Key clinical point: Topiramate can reduce the number of headache days in a month and disability levels in children with migraine.

Major finding: Topiramate vs. placebo significantly reduced the number of migraine days in a month (P = .0008) and migraine-related disability in pediatric patients (P = .04), but showed no significant difference in the proportion of patients experiencing a ≥50% reduction in monthly headache days (P = .11). Topiramate was associated with higher rates of side effects, including weight loss and paresthesia (P less than .01 for both).

Study details: A meta-analysis of 5 randomized controlled trials, including 531 children with migraine aged 6-17 years.

Disclosures: The authors declared no conflicts of interest.

Citation: Wu X et al. Front Pediatr. 2020 Feb 27. doi: 10.3389/fped.2020.00028. 

Key clinical point: Topiramate can reduce the number of headache days in a month and disability levels in children with migraine.

Major finding: Topiramate vs. placebo significantly reduced the number of migraine days in a month (P = .0008) and migraine-related disability in pediatric patients (P = .04), but showed no significant difference in the proportion of patients experiencing a ≥50% reduction in monthly headache days (P = .11). Topiramate was associated with higher rates of side effects, including weight loss and paresthesia (P less than .01 for both).

Study details: A meta-analysis of 5 randomized controlled trials, including 531 children with migraine aged 6-17 years.

Disclosures: The authors declared no conflicts of interest.

Citation: Wu X et al. Front Pediatr. 2020 Feb 27. doi: 10.3389/fped.2020.00028. 

Key clinical point: Topiramate can reduce the number of headache days in a month and disability levels in children with migraine.

Major finding: Topiramate vs. placebo significantly reduced the number of migraine days in a month (P = .0008) and migraine-related disability in pediatric patients (P = .04), but showed no significant difference in the proportion of patients experiencing a ≥50% reduction in monthly headache days (P = .11). Topiramate was associated with higher rates of side effects, including weight loss and paresthesia (P less than .01 for both).

Study details: A meta-analysis of 5 randomized controlled trials, including 531 children with migraine aged 6-17 years.

Disclosures: The authors declared no conflicts of interest.

Citation: Wu X et al. Front Pediatr. 2020 Feb 27. doi: 10.3389/fped.2020.00028. 

Key clinical point: Vitamin D supplementation may improve headache characteristics and disability levels in patients with episodic migraine, especially among those with aura, possibly through attenuation of calcitonin gene-related peptide level.

Major finding: After 12 weeks, the vitamin D vs placebo group had a significant improvement in mean headache days (4.71 vs 6.43 days/month; P = .031) and mean Migraine Disability Assessment Questionnaire score (21.49 vs 31.16; P = .016).  

Study details: A post hoc analysis of a double-blind study which included patients with episodic migraine randomly assigned to receive either vitamin D 2,000 IU/day (n = 40) or placebo (n = 40). 

Disclosures: This study was supported by the Tehran University of Medical Sciences & Health Services. The authors reported no competing interests.

Citation: Ghorbani Z et al. J Headache Pain. 2020 Feb 24. doi: 10.1186/s10194-020-01090-w. 

Key clinical point: Vitamin D supplementation may improve headache characteristics and disability levels in patients with episodic migraine, especially among those with aura, possibly through attenuation of calcitonin gene-related peptide level.

Major finding: After 12 weeks, the vitamin D vs placebo group had a significant improvement in mean headache days (4.71 vs 6.43 days/month; P = .031) and mean Migraine Disability Assessment Questionnaire score (21.49 vs 31.16; P = .016).  

Study details: A post hoc analysis of a double-blind study which included patients with episodic migraine randomly assigned to receive either vitamin D 2,000 IU/day (n = 40) or placebo (n = 40). 

Disclosures: This study was supported by the Tehran University of Medical Sciences & Health Services. The authors reported no competing interests.

Citation: Ghorbani Z et al. J Headache Pain. 2020 Feb 24. doi: 10.1186/s10194-020-01090-w. 

Key clinical point: Vitamin D supplementation may improve headache characteristics and disability levels in patients with episodic migraine, especially among those with aura, possibly through attenuation of calcitonin gene-related peptide level.

Major finding: After 12 weeks, the vitamin D vs placebo group had a significant improvement in mean headache days (4.71 vs 6.43 days/month; P = .031) and mean Migraine Disability Assessment Questionnaire score (21.49 vs 31.16; P = .016).  

Study details: A post hoc analysis of a double-blind study which included patients with episodic migraine randomly assigned to receive either vitamin D 2,000 IU/day (n = 40) or placebo (n = 40). 

Disclosures: This study was supported by the Tehran University of Medical Sciences & Health Services. The authors reported no competing interests.

Citation: Ghorbani Z et al. J Headache Pain. 2020 Feb 24. doi: 10.1186/s10194-020-01090-w. 

Key clinical point: Serotonin-norepinephrine reuptake inhibitors (SNRIs) are clinically safe and effective, and non-inferior to other active drugs for the prophylaxis of migraine and vestibular migraine (VM).

Major finding: Fewer migraine days were reported with SNRIs vs placebo (standardized mean difference [SMD] -0.38; P = .04). In patients with VM, venlafaxine had a significant advantage in decreasing the vertigo severity score (weighted mean difference (MD) -1.45; P less than .0001) and emotional domain score of dizziness handicap inventory (MD -2.64; P = .03) vs other active drugs. No significant difference was noted in withdrawal rates between the groups.

Study details: Meta-analysis of six randomized controlled trials including 418 participants.

Disclosures: This study was funded by the Natural Science Foundation of Liaoning Province. The authors declared no conflicts of interests.

Citation: Wang F et al. Reg Anesth Pain Med. 2020 March. doi: 10.1136/rapm-2019-101207

Key clinical point: Serotonin-norepinephrine reuptake inhibitors (SNRIs) are clinically safe and effective, and non-inferior to other active drugs for the prophylaxis of migraine and vestibular migraine (VM).

Major finding: Fewer migraine days were reported with SNRIs vs placebo (standardized mean difference [SMD] -0.38; P = .04). In patients with VM, venlafaxine had a significant advantage in decreasing the vertigo severity score (weighted mean difference (MD) -1.45; P less than .0001) and emotional domain score of dizziness handicap inventory (MD -2.64; P = .03) vs other active drugs. No significant difference was noted in withdrawal rates between the groups.

