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Sleep and migraine: What is the link?
Key clinical point: Poor sleep could be a significant risk factor for an ensuing migraine attack, and an intensely painful migraine attack may lead to a subsequent increase in sleep duration, thus highlighting that sleep hygiene is an inherent part of migraine management.
Major finding: The odds of having a migraine attack increased by 6.1% and 17.4% with every deviation from mean sleep and every sleep interruption, respectively, during the previous day, whereas the overall sleep duration had no effect on attack occurrences. An intensely painful attack (M = 0.13; 95% high density interval 0.06-0.20) positively predicted increased sleep duration during the same evening.
Study details: This retrospective cross-sectional study included 724 patients (ages, 18-81 years) with a mean monthly migraine attack frequency of 9.94.
Disclosures: This study was supported by a UK Medical Research Council PhD studentship. Two authors declared being employees of Healint Pte. Ltd, and some authors declared ties with various sources.
Source: Stanyer EC et al. Investigating the relationship between sleep and migraine in a global sample: A Bayesian cross-sectional approach. J Headache Pain. 2023;24:123 (Sep 8). doi: 10.1186/s10194-023-01638-6
Key clinical point: Poor sleep could be a significant risk factor for an ensuing migraine attack, and an intensely painful migraine attack may lead to a subsequent increase in sleep duration, thus highlighting that sleep hygiene is an inherent part of migraine management.
Major finding: The odds of having a migraine attack increased by 6.1% and 17.4% with every deviation from mean sleep and every sleep interruption, respectively, during the previous day, whereas the overall sleep duration had no effect on attack occurrences. An intensely painful attack (M = 0.13; 95% high density interval 0.06-0.20) positively predicted increased sleep duration during the same evening.
Study details: This retrospective cross-sectional study included 724 patients (ages, 18-81 years) with a mean monthly migraine attack frequency of 9.94.
Disclosures: This study was supported by a UK Medical Research Council PhD studentship. Two authors declared being employees of Healint Pte. Ltd, and some authors declared ties with various sources.
Source: Stanyer EC et al. Investigating the relationship between sleep and migraine in a global sample: A Bayesian cross-sectional approach. J Headache Pain. 2023;24:123 (Sep 8). doi: 10.1186/s10194-023-01638-6
Key clinical point: Poor sleep could be a significant risk factor for an ensuing migraine attack, and an intensely painful migraine attack may lead to a subsequent increase in sleep duration, thus highlighting that sleep hygiene is an inherent part of migraine management.
Major finding: The odds of having a migraine attack increased by 6.1% and 17.4% with every deviation from mean sleep and every sleep interruption, respectively, during the previous day, whereas the overall sleep duration had no effect on attack occurrences. An intensely painful attack (M = 0.13; 95% high density interval 0.06-0.20) positively predicted increased sleep duration during the same evening.
Study details: This retrospective cross-sectional study included 724 patients (ages, 18-81 years) with a mean monthly migraine attack frequency of 9.94.
Disclosures: This study was supported by a UK Medical Research Council PhD studentship. Two authors declared being employees of Healint Pte. Ltd, and some authors declared ties with various sources.
Source: Stanyer EC et al. Investigating the relationship between sleep and migraine in a global sample: A Bayesian cross-sectional approach. J Headache Pain. 2023;24:123 (Sep 8). doi: 10.1186/s10194-023-01638-6
Chronic migraine and multiple treatment failures predict poor response to galcanezumab
Key clinical point: In this real-world study of patients with migraine, galcanezumab showed higher response rates than those reported in clinical trials, with chronic migraine (CM) and multiple failures to previous preventive medication being significant predictors of a poor response to galcanezumab.
Major finding: At 3 months of galcanezumab treatment, 55.7% of patients showed a 50% response to galcanezumab. CM (odds ratio [OR] 0.09; P = .047) and the number of previous nonresponse to preventive medication classes (OR 0.55; P = .022) were significantly associated with a poor response to galcanezumab.
Study details: This real-world study involved a prospective follow-up of 104 patients with migraine who received monthly galcanezumab.
Disclosures: This study was supported by the New Faculty Startup Fund from Seoul National University and a National Research Foundation of Korea grant. The authors declared no conflicts of interest.
Source: Kim SA et al. Predictors of galcanezumab response in a real-world study of Korean patients with migraine. Sci Rep. 2023;13:14825 (Sep 8). doi: 10.1038/s41598-023-42110-4
Key clinical point: In this real-world study of patients with migraine, galcanezumab showed higher response rates than those reported in clinical trials, with chronic migraine (CM) and multiple failures to previous preventive medication being significant predictors of a poor response to galcanezumab.
Major finding: At 3 months of galcanezumab treatment, 55.7% of patients showed a 50% response to galcanezumab. CM (odds ratio [OR] 0.09; P = .047) and the number of previous nonresponse to preventive medication classes (OR 0.55; P = .022) were significantly associated with a poor response to galcanezumab.
Study details: This real-world study involved a prospective follow-up of 104 patients with migraine who received monthly galcanezumab.
Disclosures: This study was supported by the New Faculty Startup Fund from Seoul National University and a National Research Foundation of Korea grant. The authors declared no conflicts of interest.
Source: Kim SA et al. Predictors of galcanezumab response in a real-world study of Korean patients with migraine. Sci Rep. 2023;13:14825 (Sep 8). doi: 10.1038/s41598-023-42110-4
Key clinical point: In this real-world study of patients with migraine, galcanezumab showed higher response rates than those reported in clinical trials, with chronic migraine (CM) and multiple failures to previous preventive medication being significant predictors of a poor response to galcanezumab.
Major finding: At 3 months of galcanezumab treatment, 55.7% of patients showed a 50% response to galcanezumab. CM (odds ratio [OR] 0.09; P = .047) and the number of previous nonresponse to preventive medication classes (OR 0.55; P = .022) were significantly associated with a poor response to galcanezumab.
Study details: This real-world study involved a prospective follow-up of 104 patients with migraine who received monthly galcanezumab.
Disclosures: This study was supported by the New Faculty Startup Fund from Seoul National University and a National Research Foundation of Korea grant. The authors declared no conflicts of interest.
Source: Kim SA et al. Predictors of galcanezumab response in a real-world study of Korean patients with migraine. Sci Rep. 2023;13:14825 (Sep 8). doi: 10.1038/s41598-023-42110-4
Triptan non-response tied to increased migraine severity
Key clinical point: A significant proportion of patients with migraine do not respond to ≥1 triptans, and this lack of response is associated with increased migraine severity and disability.
Major finding: Overall, 42.5%, 13.1%, 3.9%, and 0.6% of patients did not respond to ≥1, ≥2 triptans, ≥3 triptans, and ≥3 triptans including a subcutaneous formulation, respectively, with triptan non-responders vs responders having a significantly higher migraine frequency (P < .001), intensity (P < .05), and disability (P < .001).
Study details: This study evaluated 2284 patients with migraine using cross-sectional data from the German Migraine and Headache Society Headache Registry.
Disclosures: This study was supported by Projekt DEAL. Several authors declared serving as advisory boards members or consultants for or receiving travel or research grants or honoraria for consulting, lectures, advisory boards, adboards, and educational talks from various sources.
Source: Ruscheweyh R et al. Triptan non-response in specialized headache care: Cross-sectional data from the DMKG Headache Registry. J Headache Pain. 2023;24:135 (Oct 10). doi: 10.1186/s10194-023-01676-0
Key clinical point: A significant proportion of patients with migraine do not respond to ≥1 triptans, and this lack of response is associated with increased migraine severity and disability.
Major finding: Overall, 42.5%, 13.1%, 3.9%, and 0.6% of patients did not respond to ≥1, ≥2 triptans, ≥3 triptans, and ≥3 triptans including a subcutaneous formulation, respectively, with triptan non-responders vs responders having a significantly higher migraine frequency (P < .001), intensity (P < .05), and disability (P < .001).
