Migraine ICYMI

The theme of this month's commentary is alternative outcomes measures for future migraine studies. The traditional outcomes measures, such as headache frequency measured in headache days, have long been considered gold standards when evaluating the efficacy of preventive interventions. When headache conditions are complicated by interictal pain or other symptoms, or when medication overuse adds a higher frequency or greater severity, those traditional measures are somewhat less exact and specific. Meaningful change for patients with higher frequency of attacks, near-continuous pain, or other migraine symptoms is quite different from that for those without these complications.

Ailani and colleagues reviewed post hoc data from the CONQUER trial, a prior study evaluating the safety and efficacy of galcanezumab vs placebo in patients who had previously not benefited from two to four categories of migraine preventive medication. This refractory population was initially noted to have 4.1 fewer headache days per month than patients taking placebo, but the authors now attempted to review these data with a focus on a different measure: total pain burden (TPB). They defined daily TPB as a single composite measure assessing the frequency, duration, and severity of migraine, calculated by multiplying the number of hours of migraine by the maximum daily migraine pain severity score. The monthly TPB was calculated by adding the daily pain burden over the entire month. The Migraine Disability Assessment questionnaire (MIDAS) and Migraine-Specific Quality of Life Questionnaire (MSQ) scores were also included to compare migraine-related disability and quality of life.

The patients who received galcanezumab were noted to have a significantly lower TPB, both in episodic and chronic migraine. Significantly greater reductions in monthly TPB relative to placebo were observed at each individual month as well. The change from baseline TPB was also noted to be significantly improved in the galcanezumab group compared with the placebo group. The reduction in TPB was noted even when migraine-day reductions were accounted for as part of a sensitivity analysis.

Preventive trials for migraine treatment focus primarily on migraine-day reduction, and for many patients with higher-frequency migraine, this measure does not adequately account for their disease-related disability. This unique way of looking at pain as part of a bigger picture is much more significant and meaningful for this patient population. Migraine frequency is still a very important outcomes measure, but it would be wise to add TBP or another measure that looks more globally at disease-related disability, especially when investigating preventive options in patients with chronic migraine.

When considering whether an intervention is helpful, most patients and clinicians follow the headache frequency, severity, or quality-of-life factors. As most patients will readily report, not all "headache-free days" are created equal. Although most people with migraine will experience days with absolutely no headache pain or other migraine-associated symptoms, on many days they will still have some symptoms of migraine. Lee and colleagues attempted to quantify the difference between headache-free days and crystal-clear days.

Most headache studies use the frequency of headache days as a primary or secondary outcome. This study collected data on both headache days and crystal-clear days, using data from a questionnaire-based large South Korean nationwide population study that evaluated headache and sleep. The study questions were validated for migraine and aura, and included: "How many days have you had a headache during the previous 30 days?" and "How many days have you had crystal-clear days without headache during the previous 30 days?" The data were then analyzed and compared with the widespread pain index (criteria for fibromyalgia) as well as sleep duration, sleep quality, depression and anxiety scales, and an allodynia checklist.

A little over 3000 respondents completed the surveys; 1938 had experienced headache over the past year, 170 were classified as having a diagnosis of migraine, and 50 of those were diagnosed with aura as well. Out of the patients with migraine, 97% had "unclear days." This was higher than the rate of those with non-migraine headaches (91%). Nearly all people surveyed had some crystal-clear days (99.4%).

The number of crystal-clear days per 30 days was significantly lower in participants with migraine than in those with non-migraine headache. Participants with migraine also had higher frequencies of cutaneous allodynia, anxiety, and depression. The weekly average sleep duration in participants with migraine did not significantly differ from that in participants with non-migraine headaches. The widespread pain index rate was much higher in those with migraine as well.

Most patients will definitely understand the difference between crystal-clear and unclear headache days. Many of the newer outcomes studies in migraine have started focusing on the most bothersome symptom, as headache pain is far from the only significant or disabling symptom associated with migraine. This study makes clear that further outcomes changes are necessary, and that a potentially more meaningful result in migraine studies may actually be crystal-clear days rather than simply headache-free days.

Although there are more acute options available for headache treatment, medication overuse headache remains a major complicating factor for most clinicians who treat headache. When educating patients, there is always a strong emphasis on guidelines for acute medication use. Many patients struggle with knowing when to use an acute treatment and when to alternate with a different treatment, and often they will withhold treatment completely due to fear of medication overuse. The new class of calcitonin gene-related peptide (CGRP) antagonist medications has shown some potential benefit as a preventive option for both medication overuse headache and migraine.

The prospective study by Curone and colleagues enrolled 300 patients with confirmed medication overuse headache who did not undergo withdrawal of the overused acute medication. Patients who are already taking preventive medications were excluded, as were patients with diagnoses other than chronic migraine or medication overuse. Patients were given one of the three injectable CGRP antagonist medications for prevention and were followed up at 3, 6, 9, and 12 months. The primary outcome was MIDAS score as well as monthly headache days and analgesic consumption.

Out of 303 patients, 242 (80%) showed both a ≥50% reduction of monthly headache days and ≥50% reduction in analgesic intake at 3-month follow-up visit. At 9 months, 198 (65%) were still responders. Monthly analgesic intake decreased ≥50% in 268 of 303 patients (88%) at 3 months and in 241 of 303 patients (79%) at the 6-month follow-up.

For years there has been a debate regarding whether withdrawal of an overused medication is necessary for effective treatment of medication overuse headache. Many preventive treatments are less effective when medication overuse is ongoing. The CGRP class of medications does appear to be effective even with ongoing acute medication overuse. This class of medications should definitely be considered when withdrawing an overused medication is complicated, or when a patient needs to continue to take analgesic medications for another condition.

The theme of this month's commentary is alternative outcomes measures for future migraine studies. The traditional outcomes measures, such as headache frequency measured in headache days, have long been considered gold standards when evaluating the efficacy of preventive interventions. When headache conditions are complicated by interictal pain or other symptoms, or when medication overuse adds a higher frequency or greater severity, those traditional measures are somewhat less exact and specific. Meaningful change for patients with higher frequency of attacks, near-continuous pain, or other migraine symptoms is quite different from that for those without these complications.

