Photo courtesy of Amgen

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding marketing authorization for blinatumomab (Blincyto) to include treatment of minimal residual disease (MRD).

The CHMP has recommended approval for blinatumomab as monotherapy for adults with Philadelphia chromosome-negative, CD19-positive, B-cell precursor acute lymphoblastic leukemia (BCP-ALL) in first or second complete remission with MRD greater than or equal to 0.1%.

The CHMP had originally adopted a negative opinion on extending the use of blinatumomab to these patients. However, the committee re-examined its opinion and reversed that decision.

The CHMP has requested that Amgen, the company developing blinatumomab, provide results from ongoing studies to support the new approval.

The CHMP’s recommendations are reviewed by the European Commission (EC), which has the authority to approve medicines for use in the European Union, Norway, Iceland, and Liechtenstein.

The EC usually makes a decision within 67 days of CHMP recommendations.

Blinatumomab is already EC-approved as monotherapy for:

• Adults with Philadelphia chromosome-negative, CD19-positive, relapsed or refractory BCP-ALL.
• Pediatric patients age 1 year or older who have relapsed/refractory, Philadelphia chromosome-negative, CD19-positive BCP-ALL and have received at least two prior therapies or relapsed after allogeneic hematopoietic stem cell transplant.

CHMP’s reversal of opinion

In July, the CHMP recommended against approving blinatumomab to treat patients with MRD based on data from the BLAST trial. Results from this phase 2 trial were published in Blood in April.

The CHMP noted that, although blinatumomab produced MRD negativity in many patients in the BLAST trial, there is no strong evidence that this leads to improved survival.

Given the uncertainty, the CHMP was of the opinion that the benefits of blinatumomab do not outweigh its risks in MRD-positive BCP-ALL patients.

However, Amgen request a re-examination of the CHMP’s opinion, and the CHMP complied.

During the re-examination, the CHMP reviewed all the data and consulted a group of experts.

The experts concluded, and the CHMP agreed, that, although there is no strong evidence of improved survival, the available data indicate a good response to blinatumomab, with around 78% of patients becoming MRD-negative after treatment.

The CHMP also noted that MRD-positive patients have a high risk of relapse and few treatment options.

Therefore, the committee concluded that the benefits of blinatumomab outweigh its risks in this patient population.

The CHMP recommended granting the change to the marketing authorization but also requested that Amgen provide data from ongoing studies of blinatumomab in MRD-positive patients, once those data are available.

Photo courtesy of Amgen

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding marketing authorization for blinatumomab (Blincyto) to include treatment of minimal residual disease (MRD).

The CHMP has recommended approval for blinatumomab as monotherapy for adults with Philadelphia chromosome-negative, CD19-positive, B-cell precursor acute lymphoblastic leukemia (BCP-ALL) in first or second complete remission with MRD greater than or equal to 0.1%.

The CHMP had originally adopted a negative opinion on extending the use of blinatumomab to these patients. However, the committee re-examined its opinion and reversed that decision.

The CHMP has requested that Amgen, the company developing blinatumomab, provide results from ongoing studies to support the new approval.

The CHMP’s recommendations are reviewed by the European Commission (EC), which has the authority to approve medicines for use in the European Union, Norway, Iceland, and Liechtenstein.

The EC usually makes a decision within 67 days of CHMP recommendations.

Blinatumomab is already EC-approved as monotherapy for:

• Adults with Philadelphia chromosome-negative, CD19-positive, relapsed or refractory BCP-ALL.
• Pediatric patients age 1 year or older who have relapsed/refractory, Philadelphia chromosome-negative, CD19-positive BCP-ALL and have received at least two prior therapies or relapsed after allogeneic hematopoietic stem cell transplant.

CHMP’s reversal of opinion

In July, the CHMP recommended against approving blinatumomab to treat patients with MRD based on data from the BLAST trial. Results from this phase 2 trial were published in Blood in April.

The CHMP noted that, although blinatumomab produced MRD negativity in many patients in the BLAST trial, there is no strong evidence that this leads to improved survival.

Given the uncertainty, the CHMP was of the opinion that the benefits of blinatumomab do not outweigh its risks in MRD-positive BCP-ALL patients.

However, Amgen request a re-examination of the CHMP’s opinion, and the CHMP complied.

During the re-examination, the CHMP reviewed all the data and consulted a group of experts.

The experts concluded, and the CHMP agreed, that, although there is no strong evidence of improved survival, the available data indicate a good response to blinatumomab, with around 78% of patients becoming MRD-negative after treatment.

The CHMP also noted that MRD-positive patients have a high risk of relapse and few treatment options.

Therefore, the committee concluded that the benefits of blinatumomab outweigh its risks in this patient population.

The CHMP recommended granting the change to the marketing authorization but also requested that Amgen provide data from ongoing studies of blinatumomab in MRD-positive patients, once those data are available.

Photo courtesy of Amgen

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding marketing authorization for blinatumomab (Blincyto) to include treatment of minimal residual disease (MRD).

The CHMP has recommended approval for blinatumomab as monotherapy for adults with Philadelphia chromosome-negative, CD19-positive, B-cell precursor acute lymphoblastic leukemia (BCP-ALL) in first or second complete remission with MRD greater than or equal to 0.1%.

The CHMP had originally adopted a negative opinion on extending the use of blinatumomab to these patients. However, the committee re-examined its opinion and reversed that decision.

The CHMP has requested that Amgen, the company developing blinatumomab, provide results from ongoing studies to support the new approval.

The CHMP’s recommendations are reviewed by the European Commission (EC), which has the authority to approve medicines for use in the European Union, Norway, Iceland, and Liechtenstein.

The EC usually makes a decision within 67 days of CHMP recommendations.

Blinatumomab is already EC-approved as monotherapy for:

• Adults with Philadelphia chromosome-negative, CD19-positive, relapsed or refractory BCP-ALL.
• Pediatric patients age 1 year or older who have relapsed/refractory, Philadelphia chromosome-negative, CD19-positive BCP-ALL and have received at least two prior therapies or relapsed after allogeneic hematopoietic stem cell transplant.