Study details: This study evaluated 2284 patients with migraine using cross-sectional data from the German Migraine and Headache Society Headache Registry.
Disclosures: This study was supported by Projekt DEAL. Several authors declared serving as advisory boards members or consultants for or receiving travel or research grants or honoraria for consulting, lectures, advisory boards, adboards, and educational talks from various sources.
Source: Ruscheweyh R et al. Triptan non-response in specialized headache care: Cross-sectional data from the DMKG Headache Registry. J Headache Pain. 2023;24:135 (Oct 10). doi: 10.1186/s10194-023-01676-0
Key clinical point: A significant proportion of patients with migraine do not respond to ≥1 triptans, and this lack of response is associated with increased migraine severity and disability.
Major finding: Overall, 42.5%, 13.1%, 3.9%, and 0.6% of patients did not respond to ≥1, ≥2 triptans, ≥3 triptans, and ≥3 triptans including a subcutaneous formulation, respectively, with triptan non-responders vs responders having a significantly higher migraine frequency (P < .001), intensity (P < .05), and disability (P < .001).
Study details: This study evaluated 2284 patients with migraine using cross-sectional data from the German Migraine and Headache Society Headache Registry.
Disclosures: This study was supported by Projekt DEAL. Several authors declared serving as advisory boards members or consultants for or receiving travel or research grants or honoraria for consulting, lectures, advisory boards, adboards, and educational talks from various sources.
Source: Ruscheweyh R et al. Triptan non-response in specialized headache care: Cross-sectional data from the DMKG Headache Registry. J Headache Pain. 2023;24:135 (Oct 10). doi: 10.1186/s10194-023-01676-0
Cutaneous allodynia and aura play significant roles in CGRP-induced migraine attacks
Key clinical point: Cutaneous allodynia and aura contribute significantly to the risk for calcitonin gene-related peptide (CGRP)-induced migraine attacks in patients having migraine with or without aura.
Major finding: Overall, 79% of patients had CGRP-induced migraine attacks during a 12-hour observation period following CGRP infusion. The presence of cutaneous allodynia and aura, respectively, led to significant increase (odds ratio [OR] 3.26; P = .013) and decrease (OR 0.32; P = .02) in the risk for CGRP-induced migraine attacks.
Study details: The data come from a non-randomized, open-label trial including 139 patients having migraine with or without aura who received a continuous 20-min intravenous infusion of CGRP (dosage, 1.5 mg/minute).
Disclosures: This study was funded by a professor grant from the Lundbeck Foundation, Denmark. Five authors declared receiving personal fees and institutional grants from various sources. M Ashina declared serving as an associate editor of Cephalalgia, The Journal of Headache and Pain, and Brain.
Source: Al-Khazali HM et al. An exploratory analysis of clinical and sociodemographic factors in CGRP-induced migraine attacks: A REFORM study. Cephalalgia. 2023 (Oct 10). doi: 10.1177/03331024231206375
Key clinical point: Cutaneous allodynia and aura contribute significantly to the risk for calcitonin gene-related peptide (CGRP)-induced migraine attacks in patients having migraine with or without aura.
Major finding: Overall, 79% of patients had CGRP-induced migraine attacks during a 12-hour observation period following CGRP infusion. The presence of cutaneous allodynia and aura, respectively, led to significant increase (odds ratio [OR] 3.26; P = .013) and decrease (OR 0.32; P = .02) in the risk for CGRP-induced migraine attacks.
Study details: The data come from a non-randomized, open-label trial including 139 patients having migraine with or without aura who received a continuous 20-min intravenous infusion of CGRP (dosage, 1.5 mg/minute).
Disclosures: This study was funded by a professor grant from the Lundbeck Foundation, Denmark. Five authors declared receiving personal fees and institutional grants from various sources. M Ashina declared serving as an associate editor of Cephalalgia, The Journal of Headache and Pain, and Brain.
Source: Al-Khazali HM et al. An exploratory analysis of clinical and sociodemographic factors in CGRP-induced migraine attacks: A REFORM study. Cephalalgia. 2023 (Oct 10). doi: 10.1177/03331024231206375
Key clinical point: Cutaneous allodynia and aura contribute significantly to the risk for calcitonin gene-related peptide (CGRP)-induced migraine attacks in patients having migraine with or without aura.
Major finding: Overall, 79% of patients had CGRP-induced migraine attacks during a 12-hour observation period following CGRP infusion. The presence of cutaneous allodynia and aura, respectively, led to significant increase (odds ratio [OR] 3.26; P = .013) and decrease (OR 0.32; P = .02) in the risk for CGRP-induced migraine attacks.
Study details: The data come from a non-randomized, open-label trial including 139 patients having migraine with or without aura who received a continuous 20-min intravenous infusion of CGRP (dosage, 1.5 mg/minute).
Disclosures: This study was funded by a professor grant from the Lundbeck Foundation, Denmark. Five authors declared receiving personal fees and institutional grants from various sources. M Ashina declared serving as an associate editor of Cephalalgia, The Journal of Headache and Pain, and Brain.
Source: Al-Khazali HM et al. An exploratory analysis of clinical and sociodemographic factors in CGRP-induced migraine attacks: A REFORM study. Cephalalgia. 2023 (Oct 10). doi: 10.1177/03331024231206375
Benefits of low-dose thyroid replacement in migraine with subclinical hypothyroidism
Key clinical point: Add-on therapy with a low fixed dose of levothyroxine significantly reduced the headache frequency and severity in patients with episodic migraine and subclinical hypothyroidism.
Major finding: At a 3-month follow-up, patients receiving levothyroxine supplementation vs placebo showed a significant reduction in the mean headache frequency (1.67 vs 3.28) and severity (2.05 vs 3.20; both P = .001), mean Migraine Disability Assessment Score (MIDAS; 6.30 vs 8.45; P = .026), and mean MIDAS grade (1.49 vs 1.84; P = .029).
Study details: The data come from a prospective, quasi-randomized interventional study including 87 patients with episodic migraine and subclinical hypothyroidism who were quasi-randomized to the levothyroxine supplementation (n = 43) or placebo (n = 44) arm.
Disclosures: This study was supported by an Institution of Eminence, India, grant. The authors declared no conflicts of interest.
Source: Dev P et al. The effect of low dose thyroid replacement therapy in patients with episodic migraine and subclinical hypothyroidism: A randomised placebo-controlled trial. Cephalalgia. 2023 (Oct 6). doi: 10.1177/03331024231182684
Key clinical point: Add-on therapy with a low fixed dose of levothyroxine significantly reduced the headache frequency and severity in patients with episodic migraine and subclinical hypothyroidism.
Major finding: At a 3-month follow-up, patients receiving levothyroxine supplementation vs placebo showed a significant reduction in the mean headache frequency (1.67 vs 3.28) and severity (2.05 vs 3.20; both P = .001), mean Migraine Disability Assessment Score (MIDAS; 6.30 vs 8.45; P = .026), and mean MIDAS grade (1.49 vs 1.84; P = .029).
Study details: The data come from a prospective, quasi-randomized interventional study including 87 patients with episodic migraine and subclinical hypothyroidism who were quasi-randomized to the levothyroxine supplementation (n = 43) or placebo (n = 44) arm.
Disclosures: This study was supported by an Institution of Eminence, India, grant. The authors declared no conflicts of interest.
Source: Dev P et al. The effect of low dose thyroid replacement therapy in patients with episodic migraine and subclinical hypothyroidism: A randomised placebo-controlled trial. Cephalalgia. 2023 (Oct 6). doi: 10.1177/03331024231182684
Key clinical point: Add-on therapy with a low fixed dose of levothyroxine significantly reduced the headache frequency and severity in patients with episodic migraine and subclinical hypothyroidism.