Ailani and colleagues reviewed post hoc data from the CONQUER trial, a prior study evaluating the safety and efficacy of galcanezumab vs placebo in patients who had previously not benefited from two to four categories of migraine preventive medication. This refractory population was initially noted to have 4.1 fewer headache days per month than patients taking placebo, but the authors now attempted to review these data with a focus on a different measure: total pain burden (TPB). They defined daily TPB as a single composite measure assessing the frequency, duration, and severity of migraine, calculated by multiplying the number of hours of migraine by the maximum daily migraine pain severity score. The monthly TPB was calculated by adding the daily pain burden over the entire month. The Migraine Disability Assessment questionnaire (MIDAS) and Migraine-Specific Quality of Life Questionnaire (MSQ) scores were also included to compare migraine-related disability and quality of life.

The patients who received galcanezumab were noted to have a significantly lower TPB, both in episodic and chronic migraine. Significantly greater reductions in monthly TPB relative to placebo were observed at each individual month as well. The change from baseline TPB was also noted to be significantly improved in the galcanezumab group compared with the placebo group. The reduction in TPB was noted even when migraine-day reductions were accounted for as part of a sensitivity analysis.

Preventive trials for migraine treatment focus primarily on migraine-day reduction, and for many patients with higher-frequency migraine, this measure does not adequately account for their disease-related disability. This unique way of looking at pain as part of a bigger picture is much more significant and meaningful for this patient population. Migraine frequency is still a very important outcomes measure, but it would be wise to add TBP or another measure that looks more globally at disease-related disability, especially when investigating preventive options in patients with chronic migraine.

When considering whether an intervention is helpful, most patients and clinicians follow the headache frequency, severity, or quality-of-life factors. As most patients will readily report, not all "headache-free days" are created equal. Although most people with migraine will experience days with absolutely no headache pain or other migraine-associated symptoms, on many days they will still have some symptoms of migraine. Lee and colleagues attempted to quantify the difference between headache-free days and crystal-clear days.

Most headache studies use the frequency of headache days as a primary or secondary outcome. This study collected data on both headache days and crystal-clear days, using data from a questionnaire-based large South Korean nationwide population study that evaluated headache and sleep. The study questions were validated for migraine and aura, and included: "How many days have you had a headache during the previous 30 days?" and "How many days have you had crystal-clear days without headache during the previous 30 days?" The data were then analyzed and compared with the widespread pain index (criteria for fibromyalgia) as well as sleep duration, sleep quality, depression and anxiety scales, and an allodynia checklist.

A little over 3000 respondents completed the surveys; 1938 had experienced headache over the past year, 170 were classified as having a diagnosis of migraine, and 50 of those were diagnosed with aura as well. Out of the patients with migraine, 97% had "unclear days." This was higher than the rate of those with non-migraine headaches (91%). Nearly all people surveyed had some crystal-clear days (99.4%).

The number of crystal-clear days per 30 days was significantly lower in participants with migraine than in those with non-migraine headache. Participants with migraine also had higher frequencies of cutaneous allodynia, anxiety, and depression. The weekly average sleep duration in participants with migraine did not significantly differ from that in participants with non-migraine headaches. The widespread pain index rate was much higher in those with migraine as well.

Most patients will definitely understand the difference between crystal-clear and unclear headache days. Many of the newer outcomes studies in migraine have started focusing on the most bothersome symptom, as headache pain is far from the only significant or disabling symptom associated with migraine. This study makes clear that further outcomes changes are necessary, and that a potentially more meaningful result in migraine studies may actually be crystal-clear days rather than simply headache-free days.

Although there are more acute options available for headache treatment, medication overuse headache remains a major complicating factor for most clinicians who treat headache. When educating patients, there is always a strong emphasis on guidelines for acute medication use. Many patients struggle with knowing when to use an acute treatment and when to alternate with a different treatment, and often they will withhold treatment completely due to fear of medication overuse. The new class of calcitonin gene-related peptide (CGRP) antagonist medications has shown some potential benefit as a preventive option for both medication overuse headache and migraine.

The prospective study by Curone and colleagues enrolled 300 patients with confirmed medication overuse headache who did not undergo withdrawal of the overused acute medication. Patients who are already taking preventive medications were excluded, as were patients with diagnoses other than chronic migraine or medication overuse. Patients were given one of the three injectable CGRP antagonist medications for prevention and were followed up at 3, 6, 9, and 12 months. The primary outcome was MIDAS score as well as monthly headache days and analgesic consumption.

Out of 303 patients, 242 (80%) showed both a ≥50% reduction of monthly headache days and ≥50% reduction in analgesic intake at 3-month follow-up visit. At 9 months, 198 (65%) were still responders. Monthly analgesic intake decreased ≥50% in 268 of 303 patients (88%) at 3 months and in 241 of 303 patients (79%) at the 6-month follow-up.

For years there has been a debate regarding whether withdrawal of an overused medication is necessary for effective treatment of medication overuse headache. Many preventive treatments are less effective when medication overuse is ongoing. The CGRP class of medications does appear to be effective even with ongoing acute medication overuse. This class of medications should definitely be considered when withdrawing an overused medication is complicated, or when a patient needs to continue to take analgesic medications for another condition.

The theme of this month's commentary is alternative outcomes measures for future migraine studies. The traditional outcomes measures, such as headache frequency measured in headache days, have long been considered gold standards when evaluating the efficacy of preventive interventions. When headache conditions are complicated by interictal pain or other symptoms, or when medication overuse adds a higher frequency or greater severity, those traditional measures are somewhat less exact and specific. Meaningful change for patients with higher frequency of attacks, near-continuous pain, or other migraine symptoms is quite different from that for those without these complications.