CHMP’s reversal of opinion

In July, the CHMP recommended against approving blinatumomab to treat patients with MRD based on data from the BLAST trial. Results from this phase 2 trial were published in Blood in April.

The CHMP noted that, although blinatumomab produced MRD negativity in many patients in the BLAST trial, there is no strong evidence that this leads to improved survival.

Given the uncertainty, the CHMP was of the opinion that the benefits of blinatumomab do not outweigh its risks in MRD-positive BCP-ALL patients.

However, Amgen request a re-examination of the CHMP’s opinion, and the CHMP complied.

During the re-examination, the CHMP reviewed all the data and consulted a group of experts.

The experts concluded, and the CHMP agreed, that, although there is no strong evidence of improved survival, the available data indicate a good response to blinatumomab, with around 78% of patients becoming MRD-negative after treatment.

The CHMP also noted that MRD-positive patients have a high risk of relapse and few treatment options.

Therefore, the committee concluded that the benefits of blinatumomab outweigh its risks in this patient population.

The CHMP recommended granting the change to the marketing authorization but also requested that Amgen provide data from ongoing studies of blinatumomab in MRD-positive patients, once those data are available.

SEATTLE – A novel formulation of methylphenidate could provide morning relief to pediatric patients with attention-deficit/hyperactivity disorder, according to results of a pivotal phase 3 classroom trial.

In the study, delayed release/extended release methylphenidate (DR/ER MPH), when taken the night before, improved ADHD symptoms throughout a 12-hour laboratory classroom period – including in the late afternoons and early mornings.

The formulation, also known as Jornay PM, received Food and Drug Administration approval for ADHD in August for patients aged 6 and older. “For kids who have a horrendous time in the morning, getting up out of bed, and getting ready for school, they get up and they’re ready to rock and roll. [The drug] makes the mornings go better,” Ann Childress, MD, said in an interview at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

In a previous phase 3 trial, DR/ER MPH proved beneficial in late afternoon and early morning symptoms in a naturalistic sample over a 3- week treatment course (J Child Adolesc Pharmacol. 2017 Aug 1;27[6]:474-82). The current work sought to show its value in a classroom setting. And in yet another earlier survey, 77% of parents rated early morning functional impairment in children with ADHD as moderate to severe (J Child Adolesc Pharmacol. 2017 Oct 1;27[8]:715-22).

“I have a lot of patients asking me when the medication is coming out, so hopefully it’ll be on the shelves in the spring,” said Dr. Childress, president of the Center for Psychiatry and Behavioral Medicine in Las Vegas.

In the current study, presented by Dr. Childress at the meeting, 117 children aged 6-12 years with ADHD and morning behavioral problems, after a 5-day washout period, were started on an evening DR/ER MPH dose of 20 mg or 40 mg. They were then seen for up to 4 more weeks, and doses optimized (maximum 100 mg/day).


Adjustments also were made in the evening dose schedule to determine an optimal dosing time, which had to range from 6:30 pm to 9:30 pm, at least 1 hour after dinner. Clinicians optimized the dose and timing to achieve maximum symptom control throughout the day (minimum 30% improvement in total symptom score from baseline), while remaining safe and well-tolerated.The participants were then randomized to maintain the current drug dose, or to switch to placebo for 1 week. The primary endpoint was the average of all post-dose SKAMP-CS (Swanson, Kotkin, Agler, M-Flynn, and Pelham combined scale) measurements, as recorded by a trained, independent observer during the 12-hour period on the last classroom day.

There was a significant improvement in the primary measure, with the treatment group averaging 14.8 on the SKAMP-CS, compared with 20.7 for the placebo group (P less than .001). The improved outcomes were steady throughout the day, failing to achieve statistical significance at 8 a.m., but achieving significance in measurements taken at 9 a.m.,10 a.m., 12 p.m., 2 pm, 4 p.m., 6 p.m., and 7 p.m.

The formulation also achieved significant difference in morning and late afternoon measurements of the Parent Rating of Evening and Morning Behavior Scale, Revised (PREMB-R AM and PREMB-R PM). The treatment group scored a mean of 0.9 on PREMB-R AM, compared with 2.7 for placebo (P less than .001), and 6.1 vs. 9.3 in the PREMB-R PM scale (P = .003).

Most treatment emergent adverse events were considered mild or moderate, and occurred in 36.9% of the treatment group and 40.7% of placebo subjects.

The study was funded by Ironshore Pharmaceuticals, which said in a press statement that it plans to launch the drug early next year. In addition to Ironshore, Dr. Childress has served on the advisory board for, consulted for, or received research support from Aevi Genomic Medicine, Akili Interactive, Alcobra, Arbor Pharmaceuticals, Eli Lilly, Forest Laboratories, Lundbeck, KemPharm, Neos Therapeutics, Noven Pharmaceuticals, Otsuka America Pharmaceutical, Pearson, Pfizer, Purdue Pharma, Rhodes Pharmaceuticals, Shire, Sunovion, and Tris Pharma.

SEATTLE – A novel formulation of methylphenidate could provide morning relief to pediatric patients with attention-deficit/hyperactivity disorder, according to results of a pivotal phase 3 classroom trial.

In the study, delayed release/extended release methylphenidate (DR/ER MPH), when taken the night before, improved ADHD symptoms throughout a 12-hour laboratory classroom period – including in the late afternoons and early mornings.

The formulation, also known as Jornay PM, received Food and Drug Administration approval for ADHD in August for patients aged 6 and older. “For kids who have a horrendous time in the morning, getting up out of bed, and getting ready for school, they get up and they’re ready to rock and roll. [The drug] makes the mornings go better,” Ann Childress, MD, said in an interview at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

In a previous phase 3 trial, DR/ER MPH proved beneficial in late afternoon and early morning symptoms in a naturalistic sample over a 3- week treatment course (J Child Adolesc Pharmacol. 2017 Aug 1;27[6]:474-82). The current work sought to show its value in a classroom setting. And in yet another earlier survey, 77% of parents rated early morning functional impairment in children with ADHD as moderate to severe (J Child Adolesc Pharmacol. 2017 Oct 1;27[8]:715-22).

