Headache & Migraine

Key clinical point: Severe obesity (body mass index [BMI] > 40 kg/m²) and postmenopausal status were associated with a significantly higher migraine frequency, with severe obesity also being associated with higher migraine severity.

Major finding: Migraine headache index scores (165.5 vs 105.5; P  =  .01) and the number of migraine headaches per month (P  =  .007) were significantly higher in patients with severe obesity vs those with healthy weight (BMI 18.5-24.9 kg/m²), with the number of migraine headaches per month being significantly higher among postmenopausal vs premenopausal women (mean 23 vs 19 days; P  =  .02).

Study details: Findings are from a retrospective cohort study including 223 patients with refractory migraine.

Disclosures: This study did not receive any specific funding. The authors declared no competing interests.

Source: Saffari TM et al. Severe obesity is associated with increased migraine severity and frequency: A retrospective cohort study. J Clin Neurosci. 2023;115:8-13 (Jul 14). doi: 10.1016/j.jocn.2023.07.007

Key clinical point: Severe obesity (body mass index [BMI] > 40 kg/m²) and postmenopausal status were associated with a significantly higher migraine frequency, with severe obesity also being associated with higher migraine severity.

Major finding: Migraine headache index scores (165.5 vs 105.5; P  =  .01) and the number of migraine headaches per month (P  =  .007) were significantly higher in patients with severe obesity vs those with healthy weight (BMI 18.5-24.9 kg/m²), with the number of migraine headaches per month being significantly higher among postmenopausal vs premenopausal women (mean 23 vs 19 days; P  =  .02).

Study details: Findings are from a retrospective cohort study including 223 patients with refractory migraine.

Disclosures: This study did not receive any specific funding. The authors declared no competing interests.

Source: Saffari TM et al. Severe obesity is associated with increased migraine severity and frequency: A retrospective cohort study. J Clin Neurosci. 2023;115:8-13 (Jul 14). doi: 10.1016/j.jocn.2023.07.007

Key clinical point: Severe obesity (body mass index [BMI] > 40 kg/m²) and postmenopausal status were associated with a significantly higher migraine frequency, with severe obesity also being associated with higher migraine severity.

Major finding: Migraine headache index scores (165.5 vs 105.5; P  =  .01) and the number of migraine headaches per month (P  =  .007) were significantly higher in patients with severe obesity vs those with healthy weight (BMI 18.5-24.9 kg/m²), with the number of migraine headaches per month being significantly higher among postmenopausal vs premenopausal women (mean 23 vs 19 days; P  =  .02).

Study details: Findings are from a retrospective cohort study including 223 patients with refractory migraine.

Disclosures: This study did not receive any specific funding. The authors declared no competing interests.

Source: Saffari TM et al. Severe obesity is associated with increased migraine severity and frequency: A retrospective cohort study. J Clin Neurosci. 2023;115:8-13 (Jul 14). doi: 10.1016/j.jocn.2023.07.007

Key clinical point: Higher dietary intake of zinc was negatively associated with the risk for migraine in adults, with the association being more prominent among those age 20-50 years.

Major finding: Compared with participants in the lowest quintile of dietary zinc consumption (≤ 5.93 mg/day), the risk for migraine was lower among those in the higher quintiles of dietary zinc consumption (5.94-8.38 mg/day: adjusted odds ratio [aOR] 0.73; P  =  .004; 8.39-11.26 mg/day: aOR 0.72; P  =  .02; and 11.27-15.75 mg/day: aOR 0.76; P  =  .04), with a non-linear association observed between zinc intake and migraine in the age 20-50 years group (P < .001).

Study details: This cross-sectional study included 9849 adult participants (age ≥ 20 years), of whom 1963 (19.93%) had migraine.

Disclosures: This study was supported by the National Natural Science Foundation of China, Natural Science Foundation of Jiangxi Province, and Jiangxi Provincial Department of Education Science and Technology Program Project. No potential conflicts of interest were declared.

Source: Zheng H et al. Dietary zinc intake in relation to migraine among adults: A cross sectional study of NHANES 1999-2004. Nutr Neurosci. 2023 (Aug 4). doi: 10.1080/1028415X.2023.2243678

Key clinical point: Higher dietary intake of zinc was negatively associated with the risk for migraine in adults, with the association being more prominent among those age 20-50 years.