Ailani and colleagues reviewed post hoc data from the CONQUER trial, a prior study evaluating the safety and efficacy of galcanezumab vs placebo in patients who had previously not benefited from two to four categories of migraine preventive medication. This refractory population was initially noted to have 4.1 fewer headache days per month than patients taking placebo, but the authors now attempted to review these data with a focus on a different measure: total pain burden (TPB). They defined daily TPB as a single composite measure assessing the frequency, duration, and severity of migraine, calculated by multiplying the number of hours of migraine by the maximum daily migraine pain severity score. The monthly TPB was calculated by adding the daily pain burden over the entire month. The Migraine Disability Assessment questionnaire (MIDAS) and Migraine-Specific Quality of Life Questionnaire (MSQ) scores were also included to compare migraine-related disability and quality of life.

The patients who received galcanezumab were noted to have a significantly lower TPB, both in episodic and chronic migraine. Significantly greater reductions in monthly TPB relative to placebo were observed at each individual month as well. The change from baseline TPB was also noted to be significantly improved in the galcanezumab group compared with the placebo group. The reduction in TPB was noted even when migraine-day reductions were accounted for as part of a sensitivity analysis.

Preventive trials for migraine treatment focus primarily on migraine-day reduction, and for many patients with higher-frequency migraine, this measure does not adequately account for their disease-related disability. This unique way of looking at pain as part of a bigger picture is much more significant and meaningful for this patient population. Migraine frequency is still a very important outcomes measure, but it would be wise to add TBP or another measure that looks more globally at disease-related disability, especially when investigating preventive options in patients with chronic migraine.

When considering whether an intervention is helpful, most patients and clinicians follow the headache frequency, severity, or quality-of-life factors. As most patients will readily report, not all "headache-free days" are created equal. Although most people with migraine will experience days with absolutely no headache pain or other migraine-associated symptoms, on many days they will still have some symptoms of migraine. Lee and colleagues attempted to quantify the difference between headache-free days and crystal-clear days.

Most headache studies use the frequency of headache days as a primary or secondary outcome. This study collected data on both headache days and crystal-clear days, using data from a questionnaire-based large South Korean nationwide population study that evaluated headache and sleep. The study questions were validated for migraine and aura, and included: "How many days have you had a headache during the previous 30 days?" and "How many days have you had crystal-clear days without headache during the previous 30 days?" The data were then analyzed and compared with the widespread pain index (criteria for fibromyalgia) as well as sleep duration, sleep quality, depression and anxiety scales, and an allodynia checklist.

A little over 3000 respondents completed the surveys; 1938 had experienced headache over the past year, 170 were classified as having a diagnosis of migraine, and 50 of those were diagnosed with aura as well. Out of the patients with migraine, 97% had "unclear days." This was higher than the rate of those with non-migraine headaches (91%). Nearly all people surveyed had some crystal-clear days (99.4%).

The number of crystal-clear days per 30 days was significantly lower in participants with migraine than in those with non-migraine headache. Participants with migraine also had higher frequencies of cutaneous allodynia, anxiety, and depression. The weekly average sleep duration in participants with migraine did not significantly differ from that in participants with non-migraine headaches. The widespread pain index rate was much higher in those with migraine as well.

Most patients will definitely understand the difference between crystal-clear and unclear headache days. Many of the newer outcomes studies in migraine have started focusing on the most bothersome symptom, as headache pain is far from the only significant or disabling symptom associated with migraine. This study makes clear that further outcomes changes are necessary, and that a potentially more meaningful result in migraine studies may actually be crystal-clear days rather than simply headache-free days.

Although there are more acute options available for headache treatment, medication overuse headache remains a major complicating factor for most clinicians who treat headache. When educating patients, there is always a strong emphasis on guidelines for acute medication use. Many patients struggle with knowing when to use an acute treatment and when to alternate with a different treatment, and often they will withhold treatment completely due to fear of medication overuse. The new class of calcitonin gene-related peptide (CGRP) antagonist medications has shown some potential benefit as a preventive option for both medication overuse headache and migraine.

The prospective study by Curone and colleagues enrolled 300 patients with confirmed medication overuse headache who did not undergo withdrawal of the overused acute medication. Patients who are already taking preventive medications were excluded, as were patients with diagnoses other than chronic migraine or medication overuse. Patients were given one of the three injectable CGRP antagonist medications for prevention and were followed up at 3, 6, 9, and 12 months. The primary outcome was MIDAS score as well as monthly headache days and analgesic consumption.

Out of 303 patients, 242 (80%) showed both a ≥50% reduction of monthly headache days and ≥50% reduction in analgesic intake at 3-month follow-up visit. At 9 months, 198 (65%) were still responders. Monthly analgesic intake decreased ≥50% in 268 of 303 patients (88%) at 3 months and in 241 of 303 patients (79%) at the 6-month follow-up.

For years there has been a debate regarding whether withdrawal of an overused medication is necessary for effective treatment of medication overuse headache. Many preventive treatments are less effective when medication overuse is ongoing. The CGRP class of medications does appear to be effective even with ongoing acute medication overuse. This class of medications should definitely be considered when withdrawing an overused medication is complicated, or when a patient needs to continue to take analgesic medications for another condition.

Key clinical point: Monoclonal antibodies inhibiting calcitonin gene-related peptide (CGRP) effectively reduced monthly headache days, symptomatic drug consumption, and headache severity consistently over 12 months in patients with chronic migraine complicated by medication overuse headache (MOH).

Major finding: Overall, 80% of patients showed both ≥50% reduction in monthly headache days and ≥50% reduction in analgesics intake at the 3-month follow-up visit and 78.8% continued to show the improvements at the 6-month follow-up visit. The mean Migraine Impact and Disability Assessment Scale score decreased from 56.5 (range 27-63) at baseline to 13.1 (range 11-37) at 9 months, with 71% of patients being responders even at 1 year.

Study details: The data come from a prospective study of 303 patients with chronic migraine complicated by MOH who received CGRP antagonists for at least 6 months up to 1 year.

Disclosures: No source of funding was declared. The authors declared no competing interests.