Major finding: At a 3-month follow-up, patients receiving levothyroxine supplementation vs placebo showed a significant reduction in the mean headache frequency (1.67 vs 3.28) and severity (2.05 vs 3.20; both P = .001), mean Migraine Disability Assessment Score (MIDAS; 6.30 vs 8.45; P = .026), and mean MIDAS grade (1.49 vs 1.84; P = .029).
Study details: The data come from a prospective, quasi-randomized interventional study including 87 patients with episodic migraine and subclinical hypothyroidism who were quasi-randomized to the levothyroxine supplementation (n = 43) or placebo (n = 44) arm.
Disclosures: This study was supported by an Institution of Eminence, India, grant. The authors declared no conflicts of interest.
Source: Dev P et al. The effect of low dose thyroid replacement therapy in patients with episodic migraine and subclinical hypothyroidism: A randomised placebo-controlled trial. Cephalalgia. 2023 (Oct 6). doi: 10.1177/03331024231182684
Intravenous dihydroergotamine safe in refractory chronic migraine regardless of cardiovascular risk
Key clinical point: Repetitive intravenous dihydroergotamine (DHE) administration using an inpatient protocol seemed effective and tolerable in patients with refractory chronic migraine (rCM), even in those at an elevated risk for atherosclerotic cardiovascular disease (ASCVD).
Major finding: The elevated-ASCVD vs low-ASCVD risk group had fewer patients receiving the maximum dose of DHE (42.2% vs 64.4%; P = .002) and lower median doses of DHE on discharge (0.75 vs 1.00 mg; P < .001). Both groups experienced significant pain reduction, but it was more pronounced in the low-ASCVD risk group (P = .037). No significant cardiovascular adverse events or electrocardiogram abnormalities were reported in either group.
Study details: This single-center retrospective cohort study included 347 patients with rCM who received inpatient intravenous DHE, of whom 64 and 163 patients had elevated and low ASCVD risk, respectively.
Disclosures: This study was partially funded by Impel Pharmaceuticals, Inc. Two authors declared being full-time employees and stockowners of Impel Pharmaceuticals. Some authors declared ties with various sources, including Impel Pharmaceuticals.
Source: Wang VS et al. Safety, tolerability, and effectiveness of repetitive intravenous dihydroergotamine for refractory chronic migraine with cardiovascular risk factors: A retrospective study. Headache. 2023;63(9):1251-1258 (Sep 23). doi: 10.1111/head.14636
Key clinical point: Repetitive intravenous dihydroergotamine (DHE) administration using an inpatient protocol seemed effective and tolerable in patients with refractory chronic migraine (rCM), even in those at an elevated risk for atherosclerotic cardiovascular disease (ASCVD).
Major finding: The elevated-ASCVD vs low-ASCVD risk group had fewer patients receiving the maximum dose of DHE (42.2% vs 64.4%; P = .002) and lower median doses of DHE on discharge (0.75 vs 1.00 mg; P < .001). Both groups experienced significant pain reduction, but it was more pronounced in the low-ASCVD risk group (P = .037). No significant cardiovascular adverse events or electrocardiogram abnormalities were reported in either group.
Study details: This single-center retrospective cohort study included 347 patients with rCM who received inpatient intravenous DHE, of whom 64 and 163 patients had elevated and low ASCVD risk, respectively.
Disclosures: This study was partially funded by Impel Pharmaceuticals, Inc. Two authors declared being full-time employees and stockowners of Impel Pharmaceuticals. Some authors declared ties with various sources, including Impel Pharmaceuticals.
Source: Wang VS et al. Safety, tolerability, and effectiveness of repetitive intravenous dihydroergotamine for refractory chronic migraine with cardiovascular risk factors: A retrospective study. Headache. 2023;63(9):1251-1258 (Sep 23). doi: 10.1111/head.14636
Key clinical point: Repetitive intravenous dihydroergotamine (DHE) administration using an inpatient protocol seemed effective and tolerable in patients with refractory chronic migraine (rCM), even in those at an elevated risk for atherosclerotic cardiovascular disease (ASCVD).
Major finding: The elevated-ASCVD vs low-ASCVD risk group had fewer patients receiving the maximum dose of DHE (42.2% vs 64.4%; P = .002) and lower median doses of DHE on discharge (0.75 vs 1.00 mg; P < .001). Both groups experienced significant pain reduction, but it was more pronounced in the low-ASCVD risk group (P = .037). No significant cardiovascular adverse events or electrocardiogram abnormalities were reported in either group.
Study details: This single-center retrospective cohort study included 347 patients with rCM who received inpatient intravenous DHE, of whom 64 and 163 patients had elevated and low ASCVD risk, respectively.
Disclosures: This study was partially funded by Impel Pharmaceuticals, Inc. Two authors declared being full-time employees and stockowners of Impel Pharmaceuticals. Some authors declared ties with various sources, including Impel Pharmaceuticals.
Source: Wang VS et al. Safety, tolerability, and effectiveness of repetitive intravenous dihydroergotamine for refractory chronic migraine with cardiovascular risk factors: A retrospective study. Headache. 2023;63(9):1251-1258 (Sep 23). doi: 10.1111/head.14636
High school students using less tobacco, vape products, CDC report shows
TOPLINE:
which have been shown to both entice teens and keep them vaping.
METHODOLOGY:
- The MMRW report from the U.S. Centers for Disease Control and Prevention presents data from an annual survey of U.S. middle and high school students of their use of tobacco products, including vapes.
- The survey is a cross-sectional, school-based, self-administered web-based questionnaire that uses a stratified, three-stage cluster sampling procedure to generate a nationally representative sample based off the responses of 22,069 students in 2023.
- The overall response rate was 30.5%.
- “Ever use” was defined as using a product once or twice previously, and “current use” was defined as use in the past 30 days.
- The survey queried students on their use of e-cigarettes, traditional cigarettes, cigars, smokeless tobacco, nicotine pouches, hookahs, pipe tobacco, and other oral nicotine products.
TAKEAWAY:
- The use of tobacco products by high school students decreased by 540,000 people from 2022 to 2023 (2.51 million vs. 1.97 million students).
- From 2022 to 2023, current e-cigarette use among high school students declined from 14.1% to 10.0%.
- Among middle and high school students, e-cigarettes were the most used nicotine product in 2023 (7.7%; 2.13 million), followed by cigarettes (1.6%), cigars (1.6%), nicotine pouches (1.5%), smokeless tobacco (1.2%), other oral nicotine products (1.2%), hookahs (1.1%), heated tobacco products (1.0%), and pipe tobacco (0.5%).
- Among students reporting current e-cigarette use, 89.4% said that they used flavored products, and 25.2% said they used an e-cigarette daily. The most commonly reported brands were Elf Bar, Esco Bar, Vuse, JUUL, and Mr. Fog. Fruit (63.4%) and candy (35%) were the most commonly reported flavors.
IN PRACTICE:
“Sustained efforts to prevent initiation of tobacco product use among young persons and strategies to help young tobacco users quit are critical to reducing U.S. youth tobacco product use,” the report states.
SOURCE:
The report was produced by the CDC and published in the Morbidity and Mortality Weekly Report for Nov. 3, 2023.
LIMITATIONS:
Data were obtained by students self-reporting their tobacco use, which can result in social desirability and recall biases, the report states. In addition, the responses were from students enrolled in school settings and may not be representative of teens who are in detention centers, alternative schools, have dropped out of school or are homeschooled. The response rate for the 2023 survey was also lower than in the previous year (30.5% in 2023 vs. 45.2% in 2022), increasing the potential for higher standard errors and reducing the power to detect significant differences.
DISCLOSURES:
No potential conflicts of interest were disclosed.
A version of this article first appeared on Medscape.com.
TOPLINE:
which have been shown to both entice teens and keep them vaping.
METHODOLOGY:
- The MMRW report from the U.S. Centers for Disease Control and Prevention presents data from an annual survey of U.S. middle and high school students of their use of tobacco products, including vapes.
- The survey is a cross-sectional, school-based, self-administered web-based questionnaire that uses a stratified, three-stage cluster sampling procedure to generate a nationally representative sample based off the responses of 22,069 students in 2023.
