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Eosinophilic esophagitis increases incident IBD risk
Key clinical point: The risk for inflammatory bowel diseases (IBD), particularly Crohn’s disease, was 3.5 times higher in patients with eosinophilic esophagitis (EoE).
Major finding: Compared with control individuals without EoE, patients with EoE were at a ~3.5-fold increased risk for IBD (adjusted hazard ratio [aHR] 3.56; 95% CI 1.79-7.11), particularly Crohn’s disease (aHR 3.39; 95% CI 1.2-9.60). When compared with siblings of patients with EoE, 12 patients with EoE were diagnosed with IBD later in life compared with 11 siblings, which corresponded to an aHR of 2.48 (95% CI 0.92-6.70).
Study details: Findings are from a nationwide cohort study including 1587 patients with histologically verified EoE and 7808 age- and sex-matched control individuals without EoE.
Disclosures: This study was funded by the Consortium of Eosinophilic Gastrointestinal Disease Researcher Training Program and Karolinska Institutet, Sweden. Some authors declared serving as consultants, advisors, or speakers for or receiving financial support, grants, or fees for lectures from Karolinska Institutet and other sources.
Source: Uchida AM et al. Eosinophilic esophagitis is associated with increased risk of later inflammatory bowel disease in a nationwide Swedish population cohort. United European Gastroenterol J. 2023 (Dec 7). doi: 10.1002/ueg2.12493
Key clinical point: The risk for inflammatory bowel diseases (IBD), particularly Crohn’s disease, was 3.5 times higher in patients with eosinophilic esophagitis (EoE).
Major finding: Compared with control individuals without EoE, patients with EoE were at a ~3.5-fold increased risk for IBD (adjusted hazard ratio [aHR] 3.56; 95% CI 1.79-7.11), particularly Crohn’s disease (aHR 3.39; 95% CI 1.2-9.60). When compared with siblings of patients with EoE, 12 patients with EoE were diagnosed with IBD later in life compared with 11 siblings, which corresponded to an aHR of 2.48 (95% CI 0.92-6.70).
Study details: Findings are from a nationwide cohort study including 1587 patients with histologically verified EoE and 7808 age- and sex-matched control individuals without EoE.
Disclosures: This study was funded by the Consortium of Eosinophilic Gastrointestinal Disease Researcher Training Program and Karolinska Institutet, Sweden. Some authors declared serving as consultants, advisors, or speakers for or receiving financial support, grants, or fees for lectures from Karolinska Institutet and other sources.
Source: Uchida AM et al. Eosinophilic esophagitis is associated with increased risk of later inflammatory bowel disease in a nationwide Swedish population cohort. United European Gastroenterol J. 2023 (Dec 7). doi: 10.1002/ueg2.12493
Key clinical point: The risk for inflammatory bowel diseases (IBD), particularly Crohn’s disease, was 3.5 times higher in patients with eosinophilic esophagitis (EoE).
Major finding: Compared with control individuals without EoE, patients with EoE were at a ~3.5-fold increased risk for IBD (adjusted hazard ratio [aHR] 3.56; 95% CI 1.79-7.11), particularly Crohn’s disease (aHR 3.39; 95% CI 1.2-9.60). When compared with siblings of patients with EoE, 12 patients with EoE were diagnosed with IBD later in life compared with 11 siblings, which corresponded to an aHR of 2.48 (95% CI 0.92-6.70).
Study details: Findings are from a nationwide cohort study including 1587 patients with histologically verified EoE and 7808 age- and sex-matched control individuals without EoE.
Disclosures: This study was funded by the Consortium of Eosinophilic Gastrointestinal Disease Researcher Training Program and Karolinska Institutet, Sweden. Some authors declared serving as consultants, advisors, or speakers for or receiving financial support, grants, or fees for lectures from Karolinska Institutet and other sources.
Source: Uchida AM et al. Eosinophilic esophagitis is associated with increased risk of later inflammatory bowel disease in a nationwide Swedish population cohort. United European Gastroenterol J. 2023 (Dec 7). doi: 10.1002/ueg2.12493
Budesonide oral suspension improves histologic, endoscopic, and clinicopathologic responses in EoE
Key clinical point: Budesonide oral suspension (BOS) significantly improved most of the efficacy outcomes in adolescents with eosinophilic esophagitis (EoE) over 12 weeks.
