 13.3 per 100-patient-years for the placebo, 70-mg, and 140-mg groups, respectively.
Also scheduled to be presented at AAN was an interim analysis of erenumab from the TELESCOPE study, which confirmed the monoclonal antibody’s real-world and long-term safety and benefit in patients with episodic and chronic migraine. Those data included 109 patients from Germany and showed an average reduction of 8 migraine days with erenumab therapy.
Additionally, 80% of the patients reported a reduction of intensity and 92% of patients had a reduction of frequency of their attacks. Using global impression scores, treating physicians noted 80% of the patients were rated as “much improved” or “very much improved” after receiving erenumab. As well, treatment with erenumab triggered a first response in 75% of patients after their first injection.
Novartis also announced interim results from the real-world PERISCOPE study, which included 91 patients who received erenumab with an overall mean disease duration of 18 years. Data showed that 85% of patients who received erenumab could cope better with daily activities and 83% lost fewer days to migraine since the start of their treatment.3
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1. Ashina M, Goadsby PJ, Reuter U, et al. Sustained Efficacy and Long-term Safety of Erenumab in Patients with Episodic Migraine: 4+ Year Results of a 5-year, Open-label Treatment Period. Neurology. 2020;94(15 Suppl): 1203.
2. Straube A, Stude P, Gaul C, Koch M, Schuh K. First one-year real world evidence data with the monoclonal antibody erenumab in Germany. Neurology. 2020;94 (15 Suppl). 1873
3. Novartis announces data in Neurology reinforcing the real-world and long-term effectiveness and safety of Aimovig as a preventive treatment across the full spectrium of migraine [news release]. Basel, Switzerland: Novartis; Published April 16, 2020. Accessed April 22, 2020. novartis.com/news/media-releases/novartis-announces-data-neurology-reinforcing-real-world-and-long-term-effectiveness-and-safety-aimovig-preventive-treatment-across-full-spectrum-migraine.