“I have a lot of patients asking me when the medication is coming out, so hopefully it’ll be on the shelves in the spring,” said Dr. Childress, president of the Center for Psychiatry and Behavioral Medicine in Las Vegas.

In the current study, presented by Dr. Childress at the meeting, 117 children aged 6-12 years with ADHD and morning behavioral problems, after a 5-day washout period, were started on an evening DR/ER MPH dose of 20 mg or 40 mg. They were then seen for up to 4 more weeks, and doses optimized (maximum 100 mg/day).


Adjustments also were made in the evening dose schedule to determine an optimal dosing time, which had to range from 6:30 pm to 9:30 pm, at least 1 hour after dinner. Clinicians optimized the dose and timing to achieve maximum symptom control throughout the day (minimum 30% improvement in total symptom score from baseline), while remaining safe and well-tolerated.The participants were then randomized to maintain the current drug dose, or to switch to placebo for 1 week. The primary endpoint was the average of all post-dose SKAMP-CS (Swanson, Kotkin, Agler, M-Flynn, and Pelham combined scale) measurements, as recorded by a trained, independent observer during the 12-hour period on the last classroom day.

There was a significant improvement in the primary measure, with the treatment group averaging 14.8 on the SKAMP-CS, compared with 20.7 for the placebo group (P less than .001). The improved outcomes were steady throughout the day, failing to achieve statistical significance at 8 a.m., but achieving significance in measurements taken at 9 a.m.,10 a.m., 12 p.m., 2 pm, 4 p.m., 6 p.m., and 7 p.m.

The formulation also achieved significant difference in morning and late afternoon measurements of the Parent Rating of Evening and Morning Behavior Scale, Revised (PREMB-R AM and PREMB-R PM). The treatment group scored a mean of 0.9 on PREMB-R AM, compared with 2.7 for placebo (P less than .001), and 6.1 vs. 9.3 in the PREMB-R PM scale (P = .003).

Most treatment emergent adverse events were considered mild or moderate, and occurred in 36.9% of the treatment group and 40.7% of placebo subjects.

The study was funded by Ironshore Pharmaceuticals, which said in a press statement that it plans to launch the drug early next year. In addition to Ironshore, Dr. Childress has served on the advisory board for, consulted for, or received research support from Aevi Genomic Medicine, Akili Interactive, Alcobra, Arbor Pharmaceuticals, Eli Lilly, Forest Laboratories, Lundbeck, KemPharm, Neos Therapeutics, Noven Pharmaceuticals, Otsuka America Pharmaceutical, Pearson, Pfizer, Purdue Pharma, Rhodes Pharmaceuticals, Shire, Sunovion, and Tris Pharma.

SEATTLE – A novel formulation of methylphenidate could provide morning relief to pediatric patients with attention-deficit/hyperactivity disorder, according to results of a pivotal phase 3 classroom trial.

In the study, delayed release/extended release methylphenidate (DR/ER MPH), when taken the night before, improved ADHD symptoms throughout a 12-hour laboratory classroom period – including in the late afternoons and early mornings.

The formulation, also known as Jornay PM, received Food and Drug Administration approval for ADHD in August for patients aged 6 and older. “For kids who have a horrendous time in the morning, getting up out of bed, and getting ready for school, they get up and they’re ready to rock and roll. [The drug] makes the mornings go better,” Ann Childress, MD, said in an interview at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

In a previous phase 3 trial, DR/ER MPH proved beneficial in late afternoon and early morning symptoms in a naturalistic sample over a 3- week treatment course (J Child Adolesc Pharmacol. 2017 Aug 1;27[6]:474-82). The current work sought to show its value in a classroom setting. And in yet another earlier survey, 77% of parents rated early morning functional impairment in children with ADHD as moderate to severe (J Child Adolesc Pharmacol. 2017 Oct 1;27[8]:715-22).

“I have a lot of patients asking me when the medication is coming out, so hopefully it’ll be on the shelves in the spring,” said Dr. Childress, president of the Center for Psychiatry and Behavioral Medicine in Las Vegas.

In the current study, presented by Dr. Childress at the meeting, 117 children aged 6-12 years with ADHD and morning behavioral problems, after a 5-day washout period, were started on an evening DR/ER MPH dose of 20 mg or 40 mg. They were then seen for up to 4 more weeks, and doses optimized (maximum 100 mg/day).


Adjustments also were made in the evening dose schedule to determine an optimal dosing time, which had to range from 6:30 pm to 9:30 pm, at least 1 hour after dinner. Clinicians optimized the dose and timing to achieve maximum symptom control throughout the day (minimum 30% improvement in total symptom score from baseline), while remaining safe and well-tolerated.The participants were then randomized to maintain the current drug dose, or to switch to placebo for 1 week. The primary endpoint was the average of all post-dose SKAMP-CS (Swanson, Kotkin, Agler, M-Flynn, and Pelham combined scale) measurements, as recorded by a trained, independent observer during the 12-hour period on the last classroom day.

There was a significant improvement in the primary measure, with the treatment group averaging 14.8 on the SKAMP-CS, compared with 20.7 for the placebo group (P less than .001). The improved outcomes were steady throughout the day, failing to achieve statistical significance at 8 a.m., but achieving significance in measurements taken at 9 a.m.,10 a.m., 12 p.m., 2 pm, 4 p.m., 6 p.m., and 7 p.m.

The formulation also achieved significant difference in morning and late afternoon measurements of the Parent Rating of Evening and Morning Behavior Scale, Revised (PREMB-R AM and PREMB-R PM). The treatment group scored a mean of 0.9 on PREMB-R AM, compared with 2.7 for placebo (P less than .001), and 6.1 vs. 9.3 in the PREMB-R PM scale (P = .003).

Most treatment emergent adverse events were considered mild or moderate, and occurred in 36.9% of the treatment group and 40.7% of placebo subjects.

The study was funded by Ironshore Pharmaceuticals, which said in a press statement that it plans to launch the drug early next year. In addition to Ironshore, Dr. Childress has served on the advisory board for, consulted for, or received research support from Aevi Genomic Medicine, Akili Interactive, Alcobra, Arbor Pharmaceuticals, Eli Lilly, Forest Laboratories, Lundbeck, KemPharm, Neos Therapeutics, Noven Pharmaceuticals, Otsuka America Pharmaceutical, Pearson, Pfizer, Purdue Pharma, Rhodes Pharmaceuticals, Shire, Sunovion, and Tris Pharma.

