Headache & Migraine

Key clinical point: Both galcanezumab and rimegepant were effective as a preventive treatment for episodic migraine, with galcanezumab not being superior to rimegepant.

Major finding: Overall, 62% vs 61% of the patients receiving galcanezumab vs rimegepant achieved ≥ 50% reduction in monthly migraine headache days after 3 months, respectively, with no statistically significant difference between the groups (P = .70). Treatment-emergent adverse events were similar between study interventions and were mostly mild or moderate in severity.

Study details: Findings are from the CHALLENGE-MIG study including 580 patients with episodic migraine with or without aura who were randomly assigned to receive galcanezumab (n = 287) or rimegepant (n = 293) for 3 months.

Disclosures: This study was funded by Eli Lilly and Company, Indianapolis, IN, USA. Eight authors declared being employees of Eli Lilly and Company. Some other authors declared ties with various sources, including Eli Lilly and Company.

Source: Schwedt TJ et al. Comparing the efficacy and safety of galcanezumab versus rimegepant for prevention of episodic migraine: Results from a randomized, controlled clinical trial. Neurol Ther. 2023 (Nov 10). doi: 10.1007/s40120-023-00562-w

Key clinical point: Both galcanezumab and rimegepant were effective as a preventive treatment for episodic migraine, with galcanezumab not being superior to rimegepant.

Major finding: Overall, 62% vs 61% of the patients receiving galcanezumab vs rimegepant achieved ≥ 50% reduction in monthly migraine headache days after 3 months, respectively, with no statistically significant difference between the groups (P = .70). Treatment-emergent adverse events were similar between study interventions and were mostly mild or moderate in severity.

Study details: Findings are from the CHALLENGE-MIG study including 580 patients with episodic migraine with or without aura who were randomly assigned to receive galcanezumab (n = 287) or rimegepant (n = 293) for 3 months.

Disclosures: This study was funded by Eli Lilly and Company, Indianapolis, IN, USA. Eight authors declared being employees of Eli Lilly and Company. Some other authors declared ties with various sources, including Eli Lilly and Company.

Source: Schwedt TJ et al. Comparing the efficacy and safety of galcanezumab versus rimegepant for prevention of episodic migraine: Results from a randomized, controlled clinical trial. Neurol Ther. 2023 (Nov 10). doi: 10.1007/s40120-023-00562-w

Key clinical point: Both galcanezumab and rimegepant were effective as a preventive treatment for episodic migraine, with galcanezumab not being superior to rimegepant.

Major finding: Overall, 62% vs 61% of the patients receiving galcanezumab vs rimegepant achieved ≥ 50% reduction in monthly migraine headache days after 3 months, respectively, with no statistically significant difference between the groups (P = .70). Treatment-emergent adverse events were similar between study interventions and were mostly mild or moderate in severity.

Study details: Findings are from the CHALLENGE-MIG study including 580 patients with episodic migraine with or without aura who were randomly assigned to receive galcanezumab (n = 287) or rimegepant (n = 293) for 3 months.

Disclosures: This study was funded by Eli Lilly and Company, Indianapolis, IN, USA. Eight authors declared being employees of Eli Lilly and Company. Some other authors declared ties with various sources, including Eli Lilly and Company.

Source: Schwedt TJ et al. Comparing the efficacy and safety of galcanezumab versus rimegepant for prevention of episodic migraine: Results from a randomized, controlled clinical trial. Neurol Ther. 2023 (Nov 10). doi: 10.1007/s40120-023-00562-w

Key clinical point: Both galcanezumab and rimegepant were effective as a preventive treatment for episodic migraine, with galcanezumab not being superior to rimegepant.

Major finding: Overall, 62% vs 61% of the patients receiving galcanezumab vs rimegepant achieved ≥ 50% reduction in monthly migraine headache days after 3 months, respectively, with no statistically significant difference between the groups (P = .70). Treatment-emergent adverse events were similar between study interventions and were mostly mild or moderate in severity.

Study details: Findings are from the CHALLENGE-MIG study including 580 patients with episodic migraine with or without aura who were randomly assigned to receive galcanezumab (n = 287) or rimegepant (n = 293) for 3 months.

Disclosures: This study was funded by Eli Lilly and Company, Indianapolis, IN, USA. Eight authors declared being employees of Eli Lilly and Company. Some other authors declared ties with various sources, including Eli Lilly and Company.

Source: Schwedt TJ et al. Comparing the efficacy and safety of galcanezumab versus rimegepant for prevention of episodic migraine: Results from a randomized, controlled clinical trial. Neurol Ther. 2023 (Nov 10). doi: 10.1007/s40120-023-00562-w

Key clinical point: Both galcanezumab and rimegepant were effective as a preventive treatment for episodic migraine, with galcanezumab not being superior to rimegepant.

Major finding: Overall, 62% vs 61% of the patients receiving galcanezumab vs rimegepant achieved ≥ 50% reduction in monthly migraine headache days after 3 months, respectively, with no statistically significant difference between the groups (P = .70). Treatment-emergent adverse events were similar between study interventions and were mostly mild or moderate in severity.

Study details: Findings are from the CHALLENGE-MIG study including 580 patients with episodic migraine with or without aura who were randomly assigned to receive galcanezumab (n = 287) or rimegepant (n = 293) for 3 months.

Disclosures: This study was funded by Eli Lilly and Company, Indianapolis, IN, USA. Eight authors declared being employees of Eli Lilly and Company. Some other authors declared ties with various sources, including Eli Lilly and Company.

Source: Schwedt TJ et al. Comparing the efficacy and safety of galcanezumab versus rimegepant for prevention of episodic migraine: Results from a randomized, controlled clinical trial. Neurol Ther. 2023 (Nov 10). doi: 10.1007/s40120-023-00562-w

Key clinical point: Both galcanezumab and rimegepant were effective as a preventive treatment for episodic migraine, with galcanezumab not being superior to rimegepant.

Major finding: Overall, 62% vs 61% of the patients receiving galcanezumab vs rimegepant achieved ≥ 50% reduction in monthly migraine headache days after 3 months, respectively, with no statistically significant difference between the groups (P = .70). Treatment-emergent adverse events were similar between study interventions and were mostly mild or moderate in severity.

