Migraine ICYMI

Key clinical point: Galcanezumab effectively reduced monthly migraine headache days (MMHD) in patients with migraine who did not benefit from commonly prescribed preventive treatments.

Major finding: Patients treated with galcanezumab vs. placebo had a greater mean reduction in MMHD across months 1-3 (all P less than .01) and improved quality of life at month 3 (P less than .01). A greater proportion of patients treated with galcanezumab vs. placebo experienced 50% or more reduction in MMHD from baseline (all P less than .05).

Study details: Data come from a post hoc analysis of phase 3b CONQUER study which included patients with chronic or episodic migraine who were not benefited from 2-4 classes of migraine preventive treatments and were randomly allocated to receive placebo (n=230) or galcanezumab 120 mg/month (n=232).

Disclosures: This study was funded by Eli Lilly and Company. DK Kuruppu, Y Dong, and LY Medina declared being full-time employees of and/or minor stockholders of Eli Lilly and Company. J Tobin and AL Green reported receiving compensation from Eli Lilly and Company.

Source: Kuruppu DK et al. BMC Neurol. 2021 Apr 23. doi: 10.1186/s12883-021-02196-7.

Key clinical point: Galcanezumab effectively reduced monthly migraine headache days (MMHD) in patients with migraine who did not benefit from commonly prescribed preventive treatments.

Major finding: Patients treated with galcanezumab vs. placebo had a greater mean reduction in MMHD across months 1-3 (all P less than .01) and improved quality of life at month 3 (P less than .01). A greater proportion of patients treated with galcanezumab vs. placebo experienced 50% or more reduction in MMHD from baseline (all P less than .05).

Study details: Data come from a post hoc analysis of phase 3b CONQUER study which included patients with chronic or episodic migraine who were not benefited from 2-4 classes of migraine preventive treatments and were randomly allocated to receive placebo (n=230) or galcanezumab 120 mg/month (n=232).

Disclosures: This study was funded by Eli Lilly and Company. DK Kuruppu, Y Dong, and LY Medina declared being full-time employees of and/or minor stockholders of Eli Lilly and Company. J Tobin and AL Green reported receiving compensation from Eli Lilly and Company.

Source: Kuruppu DK et al. BMC Neurol. 2021 Apr 23. doi: 10.1186/s12883-021-02196-7.

Key clinical point: Galcanezumab effectively reduced monthly migraine headache days (MMHD) in patients with migraine who did not benefit from commonly prescribed preventive treatments.

Major finding: Patients treated with galcanezumab vs. placebo had a greater mean reduction in MMHD across months 1-3 (all P less than .01) and improved quality of life at month 3 (P less than .01). A greater proportion of patients treated with galcanezumab vs. placebo experienced 50% or more reduction in MMHD from baseline (all P less than .05).

Study details: Data come from a post hoc analysis of phase 3b CONQUER study which included patients with chronic or episodic migraine who were not benefited from 2-4 classes of migraine preventive treatments and were randomly allocated to receive placebo (n=230) or galcanezumab 120 mg/month (n=232).

Disclosures: This study was funded by Eli Lilly and Company. DK Kuruppu, Y Dong, and LY Medina declared being full-time employees of and/or minor stockholders of Eli Lilly and Company. J Tobin and AL Green reported receiving compensation from Eli Lilly and Company.

Source: Kuruppu DK et al. BMC Neurol. 2021 Apr 23. doi: 10.1186/s12883-021-02196-7.

Key clinical point: Medication-overuse headache (MOH) was associated with an increased risk for suicidal ideation and prior suicide attempt in patients with chronic migraine (CM).

Major finding: The presence of MOH increased the risks for suicidal ideation (odds ratio [OR], 1.75; P = .004) and prior suicide attempt (OR, 1.88; P = .024) in patients with CM.

Study details: Findings are from a cross-sectional study of 603 patients with CM with (n=320) or without (n=283) coexisting MOH.

Disclosures: The study was supported in part by the Taiwan Ministry of Science and Technology, Taipei Veterans General Hospital, and others. YF Wang and SJ Wang reported receiving honoraria and/or research grants from and serving on advisory boards for multiple sources. Three other authors had no disclosures.

Source: Wang YF et al. J Headache Pain. 2021 May 10. doi: 10.1186/s10194-021-01248-0.

Key clinical point: Medication-overuse headache (MOH) was associated with an increased risk for suicidal ideation and prior suicide attempt in patients with chronic migraine (CM).

Major finding: The presence of MOH increased the risks for suicidal ideation (odds ratio [OR], 1.75; P = .004) and prior suicide attempt (OR, 1.88; P = .024) in patients with CM.

Study details: Findings are from a cross-sectional study of 603 patients with CM with (n=320) or without (n=283) coexisting MOH.

Disclosures: The study was supported in part by the Taiwan Ministry of Science and Technology, Taipei Veterans General Hospital, and others. YF Wang and SJ Wang reported receiving honoraria and/or research grants from and serving on advisory boards for multiple sources. Three other authors had no disclosures.

Source: Wang YF et al. J Headache Pain. 2021 May 10. doi: 10.1186/s10194-021-01248-0.

Key clinical point: Medication-overuse headache (MOH) was associated with an increased risk for suicidal ideation and prior suicide attempt in patients with chronic migraine (CM).

Major finding: The presence of MOH increased the risks for suicidal ideation (odds ratio [OR], 1.75; P = .004) and prior suicide attempt (OR, 1.88; P = .024) in patients with CM.

Study details: Findings are from a cross-sectional study of 603 patients with CM with (n=320) or without (n=283) coexisting MOH.

Disclosures: The study was supported in part by the Taiwan Ministry of Science and Technology, Taipei Veterans General Hospital, and others. YF Wang and SJ Wang reported receiving honoraria and/or research grants from and serving on advisory boards for multiple sources. Three other authors had no disclosures.

Source: Wang YF et al. J Headache Pain. 2021 May 10. doi: 10.1186/s10194-021-01248-0.

Key clinical point: In a real-life cohort of patients with chronic migraine (CM) and high-frequency episodic migraine (HFEM), galcanezumab was safe, well tolerated, and seemed to be more effective compared with that in randomized control trials.

Major finding: After 6 months of therapy, galcanezumab reduced monthly migraine days by 8 days in patients with HFEM and monthly headache days by 13 days in patients with CM (both P less than .001). Overall, galcanezumab was well tolerated with no serious adverse events reported.

Study details: Data come from a real-life, prospective cohort study (GARLIT) of 163 patients with HFEM and CM treated with subcutaneous galcanezumab 120 mg monthly.

Disclosures: The study was funded by Campus Bio-Medico University. Lead author F Vernieri along with other authors reported receiving travel grants, honoraria, and/or grants from various pharma companies. N Brunelli, CM Costa, and M Albanese had nothing to disclose.

Source: Vernieri F et al. J Headache Pain. 2021 May 3. doi: 10.1186/s10194-021-01247-1.

Key clinical point: In a real-life cohort of patients with chronic migraine (CM) and high-frequency episodic migraine (HFEM), galcanezumab was safe, well tolerated, and seemed to be more effective compared with that in randomized control trials.

Major finding: After 6 months of therapy, galcanezumab reduced monthly migraine days by 8 days in patients with HFEM and monthly headache days by 13 days in patients with CM (both P less than .001). Overall, galcanezumab was well tolerated with no serious adverse events reported.

Study details: Data come from a real-life, prospective cohort study (GARLIT) of 163 patients with HFEM and CM treated with subcutaneous galcanezumab 120 mg monthly.

Disclosures: The study was funded by Campus Bio-Medico University. Lead author F Vernieri along with other authors reported receiving travel grants, honoraria, and/or grants from various pharma companies. N Brunelli, CM Costa, and M Albanese had nothing to disclose.

Source: Vernieri F et al. J Headache Pain. 2021 May 3. doi: 10.1186/s10194-021-01247-1.

Key clinical point: In a real-life cohort of patients with chronic migraine (CM) and high-frequency episodic migraine (HFEM), galcanezumab was safe, well tolerated, and seemed to be more effective compared with that in randomized control trials.

Major finding: After 6 months of therapy, galcanezumab reduced monthly migraine days by 8 days in patients with HFEM and monthly headache days by 13 days in patients with CM (both P less than .001). Overall, galcanezumab was well tolerated with no serious adverse events reported.

