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23 Apr 2018
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LIBERTY: Erenumab shows sustained efficacy in refractory episodic migraine over 2 years

Pearl Toh
01 Jul 2020

The CGRP* receptor blocker erenumab shows sustained efficacy in reducing migraine frequency over 2 years in a difficult-to-treat patient population with episodic migraine who had failed 2–4 prior preventive treatments, an interim analysis of the LIBERTY** open-label extension study shows.

The phase III LIBERTY trial comprised two phases: a double-blind phase, whereby patients were randomized 1:1 to once-monthly subcutaneous erenumab 140 mg or placebo for 12 weeks, followed by an open-label phase in which all patients who completed the double-blind phase received erenumab for 3 years. Participants were 246 patients with episodic migraine (4–14 migraine days/month) who had previously failed 2–4 preventive treatments. [AHS 2020, 1st Jul session]  

Primary analysis for the double-blind phase has been reported previously, showing that erenumab was effective in this patient population compared with placebo. The current 2-year interim results represent an analysis of erenumab efficacy at week 112 of the 3-year open-label treatment phase.

“Efficacy of erenumab was sustained throughout 2 years of treatment with erenumab 140 mg in a difficult-to-treat patient population,” the researchers reported.

Changes in mean monthly migraine days (MMD) from baseline were sustained through 2 years during the open-label phase: -3.7 days at 1 year and -4.2 days at 2 years, compared with a baseline of 9.2 days in the double-blind phase.

Specifically, the proportion of patients who achieved ≥50 percent reductions in MMD with erenumab remained stable (57.2 percent) through the 2nd year of open-label treatment, similar to what was observed during the first year.

Similarly, the ≥75 percent and ≥100 percent responder rates were also sustained over 2 years, at 30.6 percent and 16.2 percent, respectively, across all treatment groups.

The improvements were seen in the overall patient population during the open-label phase, regardless of whether the patients were previously assigned to erenumab or placebo in the double-blind phase. 

In addition, improvements in functional outcomes from baseline were consistent at week 112 during open-label treatment, as indicated by the Headache Impact Test (HIT-6; mean changes, -9.5) total score and Migraine Physical Function Impact Diary (MPFID; mean changes, -4.5 for physical impairment and -5.4 for everyday activities domains, respectively).

“Erenumab was well tolerated and no new safety signals were detected over the extended treatment period,” the researchers noted.

During the open-label phase, approximately 86.3 percent of the overall patient population experienced adverse events (AEs). Specifically, 82.2 percent occurred in patients continuing erenumab (ie, initially assigned to erenumab during the double-blind phase) and 90.2 percent in those initiating erenumab during open-label treatment (ie, previously on placebo).  

After adjusting for exposure, the incidence rate of AEs was 198.0 per 100 patient-years in the overall population. The exposure-adjusted rate for serious AEs was 6.3 per 100 patient-years. AEs leading to discontinuation occurred in nine patients (3.8 percent). There were no deaths reported.

The most common AEs during open-label treatment were nasopharyngitis (33.9 per 100 patient-years), followed by influenza (10.3 per 100 patient-years) and back pain (6.6 per 100 patient-years).

“The 3-year open-label phase of the LIBERTY study is ongoing,” stated the researchers.

 

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Most Read Articles
23 Apr 2018
Long‐term treatment with perampanel in the adjunctive setting appears to provide improved seizure control without raising new safety/tolerability signals in patients with epilepsy, particularly those with secondarily generalized seizures at baseline, according to the results of an open-label extension of phase III trials.
Audrey Abella, 20 Mar 2020
The addition of highly purified cannabidiol (CBD) into an antiepileptic regimen led to reductions in convulsive seizure rates in children with Dravet syndrome (DS), the GWPCARE2* study has shown.
27 May 2020
High rather than low levels of neonatal 25(OH)D3 pose an increased risk of incident epilepsy in early childhood, a finding that may be attributed to chance, confounding, or late gestational vitamin D exposure, according to a study.
Jairia Dela Cruz, 29 Jan 2020
In the treatment of idiopathic generalized epilepsy, switching from valproate to other antiepileptic drugs due to potential childbearing issues may prove detrimental, heightening the risk of poor seizure control, as shown in a recent study.