Study details: Meta-analysis of six randomized controlled trials including 418 participants.

Disclosures: This study was funded by the Natural Science Foundation of Liaoning Province. The authors declared no conflicts of interests.

Citation: Wang F et al. Reg Anesth Pain Med. 2020 March. doi: 10.1136/rapm-2019-101207

Key clinical point: Serotonin-norepinephrine reuptake inhibitors (SNRIs) are clinically safe and effective, and non-inferior to other active drugs for the prophylaxis of migraine and vestibular migraine (VM).

Major finding: Fewer migraine days were reported with SNRIs vs placebo (standardized mean difference [SMD] -0.38; P = .04). In patients with VM, venlafaxine had a significant advantage in decreasing the vertigo severity score (weighted mean difference (MD) -1.45; P less than .0001) and emotional domain score of dizziness handicap inventory (MD -2.64; P = .03) vs other active drugs. No significant difference was noted in withdrawal rates between the groups.

Study details: Meta-analysis of six randomized controlled trials including 418 participants.

Disclosures: This study was funded by the Natural Science Foundation of Liaoning Province. The authors declared no conflicts of interests.

Citation: Wang F et al. Reg Anesth Pain Med. 2020 March. doi: 10.1136/rapm-2019-101207

Key clinical points: In episodic migraine, enhanced mindfulness-based stress reduction (MBSR+) is more effective than stress management for headache (SMH) in reducing headache and migraine days and headache related disability.

Major finding: At week 20, MBSR+ group vs. SHM group reported fewer headache days (4.6 vs. 6.0 headache days; P = .04) and had greater reduction in headache-related disability (59.6 to 54.6 vs 59.6 to 57.5; P =.02). Treatment response rate was higher in the MBSR+ group vs SMH group (52% vs. 23% reduction in headache days; P = .004). 

Study details: Patients with episodic migraine (aged, 18-65 years) were randomly assigned to receive either MBSR+ (n = 50) or SMH (n = 48).

Disclosures: This study was funded by the National Center for Complementary and Integrative Health and National Institutes of Health. The authors declared no conflicts of interest.

Citation: Seminowicz DA et al. Pain. 2020 Mar 13. doi: 10.1097/j.pain.0000000000001860.

Key clinical points: In episodic migraine, enhanced mindfulness-based stress reduction (MBSR+) is more effective than stress management for headache (SMH) in reducing headache and migraine days and headache related disability.

Major finding: At week 20, MBSR+ group vs. SHM group reported fewer headache days (4.6 vs. 6.0 headache days; P = .04) and had greater reduction in headache-related disability (59.6 to 54.6 vs 59.6 to 57.5; P =.02). Treatment response rate was higher in the MBSR+ group vs SMH group (52% vs. 23% reduction in headache days; P = .004). 

Study details: Patients with episodic migraine (aged, 18-65 years) were randomly assigned to receive either MBSR+ (n = 50) or SMH (n = 48).

Disclosures: This study was funded by the National Center for Complementary and Integrative Health and National Institutes of Health. The authors declared no conflicts of interest.

Citation: Seminowicz DA et al. Pain. 2020 Mar 13. doi: 10.1097/j.pain.0000000000001860.

Key clinical points: In episodic migraine, enhanced mindfulness-based stress reduction (MBSR+) is more effective than stress management for headache (SMH) in reducing headache and migraine days and headache related disability.

Major finding: At week 20, MBSR+ group vs. SHM group reported fewer headache days (4.6 vs. 6.0 headache days; P = .04) and had greater reduction in headache-related disability (59.6 to 54.6 vs 59.6 to 57.5; P =.02). Treatment response rate was higher in the MBSR+ group vs SMH group (52% vs. 23% reduction in headache days; P = .004). 

Study details: Patients with episodic migraine (aged, 18-65 years) were randomly assigned to receive either MBSR+ (n = 50) or SMH (n = 48).

Disclosures: This study was funded by the National Center for Complementary and Integrative Health and National Institutes of Health. The authors declared no conflicts of interest.

Citation: Seminowicz DA et al. Pain. 2020 Mar 13. doi: 10.1097/j.pain.0000000000001860.

Key clinical points: Galcanezumab significantly reduces monthly headache frequency in patients with migraine and episodic cluster headache; 120 mg is superior to 240 mg for treatment of migraine and 300 mg is effective for episodic cluster headache with no increased risk for adverse events.

Major finding: Subcutaneous injections of galcanezumab 120 mg and 240 mg were associated with a significantly increased 50% response rate vs placebo for the treatment of migraine (120 mg: relative risk [RR], 1.51; 240 mg: RR, 1.58; P less than .001 for both). Galcanezumab 120 mg vs 240 mg had similar efficacy (50% response: RR, 1.06; 75% response: RR, 1.07; 100% response: RR, 1.06; migraine headache days: RR, -0.08) and lower risk for adverse effects (120 mg: RR, 1.06; 240 mg: RR, 1.17). Galcanezumab 300 mg dose was effective in reducing episodic cluster headache (RR, 1.36; P = .048).

Study details: Meta-analysis of 6 randomized controlled trials (n=3,889) evaluating the efficacy and safety of galcanezumab across different doses.

Disclosure: This study was supported by the Suzhou Health Talents Training Project. The authors declared no conflicts of interest.

Citation: Yang Y et al. J Headache Pain. 2020 Feb 11. doi: 10.1186/s10194-020-1085-x.

Key clinical points: Galcanezumab significantly reduces monthly headache frequency in patients with migraine and episodic cluster headache; 120 mg is superior to 240 mg for treatment of migraine and 300 mg is effective for episodic cluster headache with no increased risk for adverse events.