- The overall response rate was 30.5%.
- “Ever use” was defined as using a product once or twice previously, and “current use” was defined as use in the past 30 days.
- The survey queried students on their use of e-cigarettes, traditional cigarettes, cigars, smokeless tobacco, nicotine pouches, hookahs, pipe tobacco, and other oral nicotine products.
TAKEAWAY:
- The use of tobacco products by high school students decreased by 540,000 people from 2022 to 2023 (2.51 million vs. 1.97 million students).
- From 2022 to 2023, current e-cigarette use among high school students declined from 14.1% to 10.0%.
- Among middle and high school students, e-cigarettes were the most used nicotine product in 2023 (7.7%; 2.13 million), followed by cigarettes (1.6%), cigars (1.6%), nicotine pouches (1.5%), smokeless tobacco (1.2%), other oral nicotine products (1.2%), hookahs (1.1%), heated tobacco products (1.0%), and pipe tobacco (0.5%).
- Among students reporting current e-cigarette use, 89.4% said that they used flavored products, and 25.2% said they used an e-cigarette daily. The most commonly reported brands were Elf Bar, Esco Bar, Vuse, JUUL, and Mr. Fog. Fruit (63.4%) and candy (35%) were the most commonly reported flavors.
IN PRACTICE:
“Sustained efforts to prevent initiation of tobacco product use among young persons and strategies to help young tobacco users quit are critical to reducing U.S. youth tobacco product use,” the report states.
SOURCE:
The report was produced by the CDC and published in the Morbidity and Mortality Weekly Report for Nov. 3, 2023.
LIMITATIONS:
Data were obtained by students self-reporting their tobacco use, which can result in social desirability and recall biases, the report states. In addition, the responses were from students enrolled in school settings and may not be representative of teens who are in detention centers, alternative schools, have dropped out of school or are homeschooled. The response rate for the 2023 survey was also lower than in the previous year (30.5% in 2023 vs. 45.2% in 2022), increasing the potential for higher standard errors and reducing the power to detect significant differences.
DISCLOSURES:
No potential conflicts of interest were disclosed.
A version of this article first appeared on Medscape.com.
TOPLINE:
which have been shown to both entice teens and keep them vaping.
METHODOLOGY:
- The MMRW report from the U.S. Centers for Disease Control and Prevention presents data from an annual survey of U.S. middle and high school students of their use of tobacco products, including vapes.
- The survey is a cross-sectional, school-based, self-administered web-based questionnaire that uses a stratified, three-stage cluster sampling procedure to generate a nationally representative sample based off the responses of 22,069 students in 2023.
- The overall response rate was 30.5%.
- “Ever use” was defined as using a product once or twice previously, and “current use” was defined as use in the past 30 days.
- The survey queried students on their use of e-cigarettes, traditional cigarettes, cigars, smokeless tobacco, nicotine pouches, hookahs, pipe tobacco, and other oral nicotine products.
TAKEAWAY:
- The use of tobacco products by high school students decreased by 540,000 people from 2022 to 2023 (2.51 million vs. 1.97 million students).
- From 2022 to 2023, current e-cigarette use among high school students declined from 14.1% to 10.0%.
- Among middle and high school students, e-cigarettes were the most used nicotine product in 2023 (7.7%; 2.13 million), followed by cigarettes (1.6%), cigars (1.6%), nicotine pouches (1.5%), smokeless tobacco (1.2%), other oral nicotine products (1.2%), hookahs (1.1%), heated tobacco products (1.0%), and pipe tobacco (0.5%).
- Among students reporting current e-cigarette use, 89.4% said that they used flavored products, and 25.2% said they used an e-cigarette daily. The most commonly reported brands were Elf Bar, Esco Bar, Vuse, JUUL, and Mr. Fog. Fruit (63.4%) and candy (35%) were the most commonly reported flavors.
IN PRACTICE:
“Sustained efforts to prevent initiation of tobacco product use among young persons and strategies to help young tobacco users quit are critical to reducing U.S. youth tobacco product use,” the report states.
SOURCE:
The report was produced by the CDC and published in the Morbidity and Mortality Weekly Report for Nov. 3, 2023.
LIMITATIONS:
Data were obtained by students self-reporting their tobacco use, which can result in social desirability and recall biases, the report states. In addition, the responses were from students enrolled in school settings and may not be representative of teens who are in detention centers, alternative schools, have dropped out of school or are homeschooled. The response rate for the 2023 survey was also lower than in the previous year (30.5% in 2023 vs. 45.2% in 2022), increasing the potential for higher standard errors and reducing the power to detect significant differences.
DISCLOSURES:
No potential conflicts of interest were disclosed.
A version of this article first appeared on Medscape.com.
FDA to health care providers: Double-check COVID vaccine dose for children
the Food and Drug Administration said in a MedWatch issued Nov. 1, 2023.
That dose is 0.25 mL for children 6 months through 11 years. In the MedWatch, the FDA said that it “has become aware” that the single-dose vial for use in this age group “contains notably more than 0.25 mL of the vaccine.” It added: “Some healthcare providers may be withdrawing the entire contents of the vial to administer to an individual.”
The FDA revised the Fact Sheet for Healthcare Providers Administering Vaccine to clarify that the 0.25 mL should be withdrawn from the vial and that the vial and any excess then should be discarded. It is in a single-dose vial with a blue cap and a green label.
“It is common [for vaccine makers] to put in a little bit of extra vaccine just to make sure everyone gets enough,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center, Nashville, Tenn. “The provider is supposed to be looking at the syringe when they withdraw it to make sure they get the right amount,” Dr. Schaffner said.
Recently, parents on social media had expressed concerns that their children may have gotten more than the recommended dose, with some parents noticing more reactions such as soreness and fever with the 2023-2024 vaccine dose than they did with their children’s previous COVID vaccinations.
“Since the beginning of the rollout, parents were telling us of cases where pharmacies accidentally gave their children a double dose, while doctors in our group were pointing out that their vials for children contained twice the amount than what was needed,” said Fatima Khan, a parent and cofounder of the group Protect Their Future, an organization that advocates for pediatric vaccine access. Members contacted the FDA and other officials. “We appreciate that the FDA took our concerns seriously and issued this safety update,” Ms. Khan said.
A spokesperson for Moderna is researching how much more vaccine the single-dose vials might contain.
No safety risks identified
“The FDA has not identified any safety risks associated with administration of the higher dose in individuals 6 months through 11 years of age and no serious adverse events were identified related to a dosing error for the vaccine,” Cherie Duvall-Jones, an FDA spokesperson, said in an email response.
“The FDA received questions from stakeholders about the dosing issue on Oct. 29, and contacted Moderna to discuss and better understand the issue,” Ms. Duvall-Jones said. The agency then alerted health care providers via the safety communication and other means to be sure the correct dosage is given to the children aged 12 years or younger.
One parent’s experience
Jane Jih, MD, an internist in San Francisco, took her 7-year-old daughter to a pharmacy to get the vaccine, and it was the first time the pharmacist had given a pediatric dose. “We both had to double check the dose,” Dr. Jih said. She observed that the vial had about 0.40 mL, which is 0.15 mL above the recommended dose.
A few weeks later, Dr. Jih could access the vaccine for her nearly-3-year-old son. The nurse practitioner who administered it had been giving many pediatric Moderna shots, she said, “so I felt more confident in the second scenario.”
Perhaps more reactions, no danger
“If you get a little bit more [than the recommended 0.25 mL], that certainly is not going to harm the child,” Dr. Schaffner said. “There may be a little bit more local reaction. In terms of the child’s immune system, there really isn’t any harm.”
If an entire adult dose is mistakenly given, he said, “I think the reaction locally in some children may be more evident, they may get more sore arms, redness, maybe a little bit more swelling and tenderness. Fever is also a possibility, but “these vaccines have not been associated with too much fever.”
