Key clinical point: Real-world data support fremanezumab as an effective, safe, and well-tolerated treatment option in patients with difficult-to-treat migraine and multiple preventive treatment failures.

Major finding: Overall, 83.5% and 62.6% of patients with high-frequency episodic migraine (HFEM) and chronic migraine (CM) receiving fremanezumab achieved ≥50% reduction in monthly headache days (MHD), respectively, along with a significant improvement in mean MHD, MHD with peak headache intensity of ≤5, intake of any abortive medications, migraine-related disability, and quality of life (all P < .001). Only 36 cases of mild adverse events were reported.

Study details: This open-label, single-arm, prospective, multicenter, clinical study included 204 patients with HFEM (n = 97) or CM (n = 107) who received ≥3 monthly courses of fremanezumab.

Disclosures: This study did not receive any funding. Some authors declared receiving investigator fees or travel grants from, or serving as consultants or advisory board members for various sources.

Source: Argyriou AA et al. Efficacy and safety of fremanezumab for migraine prophylaxis in patients with at least three previous preventive failures: Prospective, multicenter, real-world data from a Greek registry. Eur J Neurol. 2023 (Feb 11). Doi: 10.1111/ene.15740

Key clinical point: Real-world data support fremanezumab as an effective, safe, and well-tolerated treatment option in patients with difficult-to-treat migraine and multiple preventive treatment failures.

Major finding: Overall, 83.5% and 62.6% of patients with high-frequency episodic migraine (HFEM) and chronic migraine (CM) receiving fremanezumab achieved ≥50% reduction in monthly headache days (MHD), respectively, along with a significant improvement in mean MHD, MHD with peak headache intensity of ≤5, intake of any abortive medications, migraine-related disability, and quality of life (all P < .001). Only 36 cases of mild adverse events were reported.

Study details: This open-label, single-arm, prospective, multicenter, clinical study included 204 patients with HFEM (n = 97) or CM (n = 107) who received ≥3 monthly courses of fremanezumab.

Disclosures: This study did not receive any funding. Some authors declared receiving investigator fees or travel grants from, or serving as consultants or advisory board members for various sources.

Source: Argyriou AA et al. Efficacy and safety of fremanezumab for migraine prophylaxis in patients with at least three previous preventive failures: Prospective, multicenter, real-world data from a Greek registry. Eur J Neurol. 2023 (Feb 11). Doi: 10.1111/ene.15740

Key clinical point: Real-world data support fremanezumab as an effective, safe, and well-tolerated treatment option in patients with difficult-to-treat migraine and multiple preventive treatment failures.

Major finding: Overall, 83.5% and 62.6% of patients with high-frequency episodic migraine (HFEM) and chronic migraine (CM) receiving fremanezumab achieved ≥50% reduction in monthly headache days (MHD), respectively, along with a significant improvement in mean MHD, MHD with peak headache intensity of ≤5, intake of any abortive medications, migraine-related disability, and quality of life (all P < .001). Only 36 cases of mild adverse events were reported.

Study details: This open-label, single-arm, prospective, multicenter, clinical study included 204 patients with HFEM (n = 97) or CM (n = 107) who received ≥3 monthly courses of fremanezumab.

Disclosures: This study did not receive any funding. Some authors declared receiving investigator fees or travel grants from, or serving as consultants or advisory board members for various sources.

Source: Argyriou AA et al. Efficacy and safety of fremanezumab for migraine prophylaxis in patients with at least three previous preventive failures: Prospective, multicenter, real-world data from a Greek registry. Eur J Neurol. 2023 (Feb 11). Doi: 10.1111/ene.15740

Key clinical point: Clinical characteristics differed significantly among patients with migraine who experienced ≥75% (super-responders [SR]) vs ≤25% (non-responders [NR]) reduction in monthly headache days in the third month after initiating prophylactic treatment with calcitonin gene-related peptide receptor (CGRP-R) monoclonal antibodies (mAb).

Major finding: SR vs NR were more likely to report vomiting (P = .031) and a significant improvement in acute migraine headache with triptan treatment (P = .010). However, NR vs SR experienced chronic migraine (P = .001), medication overuse headache (P = .024), and concomitant depression (P = .005) more frequently.

Study details: This was a retrospective real-world study including 260 patients with migraine who received ≥1 treatment with CGRP-R mAbs for migraine prevention, of which 29 and 26 were SR and NR, respectively.

Disclosures: This study did not report the source of funding. Four authors declared receiving research grants, personal fees, or honoraria for consulting and lectures from various sources.

Source: Raffaelli B et al. Clinical evaluation of super-responders vs non-responders to CGRP(-receptor) monoclonal antibodies: A real-world experience. J Headache Pain. 2023;24(1):16 (Feb 27). Doi: 10.1186/s10194-023-01552-x

Key clinical point: Clinical characteristics differed significantly among patients with migraine who experienced ≥75% (super-responders [SR]) vs ≤25% (non-responders [NR]) reduction in monthly headache days in the third month after initiating prophylactic treatment with calcitonin gene-related peptide receptor (CGRP-R) monoclonal antibodies (mAb).

Major finding: SR vs NR were more likely to report vomiting (P = .031) and a significant improvement in acute migraine headache with triptan treatment (P = .010). However, NR vs SR experienced chronic migraine (P = .001), medication overuse headache (P = .024), and concomitant depression (P = .005) more frequently.

Study details: This was a retrospective real-world study including 260 patients with migraine who received ≥1 treatment with CGRP-R mAbs for migraine prevention, of which 29 and 26 were SR and NR, respectively.

Disclosures: This study did not report the source of funding. Four authors declared receiving research grants, personal fees, or honoraria for consulting and lectures from various sources.

Source: Raffaelli B et al. Clinical evaluation of super-responders vs non-responders to CGRP(-receptor) monoclonal antibodies: A real-world experience. J Headache Pain. 2023;24(1):16 (Feb 27). Doi: 10.1186/s10194-023-01552-x

Key clinical point: Clinical characteristics differed significantly among patients with migraine who experienced ≥75% (super-responders [SR]) vs ≤25% (non-responders [NR]) reduction in monthly headache days in the third month after initiating prophylactic treatment with calcitonin gene-related peptide receptor (CGRP-R) monoclonal antibodies (mAb).