Study details: Findings are from the CHALLENGE-MIG study including 580 patients with episodic migraine with or without aura who were randomly assigned to receive galcanezumab (n = 287) or rimegepant (n = 293) for 3 months.

Disclosures: This study was funded by Eli Lilly and Company, Indianapolis, IN, USA. Eight authors declared being employees of Eli Lilly and Company. Some other authors declared ties with various sources, including Eli Lilly and Company.

Source: Schwedt TJ et al. Comparing the efficacy and safety of galcanezumab versus rimegepant for prevention of episodic migraine: Results from a randomized, controlled clinical trial. Neurol Ther. 2023 (Nov 10). doi: 10.1007/s40120-023-00562-w

Key clinical point: The anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) fremanezumab, erenumab, and galcanezumab demonstrated similar efficacy during the first year of therapy in patients with chronic and high-frequency episodic migraine, and galcanezumab demonstrated a higher response rate than the other two mAb during the 1-month suspension period in patients with chronic migraine.

Major finding: The three anti-CGRP mAb significantly reduced overall migraine frequency and intensity and symptomatic medication intake per month with similar efficacy across all follow-ups up to 12 months. Patients with chronic migraine receiving galcanezumab vs fremanezumab or erenumab showed higher response rates during the 1-month suspension period (57% vs 39% or 17%, respectively; P = .009).

Study details: This retrospective longitudinal single-center study included 160 patients with chronic and high-frequency episodic migraine who were treated with an anti-CGRP mAb (fremanezumab, erenumab, or galcanezumab) for 12 months.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interests.

Source: Tereshko Y et al. Comparative study of the efficacy of anti-CGRP mAbs on migraineurs: Analysis of the first year of therapy, 1-month suspension period, and reprisal. J Clin Med. 2023;12(23):7329 (Nov 26). doi: 10.3390/jcm12237329

Key clinical point: The anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) fremanezumab, erenumab, and galcanezumab demonstrated similar efficacy during the first year of therapy in patients with chronic and high-frequency episodic migraine, and galcanezumab demonstrated a higher response rate than the other two mAb during the 1-month suspension period in patients with chronic migraine.

Major finding: The three anti-CGRP mAb significantly reduced overall migraine frequency and intensity and symptomatic medication intake per month with similar efficacy across all follow-ups up to 12 months. Patients with chronic migraine receiving galcanezumab vs fremanezumab or erenumab showed higher response rates during the 1-month suspension period (57% vs 39% or 17%, respectively; P = .009).

Study details: This retrospective longitudinal single-center study included 160 patients with chronic and high-frequency episodic migraine who were treated with an anti-CGRP mAb (fremanezumab, erenumab, or galcanezumab) for 12 months.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interests.

Source: Tereshko Y et al. Comparative study of the efficacy of anti-CGRP mAbs on migraineurs: Analysis of the first year of therapy, 1-month suspension period, and reprisal. J Clin Med. 2023;12(23):7329 (Nov 26). doi: 10.3390/jcm12237329

Key clinical point: The anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) fremanezumab, erenumab, and galcanezumab demonstrated similar efficacy during the first year of therapy in patients with chronic and high-frequency episodic migraine, and galcanezumab demonstrated a higher response rate than the other two mAb during the 1-month suspension period in patients with chronic migraine.

Major finding: The three anti-CGRP mAb significantly reduced overall migraine frequency and intensity and symptomatic medication intake per month with similar efficacy across all follow-ups up to 12 months. Patients with chronic migraine receiving galcanezumab vs fremanezumab or erenumab showed higher response rates during the 1-month suspension period (57% vs 39% or 17%, respectively; P = .009).

Study details: This retrospective longitudinal single-center study included 160 patients with chronic and high-frequency episodic migraine who were treated with an anti-CGRP mAb (fremanezumab, erenumab, or galcanezumab) for 12 months.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interests.

Source: Tereshko Y et al. Comparative study of the efficacy of anti-CGRP mAbs on migraineurs: Analysis of the first year of therapy, 1-month suspension period, and reprisal. J Clin Med. 2023;12(23):7329 (Nov 26). doi: 10.3390/jcm12237329

Key clinical point: Prior treatment with onabotulinumtoxin-A may improve subsequent clinical response to preventive treatment with anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibodies (mAb) in patients with chronic migraine.

Major finding: At 3 months of treatment with anti-CGRP mAb, patients who received vs did not receive prior onabotulinumtoxin-A had fewer mean monthly migraine days (3.3 days vs 5.2 days; P = .017), lower pain intensity (Numerical Rating Scale scores: 5.9 vs 6.6; P = .013), and a lower mean Migraine Disability Assessment score (23.2 vs 37.4; P = .013).

Study details: The data come from a retrospective observational study including 128 patients with chronic migraine who received treatment with anti-CGRP mAb, of whom 39.9% received prior treatment with onabotulinumtoxin-A.

Disclosures: This study did not receive any external funding. Three authors declared receiving speaker honoraria from or serving as consultants or scientific advisory board members for various sources.

Source: Ceccardi G et al. Onabotulinumtoxin-A: Previous prophylactic treatment might improve subsequent anti-CGRP monoclonal antibodies response in patients with chronic migraine. Toxins. 2023;15(12):677 (Nov 30). doi: 10.3390/toxins15120677

Key clinical point: Prior treatment with onabotulinumtoxin-A may improve subsequent clinical response to preventive treatment with anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibodies (mAb) in patients with chronic migraine.

Major finding: At 3 months of treatment with anti-CGRP mAb, patients who received vs did not receive prior onabotulinumtoxin-A had fewer mean monthly migraine days (3.3 days vs 5.2 days; P = .017), lower pain intensity (Numerical Rating Scale scores: 5.9 vs 6.6; P = .013), and a lower mean Migraine Disability Assessment score (23.2 vs 37.4; P = .013).