Source: Curone M et al. Overview on effectiveness of erenumab, fremanezumab, and galcanezumab in reducing medication overuse headache in chronic migraine patients. Neurol Sci. 2022 (Jul 14). Doi: 10.1007/s10072-022-06265-8

Key clinical point: Monoclonal antibodies inhibiting calcitonin gene-related peptide (CGRP) effectively reduced monthly headache days, symptomatic drug consumption, and headache severity consistently over 12 months in patients with chronic migraine complicated by medication overuse headache (MOH).

Major finding: Overall, 80% of patients showed both ≥50% reduction in monthly headache days and ≥50% reduction in analgesics intake at the 3-month follow-up visit and 78.8% continued to show the improvements at the 6-month follow-up visit. The mean Migraine Impact and Disability Assessment Scale score decreased from 56.5 (range 27-63) at baseline to 13.1 (range 11-37) at 9 months, with 71% of patients being responders even at 1 year.

Study details: The data come from a prospective study of 303 patients with chronic migraine complicated by MOH who received CGRP antagonists for at least 6 months up to 1 year.

Disclosures: No source of funding was declared. The authors declared no competing interests.

Source: Curone M et al. Overview on effectiveness of erenumab, fremanezumab, and galcanezumab in reducing medication overuse headache in chronic migraine patients. Neurol Sci. 2022 (Jul 14). Doi: 10.1007/s10072-022-06265-8

Key clinical point: Monoclonal antibodies inhibiting calcitonin gene-related peptide (CGRP) effectively reduced monthly headache days, symptomatic drug consumption, and headache severity consistently over 12 months in patients with chronic migraine complicated by medication overuse headache (MOH).

Major finding: Overall, 80% of patients showed both ≥50% reduction in monthly headache days and ≥50% reduction in analgesics intake at the 3-month follow-up visit and 78.8% continued to show the improvements at the 6-month follow-up visit. The mean Migraine Impact and Disability Assessment Scale score decreased from 56.5 (range 27-63) at baseline to 13.1 (range 11-37) at 9 months, with 71% of patients being responders even at 1 year.

Study details: The data come from a prospective study of 303 patients with chronic migraine complicated by MOH who received CGRP antagonists for at least 6 months up to 1 year.

Disclosures: No source of funding was declared. The authors declared no competing interests.

Source: Curone M et al. Overview on effectiveness of erenumab, fremanezumab, and galcanezumab in reducing medication overuse headache in chronic migraine patients. Neurol Sci. 2022 (Jul 14). Doi: 10.1007/s10072-022-06265-8

Key clinical point: The occurrence of unclear days, defined as headache-free but not crystal-clear days, is prevalent in migraine, with the number of crystal-clear days being significantly lower and unclear days being significantly higher in participants with migraine vs non-migraine headache.

Major finding: Overall, 97.1% of participants had unclear days, with the number of crystal-clear days per 30 days being significantly lower (median, 20.0 vs 25.0) and the number of severe headache days (2.0 vs 1.0), days with acute medications (2.0 vs 1.0), and unclear days (4.0 vs 1.0) per 30 days being significantly higher in participants with vs without migraine headache (all P < .001).

Study details: The data come from a cross-sectional and case-control analysis of longitudinally collected data from 170 and 1768 participants with migraine and nonmigraine headaches, respectively.

Disclosures: This study was funded by the National Research Foundation of Korea. S-J Cho and MK Chu declared being site investigators of a multicenter trial or an advisory board members or receiving lecture honoraria or grants from various sources.

Source: Lee W et al. Crystal-clear days and unclear days in migraine: A population-based study. Headache. 2022;62: 818- 827 (Jul 14). Doi: 10.1111/head.14359

Key clinical point: The occurrence of unclear days, defined as headache-free but not crystal-clear days, is prevalent in migraine, with the number of crystal-clear days being significantly lower and unclear days being significantly higher in participants with migraine vs non-migraine headache.

Major finding: Overall, 97.1% of participants had unclear days, with the number of crystal-clear days per 30 days being significantly lower (median, 20.0 vs 25.0) and the number of severe headache days (2.0 vs 1.0), days with acute medications (2.0 vs 1.0), and unclear days (4.0 vs 1.0) per 30 days being significantly higher in participants with vs without migraine headache (all P < .001).

Study details: The data come from a cross-sectional and case-control analysis of longitudinally collected data from 170 and 1768 participants with migraine and nonmigraine headaches, respectively.

Disclosures: This study was funded by the National Research Foundation of Korea. S-J Cho and MK Chu declared being site investigators of a multicenter trial or an advisory board members or receiving lecture honoraria or grants from various sources.

Source: Lee W et al. Crystal-clear days and unclear days in migraine: A population-based study. Headache. 2022;62: 818- 827 (Jul 14). Doi: 10.1111/head.14359

Key clinical point: The occurrence of unclear days, defined as headache-free but not crystal-clear days, is prevalent in migraine, with the number of crystal-clear days being significantly lower and unclear days being significantly higher in participants with migraine vs non-migraine headache.

Major finding: Overall, 97.1% of participants had unclear days, with the number of crystal-clear days per 30 days being significantly lower (median, 20.0 vs 25.0) and the number of severe headache days (2.0 vs 1.0), days with acute medications (2.0 vs 1.0), and unclear days (4.0 vs 1.0) per 30 days being significantly higher in participants with vs without migraine headache (all P < .001).

Study details: The data come from a cross-sectional and case-control analysis of longitudinally collected data from 170 and 1768 participants with migraine and nonmigraine headaches, respectively.

Disclosures: This study was funded by the National Research Foundation of Korea. S-J Cho and MK Chu declared being site investigators of a multicenter trial or an advisory board members or receiving lecture honoraria or grants from various sources.

Source: Lee W et al. Crystal-clear days and unclear days in migraine: A population-based study. Headache. 2022;62: 818- 827 (Jul 14). Doi: 10.1111/head.14359

Key clinical point: Erenumab was effective and generally well tolerated over the 3 months of follow-up in a real-world population of patients with difficult-to-treat chronic migraine.