Major finding: SR vs NR were more likely to report vomiting (P = .031) and a significant improvement in acute migraine headache with triptan treatment (P = .010). However, NR vs SR experienced chronic migraine (P = .001), medication overuse headache (P = .024), and concomitant depression (P = .005) more frequently.

Study details: This was a retrospective real-world study including 260 patients with migraine who received ≥1 treatment with CGRP-R mAbs for migraine prevention, of which 29 and 26 were SR and NR, respectively.

Disclosures: This study did not report the source of funding. Four authors declared receiving research grants, personal fees, or honoraria for consulting and lectures from various sources.

Source: Raffaelli B et al. Clinical evaluation of super-responders vs non-responders to CGRP(-receptor) monoclonal antibodies: A real-world experience. J Headache Pain. 2023;24(1):16 (Feb 27). Doi: 10.1186/s10194-023-01552-x

Key clinical point: Patients with traumatic brain injury (TBI) were at a significantly higher risk for subsequent migraine, with the risk being even higher among patients with TBI who were hospitalized and those who had a major trauma.

Major finding: The risk for migraine was significantly higher among patients with vs without TBI (adjusted hazard ratio [aHR] 1.484), with migraine incidence being higher after major vs minor trauma (aHR 1.670) and among hospitalized patients vs patients visiting the outpatient department (aHR 1.557; all P < .001).

Study details: This retrospective cohort study included 151,098 patients with newly diagnosed TBI and 604,394 propensity score-matched patients without TBI.

Disclosures: This study was supported by the National Science and Technology Council of the Republic of China, Cardinal Tien Hospital, and Tri-Service General Hospital Research Foundation. The authors declared no conflicts of interest.

Source: Chen MH et al. Risk of migraine after traumatic brain injury and effects of injury management levels and treatment modalities: A nationwide population-based cohort study in Taiwan. J Clin Med. 2023;12(4):1530 (Feb 15). Doi: 10.3390/jcm12041530

Key clinical point: Patients with traumatic brain injury (TBI) were at a significantly higher risk for subsequent migraine, with the risk being even higher among patients with TBI who were hospitalized and those who had a major trauma.

Major finding: The risk for migraine was significantly higher among patients with vs without TBI (adjusted hazard ratio [aHR] 1.484), with migraine incidence being higher after major vs minor trauma (aHR 1.670) and among hospitalized patients vs patients visiting the outpatient department (aHR 1.557; all P < .001).

Study details: This retrospective cohort study included 151,098 patients with newly diagnosed TBI and 604,394 propensity score-matched patients without TBI.

Disclosures: This study was supported by the National Science and Technology Council of the Republic of China, Cardinal Tien Hospital, and Tri-Service General Hospital Research Foundation. The authors declared no conflicts of interest.

Source: Chen MH et al. Risk of migraine after traumatic brain injury and effects of injury management levels and treatment modalities: A nationwide population-based cohort study in Taiwan. J Clin Med. 2023;12(4):1530 (Feb 15). Doi: 10.3390/jcm12041530

Key clinical point: Patients with traumatic brain injury (TBI) were at a significantly higher risk for subsequent migraine, with the risk being even higher among patients with TBI who were hospitalized and those who had a major trauma.

Major finding: The risk for migraine was significantly higher among patients with vs without TBI (adjusted hazard ratio [aHR] 1.484), with migraine incidence being higher after major vs minor trauma (aHR 1.670) and among hospitalized patients vs patients visiting the outpatient department (aHR 1.557; all P < .001).

Study details: This retrospective cohort study included 151,098 patients with newly diagnosed TBI and 604,394 propensity score-matched patients without TBI.

Disclosures: This study was supported by the National Science and Technology Council of the Republic of China, Cardinal Tien Hospital, and Tri-Service General Hospital Research Foundation. The authors declared no conflicts of interest.

Source: Chen MH et al. Risk of migraine after traumatic brain injury and effects of injury management levels and treatment modalities: A nationwide population-based cohort study in Taiwan. J Clin Med. 2023;12(4):1530 (Feb 15). Doi: 10.3390/jcm12041530

Key clinical point: Patients with benign paroxysmal positional vertigo (BPPV) are at a higher risk for migraine diagnosis, with female sex, hyperlipidemia, and anxiety being significant risk factors for migraine among patients with BPPV.

Major finding: In 11 years of follow-up, 1.35% vs 0.41% of participants with vs without BPPV had migraine, respectively. The risk for migraine was 2.96-fold higher among those with BPPV (adjusted hazard ratio [aHR] 2.96; 95% CI 2.30-3.80; P < .001) and significantly higher among women (aHR 2.91; 95% CI 2.30-3.80), those with hyperlipidemia (aHR 1.77; 95% CI 1.16-2.70), and those with anxiety (aHR 1.49; 95% CI 1.03-2.14).

Study details: Findings are from a retrospective cohort study including 1386 patients with BPPV and 5544 age- and sex-matched control individuals without a history of BPPV or migraine.

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

Source: Shih I-A et al. Benign paroxysmal positional vertigo is associated with an increased risk for migraine diagnosis: A nationwide population-based cohort study. Int J Environ Res Public Health. 2023;20(4):3563 (Feb 17). Doi: 10.3390/ijerph20043563

Key clinical point: Patients with benign paroxysmal positional vertigo (BPPV) are at a higher risk for migraine diagnosis, with female sex, hyperlipidemia, and anxiety being significant risk factors for migraine among patients with BPPV.