Study details: The data come from a retrospective observational study including 128 patients with chronic migraine who received treatment with anti-CGRP mAb, of whom 39.9% received prior treatment with onabotulinumtoxin-A.

Disclosures: This study did not receive any external funding. Three authors declared receiving speaker honoraria from or serving as consultants or scientific advisory board members for various sources.

Source: Ceccardi G et al. Onabotulinumtoxin-A: Previous prophylactic treatment might improve subsequent anti-CGRP monoclonal antibodies response in patients with chronic migraine. Toxins. 2023;15(12):677 (Nov 30). doi: 10.3390/toxins15120677

Key clinical point: Prior treatment with onabotulinumtoxin-A may improve subsequent clinical response to preventive treatment with anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibodies (mAb) in patients with chronic migraine.

Major finding: At 3 months of treatment with anti-CGRP mAb, patients who received vs did not receive prior onabotulinumtoxin-A had fewer mean monthly migraine days (3.3 days vs 5.2 days; P = .017), lower pain intensity (Numerical Rating Scale scores: 5.9 vs 6.6; P = .013), and a lower mean Migraine Disability Assessment score (23.2 vs 37.4; P = .013).

Study details: The data come from a retrospective observational study including 128 patients with chronic migraine who received treatment with anti-CGRP mAb, of whom 39.9% received prior treatment with onabotulinumtoxin-A.

Disclosures: This study did not receive any external funding. Three authors declared receiving speaker honoraria from or serving as consultants or scientific advisory board members for various sources.

Source: Ceccardi G et al. Onabotulinumtoxin-A: Previous prophylactic treatment might improve subsequent anti-CGRP monoclonal antibodies response in patients with chronic migraine. Toxins. 2023;15(12):677 (Nov 30). doi: 10.3390/toxins15120677

Key clinical point: Galcanezumab effectively reduced the effect of menstrually related migraine (MRM) and led to improved functioning in women with episodic migraine.

Major finding: Across months 4 through 6, galcanezumab vs placebo led to greater mean reduction in the monthly migraine headache days (MHD; least squares mean change from baseline [Δ] −5.1 vs −3.2), monthly perimenstrual MHD (Δ −0.75 vs −0.49), non-perimenstrual MHD (Δ −4.6 vs −2.8), and greater improvement in Role Function-Restrictive domain scores of the Migraine-Specific Quality of Life Questionnaire (Δ 30.9 vs 22.3 points; all P < .001).

Study details: This post hoc analysis of the EVOLVE-1 and EVOLVE-2 trials included 1133 women with episodic migraine who received either 120 mg galcanezumab per month or placebo, of whom 40.8% met the criteria for MRM.

Disclosures: This study was sponsored by Eli Lilly and Company. Four authors declared being current or former employees and stockowners of Eli Lilly and Company. Two authors declared receiving consulting honoraria from various sources including Eli Lilly.

Source: MacGregor EA et al. Effect of galcanezumab in women with episodic migraine meeting criteria for menstrually related migraine: A post hoc analysis of EVOLVE-1 and EVOLVE-2. Headache. 2023 (Nov 28). doi: 10.1111/head.14652

Key clinical point: Galcanezumab effectively reduced the effect of menstrually related migraine (MRM) and led to improved functioning in women with episodic migraine.

Major finding: Across months 4 through 6, galcanezumab vs placebo led to greater mean reduction in the monthly migraine headache days (MHD; least squares mean change from baseline [Δ] −5.1 vs −3.2), monthly perimenstrual MHD (Δ −0.75 vs −0.49), non-perimenstrual MHD (Δ −4.6 vs −2.8), and greater improvement in Role Function-Restrictive domain scores of the Migraine-Specific Quality of Life Questionnaire (Δ 30.9 vs 22.3 points; all P < .001).

Study details: This post hoc analysis of the EVOLVE-1 and EVOLVE-2 trials included 1133 women with episodic migraine who received either 120 mg galcanezumab per month or placebo, of whom 40.8% met the criteria for MRM.

Disclosures: This study was sponsored by Eli Lilly and Company. Four authors declared being current or former employees and stockowners of Eli Lilly and Company. Two authors declared receiving consulting honoraria from various sources including Eli Lilly.

Source: MacGregor EA et al. Effect of galcanezumab in women with episodic migraine meeting criteria for menstrually related migraine: A post hoc analysis of EVOLVE-1 and EVOLVE-2. Headache. 2023 (Nov 28). doi: 10.1111/head.14652

Key clinical point: Galcanezumab effectively reduced the effect of menstrually related migraine (MRM) and led to improved functioning in women with episodic migraine.

Major finding: Across months 4 through 6, galcanezumab vs placebo led to greater mean reduction in the monthly migraine headache days (MHD; least squares mean change from baseline [Δ] −5.1 vs −3.2), monthly perimenstrual MHD (Δ −0.75 vs −0.49), non-perimenstrual MHD (Δ −4.6 vs −2.8), and greater improvement in Role Function-Restrictive domain scores of the Migraine-Specific Quality of Life Questionnaire (Δ 30.9 vs 22.3 points; all P < .001).

Study details: This post hoc analysis of the EVOLVE-1 and EVOLVE-2 trials included 1133 women with episodic migraine who received either 120 mg galcanezumab per month or placebo, of whom 40.8% met the criteria for MRM.

Disclosures: This study was sponsored by Eli Lilly and Company. Four authors declared being current or former employees and stockowners of Eli Lilly and Company. Two authors declared receiving consulting honoraria from various sources including Eli Lilly.

Source: MacGregor EA et al. Effect of galcanezumab in women with episodic migraine meeting criteria for menstrually related migraine: A post hoc analysis of EVOLVE-1 and EVOLVE-2. Headache. 2023 (Nov 28). doi: 10.1111/head.14652

Key clinical point: Monthly fremanezumab appeared to be effective and well-tolerated for ≤ 12 months in patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) and multiple failures to previous preventive treatments.

Major finding: At 12 months of fremanezumab treatment, the monthly headache days (MHD) were reduced significantly (median reduction −9.0; P < .001), with 76.5% of patients achieving ≥ 50% response rate. Acute medication use, disability scores, and the percentage of patients with medication overuse reduced significantly from baseline (all P < .001). No severe treatment-related adverse events were reported.