Study details: Data come from a real-life, prospective cohort study (GARLIT) of 163 patients with HFEM and CM treated with subcutaneous galcanezumab 120 mg monthly.

Disclosures: The study was funded by Campus Bio-Medico University. Lead author F Vernieri along with other authors reported receiving travel grants, honoraria, and/or grants from various pharma companies. N Brunelli, CM Costa, and M Albanese had nothing to disclose.

Source: Vernieri F et al. J Headache Pain. 2021 May 3. doi: 10.1186/s10194-021-01247-1.

Key clinical point: Fremanezumab was significantly more efficacious than placebo in reducing the average number of monthly headache days (MHDs) and monthly migraine days (MMDs) in patients with chronic migraine (CM) and comorbid moderate-to-severe depression.

Major finding: At week 12, the average number of MHDs of at least moderate severity was significantly reduced in fremanezumab quarterly (least-squares mean change [LSM], −5.3) and monthly (LSM, −5.5) dose regimens vs. placebo (LSM, −2.2; both P less than .001). Similarly, MMDs were significantly reduced with fremanezumab quarterly (LSM, −5.4; P = .002) and monthly (LSM, −5.5; P less than .001) dose regimens vs. placebo (LSM, −2.4).

Study details: Findings are from a post hoc analysis of phase 3 HALO trial that included 1,130 patients with CM randomly allocated to receive fremanezumab quarterly, fremanezumab monthly, or placebo.

Disclosures: The study was funded by Teva Pharmaceutical Industries Ltd. Some of the authors declared serving as consultant, advisory board member, and/or receiving research support and honoraria from multiple sources. Some of the authors declared being current/former employees of Teva Branded Pharmaceutical Products R&D, Inc. (USA).

Source: Lipton RB et al. Headache. 2021 Apr 23. doi: 10.1111/head.14097.

Key clinical point: Fremanezumab was significantly more efficacious than placebo in reducing the average number of monthly headache days (MHDs) and monthly migraine days (MMDs) in patients with chronic migraine (CM) and comorbid moderate-to-severe depression.

Major finding: At week 12, the average number of MHDs of at least moderate severity was significantly reduced in fremanezumab quarterly (least-squares mean change [LSM], −5.3) and monthly (LSM, −5.5) dose regimens vs. placebo (LSM, −2.2; both P less than .001). Similarly, MMDs were significantly reduced with fremanezumab quarterly (LSM, −5.4; P = .002) and monthly (LSM, −5.5; P less than .001) dose regimens vs. placebo (LSM, −2.4).

Study details: Findings are from a post hoc analysis of phase 3 HALO trial that included 1,130 patients with CM randomly allocated to receive fremanezumab quarterly, fremanezumab monthly, or placebo.

Disclosures: The study was funded by Teva Pharmaceutical Industries Ltd. Some of the authors declared serving as consultant, advisory board member, and/or receiving research support and honoraria from multiple sources. Some of the authors declared being current/former employees of Teva Branded Pharmaceutical Products R&D, Inc. (USA).

Source: Lipton RB et al. Headache. 2021 Apr 23. doi: 10.1111/head.14097.

Key clinical point: Fremanezumab was significantly more efficacious than placebo in reducing the average number of monthly headache days (MHDs) and monthly migraine days (MMDs) in patients with chronic migraine (CM) and comorbid moderate-to-severe depression.

Major finding: At week 12, the average number of MHDs of at least moderate severity was significantly reduced in fremanezumab quarterly (least-squares mean change [LSM], −5.3) and monthly (LSM, −5.5) dose regimens vs. placebo (LSM, −2.2; both P less than .001). Similarly, MMDs were significantly reduced with fremanezumab quarterly (LSM, −5.4; P = .002) and monthly (LSM, −5.5; P less than .001) dose regimens vs. placebo (LSM, −2.4).

Study details: Findings are from a post hoc analysis of phase 3 HALO trial that included 1,130 patients with CM randomly allocated to receive fremanezumab quarterly, fremanezumab monthly, or placebo.

Disclosures: The study was funded by Teva Pharmaceutical Industries Ltd. Some of the authors declared serving as consultant, advisory board member, and/or receiving research support and honoraria from multiple sources. Some of the authors declared being current/former employees of Teva Branded Pharmaceutical Products R&D, Inc. (USA).

Source: Lipton RB et al. Headache. 2021 Apr 23. doi: 10.1111/head.14097.

Key clinical point: Repeated active transcranial direct current stimulation (tDCS) for at least 4 weeks significantly reduced migraine pain intensity and resulted in a trend for reduction in the duration of a migraine episode.

Major finding: Patients treated with active vs. sham tDCS showed a significantly higher reduction of pain intensity (mean difference [MD], −1.44; P less than .01) and a trend for reduction in migraine duration (MD, −1.31; P = .14).

Study details: Findings are from a meta-analysis of 5 randomized controlled trials including 104 patients with migraine with/without aura and chronic migraine who received either active or sham tDCS.

Disclosures: No information on funding was available. The authors declared no conflicts of interest.

Source: Cai G et al. J Pain Res. 2021 Apr 27. doi: 10.2147/JPR.S295704.

Key clinical point: Repeated active transcranial direct current stimulation (tDCS) for at least 4 weeks significantly reduced migraine pain intensity and resulted in a trend for reduction in the duration of a migraine episode.

Major finding: Patients treated with active vs. sham tDCS showed a significantly higher reduction of pain intensity (mean difference [MD], −1.44; P less than .01) and a trend for reduction in migraine duration (MD, −1.31; P = .14).

Study details: Findings are from a meta-analysis of 5 randomized controlled trials including 104 patients with migraine with/without aura and chronic migraine who received either active or sham tDCS.

Disclosures: No information on funding was available. The authors declared no conflicts of interest.

Source: Cai G et al. J Pain Res. 2021 Apr 27. doi: 10.2147/JPR.S295704.

Key clinical point: Repeated active transcranial direct current stimulation (tDCS) for at least 4 weeks significantly reduced migraine pain intensity and resulted in a trend for reduction in the duration of a migraine episode.

Major finding: Patients treated with active vs. sham tDCS showed a significantly higher reduction of pain intensity (mean difference [MD], −1.44; P less than .01) and a trend for reduction in migraine duration (MD, −1.31; P = .14).

Study details: Findings are from a meta-analysis of 5 randomized controlled trials including 104 patients with migraine with/without aura and chronic migraine who received either active or sham tDCS.

Disclosures: No information on funding was available. The authors declared no conflicts of interest.

Source: Cai G et al. J Pain Res. 2021 Apr 27. doi: 10.2147/JPR.S295704.

Key clinical point: Erenumab demonstrated sustained efficacy and safety through 64 weeks in patients with episodic migraine (EM) with 2-4 prior preventive treatment failures.

Major finding: Overall, the proportion of patients achieving 50% or greater reduction in monthly migraine days increased from 30.4% at weeks 13-16 to 47.3% at weeks 37-40 and remained stable through weeks 61-64 (47.1%). Overall, 6.7% of patients experienced treatment-emergent serious adverse events and 1.7% discontinued treatment because of treatment-emergent adverse events.

Study details: Findings of the first year of the ongoing 3-year open-label extension phase of LIBERTY study that evaluated monthly erenumab 140 mg in 240 patients with EM who had 2-4 prior preventive treatment failures.

Disclosures: The study was funded by Novartis Pharma AG, Basel, Switzerland. Some of the authors reported receiving grants, professional fees, consulting fees, speaking/teaching fees, and/or honoraria from; being an employee of; and/or holding stocks in various pharmaceutical companies including Novartis.

Source: Goadsby PJ et al. Neurology. 2021 Apr 28. doi: 10.1212/WNL.0000000000012029.

Key clinical point: Erenumab demonstrated sustained efficacy and safety through 64 weeks in patients with episodic migraine (EM) with 2-4 prior preventive treatment failures.

Major finding: Overall, the proportion of patients achieving 50% or greater reduction in monthly migraine days increased from 30.4% at weeks 13-16 to 47.3% at weeks 37-40 and remained stable through weeks 61-64 (47.1%). Overall, 6.7% of patients experienced treatment-emergent serious adverse events and 1.7% discontinued treatment because of treatment-emergent adverse events.

Study details: Findings of the first year of the ongoing 3-year open-label extension phase of LIBERTY study that evaluated monthly erenumab 140 mg in 240 patients with EM who had 2-4 prior preventive treatment failures.