Major finding: In 11 years of follow-up, 1.35% vs 0.41% of participants with vs without BPPV had migraine, respectively. The risk for migraine was 2.96-fold higher among those with BPPV (adjusted hazard ratio [aHR] 2.96; 95% CI 2.30-3.80; P < .001) and significantly higher among women (aHR 2.91; 95% CI 2.30-3.80), those with hyperlipidemia (aHR 1.77; 95% CI 1.16-2.70), and those with anxiety (aHR 1.49; 95% CI 1.03-2.14).

Study details: Findings are from a retrospective cohort study including 1386 patients with BPPV and 5544 age- and sex-matched control individuals without a history of BPPV or migraine.

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

Source: Shih I-A et al. Benign paroxysmal positional vertigo is associated with an increased risk for migraine diagnosis: A nationwide population-based cohort study. Int J Environ Res Public Health. 2023;20(4):3563 (Feb 17). Doi: 10.3390/ijerph20043563

Key clinical point: Patients with benign paroxysmal positional vertigo (BPPV) are at a higher risk for migraine diagnosis, with female sex, hyperlipidemia, and anxiety being significant risk factors for migraine among patients with BPPV.

Major finding: In 11 years of follow-up, 1.35% vs 0.41% of participants with vs without BPPV had migraine, respectively. The risk for migraine was 2.96-fold higher among those with BPPV (adjusted hazard ratio [aHR] 2.96; 95% CI 2.30-3.80; P < .001) and significantly higher among women (aHR 2.91; 95% CI 2.30-3.80), those with hyperlipidemia (aHR 1.77; 95% CI 1.16-2.70), and those with anxiety (aHR 1.49; 95% CI 1.03-2.14).

Study details: Findings are from a retrospective cohort study including 1386 patients with BPPV and 5544 age- and sex-matched control individuals without a history of BPPV or migraine.

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

Source: Shih I-A et al. Benign paroxysmal positional vertigo is associated with an increased risk for migraine diagnosis: A nationwide population-based cohort study. Int J Environ Res Public Health. 2023;20(4):3563 (Feb 17). Doi: 10.3390/ijerph20043563

Key clinical point: About two-thirds of patients with chronic migraine (CM) showed response to galcanezumab, and everyday headache, presence of depression, and absence of accompanying symptoms were independent predictors of a poor response to galcanezumab treatment.

Major finding: After 3 months, 64.3% of patients receiving galcanezumab achieved ≥50% reduction in monthly migraine days, with everyday headache (odds ratio [OR] 0.351; P = .017), presence of depression (OR 0.439; P = .024), and absence of accompanying symptoms (OR 0.314; P = .020) being significant predictors of response to galcanezumab.

Study details: The data come from a real-world, prospective observational study including 238 patients aged ≥18 years with CM who received preventive treatment with galcanezumab injections for 3 months.

Disclosures: This study did not report the source of funding. BK Kim declared receiving honoraria and personal fees, serving on advisory boards, and being a principal investigator of trials sponsored by various sources.

Source: Lee HC et al. Predictors of response to galcanezumab in patients with chronic migraine: A real-world prospective observational study. Neurol Sci. 2023 (Feb 24). Doi: 10.1007/s10072-023-06683-2.

Key clinical point: About two-thirds of patients with chronic migraine (CM) showed response to galcanezumab, and everyday headache, presence of depression, and absence of accompanying symptoms were independent predictors of a poor response to galcanezumab treatment.

Major finding: After 3 months, 64.3% of patients receiving galcanezumab achieved ≥50% reduction in monthly migraine days, with everyday headache (odds ratio [OR] 0.351; P = .017), presence of depression (OR 0.439; P = .024), and absence of accompanying symptoms (OR 0.314; P = .020) being significant predictors of response to galcanezumab.

Study details: The data come from a real-world, prospective observational study including 238 patients aged ≥18 years with CM who received preventive treatment with galcanezumab injections for 3 months.

Disclosures: This study did not report the source of funding. BK Kim declared receiving honoraria and personal fees, serving on advisory boards, and being a principal investigator of trials sponsored by various sources.

Source: Lee HC et al. Predictors of response to galcanezumab in patients with chronic migraine: A real-world prospective observational study. Neurol Sci. 2023 (Feb 24). Doi: 10.1007/s10072-023-06683-2.

Key clinical point: About two-thirds of patients with chronic migraine (CM) showed response to galcanezumab, and everyday headache, presence of depression, and absence of accompanying symptoms were independent predictors of a poor response to galcanezumab treatment.

Major finding: After 3 months, 64.3% of patients receiving galcanezumab achieved ≥50% reduction in monthly migraine days, with everyday headache (odds ratio [OR] 0.351; P = .017), presence of depression (OR 0.439; P = .024), and absence of accompanying symptoms (OR 0.314; P = .020) being significant predictors of response to galcanezumab.

Study details: The data come from a real-world, prospective observational study including 238 patients aged ≥18 years with CM who received preventive treatment with galcanezumab injections for 3 months.

Disclosures: This study did not report the source of funding. BK Kim declared receiving honoraria and personal fees, serving on advisory boards, and being a principal investigator of trials sponsored by various sources.

Source: Lee HC et al. Predictors of response to galcanezumab in patients with chronic migraine: A real-world prospective observational study. Neurol Sci. 2023 (Feb 24). Doi: 10.1007/s10072-023-06683-2.

Key clinical point: Galcanezumab significantly reduced interictal burden, as measured by the 4-item Migraine Interictal Burden Scale (MIBS-4), in patients with episodic or chronic migraine and multiple prior migraine preventive treatment failures.

Major finding: At 3 months, the mean MIBS-4 score reduced significantly with galcanezumab vs placebo in the overall population (least-squares mean change [Δ] −1.9 vs −0.8; P < .0001) and in patients with episodic (Δ −1.8 vs −1.1; P = .033) and chronic (Δ −1.8 vs −0.3; P < .001) migraine.

Study details: This was a post hoc analysis of the CONQUER study including 462 patients with chronic or episodic migraine and multiple prior migraine preventive treatment failures who were randomly assigned to receive galcanezumab or placebo.