Major finding: Compared with participants in the lowest quintile of dietary zinc consumption (≤ 5.93 mg/day), the risk for migraine was lower among those in the higher quintiles of dietary zinc consumption (5.94-8.38 mg/day: adjusted odds ratio [aOR] 0.73; P  =  .004; 8.39-11.26 mg/day: aOR 0.72; P  =  .02; and 11.27-15.75 mg/day: aOR 0.76; P  =  .04), with a non-linear association observed between zinc intake and migraine in the age 20-50 years group (P < .001).

Study details: This cross-sectional study included 9849 adult participants (age ≥ 20 years), of whom 1963 (19.93%) had migraine.

Disclosures: This study was supported by the National Natural Science Foundation of China, Natural Science Foundation of Jiangxi Province, and Jiangxi Provincial Department of Education Science and Technology Program Project. No potential conflicts of interest were declared.

Source: Zheng H et al. Dietary zinc intake in relation to migraine among adults: A cross sectional study of NHANES 1999-2004. Nutr Neurosci. 2023 (Aug 4). doi: 10.1080/1028415X.2023.2243678

Key clinical point: Higher dietary intake of zinc was negatively associated with the risk for migraine in adults, with the association being more prominent among those age 20-50 years.

Major finding: Compared with participants in the lowest quintile of dietary zinc consumption (≤ 5.93 mg/day), the risk for migraine was lower among those in the higher quintiles of dietary zinc consumption (5.94-8.38 mg/day: adjusted odds ratio [aOR] 0.73; P  =  .004; 8.39-11.26 mg/day: aOR 0.72; P  =  .02; and 11.27-15.75 mg/day: aOR 0.76; P  =  .04), with a non-linear association observed between zinc intake and migraine in the age 20-50 years group (P < .001).

Study details: This cross-sectional study included 9849 adult participants (age ≥ 20 years), of whom 1963 (19.93%) had migraine.

Disclosures: This study was supported by the National Natural Science Foundation of China, Natural Science Foundation of Jiangxi Province, and Jiangxi Provincial Department of Education Science and Technology Program Project. No potential conflicts of interest were declared.

Source: Zheng H et al. Dietary zinc intake in relation to migraine among adults: A cross sectional study of NHANES 1999-2004. Nutr Neurosci. 2023 (Aug 4). doi: 10.1080/1028415X.2023.2243678

Key clinical point: Patients with migraine are at a greater risk of experiencing rheumatoid arthritis (RA) attacks, with the risk being prominently higher among those having migraine without aura.

Major finding: The risk for RA was 1.94 times higher in patients with migraine vs control individuals (adjusted odds ratio [aOR] 1.94; 95% CI 1.74-2.17), with the risk being prominent in those with migraine without aura (aOR 1.49; 95% CI 1.35-1.64).

Study details: The data come from a meta-analysis of five studies including 321,877 participants.

Disclosures: This study did not disclose the funding source. The authors declared no competing interests.

Source: Tian D et al. Migraine and risk of rheumatoid arthritis: A systematic review and meta-analysis of observational studies. Heliyon. 2023;9(8):e18430 (Jul 18). doi: 10.1016/j.heliyon.2023.e18430

Key clinical point: Patients with migraine are at a greater risk of experiencing rheumatoid arthritis (RA) attacks, with the risk being prominently higher among those having migraine without aura.

Major finding: The risk for RA was 1.94 times higher in patients with migraine vs control individuals (adjusted odds ratio [aOR] 1.94; 95% CI 1.74-2.17), with the risk being prominent in those with migraine without aura (aOR 1.49; 95% CI 1.35-1.64).

Study details: The data come from a meta-analysis of five studies including 321,877 participants.

Disclosures: This study did not disclose the funding source. The authors declared no competing interests.

Source: Tian D et al. Migraine and risk of rheumatoid arthritis: A systematic review and meta-analysis of observational studies. Heliyon. 2023;9(8):e18430 (Jul 18). doi: 10.1016/j.heliyon.2023.e18430

Key clinical point: Patients with migraine are at a greater risk of experiencing rheumatoid arthritis (RA) attacks, with the risk being prominently higher among those having migraine without aura.

Major finding: The risk for RA was 1.94 times higher in patients with migraine vs control individuals (adjusted odds ratio [aOR] 1.94; 95% CI 1.74-2.17), with the risk being prominent in those with migraine without aura (aOR 1.49; 95% CI 1.35-1.64).

Study details: The data come from a meta-analysis of five studies including 321,877 participants.