Disclosures: The study was funded by Novartis Pharma AG, Basel, Switzerland. Some of the authors reported receiving grants, professional fees, consulting fees, speaking/teaching fees, and/or honoraria from; being an employee of; and/or holding stocks in various pharmaceutical companies including Novartis.

Source: Goadsby PJ et al. Neurology. 2021 Apr 28. doi: 10.1212/WNL.0000000000012029.

Key clinical point: Erenumab demonstrated sustained efficacy and safety through 64 weeks in patients with episodic migraine (EM) with 2-4 prior preventive treatment failures.

Major finding: Overall, the proportion of patients achieving 50% or greater reduction in monthly migraine days increased from 30.4% at weeks 13-16 to 47.3% at weeks 37-40 and remained stable through weeks 61-64 (47.1%). Overall, 6.7% of patients experienced treatment-emergent serious adverse events and 1.7% discontinued treatment because of treatment-emergent adverse events.

Study details: Findings of the first year of the ongoing 3-year open-label extension phase of LIBERTY study that evaluated monthly erenumab 140 mg in 240 patients with EM who had 2-4 prior preventive treatment failures.

Disclosures: The study was funded by Novartis Pharma AG, Basel, Switzerland. Some of the authors reported receiving grants, professional fees, consulting fees, speaking/teaching fees, and/or honoraria from; being an employee of; and/or holding stocks in various pharmaceutical companies including Novartis.

Source: Goadsby PJ et al. Neurology. 2021 Apr 28. doi: 10.1212/WNL.0000000000012029.

Key clinical point: Calcitonin gene-related peptide (CGRP) monoclonal antibody was superior to botulinum toxin in reducing the frequency of acute analgesic intake in patients with chronic migraine (CM). Treatment-related serious adverse events (SAEs) were lower with CGRP monoclonal antibody.

Major finding: CGRP monoclonal antibody was superior to botulinum toxin in reducing the frequency of acute analgesics intake (weighted mean difference, −1.31; P = .02113). Treatment-related SAEs were lower with CGRP monoclonal antibody vs. botulinum toxin (relative risk, 0.505; P = .001).

Study details: Findings are from a meta-analysis of 10 studies including 6,325 patients, which performed indirect treatment comparison between CGRP monoclonal antibody and botulinum toxin for prophylactic treatment of CM.

Disclosures: No information on funding was available. The authors declared no conflicts of interest.

Source: Lu J et al. Front Pharmacol. 2021 May 3. doi: 10.3389/fphar.2021.631204.

Key clinical point: Calcitonin gene-related peptide (CGRP) monoclonal antibody was superior to botulinum toxin in reducing the frequency of acute analgesic intake in patients with chronic migraine (CM). Treatment-related serious adverse events (SAEs) were lower with CGRP monoclonal antibody.

Major finding: CGRP monoclonal antibody was superior to botulinum toxin in reducing the frequency of acute analgesics intake (weighted mean difference, −1.31; P = .02113). Treatment-related SAEs were lower with CGRP monoclonal antibody vs. botulinum toxin (relative risk, 0.505; P = .001).

Study details: Findings are from a meta-analysis of 10 studies including 6,325 patients, which performed indirect treatment comparison between CGRP monoclonal antibody and botulinum toxin for prophylactic treatment of CM.

Disclosures: No information on funding was available. The authors declared no conflicts of interest.

Source: Lu J et al. Front Pharmacol. 2021 May 3. doi: 10.3389/fphar.2021.631204.

Key clinical point: Calcitonin gene-related peptide (CGRP) monoclonal antibody was superior to botulinum toxin in reducing the frequency of acute analgesic intake in patients with chronic migraine (CM). Treatment-related serious adverse events (SAEs) were lower with CGRP monoclonal antibody.

Major finding: CGRP monoclonal antibody was superior to botulinum toxin in reducing the frequency of acute analgesics intake (weighted mean difference, −1.31; P = .02113). Treatment-related SAEs were lower with CGRP monoclonal antibody vs. botulinum toxin (relative risk, 0.505; P = .001).

Study details: Findings are from a meta-analysis of 10 studies including 6,325 patients, which performed indirect treatment comparison between CGRP monoclonal antibody and botulinum toxin for prophylactic treatment of CM.

Disclosures: No information on funding was available. The authors declared no conflicts of interest.

Source: Lu J et al. Front Pharmacol. 2021 May 3. doi: 10.3389/fphar.2021.631204.

Key clinical point: In patients with episodic migraine (EM), erenumab reduced both monthly migraine days (MMD) and monthly migraine attacks (MMA) by a similar magnitude. However, the impact on migraine attack duration was minor.

Major finding: Erenumab 70 mg and 140 mg vs. placebo were associated with a greater reduction in MMD (least square mean percent change [LSM%], −39% and −44% vs. 22%) and MMA (LSM%, −40% and −43% vs. −26%). The percentage change from baseline in migraine attack duration was minor with erenumab 70 mg and 140 mg vs. placebo (LSM%, −7% and −8% vs. −1%).

Study details: Findings are from a post hoc analysis of phase 3 STRIVE study including 955 patients with EM who were randomly allocated to receive either erenumab 70 mg or 140 mg or placebo once monthly for 6 months.

Disclosures: The study was supported by Amgen Inc., Thousand Oaks, CA, USA. HC Diener and M Ashina reported receiving honoraria, financial support, and/or serving as a consultant, speaker, or scientific advisor or primary investigator for various sources. GPDS Lima and S Rasmussen declared being employees and holding stocks at Amgen Inc.

Source: Diener HC et al. Cephalalgia. 2021 May 3. doi: 10.1177/03331024211010308.

Key clinical point: In patients with episodic migraine (EM), erenumab reduced both monthly migraine days (MMD) and monthly migraine attacks (MMA) by a similar magnitude. However, the impact on migraine attack duration was minor.

Major finding: Erenumab 70 mg and 140 mg vs. placebo were associated with a greater reduction in MMD (least square mean percent change [LSM%], −39% and −44% vs. 22%) and MMA (LSM%, −40% and −43% vs. −26%). The percentage change from baseline in migraine attack duration was minor with erenumab 70 mg and 140 mg vs. placebo (LSM%, −7% and −8% vs. −1%).

Study details: Findings are from a post hoc analysis of phase 3 STRIVE study including 955 patients with EM who were randomly allocated to receive either erenumab 70 mg or 140 mg or placebo once monthly for 6 months.

Disclosures: The study was supported by Amgen Inc., Thousand Oaks, CA, USA. HC Diener and M Ashina reported receiving honoraria, financial support, and/or serving as a consultant, speaker, or scientific advisor or primary investigator for various sources. GPDS Lima and S Rasmussen declared being employees and holding stocks at Amgen Inc.

Source: Diener HC et al. Cephalalgia. 2021 May 3. doi: 10.1177/03331024211010308.

Key clinical point: In patients with episodic migraine (EM), erenumab reduced both monthly migraine days (MMD) and monthly migraine attacks (MMA) by a similar magnitude. However, the impact on migraine attack duration was minor.

Major finding: Erenumab 70 mg and 140 mg vs. placebo were associated with a greater reduction in MMD (least square mean percent change [LSM%], −39% and −44% vs. 22%) and MMA (LSM%, −40% and −43% vs. −26%). The percentage change from baseline in migraine attack duration was minor with erenumab 70 mg and 140 mg vs. placebo (LSM%, −7% and −8% vs. −1%).

Study details: Findings are from a post hoc analysis of phase 3 STRIVE study including 955 patients with EM who were randomly allocated to receive either erenumab 70 mg or 140 mg or placebo once monthly for 6 months.

Disclosures: The study was supported by Amgen Inc., Thousand Oaks, CA, USA. HC Diener and M Ashina reported receiving honoraria, financial support, and/or serving as a consultant, speaker, or scientific advisor or primary investigator for various sources. GPDS Lima and S Rasmussen declared being employees and holding stocks at Amgen Inc.

Source: Diener HC et al. Cephalalgia. 2021 May 3. doi: 10.1177/03331024211010308.

People with migraine tend to have lower levels of physical activity than those without migraine despite the beneficial effects of physical activity on reducing frequency of migraine, according to a presentation at the American Headache Society’s 2021 annual meeting.