Could a double dose do more harm than that? “It is unknown,” said Aaron Glatt, MD, chief of infectious diseases and hospital epidemiologist for Mount Sinai South Nassau, Oceanside, N.Y. “But there is the theoretical potential for some more complications. I do not know whether this [excess vaccine] would cause an increased likelihood of cardiac inflammatory problems like myocarditis or other rare complications to occur more frequently.”
The message for health care providers giving the vaccine, Dr. Schaffner said, is: “Look at your syringe to make sure the dose is appropriate.”
A version of this article appeared on Medscape.com.
the Food and Drug Administration said in a MedWatch issued Nov. 1, 2023.
That dose is 0.25 mL for children 6 months through 11 years. In the MedWatch, the FDA said that it “has become aware” that the single-dose vial for use in this age group “contains notably more than 0.25 mL of the vaccine.” It added: “Some healthcare providers may be withdrawing the entire contents of the vial to administer to an individual.”
The FDA revised the Fact Sheet for Healthcare Providers Administering Vaccine to clarify that the 0.25 mL should be withdrawn from the vial and that the vial and any excess then should be discarded. It is in a single-dose vial with a blue cap and a green label.
“It is common [for vaccine makers] to put in a little bit of extra vaccine just to make sure everyone gets enough,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center, Nashville, Tenn. “The provider is supposed to be looking at the syringe when they withdraw it to make sure they get the right amount,” Dr. Schaffner said.
Recently, parents on social media had expressed concerns that their children may have gotten more than the recommended dose, with some parents noticing more reactions such as soreness and fever with the 2023-2024 vaccine dose than they did with their children’s previous COVID vaccinations.
“Since the beginning of the rollout, parents were telling us of cases where pharmacies accidentally gave their children a double dose, while doctors in our group were pointing out that their vials for children contained twice the amount than what was needed,” said Fatima Khan, a parent and cofounder of the group Protect Their Future, an organization that advocates for pediatric vaccine access. Members contacted the FDA and other officials. “We appreciate that the FDA took our concerns seriously and issued this safety update,” Ms. Khan said.
A spokesperson for Moderna is researching how much more vaccine the single-dose vials might contain.
No safety risks identified
“The FDA has not identified any safety risks associated with administration of the higher dose in individuals 6 months through 11 years of age and no serious adverse events were identified related to a dosing error for the vaccine,” Cherie Duvall-Jones, an FDA spokesperson, said in an email response.
“The FDA received questions from stakeholders about the dosing issue on Oct. 29, and contacted Moderna to discuss and better understand the issue,” Ms. Duvall-Jones said. The agency then alerted health care providers via the safety communication and other means to be sure the correct dosage is given to the children aged 12 years or younger.
One parent’s experience
Jane Jih, MD, an internist in San Francisco, took her 7-year-old daughter to a pharmacy to get the vaccine, and it was the first time the pharmacist had given a pediatric dose. “We both had to double check the dose,” Dr. Jih said. She observed that the vial had about 0.40 mL, which is 0.15 mL above the recommended dose.
A few weeks later, Dr. Jih could access the vaccine for her nearly-3-year-old son. The nurse practitioner who administered it had been giving many pediatric Moderna shots, she said, “so I felt more confident in the second scenario.”
Perhaps more reactions, no danger
“If you get a little bit more [than the recommended 0.25 mL], that certainly is not going to harm the child,” Dr. Schaffner said. “There may be a little bit more local reaction. In terms of the child’s immune system, there really isn’t any harm.”
If an entire adult dose is mistakenly given, he said, “I think the reaction locally in some children may be more evident, they may get more sore arms, redness, maybe a little bit more swelling and tenderness. Fever is also a possibility, but “these vaccines have not been associated with too much fever.”
Could a double dose do more harm than that? “It is unknown,” said Aaron Glatt, MD, chief of infectious diseases and hospital epidemiologist for Mount Sinai South Nassau, Oceanside, N.Y. “But there is the theoretical potential for some more complications. I do not know whether this [excess vaccine] would cause an increased likelihood of cardiac inflammatory problems like myocarditis or other rare complications to occur more frequently.”
The message for health care providers giving the vaccine, Dr. Schaffner said, is: “Look at your syringe to make sure the dose is appropriate.”
A version of this article appeared on Medscape.com.
the Food and Drug Administration said in a MedWatch issued Nov. 1, 2023.
That dose is 0.25 mL for children 6 months through 11 years. In the MedWatch, the FDA said that it “has become aware” that the single-dose vial for use in this age group “contains notably more than 0.25 mL of the vaccine.” It added: “Some healthcare providers may be withdrawing the entire contents of the vial to administer to an individual.”
The FDA revised the Fact Sheet for Healthcare Providers Administering Vaccine to clarify that the 0.25 mL should be withdrawn from the vial and that the vial and any excess then should be discarded. It is in a single-dose vial with a blue cap and a green label.
“It is common [for vaccine makers] to put in a little bit of extra vaccine just to make sure everyone gets enough,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center, Nashville, Tenn. “The provider is supposed to be looking at the syringe when they withdraw it to make sure they get the right amount,” Dr. Schaffner said.
Recently, parents on social media had expressed concerns that their children may have gotten more than the recommended dose, with some parents noticing more reactions such as soreness and fever with the 2023-2024 vaccine dose than they did with their children’s previous COVID vaccinations.
“Since the beginning of the rollout, parents were telling us of cases where pharmacies accidentally gave their children a double dose, while doctors in our group were pointing out that their vials for children contained twice the amount than what was needed,” said Fatima Khan, a parent and cofounder of the group Protect Their Future, an organization that advocates for pediatric vaccine access. Members contacted the FDA and other officials. “We appreciate that the FDA took our concerns seriously and issued this safety update,” Ms. Khan said.
A spokesperson for Moderna is researching how much more vaccine the single-dose vials might contain.
No safety risks identified
“The FDA has not identified any safety risks associated with administration of the higher dose in individuals 6 months through 11 years of age and no serious adverse events were identified related to a dosing error for the vaccine,” Cherie Duvall-Jones, an FDA spokesperson, said in an email response.
“The FDA received questions from stakeholders about the dosing issue on Oct. 29, and contacted Moderna to discuss and better understand the issue,” Ms. Duvall-Jones said. The agency then alerted health care providers via the safety communication and other means to be sure the correct dosage is given to the children aged 12 years or younger.
One parent’s experience
Jane Jih, MD, an internist in San Francisco, took her 7-year-old daughter to a pharmacy to get the vaccine, and it was the first time the pharmacist had given a pediatric dose. “We both had to double check the dose,” Dr. Jih said. She observed that the vial had about 0.40 mL, which is 0.15 mL above the recommended dose.
A few weeks later, Dr. Jih could access the vaccine for her nearly-3-year-old son. The nurse practitioner who administered it had been giving many pediatric Moderna shots, she said, “so I felt more confident in the second scenario.”
Perhaps more reactions, no danger
“If you get a little bit more [than the recommended 0.25 mL], that certainly is not going to harm the child,” Dr. Schaffner said. “There may be a little bit more local reaction. In terms of the child’s immune system, there really isn’t any harm.”
If an entire adult dose is mistakenly given, he said, “I think the reaction locally in some children may be more evident, they may get more sore arms, redness, maybe a little bit more swelling and tenderness. Fever is also a possibility, but “these vaccines have not been associated with too much fever.”
Could a double dose do more harm than that? “It is unknown,” said Aaron Glatt, MD, chief of infectious diseases and hospital epidemiologist for Mount Sinai South Nassau, Oceanside, N.Y. “But there is the theoretical potential for some more complications. I do not know whether this [excess vaccine] would cause an increased likelihood of cardiac inflammatory problems like myocarditis or other rare complications to occur more frequently.”
The message for health care providers giving the vaccine, Dr. Schaffner said, is: “Look at your syringe to make sure the dose is appropriate.”
A version of this article appeared on Medscape.com.