Major finding: At 3 months follow-up, the median total and severe monthly migraine days reduced significantly from 28 to 20 and from 15 to 5, respectively (both P < .0001), with 39.8%, 22.3%, and 7.8% of patients achieving at least 30%, 50%, and 75% reductions in mean monthly headache days, respectively. Overall, 43% of patients reported ≥1 adverse event, with constipation being the most common adverse event.

Study details: The data come from a prospective clinical audit of a treatment-resistant population of 103 patients with chronic migraine, high prevalence of medication overuse, and high headache burden who received 140 mg erenumab monthly for 3 months.

Disclosures: This study did not receive any funding. Some authors declared serving on advisory boards or as principal investigators for clinical trials or receiving speaker honoraria, conference sponsorship, or grants from various sources.

Source: Lowe M et al. Efficacy of erenumab and factors predicting response after 3 months in treatment resistant chronic migraine: A clinical service evaluation. J Headache Pain. 2022;23:86 (Jul 22). Doi: 10.1186/s10194-022-01456-2

Key clinical point: Erenumab was effective and generally well tolerated over the 3 months of follow-up in a real-world population of patients with difficult-to-treat chronic migraine.

Major finding: At 3 months follow-up, the median total and severe monthly migraine days reduced significantly from 28 to 20 and from 15 to 5, respectively (both P < .0001), with 39.8%, 22.3%, and 7.8% of patients achieving at least 30%, 50%, and 75% reductions in mean monthly headache days, respectively. Overall, 43% of patients reported ≥1 adverse event, with constipation being the most common adverse event.

Study details: The data come from a prospective clinical audit of a treatment-resistant population of 103 patients with chronic migraine, high prevalence of medication overuse, and high headache burden who received 140 mg erenumab monthly for 3 months.

Disclosures: This study did not receive any funding. Some authors declared serving on advisory boards or as principal investigators for clinical trials or receiving speaker honoraria, conference sponsorship, or grants from various sources.

Source: Lowe M et al. Efficacy of erenumab and factors predicting response after 3 months in treatment resistant chronic migraine: A clinical service evaluation. J Headache Pain. 2022;23:86 (Jul 22). Doi: 10.1186/s10194-022-01456-2

Key clinical point: Erenumab was effective and generally well tolerated over the 3 months of follow-up in a real-world population of patients with difficult-to-treat chronic migraine.

Major finding: At 3 months follow-up, the median total and severe monthly migraine days reduced significantly from 28 to 20 and from 15 to 5, respectively (both P < .0001), with 39.8%, 22.3%, and 7.8% of patients achieving at least 30%, 50%, and 75% reductions in mean monthly headache days, respectively. Overall, 43% of patients reported ≥1 adverse event, with constipation being the most common adverse event.

Study details: The data come from a prospective clinical audit of a treatment-resistant population of 103 patients with chronic migraine, high prevalence of medication overuse, and high headache burden who received 140 mg erenumab monthly for 3 months.

Disclosures: This study did not receive any funding. Some authors declared serving on advisory boards or as principal investigators for clinical trials or receiving speaker honoraria, conference sponsorship, or grants from various sources.

Source: Lowe M et al. Efficacy of erenumab and factors predicting response after 3 months in treatment resistant chronic migraine: A clinical service evaluation. J Headache Pain. 2022;23:86 (Jul 22). Doi: 10.1186/s10194-022-01456-2

Key clinical point: Meta-analysis demonstrated lower general cognitive and language functions in patients with migraine, along with a significant association between migraine and risk for all-cause dementia.

Major finding: General cognitive (standard mean difference [SMD] −0.40; 95% CI −0.66 to −0.15) and language (SMD −0.14; 95% CI −0.27 to −0.00) functions were lower in the group of participants with vs without migraine, and no significant between-group differences were observed for visuospatial, attention, executive, and memory functions. Moreover, migraine was significantly associated with the risk for dementia (odds ratio/relative risk 1.30; 95% CI 1.11-1.52).

Study details: Findings are from a meta-analysis of 22 studies (including 3295 patients with migraine) that assessed cognitive function and 11 studies (including 12,871 patients with dementia, 56,365 participants without dementia, 47,942 patients with migraine, and 190,024 healthy controls) that assessed the association between migraine and risk for dementia.

Disclosures: This study was supported by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Gu L et al. Association between migraine and cognitive impairment. J Headache Pain. 2022;23:88 (Jul 26). Doi: 10.1186/s10194-022-01462-4

Key clinical point: Meta-analysis demonstrated lower general cognitive and language functions in patients with migraine, along with a significant association between migraine and risk for all-cause dementia.

Major finding: General cognitive (standard mean difference [SMD] −0.40; 95% CI −0.66 to −0.15) and language (SMD −0.14; 95% CI −0.27 to −0.00) functions were lower in the group of participants with vs without migraine, and no significant between-group differences were observed for visuospatial, attention, executive, and memory functions. Moreover, migraine was significantly associated with the risk for dementia (odds ratio/relative risk 1.30; 95% CI 1.11-1.52).

Study details: Findings are from a meta-analysis of 22 studies (including 3295 patients with migraine) that assessed cognitive function and 11 studies (including 12,871 patients with dementia, 56,365 participants without dementia, 47,942 patients with migraine, and 190,024 healthy controls) that assessed the association between migraine and risk for dementia.

Disclosures: This study was supported by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Gu L et al. Association between migraine and cognitive impairment. J Headache Pain. 2022;23:88 (Jul 26). Doi: 10.1186/s10194-022-01462-4

Key clinical point: Meta-analysis demonstrated lower general cognitive and language functions in patients with migraine, along with a significant association between migraine and risk for all-cause dementia.

Major finding: General cognitive (standard mean difference [SMD] −0.40; 95% CI −0.66 to −0.15) and language (SMD −0.14; 95% CI −0.27 to −0.00) functions were lower in the group of participants with vs without migraine, and no significant between-group differences were observed for visuospatial, attention, executive, and memory functions. Moreover, migraine was significantly associated with the risk for dementia (odds ratio/relative risk 1.30; 95% CI 1.11-1.52).