Risk stratification tools that omit lumbar puncture accurately classified most well-appearing febrile infants with invasive bacterial infections as being at low risk, results of a recent study show.

The modified Philadelphia criteria were highly sensitive for risk stratifying febrile infants, in a recent validation study based on a large, multicenter sample, investigators report. No infants with bacterial meningitis were classified as low risk using the modified criteria, which do not include routine testing of cerebrospinal fluid (CSF). Two infants with bacterial meningitis, both younger than 28 days old, were classified as low risk using the Rochester criteria, which also avoid routine lumbar puncture, investigators reported.

“Our findings support the use of the modified Philadelphia criteria without routine CSF testing for febrile infants in the second month of life,” the investigators said in their report, published in Pediatrics.

However, to confirm the safety of omitting CSF testing in low-risk febrile infants older than 28 days, a prospective study will be needed, cautioned the researchers, led by Paul L. Aronson, MD, of the department of pediatrics at Yale University in New Haven, Conn.

Nevertheless, some clinicians do not automatically perform CSF testing in infants older than 28 days because of the rarity of bacterial meningitis in that age group, they said in the report.

The study by Dr. Aronson and colleagues was based on data for infants younger than 60 days of age seen in the emergency departments of 9 hospitals between July 2011 and June 2016. The final sample included 135 infants with invasive bacterial infections, including 118 who had bacteremia without meningitis and 17 who had bacterial meningitis, along with 249 matched febrile infant controls.

A total of 25 infants with invasive bacterial infections were classified as low risk by the Rochester criteria, and 11 of those were low risk by the modified Philadelphia criteria, investigators said.

Compared with the modified Philadelphia criteria, the Rochester criteria had a lower sensitivity (81.5% vs. 91.9%; P = 0.01) and a higher specificity (59.8 vs. 34.5%; P less than 0.001).

Out of the 11 infants deemed low risk per the modified Philadelphia criteria, none were diagnosed with bacterial meningitis. By contrast, 2 of the 25 infants who were low risk per the Rochester criteria had bacterial meningitis, and both were younger than or equal to 28 days of age. “Both of these infants would have been classified as high risk per the modified Philadelphia criteria,” Dr. Aronson and his coauthors said.

Based on the findings of this study, caution should be exercised in applying low-risk criteria to infants 28 days of age or younger, according to the investigators.

“Febrile infants discharged from the emergency department without CSF testing should have close outpatient follow-up,” they wrote.

Dr. Aronson and his coauthors reported that they had no relevant disclosures. One coauthor reported serving as an expert witness in malpractice cases involving evaluation of febrile children.

SOURCE: Aronson PL et al. Pediatrics. 13 Nov 2018. doi: 10.1542/peds.2018-1879).

Risk stratification tools that omit lumbar puncture accurately classified most well-appearing febrile infants with invasive bacterial infections as being at low risk, results of a recent study show.

The modified Philadelphia criteria were highly sensitive for risk stratifying febrile infants, in a recent validation study based on a large, multicenter sample, investigators report. No infants with bacterial meningitis were classified as low risk using the modified criteria, which do not include routine testing of cerebrospinal fluid (CSF). Two infants with bacterial meningitis, both younger than 28 days old, were classified as low risk using the Rochester criteria, which also avoid routine lumbar puncture, investigators reported.

“Our findings support the use of the modified Philadelphia criteria without routine CSF testing for febrile infants in the second month of life,” the investigators said in their report, published in Pediatrics.

However, to confirm the safety of omitting CSF testing in low-risk febrile infants older than 28 days, a prospective study will be needed, cautioned the researchers, led by Paul L. Aronson, MD, of the department of pediatrics at Yale University in New Haven, Conn.

Nevertheless, some clinicians do not automatically perform CSF testing in infants older than 28 days because of the rarity of bacterial meningitis in that age group, they said in the report.

The study by Dr. Aronson and colleagues was based on data for infants younger than 60 days of age seen in the emergency departments of 9 hospitals between July 2011 and June 2016. The final sample included 135 infants with invasive bacterial infections, including 118 who had bacteremia without meningitis and 17 who had bacterial meningitis, along with 249 matched febrile infant controls.

A total of 25 infants with invasive bacterial infections were classified as low risk by the Rochester criteria, and 11 of those were low risk by the modified Philadelphia criteria, investigators said.

Compared with the modified Philadelphia criteria, the Rochester criteria had a lower sensitivity (81.5% vs. 91.9%; P = 0.01) and a higher specificity (59.8 vs. 34.5%; P less than 0.001).

Out of the 11 infants deemed low risk per the modified Philadelphia criteria, none were diagnosed with bacterial meningitis. By contrast, 2 of the 25 infants who were low risk per the Rochester criteria had bacterial meningitis, and both were younger than or equal to 28 days of age. “Both of these infants would have been classified as high risk per the modified Philadelphia criteria,” Dr. Aronson and his coauthors said.

Based on the findings of this study, caution should be exercised in applying low-risk criteria to infants 28 days of age or younger, according to the investigators.

“Febrile infants discharged from the emergency department without CSF testing should have close outpatient follow-up,” they wrote.

Dr. Aronson and his coauthors reported that they had no relevant disclosures. One coauthor reported serving as an expert witness in malpractice cases involving evaluation of febrile children.

SOURCE: Aronson PL et al. Pediatrics. 13 Nov 2018. doi: 10.1542/peds.2018-1879).

Risk stratification tools that omit lumbar puncture accurately classified most well-appearing febrile infants with invasive bacterial infections as being at low risk, results of a recent study show.

The modified Philadelphia criteria were highly sensitive for risk stratifying febrile infants, in a recent validation study based on a large, multicenter sample, investigators report. No infants with bacterial meningitis were classified as low risk using the modified criteria, which do not include routine testing of cerebrospinal fluid (CSF). Two infants with bacterial meningitis, both younger than 28 days old, were classified as low risk using the Rochester criteria, which also avoid routine lumbar puncture, investigators reported.