Major finding: Subcutaneous injections of galcanezumab 120 mg and 240 mg were associated with a significantly increased 50% response rate vs placebo for the treatment of migraine (120 mg: relative risk [RR], 1.51; 240 mg: RR, 1.58; P less than .001 for both). Galcanezumab 120 mg vs 240 mg had similar efficacy (50% response: RR, 1.06; 75% response: RR, 1.07; 100% response: RR, 1.06; migraine headache days: RR, -0.08) and lower risk for adverse effects (120 mg: RR, 1.06; 240 mg: RR, 1.17). Galcanezumab 300 mg dose was effective in reducing episodic cluster headache (RR, 1.36; P = .048).

Study details: Meta-analysis of 6 randomized controlled trials (n=3,889) evaluating the efficacy and safety of galcanezumab across different doses.

Disclosure: This study was supported by the Suzhou Health Talents Training Project. The authors declared no conflicts of interest.

Citation: Yang Y et al. J Headache Pain. 2020 Feb 11. doi: 10.1186/s10194-020-1085-x.

Key clinical points: Galcanezumab significantly reduces monthly headache frequency in patients with migraine and episodic cluster headache; 120 mg is superior to 240 mg for treatment of migraine and 300 mg is effective for episodic cluster headache with no increased risk for adverse events.

Major finding: Subcutaneous injections of galcanezumab 120 mg and 240 mg were associated with a significantly increased 50% response rate vs placebo for the treatment of migraine (120 mg: relative risk [RR], 1.51; 240 mg: RR, 1.58; P less than .001 for both). Galcanezumab 120 mg vs 240 mg had similar efficacy (50% response: RR, 1.06; 75% response: RR, 1.07; 100% response: RR, 1.06; migraine headache days: RR, -0.08) and lower risk for adverse effects (120 mg: RR, 1.06; 240 mg: RR, 1.17). Galcanezumab 300 mg dose was effective in reducing episodic cluster headache (RR, 1.36; P = .048).

Study details: Meta-analysis of 6 randomized controlled trials (n=3,889) evaluating the efficacy and safety of galcanezumab across different doses.

Disclosure: This study was supported by the Suzhou Health Talents Training Project. The authors declared no conflicts of interest.

Citation: Yang Y et al. J Headache Pain. 2020 Feb 11. doi: 10.1186/s10194-020-1085-x.

Key clinical point: Ubrogepant as an acute treatment for episodic migraine in adults is associated with an increased rate of achieving freedom from pain and absence of the most bothersome symptoms at 2 hours post-dose.

Major finding: At 2 hours post-dose, ubrogepant vs placebo use was associated with a significantly higher percentage of patients with pain freedom (20.80% vs 12.60%; relative risk [RR], 1.65) and absence of the most bothersome migraine-associated symptoms (37.34% vs 27.58%; RR, 1.35) (P less than .001 for both). No significant difference was observed in treatment-related adverse events within 48 hours or 30 days between the two groups.

Study details: Meta-analysis of 3 randomized clinical trials including 3,326 participants.

Disclosures: This study was supported by the Suzhou Health Talents Training Project. The authors declared no conflicts of interest.

Citation: Yang Y et al. CNS Drugs. 2020 Mar 19. doi: 10.1007/s40263-020-00715-7.

Key clinical point: Ubrogepant as an acute treatment for episodic migraine in adults is associated with an increased rate of achieving freedom from pain and absence of the most bothersome symptoms at 2 hours post-dose.

Major finding: At 2 hours post-dose, ubrogepant vs placebo use was associated with a significantly higher percentage of patients with pain freedom (20.80% vs 12.60%; relative risk [RR], 1.65) and absence of the most bothersome migraine-associated symptoms (37.34% vs 27.58%; RR, 1.35) (P less than .001 for both). No significant difference was observed in treatment-related adverse events within 48 hours or 30 days between the two groups.

Study details: Meta-analysis of 3 randomized clinical trials including 3,326 participants.

Disclosures: This study was supported by the Suzhou Health Talents Training Project. The authors declared no conflicts of interest.

Citation: Yang Y et al. CNS Drugs. 2020 Mar 19. doi: 10.1007/s40263-020-00715-7.

Key clinical point: Ubrogepant as an acute treatment for episodic migraine in adults is associated with an increased rate of achieving freedom from pain and absence of the most bothersome symptoms at 2 hours post-dose.

Major finding: At 2 hours post-dose, ubrogepant vs placebo use was associated with a significantly higher percentage of patients with pain freedom (20.80% vs 12.60%; relative risk [RR], 1.65) and absence of the most bothersome migraine-associated symptoms (37.34% vs 27.58%; RR, 1.35) (P less than .001 for both). No significant difference was observed in treatment-related adverse events within 48 hours or 30 days between the two groups.

Study details: Meta-analysis of 3 randomized clinical trials including 3,326 participants.

Disclosures: This study was supported by the Suzhou Health Talents Training Project. The authors declared no conflicts of interest.

Citation: Yang Y et al. CNS Drugs. 2020 Mar 19. doi: 10.1007/s40263-020-00715-7.

Key clinical points: Migraine and non-migraine headache show no association with all-cause mortality; however, the risk of cardiovascular mortality is higher in women experiencing from migraine with aura.

Major finding: All-cause mortality did not differ among individuals experiencing any migraine (hazard ratio [HR], 0.96; 95% confidence interval, 0.89-1.04) or non-migraine headache (HR, 1.01; 95% confidence interval, 0.93-1.10). Women experiencing migraine with aura had a higher risk of cardiovascular mortality vs. those with no history of migraine or headache (HR, 1.64; 95% confidence interval, 1.06-2.54).

Study details: The data come from an analysis of 27,844 Women’s Health Study participants, (aged ≥ 45 years) who were followed up for a median of 22.7 years.

Disclosures: Tobias Kurth reported receiving honoraria from Novartis and Daiichi-Sankyo for lectures on neuroepidemiology and research methods, from Lilly, Newsenselab, and Total for providing methodological advice, and from The BMJ for editorial services. The Women’s Health Study was funded by grants from the National Institutes of Health.

Citation: Rohmann JL et al. J Headache Pain. 2020 Mar 17. doi: 10.1186/s10194-020-01091-9. 

Key clinical points: Migraine and non-migraine headache show no association with all-cause mortality; however, the risk of cardiovascular mortality is higher in women experiencing from migraine with aura.

