Erenumab also demonstrated improvements in standard measures of efficacy, such as monthly migraine days.
Data from the recent LIBERTY study (NCT03096834) show that erenumab (Aimovig; Amgen/Novartis) produced greater improvements when compared with placebo in patient-reported outcomes (PROs) of migraine-related functional and physical impairment, work productivity, and everyday activities in patients for which 2–4 preventive medications have failed.
Erenumab significantly improved scores in Migraine Physical Function Impact Diary (MPFID) physical impairment (PI) and everyday activities (EA) subsets. When compared to placebo, patients on erenumab experienced a score difference of –3.5 (95% CI, –5.7 to –1.2; P = .003) in MPFID-PI and a difference of –3.9 (95% CI, –6.1 to –1.7; P <.001) in MPFID-EA at 12 weeks.
Michel Lantéri-Minet, MD, neurologist and medical director, department of pain, University of Nice Hospital, France, and colleagues wrote that “these findings... corroborate the efficacy observed with erenumab in LIBERTY on traditional measures of treatment efficacy (such as number of migraine days). Efficacy on PROs appeared to be of rapid onset, with differences versus placebo observed at all time points of assessment. These benefits were sustained throughout the 12-week double-blind treatment phase.”
Lantéri-Minet et al. analyzed data from 246 patients enrolled in the LIBERTY study, 121 of which were randomized to receive 140 mg of erenumab and 125 to receive placebo. In both erenumab and placebo groups, 1 patient (0.8%) had failed <2 previous migraine treatments. In the erenumab group, 43 (35.5%) failed 2 treatments and 77 (63.6%) failed >2. In the placebo group, 52 (41.6%) failed 2 treatments and 72 (57.6%) failed >2.
The authors found that at Week 12, 36 (30.0%) patients treated with erenumab had a ≥50% reduction from baseline in mean monthly migraine days (MMD; odds ratio [OR], 2.7; 95% CI, 1.4–5.2) as compared to 17 patients (14.0%) in the placebo group (P = .002).
At week 12, 45 of 119 (37.8%) patients treated with erenumab experienced a ≥5-point reduction from baseline in MPFID-PI (OR ≥5-point reduction, 2.5; 95% CI. 1.4–4.5) as compared to 24 of 123 (19.5%) of the placebo group. Similarly, 49 of 119 (41.2%) patients treated with erenumab experienced a ≥5-point reduction from baseline in MPFID-EA (OR, 2.1; 95% CI, 1.2–3.6) as compared to 31 of 123 (25.2%) treated with placebo.
The mean change from baseline at week 12 in MPFID-PI was –1.9 (SD, 0.8) in the erenumab group and 1.6 (SD, 0.8) in the placebo group. The mean change in MPFID-EA was –3.4 (SD, 0.8) in the erenumab group and 0.6 (SD, 0.8) in placebo.
Page BreakLantéri-Minet and colleagues found that by week 12, 55 of 119 (46.2%) patients treated with erenumab had a ≥5-point reduction in Headache Impact Test (HIT-6) total score from baseline (OR, 2.4; 95% CI, 1.4–4.1) compared with 33 of 124 (26.6%) of patients in the placebo group (P = .002).
The authors also saw improvements in the Work Productivity and Activity Index (WPAI) score, the greatest of which were observed in impairment while working (IWW) and overall work impairment (OWW) subsets. Patients treated with erenumab saw a mean reduction of 11.1% from baseline in WPAI-IWW compared to a –2.3% reduction in placebo (treatment difference [TD], 8.8; 95% CI, –15.5 to –2.1; P = .01) and a mean reduction of –13.1% from baseline in WPAI-OWW as compared to a –2.5% reduction in placebo (TD, 10.6; 95% CI, –17.7 to 3.5; P = .004).
“The findings of these analyses add to previous erenumab efficacy and safety data obtained from the LIBERTY study. They show that erenumab exerts a positive effect on patient functioning and work productivity, as assessed by PRO measures among patients with EM in whom 2–4 preventives had not been useful,” Lantéri-Minet and colleagues concluded.