Study details: Findings are from a prospective multicenter long-term study including 83 patients with HFEM (n = 16) or CM (n = 67) and multiple preventive treatment failures who received monthly fremanezumab.

Disclosures: This study was funded by Università degli Studi di Firenze, Italy, within the CRUI-CARE Agreement. Several authors declared receiving travel or research grants, personal fees as speakers or advisors, or honoraria for scientific presentations from various sources.

Source: Caponnetto V et al for The Italian Headache Registry (RICe) Study Group. Long-term treatment over 52 weeks with monthly fremanezumab in drug-resistant migraine: A prospective multicenter cohort study. CNS Drugs. 2023;37:1069-1080 (Nov 24). doi: 10.1007/s40263-023-01050-3

Key clinical point: Monthly fremanezumab appeared to be effective and well-tolerated for ≤ 12 months in patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) and multiple failures to previous preventive treatments.

Major finding: At 12 months of fremanezumab treatment, the monthly headache days (MHD) were reduced significantly (median reduction −9.0; P < .001), with 76.5% of patients achieving ≥ 50% response rate. Acute medication use, disability scores, and the percentage of patients with medication overuse reduced significantly from baseline (all P < .001). No severe treatment-related adverse events were reported.

Study details: Findings are from a prospective multicenter long-term study including 83 patients with HFEM (n = 16) or CM (n = 67) and multiple preventive treatment failures who received monthly fremanezumab.

Disclosures: This study was funded by Università degli Studi di Firenze, Italy, within the CRUI-CARE Agreement. Several authors declared receiving travel or research grants, personal fees as speakers or advisors, or honoraria for scientific presentations from various sources.

Source: Caponnetto V et al for The Italian Headache Registry (RICe) Study Group. Long-term treatment over 52 weeks with monthly fremanezumab in drug-resistant migraine: A prospective multicenter cohort study. CNS Drugs. 2023;37:1069-1080 (Nov 24). doi: 10.1007/s40263-023-01050-3

Key clinical point: Monthly fremanezumab appeared to be effective and well-tolerated for ≤ 12 months in patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) and multiple failures to previous preventive treatments.

Major finding: At 12 months of fremanezumab treatment, the monthly headache days (MHD) were reduced significantly (median reduction −9.0; P < .001), with 76.5% of patients achieving ≥ 50% response rate. Acute medication use, disability scores, and the percentage of patients with medication overuse reduced significantly from baseline (all P < .001). No severe treatment-related adverse events were reported.

Study details: Findings are from a prospective multicenter long-term study including 83 patients with HFEM (n = 16) or CM (n = 67) and multiple preventive treatment failures who received monthly fremanezumab.

Disclosures: This study was funded by Università degli Studi di Firenze, Italy, within the CRUI-CARE Agreement. Several authors declared receiving travel or research grants, personal fees as speakers or advisors, or honoraria for scientific presentations from various sources.

Source: Caponnetto V et al for The Italian Headache Registry (RICe) Study Group. Long-term treatment over 52 weeks with monthly fremanezumab in drug-resistant migraine: A prospective multicenter cohort study. CNS Drugs. 2023;37:1069-1080 (Nov 24). doi: 10.1007/s40263-023-01050-3

Key clinical point: The interim analysis of this real-world study confirmed the effectiveness and safety of fremanezumab for the prevention of both chronic migraine (CM) and episodic migraine (EM) attacks.

Major finding: The majority of patients (55.9%) with migraine achieved ≥50% reduction in monthly migraine days (MMD) during 6 months after fremanezumab initiation, with 69.4% and 51.9% of participants with EM and CM, respectively, achieving ≥50% MMD reduction. Very few patients (2.2%) discontinued treatment due to adverse events.

Study details: This interim analysis of the pan-European Real Life study, an ongoing phase 4 study, included 574 patients with EM (25.8%) or CM (74.2%) who initiated fremanezumab on a monthly or quarterly basis.

Disclosures: This study was funded by Teva Pharmaceuticals. Four authors declared being current or former employees or shareholders of Teva Pharmaceuticals. Other authors declared receiving personal fees, research grants, travel grants, honoraria, or research support from or having other ties with various sources, including Teva.

Source: Ashina M et al. Real-world effectiveness of fremanezumab for the preventive treatment of migraine: Interim analysis of the pan-European, prospective, observational, phase 4 PEARL study. Cephalalgia. 2023;43(11):3331024231214987 (Nov 21). doi: 10.1177/03331024231214987

Key clinical point: The interim analysis of this real-world study confirmed the effectiveness and safety of fremanezumab for the prevention of both chronic migraine (CM) and episodic migraine (EM) attacks.

Major finding: The majority of patients (55.9%) with migraine achieved ≥50% reduction in monthly migraine days (MMD) during 6 months after fremanezumab initiation, with 69.4% and 51.9% of participants with EM and CM, respectively, achieving ≥50% MMD reduction. Very few patients (2.2%) discontinued treatment due to adverse events.

Study details: This interim analysis of the pan-European Real Life study, an ongoing phase 4 study, included 574 patients with EM (25.8%) or CM (74.2%) who initiated fremanezumab on a monthly or quarterly basis.

Disclosures: This study was funded by Teva Pharmaceuticals. Four authors declared being current or former employees or shareholders of Teva Pharmaceuticals. Other authors declared receiving personal fees, research grants, travel grants, honoraria, or research support from or having other ties with various sources, including Teva.

Source: Ashina M et al. Real-world effectiveness of fremanezumab for the preventive treatment of migraine: Interim analysis of the pan-European, prospective, observational, phase 4 PEARL study. Cephalalgia. 2023;43(11):3331024231214987 (Nov 21). doi: 10.1177/03331024231214987

Key clinical point: The interim analysis of this real-world study confirmed the effectiveness and safety of fremanezumab for the prevention of both chronic migraine (CM) and episodic migraine (EM) attacks.