In myasthenia gravis, antibodies pass open-label tests
PHOENIX – . The two drugs, rozanolixizumab (Rystiggo, UCB) and efgartigimod PH20 (Vyvgart, Argenx SE), received Food and Drug Administration approval in June 2023 and December 2021, respectively, for the treatment of MG.
The neonatal Fc receptor binds to IgG within cells and recycles it back into the blood, leading to increased serum levels. The antibodies bind to the neonatal Fc receptor and promote its degradation, therefore preventing IgG recycling without interfering with its production. They do not affect the levels of other immunoglobulin isotypes.
At the 2023 annual meeting of the American Association for Neuromuscular and Electrodiagnostic Medicine (AANEM), researchers presented data from an open-label extension study following the phase 3 MycarinG trial of rozanolixizumab and the ADAPT-SC+ study of efgartigimod.
In the MycarinG study, rozanolixizumab “showed both statistically significant and clinically meaningful improvements in multiple endpoints,” said Vera Bril, MD, during a presentation of the results.
Rozanolixizumab is approved for MG patients who are anti–acetylcholine receptor (AchR) or anti–muscle-specific tyrosine kinase (MuSK) antibody positive. Efgartigimod is approved for MG patients who are AChR positive.
After completing MycarinG, patients were eligible to enroll in one of two open-label studies, one of each dose.
The new efficacy analysis focused on 110 patients who underwent two or more consecutive symptom-driven treatment cycles. A safety analysis focused on 188 patients who received at least one cycle of treatment.
“The post hoc analysis showed that the clinically meaningful improvements in the generalized myasthenia gravis symptoms were maintained over time for the cohort across rozanolixizumab cycles, while individual patients move through the consecutive treatment cycles, rozanolixizumab had an acceptable safety profile that was maintained across repeated treatments cycles. This is consistent with previous results of rozanolixizumab,” said Dr. Bril, who is a clinical investigator at University of Toronto
A reduction in steroid use?
During the Q&A session, George Small, MD, asked if the study had shown a reduction in steroid use among patients with MG.
As clinical associate director of neurology at Allegheny Medical Center, Pittsburgh, he has overseen the care of several hundred patients with generalized MG, as well as participated in clinical trials. “Many physicians use steroids for very quick responses in their patients. I love steroids and I hate steroids. I’ve helped save people’s lives with them, but I’ve also probably hastened their demise, unfortunately, because of the long-term side effects of the medications. Many neurologists in the community will over-utilize steroids because they don’t have access to these more expensive therapies. I look forward to both using these medications more as they become FDA approved and being an advocate for them, because it is my belief that they help decrease the use of steroids,” said Dr. Small in an interview.
Even if new medications do reduce steroid use, there remains a hurdle with insurance companies. “I’ve felt I’ve been forced to use treatments that I know may not be efficacious in the short term in order to get authorization for more expensive therapies that I use now. I’ve had patients admitted to the hospital as I’ve tried to jump through hoops that the insurance companies demanded,” said Dr. Small.
Clinical improvements seen
In the MycarinG study, patients received weekly injections of 7 mg/kg, 10 mg/kg rozanolixizumab, or placebo over a 6-week period. Both treatment groups had reductions in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores compared with placebo.
MG-ADL and Quantitative Myasthenia Gravis (QMG) scores were consistent across treatment cycles. The mean MG-ADL score dropped by about 4 points at week 6. At around week 10, the mean improvement declined to 2 points, and then by week 14 it increased to 3 points, where it remained consistent out to 50 weeks. A similar pattern was seen in QMG scores, with an approximate 5-point drop at 6 weeks, then about a 1.5-point improvement at 10 weeks, then a mean decrease of around 4 points that stayed stable out to 50 weeks.
Over all cycles of treatment, 89.9% of patients experienced a treatment-emergent adverse event, including 22.3% who had a serious TEAE; the study dropout rate because of TEAEs was 15.4%.
In the ADAPT-SC study, 110 patients were randomized to 10 mg/kg intravenous efgartigimod or 1,000 mg efgartigimod PH20, which is formulated with recombinant human hyaluronidase to allow for rapid administration of larger volumes. After completion of ADAPT-SC, 105 patients from both groups and an additional 79 patients entered the open-label extension study with 1,000 mg efgartigimod PH20.
The study included 141 patients who were AChR-Ab positive and 38 who were AChR-Ab negative. In the first cycle, 34.6% experienced an injection-site reaction, which steadily dropped to 11.5% by the sixth cycle. After each cycle of treatment, the mean change in MG-ADL from study baseline at week 4 was between 4.1 and 4.7 points. The mean change in Myasthenia Gravis Quality of Life 15-Item Questionnaire revisited from study baseline at week 4 was between 5.1 and 6.5 points. The mean change in EuroQoL 5-dimension, 5-level visual analog scale was between 12.3 and 16.0 points at week 4.
MyCarinG was funded by UCB Pharma. ADAPT-SC was funded by Argenx SE. Dr. Bril has financial relationships with Behring, Argenyx, Alexion, Immunovant, Alnylam, Akcea, Takeda, Sanofi, Ionis, Roche, Novo Nordisk, Octapharma, Momenta, Pfizer, CSL Behring, Grifols, Powell Mansfield, UCB, and Viela Bio. Dr. Small is on the speaker’s bureau for Alexion.
PHOENIX – . The two drugs, rozanolixizumab (Rystiggo, UCB) and efgartigimod PH20 (Vyvgart, Argenx SE), received Food and Drug Administration approval in June 2023 and December 2021, respectively, for the treatment of MG.
The neonatal Fc receptor binds to IgG within cells and recycles it back into the blood, leading to increased serum levels. The antibodies bind to the neonatal Fc receptor and promote its degradation, therefore preventing IgG recycling without interfering with its production. They do not affect the levels of other immunoglobulin isotypes.
At the 2023 annual meeting of the American Association for Neuromuscular and Electrodiagnostic Medicine (AANEM), researchers presented data from an open-label extension study following the phase 3 MycarinG trial of rozanolixizumab and the ADAPT-SC+ study of efgartigimod.
In the MycarinG study, rozanolixizumab “showed both statistically significant and clinically meaningful improvements in multiple endpoints,” said Vera Bril, MD, during a presentation of the results.
Rozanolixizumab is approved for MG patients who are anti–acetylcholine receptor (AchR) or anti–muscle-specific tyrosine kinase (MuSK) antibody positive. Efgartigimod is approved for MG patients who are AChR positive.
After completing MycarinG, patients were eligible to enroll in one of two open-label studies, one of each dose.
The new efficacy analysis focused on 110 patients who underwent two or more consecutive symptom-driven treatment cycles. A safety analysis focused on 188 patients who received at least one cycle of treatment.
“The post hoc analysis showed that the clinically meaningful improvements in the generalized myasthenia gravis symptoms were maintained over time for the cohort across rozanolixizumab cycles, while individual patients move through the consecutive treatment cycles, rozanolixizumab had an acceptable safety profile that was maintained across repeated treatments cycles. This is consistent with previous results of rozanolixizumab,” said Dr. Bril, who is a clinical investigator at University of Toronto
A reduction in steroid use?
During the Q&A session, George Small, MD, asked if the study had shown a reduction in steroid use among patients with MG.
As clinical associate director of neurology at Allegheny Medical Center, Pittsburgh, he has overseen the care of several hundred patients with generalized MG, as well as participated in clinical trials. “Many physicians use steroids for very quick responses in their patients. I love steroids and I hate steroids. I’ve helped save people’s lives with them, but I’ve also probably hastened their demise, unfortunately, because of the long-term side effects of the medications. Many neurologists in the community will over-utilize steroids because they don’t have access to these more expensive therapies. I look forward to both using these medications more as they become FDA approved and being an advocate for them, because it is my belief that they help decrease the use of steroids,” said Dr. Small in an interview.