Disclosures: This study did not disclose the funding source. The authors declared no competing interests.

Source: Tian D et al. Migraine and risk of rheumatoid arthritis: A systematic review and meta-analysis of observational studies. Heliyon. 2023;9(8):e18430 (Jul 18). doi: 10.1016/j.heliyon.2023.e18430

Key clinical point: Ubrogepant in combination with onabotulinumtoxinA led to meaningful pain relief and return to normal function at 2 and 4 hours post-dose in patients with self-identified migraine.

Major finding: Overall, 53.3% and 76.2% of patients achieved meaningful pain relief and 25.4% and 45.9% of patients achieved returned to normal function at 2 and 4 hours post-dose after the first treated attack, respectively.

Study details: The data come from a prospective real-world study including 122 patients with migraine (age ≥ 18 years) who received ubrogepant in combination with onabotulinumtoxinA.

Disclosures: This study was funded by Allergan (prior to its acquisition by AbbVie). Some authors declared receiving research support, royalties, or honoraria from, and serving as consultants and advisory board members for various sources, including AbbVie. Three authors declared being employees of or holding stocks in AbbVie.

Source: Manack Adams A et al. Real-world effectiveness, satisfaction, and optimization of ubrogepant for the acute treatment of migraine in combination with onabotulinumtoxinA: Results from the COURAGE Study. J Headache Pain. 2023;24:102 (Aug 3). doi: 10.1186/s10194-023-01622-0

Key clinical point: Ubrogepant in combination with onabotulinumtoxinA led to meaningful pain relief and return to normal function at 2 and 4 hours post-dose in patients with self-identified migraine.

Major finding: Overall, 53.3% and 76.2% of patients achieved meaningful pain relief and 25.4% and 45.9% of patients achieved returned to normal function at 2 and 4 hours post-dose after the first treated attack, respectively.

Study details: The data come from a prospective real-world study including 122 patients with migraine (age ≥ 18 years) who received ubrogepant in combination with onabotulinumtoxinA.

Disclosures: This study was funded by Allergan (prior to its acquisition by AbbVie). Some authors declared receiving research support, royalties, or honoraria from, and serving as consultants and advisory board members for various sources, including AbbVie. Three authors declared being employees of or holding stocks in AbbVie.

Source: Manack Adams A et al. Real-world effectiveness, satisfaction, and optimization of ubrogepant for the acute treatment of migraine in combination with onabotulinumtoxinA: Results from the COURAGE Study. J Headache Pain. 2023;24:102 (Aug 3). doi: 10.1186/s10194-023-01622-0

Key clinical point: Ubrogepant in combination with onabotulinumtoxinA led to meaningful pain relief and return to normal function at 2 and 4 hours post-dose in patients with self-identified migraine.

Major finding: Overall, 53.3% and 76.2% of patients achieved meaningful pain relief and 25.4% and 45.9% of patients achieved returned to normal function at 2 and 4 hours post-dose after the first treated attack, respectively.

Study details: The data come from a prospective real-world study including 122 patients with migraine (age ≥ 18 years) who received ubrogepant in combination with onabotulinumtoxinA.

Disclosures: This study was funded by Allergan (prior to its acquisition by AbbVie). Some authors declared receiving research support, royalties, or honoraria from, and serving as consultants and advisory board members for various sources, including AbbVie. Three authors declared being employees of or holding stocks in AbbVie.

Source: Manack Adams A et al. Real-world effectiveness, satisfaction, and optimization of ubrogepant for the acute treatment of migraine in combination with onabotulinumtoxinA: Results from the COURAGE Study. J Headache Pain. 2023;24:102 (Aug 3). doi: 10.1186/s10194-023-01622-0

Key clinical point: Addition of mindfulness-based intervention (MIND) comprising 6 weekly sessions and 7-10 minutes daily self-practice to treatment as usual (TaU) led to greater improvements in clinical outcomes compared with TaU alone in patients with chronic migraine (CM) and medication-overuse headache (MOH).

Major finding: TaU-plus-MIND outperformed TaU in the achievement of ≥ 50% reduction in headache frequency at 12 months (P < .0001), percentage reduction in headache days (P  =  .0001), and reduction in intake of total medication and non-steroidal anti-inflammatory drugs (P  =  .0001).

Study details: Finding are from MIND-CM, a phase 3 trial including 177 patients with CM and MOH who were randomly assigned to receive either TaU (including withdrawal from overused drugs, education on proper medication use and lifestyle issues, and tailored prophylaxis; n = 89) or MIND added to TaU (n = 88).