Major finding: The majority of patients (55.9%) with migraine achieved ≥50% reduction in monthly migraine days (MMD) during 6 months after fremanezumab initiation, with 69.4% and 51.9% of participants with EM and CM, respectively, achieving ≥50% MMD reduction. Very few patients (2.2%) discontinued treatment due to adverse events.

Study details: This interim analysis of the pan-European Real Life study, an ongoing phase 4 study, included 574 patients with EM (25.8%) or CM (74.2%) who initiated fremanezumab on a monthly or quarterly basis.

Disclosures: This study was funded by Teva Pharmaceuticals. Four authors declared being current or former employees or shareholders of Teva Pharmaceuticals. Other authors declared receiving personal fees, research grants, travel grants, honoraria, or research support from or having other ties with various sources, including Teva.

Source: Ashina M et al. Real-world effectiveness of fremanezumab for the preventive treatment of migraine: Interim analysis of the pan-European, prospective, observational, phase 4 PEARL study. Cephalalgia. 2023;43(11):3331024231214987 (Nov 21). doi: 10.1177/03331024231214987

Key clinical point: Eptinezumab vs placebo reduced the monthly migraine days by ≥30% in a significantly higher proportion of patients with migraine during the first infusion (weeks 1-12), with further improvements in migraine response following the second infusion (weeks 13-24).

Major finding: A significantly higher proportion of patients receiving 100 mg and 300 mg eptinezumab vs placebo achieved ≥30% reduction in monthly migraine days during weeks 1-12 (65.9% and 71.0% vs 36.9%, respectively; P < .0001) and weeks 13-24 (70.4% and 74.5% vs 43.1%, respectively; P < .0001).

Study details: This post hoc analysis of the DELIVER trial included 890 patients with migraine who had experienced 2-4 prior preventive treatment failures and were randomly assigned to receive 100 mg or 300 mg eptinezumab or placebo every 12 weeks.

Disclosures: This study was funded by H. Lundbeck A/S. Three authors declared being full-time employees of H. Lundbeck A/S or one of its subsidiary companies. Other authors declared having ties with various sources including H. Lundbeck A/S.

Source: Ashina M et al. Responder rates with eptinezumab over 24 weeks in patients with prior preventive migraine treatment failures: Post hoc analysis of the DELIVER randomized clinical trial. Eur J Neurol. 2023 (Nov 13). doi: 10.1111/ene.16131

Key clinical point: Eptinezumab vs placebo reduced the monthly migraine days by ≥30% in a significantly higher proportion of patients with migraine during the first infusion (weeks 1-12), with further improvements in migraine response following the second infusion (weeks 13-24).

Major finding: A significantly higher proportion of patients receiving 100 mg and 300 mg eptinezumab vs placebo achieved ≥30% reduction in monthly migraine days during weeks 1-12 (65.9% and 71.0% vs 36.9%, respectively; P < .0001) and weeks 13-24 (70.4% and 74.5% vs 43.1%, respectively; P < .0001).

Study details: This post hoc analysis of the DELIVER trial included 890 patients with migraine who had experienced 2-4 prior preventive treatment failures and were randomly assigned to receive 100 mg or 300 mg eptinezumab or placebo every 12 weeks.

Disclosures: This study was funded by H. Lundbeck A/S. Three authors declared being full-time employees of H. Lundbeck A/S or one of its subsidiary companies. Other authors declared having ties with various sources including H. Lundbeck A/S.

Source: Ashina M et al. Responder rates with eptinezumab over 24 weeks in patients with prior preventive migraine treatment failures: Post hoc analysis of the DELIVER randomized clinical trial. Eur J Neurol. 2023 (Nov 13). doi: 10.1111/ene.16131

Key clinical point: Eptinezumab vs placebo reduced the monthly migraine days by ≥30% in a significantly higher proportion of patients with migraine during the first infusion (weeks 1-12), with further improvements in migraine response following the second infusion (weeks 13-24).

Major finding: A significantly higher proportion of patients receiving 100 mg and 300 mg eptinezumab vs placebo achieved ≥30% reduction in monthly migraine days during weeks 1-12 (65.9% and 71.0% vs 36.9%, respectively; P < .0001) and weeks 13-24 (70.4% and 74.5% vs 43.1%, respectively; P < .0001).

Study details: This post hoc analysis of the DELIVER trial included 890 patients with migraine who had experienced 2-4 prior preventive treatment failures and were randomly assigned to receive 100 mg or 300 mg eptinezumab or placebo every 12 weeks.

Disclosures: This study was funded by H. Lundbeck A/S. Three authors declared being full-time employees of H. Lundbeck A/S or one of its subsidiary companies. Other authors declared having ties with various sources including H. Lundbeck A/S.

Source: Ashina M et al. Responder rates with eptinezumab over 24 weeks in patients with prior preventive migraine treatment failures: Post hoc analysis of the DELIVER randomized clinical trial. Eur J Neurol. 2023 (Nov 13). doi: 10.1111/ene.16131

Key clinical point: When taken during the prodrome, ubrogepant was more effective than placebo in reducing headaches in patients with a ≥1-year history of migraine and had a tolerable safety profile.

Major finding: A significantly higher proportion of patients reported the absence of moderate or severe headaches within 24 hours of receiving ubrogepant vs placebo (46% vs 29%; odds ratio 2.09; P < .0001). Nausea, fatigue, dizziness, and somnolence were reported by ≤5% of patients receiving ubrogepant.

Study details: The PRODROME trial included 518 patients with migraine who were randomly assigned to receive placebo followed by 100 mg ubrogepant to treat the first and second qualifying prodrome events, respectively, or 100 mg ubrogepant followed by placebo to treat the first and second qualifying prodrome events, respectively.

Disclosures: This study was funded by AbbVie. Six authors declared being current or former employees of or holding stocks in AbbVie. Other authors declared having ties with various sources including AbbVie.

Source: Dodick DW et al. Ubrogepant for the treatment of migraine attacks during the prodrome: A phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA. Lancet. 2023 (Nov 15). doi: 10.1016/S0140-6736(23)01683-5

Key clinical point: When taken during the prodrome, ubrogepant was more effective than placebo in reducing headaches in patients with a ≥1-year history of migraine and had a tolerable safety profile.