Major finding: All-cause mortality did not differ among individuals experiencing any migraine (hazard ratio [HR], 0.96; 95% confidence interval, 0.89-1.04) or non-migraine headache (HR, 1.01; 95% confidence interval, 0.93-1.10). Women experiencing migraine with aura had a higher risk of cardiovascular mortality vs. those with no history of migraine or headache (HR, 1.64; 95% confidence interval, 1.06-2.54).

Study details: The data come from an analysis of 27,844 Women’s Health Study participants, (aged ≥ 45 years) who were followed up for a median of 22.7 years.

Disclosures: Tobias Kurth reported receiving honoraria from Novartis and Daiichi-Sankyo for lectures on neuroepidemiology and research methods, from Lilly, Newsenselab, and Total for providing methodological advice, and from The BMJ for editorial services. The Women’s Health Study was funded by grants from the National Institutes of Health.

Citation: Rohmann JL et al. J Headache Pain. 2020 Mar 17. doi: 10.1186/s10194-020-01091-9. 

Key clinical points: Migraine and non-migraine headache show no association with all-cause mortality; however, the risk of cardiovascular mortality is higher in women experiencing from migraine with aura.

Major finding: All-cause mortality did not differ among individuals experiencing any migraine (hazard ratio [HR], 0.96; 95% confidence interval, 0.89-1.04) or non-migraine headache (HR, 1.01; 95% confidence interval, 0.93-1.10). Women experiencing migraine with aura had a higher risk of cardiovascular mortality vs. those with no history of migraine or headache (HR, 1.64; 95% confidence interval, 1.06-2.54).

Study details: The data come from an analysis of 27,844 Women’s Health Study participants, (aged ≥ 45 years) who were followed up for a median of 22.7 years.

Disclosures: Tobias Kurth reported receiving honoraria from Novartis and Daiichi-Sankyo for lectures on neuroepidemiology and research methods, from Lilly, Newsenselab, and Total for providing methodological advice, and from The BMJ for editorial services. The Women’s Health Study was funded by grants from the National Institutes of Health.

Citation: Rohmann JL et al. J Headache Pain. 2020 Mar 17. doi: 10.1186/s10194-020-01091-9. 

Almost all patients who develop gastrointestinal side effects from oral immunotherapy for severe food allergies develop some degree of esophageal eosinophilia, but that eventually resolves in most of them after a year of treatment, according to results of a pilot study that was to be presented at the American Academy of Allergy, Asthma & Immunology annual meeting. The AAAAI canceled the meeting and provided abstracts and access to presenters for press coverage.

The findings may help identify biomarkers of persistent eosinophilia despite oral immunotherapy.

In January of this year the Food and Drug Administration approved oral immunotherapy (OIT), known as peanut allergen powder-dnfp, or peanut OIT (POIT), for severe food allergies. In an interview, lead study author Benjamin Wright, MD, of the Mayo Clinic, Phoenix, said OIT is a “promising proactive” treatment for food allergies. “But questions regarding the safety of immunotherapy remain,” he said. “About 30% of patients can develop GI side effects, including abdominal pain and vomiting; most concerning is that some patients develop eosinophilic esophagitis (EoE).”

The pilot study was a mechanistic substudy of 20 adult patients with immunoglobulin E–mediated peanut allergies enrolled in the phase 2 Peanut Oral Immunotherapy Safety, Efficacy and Discovery trial (POISED), with 15 randomized to treatment and the remainder to placebo. They had serial gastrointestinal biopsies at baseline (n = 20), 1 year (n = 7 treatment, 3 placebo) and 2 years (n = 7 treatment, 4 placebo) to evaluate eosinophils per high-power field (eos/hpf).

Baseline characteristics between the treatment and placebo groups were similar, with some having signs of preexisting disease. About 14% of them had clinically significant EoE, represented as a measure of more than 15 eos/hpf, Dr. Wright said. “One of the findings that was really fascinating to us was that all of the subjects had evidence of dilated intercellular spaces at baseline,” he said. “This indicates that all the subjects have some degree of epithelial barrier dysfunction before they start OIT.” Dilated intercellular spaces are a marker of inflammation.

Four patients in the treatment group had mild endoscopic findings at weeks 52 and 104, as did one patient on placebo, Dr. Wright said. A plot of eosinophil counts showed a peak at 52 weeks but near resolution at 104 weeks for all but one patient on OIT. “One of the most interesting trends that we noted was that, for most of patients, OIT-induced eosinophilia was transient and not fixed,” he said. “We noted a triangle pattern where tissue eosinophilia peaks and then resolves with the continuation of therapy.” EoE Histologic scoring system results followed a similar pattern in these patients, he added.

Also, results of the comprehensive GI Symptom Questionnaire, which assessed symptoms such as abdominal pain, difficulty swallowing, refusal to eat, and vomiting, showed that patient-reported GI symptoms did not correlate with tissue eosinophilia, Dr. Wright said. “To us, that suggests that perhaps eosinophils are not central to disease pathology or symptom development in these patients,” he said.

However, the findings validate that, in a small number of patients, OIT induces EoE, Dr. Wright said. He used a treadmill analogy to explain how OIT influences epithelial remodeling in some patients. “We’re constantly renewing our esophageal epithelium every 2 weeks, and when you challenge it with an antigen (i.e., OIT), the treadmill speeds up,” he said. “There may be some patients who will fall if the treadmill gets too fast, and they develop disease.”

He added, “Distinguishing someone’s fitness before they get on the treadmill is really going be a key moving forward in determining which subjects are good participants for OIT or how to dose OIT.”

Dr. Wright reported receiving grants from the Arizona Biomedical Research Consortium and Phoenix Children’s Hospital Foundation. Coauthors reported receiving grants from the National Institutes of Health and the Consortium for Food Allergy Research, as well as relationships with Aimmune Therapeutics, Regeneron Pharmaceuticals, Sanofi, Consortium for Food Allergy Research, DBV Technologies, Astellas, AnaptysBio, and Novartis.

SOURCE: Wright B et al. AAAAI, Session 2605, Abstract No. 259.

