One-year sustained efficacy of erenumab in episodic migraine

Abstract

<jats:sec><jats:title>Objective:</jats:title><jats:p>To assess efficacy and tolerability of 1-year erenumab treatment in patients with episodic migraine.</jats:p></jats:sec><jats:sec><jats:title>Methods:</jats:title><jats:p>Patients were randomized (<jats:italic>n</jats:italic>=955; 1:1:1) during the 24-week double-blind treatment phase (DBTP) to monthly subcutaneous placebo, erenumab 70 or 140mg. At Week 24, 845 patients were re-randomized (1:1) to erenumab 70 or 140mg during the 28-week dose-blinded active-treatment phase (ATP). Monthly migraine days (MMD), achieving ≥50%, ≥75% and 100% reduction in MMD, and safety/tolerability were assessed.</jats:p></jats:sec><jats:sec><jats:title>Results:</jats:title><jats:p>Mean MMD at DBTP baseline was 8.3. At Week 52, mean changes (SE) from pre-DBTP baseline/Week 24 (pre-ATP baseline) in MMD were −4.2 (0.2)/−1.1 (0.2) (70mg) and −4.6 (0.2)/−1.8 (0.2) (140mg) irrespective of treatment during the DBTP. For patients reducing dose from 140 (DBTP) to 70mg (ATP), change in MMD from Week 24 to 52 was −0.1 (0.3), and for those increasing from 70 (DBTP) to 140mg (ATP) was −1.8 (0.3). At Week 52, 61.0%, 38.5% and 19.8% of patients on erenumab 70mg, and 64.9%, 40.8% and 21.2% on erenumab 140mg, achieved ≥50%, ≥75% and 100% reduction in MMD from DBTP baseline, respectively. Among erenumab-treated patients in DBTP who showed ≥50% reduction in MMD during the last 3 months of DBTP and completed ATP, 86% showed sustained responses at ≥50% during the last 3 months of ATP. Safety of erenumab in the ATP was similar to the DBTP; exposure-adjusted incidence rates of adverse events were similar for either dose.</jats:p></jats:sec><jats:sec><jats:title>Conclusion:</jats:title><jats:p>Over 52 weeks, erenumab provided sustained efficacy in episodic migraine; the safety profiles were similar between erenumab dose groups in the presence of dose blinding.</jats:p></jats:sec><jats:sec><jats:title>Clinicaltrials.gov identifier:</jats:title><jats:p>NCT02456740</jats:p></jats:sec><jats:sec><jats:title>Classification of evidence:</jats:title><jats:p>Class II evidence that 52 weeks of treatment with erenumab 70 and 140mg subcutaneously monthly results in sustained reductions in monthly migraine days and similar dose tolerability for patients with episodic migraine.</jats:p></jats:sec>

Impact on monthly migraine days of discontinuing anti-CGRP antibodies after one year of treatment – a real-life cohort study

“…So far, available safety data have not raised concerns against long-term therapy ( 3 – 6 ). However, given the high treatment costs, a limitation of the treatment duration to the essential minimum is desirable.…”

Impact of erenumab on acute medication usage and health care resource utilization among migraine patients: a US claims database study

“…Erenumab, approved in the US for the preventive treatment of migraine in adults in May 2018, is a fully human mAb that selectively binds to and inhibits the CGRP receptor [ 14 , 15 ]. The efficacy and safety of erenumab in migraine patients have been evaluated in multiple clinical trials [ 5 , 9 , 10 , 16 – 20 ], showing a significant reduction in the mean change from baseline in monthly migraine days [ 16 , 21 ]. In addition, post-hoc analyses have shown significant improvements in quality of life and disability scales [ 22 ].…”

Monoclonal Antibodies Targeting CGRP: From Clinical Studies to Real-World Evidence—What Do We Know So Far?

“…Data from up to five years of the extension to open-label phase of three Phase III RCTs (OLTP) [ 14 , 17 , 18 ] are available [ 21 , 22 , 23 , 24 , 25 ], confirming the consistency of sustained efficacy in prevention of EM and CM and safety profile, while highlighting the stability of the improvements in functional outcomes and migraine-related quality of life scoring for at least 5 years [ 22 ].…”