Full data from LIBERTY study of Aimovig in episodic migraine patients. Novartis

Novartis announced that the full data from the LIBERTY study of Aimovig (erenumab) in episodic migraine patients who had tried and failed two to four prior preventive treatments have been published in the Lancet. Patients treated with Aimovig had significant improvements on all primary and secondary endpoints of the study. Aimovig is specifically developed to prevent migraine by blocking the calcitonin gene-related peptide receptor (CGRP-R), which plays a critical role in migraine.

The LIBERTY data show that, compared to placebo, from baseline to the last month of therapy (weeks 9-12):� The primary endpoint showed that more than twice as many patients on Aimovig had their migraine days cut by 50% or more (30% vs.14%; odds ratio 2.7, p=0.002) .� Almost three times as many patients on Aimovig had their migraine days cut by 75% or more (12% vs. 4%; odds ratio 3.2, p=0.025, secondary endpoint).� 6% of patients on Aimovig were completely migraine free (migraine days cut by 100%) vs no patients (0%) on placebo (secondary endpoint).� Patients on Aimovig experienced a substantial reduction in monthly migraine days (MMD) (1.8 vs 0.2 fewer MMD, p=0.004, secondary endpoint). � Those in the Aimovig arm reported significant reductions in the number of days per month using acute migraine-specific medication (1.3 reduction vs 0.5 day increase; p<0.001, secondary endpoint). � overall, the tolerability and safety profiles for aimovig were similar to placebo, in keeping with findings throughout the drug's clinical trial program of over 3,000 patients.>

The patients in LIBERTY, who had tried multiple treatments without success, represent a section of the migraine community which is highly impacted by the disease in all areas of life. Of note, the recent My Migraine Voice study showed that patients with multiple prior treatment failures reported the greatest impact on work productivity compared to those who had not previously tried treatments without success. Moreover, a higher proportion of these patients reported a negative impact on their social and personal life. In LIBERTY, in an additional secondary endpoint, patients treated with Aimovig reported a significantly greater improvement on all outcomes including ability to complete everyday activities, such as chores and getting out of bed, compared to placebo (Migraine Physical Function Impact Diary [MPFID] physical impairment scale, 3.5 point difference, p= 0�003; everyday activities scale, 3.9 point difference, p<0�001)..>

See- Reuter U, Goadsby PJ, Lanteri-Minet M, et al. "Efficacy and tolerability of erenumab in episodic migraine patients who previously failed 2-4 preventive treatments". Lancet. 2018 Oct.

See- Schwedt T, Martelletti P, Hans-Christoph D, et al."Work productivity amongst those with migraine: results from the My Migraine Voice survey". MTIS. 2018 Sept.