Study details: Findings are from a meta-analysis of 22 studies (including 3295 patients with migraine) that assessed cognitive function and 11 studies (including 12,871 patients with dementia, 56,365 participants without dementia, 47,942 patients with migraine, and 190,024 healthy controls) that assessed the association between migraine and risk for dementia.

Disclosures: This study was supported by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Gu L et al. Association between migraine and cognitive impairment. J Headache Pain. 2022;23:88 (Jul 26). Doi: 10.1186/s10194-022-01462-4

Key clinical point: Increased dietary niacin intake may have a beneficial effect on migraine outcomes in adults with inadequate niacin consumption and the effect seems to peak in patients with adequate niacin intake, with the threshold level being approximately 21.0 mg/day.

Major finding: The risk for migraine was lower among adults in the higher (18.4-26.2 mg/day: odds ratio [OR] 0.78; P  =  .004, and ≥26.3 mg/day: OR 0.74; P  =  .006) vs lower (≤12.3 mg/day) quartile of daily niacin intake, with the risk of developing migraine reducing by 2.5% with every 1 mg increase in daily dietary niacin consumption (OR 0.975; P  =  .011) in those with dietary niacin intake of <21 mg/day, but no such association was observed in those with dietary niacin intake of ≥21 mg/day.

Study details: This was a cross-sectional study including 10,246 participants aged ≥20 years, of whom 20.1% experienced migraine.

Disclosures: This study was supported by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Liu H et al. Association between dietary niacin intake and migraine among american adults: National Health and Nutrition Examination Survey. Nutrients. 2022;14(15):3052 (Jul 25). Doi: 10.3390/nu14153052

Key clinical point: Increased dietary niacin intake may have a beneficial effect on migraine outcomes in adults with inadequate niacin consumption and the effect seems to peak in patients with adequate niacin intake, with the threshold level being approximately 21.0 mg/day.

Major finding: The risk for migraine was lower among adults in the higher (18.4-26.2 mg/day: odds ratio [OR] 0.78; P  =  .004, and ≥26.3 mg/day: OR 0.74; P  =  .006) vs lower (≤12.3 mg/day) quartile of daily niacin intake, with the risk of developing migraine reducing by 2.5% with every 1 mg increase in daily dietary niacin consumption (OR 0.975; P  =  .011) in those with dietary niacin intake of <21 mg/day, but no such association was observed in those with dietary niacin intake of ≥21 mg/day.

Study details: This was a cross-sectional study including 10,246 participants aged ≥20 years, of whom 20.1% experienced migraine.

Disclosures: This study was supported by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Liu H et al. Association between dietary niacin intake and migraine among american adults: National Health and Nutrition Examination Survey. Nutrients. 2022;14(15):3052 (Jul 25). Doi: 10.3390/nu14153052

Key clinical point: Increased dietary niacin intake may have a beneficial effect on migraine outcomes in adults with inadequate niacin consumption and the effect seems to peak in patients with adequate niacin intake, with the threshold level being approximately 21.0 mg/day.

Major finding: The risk for migraine was lower among adults in the higher (18.4-26.2 mg/day: odds ratio [OR] 0.78; P  =  .004, and ≥26.3 mg/day: OR 0.74; P  =  .006) vs lower (≤12.3 mg/day) quartile of daily niacin intake, with the risk of developing migraine reducing by 2.5% with every 1 mg increase in daily dietary niacin consumption (OR 0.975; P  =  .011) in those with dietary niacin intake of <21 mg/day, but no such association was observed in those with dietary niacin intake of ≥21 mg/day.

Study details: This was a cross-sectional study including 10,246 participants aged ≥20 years, of whom 20.1% experienced migraine.

Disclosures: This study was supported by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Liu H et al. Association between dietary niacin intake and migraine among american adults: National Health and Nutrition Examination Survey. Nutrients. 2022;14(15):3052 (Jul 25). Doi: 10.3390/nu14153052

Key clinical point: Soy isoflavones significantly reduced the frequency and duration of migraine attacks, clinical indices, and calcitonin gene-related peptide (CGRP) levels and improved the quality of life in women with migraine.

Major finding: At 8 weeks, soy isoflavones vs placebo significantly reduced migraine frequency (mean change [MC] −2.36 vs −0.43; P < .001) and duration of attacks (MC −2.50 vs −0.02; P < .001), Migraine Headache Index score (MC −10.46 vs −1.47; P < .001), and CGRP levels (MC −12.18 vs −8.62 ng/L; P  =  .002) and significantly improved migraine-specific quality-of-life score (MC 16.76 vs 2.52; P < .001). No adverse effects were reported.

Study details: Findings are from a phase 3 trial including 88 adult women with migraine who had not reached menopausal/perimenopausal age and were randomly assigned to receive 50 mg/day soy isoflavones or placebo supplementation for 8 weeks.

Disclosures: This study was supported by Isfahan University of Medical Sciences, Iran. The authors declared no conflicts of interest.

Source: Babapour M et al. Effect of soy isoflavones supplementation on migraine characteristics, mental status and calcitonin gene-related peptide (CGRP) levels in women with migraine: results of randomised controlled trial. Nutr J. 2022;21:50 (Jul 30). Doi: 10.1186/s12937-022-00802-z

Key clinical point: Soy isoflavones significantly reduced the frequency and duration of migraine attacks, clinical indices, and calcitonin gene-related peptide (CGRP) levels and improved the quality of life in women with migraine.

Major finding: At 8 weeks, soy isoflavones vs placebo significantly reduced migraine frequency (mean change [MC] −2.36 vs −0.43; P < .001) and duration of attacks (MC −2.50 vs −0.02; P < .001), Migraine Headache Index score (MC −10.46 vs −1.47; P < .001), and CGRP levels (MC −12.18 vs −8.62 ng/L; P  =  .002) and significantly improved migraine-specific quality-of-life score (MC 16.76 vs 2.52; P < .001). No adverse effects were reported.

Study details: Findings are from a phase 3 trial including 88 adult women with migraine who had not reached menopausal/perimenopausal age and were randomly assigned to receive 50 mg/day soy isoflavones or placebo supplementation for 8 weeks.