Though reliable research is sparse overall on how much physical activity people with migraine get, enough exists to reveal the need for clinicians to help patients identify ways to increase their levels of physical activity and make it a habit, said Dale S. Bond, PhD, a professor of psychiatry and human behavior at the Miriam Hospital and Brown University, both in Providence, R.I.

He emphasized the need not only to replace sedentary time with physical activity but also to reduce sedentary time overall.

“It’s important to note that because active and sedentary represent different behavioral domains, people can still be active – that is, achieving recommended levels of moderate to vigorous physical activity [MVPA] – but still be highly sedentary because they sit for long hours throughout the day,” Dr. Bond said. “This is important because MVPA will not necessarily eliminate the health risks of long hours of sitting.”

Dr. Bond reviewed the existing literature on physical activity and sedentary behavior among patients with migraine. His presentation, “Move More, Sit Less,” aimed at finding ways to incorporate more physical activity into the daily lives of those with migraine. Dr. Bond began by briefly reviewing the well-established benefits of physical activity, including healthy sleep; cardiovascular, respiratory, musculoskeletal, mental, and cognitive health; and metabolic functioning.

“Physical activity and exercise in particular enhances the functioning of bodily systems, including those that have direct relevance to migraine in its comorbidities,” Dr. Bond said. “The positive systemic effects of exercise on bodily systems carries potential to reduce migraine severity and related disability and morbidity.”

He also explained the ways in which excessive sedentary time can exacerbate migraine triggers. “Long periods of interrupted sitting elevated levels of glucose and fat in the bloodstream, which in turn triggers the immune system to attack the body via inflammation,” Dr. Bond said. “Low grade chronic inflammation has long been hypothesized to play a role in migraine pathogenesis.”
 

Recommended levels of exercise

The World Health Organization and the U.S. Department of Health & Human Services recommends at least 150-300 minutes of moderate-intensity aerobic physical activity or 75-150 minutes of vigorous activity each week. An additional recommendation is at least 2 days per week of muscle strengthening activities that involve all major muscle groups.

While neither of those organizations has specific guidelines on how much reduction of sedentary time is recommended, the Canadian Society for Exercise Physiology recommends limiting sedentary time to 8 or fewer hours per day.
 

Exercise and migraine

“Unfortunately, at present, we have very few studies from which to draw conclusions about the extent to which individuals with migraine adhere to physical activity and sedentary guidelines,” Dr. Bond said. Existing studies vary widely in sample types, study design, physical activity measure and MVPA outcome, including the type or definition of MVPA. “This wide variability in measures and outcomes makes it challenging to draw any conclusions about adherence to guidelines among individuals with migraine,” he said.

Existing evidence suggests anywhere from 32% to 66% of migraine patients are at least moderately active, though it’s not clear what constitutes “moderately active” behavior. It appears that activity levels of patients with migraine are low overall, but it’s less clear the extent to which these levels are lower than in controls given the paucity of evidence.

In one of the few studies using objective measures to assess physical activity in migraine patients, the daily level of MVPA was significantly lower in 25 women with migraine than in 25 age- and body mass index–matched women without migraine (P <. 003). Both groups had obesity. The same study found that virtually no women with migraine adhered to the guidelines recommending less than 8 hours a day of sedentary time, compared with 30% of women without migraine.

“Also, low physical activity and high sedentary levels appear to be consistent across headache and nonheadache days,” Dr. Bond said. “This finding in particular raises an interesting question: If migraine severity is not related to physical activity and sedentary time, what is it about migraine that contributes to an inactive and sedentary lifestyle?”

Dr. Bond noted that future research needs to include reports of frequency, duration, and intensity of activities performed as well as the percentage of participants who meet guidelines for physical activity and sedentary time. Ideally, these studies should include not only self-report but also objective measures of activity as well as assess sleep and identify barriers and facilitators to physical activity in patients.
 

Exercise avoidance

Dr. Bond described findings from survey of 100 women he conducted to better understand potential barriers and reported that 78% of patients report intentionally avoiding physical activity. These patients typically avoided it an average of 4 days per week, regardless of intensity, and additional survey findings found “that participants who reported any avoidance had stronger beliefs that physical activity would both trigger and worsen a migraine attack, compared with participants who reported no avoidance,” he said.

That finding matches the clinical experience of Jennifer Robblee, MD, MSc, assistant professor of neurology at Barrow Neurological Institute in Phoenix, who viewed the presentation but was not involved with it.

“They often feel that it is a trigger for worsening an attack or, for some people, can actually trigger an attack, and that they feel worse in the midst of an attack when they’re exercising,” Dr. Robblee said in an interview regarding her patients who exercise less frequently. “Since so many of the patients I see have a daily and constant headache, it’s about how they can get themselves to start to exercise when something makes them feel worse, even if it makes them feel better in the long run.”

Yet, experimental research suggests that physical activity is not necessarily a reliable trigger of migraine attacks and only worsens migraine in a minority of attacks, Dr. Bond said, revealing an interesting paradox: “While engaging in regular physical activity is an important migraine management strategy, most individuals in the study reported doing the exact opposite – that is, avoiding physical activity as a management strategy – and this strategy was associated with higher frequency and duration of attacks. Research from our group and others also suggested individuals with migraine could be overestimating the role that physical activity hasn’t triggering or worsening of attacks.”
 

Encouraging patients to exercise

Since the benefits of physical activity and limiting sedentary time outweigh the potential harms, “some physical activity is better than none,” Dr. Bond said. To help patients begin increasing their physical activity, he recommended advising them to start with small amounts and then gradually increase frequency, intensity, and duration over time.

Dr. Robblee follows a similar approach, taking into account each patient’s particular circumstances and any medications they’re taking, including the side effects of those medications.

“It’s about starting where they are,” Dr. Robblee said. “Some patients, despite having severe migraine, have built themselves up so they’re doing exercise three or four times per week, or every day, and I have other people who never exercise,” she said. “For those patients who are very sedentary, if I can get them to start with 5 minutes per week so they have that sense of accomplishment, then that’s where I start. Then slowly build it up over time. Like most things in the migraine world, I individualize it for the person.”

Dr. Bond offered the following specific tips to clinicians in educating and encouraging patients to increase physical activity:

• Educate patients regarding the short-and long-term benefits of moving more and sitting less, both for their migraines and for overall health.
• Correct misconceptions about the negative effects of physical activity as it relates to migraines.
• Personalize the rationale for physical activity to that patient’s specific values and personal goals.
• Encourage patients to use an activity tracker, both for tracking physical activity and sedentary time, and to monitor migraine attacks, stress, energy levels, and fatigue on days they do and do not exercise.
• Help patients set goals for eventually meeting MVPA recommendations and interrupting prolonged periods of sitting with brief movement breaks.
• Help patients identify rewards for meeting goals that are tied to the activity, such as new exercise clothing.
• Encourage patients to identify a consistent time for physical activity each day to establish a habit, “ideally in the morning before barriers and life get in the way,” he said.

Eventually, physical activity itself should become intrinsically rewarding, Dr. Bond said.

“To limit sitting and encourage more movement throughout the day, we want to make the choice to engage in physical activity easier by adding environmental cues that encourage physical activity,” he said. “Conversely, we want to make the choice to engage in sedentary behavior more difficult by increasing the amount of effort that is required to engage in these behaviors.”

Dr. Robblee found Dr. Bond’s emphasis on sitting less – distinct from moving more – a helpful frame to consider with her patients. “I really like the approach of looking at it from that approach: in addition to how do we get you up and moving, how much time are you sitting, and how often can you break that up into smaller increments so that you’re up more often?” Dr. Robblee said. “That sometimes sounds less scary than ‘let’s get you exercising.’ So ‘let’s get you sitting a little bit less.’ I think that is something I might start to adopt.”

No external funding was noted. Dr. Robblee is a principal investigator for a study sponsored by Eli Lilly and receives stipends for MedLink Neurology and Neurodiem. Dr. Bond reported no disclosures.
 

People with migraine tend to have lower levels of physical activity than those without migraine despite the beneficial effects of physical activity on reducing frequency of migraine, according to a presentation at the American Headache Society’s 2021 annual meeting.

Though reliable research is sparse overall on how much physical activity people with migraine get, enough exists to reveal the need for clinicians to help patients identify ways to increase their levels of physical activity and make it a habit, said Dale S. Bond, PhD, a professor of psychiatry and human behavior at the Miriam Hospital and Brown University, both in Providence, R.I.