Disclosures: This study was funded by Eli Lilly and Company. Some authors declared receiving research funding or support from various pharmaceutical sources, including Eli Lilly and Company. Some others declared being employees and minor stockholders of Eli Lilly and Company.

Source: Lipton RB et al. Changes in migraine interictal burden following treatment with galcanezumab: Results from a phase III randomized, placebo-controlled study. Headache. 2023 (Feb 16). Doi: 10.1111/head.14460

Key clinical point: Galcanezumab significantly reduced interictal burden, as measured by the 4-item Migraine Interictal Burden Scale (MIBS-4), in patients with episodic or chronic migraine and multiple prior migraine preventive treatment failures.

Major finding: At 3 months, the mean MIBS-4 score reduced significantly with galcanezumab vs placebo in the overall population (least-squares mean change [Δ] −1.9 vs −0.8; P < .0001) and in patients with episodic (Δ −1.8 vs −1.1; P = .033) and chronic (Δ −1.8 vs −0.3; P < .001) migraine.

Study details: This was a post hoc analysis of the CONQUER study including 462 patients with chronic or episodic migraine and multiple prior migraine preventive treatment failures who were randomly assigned to receive galcanezumab or placebo.

Disclosures: This study was funded by Eli Lilly and Company. Some authors declared receiving research funding or support from various pharmaceutical sources, including Eli Lilly and Company. Some others declared being employees and minor stockholders of Eli Lilly and Company.

Source: Lipton RB et al. Changes in migraine interictal burden following treatment with galcanezumab: Results from a phase III randomized, placebo-controlled study. Headache. 2023 (Feb 16). Doi: 10.1111/head.14460

Key clinical point: Galcanezumab significantly reduced interictal burden, as measured by the 4-item Migraine Interictal Burden Scale (MIBS-4), in patients with episodic or chronic migraine and multiple prior migraine preventive treatment failures.

Major finding: At 3 months, the mean MIBS-4 score reduced significantly with galcanezumab vs placebo in the overall population (least-squares mean change [Δ] −1.9 vs −0.8; P < .0001) and in patients with episodic (Δ −1.8 vs −1.1; P = .033) and chronic (Δ −1.8 vs −0.3; P < .001) migraine.

Study details: This was a post hoc analysis of the CONQUER study including 462 patients with chronic or episodic migraine and multiple prior migraine preventive treatment failures who were randomly assigned to receive galcanezumab or placebo.

Disclosures: This study was funded by Eli Lilly and Company. Some authors declared receiving research funding or support from various pharmaceutical sources, including Eli Lilly and Company. Some others declared being employees and minor stockholders of Eli Lilly and Company.

Source: Lipton RB et al. Changes in migraine interictal burden following treatment with galcanezumab: Results from a phase III randomized, placebo-controlled study. Headache. 2023 (Feb 16). Doi: 10.1111/head.14460

Key clinical point: Network meta-analysis confirms the overall safety of anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies and gepants for migraine prevention, with rare instances of treatment discontinuation.

Major finding: The risk for serious adverse events was not significantly different with active treatments and placebo, with 30 mg eptinezumab being the only treatment significantly associated with higher odds of adverse events leading to treatment discontinuation (odds ratio [OR] 2.62; 95% CI 1.03-6.66). Compared with placebo, the risk for treatment-emergent adverse events was not significantly different with 30 mg and 100 mg eptinezumab and was the highest with 240 mg galcanezumab (OR 1.63; 95% CI 1.33-2.00) and 120 mg galcanezumab (OR 1.40; 95% CI 1.16-1.70), with the most frequent being injection site erythema, induration, and pruritus.

Study details: The data come from a network meta-analysis of 19 phase 3 randomized controlled trials including 14,584 patients with migraine.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Messina R et al. Safety and tolerability of monoclonal antibodies targeting the CGRP pathway and gepants in migraine prevention: A systematic review and network meta-analysis. Cephalalgia. 2023;43(3):3331024231152169 (Feb 14). Doi: 10.1177/03331024231152169

Key clinical point: Network meta-analysis confirms the overall safety of anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies and gepants for migraine prevention, with rare instances of treatment discontinuation.

Major finding: The risk for serious adverse events was not significantly different with active treatments and placebo, with 30 mg eptinezumab being the only treatment significantly associated with higher odds of adverse events leading to treatment discontinuation (odds ratio [OR] 2.62; 95% CI 1.03-6.66). Compared with placebo, the risk for treatment-emergent adverse events was not significantly different with 30 mg and 100 mg eptinezumab and was the highest with 240 mg galcanezumab (OR 1.63; 95% CI 1.33-2.00) and 120 mg galcanezumab (OR 1.40; 95% CI 1.16-1.70), with the most frequent being injection site erythema, induration, and pruritus.

Study details: The data come from a network meta-analysis of 19 phase 3 randomized controlled trials including 14,584 patients with migraine.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Messina R et al. Safety and tolerability of monoclonal antibodies targeting the CGRP pathway and gepants in migraine prevention: A systematic review and network meta-analysis. Cephalalgia. 2023;43(3):3331024231152169 (Feb 14). Doi: 10.1177/03331024231152169

Key clinical point: Network meta-analysis confirms the overall safety of anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies and gepants for migraine prevention, with rare instances of treatment discontinuation.

Major finding: The risk for serious adverse events was not significantly different with active treatments and placebo, with 30 mg eptinezumab being the only treatment significantly associated with higher odds of adverse events leading to treatment discontinuation (odds ratio [OR] 2.62; 95% CI 1.03-6.66). Compared with placebo, the risk for treatment-emergent adverse events was not significantly different with 30 mg and 100 mg eptinezumab and was the highest with 240 mg galcanezumab (OR 1.63; 95% CI 1.33-2.00) and 120 mg galcanezumab (OR 1.40; 95% CI 1.16-1.70), with the most frequent being injection site erythema, induration, and pruritus.