Disclosures: This study was funded by the Italian Ministry of Health. The authors declared no conflicts of interest.

Source: Grazzi L at al. Efficacy of mindfulness added to treatment as usual in patients with chronic migraine and medication overuse headache: A phase-III single-blind randomized-controlled trial (the MIND-CM study). J Headache Pain. 2023;24 (Jul 14). doi:  10.1186/s10194-023-01630-0

Key clinical point: Addition of mindfulness-based intervention (MIND) comprising 6 weekly sessions and 7-10 minutes daily self-practice to treatment as usual (TaU) led to greater improvements in clinical outcomes compared with TaU alone in patients with chronic migraine (CM) and medication-overuse headache (MOH).

Major finding: TaU-plus-MIND outperformed TaU in the achievement of ≥ 50% reduction in headache frequency at 12 months (P < .0001), percentage reduction in headache days (P  =  .0001), and reduction in intake of total medication and non-steroidal anti-inflammatory drugs (P  =  .0001).

Study details: Finding are from MIND-CM, a phase 3 trial including 177 patients with CM and MOH who were randomly assigned to receive either TaU (including withdrawal from overused drugs, education on proper medication use and lifestyle issues, and tailored prophylaxis; n = 89) or MIND added to TaU (n = 88).

Disclosures: This study was funded by the Italian Ministry of Health. The authors declared no conflicts of interest.

Source: Grazzi L at al. Efficacy of mindfulness added to treatment as usual in patients with chronic migraine and medication overuse headache: A phase-III single-blind randomized-controlled trial (the MIND-CM study). J Headache Pain. 2023;24 (Jul 14). doi:  10.1186/s10194-023-01630-0

Key clinical point: Addition of mindfulness-based intervention (MIND) comprising 6 weekly sessions and 7-10 minutes daily self-practice to treatment as usual (TaU) led to greater improvements in clinical outcomes compared with TaU alone in patients with chronic migraine (CM) and medication-overuse headache (MOH).

Major finding: TaU-plus-MIND outperformed TaU in the achievement of ≥ 50% reduction in headache frequency at 12 months (P < .0001), percentage reduction in headache days (P  =  .0001), and reduction in intake of total medication and non-steroidal anti-inflammatory drugs (P  =  .0001).

Study details: Finding are from MIND-CM, a phase 3 trial including 177 patients with CM and MOH who were randomly assigned to receive either TaU (including withdrawal from overused drugs, education on proper medication use and lifestyle issues, and tailored prophylaxis; n = 89) or MIND added to TaU (n = 88).

Disclosures: This study was funded by the Italian Ministry of Health. The authors declared no conflicts of interest.

Source: Grazzi L at al. Efficacy of mindfulness added to treatment as usual in patients with chronic migraine and medication overuse headache: A phase-III single-blind randomized-controlled trial (the MIND-CM study). J Headache Pain. 2023;24 (Jul 14). doi:  10.1186/s10194-023-01630-0

Key clinical point: Migraine increased the risk for ischemic cardio-cerebrovascular diseases (CCVD), but the risk was lower in those treated with triptans or ergotamine (TE).

Major finding: Compared with patients having non-migraine headaches (NMH), the risk for ischemic CCVD was higher in patients with migraine receiving TE (men: adjusted hazard ratio [aHR] 1.18; 95% CI 1.01-1.39; women: aHR 1.22; 95% CI 1.09-1.37) and in those receiving neither triptans nor ergotamine (NTNE; men: aHR 1.39; 95% CI 1.28-1.50; women: aHR 1.53; 95% CI 1.42-1.65). The risk for ischemic CCVD was lower in the TE vs NTNE group (men: aHR 0.86; 95% CI 0.73-0.999; women: aHR 0.80; 95% CI 0.72-0.88).

Study details: This study included 62,272 patients with migraine or NMH. Patients with migraine were categorized into those who received ≥ 1 prescriptions for TE (n = 4959) and those who received NTNE (n = 37,624).

Disclosures: This study received no specific funding. The authors declared no conflicts of interest.