“Our findings support the use of the modified Philadelphia criteria without routine CSF testing for febrile infants in the second month of life,” the investigators said in their report, published in Pediatrics.

However, to confirm the safety of omitting CSF testing in low-risk febrile infants older than 28 days, a prospective study will be needed, cautioned the researchers, led by Paul L. Aronson, MD, of the department of pediatrics at Yale University in New Haven, Conn.

Nevertheless, some clinicians do not automatically perform CSF testing in infants older than 28 days because of the rarity of bacterial meningitis in that age group, they said in the report.

The study by Dr. Aronson and colleagues was based on data for infants younger than 60 days of age seen in the emergency departments of 9 hospitals between July 2011 and June 2016. The final sample included 135 infants with invasive bacterial infections, including 118 who had bacteremia without meningitis and 17 who had bacterial meningitis, along with 249 matched febrile infant controls.

A total of 25 infants with invasive bacterial infections were classified as low risk by the Rochester criteria, and 11 of those were low risk by the modified Philadelphia criteria, investigators said.

Compared with the modified Philadelphia criteria, the Rochester criteria had a lower sensitivity (81.5% vs. 91.9%; P = 0.01) and a higher specificity (59.8 vs. 34.5%; P less than 0.001).

Out of the 11 infants deemed low risk per the modified Philadelphia criteria, none were diagnosed with bacterial meningitis. By contrast, 2 of the 25 infants who were low risk per the Rochester criteria had bacterial meningitis, and both were younger than or equal to 28 days of age. “Both of these infants would have been classified as high risk per the modified Philadelphia criteria,” Dr. Aronson and his coauthors said.

Based on the findings of this study, caution should be exercised in applying low-risk criteria to infants 28 days of age or younger, according to the investigators.

“Febrile infants discharged from the emergency department without CSF testing should have close outpatient follow-up,” they wrote.

Dr. Aronson and his coauthors reported that they had no relevant disclosures. One coauthor reported serving as an expert witness in malpractice cases involving evaluation of febrile children.

SOURCE: Aronson PL et al. Pediatrics. 13 Nov 2018. doi: 10.1542/peds.2018-1879).

Using maternal characteristics to identify high-risk pregnant women for second-stage preeclampsia screening achieved similar detection rates as screening all pregnant women, based on data from a prospective study of 61,174 singleton pregnancies.

About 90% of preeclampsia cases can be predicted using the “triple test” of mean arterial pressure (MAP), uterine artery pulsatility index (UtA-PI) and serum placental growth factor (PlGF) plus a combination of maternal factors at 11 to 13 weeks’ gestation, wrote Alan Wright, PhD, of the University of Exeter, United Kingdom, and colleagues. The need for detection of preeclampsia is important, as high-risk pregnant women who take aspirin before 16 weeks’ gestation can reduce early preeclampsia by 90% and preterm preeclampsia by 60%, they said.

However, “measurements of serum PlGF and UtA-PI are not part of routine care and would be associated with an additional cost,” Dr. Wright and his colleagues noted in the American Journal of Obstetrics & Gynecology.

In the study, the researchers used a competing risks model to combine MAP, UtA-PI, and PlGF and maternal factors to compare detection rates if the triple test were used for a subset of high-risk women. Most of the women in the study were white.

Overall, Dr. Wright and his colleagues found, if first-stage screening method is maternal factors, then measurements of MAP, UtA-PI, and PlGF can be reserved for 70% of the pregnant population.

When the researchers compared various components of the triple test, they found that, if the first stage of screening included maternal factors along with MAP and UtA-PI, measurement of PlGF could be saved for 30%-40% of pregnant women. Similarly, if first-stage screening included maternal factors, MAP, and PlGF, measurement of UtA-PI can be saved for 20%-30% of the population, they said.

The study findings were limited by several factors, including the homogeneity of the population studied, the researchers noted. “The risk for development of [preeclampsia] is higher in women of black or South Asian racial origin than in white women,” Dr. Wright and his colleagues wrote. “Consequently, in screening in a population of mixed racial origins, for a given risk cut-off, the [detection rate] and [screen positive rate] would be higher in black and South Asian than white women and the overall performance would be dependent on the proportion of the various racial groups within that population.”

However, the results support the effectiveness of using only certain tests paired with maternal factors to identify high-risk patients for further screening.

“Inevitably, biomarker screening for only part of the population will have financial benefits over conducting the test for the entire population,” the researchers said.

Dr. Wright and his colleagues reported no conflicts of interest. The study was supported in part by the Fetal Medicine Foundation, and the reagents and equipment used for the measurement of serum placental growth factor were provided by PerkinElmer Life and Analytical Sciences.

SOURCE: Wright A et al. Am J Obstet Gynecol. 2018. doi: 10.1016/j.ajog.2018.10.092.

Using maternal characteristics to identify high-risk pregnant women for second-stage preeclampsia screening achieved similar detection rates as screening all pregnant women, based on data from a prospective study of 61,174 singleton pregnancies.

About 90% of preeclampsia cases can be predicted using the “triple test” of mean arterial pressure (MAP), uterine artery pulsatility index (UtA-PI) and serum placental growth factor (PlGF) plus a combination of maternal factors at 11 to 13 weeks’ gestation, wrote Alan Wright, PhD, of the University of Exeter, United Kingdom, and colleagues. The need for detection of preeclampsia is important, as high-risk pregnant women who take aspirin before 16 weeks’ gestation can reduce early preeclampsia by 90% and preterm preeclampsia by 60%, they said.

However, “measurements of serum PlGF and UtA-PI are not part of routine care and would be associated with an additional cost,” Dr. Wright and his colleagues noted in the American Journal of Obstetrics & Gynecology.

In the study, the researchers used a competing risks model to combine MAP, UtA-PI, and PlGF and maternal factors to compare detection rates if the triple test were used for a subset of high-risk women. Most of the women in the study were white.

Overall, Dr. Wright and his colleagues found, if first-stage screening method is maternal factors, then measurements of MAP, UtA-PI, and PlGF can be reserved for 70% of the pregnant population.