Study details: The data come from a network meta-analysis of 19 phase 3 randomized controlled trials including 14,584 patients with migraine.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Messina R et al. Safety and tolerability of monoclonal antibodies targeting the CGRP pathway and gepants in migraine prevention: A systematic review and network meta-analysis. Cephalalgia. 2023;43(3):3331024231152169 (Feb 14). Doi: 10.1177/03331024231152169

It’s estimated that half of all people in the world are infected with Helicobacter pylori, a bacterium associated with increased risk for gastric ulcers and gastric cancer.

However, only a small percentage of people with H. pylori infection will go on to develop gastric cancer.

Now a team from Japan reports that specific mutations in genes associated with DNA repair, when combined with the common bacterial infection H. pylori, appear to significantly increase the risk for gastric cancer.

The new findings imply that the hereditary contribution to the risk of gastric cancer is more important than previously believed, say editorialists commenting on the study.

The article and accompanying editorial were published in The New England Journal of Medicine.

For this study, Yoshiaki Usui, MD, PhD, of the RIKEN Center for Integrative Medical Sciences in Yokohama, Japan, and colleagues analyzed samples from 10,426 patients with gastric cancer as well as 38,153 control samples from a Japanese biobank.

First, they looked at the association between gastric cancer and germline pathogenic variants in 27 genes known to predispose carriers to cancers.

They also looked at the combined effects of pathogenic variants and H. pylori infection and calculated the cumulative risk among 1,433 patients with gastric cancer and 5,997 control samples from a cancer-center research database.

They found that germline pathogenic variants in nine genes were associated with the risk for gastric cancer. The genes were APC, ATM, BRCA1, BRCA2, CDH1, MLH1, MSH2, MSH6, and PALB2.

The pathogenic germline (inherited) variants in these nine genes were associated with homologous recombination, which involves an exchange of nucleotide sequences between two similar or identical DNA molecules that occurs during meiosis and during repair of double-strand DNA breaks.

The investigators calculated that the cumulative risk for gastric cancer at age 85 among carriers of the variants who were infected with H. pylori was 45.5%, compared with 14.4% for control persons who were infected but were not carriers of the germline pathogenic variants.

The risk for gastric cancer was less than 5% among those without H. pylori infections, regardless of their carrier status.

“Our results suggest that in persons known to carry a pathogenic variant in a homologous-recombination gene, evaluation and eradication of H. pylori infection may be particularly important,” Dr. Usui and colleagues wrote.

“It is remarkable that pathogenic variants in homologous-recombination genes drive tumorigenesis only in the context of H. pylori infection,” Anne Müller, PhD, and Jiazhuo He, MD, of the University of Zürich, wrote in the accompanying editorial.

“This observation has numerous implications, not only for the diagnosis, prevention, and possibly treatment of the fraction of cases of gastric cancer with pathogenic gene variants that arise due to H. pylori infection but also for a better understanding of the biology of other cancers arising on a background of homologous-recombination deficiency. It is quite conceivable that other DNA-damaging environmental factors contributing to human carcinogenesis have been overlooked.” they wrote.

The study was supported by grants from the Japan Agency for Medical Research and Development; the Ministry of Education, Science, Sports, Culture, and Technology of Japan; the Ministry of Health, Labor, and Welfare of Japan; and the Australian National Health and Medical Research Council. Dr. Usui, Dr. Müller, and Dr. He have disclosed no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

It’s estimated that half of all people in the world are infected with Helicobacter pylori, a bacterium associated with increased risk for gastric ulcers and gastric cancer.

However, only a small percentage of people with H. pylori infection will go on to develop gastric cancer.

Now a team from Japan reports that specific mutations in genes associated with DNA repair, when combined with the common bacterial infection H. pylori, appear to significantly increase the risk for gastric cancer.

The new findings imply that the hereditary contribution to the risk of gastric cancer is more important than previously believed, say editorialists commenting on the study.

The article and accompanying editorial were published in The New England Journal of Medicine.

For this study, Yoshiaki Usui, MD, PhD, of the RIKEN Center for Integrative Medical Sciences in Yokohama, Japan, and colleagues analyzed samples from 10,426 patients with gastric cancer as well as 38,153 control samples from a Japanese biobank.

First, they looked at the association between gastric cancer and germline pathogenic variants in 27 genes known to predispose carriers to cancers.

They also looked at the combined effects of pathogenic variants and H. pylori infection and calculated the cumulative risk among 1,433 patients with gastric cancer and 5,997 control samples from a cancer-center research database.

They found that germline pathogenic variants in nine genes were associated with the risk for gastric cancer. The genes were APC, ATM, BRCA1, BRCA2, CDH1, MLH1, MSH2, MSH6, and PALB2.

The pathogenic germline (inherited) variants in these nine genes were associated with homologous recombination, which involves an exchange of nucleotide sequences between two similar or identical DNA molecules that occurs during meiosis and during repair of double-strand DNA breaks.

The investigators calculated that the cumulative risk for gastric cancer at age 85 among carriers of the variants who were infected with H. pylori was 45.5%, compared with 14.4% for control persons who were infected but were not carriers of the germline pathogenic variants.

The risk for gastric cancer was less than 5% among those without H. pylori infections, regardless of their carrier status.

“Our results suggest that in persons known to carry a pathogenic variant in a homologous-recombination gene, evaluation and eradication of H. pylori infection may be particularly important,” Dr. Usui and colleagues wrote.

“It is remarkable that pathogenic variants in homologous-recombination genes drive tumorigenesis only in the context of H. pylori infection,” Anne Müller, PhD, and Jiazhuo He, MD, of the University of Zürich, wrote in the accompanying editorial.

“This observation has numerous implications, not only for the diagnosis, prevention, and possibly treatment of the fraction of cases of gastric cancer with pathogenic gene variants that arise due to H. pylori infection but also for a better understanding of the biology of other cancers arising on a background of homologous-recombination deficiency. It is quite conceivable that other DNA-damaging environmental factors contributing to human carcinogenesis have been overlooked.” they wrote.