Almost all patients who develop gastrointestinal side effects from oral immunotherapy for severe food allergies develop some degree of esophageal eosinophilia, but that eventually resolves in most of them after a year of treatment, according to results of a pilot study that was to be presented at the American Academy of Allergy, Asthma & Immunology annual meeting. The AAAAI canceled the meeting and provided abstracts and access to presenters for press coverage.

The findings may help identify biomarkers of persistent eosinophilia despite oral immunotherapy.

In January of this year the Food and Drug Administration approved oral immunotherapy (OIT), known as peanut allergen powder-dnfp, or peanut OIT (POIT), for severe food allergies. In an interview, lead study author Benjamin Wright, MD, of the Mayo Clinic, Phoenix, said OIT is a “promising proactive” treatment for food allergies. “But questions regarding the safety of immunotherapy remain,” he said. “About 30% of patients can develop GI side effects, including abdominal pain and vomiting; most concerning is that some patients develop eosinophilic esophagitis (EoE).”

The pilot study was a mechanistic substudy of 20 adult patients with immunoglobulin E–mediated peanut allergies enrolled in the phase 2 Peanut Oral Immunotherapy Safety, Efficacy and Discovery trial (POISED), with 15 randomized to treatment and the remainder to placebo. They had serial gastrointestinal biopsies at baseline (n = 20), 1 year (n = 7 treatment, 3 placebo) and 2 years (n = 7 treatment, 4 placebo) to evaluate eosinophils per high-power field (eos/hpf).

Baseline characteristics between the treatment and placebo groups were similar, with some having signs of preexisting disease. About 14% of them had clinically significant EoE, represented as a measure of more than 15 eos/hpf, Dr. Wright said. “One of the findings that was really fascinating to us was that all of the subjects had evidence of dilated intercellular spaces at baseline,” he said. “This indicates that all the subjects have some degree of epithelial barrier dysfunction before they start OIT.” Dilated intercellular spaces are a marker of inflammation.

Four patients in the treatment group had mild endoscopic findings at weeks 52 and 104, as did one patient on placebo, Dr. Wright said. A plot of eosinophil counts showed a peak at 52 weeks but near resolution at 104 weeks for all but one patient on OIT. “One of the most interesting trends that we noted was that, for most of patients, OIT-induced eosinophilia was transient and not fixed,” he said. “We noted a triangle pattern where tissue eosinophilia peaks and then resolves with the continuation of therapy.” EoE Histologic scoring system results followed a similar pattern in these patients, he added.

Also, results of the comprehensive GI Symptom Questionnaire, which assessed symptoms such as abdominal pain, difficulty swallowing, refusal to eat, and vomiting, showed that patient-reported GI symptoms did not correlate with tissue eosinophilia, Dr. Wright said. “To us, that suggests that perhaps eosinophils are not central to disease pathology or symptom development in these patients,” he said.

However, the findings validate that, in a small number of patients, OIT induces EoE, Dr. Wright said. He used a treadmill analogy to explain how OIT influences epithelial remodeling in some patients. “We’re constantly renewing our esophageal epithelium every 2 weeks, and when you challenge it with an antigen (i.e., OIT), the treadmill speeds up,” he said. “There may be some patients who will fall if the treadmill gets too fast, and they develop disease.”

He added, “Distinguishing someone’s fitness before they get on the treadmill is really going be a key moving forward in determining which subjects are good participants for OIT or how to dose OIT.”

Dr. Wright reported receiving grants from the Arizona Biomedical Research Consortium and Phoenix Children’s Hospital Foundation. Coauthors reported receiving grants from the National Institutes of Health and the Consortium for Food Allergy Research, as well as relationships with Aimmune Therapeutics, Regeneron Pharmaceuticals, Sanofi, Consortium for Food Allergy Research, DBV Technologies, Astellas, AnaptysBio, and Novartis.

SOURCE: Wright B et al. AAAAI, Session 2605, Abstract No. 259.

Almost all patients who develop gastrointestinal side effects from oral immunotherapy for severe food allergies develop some degree of esophageal eosinophilia, but that eventually resolves in most of them after a year of treatment, according to results of a pilot study that was to be presented at the American Academy of Allergy, Asthma & Immunology annual meeting. The AAAAI canceled the meeting and provided abstracts and access to presenters for press coverage.

The findings may help identify biomarkers of persistent eosinophilia despite oral immunotherapy.

In January of this year the Food and Drug Administration approved oral immunotherapy (OIT), known as peanut allergen powder-dnfp, or peanut OIT (POIT), for severe food allergies. In an interview, lead study author Benjamin Wright, MD, of the Mayo Clinic, Phoenix, said OIT is a “promising proactive” treatment for food allergies. “But questions regarding the safety of immunotherapy remain,” he said. “About 30% of patients can develop GI side effects, including abdominal pain and vomiting; most concerning is that some patients develop eosinophilic esophagitis (EoE).”

The pilot study was a mechanistic substudy of 20 adult patients with immunoglobulin E–mediated peanut allergies enrolled in the phase 2 Peanut Oral Immunotherapy Safety, Efficacy and Discovery trial (POISED), with 15 randomized to treatment and the remainder to placebo. They had serial gastrointestinal biopsies at baseline (n = 20), 1 year (n = 7 treatment, 3 placebo) and 2 years (n = 7 treatment, 4 placebo) to evaluate eosinophils per high-power field (eos/hpf).

Baseline characteristics between the treatment and placebo groups were similar, with some having signs of preexisting disease. About 14% of them had clinically significant EoE, represented as a measure of more than 15 eos/hpf, Dr. Wright said. “One of the findings that was really fascinating to us was that all of the subjects had evidence of dilated intercellular spaces at baseline,” he said. “This indicates that all the subjects have some degree of epithelial barrier dysfunction before they start OIT.” Dilated intercellular spaces are a marker of inflammation.

Four patients in the treatment group had mild endoscopic findings at weeks 52 and 104, as did one patient on placebo, Dr. Wright said. A plot of eosinophil counts showed a peak at 52 weeks but near resolution at 104 weeks for all but one patient on OIT. “One of the most interesting trends that we noted was that, for most of patients, OIT-induced eosinophilia was transient and not fixed,” he said. “We noted a triangle pattern where tissue eosinophilia peaks and then resolves with the continuation of therapy.” EoE Histologic scoring system results followed a similar pattern in these patients, he added.