Disclosures: This study was supported by Isfahan University of Medical Sciences, Iran. The authors declared no conflicts of interest.

Source: Babapour M et al. Effect of soy isoflavones supplementation on migraine characteristics, mental status and calcitonin gene-related peptide (CGRP) levels in women with migraine: results of randomised controlled trial. Nutr J. 2022;21:50 (Jul 30). Doi: 10.1186/s12937-022-00802-z

Key clinical point: Soy isoflavones significantly reduced the frequency and duration of migraine attacks, clinical indices, and calcitonin gene-related peptide (CGRP) levels and improved the quality of life in women with migraine.

Major finding: At 8 weeks, soy isoflavones vs placebo significantly reduced migraine frequency (mean change [MC] −2.36 vs −0.43; P < .001) and duration of attacks (MC −2.50 vs −0.02; P < .001), Migraine Headache Index score (MC −10.46 vs −1.47; P < .001), and CGRP levels (MC −12.18 vs −8.62 ng/L; P  =  .002) and significantly improved migraine-specific quality-of-life score (MC 16.76 vs 2.52; P < .001). No adverse effects were reported.

Study details: Findings are from a phase 3 trial including 88 adult women with migraine who had not reached menopausal/perimenopausal age and were randomly assigned to receive 50 mg/day soy isoflavones or placebo supplementation for 8 weeks.

Disclosures: This study was supported by Isfahan University of Medical Sciences, Iran. The authors declared no conflicts of interest.

Source: Babapour M et al. Effect of soy isoflavones supplementation on migraine characteristics, mental status and calcitonin gene-related peptide (CGRP) levels in women with migraine: results of randomised controlled trial. Nutr J. 2022;21:50 (Jul 30). Doi: 10.1186/s12937-022-00802-z

Key clinical point: Patients with diabetes who were screened for diabetic retinopathy (DR) had a lower risk of having migraine; however, DR was not a protective marker of incident migraine.

Major finding: The prevalence of migraine was 17% lower in patients with vs without diabetes (odds ratio [OR] 0.83; 95% CI 0.81-0.85), with the risk being lower in patients with vs without DR (OR 0.69; 95% CI 0.65-0.72). The risk of developing migraine was significantly lower in patients with diabetes and DR level ranging between 1 and 4 compared with matched individuals without diabetes (hazard ratio [HR] 0.66; 95% CI 0.55-0.80), but the risk was independent of the presence of DR.

Study details: The data come from a cross-sectional study including patients with diabetes who attended DR screening (n = 205,970) and age- and sex-matched patients without diabetes (n = 1,003,170).

Disclosures: This study was funded by the The Velux Foundation, Denmark. The authors declared no competing interests.

Source: Vergmann AS et al. Investigation of the correlation between diabetic retinopathy and prevalent and incident migraine in a national cohort study. Sci Rep. 2022;12:12443 (Jul 20). Doi: 10.1038/s41598-022-16793-0

Key clinical point: Patients with diabetes who were screened for diabetic retinopathy (DR) had a lower risk of having migraine; however, DR was not a protective marker of incident migraine.

Major finding: The prevalence of migraine was 17% lower in patients with vs without diabetes (odds ratio [OR] 0.83; 95% CI 0.81-0.85), with the risk being lower in patients with vs without DR (OR 0.69; 95% CI 0.65-0.72). The risk of developing migraine was significantly lower in patients with diabetes and DR level ranging between 1 and 4 compared with matched individuals without diabetes (hazard ratio [HR] 0.66; 95% CI 0.55-0.80), but the risk was independent of the presence of DR.

Study details: The data come from a cross-sectional study including patients with diabetes who attended DR screening (n = 205,970) and age- and sex-matched patients without diabetes (n = 1,003,170).

Disclosures: This study was funded by the The Velux Foundation, Denmark. The authors declared no competing interests.

Source: Vergmann AS et al. Investigation of the correlation between diabetic retinopathy and prevalent and incident migraine in a national cohort study. Sci Rep. 2022;12:12443 (Jul 20). Doi: 10.1038/s41598-022-16793-0

Key clinical point: Patients with diabetes who were screened for diabetic retinopathy (DR) had a lower risk of having migraine; however, DR was not a protective marker of incident migraine.

Major finding: The prevalence of migraine was 17% lower in patients with vs without diabetes (odds ratio [OR] 0.83; 95% CI 0.81-0.85), with the risk being lower in patients with vs without DR (OR 0.69; 95% CI 0.65-0.72). The risk of developing migraine was significantly lower in patients with diabetes and DR level ranging between 1 and 4 compared with matched individuals without diabetes (hazard ratio [HR] 0.66; 95% CI 0.55-0.80), but the risk was independent of the presence of DR.

Study details: The data come from a cross-sectional study including patients with diabetes who attended DR screening (n = 205,970) and age- and sex-matched patients without diabetes (n = 1,003,170).

Disclosures: This study was funded by the The Velux Foundation, Denmark. The authors declared no competing interests.

Source: Vergmann AS et al. Investigation of the correlation between diabetic retinopathy and prevalent and incident migraine in a national cohort study. Sci Rep. 2022;12:12443 (Jul 20). Doi: 10.1038/s41598-022-16793-0

Key clinical point: Bariatric surgery significantly reduced the frequency of migraine attacks, headache severity, and improved the quality of life and disability in patients with chronic migraine and severe obesity.

Major finding: After a mean period of 7.5 ± 2.3 months, there was a significant reduction in the number of migraine attacks (20.9 to 8.3 days; P < .001), headache severity score (7.7 to 4.8; P < .001), Migraine-Specific Quality-of-Life score (44.6 to 26.8; P < .001), and Migraine Disability Assessment Scale score (64.4 to 25.5; P < .001) in patients with chronic migraine who underwent bariatric surgery.

Study details: Findings are from a prospective study including 60 patients with chronic migraine and severe obesity who were referred for bariatric surgery.