Source: Kim Y et al. Association between migraine and ischemic cardio-cerebrovascular disease (CCVD) and effects of triptans and ergotamine on the risk of ischemic CCVD in patients with migraine in the Korean NHIS-HEALS cohort. Clin Drug Investig. 2023;43(7):541-550 (Jul 17). doi:  10.1007/s40261-023-01290-7

Key clinical point: Migraine increased the risk for ischemic cardio-cerebrovascular diseases (CCVD), but the risk was lower in those treated with triptans or ergotamine (TE).

Major finding: Compared with patients having non-migraine headaches (NMH), the risk for ischemic CCVD was higher in patients with migraine receiving TE (men: adjusted hazard ratio [aHR] 1.18; 95% CI 1.01-1.39; women: aHR 1.22; 95% CI 1.09-1.37) and in those receiving neither triptans nor ergotamine (NTNE; men: aHR 1.39; 95% CI 1.28-1.50; women: aHR 1.53; 95% CI 1.42-1.65). The risk for ischemic CCVD was lower in the TE vs NTNE group (men: aHR 0.86; 95% CI 0.73-0.999; women: aHR 0.80; 95% CI 0.72-0.88).

Study details: This study included 62,272 patients with migraine or NMH. Patients with migraine were categorized into those who received ≥ 1 prescriptions for TE (n = 4959) and those who received NTNE (n = 37,624).

Disclosures: This study received no specific funding. The authors declared no conflicts of interest.

Source: Kim Y et al. Association between migraine and ischemic cardio-cerebrovascular disease (CCVD) and effects of triptans and ergotamine on the risk of ischemic CCVD in patients with migraine in the Korean NHIS-HEALS cohort. Clin Drug Investig. 2023;43(7):541-550 (Jul 17). doi:  10.1007/s40261-023-01290-7

Key clinical point: Migraine increased the risk for ischemic cardio-cerebrovascular diseases (CCVD), but the risk was lower in those treated with triptans or ergotamine (TE).

Major finding: Compared with patients having non-migraine headaches (NMH), the risk for ischemic CCVD was higher in patients with migraine receiving TE (men: adjusted hazard ratio [aHR] 1.18; 95% CI 1.01-1.39; women: aHR 1.22; 95% CI 1.09-1.37) and in those receiving neither triptans nor ergotamine (NTNE; men: aHR 1.39; 95% CI 1.28-1.50; women: aHR 1.53; 95% CI 1.42-1.65). The risk for ischemic CCVD was lower in the TE vs NTNE group (men: aHR 0.86; 95% CI 0.73-0.999; women: aHR 0.80; 95% CI 0.72-0.88).

Study details: This study included 62,272 patients with migraine or NMH. Patients with migraine were categorized into those who received ≥ 1 prescriptions for TE (n = 4959) and those who received NTNE (n = 37,624).

Disclosures: This study received no specific funding. The authors declared no conflicts of interest.

Source: Kim Y et al. Association between migraine and ischemic cardio-cerebrovascular disease (CCVD) and effects of triptans and ergotamine on the risk of ischemic CCVD in patients with migraine in the Korean NHIS-HEALS cohort. Clin Drug Investig. 2023;43(7):541-550 (Jul 17). doi:  10.1007/s40261-023-01290-7

Key clinical point: Retreatment with monoclonal antibodies (mAb) targeting the calcitonin gene-related peptide (CGRP) or its receptor was highly effective with persistent benefits in patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) who completed the first treatment year followed by 1-3 months of discontinuation.

Major finding: In the second treatment year, monthly migraine days (MMD) were lower than pre-treatment baseline levels (P < .0001), with only 23.5% presenting with same or higher MMD at the baseline of the second vs first treatment year (P  =  .207). MMD at 90-112 days after treatment initiation were also lower in the second vs first treatment year (7.2 vs 8.8; P < .001).

Study details: Findings are from a prospective observational cohort study including 226 patients with HFEM and CM who received erenumab (n = 125) and either galcanezumab or fremanezumab (n = 101).

Disclosures: This study was funded by Fondazione Policlinico Campus Bio-Medico, Italy. Some authors declared receiving travel grants, personal fees, research support, or honoraria for participation in advisory boards, speaker panels, or clinical investigation studies from various sources.

Source: Vernieri F et al. Retreating migraine patients in the second year with monoclonal antibodies anti-CGRP pathway: The multicenter prospective cohort RE-DO study. J Neurol. 2023 (Jul 19). doi: 10.1007/s00415-023-11872-2

Key clinical point: Retreatment with monoclonal antibodies (mAb) targeting the calcitonin gene-related peptide (CGRP) or its receptor was highly effective with persistent benefits in patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) who completed the first treatment year followed by 1-3 months of discontinuation.