He emphasized the need not only to replace sedentary time with physical activity but also to reduce sedentary time overall.

“It’s important to note that because active and sedentary represent different behavioral domains, people can still be active – that is, achieving recommended levels of moderate to vigorous physical activity [MVPA] – but still be highly sedentary because they sit for long hours throughout the day,” Dr. Bond said. “This is important because MVPA will not necessarily eliminate the health risks of long hours of sitting.”

Dr. Bond reviewed the existing literature on physical activity and sedentary behavior among patients with migraine. His presentation, “Move More, Sit Less,” aimed at finding ways to incorporate more physical activity into the daily lives of those with migraine. Dr. Bond began by briefly reviewing the well-established benefits of physical activity, including healthy sleep; cardiovascular, respiratory, musculoskeletal, mental, and cognitive health; and metabolic functioning.

“Physical activity and exercise in particular enhances the functioning of bodily systems, including those that have direct relevance to migraine in its comorbidities,” Dr. Bond said. “The positive systemic effects of exercise on bodily systems carries potential to reduce migraine severity and related disability and morbidity.”

He also explained the ways in which excessive sedentary time can exacerbate migraine triggers. “Long periods of interrupted sitting elevated levels of glucose and fat in the bloodstream, which in turn triggers the immune system to attack the body via inflammation,” Dr. Bond said. “Low grade chronic inflammation has long been hypothesized to play a role in migraine pathogenesis.”
 

Recommended levels of exercise

The World Health Organization and the U.S. Department of Health & Human Services recommends at least 150-300 minutes of moderate-intensity aerobic physical activity or 75-150 minutes of vigorous activity each week. An additional recommendation is at least 2 days per week of muscle strengthening activities that involve all major muscle groups.

While neither of those organizations has specific guidelines on how much reduction of sedentary time is recommended, the Canadian Society for Exercise Physiology recommends limiting sedentary time to 8 or fewer hours per day.
 

Exercise and migraine

“Unfortunately, at present, we have very few studies from which to draw conclusions about the extent to which individuals with migraine adhere to physical activity and sedentary guidelines,” Dr. Bond said. Existing studies vary widely in sample types, study design, physical activity measure and MVPA outcome, including the type or definition of MVPA. “This wide variability in measures and outcomes makes it challenging to draw any conclusions about adherence to guidelines among individuals with migraine,” he said.

Existing evidence suggests anywhere from 32% to 66% of migraine patients are at least moderately active, though it’s not clear what constitutes “moderately active” behavior. It appears that activity levels of patients with migraine are low overall, but it’s less clear the extent to which these levels are lower than in controls given the paucity of evidence.

In one of the few studies using objective measures to assess physical activity in migraine patients, the daily level of MVPA was significantly lower in 25 women with migraine than in 25 age- and body mass index–matched women without migraine (P <. 003). Both groups had obesity. The same study found that virtually no women with migraine adhered to the guidelines recommending less than 8 hours a day of sedentary time, compared with 30% of women without migraine.

“Also, low physical activity and high sedentary levels appear to be consistent across headache and nonheadache days,” Dr. Bond said. “This finding in particular raises an interesting question: If migraine severity is not related to physical activity and sedentary time, what is it about migraine that contributes to an inactive and sedentary lifestyle?”

Dr. Bond noted that future research needs to include reports of frequency, duration, and intensity of activities performed as well as the percentage of participants who meet guidelines for physical activity and sedentary time. Ideally, these studies should include not only self-report but also objective measures of activity as well as assess sleep and identify barriers and facilitators to physical activity in patients.
 

Exercise avoidance

Dr. Bond described findings from survey of 100 women he conducted to better understand potential barriers and reported that 78% of patients report intentionally avoiding physical activity. These patients typically avoided it an average of 4 days per week, regardless of intensity, and additional survey findings found “that participants who reported any avoidance had stronger beliefs that physical activity would both trigger and worsen a migraine attack, compared with participants who reported no avoidance,” he said.

That finding matches the clinical experience of Jennifer Robblee, MD, MSc, assistant professor of neurology at Barrow Neurological Institute in Phoenix, who viewed the presentation but was not involved with it.

“They often feel that it is a trigger for worsening an attack or, for some people, can actually trigger an attack, and that they feel worse in the midst of an attack when they’re exercising,” Dr. Robblee said in an interview regarding her patients who exercise less frequently. “Since so many of the patients I see have a daily and constant headache, it’s about how they can get themselves to start to exercise when something makes them feel worse, even if it makes them feel better in the long run.”

Yet, experimental research suggests that physical activity is not necessarily a reliable trigger of migraine attacks and only worsens migraine in a minority of attacks, Dr. Bond said, revealing an interesting paradox: “While engaging in regular physical activity is an important migraine management strategy, most individuals in the study reported doing the exact opposite – that is, avoiding physical activity as a management strategy – and this strategy was associated with higher frequency and duration of attacks. Research from our group and others also suggested individuals with migraine could be overestimating the role that physical activity hasn’t triggering or worsening of attacks.”
 

Encouraging patients to exercise

Since the benefits of physical activity and limiting sedentary time outweigh the potential harms, “some physical activity is better than none,” Dr. Bond said. To help patients begin increasing their physical activity, he recommended advising them to start with small amounts and then gradually increase frequency, intensity, and duration over time.

Dr. Robblee follows a similar approach, taking into account each patient’s particular circumstances and any medications they’re taking, including the side effects of those medications.

“It’s about starting where they are,” Dr. Robblee said. “Some patients, despite having severe migraine, have built themselves up so they’re doing exercise three or four times per week, or every day, and I have other people who never exercise,” she said. “For those patients who are very sedentary, if I can get them to start with 5 minutes per week so they have that sense of accomplishment, then that’s where I start. Then slowly build it up over time. Like most things in the migraine world, I individualize it for the person.”

Dr. Bond offered the following specific tips to clinicians in educating and encouraging patients to increase physical activity:

• Educate patients regarding the short-and long-term benefits of moving more and sitting less, both for their migraines and for overall health.
• Correct misconceptions about the negative effects of physical activity as it relates to migraines.
• Personalize the rationale for physical activity to that patient’s specific values and personal goals.
• Encourage patients to use an activity tracker, both for tracking physical activity and sedentary time, and to monitor migraine attacks, stress, energy levels, and fatigue on days they do and do not exercise.
• Help patients set goals for eventually meeting MVPA recommendations and interrupting prolonged periods of sitting with brief movement breaks.
• Help patients identify rewards for meeting goals that are tied to the activity, such as new exercise clothing.
• Encourage patients to identify a consistent time for physical activity each day to establish a habit, “ideally in the morning before barriers and life get in the way,” he said.

Eventually, physical activity itself should become intrinsically rewarding, Dr. Bond said.

“To limit sitting and encourage more movement throughout the day, we want to make the choice to engage in physical activity easier by adding environmental cues that encourage physical activity,” he said. “Conversely, we want to make the choice to engage in sedentary behavior more difficult by increasing the amount of effort that is required to engage in these behaviors.”

Dr. Robblee found Dr. Bond’s emphasis on sitting less – distinct from moving more – a helpful frame to consider with her patients. “I really like the approach of looking at it from that approach: in addition to how do we get you up and moving, how much time are you sitting, and how often can you break that up into smaller increments so that you’re up more often?” Dr. Robblee said. “That sometimes sounds less scary than ‘let’s get you exercising.’ So ‘let’s get you sitting a little bit less.’ I think that is something I might start to adopt.”

No external funding was noted. Dr. Robblee is a principal investigator for a study sponsored by Eli Lilly and receives stipends for MedLink Neurology and Neurodiem. Dr. Bond reported no disclosures.
 

People with migraine tend to have lower levels of physical activity than those without migraine despite the beneficial effects of physical activity on reducing frequency of migraine, according to a presentation at the American Headache Society’s 2021 annual meeting.

Though reliable research is sparse overall on how much physical activity people with migraine get, enough exists to reveal the need for clinicians to help patients identify ways to increase their levels of physical activity and make it a habit, said Dale S. Bond, PhD, a professor of psychiatry and human behavior at the Miriam Hospital and Brown University, both in Providence, R.I.

He emphasized the need not only to replace sedentary time with physical activity but also to reduce sedentary time overall.

