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Results from the phase 3b LIBERTY trial of the investigational migraine-prevention drug erenumab indicate its potential effectiveness in patients with episodic migraine attacks who have unsuccessfully tried other migraine-prevention drugs to reduce the frequency of migraine days.

Erenumab, a fully human monoclonal antibody that is designed to block the calcitonin gene-related peptide (CGRP) receptor, reduced the average number of monthly migraine headaches by half or more for 30% of study participants, which is a level of improvement that “can greatly improve a person’s quality of life,” first author Uwe Reuter, MD, of Charité–University Medicine Berlin said in a press release. Dr. Reuter will present the full results of the study during the Emerging Science Platform Session at the annual meeting of the American Academy of Neurology in Los Angeles on April 24.

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The study randomized 246 patients to double-blind, once-monthly injections with either 140 mg erenumab (also known as AMG 334) or placebo over 3 months. All patients in the study had been treated unsuccessfully with at least two previous preventive medications for migraine: 39% with two, 38% with three, and 23% with four. The patients had a mean of nine migraine headaches a month and used an acute migraine drug to stop an attack five times a month.

At 3 months, patients treated with erenumab significantly more often met the study’s primary endpoint of the proportion of patients achieving a 50% or greater reduction in mean monthly migraine days (MMDs) during weeks 9-12: At week 12, 30% on erenumab vs. 14% on placebo (odds ratio, 2.73; 95% confidence interval, 1.43-5.19) met the endpoint.

 

 


Those treated with erenumab also had a greater average reduction in MMDs in several secondary endpoints. For those on erenumab, there was an overall mean difference of –1.61 MMDs, compared with placebo. Erenumab-treated patients also had an overall mean difference of –1.73 acute medication days, compared with placebo.

The authors reported that erenumab had safety and tolerability comparable to placebo, and none of the patients taking erenumab discontinued because of adverse events.

Dr. Reuter cautioned that additional studies will need to be conducted to determine if the effects last longer than 3 months and to identify patients most likely to respond.

The study was funded by Novartis, which is developing erenumab.

SOURCE: Reuter E et al. AAN 2018, Emerging Science Abstract 009.

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Results from the phase 3b LIBERTY trial of the investigational migraine-prevention drug erenumab indicate its potential effectiveness in patients with episodic migraine attacks who have unsuccessfully tried other migraine-prevention drugs to reduce the frequency of migraine days.

Erenumab, a fully human monoclonal antibody that is designed to block the calcitonin gene-related peptide (CGRP) receptor, reduced the average number of monthly migraine headaches by half or more for 30% of study participants, which is a level of improvement that “can greatly improve a person’s quality of life,” first author Uwe Reuter, MD, of Charité–University Medicine Berlin said in a press release. Dr. Reuter will present the full results of the study during the Emerging Science Platform Session at the annual meeting of the American Academy of Neurology in Los Angeles on April 24.

laflor/gettyimages
The study randomized 246 patients to double-blind, once-monthly injections with either 140 mg erenumab (also known as AMG 334) or placebo over 3 months. All patients in the study had been treated unsuccessfully with at least two previous preventive medications for migraine: 39% with two, 38% with three, and 23% with four. The patients had a mean of nine migraine headaches a month and used an acute migraine drug to stop an attack five times a month.

At 3 months, patients treated with erenumab significantly more often met the study’s primary endpoint of the proportion of patients achieving a 50% or greater reduction in mean monthly migraine days (MMDs) during weeks 9-12: At week 12, 30% on erenumab vs. 14% on placebo (odds ratio, 2.73; 95% confidence interval, 1.43-5.19) met the endpoint.

 

 


Those treated with erenumab also had a greater average reduction in MMDs in several secondary endpoints. For those on erenumab, there was an overall mean difference of –1.61 MMDs, compared with placebo. Erenumab-treated patients also had an overall mean difference of –1.73 acute medication days, compared with placebo.

The authors reported that erenumab had safety and tolerability comparable to placebo, and none of the patients taking erenumab discontinued because of adverse events.

Dr. Reuter cautioned that additional studies will need to be conducted to determine if the effects last longer than 3 months and to identify patients most likely to respond.

The study was funded by Novartis, which is developing erenumab.

SOURCE: Reuter E et al. AAN 2018, Emerging Science Abstract 009.

 

Results from the phase 3b LIBERTY trial of the investigational migraine-prevention drug erenumab indicate its potential effectiveness in patients with episodic migraine attacks who have unsuccessfully tried other migraine-prevention drugs to reduce the frequency of migraine days.

Erenumab, a fully human monoclonal antibody that is designed to block the calcitonin gene-related peptide (CGRP) receptor, reduced the average number of monthly migraine headaches by half or more for 30% of study participants, which is a level of improvement that “can greatly improve a person’s quality of life,” first author Uwe Reuter, MD, of Charité–University Medicine Berlin said in a press release. Dr. Reuter will present the full results of the study during the Emerging Science Platform Session at the annual meeting of the American Academy of Neurology in Los Angeles on April 24.

laflor/gettyimages
The study randomized 246 patients to double-blind, once-monthly injections with either 140 mg erenumab (also known as AMG 334) or placebo over 3 months. All patients in the study had been treated unsuccessfully with at least two previous preventive medications for migraine: 39% with two, 38% with three, and 23% with four. The patients had a mean of nine migraine headaches a month and used an acute migraine drug to stop an attack five times a month.

At 3 months, patients treated with erenumab significantly more often met the study’s primary endpoint of the proportion of patients achieving a 50% or greater reduction in mean monthly migraine days (MMDs) during weeks 9-12: At week 12, 30% on erenumab vs. 14% on placebo (odds ratio, 2.73; 95% confidence interval, 1.43-5.19) met the endpoint.

 

 


Those treated with erenumab also had a greater average reduction in MMDs in several secondary endpoints. For those on erenumab, there was an overall mean difference of –1.61 MMDs, compared with placebo. Erenumab-treated patients also had an overall mean difference of –1.73 acute medication days, compared with placebo.

The authors reported that erenumab had safety and tolerability comparable to placebo, and none of the patients taking erenumab discontinued because of adverse events.

Dr. Reuter cautioned that additional studies will need to be conducted to determine if the effects last longer than 3 months and to identify patients most likely to respond.

The study was funded by Novartis, which is developing erenumab.

SOURCE: Reuter E et al. AAN 2018, Emerging Science Abstract 009.

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Key clinical point: Erenumab shows promise as a preventive migraine treatment for patients with episodic migraine who failed other preventive drugs.

Major finding: Patients treated with erenumab significantly more often achieved a 50% or greater reduction in mean monthly migraine days during weeks 9-12: At week 12, 30% with erenumab vs. 14% with placebo met the endpoint.

Study details: A 12-week, double-blind study of 246 patients with episodic migraine randomized to receive erenumab 140 mg or placebo.

Disclosures: The study was funded by Novartis, which is developing erenumab.

Source: Reuter E et al. AAN 2018, Emerging Science Abstract 009.

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