The study was supported by grants from the Japan Agency for Medical Research and Development; the Ministry of Education, Science, Sports, Culture, and Technology of Japan; the Ministry of Health, Labor, and Welfare of Japan; and the Australian National Health and Medical Research Council. Dr. Usui, Dr. Müller, and Dr. He have disclosed no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

It’s estimated that half of all people in the world are infected with Helicobacter pylori, a bacterium associated with increased risk for gastric ulcers and gastric cancer.

However, only a small percentage of people with H. pylori infection will go on to develop gastric cancer.

Now a team from Japan reports that specific mutations in genes associated with DNA repair, when combined with the common bacterial infection H. pylori, appear to significantly increase the risk for gastric cancer.

The new findings imply that the hereditary contribution to the risk of gastric cancer is more important than previously believed, say editorialists commenting on the study.

The article and accompanying editorial were published in The New England Journal of Medicine.

For this study, Yoshiaki Usui, MD, PhD, of the RIKEN Center for Integrative Medical Sciences in Yokohama, Japan, and colleagues analyzed samples from 10,426 patients with gastric cancer as well as 38,153 control samples from a Japanese biobank.

First, they looked at the association between gastric cancer and germline pathogenic variants in 27 genes known to predispose carriers to cancers.

They also looked at the combined effects of pathogenic variants and H. pylori infection and calculated the cumulative risk among 1,433 patients with gastric cancer and 5,997 control samples from a cancer-center research database.

They found that germline pathogenic variants in nine genes were associated with the risk for gastric cancer. The genes were APC, ATM, BRCA1, BRCA2, CDH1, MLH1, MSH2, MSH6, and PALB2.

The pathogenic germline (inherited) variants in these nine genes were associated with homologous recombination, which involves an exchange of nucleotide sequences between two similar or identical DNA molecules that occurs during meiosis and during repair of double-strand DNA breaks.

The investigators calculated that the cumulative risk for gastric cancer at age 85 among carriers of the variants who were infected with H. pylori was 45.5%, compared with 14.4% for control persons who were infected but were not carriers of the germline pathogenic variants.

The risk for gastric cancer was less than 5% among those without H. pylori infections, regardless of their carrier status.

“Our results suggest that in persons known to carry a pathogenic variant in a homologous-recombination gene, evaluation and eradication of H. pylori infection may be particularly important,” Dr. Usui and colleagues wrote.

“It is remarkable that pathogenic variants in homologous-recombination genes drive tumorigenesis only in the context of H. pylori infection,” Anne Müller, PhD, and Jiazhuo He, MD, of the University of Zürich, wrote in the accompanying editorial.

“This observation has numerous implications, not only for the diagnosis, prevention, and possibly treatment of the fraction of cases of gastric cancer with pathogenic gene variants that arise due to H. pylori infection but also for a better understanding of the biology of other cancers arising on a background of homologous-recombination deficiency. It is quite conceivable that other DNA-damaging environmental factors contributing to human carcinogenesis have been overlooked.” they wrote.

The study was supported by grants from the Japan Agency for Medical Research and Development; the Ministry of Education, Science, Sports, Culture, and Technology of Japan; the Ministry of Health, Labor, and Welfare of Japan; and the Australian National Health and Medical Research Council. Dr. Usui, Dr. Müller, and Dr. He have disclosed no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

Key clinical point: Zavegepant nasal spray was effective in the acute treatment of migraine, with favorable tolerability and safety profiles.

Major finding: At 2 hours post-dose, higher proportions of patients treated with zavegepant vs placebo were free from pain (risk difference 8.8 percentage points; P < .0001) and from their most bothersome symptom (risk difference 8.7 percentage points; P = .0012). Dysgeusia (21% vs 5%), nasal discomfort (4% vs 1%), and nausea (3% vs 1%) were the most common adverse events in the zavegepant vs placebo group.

Study details: Findings are from a phase 3 trial including 1405 patients with ≥1-year history of migraine with or without aura who were randomly assigned to receive zavegepant 10 mg nasal spray (n = 703) or matching placebo (n = 702).

Disclosures: This study was funded by Biohaven Pharmaceuticals. Some authors declared being employees of and holding stocks or stock options in Biohaven Pharmaceuticals. Some others declared ties with various sources, including Biohaven Pharmaceuticals.

Source: Lipton RB et al. Safety, tolerability, and efficacy of zavegepant 10 mg nasal spray for the acute treatment of migraine in the USA: A phase 3, double-blind, randomised, placebo-controlled multicentre trial. Lancet Neurol. 2023;22(3):209-217 (Mar). Doi: 10.1016/S1474-4422(22)00517-8

Key clinical point: Zavegepant nasal spray was effective in the acute treatment of migraine, with favorable tolerability and safety profiles.

Major finding: At 2 hours post-dose, higher proportions of patients treated with zavegepant vs placebo were free from pain (risk difference 8.8 percentage points; P < .0001) and from their most bothersome symptom (risk difference 8.7 percentage points; P = .0012). Dysgeusia (21% vs 5%), nasal discomfort (4% vs 1%), and nausea (3% vs 1%) were the most common adverse events in the zavegepant vs placebo group.

Study details: Findings are from a phase 3 trial including 1405 patients with ≥1-year history of migraine with or without aura who were randomly assigned to receive zavegepant 10 mg nasal spray (n = 703) or matching placebo (n = 702).

Disclosures: This study was funded by Biohaven Pharmaceuticals. Some authors declared being employees of and holding stocks or stock options in Biohaven Pharmaceuticals. Some others declared ties with various sources, including Biohaven Pharmaceuticals.

Source: Lipton RB et al. Safety, tolerability, and efficacy of zavegepant 10 mg nasal spray for the acute treatment of migraine in the USA: A phase 3, double-blind, randomised, placebo-controlled multicentre trial. Lancet Neurol. 2023;22(3):209-217 (Mar). Doi: 10.1016/S1474-4422(22)00517-8

Key clinical point: Zavegepant nasal spray was effective in the acute treatment of migraine, with favorable tolerability and safety profiles.

