Erenumab Shows Sustainable Efficacy in Refractory Episodic Migraine

June 16, 2020

Over a 2-year stretch, change in monthly migraine days from the double-blind treatment period baseline was sustained in those treated with erenumab.

Nadia Tenenbaum, MD

Interim r­esults from the 3-year open-label treatment phase (OTLP) of the LIBERTY study (NCT03096834) demonstrated that treatment with erenumab (Aimoig; Novartis) is associated with sustained reductions in migraine frequency among patients with episodic migraine with 2—4 prior preventive treatment failures.1

The mean monthly migraine days (MMD) at double-blind treatment phase (DBTP) baseline was 9.2 (standard deviation [SD], 2.5) days in patients who received at least 1 open-label dose. At Week 112, 99 (57.2%), 53 (30.6%), and 28 (16.2%) patients achieved ≥50%, ≥75%, or 100% reductions in MMD, respectively.

The research, presented at the 2020 American Headache Society Annual Meeting, on June 13, revealed that the change in MMD from DBTP baseline in the overall group sustained over 2 years (1 year: —3.7 [SD, 4.1]; 2 year: –4.2 [SD, 5.0]). Additionally, the same consistent improvement was observed in functional outcomes as measured by the Headache Impact Test (HIT-6) total score and Migraine Physical Function Impact Diary (MPFID).

Study author Nadia Tenenbaum, MD, senior clinical development medical director, Novartis, and colleagues noted that patients within the continuous erenumab and initiated erenumab groups in the OLTP demonstrated improvement through 2 years of treatment similar to what was reported at year 1.

During the OLTP, the median (Q1, Q3) erenumab exposure was 106 (103.8, 106.1) weeks, with nearly 86.3% of the overall, 82.2% of the continuing erenumab, and 90.2% initiating erenumab groups experiencing adverse events (AEs). After adjusting to exposure, the incidence rate of AEs during the OLTP for the overall population was 198.0 per 100 patient-years (390.0 per 100 patient-years at 1 year). Nasopharyngitis (33.9 per 100 patient-years), influenza (10.3), and back pain (6.6) were the 3 most frequently reported AEs during the OLTP.

The exposure-adjusted patient incidence of serious AEs was 6.3 per 100 patient-years for the overall population. In total, 59 patients (24.6%) discontinued in the OLTP, with lack of efficacy (10.8%) and subject/guardian’s decision (9.2%) as the most common reasons reported. Discontinuation of erenumab treatment due to AE was reported for 9 patients (3.8%). No deaths were reported.

The LIBERTY study included 246 patients randomized 1:1 to erenumab 140 mg or placebo for 12 weeks during the DBTP. Upon completion, 240 patients enrolled into OLTP and received OL treatment with monthly erenumab 140 mg for 3 years. Tenenbaum and colleagues used achievement of ≥50%, ≥75%, or 100% reduction from the DBTP baseline in MDD as the primary outcome measure of the study.

Other outcome measures such as HIT-6, MPFID, Everyday Activities and Physical Impairment (EA/PI) scores, and safety in the overall population in both patients on continuous erenumab and patients from the placebo group who initiated erenumab in the OLTP.

Results of this study were consistent with a previous study presented at the American Academy of Neurology (AAN) 2020 Annual Meeting, which showed the therapy’s sustained benefit in reducing migraine frequency while being tolerated and safe throughout a 4-year treatment period.2

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REFERENCES

1. Reuter U, Goadsby PJ, Lanteri-Minet M, et al. Sustained efficacy and safety of erenumab in patients with episodic migraine who failed 2—4 prior preventive treatments: 2-year interim results of the LIBERTY open-label extension study. Headache. 2020;60(S1 suppl). 1—156. doi: 10.1111/head.13854.

2. 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.