Article

Key clinical point: The use of antibiotics and acid-suppressants during the prenatal period and infancy increased the risk of developing eosinophilic esophagitis (EoE) later in life.

Major finding: The risk for EoE increased by 50% in offsprings who were administered antibiotics during the prenatal period (adjusted odds ratio [aOR] 1.5; 95% CI 1.2-1.9); moreover, the administration of antibiotics (aOR 1.4; 95% CI 1.1-1.7) and acid-suppressants (aOR 15.9; 95% CI 9.1-27.7) in infancy was significantly associated with an increased risk for EoE.

Study details: Findings are from a case-control study including 392 children with EoE and 3637 age- and sex-matched control individuals without EoE.

Disclosures: This study was supported by a grant from the US National Institutes of Allergy and Infectious Diseases. Some authors declared receiving grants, consulting fees, or funding from various sources.

Source: Jensen ET et al. Maternal and infant antibiotic and acid suppressant use and risk of eosinophilic esophagitis. JAMA Pediatr. 2023;177(12):1285-1293 (Oct 30). doi: 10.1001/jamapediatrics.2023.4609

Key clinical point: The use of antibiotics and acid-suppressants during the prenatal period and infancy increased the risk of developing eosinophilic esophagitis (EoE) later in life.

Major finding: The risk for EoE increased by 50% in offsprings who were administered antibiotics during the prenatal period (adjusted odds ratio [aOR] 1.5; 95% CI 1.2-1.9); moreover, the administration of antibiotics (aOR 1.4; 95% CI 1.1-1.7) and acid-suppressants (aOR 15.9; 95% CI 9.1-27.7) in infancy was significantly associated with an increased risk for EoE.

Study details: Findings are from a case-control study including 392 children with EoE and 3637 age- and sex-matched control individuals without EoE.

Disclosures: This study was supported by a grant from the US National Institutes of Allergy and Infectious Diseases. Some authors declared receiving grants, consulting fees, or funding from various sources.

Source: Jensen ET et al. Maternal and infant antibiotic and acid suppressant use and risk of eosinophilic esophagitis. JAMA Pediatr. 2023;177(12):1285-1293 (Oct 30). doi: 10.1001/jamapediatrics.2023.4609

Key clinical point: The use of antibiotics and acid-suppressants during the prenatal period and infancy increased the risk of developing eosinophilic esophagitis (EoE) later in life.

Major finding: The risk for EoE increased by 50% in offsprings who were administered antibiotics during the prenatal period (adjusted odds ratio [aOR] 1.5; 95% CI 1.2-1.9); moreover, the administration of antibiotics (aOR 1.4; 95% CI 1.1-1.7) and acid-suppressants (aOR 15.9; 95% CI 9.1-27.7) in infancy was significantly associated with an increased risk for EoE.

Study details: Findings are from a case-control study including 392 children with EoE and 3637 age- and sex-matched control individuals without EoE.

Disclosures: This study was supported by a grant from the US National Institutes of Allergy and Infectious Diseases. Some authors declared receiving grants, consulting fees, or funding from various sources.

Source: Jensen ET et al. Maternal and infant antibiotic and acid suppressant use and risk of eosinophilic esophagitis. JAMA Pediatr. 2023;177(12):1285-1293 (Oct 30). doi: 10.1001/jamapediatrics.2023.4609

Key clinical point: Fremanezumab demonstrated improved efficacy, tolerability, and safety outcomes in patients with chronic or episodic migraine who reported prior inadequate response to 2-4 classes of preventive migraine medications.

Major finding: At 12 weeks, the number needed to treat to achieve ≥50% reduction in monthly average number of migraine days was 3.9 with both quarterly and monthly fremanezumab dosing. The numbers needed to harm for one patient to discontinue treatment due to adverse events were 1000 and 144 for quarterly and monthly fremanezumab dosing, respectively.

Study details: This post hoc analysis of the FOCUS trial included 838 patients with chronic (n = 509) or episodic (n = 329) migraine who had prior inadequate response to 2-4 migraine preventive medication classes and were randomly assigned to receive quarterly or monthly fremanezumab or placebo.

Disclosures: This study was funded by Teva Pharmaceuticals. Three authors declared being employees of Teva Pharmaceuticals, and  other authors declared having ties with various sources including Teva Pharmaceuticals.

Source: Ashina M et al. Numbers needed to treat or harm and likelihood of being helped versus harmed for fremanezumab in patients who had prior inadequate response to two to four classes of migraine preventive medications: A post hoc analysis. Headache. 2023;63(10):1351-1358 (Nov 13). doi: 10.1111/head.14651

Key clinical point: Fremanezumab demonstrated improved efficacy, tolerability, and safety outcomes in patients with chronic or episodic migraine who reported prior inadequate response to 2-4 classes of preventive migraine medications.

Major finding: At 12 weeks, the number needed to treat to achieve ≥50% reduction in monthly average number of migraine days was 3.9 with both quarterly and monthly fremanezumab dosing. The numbers needed to harm for one patient to discontinue treatment due to adverse events were 1000 and 144 for quarterly and monthly fremanezumab dosing, respectively.

Study details: This post hoc analysis of the FOCUS trial included 838 patients with chronic (n = 509) or episodic (n = 329) migraine who had prior inadequate response to 2-4 migraine preventive medication classes and were randomly assigned to receive quarterly or monthly fremanezumab or placebo.

Disclosures: This study was funded by Teva Pharmaceuticals. Three authors declared being employees of Teva Pharmaceuticals, and  other authors declared having ties with various sources including Teva Pharmaceuticals.

Source: Ashina M et al. Numbers needed to treat or harm and likelihood of being helped versus harmed for fremanezumab in patients who had prior inadequate response to two to four classes of migraine preventive medications: A post hoc analysis. Headache. 2023;63(10):1351-1358 (Nov 13). doi: 10.1111/head.14651

Key clinical point: Fremanezumab demonstrated improved efficacy, tolerability, and safety outcomes in patients with chronic or episodic migraine who reported prior inadequate response to 2-4 classes of preventive migraine medications.

Major finding: At 12 weeks, the number needed to treat to achieve ≥50% reduction in monthly average number of migraine days was 3.9 with both quarterly and monthly fremanezumab dosing. The numbers needed to harm for one patient to discontinue treatment due to adverse events were 1000 and 144 for quarterly and monthly fremanezumab dosing, respectively.

Study details: This post hoc analysis of the FOCUS trial included 838 patients with chronic (n = 509) or episodic (n = 329) migraine who had prior inadequate response to 2-4 migraine preventive medication classes and were randomly assigned to receive quarterly or monthly fremanezumab or placebo.

Disclosures: This study was funded by Teva Pharmaceuticals. Three authors declared being employees of Teva Pharmaceuticals, and  other authors declared having ties with various sources including Teva Pharmaceuticals.

Source: Ashina M et al. Numbers needed to treat or harm and likelihood of being helped versus harmed for fremanezumab in patients who had prior inadequate response to two to four classes of migraine preventive medications: A post hoc analysis. Headache. 2023;63(10):1351-1358 (Nov 13). doi: 10.1111/head.14651

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