Major finding: At 2 hours post-dose, higher proportions of patients treated with zavegepant vs placebo were free from pain (risk difference 8.8 percentage points; P < .0001) and from their most bothersome symptom (risk difference 8.7 percentage points; P = .0012). Dysgeusia (21% vs 5%), nasal discomfort (4% vs 1%), and nausea (3% vs 1%) were the most common adverse events in the zavegepant vs placebo group.

Study details: Findings are from a phase 3 trial including 1405 patients with ≥1-year history of migraine with or without aura who were randomly assigned to receive zavegepant 10 mg nasal spray (n = 703) or matching placebo (n = 702).

Disclosures: This study was funded by Biohaven Pharmaceuticals. Some authors declared being employees of and holding stocks or stock options in Biohaven Pharmaceuticals. Some others declared ties with various sources, including Biohaven Pharmaceuticals.

Source: Lipton RB et al. Safety, tolerability, and efficacy of zavegepant 10 mg nasal spray for the acute treatment of migraine in the USA: A phase 3, double-blind, randomised, placebo-controlled multicentre trial. Lancet Neurol. 2023;22(3):209-217 (Mar). Doi: 10.1016/S1474-4422(22)00517-8

Vaginal swabs are more effective than urine analysis in detecting certain types of sexually transmitted infections, researchers have found.

In the study, which was published online in the Annals of Family Medicine, investigators found that the diagnostic sensitivity of commercially available vaginal swabs was significantly greater than that of urine tests in detecting certain infections, including those caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.

Researchers studied chlamydia and gonorrhea, which are two of the most frequently reported STIs in the United States. Trichomoniasis is the most curable nonviral STI globally, with 156 million cases worldwide in 2016.

The Centers for Disease Control and Prevention has long recommended that vaginal swabs be used to produce optimal samples.

But despite the CDC’s recommendation, urine analysis for these STIs is more commonly used than vaginal swabs among U.S. health care providers.

“We’re using a poor sample type, and we can do better,” said Barbara Van Der Pol, PhD, a professor of medicine and public health at the University of Alabama at Birmingham and an author of the new study, a meta-analysis of 97 studies published between 1995 and 2021.

Vaginal swabs for chlamydia trachomatis had a diagnostic sensitivity of 94.1% (95% confidence interval, 93.2%-94.9%; P < .001), higher than urine testing (86.9%; 95% CI, 85.6%-88.0%; P < .001). The pooled sensitivity estimates for Neisseria gonorrhoeae were 96.5% (95% CI, 94.8%-97.7%; P < .001) for vaginal swabs and 90.7% (95% CI, 88.4%-92.5%; P < .001) for urine specimens.

The difference in pooled sensitivity estimates between vaginal swabs and urine analyses for Trichomonas vaginalis was 98% (95% CI, 97.0%-98.7%; P < .001) for vaginal swabs and 95.1% (95% CI, 93.6%-96.3%) for urine specimens.

STIs included in the study are not typically found in the urethra and appear in urine analyses only if cervical or vaginal cells have dripped into a urine sample. Dr. Van Der Pol and her colleagues estimated that the use of urine samples rather than vaginal swabs may result in more than 400,000 undiagnosed infections annually.

Undiagnosed and untreated STIs can lead to transmissions of the infection as well as infertility and can have negative effects on romantic relationships, according to Dr. Van Der Pol.

Sarah Wood, MD, an attending physician at Children’s Hospital of Philadelphia, said some health care providers may use urine analysis because patients may be more comfortable with this method. The approach also can be more convenient for medical offices: All they must do is hand a specimen container to the patient.

Conversations between clinicians and patients about vaginal swabbing may be considered “sensitive” and the swabbing more invasive, Dr. Wood, an author of an editorial accompanying the journal article, said. Clinicians may also lack awareness that the swab is a more sensitive method of detecting these STIs.

“We all want to do what’s right for our patient, but we often don’t know what’s right for the patient,” Dr. Wood said. “I don’t think people are really aware of a potential real difference in outcomes with one method over the other.”

Dr. Wood advised making STI screening using vaginal swabs more common by “offering universal opt-out screening, so not waiting until you find out if someone’s having sex but just sort of saying, ‘Hey, across our practice, we screen everybody for chlamydia. Is that something that you want to do today?’ That approach sort of takes out the piece of talking about sex, talking about sexual activity.”

Dr. Van Der Pol, who said she has worked in STI diagnostics for 40 years, said she was not surprised by the results and hopes the study changes how samples are collected and used.

“I really hope that it influences practice so that we really start using vaginal swabs, because it gives us better diagnostics for chlamydia and gonorrhea,” Dr. Van Der Pol said.

“Also, then starting to think about comprehensive women’s care in such a way that they actually order other tests on that same sample if a woman is presenting with complaints.”

A version of this article originally appeared on Medscape.com.

Vaginal swabs are more effective than urine analysis in detecting certain types of sexually transmitted infections, researchers have found.

In the study, which was published online in the Annals of Family Medicine, investigators found that the diagnostic sensitivity of commercially available vaginal swabs was significantly greater than that of urine tests in detecting certain infections, including those caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.

Researchers studied chlamydia and gonorrhea, which are two of the most frequently reported STIs in the United States. Trichomoniasis is the most curable nonviral STI globally, with 156 million cases worldwide in 2016.

The Centers for Disease Control and Prevention has long recommended that vaginal swabs be used to produce optimal samples.

But despite the CDC’s recommendation, urine analysis for these STIs is more commonly used than vaginal swabs among U.S. health care providers.

“We’re using a poor sample type, and we can do better,” said Barbara Van Der Pol, PhD, a professor of medicine and public health at the University of Alabama at Birmingham and an author of the new study, a meta-analysis of 97 studies published between 1995 and 2021.

Vaginal swabs for chlamydia trachomatis had a diagnostic sensitivity of 94.1% (95% confidence interval, 93.2%-94.9%; P < .001), higher than urine testing (86.9%; 95% CI, 85.6%-88.0%; P < .001). The pooled sensitivity estimates for Neisseria gonorrhoeae were 96.5% (95% CI, 94.8%-97.7%; P < .001) for vaginal swabs and 90.7% (95% CI, 88.4%-92.5%; P < .001) for urine specimens.