Major finding: In the second treatment year, monthly migraine days (MMD) were lower than pre-treatment baseline levels (P < .0001), with only 23.5% presenting with same or higher MMD at the baseline of the second vs first treatment year (P  =  .207). MMD at 90-112 days after treatment initiation were also lower in the second vs first treatment year (7.2 vs 8.8; P < .001).

Study details: Findings are from a prospective observational cohort study including 226 patients with HFEM and CM who received erenumab (n = 125) and either galcanezumab or fremanezumab (n = 101).

Disclosures: This study was funded by Fondazione Policlinico Campus Bio-Medico, Italy. Some authors declared receiving travel grants, personal fees, research support, or honoraria for participation in advisory boards, speaker panels, or clinical investigation studies from various sources.

Source: Vernieri F et al. Retreating migraine patients in the second year with monoclonal antibodies anti-CGRP pathway: The multicenter prospective cohort RE-DO study. J Neurol. 2023 (Jul 19). doi: 10.1007/s00415-023-11872-2

Key clinical point: Retreatment with monoclonal antibodies (mAb) targeting the calcitonin gene-related peptide (CGRP) or its receptor was highly effective with persistent benefits in patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) who completed the first treatment year followed by 1-3 months of discontinuation.

Major finding: In the second treatment year, monthly migraine days (MMD) were lower than pre-treatment baseline levels (P < .0001), with only 23.5% presenting with same or higher MMD at the baseline of the second vs first treatment year (P  =  .207). MMD at 90-112 days after treatment initiation were also lower in the second vs first treatment year (7.2 vs 8.8; P < .001).

Study details: Findings are from a prospective observational cohort study including 226 patients with HFEM and CM who received erenumab (n = 125) and either galcanezumab or fremanezumab (n = 101).

Disclosures: This study was funded by Fondazione Policlinico Campus Bio-Medico, Italy. Some authors declared receiving travel grants, personal fees, research support, or honoraria for participation in advisory boards, speaker panels, or clinical investigation studies from various sources.

Source: Vernieri F et al. Retreating migraine patients in the second year with monoclonal antibodies anti-CGRP pathway: The multicenter prospective cohort RE-DO study. J Neurol. 2023 (Jul 19). doi: 10.1007/s00415-023-11872-2

Key clinical point: Once-monthly galcanezumab appeared to be effective and well-tolerated for up to 6 months in patients with episodic migraine.

Major finding: Patients who continued to receive galcanezumab showed sustained improvements in the least squares mean reduction in monthly migraine headache days from 4.01 at 3 months to 4.62 at 6 months, with the proportion of patients achieving ≥ 50% response increasing from 59.7% at 3 months to 70.9% at 6 months. No serious treatment-related adverse events were reported.

Study details: Findings are from a 3-month open-label extension (OLE) of the phase 3 PERSIST trial including 484 patients with episodic migraine who were previously assigned to receive galcanezumab (n = 243) or placebo (n = 241).

Disclosures: The PERSIST study was funded by Eli Lilly and Company. Three authors declared being full-time employees of Eli Lilly and Company while some other authors declared ties with various sources, including Eli Lilly.

Source: Zhou J et al. Galcanezumab in patients with episodic migraine: Results from the open-label period of the phase 3 PERSIST study. J Headache Pain. 2023;24:103 (Aug 4). doi: 10.1186/s10194-023-01613-1

Key clinical point: Once-monthly galcanezumab appeared to be effective and well-tolerated for up to 6 months in patients with episodic migraine.

Major finding: Patients who continued to receive galcanezumab showed sustained improvements in the least squares mean reduction in monthly migraine headache days from 4.01 at 3 months to 4.62 at 6 months, with the proportion of patients achieving ≥ 50% response increasing from 59.7% at 3 months to 70.9% at 6 months. No serious treatment-related adverse events were reported.

Study details: Findings are from a 3-month open-label extension (OLE) of the phase 3 PERSIST trial including 484 patients with episodic migraine who were previously assigned to receive galcanezumab (n = 243) or placebo (n = 241).

Disclosures: The PERSIST study was funded by Eli Lilly and Company. Three authors declared being full-time employees of Eli Lilly and Company while some other authors declared ties with various sources, including Eli Lilly.

