VIDEO: Eptinezumab shows efficacy in episodic and chronic migraine trials

LOS ANGELES – New results from phase 3 randomized trials of the prophylactic migraine treatment eptinezumab show significant reductions in the number of monthly migraine headache days experienced by patients with chronic or frequent episodic migraines.

Eptinezumab, an experimental monoclonal antibody delivered by intravenous infusion, is one of several antimigraine agents in development that targets calcitonin gene-related peptide (CGRP), a key mediator of migraine.

At the annual meeting of the American Academy of Neurology, Richard Lipton, MD, of Albert Einstein College of Medicine in New York, presented results from PROMISE 2, a phase 3 randomized, placebo-controlled trial of eptinezumab in patients with chronic migraine, or 15 or more days with migraine per month.

The investigators randomized 1,072 patients to quarterly IV infusions of eptinezumab 100 or 300 mg or placebo.

The vast majority of patients in the study were women, (86%-90% across groups) with a mean age of about 40 years. Patients reported 11-12 years of chronic migraine and about 16 migraine days per month at baseline, Dr. Lipton told the conference, reflecting a high level of disability in the cohort.

The primary endpoint of the study was mean change in monthly migraine days from baseline through week 12. Dr. Lipton reported that the placebo group saw a 5.6-day reduction in migraine, while the 100-mg group saw a 7.7-day reduction, and patients receiving the 300-mg dose saw an 8.2-day reduction during the first 12 weeks after injection (P less than .0001 for both).

One-third of patients receiving the highest dose saw a 75% or greater reduction in monthly migraine days by week 12, “a relatively high bar” to meet, Dr. Lipton said. Some 61% of patients on the high dose saw a reduction of 50% or more in the same time period.

 

A unique secondary endpoint of the study was the proportion of patients who experienced migraine on day 1 after the initial dose. The treatment groups saw a 52% reduction 1 day after receiving the study drug, while the placebo group saw a 27% reduction in the expected prevalence of migraine in the cohort for any single day, and the decrease was sustained through day 28. The results suggest a rapid onset of action for eptinezumab, followed by a sustained benefit, Dr. Lipton said.

Also at AAN, Stephen D. Silberstein, MD, of Thomas Jefferson University in Philadelphia, presented new 12-month results from the PROMISE 1 trial, a randomized clinical trial to evaluate quarterly IV infusions of eptinezumab 30 mg, 100 mg, 300 mg, or placebo, in 888 patients with episodic migraines, defined as 14 or fewer days per month with migraine.

The researchers, who last year published 6-month results showing significant reductions in monthly migraine days associated with eptinezumab treatment over placebo, described further reductions from patients’ baseline frequency of migraines with longer duration of treatment.

After their third and fourth quarterly injections, 70.7% of eptinezumab-treated patients achieved a 50% reduction of monthly migraine days from baseline, compared with 58.7% for placebo, the investigators reported. These findings represent an 8.9% improvement over the reductions experienced during the first two quarterly doses of eptinezumab in this cohort.

More than half of patients in the treatment arms achieved on average a 75% reduction or greater of monthly migraine days from baseline, compared with 38.7% for placebo, a 12.8% improvement from the reductions experienced with the first two doses of eptinezumab.

Adverse effects seen in the trials were upper respiratory infection, nasopharyngitis, sinusitis, and nausea.

Both trials were sponsored by eptinezumab’s manufacturer, Alder. Dr. Lipton, Dr. Silberstein, and several of their coauthors disclosed support from Alder and other manufacturers, while some coauthors on the studies are employees of Alder.

SOURCE: Saper J et al. AAN 2018, Abstract S20.001 and Lipton R et al. AAN 2018, Clinical Trials Plenary Session Abstract.

 

LOS ANGELES – New results from phase 3 randomized trials of the prophylactic migraine treatment eptinezumab show significant reductions in the number of monthly migraine headache days experienced by patients with chronic or frequent episodic migraines.

Eptinezumab, an experimental monoclonal antibody delivered by intravenous infusion, is one of several antimigraine agents in development that targets calcitonin gene-related peptide (CGRP), a key mediator of migraine.

At the annual meeting of the American Academy of Neurology, Richard Lipton, MD, of Albert Einstein College of Medicine in New York, presented results from PROMISE 2, a phase 3 randomized, placebo-controlled trial of eptinezumab in patients with chronic migraine, or 15 or more days with migraine per month.

The investigators randomized 1,072 patients to quarterly IV infusions of eptinezumab 100 or 300 mg or placebo.

The vast majority of patients in the study were women, (86%-90% across groups) with a mean age of about 40 years. Patients reported 11-12 years of chronic migraine and about 16 migraine days per month at baseline, Dr. Lipton told the conference, reflecting a high level of disability in the cohort.

The primary endpoint of the study was mean change in monthly migraine days from baseline through week 12. Dr. Lipton reported that the placebo group saw a 5.6-day reduction in migraine, while the 100-mg group saw a 7.7-day reduction, and patients receiving the 300-mg dose saw an 8.2-day reduction during the first 12 weeks after injection (P less than .0001 for both).

One-third of patients receiving the highest dose saw a 75% or greater reduction in monthly migraine days by week 12, “a relatively high bar” to meet, Dr. Lipton said. Some 61% of patients on the high dose saw a reduction of 50% or more in the same time period.