The difference in pooled sensitivity estimates between vaginal swabs and urine analyses for Trichomonas vaginalis was 98% (95% CI, 97.0%-98.7%; P < .001) for vaginal swabs and 95.1% (95% CI, 93.6%-96.3%) for urine specimens.

STIs included in the study are not typically found in the urethra and appear in urine analyses only if cervical or vaginal cells have dripped into a urine sample. Dr. Van Der Pol and her colleagues estimated that the use of urine samples rather than vaginal swabs may result in more than 400,000 undiagnosed infections annually.

Undiagnosed and untreated STIs can lead to transmissions of the infection as well as infertility and can have negative effects on romantic relationships, according to Dr. Van Der Pol.

Sarah Wood, MD, an attending physician at Children’s Hospital of Philadelphia, said some health care providers may use urine analysis because patients may be more comfortable with this method. The approach also can be more convenient for medical offices: All they must do is hand a specimen container to the patient.

Conversations between clinicians and patients about vaginal swabbing may be considered “sensitive” and the swabbing more invasive, Dr. Wood, an author of an editorial accompanying the journal article, said. Clinicians may also lack awareness that the swab is a more sensitive method of detecting these STIs.

“We all want to do what’s right for our patient, but we often don’t know what’s right for the patient,” Dr. Wood said. “I don’t think people are really aware of a potential real difference in outcomes with one method over the other.”

Dr. Wood advised making STI screening using vaginal swabs more common by “offering universal opt-out screening, so not waiting until you find out if someone’s having sex but just sort of saying, ‘Hey, across our practice, we screen everybody for chlamydia. Is that something that you want to do today?’ That approach sort of takes out the piece of talking about sex, talking about sexual activity.”

Dr. Van Der Pol, who said she has worked in STI diagnostics for 40 years, said she was not surprised by the results and hopes the study changes how samples are collected and used.

“I really hope that it influences practice so that we really start using vaginal swabs, because it gives us better diagnostics for chlamydia and gonorrhea,” Dr. Van Der Pol said.

“Also, then starting to think about comprehensive women’s care in such a way that they actually order other tests on that same sample if a woman is presenting with complaints.”

A version of this article originally appeared on Medscape.com.

Vaginal swabs are more effective than urine analysis in detecting certain types of sexually transmitted infections, researchers have found.

In the study, which was published online in the Annals of Family Medicine, investigators found that the diagnostic sensitivity of commercially available vaginal swabs was significantly greater than that of urine tests in detecting certain infections, including those caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.

Researchers studied chlamydia and gonorrhea, which are two of the most frequently reported STIs in the United States. Trichomoniasis is the most curable nonviral STI globally, with 156 million cases worldwide in 2016.

The Centers for Disease Control and Prevention has long recommended that vaginal swabs be used to produce optimal samples.

But despite the CDC’s recommendation, urine analysis for these STIs is more commonly used than vaginal swabs among U.S. health care providers.

“We’re using a poor sample type, and we can do better,” said Barbara Van Der Pol, PhD, a professor of medicine and public health at the University of Alabama at Birmingham and an author of the new study, a meta-analysis of 97 studies published between 1995 and 2021.

Vaginal swabs for chlamydia trachomatis had a diagnostic sensitivity of 94.1% (95% confidence interval, 93.2%-94.9%; P < .001), higher than urine testing (86.9%; 95% CI, 85.6%-88.0%; P < .001). The pooled sensitivity estimates for Neisseria gonorrhoeae were 96.5% (95% CI, 94.8%-97.7%; P < .001) for vaginal swabs and 90.7% (95% CI, 88.4%-92.5%; P < .001) for urine specimens.

The difference in pooled sensitivity estimates between vaginal swabs and urine analyses for Trichomonas vaginalis was 98% (95% CI, 97.0%-98.7%; P < .001) for vaginal swabs and 95.1% (95% CI, 93.6%-96.3%) for urine specimens.

STIs included in the study are not typically found in the urethra and appear in urine analyses only if cervical or vaginal cells have dripped into a urine sample. Dr. Van Der Pol and her colleagues estimated that the use of urine samples rather than vaginal swabs may result in more than 400,000 undiagnosed infections annually.

Undiagnosed and untreated STIs can lead to transmissions of the infection as well as infertility and can have negative effects on romantic relationships, according to Dr. Van Der Pol.

Sarah Wood, MD, an attending physician at Children’s Hospital of Philadelphia, said some health care providers may use urine analysis because patients may be more comfortable with this method. The approach also can be more convenient for medical offices: All they must do is hand a specimen container to the patient.

Conversations between clinicians and patients about vaginal swabbing may be considered “sensitive” and the swabbing more invasive, Dr. Wood, an author of an editorial accompanying the journal article, said. Clinicians may also lack awareness that the swab is a more sensitive method of detecting these STIs.

“We all want to do what’s right for our patient, but we often don’t know what’s right for the patient,” Dr. Wood said. “I don’t think people are really aware of a potential real difference in outcomes with one method over the other.”

Dr. Wood advised making STI screening using vaginal swabs more common by “offering universal opt-out screening, so not waiting until you find out if someone’s having sex but just sort of saying, ‘Hey, across our practice, we screen everybody for chlamydia. Is that something that you want to do today?’ That approach sort of takes out the piece of talking about sex, talking about sexual activity.”

Dr. Van Der Pol, who said she has worked in STI diagnostics for 40 years, said she was not surprised by the results and hopes the study changes how samples are collected and used.

“I really hope that it influences practice so that we really start using vaginal swabs, because it gives us better diagnostics for chlamydia and gonorrhea,” Dr. Van Der Pol said.

“Also, then starting to think about comprehensive women’s care in such a way that they actually order other tests on that same sample if a woman is presenting with complaints.”

A version of this article originally appeared on Medscape.com.