Major finding: A significantly higher proportion of patients reported the absence of moderate or severe headaches within 24 hours of receiving ubrogepant vs placebo (46% vs 29%; odds ratio 2.09; P < .0001). Nausea, fatigue, dizziness, and somnolence were reported by ≤5% of patients receiving ubrogepant.

Study details: The PRODROME trial included 518 patients with migraine who were randomly assigned to receive placebo followed by 100 mg ubrogepant to treat the first and second qualifying prodrome events, respectively, or 100 mg ubrogepant followed by placebo to treat the first and second qualifying prodrome events, respectively.

Disclosures: This study was funded by AbbVie. Six authors declared being current or former employees of or holding stocks in AbbVie. Other authors declared having ties with various sources including AbbVie.

Source: Dodick DW et al. Ubrogepant for the treatment of migraine attacks during the prodrome: A phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA. Lancet. 2023 (Nov 15). doi: 10.1016/S0140-6736(23)01683-5

Key clinical point: When taken during the prodrome, ubrogepant was more effective than placebo in reducing headaches in patients with a ≥1-year history of migraine and had a tolerable safety profile.

Major finding: A significantly higher proportion of patients reported the absence of moderate or severe headaches within 24 hours of receiving ubrogepant vs placebo (46% vs 29%; odds ratio 2.09; P < .0001). Nausea, fatigue, dizziness, and somnolence were reported by ≤5% of patients receiving ubrogepant.

Study details: The PRODROME trial included 518 patients with migraine who were randomly assigned to receive placebo followed by 100 mg ubrogepant to treat the first and second qualifying prodrome events, respectively, or 100 mg ubrogepant followed by placebo to treat the first and second qualifying prodrome events, respectively.

Disclosures: This study was funded by AbbVie. Six authors declared being current or former employees of or holding stocks in AbbVie. Other authors declared having ties with various sources including AbbVie.

Source: Dodick DW et al. Ubrogepant for the treatment of migraine attacks during the prodrome: A phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA. Lancet. 2023 (Nov 15). doi: 10.1016/S0140-6736(23)01683-5

BARCELONA, SPAIN — For the first time, new research shows that taking a specific class of migraine medication during the prodromal phase reduces the development and severity of the subsequent headache. In the randomized, placebo-controlled crossover PRODROME trial, treatment with ubrogepant (Ubrelvy) 100 mg, one of the new CGRP receptor antagonists, during the prodrome prevented the development of moderate/severe headache at both 24 hours and 48 hours post-dose. The medication also reduced headache of any intensity within 24 hours and functional disability compared with placebo.

“This represents a totally different way of treating a migraine attack – to treat it before the headache starts. This is a paradigm shift in the way we approach the acute treatment of migraine,” study investigator Peter Goadsby, MBBS, MD, PhD, professor of neurology at Kings College London, UK, said in an interview.

The findings were presented at 17th European Headache Congress (EHC) and were also recently published online in The Lancet. 
 

A New Way to Manage Migraine?

The prodrome is usually the earliest phase of a migraine attack and is believed to be experienced by the vast majority of patients with migraine. It consists of various symptoms, including sensitivity to light, fatigue, mood changes, cognitive dysfunction, craving certain foods, and neck pain, which can occur several hours or days before onset.

Dr. Goadsby notes that, at present, there isn’t very much a patient can do about the prodrome. 

“We advise patients if they feel an attack is coming not to do anything that might make it worse and make sure they have their acute treatment available for when the headache phase starts. So, we just advise people to prepare for the attack rather than doing anything specific to stop it. But with new data from this study, we now have something that can be done. Patients have an option,” he said.

Dr. Goadsby explained that currently patients are not encouraged to use acute migraine medications such as triptans in the prodrome phase. 

“There is actually no evidence that taking a triptan during the prodromal phase works. The advice is to take a triptan as soon as the headache starts, but not before the headache starts.”

He noted that there is also the problem of medication overuse that is seen with triptans, and most other medications used to treat acute migraine, which leads to medication overuse headache, “so we don’t like to encourage patients to increase the frequency of taking triptans for this reason.” 

But ubrogepant and other members of the “gepant” class do not seem to have the propensity for medication overuse problems. “Rather, the more a patient takes the less likely they are to get a headache as these drugs also have a preventative effect,” Dr. Goadsby said. 

Major Reduction in Severity

The PRODROME trial was conducted at 75 sites in the United States in 518 patients who had at least a 1-year history of migraine with or without aura and a history of two to eight migraine attacks per month with moderate to severe headache in each of the 3 months before study entry. 

Participants underwent a rigorous screening period during which they were required to show that they could identify prodromal symptoms that were reliably followed by migraine headache within 1-6 hours.

They were randomly assigned to receive either placebo to treat the first qualifying prodrome event and ubrogepant 100 mg to treat the second qualifying prodrome event or vice versa, with instructions to take the study drug at the onset of the prodrome event.

Efficacy assessments during the double-blind treatment period were recorded by the participant in an electronic diary. On identifying a qualifying prodrome, the patient recorded prodromal symptoms, and was then required to report the absence or presence of a headache at regular intervals up to 48 hours after the study drug dose. If a headache was reported, participants rated the intensity as mild, moderate, or severe and reported whether rescue medication was taken to treat it.

The primary endpoint was absence of moderate or severe intensity headache within 24 hours after study-drug dose. This occurred after 46% of 418 qualifying prodrome events that had been treated with ubrogepant and after 29% of 423 qualifying prodrome events that had been treated with placebo (odds ratio, 2.09; 95% CI, 1.63 - 2.69; P < .0001). 

“The incidence of moderate to severe headache was almost halved when ubrogepant was taken in the prodrome,” Dr. Goadsby reported. 

Ubrogepant also showed similar impressive results for the secondary endpoints in the absence of moderate to severe headache within 48 hours post-dose and the absence of any headache of any intensity at 24 hours. 

Little to No Disability

The researchers also evaluated functional ability, and more participants reported “no disability or able to function normally” during the 24 hours after treatment with ubrogepant than after placebo (OR, 1.66; P < .0001).