Major finding: At week 12, a significantly higher number of adolescents receiving BOS vs placebo achieved histologic (≤6, ≤1, and <15 eosinophils/high-power field; all P < .001) and clinicopathologic (P = .003) responses. BOS vs placebo led to greater reductions in the EoE histology scoring system grade (P < .001) and total EoE endoscopic reference scores (P = .021). Treatment-emergent adverse events were mild or moderate in severity.
Study details: This post hoc analysis of pooled data from a phase 2 and a phase 3 study included 76 adolescents with EoE (age 11-17 years) who were randomly assigned to receive 2 mg BOS twice daily or placebo.
Disclosures: These studies were funded by Shire ViroPharma, Inc., a Takeda company, and Meritage Pharma, Inc. (now part of Shire). Some authors declared serving as consultants for or receiving research funding, etc., from Meritage, Shire, and others. Four authors declared being employees and stockholders of Takeda.
Source: Mukkada VA et al. Pooled phase 2 and 3 efficacy and safety data on budesonide oral suspension in adolescents with eosinophilic esophagitis. J Pediatr Gastroenterol Nutr. 2023;77(6):760-768 (Sep 18). doi: 10.1097/MPG.0000000000003948
Key clinical point: Budesonide oral suspension (BOS) significantly improved most of the efficacy outcomes in adolescents with eosinophilic esophagitis (EoE) over 12 weeks.
Major finding: At week 12, a significantly higher number of adolescents receiving BOS vs placebo achieved histologic (≤6, ≤1, and <15 eosinophils/high-power field; all P < .001) and clinicopathologic (P = .003) responses. BOS vs placebo led to greater reductions in the EoE histology scoring system grade (P < .001) and total EoE endoscopic reference scores (P = .021). Treatment-emergent adverse events were mild or moderate in severity.
Study details: This post hoc analysis of pooled data from a phase 2 and a phase 3 study included 76 adolescents with EoE (age 11-17 years) who were randomly assigned to receive 2 mg BOS twice daily or placebo.
Disclosures: These studies were funded by Shire ViroPharma, Inc., a Takeda company, and Meritage Pharma, Inc. (now part of Shire). Some authors declared serving as consultants for or receiving research funding, etc., from Meritage, Shire, and others. Four authors declared being employees and stockholders of Takeda.
Source: Mukkada VA et al. Pooled phase 2 and 3 efficacy and safety data on budesonide oral suspension in adolescents with eosinophilic esophagitis. J Pediatr Gastroenterol Nutr. 2023;77(6):760-768 (Sep 18). doi: 10.1097/MPG.0000000000003948
Key clinical point: Budesonide oral suspension (BOS) significantly improved most of the efficacy outcomes in adolescents with eosinophilic esophagitis (EoE) over 12 weeks.
Major finding: At week 12, a significantly higher number of adolescents receiving BOS vs placebo achieved histologic (≤6, ≤1, and <15 eosinophils/high-power field; all P < .001) and clinicopathologic (P = .003) responses. BOS vs placebo led to greater reductions in the EoE histology scoring system grade (P < .001) and total EoE endoscopic reference scores (P = .021). Treatment-emergent adverse events were mild or moderate in severity.
Study details: This post hoc analysis of pooled data from a phase 2 and a phase 3 study included 76 adolescents with EoE (age 11-17 years) who were randomly assigned to receive 2 mg BOS twice daily or placebo.
Disclosures: These studies were funded by Shire ViroPharma, Inc., a Takeda company, and Meritage Pharma, Inc. (now part of Shire). Some authors declared serving as consultants for or receiving research funding, etc., from Meritage, Shire, and others. Four authors declared being employees and stockholders of Takeda.
Source: Mukkada VA et al. Pooled phase 2 and 3 efficacy and safety data on budesonide oral suspension in adolescents with eosinophilic esophagitis. J Pediatr Gastroenterol Nutr. 2023;77(6):760-768 (Sep 18). doi: 10.1097/MPG.0000000000003948
Dupilumab is promising for eosinophilic esophagitis regardless of swallowed topical corticosteroids use
Key clinical point: In adolescents and adults with eosinophilic esophagitis (EoE), 300 mg dupilumab per week was effective and well-tolerated regardless of prior exposure to swallowed topical corticosteroids (STC).