Even if new medications do reduce steroid use, there remains a hurdle with insurance companies. “I’ve felt I’ve been forced to use treatments that I know may not be efficacious in the short term in order to get authorization for more expensive therapies that I use now. I’ve had patients admitted to the hospital as I’ve tried to jump through hoops that the insurance companies demanded,” said Dr. Small.
Clinical improvements seen
In the MycarinG study, patients received weekly injections of 7 mg/kg, 10 mg/kg rozanolixizumab, or placebo over a 6-week period. Both treatment groups had reductions in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores compared with placebo.
MG-ADL and Quantitative Myasthenia Gravis (QMG) scores were consistent across treatment cycles. The mean MG-ADL score dropped by about 4 points at week 6. At around week 10, the mean improvement declined to 2 points, and then by week 14 it increased to 3 points, where it remained consistent out to 50 weeks. A similar pattern was seen in QMG scores, with an approximate 5-point drop at 6 weeks, then about a 1.5-point improvement at 10 weeks, then a mean decrease of around 4 points that stayed stable out to 50 weeks.
Over all cycles of treatment, 89.9% of patients experienced a treatment-emergent adverse event, including 22.3% who had a serious TEAE; the study dropout rate because of TEAEs was 15.4%.
In the ADAPT-SC study, 110 patients were randomized to 10 mg/kg intravenous efgartigimod or 1,000 mg efgartigimod PH20, which is formulated with recombinant human hyaluronidase to allow for rapid administration of larger volumes. After completion of ADAPT-SC, 105 patients from both groups and an additional 79 patients entered the open-label extension study with 1,000 mg efgartigimod PH20.
The study included 141 patients who were AChR-Ab positive and 38 who were AChR-Ab negative. In the first cycle, 34.6% experienced an injection-site reaction, which steadily dropped to 11.5% by the sixth cycle. After each cycle of treatment, the mean change in MG-ADL from study baseline at week 4 was between 4.1 and 4.7 points. The mean change in Myasthenia Gravis Quality of Life 15-Item Questionnaire revisited from study baseline at week 4 was between 5.1 and 6.5 points. The mean change in EuroQoL 5-dimension, 5-level visual analog scale was between 12.3 and 16.0 points at week 4.
MyCarinG was funded by UCB Pharma. ADAPT-SC was funded by Argenx SE. Dr. Bril has financial relationships with Behring, Argenyx, Alexion, Immunovant, Alnylam, Akcea, Takeda, Sanofi, Ionis, Roche, Novo Nordisk, Octapharma, Momenta, Pfizer, CSL Behring, Grifols, Powell Mansfield, UCB, and Viela Bio. Dr. Small is on the speaker’s bureau for Alexion.
PHOENIX – . The two drugs, rozanolixizumab (Rystiggo, UCB) and efgartigimod PH20 (Vyvgart, Argenx SE), received Food and Drug Administration approval in June 2023 and December 2021, respectively, for the treatment of MG.
The neonatal Fc receptor binds to IgG within cells and recycles it back into the blood, leading to increased serum levels. The antibodies bind to the neonatal Fc receptor and promote its degradation, therefore preventing IgG recycling without interfering with its production. They do not affect the levels of other immunoglobulin isotypes.
At the 2023 annual meeting of the American Association for Neuromuscular and Electrodiagnostic Medicine (AANEM), researchers presented data from an open-label extension study following the phase 3 MycarinG trial of rozanolixizumab and the ADAPT-SC+ study of efgartigimod.
In the MycarinG study, rozanolixizumab “showed both statistically significant and clinically meaningful improvements in multiple endpoints,” said Vera Bril, MD, during a presentation of the results.
Rozanolixizumab is approved for MG patients who are anti–acetylcholine receptor (AchR) or anti–muscle-specific tyrosine kinase (MuSK) antibody positive. Efgartigimod is approved for MG patients who are AChR positive.
After completing MycarinG, patients were eligible to enroll in one of two open-label studies, one of each dose.
The new efficacy analysis focused on 110 patients who underwent two or more consecutive symptom-driven treatment cycles. A safety analysis focused on 188 patients who received at least one cycle of treatment.
“The post hoc analysis showed that the clinically meaningful improvements in the generalized myasthenia gravis symptoms were maintained over time for the cohort across rozanolixizumab cycles, while individual patients move through the consecutive treatment cycles, rozanolixizumab had an acceptable safety profile that was maintained across repeated treatments cycles. This is consistent with previous results of rozanolixizumab,” said Dr. Bril, who is a clinical investigator at University of Toronto
A reduction in steroid use?
During the Q&A session, George Small, MD, asked if the study had shown a reduction in steroid use among patients with MG.
As clinical associate director of neurology at Allegheny Medical Center, Pittsburgh, he has overseen the care of several hundred patients with generalized MG, as well as participated in clinical trials. “Many physicians use steroids for very quick responses in their patients. I love steroids and I hate steroids. I’ve helped save people’s lives with them, but I’ve also probably hastened their demise, unfortunately, because of the long-term side effects of the medications. Many neurologists in the community will over-utilize steroids because they don’t have access to these more expensive therapies. I look forward to both using these medications more as they become FDA approved and being an advocate for them, because it is my belief that they help decrease the use of steroids,” said Dr. Small in an interview.
Even if new medications do reduce steroid use, there remains a hurdle with insurance companies. “I’ve felt I’ve been forced to use treatments that I know may not be efficacious in the short term in order to get authorization for more expensive therapies that I use now. I’ve had patients admitted to the hospital as I’ve tried to jump through hoops that the insurance companies demanded,” said Dr. Small.
Clinical improvements seen
In the MycarinG study, patients received weekly injections of 7 mg/kg, 10 mg/kg rozanolixizumab, or placebo over a 6-week period. Both treatment groups had reductions in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores compared with placebo.
MG-ADL and Quantitative Myasthenia Gravis (QMG) scores were consistent across treatment cycles. The mean MG-ADL score dropped by about 4 points at week 6. At around week 10, the mean improvement declined to 2 points, and then by week 14 it increased to 3 points, where it remained consistent out to 50 weeks. A similar pattern was seen in QMG scores, with an approximate 5-point drop at 6 weeks, then about a 1.5-point improvement at 10 weeks, then a mean decrease of around 4 points that stayed stable out to 50 weeks.
Over all cycles of treatment, 89.9% of patients experienced a treatment-emergent adverse event, including 22.3% who had a serious TEAE; the study dropout rate because of TEAEs was 15.4%.
In the ADAPT-SC study, 110 patients were randomized to 10 mg/kg intravenous efgartigimod or 1,000 mg efgartigimod PH20, which is formulated with recombinant human hyaluronidase to allow for rapid administration of larger volumes. After completion of ADAPT-SC, 105 patients from both groups and an additional 79 patients entered the open-label extension study with 1,000 mg efgartigimod PH20.
The study included 141 patients who were AChR-Ab positive and 38 who were AChR-Ab negative. In the first cycle, 34.6% experienced an injection-site reaction, which steadily dropped to 11.5% by the sixth cycle. After each cycle of treatment, the mean change in MG-ADL from study baseline at week 4 was between 4.1 and 4.7 points. The mean change in Myasthenia Gravis Quality of Life 15-Item Questionnaire revisited from study baseline at week 4 was between 5.1 and 6.5 points. The mean change in EuroQoL 5-dimension, 5-level visual analog scale was between 12.3 and 16.0 points at week 4.
MyCarinG was funded by UCB Pharma. ADAPT-SC was funded by Argenx SE. Dr. Bril has financial relationships with Behring, Argenyx, Alexion, Immunovant, Alnylam, Akcea, Takeda, Sanofi, Ionis, Roche, Novo Nordisk, Octapharma, Momenta, Pfizer, CSL Behring, Grifols, Powell Mansfield, UCB, and Viela Bio. Dr. Small is on the speaker’s bureau for Alexion.
AT AANEM 2023
FDA OKs new treatment for erosive esophagitis
also known as erosive gastroesophageal reflux disease (GERD), as well as relief of associated heartburn, the company has announced.