Other findings showed that the prodromal symptoms themselves, such as light sensitivity and cognitive dysfunction, were also reduced with ubrogepant. 

Dr. Goadsby said he was pleased but not surprised by the results, as the “gepant” class of drugs are used in both the acute treatment of migraine and as preventive agents, although different agents have been approved for different indications in this regard.

“The ‘gepants’ are a class of medication that can be used in almost any way in migraine — to treat an acute migraine headache, to prevent migraine if taken chronically, and now we see that they can also stop a migraine from developing if taken during the initial prodromal phase. That’s unique for a migraine medication,” he said. 

While the current study was conducted with ubrogepant, Dr. Goadsby suspects that any of the “gepants” would probably have a similar effect. 

He noted that the prodromal phase of migraine has only just started to be explored, with functional imaging studies showing that structural brain changes occur during this phase. 

Dr. Goadsby said the current study opens up a whole new area of interest, emphasizing the clinical value of identifying the prodrome in individuals with migraine, better characterizing the symptomology of the prodrome and understanding more about how to treat it.

“It’s the ultimate way of treating migraine early, and by taking this type of medication in the prodromal phase, patients may be able to stop having pain. That’s quite an implication,” he concluded. 

The PRODROME study was funded by AbbVie. Dr. Goadsby reports personal fees from AbbVie.

A version of this article appeared on Medscape.com.

BARCELONA, SPAIN — For the first time, new research shows that taking a specific class of migraine medication during the prodromal phase reduces the development and severity of the subsequent headache. In the randomized, placebo-controlled crossover PRODROME trial, treatment with ubrogepant (Ubrelvy) 100 mg, one of the new CGRP receptor antagonists, during the prodrome prevented the development of moderate/severe headache at both 24 hours and 48 hours post-dose. The medication also reduced headache of any intensity within 24 hours and functional disability compared with placebo.

“This represents a totally different way of treating a migraine attack – to treat it before the headache starts. This is a paradigm shift in the way we approach the acute treatment of migraine,” study investigator Peter Goadsby, MBBS, MD, PhD, professor of neurology at Kings College London, UK, said in an interview.

The findings were presented at 17th European Headache Congress (EHC) and were also recently published online in The Lancet. 
 

A New Way to Manage Migraine?

The prodrome is usually the earliest phase of a migraine attack and is believed to be experienced by the vast majority of patients with migraine. It consists of various symptoms, including sensitivity to light, fatigue, mood changes, cognitive dysfunction, craving certain foods, and neck pain, which can occur several hours or days before onset.

Dr. Goadsby notes that, at present, there isn’t very much a patient can do about the prodrome. 

“We advise patients if they feel an attack is coming not to do anything that might make it worse and make sure they have their acute treatment available for when the headache phase starts. So, we just advise people to prepare for the attack rather than doing anything specific to stop it. But with new data from this study, we now have something that can be done. Patients have an option,” he said.

Dr. Goadsby explained that currently patients are not encouraged to use acute migraine medications such as triptans in the prodrome phase. 

“There is actually no evidence that taking a triptan during the prodromal phase works. The advice is to take a triptan as soon as the headache starts, but not before the headache starts.”

He noted that there is also the problem of medication overuse that is seen with triptans, and most other medications used to treat acute migraine, which leads to medication overuse headache, “so we don’t like to encourage patients to increase the frequency of taking triptans for this reason.” 

But ubrogepant and other members of the “gepant” class do not seem to have the propensity for medication overuse problems. “Rather, the more a patient takes the less likely they are to get a headache as these drugs also have a preventative effect,” Dr. Goadsby said. 

Major Reduction in Severity

The PRODROME trial was conducted at 75 sites in the United States in 518 patients who had at least a 1-year history of migraine with or without aura and a history of two to eight migraine attacks per month with moderate to severe headache in each of the 3 months before study entry. 

Participants underwent a rigorous screening period during which they were required to show that they could identify prodromal symptoms that were reliably followed by migraine headache within 1-6 hours.

They were randomly assigned to receive either placebo to treat the first qualifying prodrome event and ubrogepant 100 mg to treat the second qualifying prodrome event or vice versa, with instructions to take the study drug at the onset of the prodrome event.

Efficacy assessments during the double-blind treatment period were recorded by the participant in an electronic diary. On identifying a qualifying prodrome, the patient recorded prodromal symptoms, and was then required to report the absence or presence of a headache at regular intervals up to 48 hours after the study drug dose. If a headache was reported, participants rated the intensity as mild, moderate, or severe and reported whether rescue medication was taken to treat it.

The primary endpoint was absence of moderate or severe intensity headache within 24 hours after study-drug dose. This occurred after 46% of 418 qualifying prodrome events that had been treated with ubrogepant and after 29% of 423 qualifying prodrome events that had been treated with placebo (odds ratio, 2.09; 95% CI, 1.63 - 2.69; P < .0001). 

“The incidence of moderate to severe headache was almost halved when ubrogepant was taken in the prodrome,” Dr. Goadsby reported. 

Ubrogepant also showed similar impressive results for the secondary endpoints in the absence of moderate to severe headache within 48 hours post-dose and the absence of any headache of any intensity at 24 hours. 

Little to No Disability

The researchers also evaluated functional ability, and more participants reported “no disability or able to function normally” during the 24 hours after treatment with ubrogepant than after placebo (OR, 1.66; P < .0001).

Other findings showed that the prodromal symptoms themselves, such as light sensitivity and cognitive dysfunction, were also reduced with ubrogepant. 

Dr. Goadsby said he was pleased but not surprised by the results, as the “gepant” class of drugs are used in both the acute treatment of migraine and as preventive agents, although different agents have been approved for different indications in this regard.

“The ‘gepants’ are a class of medication that can be used in almost any way in migraine — to treat an acute migraine headache, to prevent migraine if taken chronically, and now we see that they can also stop a migraine from developing if taken during the initial prodromal phase. That’s unique for a migraine medication,” he said. 