“It’s important to note that because active and sedentary represent different behavioral domains, people can still be active – that is, achieving recommended levels of moderate to vigorous physical activity [MVPA] – but still be highly sedentary because they sit for long hours throughout the day,” Dr. Bond said. “This is important because MVPA will not necessarily eliminate the health risks of long hours of sitting.”

Dr. Bond reviewed the existing literature on physical activity and sedentary behavior among patients with migraine. His presentation, “Move More, Sit Less,” aimed at finding ways to incorporate more physical activity into the daily lives of those with migraine. Dr. Bond began by briefly reviewing the well-established benefits of physical activity, including healthy sleep; cardiovascular, respiratory, musculoskeletal, mental, and cognitive health; and metabolic functioning.

“Physical activity and exercise in particular enhances the functioning of bodily systems, including those that have direct relevance to migraine in its comorbidities,” Dr. Bond said. “The positive systemic effects of exercise on bodily systems carries potential to reduce migraine severity and related disability and morbidity.”

He also explained the ways in which excessive sedentary time can exacerbate migraine triggers. “Long periods of interrupted sitting elevated levels of glucose and fat in the bloodstream, which in turn triggers the immune system to attack the body via inflammation,” Dr. Bond said. “Low grade chronic inflammation has long been hypothesized to play a role in migraine pathogenesis.”
 

Recommended levels of exercise

The World Health Organization and the U.S. Department of Health & Human Services recommends at least 150-300 minutes of moderate-intensity aerobic physical activity or 75-150 minutes of vigorous activity each week. An additional recommendation is at least 2 days per week of muscle strengthening activities that involve all major muscle groups.

While neither of those organizations has specific guidelines on how much reduction of sedentary time is recommended, the Canadian Society for Exercise Physiology recommends limiting sedentary time to 8 or fewer hours per day.
 

Exercise and migraine

“Unfortunately, at present, we have very few studies from which to draw conclusions about the extent to which individuals with migraine adhere to physical activity and sedentary guidelines,” Dr. Bond said. Existing studies vary widely in sample types, study design, physical activity measure and MVPA outcome, including the type or definition of MVPA. “This wide variability in measures and outcomes makes it challenging to draw any conclusions about adherence to guidelines among individuals with migraine,” he said.

Existing evidence suggests anywhere from 32% to 66% of migraine patients are at least moderately active, though it’s not clear what constitutes “moderately active” behavior. It appears that activity levels of patients with migraine are low overall, but it’s less clear the extent to which these levels are lower than in controls given the paucity of evidence.

In one of the few studies using objective measures to assess physical activity in migraine patients, the daily level of MVPA was significantly lower in 25 women with migraine than in 25 age- and body mass index–matched women without migraine (P <. 003). Both groups had obesity. The same study found that virtually no women with migraine adhered to the guidelines recommending less than 8 hours a day of sedentary time, compared with 30% of women without migraine.

“Also, low physical activity and high sedentary levels appear to be consistent across headache and nonheadache days,” Dr. Bond said. “This finding in particular raises an interesting question: If migraine severity is not related to physical activity and sedentary time, what is it about migraine that contributes to an inactive and sedentary lifestyle?”

Dr. Bond noted that future research needs to include reports of frequency, duration, and intensity of activities performed as well as the percentage of participants who meet guidelines for physical activity and sedentary time. Ideally, these studies should include not only self-report but also objective measures of activity as well as assess sleep and identify barriers and facilitators to physical activity in patients.
 

Exercise avoidance

Dr. Bond described findings from survey of 100 women he conducted to better understand potential barriers and reported that 78% of patients report intentionally avoiding physical activity. These patients typically avoided it an average of 4 days per week, regardless of intensity, and additional survey findings found “that participants who reported any avoidance had stronger beliefs that physical activity would both trigger and worsen a migraine attack, compared with participants who reported no avoidance,” he said.

That finding matches the clinical experience of Jennifer Robblee, MD, MSc, assistant professor of neurology at Barrow Neurological Institute in Phoenix, who viewed the presentation but was not involved with it.

“They often feel that it is a trigger for worsening an attack or, for some people, can actually trigger an attack, and that they feel worse in the midst of an attack when they’re exercising,” Dr. Robblee said in an interview regarding her patients who exercise less frequently. “Since so many of the patients I see have a daily and constant headache, it’s about how they can get themselves to start to exercise when something makes them feel worse, even if it makes them feel better in the long run.”

Yet, experimental research suggests that physical activity is not necessarily a reliable trigger of migraine attacks and only worsens migraine in a minority of attacks, Dr. Bond said, revealing an interesting paradox: “While engaging in regular physical activity is an important migraine management strategy, most individuals in the study reported doing the exact opposite – that is, avoiding physical activity as a management strategy – and this strategy was associated with higher frequency and duration of attacks. Research from our group and others also suggested individuals with migraine could be overestimating the role that physical activity hasn’t triggering or worsening of attacks.”
 

Encouraging patients to exercise

Since the benefits of physical activity and limiting sedentary time outweigh the potential harms, “some physical activity is better than none,” Dr. Bond said. To help patients begin increasing their physical activity, he recommended advising them to start with small amounts and then gradually increase frequency, intensity, and duration over time.

Dr. Robblee follows a similar approach, taking into account each patient’s particular circumstances and any medications they’re taking, including the side effects of those medications.

“It’s about starting where they are,” Dr. Robblee said. “Some patients, despite having severe migraine, have built themselves up so they’re doing exercise three or four times per week, or every day, and I have other people who never exercise,” she said. “For those patients who are very sedentary, if I can get them to start with 5 minutes per week so they have that sense of accomplishment, then that’s where I start. Then slowly build it up over time. Like most things in the migraine world, I individualize it for the person.”

Dr. Bond offered the following specific tips to clinicians in educating and encouraging patients to increase physical activity:

• Educate patients regarding the short-and long-term benefits of moving more and sitting less, both for their migraines and for overall health.
• Correct misconceptions about the negative effects of physical activity as it relates to migraines.
• Personalize the rationale for physical activity to that patient’s specific values and personal goals.
• Encourage patients to use an activity tracker, both for tracking physical activity and sedentary time, and to monitor migraine attacks, stress, energy levels, and fatigue on days they do and do not exercise.
• Help patients set goals for eventually meeting MVPA recommendations and interrupting prolonged periods of sitting with brief movement breaks.
• Help patients identify rewards for meeting goals that are tied to the activity, such as new exercise clothing.
• Encourage patients to identify a consistent time for physical activity each day to establish a habit, “ideally in the morning before barriers and life get in the way,” he said.

Eventually, physical activity itself should become intrinsically rewarding, Dr. Bond said.

“To limit sitting and encourage more movement throughout the day, we want to make the choice to engage in physical activity easier by adding environmental cues that encourage physical activity,” he said. “Conversely, we want to make the choice to engage in sedentary behavior more difficult by increasing the amount of effort that is required to engage in these behaviors.”

Dr. Robblee found Dr. Bond’s emphasis on sitting less – distinct from moving more – a helpful frame to consider with her patients. “I really like the approach of looking at it from that approach: in addition to how do we get you up and moving, how much time are you sitting, and how often can you break that up into smaller increments so that you’re up more often?” Dr. Robblee said. “That sometimes sounds less scary than ‘let’s get you exercising.’ So ‘let’s get you sitting a little bit less.’ I think that is something I might start to adopt.”

No external funding was noted. Dr. Robblee is a principal investigator for a study sponsored by Eli Lilly and receives stipends for MedLink Neurology and Neurodiem. Dr. Bond reported no disclosures.
 

Ubrogepant showed effectiveness for acute treatment of migraine when used with an anti–calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) preventive or with onabotulinumtoxinA (onabotA), or both, according to preliminary findings presented at the American Headache Society’s 2021 annual meeting.

“Because prevention [with mAbs] is rarely 100% effective, virtually everyone on preventive treatment needs to also take acute treatment,” presenter Richard B. Lipton, MD, a professor of neurology and director of the Montefiore Headache Center at Albert Einstein College of Medicine, New York, said in an interview after his presentation. He explained that ubrogepant, a small-molecule CGRP receptor blocker, is approved for acute treatment of migraine, while mAbs, which block the CGRP receptor or CGRP itself, are approved for prevention. “Many people predicted that gepants would not work in people on CGRP-targeted mAbs because of overlapping mechanisms.”

Dr. Lipton himself was not surprised by the findings, however. “For me, the surprise was that ubrogepant worked so well,” he said.  
 