Also, results of the comprehensive GI Symptom Questionnaire, which assessed symptoms such as abdominal pain, difficulty swallowing, refusal to eat, and vomiting, showed that patient-reported GI symptoms did not correlate with tissue eosinophilia, Dr. Wright said. “To us, that suggests that perhaps eosinophils are not central to disease pathology or symptom development in these patients,” he said.

However, the findings validate that, in a small number of patients, OIT induces EoE, Dr. Wright said. He used a treadmill analogy to explain how OIT influences epithelial remodeling in some patients. “We’re constantly renewing our esophageal epithelium every 2 weeks, and when you challenge it with an antigen (i.e., OIT), the treadmill speeds up,” he said. “There may be some patients who will fall if the treadmill gets too fast, and they develop disease.”

He added, “Distinguishing someone’s fitness before they get on the treadmill is really going be a key moving forward in determining which subjects are good participants for OIT or how to dose OIT.”

Dr. Wright reported receiving grants from the Arizona Biomedical Research Consortium and Phoenix Children’s Hospital Foundation. Coauthors reported receiving grants from the National Institutes of Health and the Consortium for Food Allergy Research, as well as relationships with Aimmune Therapeutics, Regeneron Pharmaceuticals, Sanofi, Consortium for Food Allergy Research, DBV Technologies, Astellas, AnaptysBio, and Novartis.

SOURCE: Wright B et al. AAAAI, Session 2605, Abstract No. 259.

Loss of meibomian glands in the eye, which contribute to producing tears, appears to be associated with high rates of dry eye in individuals with diabetes and may serve as a biomarker for suboptimal glycemic control, new research suggests.

Gloria Wu, MD, an ophthalmologist at the University of California, San Francisco, presented the findings from a small study using infrared imaging of the eyelids in 120 patients with dry eye during a virtual press briefing held March 30, originally scheduled for the ENDO 2020 meeting.

The meibomian glands are the vertical striations that line the margins of the lower eyelids. They produce the lipid that combines with aqueous fluid from the lacrimal gland to create the tear film. Absence of meibomian glands can lead to dry eyes, eye pain, discomfort, and blurred vision.

Dry eye affects about 7% of the U.S. population, compared with 57% of people with type 1 diabetes and 70% with type 2 diabetes. Two proposed mechanisms for the phenomenon in diabetes are microischemia and inflammation, Dr. Wu said.

In her study, loss of meibomian glands was far more common among the 60 participants with dry eye and diabetes than among the 60 participants with dry eye but without diabetes, and the amount of gland loss was directly linked to A_1c level.

The findings suggest that loss of meibomian glands could serve as a diabetes biomarker, particularly in underserved areas where A_1c testing might not be readily available.

Dr. Wu noted many newer smartphones, including the Samsung Galaxy 10S and iPhone 10, Xs, and 11, have infrared cameras that could help characterize dry eye in patients with diabetes.

“In the future, we hope patients can use [smartphones] and flip their own eyelids and take a picture. We hope that in rural health clinics and community health centers we can use this device that people have ... When people complain of dry eye and they have diabetes we can consider [closer diabetes monitoring],” said Dr. Wu.

Asked to comment, endocrinologist David C. Lieb, MD, said in an interview: “It’s important for providers who care for people with diabetes to know that diabetes is associated with a high incidence of meibomian gland dysfunction leading to dry eye. That’s another reason people with diabetes need to make sure they see their eye care specialist on a regular basis.

“When I ask patients if they’ve seen their eye specialist I may add dry eye to my list of questions rather than just asking them when was the last time they went,” added Dr. Lieb, associate professor of medicine at Eastern Virginia Medical School in Norfolk.

“I may ask them if they have symptoms of dry eye, and if they do, it’s something they need to talk about with that individual.”
 

Gland disappearance correlated with glycemic control

Dr. Wu and colleagues retrospectively reviewed electronic health records for 120 patients diagnosed with dry eye: 60 patients with and 60 patients without type 2 diabetes.

Those with diabetes were a mean age of 65 years, and were split evenly between men and women. The controls were younger, averaging 54 years, and comprised 37 men and 23 women.

Researchers performed infrared imaging (820 nm) of the lid; percentage loss of meibomian glands was calculated for each eye, then averaged per patient.

They found that 51.5% of patients in the diabetes group had lost meibomian glands, compared with just 11.3% of controls, a highly significant difference (P = .0001).

When A_1c was also assessed, only 4 of 60 participants with A_1c ≤ 5.9% lost ≥ 25% of the glands, compared with 55 of 60 participants with A_1c ≥ 6.0%.

And specifically among those with diabetes, 35 of 37 with A_1c > 6.6% lost > 40% of the glands, compared with just 12 of 23 participants with A_1c < 6.5% (all P < .0001).

“In patients with dry eye and diabetes, loss of meibomian glands is associated with elevated A_1c ... [and] may suggest a need for ... further monitoring of the patient’s diabetic condition,” the researchers noted.

Asked whether the glands could re-grow with improved glycemic control, Dr. Wu said she has not looked at that in people with diabetes, but in some patients who receive intensive treatment for dry eye with artificial tears or cyclosporine, the glands do grow back after about 6 months.

Dr. Lieb said he found the smartphone diagnostic idea “fascinating, especially in an area where you might not be able to easily measure an A_1c. Most people have access to point-of-care A_1c testing but not everybody can make it to a doctor’s office.”

And, he added, “anything that’s noninvasive has some potential benefit.”

Dr. Wu and Dr. Lieb have reported no relevant financial relationships.
 

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

Loss of meibomian glands in the eye, which contribute to producing tears, appears to be associated with high rates of dry eye in individuals with diabetes and may serve as a biomarker for suboptimal glycemic control, new research suggests.

Gloria Wu, MD, an ophthalmologist at the University of California, San Francisco, presented the findings from a small study using infrared imaging of the eyelids in 120 patients with dry eye during a virtual press briefing held March 30, originally scheduled for the ENDO 2020 meeting.