 

A unique secondary endpoint of the study was the proportion of patients who experienced migraine on day 1 after the initial dose. The treatment groups saw a 52% reduction 1 day after receiving the study drug, while the placebo group saw a 27% reduction in the expected prevalence of migraine in the cohort for any single day, and the decrease was sustained through day 28. The results suggest a rapid onset of action for eptinezumab, followed by a sustained benefit, Dr. Lipton said.

Also at AAN, Stephen D. Silberstein, MD, of Thomas Jefferson University in Philadelphia, presented new 12-month results from the PROMISE 1 trial, a randomized clinical trial to evaluate quarterly IV infusions of eptinezumab 30 mg, 100 mg, 300 mg, or placebo, in 888 patients with episodic migraines, defined as 14 or fewer days per month with migraine.

The researchers, who last year published 6-month results showing significant reductions in monthly migraine days associated with eptinezumab treatment over placebo, described further reductions from patients’ baseline frequency of migraines with longer duration of treatment.

After their third and fourth quarterly injections, 70.7% of eptinezumab-treated patients achieved a 50% reduction of monthly migraine days from baseline, compared with 58.7% for placebo, the investigators reported. These findings represent an 8.9% improvement over the reductions experienced during the first two quarterly doses of eptinezumab in this cohort.

More than half of patients in the treatment arms achieved on average a 75% reduction or greater of monthly migraine days from baseline, compared with 38.7% for placebo, a 12.8% improvement from the reductions experienced with the first two doses of eptinezumab.

Adverse effects seen in the trials were upper respiratory infection, nasopharyngitis, sinusitis, and nausea.

Both trials were sponsored by eptinezumab’s manufacturer, Alder. Dr. Lipton, Dr. Silberstein, and several of their coauthors disclosed support from Alder and other manufacturers, while some coauthors on the studies are employees of Alder.

SOURCE: Saper J et al. AAN 2018, Abstract S20.001 and Lipton R et al. AAN 2018, Clinical Trials Plenary Session Abstract.

 

LOS ANGELES – New results from phase 3 randomized trials of the prophylactic migraine treatment eptinezumab show significant reductions in the number of monthly migraine headache days experienced by patients with chronic or frequent episodic migraines.

Eptinezumab, an experimental monoclonal antibody delivered by intravenous infusion, is one of several antimigraine agents in development that targets calcitonin gene-related peptide (CGRP), a key mediator of migraine.

At the annual meeting of the American Academy of Neurology, Richard Lipton, MD, of Albert Einstein College of Medicine in New York, presented results from PROMISE 2, a phase 3 randomized, placebo-controlled trial of eptinezumab in patients with chronic migraine, or 15 or more days with migraine per month.

The investigators randomized 1,072 patients to quarterly IV infusions of eptinezumab 100 or 300 mg or placebo.

The vast majority of patients in the study were women, (86%-90% across groups) with a mean age of about 40 years. Patients reported 11-12 years of chronic migraine and about 16 migraine days per month at baseline, Dr. Lipton told the conference, reflecting a high level of disability in the cohort.

The primary endpoint of the study was mean change in monthly migraine days from baseline through week 12. Dr. Lipton reported that the placebo group saw a 5.6-day reduction in migraine, while the 100-mg group saw a 7.7-day reduction, and patients receiving the 300-mg dose saw an 8.2-day reduction during the first 12 weeks after injection (P less than .0001 for both).

One-third of patients receiving the highest dose saw a 75% or greater reduction in monthly migraine days by week 12, “a relatively high bar” to meet, Dr. Lipton said. Some 61% of patients on the high dose saw a reduction of 50% or more in the same time period.

 

A unique secondary endpoint of the study was the proportion of patients who experienced migraine on day 1 after the initial dose. The treatment groups saw a 52% reduction 1 day after receiving the study drug, while the placebo group saw a 27% reduction in the expected prevalence of migraine in the cohort for any single day, and the decrease was sustained through day 28. The results suggest a rapid onset of action for eptinezumab, followed by a sustained benefit, Dr. Lipton said.

Also at AAN, Stephen D. Silberstein, MD, of Thomas Jefferson University in Philadelphia, presented new 12-month results from the PROMISE 1 trial, a randomized clinical trial to evaluate quarterly IV infusions of eptinezumab 30 mg, 100 mg, 300 mg, or placebo, in 888 patients with episodic migraines, defined as 14 or fewer days per month with migraine.

The researchers, who last year published 6-month results showing significant reductions in monthly migraine days associated with eptinezumab treatment over placebo, described further reductions from patients’ baseline frequency of migraines with longer duration of treatment.

After their third and fourth quarterly injections, 70.7% of eptinezumab-treated patients achieved a 50% reduction of monthly migraine days from baseline, compared with 58.7% for placebo, the investigators reported. These findings represent an 8.9% improvement over the reductions experienced during the first two quarterly doses of eptinezumab in this cohort.

More than half of patients in the treatment arms achieved on average a 75% reduction or greater of monthly migraine days from baseline, compared with 38.7% for placebo, a 12.8% improvement from the reductions experienced with the first two doses of eptinezumab.

Adverse effects seen in the trials were upper respiratory infection, nasopharyngitis, sinusitis, and nausea.

Both trials were sponsored by eptinezumab’s manufacturer, Alder. Dr. Lipton, Dr. Silberstein, and several of their coauthors disclosed support from Alder and other manufacturers, while some coauthors on the studies are employees of Alder.

SOURCE: Saper J et al. AAN 2018, Abstract S20.001 and Lipton R et al. AAN 2018, Clinical Trials Plenary Session Abstract.