When the researchers compared various components of the triple test, they found that, if the first stage of screening included maternal factors along with MAP and UtA-PI, measurement of PlGF could be saved for 30%-40% of pregnant women. Similarly, if first-stage screening included maternal factors, MAP, and PlGF, measurement of UtA-PI can be saved for 20%-30% of the population, they said.

The study findings were limited by several factors, including the homogeneity of the population studied, the researchers noted. “The risk for development of [preeclampsia] is higher in women of black or South Asian racial origin than in white women,” Dr. Wright and his colleagues wrote. “Consequently, in screening in a population of mixed racial origins, for a given risk cut-off, the [detection rate] and [screen positive rate] would be higher in black and South Asian than white women and the overall performance would be dependent on the proportion of the various racial groups within that population.”

However, the results support the effectiveness of using only certain tests paired with maternal factors to identify high-risk patients for further screening.

“Inevitably, biomarker screening for only part of the population will have financial benefits over conducting the test for the entire population,” the researchers said.

Dr. Wright and his colleagues reported no conflicts of interest. The study was supported in part by the Fetal Medicine Foundation, and the reagents and equipment used for the measurement of serum placental growth factor were provided by PerkinElmer Life and Analytical Sciences.

SOURCE: Wright A et al. Am J Obstet Gynecol. 2018. doi: 10.1016/j.ajog.2018.10.092.

Using maternal characteristics to identify high-risk pregnant women for second-stage preeclampsia screening achieved similar detection rates as screening all pregnant women, based on data from a prospective study of 61,174 singleton pregnancies.

About 90% of preeclampsia cases can be predicted using the “triple test” of mean arterial pressure (MAP), uterine artery pulsatility index (UtA-PI) and serum placental growth factor (PlGF) plus a combination of maternal factors at 11 to 13 weeks’ gestation, wrote Alan Wright, PhD, of the University of Exeter, United Kingdom, and colleagues. The need for detection of preeclampsia is important, as high-risk pregnant women who take aspirin before 16 weeks’ gestation can reduce early preeclampsia by 90% and preterm preeclampsia by 60%, they said.

However, “measurements of serum PlGF and UtA-PI are not part of routine care and would be associated with an additional cost,” Dr. Wright and his colleagues noted in the American Journal of Obstetrics & Gynecology.

In the study, the researchers used a competing risks model to combine MAP, UtA-PI, and PlGF and maternal factors to compare detection rates if the triple test were used for a subset of high-risk women. Most of the women in the study were white.

Overall, Dr. Wright and his colleagues found, if first-stage screening method is maternal factors, then measurements of MAP, UtA-PI, and PlGF can be reserved for 70% of the pregnant population.

When the researchers compared various components of the triple test, they found that, if the first stage of screening included maternal factors along with MAP and UtA-PI, measurement of PlGF could be saved for 30%-40% of pregnant women. Similarly, if first-stage screening included maternal factors, MAP, and PlGF, measurement of UtA-PI can be saved for 20%-30% of the population, they said.

The study findings were limited by several factors, including the homogeneity of the population studied, the researchers noted. “The risk for development of [preeclampsia] is higher in women of black or South Asian racial origin than in white women,” Dr. Wright and his colleagues wrote. “Consequently, in screening in a population of mixed racial origins, for a given risk cut-off, the [detection rate] and [screen positive rate] would be higher in black and South Asian than white women and the overall performance would be dependent on the proportion of the various racial groups within that population.”

However, the results support the effectiveness of using only certain tests paired with maternal factors to identify high-risk patients for further screening.

“Inevitably, biomarker screening for only part of the population will have financial benefits over conducting the test for the entire population,” the researchers said.

Dr. Wright and his colleagues reported no conflicts of interest. The study was supported in part by the Fetal Medicine Foundation, and the reagents and equipment used for the measurement of serum placental growth factor were provided by PerkinElmer Life and Analytical Sciences.

SOURCE: Wright A et al. Am J Obstet Gynecol. 2018. doi: 10.1016/j.ajog.2018.10.092.

The Food and Drug Administration has approved use of eltrombopag (Promacta) for patients severe aplastic anemia (SAA), Novartis announced Nov. 16.

The agency’s move means that eltrombopag, a synthetic thrombopoietin-receptor agonist, is now approved for use in combination with standard immunosuppressive therapy as first-line treatment for adults, and pediatric patients aged 2 and older with SAA. The drug received breakthrough therapy designation and priority review for this indication, the company said in a press release.

In addition, eltrombopag is FDA-approved for SAA patients who have had an insufficient response to immunosuppressive therapy, those with chronic immune thrombocytopenia who have had an insufficient response to other treatments, and those with thrombocytopenia and with chronic hepatitis C infection.

The expanded approval is based on results of a phase 1-2 trial (NCT01623167), which were published last year (N Eng J Med. 2017 Apr 20;376[16]:1540-50). The trial included 153 previously untreated SAA patients aged 2 and older. The patients received eltrombopag in combination with horse antithymocyte globulin and cyclosporine.

The starting dose of eltrombopag in the trial was 150 mg once daily for patients aged 12 and older (75 mg for East and Southeast Asians), 75 mg once daily for patients aged 6 to 11 (37.5 mg for East and Southeast Asians), and 2.5 mg/kg once daily for patients aged 2 to 5 (1.25 mg/kg for East and Southeast Asians).

Patients were divided into three cohorts with different dosing schedules. The recommended schedule from the third cohort (n = 92) was eltrombopag from day 1 to month 6, plus horse antithymocyte globulin and cyclosporine. All patients in this cohort were eligible to receive a low dose of cyclosporine for an additional 18 months if they achieved a hematologic response at 6 months.

Among the patients treated at the recommended dosing schedule, the 6-month overall response rate was 79%, and the complete response rate was 44%. The median duration of both overall and complete response was 24.3 months.

The most common adverse events in these patients were increases in ALT (29%), AST (17%), and blood bilirubin (17%). Also, rash (8%), and skin discoloration, including hyperpigmentation (5%), were cited as adverse events.