The meibomian glands are the vertical striations that line the margins of the lower eyelids. They produce the lipid that combines with aqueous fluid from the lacrimal gland to create the tear film. Absence of meibomian glands can lead to dry eyes, eye pain, discomfort, and blurred vision.

Dry eye affects about 7% of the U.S. population, compared with 57% of people with type 1 diabetes and 70% with type 2 diabetes. Two proposed mechanisms for the phenomenon in diabetes are microischemia and inflammation, Dr. Wu said.

In her study, loss of meibomian glands was far more common among the 60 participants with dry eye and diabetes than among the 60 participants with dry eye but without diabetes, and the amount of gland loss was directly linked to A_1c level.

The findings suggest that loss of meibomian glands could serve as a diabetes biomarker, particularly in underserved areas where A_1c testing might not be readily available.

Dr. Wu noted many newer smartphones, including the Samsung Galaxy 10S and iPhone 10, Xs, and 11, have infrared cameras that could help characterize dry eye in patients with diabetes.

“In the future, we hope patients can use [smartphones] and flip their own eyelids and take a picture. We hope that in rural health clinics and community health centers we can use this device that people have ... When people complain of dry eye and they have diabetes we can consider [closer diabetes monitoring],” said Dr. Wu.

Asked to comment, endocrinologist David C. Lieb, MD, said in an interview: “It’s important for providers who care for people with diabetes to know that diabetes is associated with a high incidence of meibomian gland dysfunction leading to dry eye. That’s another reason people with diabetes need to make sure they see their eye care specialist on a regular basis.

“When I ask patients if they’ve seen their eye specialist I may add dry eye to my list of questions rather than just asking them when was the last time they went,” added Dr. Lieb, associate professor of medicine at Eastern Virginia Medical School in Norfolk.

“I may ask them if they have symptoms of dry eye, and if they do, it’s something they need to talk about with that individual.”
 

Gland disappearance correlated with glycemic control

Dr. Wu and colleagues retrospectively reviewed electronic health records for 120 patients diagnosed with dry eye: 60 patients with and 60 patients without type 2 diabetes.

Those with diabetes were a mean age of 65 years, and were split evenly between men and women. The controls were younger, averaging 54 years, and comprised 37 men and 23 women.

Researchers performed infrared imaging (820 nm) of the lid; percentage loss of meibomian glands was calculated for each eye, then averaged per patient.

They found that 51.5% of patients in the diabetes group had lost meibomian glands, compared with just 11.3% of controls, a highly significant difference (P = .0001).

When A_1c was also assessed, only 4 of 60 participants with A_1c ≤ 5.9% lost ≥ 25% of the glands, compared with 55 of 60 participants with A_1c ≥ 6.0%.

And specifically among those with diabetes, 35 of 37 with A_1c > 6.6% lost > 40% of the glands, compared with just 12 of 23 participants with A_1c < 6.5% (all P < .0001).

“In patients with dry eye and diabetes, loss of meibomian glands is associated with elevated A_1c ... [and] may suggest a need for ... further monitoring of the patient’s diabetic condition,” the researchers noted.

Asked whether the glands could re-grow with improved glycemic control, Dr. Wu said she has not looked at that in people with diabetes, but in some patients who receive intensive treatment for dry eye with artificial tears or cyclosporine, the glands do grow back after about 6 months.

Dr. Lieb said he found the smartphone diagnostic idea “fascinating, especially in an area where you might not be able to easily measure an A_1c. Most people have access to point-of-care A_1c testing but not everybody can make it to a doctor’s office.”

And, he added, “anything that’s noninvasive has some potential benefit.”

Dr. Wu and Dr. Lieb have reported no relevant financial relationships.
 

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

Loss of meibomian glands in the eye, which contribute to producing tears, appears to be associated with high rates of dry eye in individuals with diabetes and may serve as a biomarker for suboptimal glycemic control, new research suggests.

Gloria Wu, MD, an ophthalmologist at the University of California, San Francisco, presented the findings from a small study using infrared imaging of the eyelids in 120 patients with dry eye during a virtual press briefing held March 30, originally scheduled for the ENDO 2020 meeting.

The meibomian glands are the vertical striations that line the margins of the lower eyelids. They produce the lipid that combines with aqueous fluid from the lacrimal gland to create the tear film. Absence of meibomian glands can lead to dry eyes, eye pain, discomfort, and blurred vision.

Dry eye affects about 7% of the U.S. population, compared with 57% of people with type 1 diabetes and 70% with type 2 diabetes. Two proposed mechanisms for the phenomenon in diabetes are microischemia and inflammation, Dr. Wu said.

In her study, loss of meibomian glands was far more common among the 60 participants with dry eye and diabetes than among the 60 participants with dry eye but without diabetes, and the amount of gland loss was directly linked to A_1c level.

The findings suggest that loss of meibomian glands could serve as a diabetes biomarker, particularly in underserved areas where A_1c testing might not be readily available.

Dr. Wu noted many newer smartphones, including the Samsung Galaxy 10S and iPhone 10, Xs, and 11, have infrared cameras that could help characterize dry eye in patients with diabetes.

“In the future, we hope patients can use [smartphones] and flip their own eyelids and take a picture. We hope that in rural health clinics and community health centers we can use this device that people have ... When people complain of dry eye and they have diabetes we can consider [closer diabetes monitoring],” said Dr. Wu.

Asked to comment, endocrinologist David C. Lieb, MD, said in an interview: “It’s important for providers who care for people with diabetes to know that diabetes is associated with a high incidence of meibomian gland dysfunction leading to dry eye. That’s another reason people with diabetes need to make sure they see their eye care specialist on a regular basis.

“When I ask patients if they’ve seen their eye specialist I may add dry eye to my list of questions rather than just asking them when was the last time they went,” added Dr. Lieb, associate professor of medicine at Eastern Virginia Medical School in Norfolk.

“I may ask them if they have symptoms of dry eye, and if they do, it’s something they need to talk about with that individual.”
 

Gland disappearance correlated with glycemic control

Dr. Wu and colleagues retrospectively reviewed electronic health records for 120 patients diagnosed with dry eye: 60 patients with and 60 patients without type 2 diabetes.

Those with diabetes were a mean age of 65 years, and were split evenly between men and women. The controls were younger, averaging 54 years, and comprised 37 men and 23 women.