Source: Zhou J et al. Galcanezumab in patients with episodic migraine: Results from the open-label period of the phase 3 PERSIST study. J Headache Pain. 2023;24:103 (Aug 4). doi: 10.1186/s10194-023-01613-1

Key clinical point: Once-monthly galcanezumab appeared to be effective and well-tolerated for up to 6 months in patients with episodic migraine.

Major finding: Patients who continued to receive galcanezumab showed sustained improvements in the least squares mean reduction in monthly migraine headache days from 4.01 at 3 months to 4.62 at 6 months, with the proportion of patients achieving ≥ 50% response increasing from 59.7% at 3 months to 70.9% at 6 months. No serious treatment-related adverse events were reported.

Study details: Findings are from a 3-month open-label extension (OLE) of the phase 3 PERSIST trial including 484 patients with episodic migraine who were previously assigned to receive galcanezumab (n = 243) or placebo (n = 241).

Disclosures: The PERSIST study was funded by Eli Lilly and Company. Three authors declared being full-time employees of Eli Lilly and Company while some other authors declared ties with various sources, including Eli Lilly.

Source: Zhou J et al. Galcanezumab in patients with episodic migraine: Results from the open-label period of the phase 3 PERSIST study. J Headache Pain. 2023;24:103 (Aug 4). doi: 10.1186/s10194-023-01613-1

Key clinical point: Treatment with calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) did not increase the risk for SARS-CoV‑2 infection or its severe clinical outcomes in veterans with migraine.

Major finding: Over a 28-month follow-up, 12.5% vs 9.6% of CGRP mAb initiators vs non-initiators tested positive for SARS-CoV-2, respectively, with the incidence of SARS-CoV-2 infection (P  =  .08) and hospitalization (P  =  .45), requirement for supplemental oxygen (P  =  .27) or mechanical ventilation (P  =  .96), and death (P  =  .37) among those testing positive for SARS-CoV-2 not being significantly different between CGRP mAb initiators and non-initiators.

Study details: The data come from a retrospective cohort study including 354,294 veterans (8,178,652 person-trials) with migraine who were at risk for COVID-19, of whom 9382 initiated a CGRP mAb.

Disclosures: This study was supported by the special purpose medical service award from the US Department of Veterans Affairs. Dr. Schindler, Prof. Lipton, and Dr. Seng declared receiving grants, personal fees, or paid royalties from various sources.

Source: Wang K et al. Calcitonin gene-related peptide monoclonal antibodies and risk of SARS-CoV-2 infection and severe COVID-19 outcomes among veterans with migraine disorder. JAMA Netw Open. 2023;6(7):e2326371 (Jul 31). doi: 10.1001/jamanetworkopen.2023.26371

Key clinical point: Treatment with calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) did not increase the risk for SARS-CoV‑2 infection or its severe clinical outcomes in veterans with migraine.

Major finding: Over a 28-month follow-up, 12.5% vs 9.6% of CGRP mAb initiators vs non-initiators tested positive for SARS-CoV-2, respectively, with the incidence of SARS-CoV-2 infection (P  =  .08) and hospitalization (P  =  .45), requirement for supplemental oxygen (P  =  .27) or mechanical ventilation (P  =  .96), and death (P  =  .37) among those testing positive for SARS-CoV-2 not being significantly different between CGRP mAb initiators and non-initiators.

Study details: The data come from a retrospective cohort study including 354,294 veterans (8,178,652 person-trials) with migraine who were at risk for COVID-19, of whom 9382 initiated a CGRP mAb.

Disclosures: This study was supported by the special purpose medical service award from the US Department of Veterans Affairs. Dr. Schindler, Prof. Lipton, and Dr. Seng declared receiving grants, personal fees, or paid royalties from various sources.

Source: Wang K et al. Calcitonin gene-related peptide monoclonal antibodies and risk of SARS-CoV-2 infection and severe COVID-19 outcomes among veterans with migraine disorder. JAMA Netw Open. 2023;6(7):e2326371 (Jul 31). doi: 10.1001/jamanetworkopen.2023.26371

Key clinical point: Treatment with calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) did not increase the risk for SARS-CoV‑2 infection or its severe clinical outcomes in veterans with migraine.

Major finding: Over a 28-month follow-up, 12.5% vs 9.6% of CGRP mAb initiators vs non-initiators tested positive for SARS-CoV-2, respectively, with the incidence of SARS-CoV-2 infection (P  =  .08) and hospitalization (P  =  .45), requirement for supplemental oxygen (P  =  .27) or mechanical ventilation (P  =  .96), and death (P  =  .37) among those testing positive for SARS-CoV-2 not being significantly different between CGRP mAb initiators and non-initiators.