While the current study was conducted with ubrogepant, Dr. Goadsby suspects that any of the “gepants” would probably have a similar effect. 

He noted that the prodromal phase of migraine has only just started to be explored, with functional imaging studies showing that structural brain changes occur during this phase. 

Dr. Goadsby said the current study opens up a whole new area of interest, emphasizing the clinical value of identifying the prodrome in individuals with migraine, better characterizing the symptomology of the prodrome and understanding more about how to treat it.

“It’s the ultimate way of treating migraine early, and by taking this type of medication in the prodromal phase, patients may be able to stop having pain. That’s quite an implication,” he concluded. 

The PRODROME study was funded by AbbVie. Dr. Goadsby reports personal fees from AbbVie.

A version of this article appeared on Medscape.com.

BARCELONA, SPAIN — For the first time, new research shows that taking a specific class of migraine medication during the prodromal phase reduces the development and severity of the subsequent headache. In the randomized, placebo-controlled crossover PRODROME trial, treatment with ubrogepant (Ubrelvy) 100 mg, one of the new CGRP receptor antagonists, during the prodrome prevented the development of moderate/severe headache at both 24 hours and 48 hours post-dose. The medication also reduced headache of any intensity within 24 hours and functional disability compared with placebo.

“This represents a totally different way of treating a migraine attack – to treat it before the headache starts. This is a paradigm shift in the way we approach the acute treatment of migraine,” study investigator Peter Goadsby, MBBS, MD, PhD, professor of neurology at Kings College London, UK, said in an interview.

The findings were presented at 17th European Headache Congress (EHC) and were also recently published online in The Lancet. 
 

A New Way to Manage Migraine?

The prodrome is usually the earliest phase of a migraine attack and is believed to be experienced by the vast majority of patients with migraine. It consists of various symptoms, including sensitivity to light, fatigue, mood changes, cognitive dysfunction, craving certain foods, and neck pain, which can occur several hours or days before onset.

Dr. Goadsby notes that, at present, there isn’t very much a patient can do about the prodrome. 

“We advise patients if they feel an attack is coming not to do anything that might make it worse and make sure they have their acute treatment available for when the headache phase starts. So, we just advise people to prepare for the attack rather than doing anything specific to stop it. But with new data from this study, we now have something that can be done. Patients have an option,” he said.

Dr. Goadsby explained that currently patients are not encouraged to use acute migraine medications such as triptans in the prodrome phase. 

“There is actually no evidence that taking a triptan during the prodromal phase works. The advice is to take a triptan as soon as the headache starts, but not before the headache starts.”

He noted that there is also the problem of medication overuse that is seen with triptans, and most other medications used to treat acute migraine, which leads to medication overuse headache, “so we don’t like to encourage patients to increase the frequency of taking triptans for this reason.” 

But ubrogepant and other members of the “gepant” class do not seem to have the propensity for medication overuse problems. “Rather, the more a patient takes the less likely they are to get a headache as these drugs also have a preventative effect,” Dr. Goadsby said. 

Major Reduction in Severity

The PRODROME trial was conducted at 75 sites in the United States in 518 patients who had at least a 1-year history of migraine with or without aura and a history of two to eight migraine attacks per month with moderate to severe headache in each of the 3 months before study entry. 

Participants underwent a rigorous screening period during which they were required to show that they could identify prodromal symptoms that were reliably followed by migraine headache within 1-6 hours.

They were randomly assigned to receive either placebo to treat the first qualifying prodrome event and ubrogepant 100 mg to treat the second qualifying prodrome event or vice versa, with instructions to take the study drug at the onset of the prodrome event.

Efficacy assessments during the double-blind treatment period were recorded by the participant in an electronic diary. On identifying a qualifying prodrome, the patient recorded prodromal symptoms, and was then required to report the absence or presence of a headache at regular intervals up to 48 hours after the study drug dose. If a headache was reported, participants rated the intensity as mild, moderate, or severe and reported whether rescue medication was taken to treat it.

The primary endpoint was absence of moderate or severe intensity headache within 24 hours after study-drug dose. This occurred after 46% of 418 qualifying prodrome events that had been treated with ubrogepant and after 29% of 423 qualifying prodrome events that had been treated with placebo (odds ratio, 2.09; 95% CI, 1.63 - 2.69; P < .0001). 

“The incidence of moderate to severe headache was almost halved when ubrogepant was taken in the prodrome,” Dr. Goadsby reported. 

Ubrogepant also showed similar impressive results for the secondary endpoints in the absence of moderate to severe headache within 48 hours post-dose and the absence of any headache of any intensity at 24 hours. 

Little to No Disability

The researchers also evaluated functional ability, and more participants reported “no disability or able to function normally” during the 24 hours after treatment with ubrogepant than after placebo (OR, 1.66; P < .0001).

Other findings showed that the prodromal symptoms themselves, such as light sensitivity and cognitive dysfunction, were also reduced with ubrogepant. 

Dr. Goadsby said he was pleased but not surprised by the results, as the “gepant” class of drugs are used in both the acute treatment of migraine and as preventive agents, although different agents have been approved for different indications in this regard.

“The ‘gepants’ are a class of medication that can be used in almost any way in migraine — to treat an acute migraine headache, to prevent migraine if taken chronically, and now we see that they can also stop a migraine from developing if taken during the initial prodromal phase. That’s unique for a migraine medication,” he said. 

While the current study was conducted with ubrogepant, Dr. Goadsby suspects that any of the “gepants” would probably have a similar effect. 

He noted that the prodromal phase of migraine has only just started to be explored, with functional imaging studies showing that structural brain changes occur during this phase. 

Dr. Goadsby said the current study opens up a whole new area of interest, emphasizing the clinical value of identifying the prodrome in individuals with migraine, better characterizing the symptomology of the prodrome and understanding more about how to treat it.

“It’s the ultimate way of treating migraine early, and by taking this type of medication in the prodromal phase, patients may be able to stop having pain. That’s quite an implication,” he concluded. 

The PRODROME study was funded by AbbVie. Dr. Goadsby reports personal fees from AbbVie.

A version of this article appeared on Medscape.com.