Vonoprazan, an oral potassium-competitive acid blocker (PCAB), provides more potent inhibition of gastric acid than do proton pump inhibitors (PPIs) and is seen as a potential alternative.
The approval of vonoprazan for erosive GERD was based on results from the phase 3 PHALCON-EE study.
The randomized, double-blind, multicenter study enrolled 1,024 patients with erosive GERD in the United States and Europe and compared vonoprazan with the PPI lansoprazole (Prevacid) in the healing and maintenance of healing of erosive GERD and associated heartburn symptom relief.
Vonoprazan 20 mg was noninferior to lansoprazole 30 mg for complete healing by week 8 in patients with all grades of erosive GERD, with healing rates of 93% vs. 85% for lansoprazole.
In addition, vonoprazan showed superior rates of healing in patients with moderate to severe disease (LA Grade C/D) at week 2 (70% vs. 53% with lansoprazole). Vonoprazan was also noninferior to lansoprazole in terms of heartburn-free days over the healing period.
In the maintenance phase of the trial, vonoprazan 10 mg was superior to lansoprazole 15 mg in maintaining healing at 6 months in all patients who were randomly assigned (79% vs. 72%) and in the subset of patients with moderate to severe erosive GERD (75% vs. 61%).
Adverse event (AE) rates for vonoprazan were comparable to lansoprazole. The most common AEs in the healing phase (≥ 2% with vonoprazan) were gastritis, diarrhea, abdominal distention, abdominal pain, and nausea.
The most common AEs in the maintenance phase (≥ 3% with vonoprazan) were gastritis, abdominal pain, dyspepsia, hypertension, and urinary tract infection.
“For many GERD patients with erosive esophagitis, the response to current treatment is suboptimal, leaving them with incomplete healing and ongoing symptoms,” Colin W. Howden, MD, professor emeritus, University of Tennessee, Memphis, said in the news release.
Vonoprazan provides clinicians with a “new first-in-class therapeutic option that demonstrated faster healing in the more difficult-to-treat GERD patients with erosive esophagitis,” Dr. Howden added.
Vonoprazan is expected to be available in the United States in December.
The FDA also recently approved reformulated vonoprazan tablets for Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin) for the treatment of Helicobacter pylori infection in adults, Phathom Pharmaceuticals announced.
In February, the FDA had put both the vonoprazan new drug application for erosive esophagitis and the postapproval supplement for H. pylori on hold until the company addressed concerns over the presence of nitrosamine impurities.
Dr. Howden is a former editor-in-chief of GI&Hepatology News. A version of this article appeared on Medscape.com.
also known as erosive gastroesophageal reflux disease (GERD), as well as relief of associated heartburn, the company has announced.
Vonoprazan, an oral potassium-competitive acid blocker (PCAB), provides more potent inhibition of gastric acid than do proton pump inhibitors (PPIs) and is seen as a potential alternative.
The approval of vonoprazan for erosive GERD was based on results from the phase 3 PHALCON-EE study.
The randomized, double-blind, multicenter study enrolled 1,024 patients with erosive GERD in the United States and Europe and compared vonoprazan with the PPI lansoprazole (Prevacid) in the healing and maintenance of healing of erosive GERD and associated heartburn symptom relief.
Vonoprazan 20 mg was noninferior to lansoprazole 30 mg for complete healing by week 8 in patients with all grades of erosive GERD, with healing rates of 93% vs. 85% for lansoprazole.
In addition, vonoprazan showed superior rates of healing in patients with moderate to severe disease (LA Grade C/D) at week 2 (70% vs. 53% with lansoprazole). Vonoprazan was also noninferior to lansoprazole in terms of heartburn-free days over the healing period.
In the maintenance phase of the trial, vonoprazan 10 mg was superior to lansoprazole 15 mg in maintaining healing at 6 months in all patients who were randomly assigned (79% vs. 72%) and in the subset of patients with moderate to severe erosive GERD (75% vs. 61%).
Adverse event (AE) rates for vonoprazan were comparable to lansoprazole. The most common AEs in the healing phase (≥ 2% with vonoprazan) were gastritis, diarrhea, abdominal distention, abdominal pain, and nausea.
The most common AEs in the maintenance phase (≥ 3% with vonoprazan) were gastritis, abdominal pain, dyspepsia, hypertension, and urinary tract infection.
“For many GERD patients with erosive esophagitis, the response to current treatment is suboptimal, leaving them with incomplete healing and ongoing symptoms,” Colin W. Howden, MD, professor emeritus, University of Tennessee, Memphis, said in the news release.
Vonoprazan provides clinicians with a “new first-in-class therapeutic option that demonstrated faster healing in the more difficult-to-treat GERD patients with erosive esophagitis,” Dr. Howden added.
Vonoprazan is expected to be available in the United States in December.
The FDA also recently approved reformulated vonoprazan tablets for Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin) for the treatment of Helicobacter pylori infection in adults, Phathom Pharmaceuticals announced.
In February, the FDA had put both the vonoprazan new drug application for erosive esophagitis and the postapproval supplement for H. pylori on hold until the company addressed concerns over the presence of nitrosamine impurities.
Dr. Howden is a former editor-in-chief of GI&Hepatology News. A version of this article appeared on Medscape.com.
also known as erosive gastroesophageal reflux disease (GERD), as well as relief of associated heartburn, the company has announced.
Vonoprazan, an oral potassium-competitive acid blocker (PCAB), provides more potent inhibition of gastric acid than do proton pump inhibitors (PPIs) and is seen as a potential alternative.
The approval of vonoprazan for erosive GERD was based on results from the phase 3 PHALCON-EE study.
The randomized, double-blind, multicenter study enrolled 1,024 patients with erosive GERD in the United States and Europe and compared vonoprazan with the PPI lansoprazole (Prevacid) in the healing and maintenance of healing of erosive GERD and associated heartburn symptom relief.
Vonoprazan 20 mg was noninferior to lansoprazole 30 mg for complete healing by week 8 in patients with all grades of erosive GERD, with healing rates of 93% vs. 85% for lansoprazole.
In addition, vonoprazan showed superior rates of healing in patients with moderate to severe disease (LA Grade C/D) at week 2 (70% vs. 53% with lansoprazole). Vonoprazan was also noninferior to lansoprazole in terms of heartburn-free days over the healing period.
In the maintenance phase of the trial, vonoprazan 10 mg was superior to lansoprazole 15 mg in maintaining healing at 6 months in all patients who were randomly assigned (79% vs. 72%) and in the subset of patients with moderate to severe erosive GERD (75% vs. 61%).
Adverse event (AE) rates for vonoprazan were comparable to lansoprazole. The most common AEs in the healing phase (≥ 2% with vonoprazan) were gastritis, diarrhea, abdominal distention, abdominal pain, and nausea.
The most common AEs in the maintenance phase (≥ 3% with vonoprazan) were gastritis, abdominal pain, dyspepsia, hypertension, and urinary tract infection.
“For many GERD patients with erosive esophagitis, the response to current treatment is suboptimal, leaving them with incomplete healing and ongoing symptoms,” Colin W. Howden, MD, professor emeritus, University of Tennessee, Memphis, said in the news release.
Vonoprazan provides clinicians with a “new first-in-class therapeutic option that demonstrated faster healing in the more difficult-to-treat GERD patients with erosive esophagitis,” Dr. Howden added.
Vonoprazan is expected to be available in the United States in December.
The FDA also recently approved reformulated vonoprazan tablets for Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin) for the treatment of Helicobacter pylori infection in adults, Phathom Pharmaceuticals announced.
In February, the FDA had put both the vonoprazan new drug application for erosive esophagitis and the postapproval supplement for H. pylori on hold until the company addressed concerns over the presence of nitrosamine impurities.
Dr. Howden is a former editor-in-chief of GI&Hepatology News. A version of this article appeared on Medscape.com.