Novel data collection

Uniquely, his study used an entirely remote design with mobile applications to safely evaluate the drug’s real-world effectiveness in the midst of the COVID-19 pandemic. The prospective, observational study used the mobile app Migraine Buddy to collect data and assess outcomes from the use of 50 mg or 100 mg of ubrogepant along with a mAb, onabotA, or both.

In most migraine trials, researchers ask patients to track their symptoms in electronic diaries they learn how to use in the clinic.

“One disadvantage of this approach is that people usually need to carry two devices, the study device and their smartphone,” Dr. Lipton said in an interview. “In this study, people download an app at home to their smartphone and only need to carry one device. Though remote studies are particularly valuable in the time of pandemic, I believe that apps like Migraine Buddy are and will remain a valuable tool for addressing many research questions.”

Jennifer Robblee, MD, MSc, an assistant professor of neurology at Barrow Neurological Institute in Phoenix, viewed the presentation and was also impressed with the novel use of a smartphone app to conduct the study. “I think that was a unique and cool demonstration of what can be done with the apps out there now,” Dr. Robblee said in an interview. “If you want to have really good tracking and more through tracking, apps like this are fabulous and are very patient forward and patient friendly.”
 

Combination therapy

The researchers invited 4,541 adults to participate in the study if they had previously reported at least three migraine attacks in the past 30 days and if they had treated at least three prior attacks with ubrogepant. The 483 participants who enrolled after consent and screening included 272 taking ubrogepant with mAb, 132 participants taking ubrogepant with onabotA, and 79 taking ubrogepant with both onabotA and mAb.

For 30 days, participants reported in the app’s diary their pain relief and the time elapsed since taking ubrogepant until they returned to normal functioning. Endpoints included meaningful pain relief – defined as “a level of pain relief that is meaningful to you” – and return to normal function at 2 and 4 hours.

During the study, 352 participants reported treating a migraine attack with a single dose of ubrogepant, and 78 participants treated migraine with two doses. The former group included 193 patients in the ubrogepant plus mAb group, 102 patients in the ubrogepant plus onabotA group, and 57 patients in the ubrogepant plus both group. Because of the limited enrollment in the second two arms, the data Dr. Lipton presented data only on the ubrogepant with mAb arm.

Most of this group (89.1%) was female, with an average age of 40 years and an average Migraine Disability Assessment score of 72.2. Most of the patients were taking erenumab (44.6%) or galcanezumab (34.2%) with the remaining patients taking fremanezumab (17.6%), eptinezumab (3.1%) or multiple mAbs (0.5%). Most participants (59.6%) were prescribed 100-mg ubrogepant dose while the remaining participants took 50 mg.

The analysis of the ubrogepant plus mAb group revealed that 64.2% of patients reported meaningful pain relief at 2 hours, and 84.5% had meaningful pain relief 4 hours after taking ubrogepant. The odds of achieving meaningful pain relief were statistically significant at both time points and remained significant after adjustment for participants’ age, Migraine Disability Assessment score and self-reported prescribed ubrogepant dose (P < .001).

“This study shows that in patients with migraine on CGRP-targeted monoclonal antibodies, ubrogepant is an acute treatment to consider for breakthrough headaches,” Dr. Lipton said. He added that they have now completed the study with more participants and begun analyzing all three groups.

“Full analyses will include data from multiple attacks, attacks treated with a second dose of ubrogepant, additional daily and 30-day effectiveness measures for use of ubrogepant with onabotA and use of ubrogepant with both onabotA and CGRP mAbs,” Dr. Lipton said.

While the findings did not surprise Dr. Robblee, she was happy to see a study that explicitly testing the combination of these treatments, especially given access challenges. “Right now, because treatments are new, we get a lot of insurance denials,” Dr. Robblee said in an interview. “It’s great to have a study out there that we can turn to and say, ‘hey, look, they had all these patients safely using these together.’ It’s going to help us improve access for patients.”

Though Dr. Robblee typically uses old-school pen-and-calendar diaries with her patients, she also sees potential for the use of apps going forward, just as she sees for virtual health care.

“I’ve found telemedicine in general to be a really great addition to the migraine world, and this plays into our ability to use telemedicine paired with tracking,” Dr. Robblee said. “In so many studies, we’re doing a diary anyway, so if there are standard diaries and programs we’re all using, that would be a nice way to do these.”

She notes that most symptom tracking for pain is subjective already, and these apps often include the options to print out the data or to export or transfer it electronically to physicians. “It’s giving us meaningful data,” she said.

The research was funded by AbbVie. Dr. Lipton has received honoraria or research support from AbbVie, Amgen, Biohaven, Dr. Reddy’s Laboratories, electroCore, Eli Lilly, eNeura Therapeutics, GlaxoSmithKline, Merck, Novartis, Teva, Vector and Vedanta Research. He holds stock options in Biohaven and Ctrl M. Dr. Robblee is a principal investigator for a study sponsored by Eli Lilly and receives stipends for MedLink Neurology and Neurodiem.

Ubrogepant showed effectiveness for acute treatment of migraine when used with an anti–calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) preventive or with onabotulinumtoxinA (onabotA), or both, according to preliminary findings presented at the American Headache Society’s 2021 annual meeting.

“Because prevention [with mAbs] is rarely 100% effective, virtually everyone on preventive treatment needs to also take acute treatment,” presenter Richard B. Lipton, MD, a professor of neurology and director of the Montefiore Headache Center at Albert Einstein College of Medicine, New York, said in an interview after his presentation. He explained that ubrogepant, a small-molecule CGRP receptor blocker, is approved for acute treatment of migraine, while mAbs, which block the CGRP receptor or CGRP itself, are approved for prevention. “Many people predicted that gepants would not work in people on CGRP-targeted mAbs because of overlapping mechanisms.”

Dr. Lipton himself was not surprised by the findings, however. “For me, the surprise was that ubrogepant worked so well,” he said.  
 

Novel data collection

Uniquely, his study used an entirely remote design with mobile applications to safely evaluate the drug’s real-world effectiveness in the midst of the COVID-19 pandemic. The prospective, observational study used the mobile app Migraine Buddy to collect data and assess outcomes from the use of 50 mg or 100 mg of ubrogepant along with a mAb, onabotA, or both.

In most migraine trials, researchers ask patients to track their symptoms in electronic diaries they learn how to use in the clinic.

“One disadvantage of this approach is that people usually need to carry two devices, the study device and their smartphone,” Dr. Lipton said in an interview. “In this study, people download an app at home to their smartphone and only need to carry one device. Though remote studies are particularly valuable in the time of pandemic, I believe that apps like Migraine Buddy are and will remain a valuable tool for addressing many research questions.”

Jennifer Robblee, MD, MSc, an assistant professor of neurology at Barrow Neurological Institute in Phoenix, viewed the presentation and was also impressed with the novel use of a smartphone app to conduct the study. “I think that was a unique and cool demonstration of what can be done with the apps out there now,” Dr. Robblee said in an interview. “If you want to have really good tracking and more through tracking, apps like this are fabulous and are very patient forward and patient friendly.”
 

Combination therapy

The researchers invited 4,541 adults to participate in the study if they had previously reported at least three migraine attacks in the past 30 days and if they had treated at least three prior attacks with ubrogepant. The 483 participants who enrolled after consent and screening included 272 taking ubrogepant with mAb, 132 participants taking ubrogepant with onabotA, and 79 taking ubrogepant with both onabotA and mAb.

For 30 days, participants reported in the app’s diary their pain relief and the time elapsed since taking ubrogepant until they returned to normal functioning. Endpoints included meaningful pain relief – defined as “a level of pain relief that is meaningful to you” – and return to normal function at 2 and 4 hours.

During the study, 352 participants reported treating a migraine attack with a single dose of ubrogepant, and 78 participants treated migraine with two doses. The former group included 193 patients in the ubrogepant plus mAb group, 102 patients in the ubrogepant plus onabotA group, and 57 patients in the ubrogepant plus both group. Because of the limited enrollment in the second two arms, the data Dr. Lipton presented data only on the ubrogepant with mAb arm.

Most of this group (89.1%) was female, with an average age of 40 years and an average Migraine Disability Assessment score of 72.2. Most of the patients were taking erenumab (44.6%) or galcanezumab (34.2%) with the remaining patients taking fremanezumab (17.6%), eptinezumab (3.1%) or multiple mAbs (0.5%). Most participants (59.6%) were prescribed 100-mg ubrogepant dose while the remaining participants took 50 mg.