Updated results from the trial are available in the prescribing information for eltrombopag. In most countries outside of the United States, the drug is marketed as Revolade.

jensmith@mdedge.com

The Food and Drug Administration has approved use of eltrombopag (Promacta) for patients severe aplastic anemia (SAA), Novartis announced Nov. 16.

The agency’s move means that eltrombopag, a synthetic thrombopoietin-receptor agonist, is now approved for use in combination with standard immunosuppressive therapy as first-line treatment for adults, and pediatric patients aged 2 and older with SAA. The drug received breakthrough therapy designation and priority review for this indication, the company said in a press release.

In addition, eltrombopag is FDA-approved for SAA patients who have had an insufficient response to immunosuppressive therapy, those with chronic immune thrombocytopenia who have had an insufficient response to other treatments, and those with thrombocytopenia and with chronic hepatitis C infection.

The expanded approval is based on results of a phase 1-2 trial (NCT01623167), which were published last year (N Eng J Med. 2017 Apr 20;376[16]:1540-50). The trial included 153 previously untreated SAA patients aged 2 and older. The patients received eltrombopag in combination with horse antithymocyte globulin and cyclosporine.

The starting dose of eltrombopag in the trial was 150 mg once daily for patients aged 12 and older (75 mg for East and Southeast Asians), 75 mg once daily for patients aged 6 to 11 (37.5 mg for East and Southeast Asians), and 2.5 mg/kg once daily for patients aged 2 to 5 (1.25 mg/kg for East and Southeast Asians).

Patients were divided into three cohorts with different dosing schedules. The recommended schedule from the third cohort (n = 92) was eltrombopag from day 1 to month 6, plus horse antithymocyte globulin and cyclosporine. All patients in this cohort were eligible to receive a low dose of cyclosporine for an additional 18 months if they achieved a hematologic response at 6 months.

Among the patients treated at the recommended dosing schedule, the 6-month overall response rate was 79%, and the complete response rate was 44%. The median duration of both overall and complete response was 24.3 months.

The most common adverse events in these patients were increases in ALT (29%), AST (17%), and blood bilirubin (17%). Also, rash (8%), and skin discoloration, including hyperpigmentation (5%), were cited as adverse events.

Updated results from the trial are available in the prescribing information for eltrombopag. In most countries outside of the United States, the drug is marketed as Revolade.

jensmith@mdedge.com

The Food and Drug Administration has approved use of eltrombopag (Promacta) for patients severe aplastic anemia (SAA), Novartis announced Nov. 16.

The agency’s move means that eltrombopag, a synthetic thrombopoietin-receptor agonist, is now approved for use in combination with standard immunosuppressive therapy as first-line treatment for adults, and pediatric patients aged 2 and older with SAA. The drug received breakthrough therapy designation and priority review for this indication, the company said in a press release.

In addition, eltrombopag is FDA-approved for SAA patients who have had an insufficient response to immunosuppressive therapy, those with chronic immune thrombocytopenia who have had an insufficient response to other treatments, and those with thrombocytopenia and with chronic hepatitis C infection.

The expanded approval is based on results of a phase 1-2 trial (NCT01623167), which were published last year (N Eng J Med. 2017 Apr 20;376[16]:1540-50). The trial included 153 previously untreated SAA patients aged 2 and older. The patients received eltrombopag in combination with horse antithymocyte globulin and cyclosporine.

The starting dose of eltrombopag in the trial was 150 mg once daily for patients aged 12 and older (75 mg for East and Southeast Asians), 75 mg once daily for patients aged 6 to 11 (37.5 mg for East and Southeast Asians), and 2.5 mg/kg once daily for patients aged 2 to 5 (1.25 mg/kg for East and Southeast Asians).

Patients were divided into three cohorts with different dosing schedules. The recommended schedule from the third cohort (n = 92) was eltrombopag from day 1 to month 6, plus horse antithymocyte globulin and cyclosporine. All patients in this cohort were eligible to receive a low dose of cyclosporine for an additional 18 months if they achieved a hematologic response at 6 months.

Among the patients treated at the recommended dosing schedule, the 6-month overall response rate was 79%, and the complete response rate was 44%. The median duration of both overall and complete response was 24.3 months.

The most common adverse events in these patients were increases in ALT (29%), AST (17%), and blood bilirubin (17%). Also, rash (8%), and skin discoloration, including hyperpigmentation (5%), were cited as adverse events.

Updated results from the trial are available in the prescribing information for eltrombopag. In most countries outside of the United States, the drug is marketed as Revolade.

jensmith@mdedge.com

Photo courtesy of GSK

The U.S. Food and Drug Administration (FDA) has expanded the approved use of eltrombopag (Promacta®) in severe aplastic anemia (SAA).

Eltrombopag is now approved for use in combination with standard immunosuppressive therapy as first-line treatment for adults and pediatric patients age 2 and older with SAA.

Eltrombopag received breakthrough therapy designation and priority review for this indication.

Eltrombopag is also FDA-approved for SAA patients who have had an insufficient response to immunosuppressive therapy, for patients with chronic immune thrombocytopenia who have had an insufficient response to other treatments, and to treat thrombocytopenia in patients with chronic hepatitis C virus infection.

The FDA’s latest approval of eltrombopag is based on results from a phase 1/2 trial (NCT01623167), which were published in The New England Journal of Medicine in April 2017.

Updated results from the trial are available in the prescribing information for eltrombopag.

The trial included 153 previously untreated SAA patients age 2 and older. The patients received eltrombopag in combination with horse antithymocyte globulin and cyclosporine.

The starting dose of eltrombopag was:

• 150 mg once daily for patients age 12 and older (75 mg for East and Southeast Asians)
• 75 mg once daily for patients ages 6 to 11 (37.5 mg for East and Southeast Asians)
• 5 mg/kg once daily for patients ages 2 to 5 (1.25 mg/kg for East and Southeast Asians).

Patients were divided into three cohorts with different dosing schedules.

The recommended schedule, from the third cohort (n=92), was eltrombopag from day 1 to month 6, plus horse antithymocyte globulin and cyclosporine. All patients in this cohort were eligible to receive a low dose of cyclosporine for an additional 18 months if they achieved a hematologic response at 6 months.