Major finding: At week 24, a significantly higher proportion of patients receiving dupilumab vs placebo with (>50% vs ≤5%; P < .0001) or without (>45% vs ≤25%; P < .05) prior exposure to STC achieved a peak esophageal intraepithelial eosinophil count of ≤6 eosinophils per high-power field, with the improvements being maintained till week 52. No new adverse events were reported.
Study details: This sub-group analysis of the phase 3 LIBERTY EoE TREET study included 321 patients with EoE who were randomly assigned to receive dupilumab or placebo for 24 weeks, after which 304 patients received dupilumab for 28 weeks additionally.
Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Seven authors declared being employees or stockholders of Regeneron Pharmaceuticals or Sanofi. The other authors declared ties with various sources, including Sanofi and Regeneron.
Source: Bredenoord AJ et al. Dupilumab demonstrated efficacy and was well tolerated regardless of prior use of swallowed topical corticosteroids in adolescent and adult patients with eosinophilic oesophagitis: A subgroup analysis of the phase 3 LIBERTY EoE TREET study. Gut. 2023 (Nov 27). doi: 10.1136/gutjnl-2023-330220
Key clinical point: In adolescents and adults with eosinophilic esophagitis (EoE), 300 mg dupilumab per week was effective and well-tolerated regardless of prior exposure to swallowed topical corticosteroids (STC).
Major finding: At week 24, a significantly higher proportion of patients receiving dupilumab vs placebo with (>50% vs ≤5%; P < .0001) or without (>45% vs ≤25%; P < .05) prior exposure to STC achieved a peak esophageal intraepithelial eosinophil count of ≤6 eosinophils per high-power field, with the improvements being maintained till week 52. No new adverse events were reported.
Study details: This sub-group analysis of the phase 3 LIBERTY EoE TREET study included 321 patients with EoE who were randomly assigned to receive dupilumab or placebo for 24 weeks, after which 304 patients received dupilumab for 28 weeks additionally.
Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Seven authors declared being employees or stockholders of Regeneron Pharmaceuticals or Sanofi. The other authors declared ties with various sources, including Sanofi and Regeneron.
Source: Bredenoord AJ et al. Dupilumab demonstrated efficacy and was well tolerated regardless of prior use of swallowed topical corticosteroids in adolescent and adult patients with eosinophilic oesophagitis: A subgroup analysis of the phase 3 LIBERTY EoE TREET study. Gut. 2023 (Nov 27). doi: 10.1136/gutjnl-2023-330220
Key clinical point: In adolescents and adults with eosinophilic esophagitis (EoE), 300 mg dupilumab per week was effective and well-tolerated regardless of prior exposure to swallowed topical corticosteroids (STC).
Major finding: At week 24, a significantly higher proportion of patients receiving dupilumab vs placebo with (>50% vs ≤5%; P < .0001) or without (>45% vs ≤25%; P < .05) prior exposure to STC achieved a peak esophageal intraepithelial eosinophil count of ≤6 eosinophils per high-power field, with the improvements being maintained till week 52. No new adverse events were reported.
Study details: This sub-group analysis of the phase 3 LIBERTY EoE TREET study included 321 patients with EoE who were randomly assigned to receive dupilumab or placebo for 24 weeks, after which 304 patients received dupilumab for 28 weeks additionally.
Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Seven authors declared being employees or stockholders of Regeneron Pharmaceuticals or Sanofi. The other authors declared ties with various sources, including Sanofi and Regeneron.
Source: Bredenoord AJ et al. Dupilumab demonstrated efficacy and was well tolerated regardless of prior use of swallowed topical corticosteroids in adolescent and adult patients with eosinophilic oesophagitis: A subgroup analysis of the phase 3 LIBERTY EoE TREET study. Gut. 2023 (Nov 27). doi: 10.1136/gutjnl-2023-330220
Maternal and infant use of antibiotics and acid-suppressants increases eosinophilic esophagitis risk
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
Fremanezumab benefits migraine patients with inadequate response to prior preventive medications
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
Galcanezumab and rimegepant offer effective options for prevention of episodic 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
Galcanezumab and rimegepant offer effective options for prevention of episodic 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
Comparative efficacy of anti-CGRP mAb in chronic and high-frequency episodic migraine
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
Prior onabotulinumtoxin-A improves subsequent anti-CGRP mAb response in chronic migraine
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
Galcanezumab effective for migraine prevention in women with menstrually related migraine
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