Disclosures: This study was supported by Isfahan University of Medical Sciences, Iran, and others. The authors declared no conflicts of interest.

Source: Etefagh HH et al. Bariatric surgery in migraine patients: CGRP level and weight loss. Obes Surg. 2022 (Aug 3). Doi: 10.1007/s11695-022-06218-2

Key clinical point: Bariatric surgery significantly reduced the frequency of migraine attacks, headache severity, and improved the quality of life and disability in patients with chronic migraine and severe obesity.

Major finding: After a mean period of 7.5 ± 2.3 months, there was a significant reduction in the number of migraine attacks (20.9 to 8.3 days; P < .001), headache severity score (7.7 to 4.8; P < .001), Migraine-Specific Quality-of-Life score (44.6 to 26.8; P < .001), and Migraine Disability Assessment Scale score (64.4 to 25.5; P < .001) in patients with chronic migraine who underwent bariatric surgery.

Study details: Findings are from a prospective study including 60 patients with chronic migraine and severe obesity who were referred for bariatric surgery.

Disclosures: This study was supported by Isfahan University of Medical Sciences, Iran, and others. The authors declared no conflicts of interest.

Source: Etefagh HH et al. Bariatric surgery in migraine patients: CGRP level and weight loss. Obes Surg. 2022 (Aug 3). Doi: 10.1007/s11695-022-06218-2

Key clinical point: Bariatric surgery significantly reduced the frequency of migraine attacks, headache severity, and improved the quality of life and disability in patients with chronic migraine and severe obesity.

Major finding: After a mean period of 7.5 ± 2.3 months, there was a significant reduction in the number of migraine attacks (20.9 to 8.3 days; P < .001), headache severity score (7.7 to 4.8; P < .001), Migraine-Specific Quality-of-Life score (44.6 to 26.8; P < .001), and Migraine Disability Assessment Scale score (64.4 to 25.5; P < .001) in patients with chronic migraine who underwent bariatric surgery.

Study details: Findings are from a prospective study including 60 patients with chronic migraine and severe obesity who were referred for bariatric surgery.

Disclosures: This study was supported by Isfahan University of Medical Sciences, Iran, and others. The authors declared no conflicts of interest.

Source: Etefagh HH et al. Bariatric surgery in migraine patients: CGRP level and weight loss. Obes Surg. 2022 (Aug 3). Doi: 10.1007/s11695-022-06218-2

Key clinical point: Once-monthly 120 mg galcanezumab was more effective than placebo in reducing total pain burden (TPB) in patients with chronic or episodic migraine who previously did not benefit from 2-4 categories of migraine preventive medication.

Major finding: At 3 months, galcanezumab vs placebo led to a significantly higher overall percentage change in TPB in patients with chronic (mean difference [MD] −40.4%; P < .001) or episodic (MD −53.1%; P < .001) migraine and significant reductions in monthly number, duration, and severity of migraine headache days in the overall population (all P < .001).

Study details: Findings are from a post hoc analysis of a phase 3 trial, CONQUER, including 458 patients with chronic or episodic migraine who previously did not benefit from 2-4 categories of migraine preventive medication and were randomly assigned to receive galcanezumab or placebo.

Disclosures: This study was sponsored by Eli Lilly and Company. Four authors declared being current or former employees or stockholders of Eli Lilly. J Ailani reported ties with various sources, including Eli Lilly and Company.

Source: Ailani J et al. Effect of galcanezumab on total pain burden in patients who had previously not benefited from migraine preventive medication (CONQUER Trial): A post hoc analysis. Adv Ther. 2022 (Aug 5). Doi: 10.1007/s12325-022-02233-y

Key clinical point: Once-monthly 120 mg galcanezumab was more effective than placebo in reducing total pain burden (TPB) in patients with chronic or episodic migraine who previously did not benefit from 2-4 categories of migraine preventive medication.

Major finding: At 3 months, galcanezumab vs placebo led to a significantly higher overall percentage change in TPB in patients with chronic (mean difference [MD] −40.4%; P < .001) or episodic (MD −53.1%; P < .001) migraine and significant reductions in monthly number, duration, and severity of migraine headache days in the overall population (all P < .001).

Study details: Findings are from a post hoc analysis of a phase 3 trial, CONQUER, including 458 patients with chronic or episodic migraine who previously did not benefit from 2-4 categories of migraine preventive medication and were randomly assigned to receive galcanezumab or placebo.

Disclosures: This study was sponsored by Eli Lilly and Company. Four authors declared being current or former employees or stockholders of Eli Lilly. J Ailani reported ties with various sources, including Eli Lilly and Company.

Source: Ailani J et al. Effect of galcanezumab on total pain burden in patients who had previously not benefited from migraine preventive medication (CONQUER Trial): A post hoc analysis. Adv Ther. 2022 (Aug 5). Doi: 10.1007/s12325-022-02233-y

Key clinical point: Once-monthly 120 mg galcanezumab was more effective than placebo in reducing total pain burden (TPB) in patients with chronic or episodic migraine who previously did not benefit from 2-4 categories of migraine preventive medication.

Major finding: At 3 months, galcanezumab vs placebo led to a significantly higher overall percentage change in TPB in patients with chronic (mean difference [MD] −40.4%; P < .001) or episodic (MD −53.1%; P < .001) migraine and significant reductions in monthly number, duration, and severity of migraine headache days in the overall population (all P < .001).

Study details: Findings are from a post hoc analysis of a phase 3 trial, CONQUER, including 458 patients with chronic or episodic migraine who previously did not benefit from 2-4 categories of migraine preventive medication and were randomly assigned to receive galcanezumab or placebo.

Disclosures: This study was sponsored by Eli Lilly and Company. Four authors declared being current or former employees or stockholders of Eli Lilly. J Ailani reported ties with various sources, including Eli Lilly and Company.

Source: Ailani J et al. Effect of galcanezumab on total pain burden in patients who had previously not benefited from migraine preventive medication (CONQUER Trial): A post hoc analysis. Adv Ther. 2022 (Aug 5). Doi: 10.1007/s12325-022-02233-y