Study details: The data come from a retrospective cohort study including 354,294 veterans (8,178,652 person-trials) with migraine who were at risk for COVID-19, of whom 9382 initiated a CGRP mAb.

Disclosures: This study was supported by the special purpose medical service award from the US Department of Veterans Affairs. Dr. Schindler, Prof. Lipton, and Dr. Seng declared receiving grants, personal fees, or paid royalties from various sources.

Source: Wang K et al. Calcitonin gene-related peptide monoclonal antibodies and risk of SARS-CoV-2 infection and severe COVID-19 outcomes among veterans with migraine disorder. JAMA Netw Open. 2023;6(7):e2326371 (Jul 31). doi: 10.1001/jamanetworkopen.2023.26371

Key clinical point: Atogepant showed clinically relevant benefits in patients with chronic migraine (CM), making it the first calcitonin gene-related peptide (CGRP)-targeted, efficacious, and safe oral preventive treatment option for CM.

Major finding: Compared with placebo, the reduction in mean monthly migraine days at week 12 was significantly higher in patients who received 30 mg atogepant twice daily (adjusted least squares mean difference from placebo [LSMD] −2.4; P < .0001) and 60 mg once daily (adjusted LSMD −1.8; P  =  .0009). Constipation and nausea were the most common adverse events in both atogepant groups.

Study details: This phase 3 PROGRESS trial included 755 patients with CM who were randomly assigned to receive atogepant (30 mg twice daily or 60 mg once daily) or placebo.

Disclosures: This study was funded by Allergan (now AbbVie). Some authors declared receiving research support and personal and institutional fees from various sources, including AbbVie. Eleven authors declared being current or former employees or stockholders of AbbVie.

Source: Pozo-Rosich P et al. Atogepant for the preventive treatment of chronic migraine (PROGRESS): A randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 (Jul 26). doi: 10.1016/S0140-6736(23)01049-8

Key clinical point: Atogepant showed clinically relevant benefits in patients with chronic migraine (CM), making it the first calcitonin gene-related peptide (CGRP)-targeted, efficacious, and safe oral preventive treatment option for CM.

Major finding: Compared with placebo, the reduction in mean monthly migraine days at week 12 was significantly higher in patients who received 30 mg atogepant twice daily (adjusted least squares mean difference from placebo [LSMD] −2.4; P < .0001) and 60 mg once daily (adjusted LSMD −1.8; P  =  .0009). Constipation and nausea were the most common adverse events in both atogepant groups.

Study details: This phase 3 PROGRESS trial included 755 patients with CM who were randomly assigned to receive atogepant (30 mg twice daily or 60 mg once daily) or placebo.

Disclosures: This study was funded by Allergan (now AbbVie). Some authors declared receiving research support and personal and institutional fees from various sources, including AbbVie. Eleven authors declared being current or former employees or stockholders of AbbVie.

Source: Pozo-Rosich P et al. Atogepant for the preventive treatment of chronic migraine (PROGRESS): A randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 (Jul 26). doi: 10.1016/S0140-6736(23)01049-8

Key clinical point: Atogepant showed clinically relevant benefits in patients with chronic migraine (CM), making it the first calcitonin gene-related peptide (CGRP)-targeted, efficacious, and safe oral preventive treatment option for CM.

Major finding: Compared with placebo, the reduction in mean monthly migraine days at week 12 was significantly higher in patients who received 30 mg atogepant twice daily (adjusted least squares mean difference from placebo [LSMD] −2.4; P < .0001) and 60 mg once daily (adjusted LSMD −1.8; P  =  .0009). Constipation and nausea were the most common adverse events in both atogepant groups.

Study details: This phase 3 PROGRESS trial included 755 patients with CM who were randomly assigned to receive atogepant (30 mg twice daily or 60 mg once daily) or placebo.

Disclosures: This study was funded by Allergan (now AbbVie). Some authors declared receiving research support and personal and institutional fees from various sources, including AbbVie. Eleven authors declared being current or former employees or stockholders of AbbVie.

Source: Pozo-Rosich P et al. Atogepant for the preventive treatment of chronic migraine (PROGRESS): A randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 (Jul 26). doi: 10.1016/S0140-6736(23)01049-8