The analysis of the ubrogepant plus mAb group revealed that 64.2% of patients reported meaningful pain relief at 2 hours, and 84.5% had meaningful pain relief 4 hours after taking ubrogepant. The odds of achieving meaningful pain relief were statistically significant at both time points and remained significant after adjustment for participants’ age, Migraine Disability Assessment score and self-reported prescribed ubrogepant dose (P < .001).

“This study shows that in patients with migraine on CGRP-targeted monoclonal antibodies, ubrogepant is an acute treatment to consider for breakthrough headaches,” Dr. Lipton said. He added that they have now completed the study with more participants and begun analyzing all three groups.

“Full analyses will include data from multiple attacks, attacks treated with a second dose of ubrogepant, additional daily and 30-day effectiveness measures for use of ubrogepant with onabotA and use of ubrogepant with both onabotA and CGRP mAbs,” Dr. Lipton said.

While the findings did not surprise Dr. Robblee, she was happy to see a study that explicitly testing the combination of these treatments, especially given access challenges. “Right now, because treatments are new, we get a lot of insurance denials,” Dr. Robblee said in an interview. “It’s great to have a study out there that we can turn to and say, ‘hey, look, they had all these patients safely using these together.’ It’s going to help us improve access for patients.”

Though Dr. Robblee typically uses old-school pen-and-calendar diaries with her patients, she also sees potential for the use of apps going forward, just as she sees for virtual health care.

“I’ve found telemedicine in general to be a really great addition to the migraine world, and this plays into our ability to use telemedicine paired with tracking,” Dr. Robblee said. “In so many studies, we’re doing a diary anyway, so if there are standard diaries and programs we’re all using, that would be a nice way to do these.”

She notes that most symptom tracking for pain is subjective already, and these apps often include the options to print out the data or to export or transfer it electronically to physicians. “It’s giving us meaningful data,” she said.

The research was funded by AbbVie. Dr. Lipton has received honoraria or research support from AbbVie, Amgen, Biohaven, Dr. Reddy’s Laboratories, electroCore, Eli Lilly, eNeura Therapeutics, GlaxoSmithKline, Merck, Novartis, Teva, Vector and Vedanta Research. He holds stock options in Biohaven and Ctrl M. Dr. Robblee is a principal investigator for a study sponsored by Eli Lilly and receives stipends for MedLink Neurology and Neurodiem.

Ubrogepant showed effectiveness for acute treatment of migraine when used with an anti–calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) preventive or with onabotulinumtoxinA (onabotA), or both, according to preliminary findings presented at the American Headache Society’s 2021 annual meeting.

“Because prevention [with mAbs] is rarely 100% effective, virtually everyone on preventive treatment needs to also take acute treatment,” presenter Richard B. Lipton, MD, a professor of neurology and director of the Montefiore Headache Center at Albert Einstein College of Medicine, New York, said in an interview after his presentation. He explained that ubrogepant, a small-molecule CGRP receptor blocker, is approved for acute treatment of migraine, while mAbs, which block the CGRP receptor or CGRP itself, are approved for prevention. “Many people predicted that gepants would not work in people on CGRP-targeted mAbs because of overlapping mechanisms.”

Dr. Lipton himself was not surprised by the findings, however. “For me, the surprise was that ubrogepant worked so well,” he said.  
 

Novel data collection

Uniquely, his study used an entirely remote design with mobile applications to safely evaluate the drug’s real-world effectiveness in the midst of the COVID-19 pandemic. The prospective, observational study used the mobile app Migraine Buddy to collect data and assess outcomes from the use of 50 mg or 100 mg of ubrogepant along with a mAb, onabotA, or both.

In most migraine trials, researchers ask patients to track their symptoms in electronic diaries they learn how to use in the clinic.

“One disadvantage of this approach is that people usually need to carry two devices, the study device and their smartphone,” Dr. Lipton said in an interview. “In this study, people download an app at home to their smartphone and only need to carry one device. Though remote studies are particularly valuable in the time of pandemic, I believe that apps like Migraine Buddy are and will remain a valuable tool for addressing many research questions.”

Jennifer Robblee, MD, MSc, an assistant professor of neurology at Barrow Neurological Institute in Phoenix, viewed the presentation and was also impressed with the novel use of a smartphone app to conduct the study. “I think that was a unique and cool demonstration of what can be done with the apps out there now,” Dr. Robblee said in an interview. “If you want to have really good tracking and more through tracking, apps like this are fabulous and are very patient forward and patient friendly.”
 

Combination therapy

The researchers invited 4,541 adults to participate in the study if they had previously reported at least three migraine attacks in the past 30 days and if they had treated at least three prior attacks with ubrogepant. The 483 participants who enrolled after consent and screening included 272 taking ubrogepant with mAb, 132 participants taking ubrogepant with onabotA, and 79 taking ubrogepant with both onabotA and mAb.

For 30 days, participants reported in the app’s diary their pain relief and the time elapsed since taking ubrogepant until they returned to normal functioning. Endpoints included meaningful pain relief – defined as “a level of pain relief that is meaningful to you” – and return to normal function at 2 and 4 hours.

During the study, 352 participants reported treating a migraine attack with a single dose of ubrogepant, and 78 participants treated migraine with two doses. The former group included 193 patients in the ubrogepant plus mAb group, 102 patients in the ubrogepant plus onabotA group, and 57 patients in the ubrogepant plus both group. Because of the limited enrollment in the second two arms, the data Dr. Lipton presented data only on the ubrogepant with mAb arm.

Most of this group (89.1%) was female, with an average age of 40 years and an average Migraine Disability Assessment score of 72.2. Most of the patients were taking erenumab (44.6%) or galcanezumab (34.2%) with the remaining patients taking fremanezumab (17.6%), eptinezumab (3.1%) or multiple mAbs (0.5%). Most participants (59.6%) were prescribed 100-mg ubrogepant dose while the remaining participants took 50 mg.

The analysis of the ubrogepant plus mAb group revealed that 64.2% of patients reported meaningful pain relief at 2 hours, and 84.5% had meaningful pain relief 4 hours after taking ubrogepant. The odds of achieving meaningful pain relief were statistically significant at both time points and remained significant after adjustment for participants’ age, Migraine Disability Assessment score and self-reported prescribed ubrogepant dose (P < .001).

“This study shows that in patients with migraine on CGRP-targeted monoclonal antibodies, ubrogepant is an acute treatment to consider for breakthrough headaches,” Dr. Lipton said. He added that they have now completed the study with more participants and begun analyzing all three groups.

“Full analyses will include data from multiple attacks, attacks treated with a second dose of ubrogepant, additional daily and 30-day effectiveness measures for use of ubrogepant with onabotA and use of ubrogepant with both onabotA and CGRP mAbs,” Dr. Lipton said.

While the findings did not surprise Dr. Robblee, she was happy to see a study that explicitly testing the combination of these treatments, especially given access challenges. “Right now, because treatments are new, we get a lot of insurance denials,” Dr. Robblee said in an interview. “It’s great to have a study out there that we can turn to and say, ‘hey, look, they had all these patients safely using these together.’ It’s going to help us improve access for patients.”

Though Dr. Robblee typically uses old-school pen-and-calendar diaries with her patients, she also sees potential for the use of apps going forward, just as she sees for virtual health care.

“I’ve found telemedicine in general to be a really great addition to the migraine world, and this plays into our ability to use telemedicine paired with tracking,” Dr. Robblee said. “In so many studies, we’re doing a diary anyway, so if there are standard diaries and programs we’re all using, that would be a nice way to do these.”

She notes that most symptom tracking for pain is subjective already, and these apps often include the options to print out the data or to export or transfer it electronically to physicians. “It’s giving us meaningful data,” she said.

The research was funded by AbbVie. Dr. Lipton has received honoraria or research support from AbbVie, Amgen, Biohaven, Dr. Reddy’s Laboratories, electroCore, Eli Lilly, eNeura Therapeutics, GlaxoSmithKline, Merck, Novartis, Teva, Vector and Vedanta Research. He holds stock options in Biohaven and Ctrl M. Dr. Robblee is a principal investigator for a study sponsored by Eli Lilly and receives stipends for MedLink Neurology and Neurodiem.