Researchers performed infrared imaging (820 nm) of the lid; percentage loss of meibomian glands was calculated for each eye, then averaged per patient.

They found that 51.5% of patients in the diabetes group had lost meibomian glands, compared with just 11.3% of controls, a highly significant difference (P = .0001).

When A_1c was also assessed, only 4 of 60 participants with A_1c ≤ 5.9% lost ≥ 25% of the glands, compared with 55 of 60 participants with A_1c ≥ 6.0%.

And specifically among those with diabetes, 35 of 37 with A_1c > 6.6% lost > 40% of the glands, compared with just 12 of 23 participants with A_1c < 6.5% (all P < .0001).

“In patients with dry eye and diabetes, loss of meibomian glands is associated with elevated A_1c ... [and] may suggest a need for ... further monitoring of the patient’s diabetic condition,” the researchers noted.

Asked whether the glands could re-grow with improved glycemic control, Dr. Wu said she has not looked at that in people with diabetes, but in some patients who receive intensive treatment for dry eye with artificial tears or cyclosporine, the glands do grow back after about 6 months.

Dr. Lieb said he found the smartphone diagnostic idea “fascinating, especially in an area where you might not be able to easily measure an A_1c. Most people have access to point-of-care A_1c testing but not everybody can make it to a doctor’s office.”

And, he added, “anything that’s noninvasive has some potential benefit.”

Dr. Wu and Dr. Lieb have reported no relevant financial relationships.
 

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

The Endocrine Society will now hold its annual meeting online in June.

ENDO 2020, originally scheduled for March 27-31 in San Francisco, was canceled March 9 because of the COVID-19 pandemic. Virtual press briefings were held on March 30 and 31.

Now, ENDO Online 2020, scheduled for June 8-22, will include both on-demand and live programming. Registration will be complimentary for health care providers who treat endocrine conditions and researchers in the field.

“The Endocrine Society will host its largest-ever online meeting in June to ensure endocrine researchers and clinicians continue to have access to the latest scientific information, despite the COVID-19 pandemic,” the society said in an announcement.

Content will include on-demand clinical sessions, continuing medical education sessions, programming for early career endocrinologists, and a digital exhibit hall.

The exact content mix is still being worked out, Endocrine Society spokeswoman Jenni Gingery told Medscape Medical News.

Society President E. Dale Abel, MD, PhD, said: “We recognize that many of the members of our field have been mobilized and are actively responding to the COVID-19 pandemic, and we also acknowledge that many have had to close their offices and labs.”

However, Abel, of the University of Iowa, Carver College of Medicine, Iowa City, noted, “We have received feedback that many endocrine investigators, clinicians, and trainees have indicated their desire to continue to advance their clinical knowledge and to be exposed to emerging science. We are proud to support them by virtually delivering the content they need during this challenging period.”

About 9,500 attendees were expected to attend ENDO 2020 in San Francisco.

This is only the third annual meeting cancellation in the Society’s 104-year history. The other two were both during World War II.

This article first appeared on Medscape.com.

The Endocrine Society will now hold its annual meeting online in June.

ENDO 2020, originally scheduled for March 27-31 in San Francisco, was canceled March 9 because of the COVID-19 pandemic. Virtual press briefings were held on March 30 and 31.

Now, ENDO Online 2020, scheduled for June 8-22, will include both on-demand and live programming. Registration will be complimentary for health care providers who treat endocrine conditions and researchers in the field.

“The Endocrine Society will host its largest-ever online meeting in June to ensure endocrine researchers and clinicians continue to have access to the latest scientific information, despite the COVID-19 pandemic,” the society said in an announcement.

Content will include on-demand clinical sessions, continuing medical education sessions, programming for early career endocrinologists, and a digital exhibit hall.

The exact content mix is still being worked out, Endocrine Society spokeswoman Jenni Gingery told Medscape Medical News.

Society President E. Dale Abel, MD, PhD, said: “We recognize that many of the members of our field have been mobilized and are actively responding to the COVID-19 pandemic, and we also acknowledge that many have had to close their offices and labs.”

However, Abel, of the University of Iowa, Carver College of Medicine, Iowa City, noted, “We have received feedback that many endocrine investigators, clinicians, and trainees have indicated their desire to continue to advance their clinical knowledge and to be exposed to emerging science. We are proud to support them by virtually delivering the content they need during this challenging period.”

About 9,500 attendees were expected to attend ENDO 2020 in San Francisco.

This is only the third annual meeting cancellation in the Society’s 104-year history. The other two were both during World War II.

This article first appeared on Medscape.com.

The Endocrine Society will now hold its annual meeting online in June.

ENDO 2020, originally scheduled for March 27-31 in San Francisco, was canceled March 9 because of the COVID-19 pandemic. Virtual press briefings were held on March 30 and 31.

Now, ENDO Online 2020, scheduled for June 8-22, will include both on-demand and live programming. Registration will be complimentary for health care providers who treat endocrine conditions and researchers in the field.

“The Endocrine Society will host its largest-ever online meeting in June to ensure endocrine researchers and clinicians continue to have access to the latest scientific information, despite the COVID-19 pandemic,” the society said in an announcement.

Content will include on-demand clinical sessions, continuing medical education sessions, programming for early career endocrinologists, and a digital exhibit hall.

The exact content mix is still being worked out, Endocrine Society spokeswoman Jenni Gingery told Medscape Medical News.

Society President E. Dale Abel, MD, PhD, said: “We recognize that many of the members of our field have been mobilized and are actively responding to the COVID-19 pandemic, and we also acknowledge that many have had to close their offices and labs.”

However, Abel, of the University of Iowa, Carver College of Medicine, Iowa City, noted, “We have received feedback that many endocrine investigators, clinicians, and trainees have indicated their desire to continue to advance their clinical knowledge and to be exposed to emerging science. We are proud to support them by virtually delivering the content they need during this challenging period.”

About 9,500 attendees were expected to attend ENDO 2020 in San Francisco.

This is only the third annual meeting cancellation in the Society’s 104-year history. The other two were both during World War II.

This article first appeared on Medscape.com.