Among the patients treated at the recommended dosing schedule, the 6-month overall response rate was 79%, and the complete response rate was 44%.

The median duration of both overall and complete response was 24.3 months.

The most common adverse events in these patients were ALT increase (29%), AST increase (17%), blood bilirubin increase (17%), rash (8%), and skin discoloration including hyperpigmentation (5%).

Eltrombopag is a product of Novartis.

Photo courtesy of GSK

The U.S. Food and Drug Administration (FDA) has expanded the approved use of eltrombopag (Promacta®) in severe aplastic anemia (SAA).

Eltrombopag is now approved for use in combination with standard immunosuppressive therapy as first-line treatment for adults and pediatric patients age 2 and older with SAA.

Eltrombopag received breakthrough therapy designation and priority review for this indication.

Eltrombopag is also FDA-approved for SAA patients who have had an insufficient response to immunosuppressive therapy, for patients with chronic immune thrombocytopenia who have had an insufficient response to other treatments, and to treat thrombocytopenia in patients with chronic hepatitis C virus infection.

The FDA’s latest approval of eltrombopag is based on results from a phase 1/2 trial (NCT01623167), which were published in The New England Journal of Medicine in April 2017.

Updated results from the trial are available in the prescribing information for eltrombopag.

The trial included 153 previously untreated SAA patients age 2 and older. The patients received eltrombopag in combination with horse antithymocyte globulin and cyclosporine.

The starting dose of eltrombopag was:

• 150 mg once daily for patients age 12 and older (75 mg for East and Southeast Asians)
• 75 mg once daily for patients ages 6 to 11 (37.5 mg for East and Southeast Asians)
• 5 mg/kg once daily for patients ages 2 to 5 (1.25 mg/kg for East and Southeast Asians).

Patients were divided into three cohorts with different dosing schedules.

The recommended schedule, from the third cohort (n=92), was eltrombopag from day 1 to month 6, plus horse antithymocyte globulin and cyclosporine. All patients in this cohort were eligible to receive a low dose of cyclosporine for an additional 18 months if they achieved a hematologic response at 6 months.

Among the patients treated at the recommended dosing schedule, the 6-month overall response rate was 79%, and the complete response rate was 44%.

The median duration of both overall and complete response was 24.3 months.

The most common adverse events in these patients were ALT increase (29%), AST increase (17%), blood bilirubin increase (17%), rash (8%), and skin discoloration including hyperpigmentation (5%).

Eltrombopag is a product of Novartis.

Photo courtesy of GSK

The U.S. Food and Drug Administration (FDA) has expanded the approved use of eltrombopag (Promacta®) in severe aplastic anemia (SAA).

Eltrombopag is now approved for use in combination with standard immunosuppressive therapy as first-line treatment for adults and pediatric patients age 2 and older with SAA.

Eltrombopag received breakthrough therapy designation and priority review for this indication.

Eltrombopag is also FDA-approved for SAA patients who have had an insufficient response to immunosuppressive therapy, for patients with chronic immune thrombocytopenia who have had an insufficient response to other treatments, and to treat thrombocytopenia in patients with chronic hepatitis C virus infection.

The FDA’s latest approval of eltrombopag is based on results from a phase 1/2 trial (NCT01623167), which were published in The New England Journal of Medicine in April 2017.

Updated results from the trial are available in the prescribing information for eltrombopag.

The trial included 153 previously untreated SAA patients age 2 and older. The patients received eltrombopag in combination with horse antithymocyte globulin and cyclosporine.

The starting dose of eltrombopag was:

• 150 mg once daily for patients age 12 and older (75 mg for East and Southeast Asians)
• 75 mg once daily for patients ages 6 to 11 (37.5 mg for East and Southeast Asians)
• 5 mg/kg once daily for patients ages 2 to 5 (1.25 mg/kg for East and Southeast Asians).

Patients were divided into three cohorts with different dosing schedules.

The recommended schedule, from the third cohort (n=92), was eltrombopag from day 1 to month 6, plus horse antithymocyte globulin and cyclosporine. All patients in this cohort were eligible to receive a low dose of cyclosporine for an additional 18 months if they achieved a hematologic response at 6 months.

Among the patients treated at the recommended dosing schedule, the 6-month overall response rate was 79%, and the complete response rate was 44%.

The median duration of both overall and complete response was 24.3 months.

The most common adverse events in these patients were ALT increase (29%), AST increase (17%), blood bilirubin increase (17%), rash (8%), and skin discoloration including hyperpigmentation (5%).

Eltrombopag is a product of Novartis.

Patients with migrane are more sensitive to all colors of light during the ictal phase than the during interictal phase, according to a recent study, but control subjects do not experience pain when exposed to different colors of light. In order to identify the origin of this photophobia in migraineurs, researchers compared the electrical waveforms that were generated in the retina and visual cortex of 46 interictal migraineurs to those generated in 42 healthy controls using color-based electroretinography and visual evoked potential paradigms. They found:

• Unexpectedly, it was the amplitude of the retinal rod-driven b-wave, which was consistently larger in the migraineurs than in the controls, rather than the retinal cone-driven a-wave or the visual evoked potentials that differ most strikingly between the 2 groups.
• Mechanistically, these findings suggest that the inherent hypersensitivity to light among migraine patients may originate in the retinal rods rather than retinal cones or the visual cortex.

Clinically, these findings may explain why migraineurs complain that the light is too bright even when it is dim.

Bernstein CA, N R-R, Noseda R, et al. The migraine eye: distinct rod-driven retinal pathways’ response to dim light challenges the visual cortex hyperexcitability theory. [Published online ahead of print October 29, 2018]. Pain. doi:10.1097/j.pain.0000000000001434.

Patients with migrane are more sensitive to all colors of light during the ictal phase than the during interictal phase, according to a recent study, but control subjects do not experience pain when exposed to different colors of light. In order to identify the origin of this photophobia in migraineurs, researchers compared the electrical waveforms that were generated in the retina and visual cortex of 46 interictal migraineurs to those generated in 42 healthy controls using color-based electroretinography and visual evoked potential paradigms. They found:

• Unexpectedly, it was the amplitude of the retinal rod-driven b-wave, which was consistently larger in the migraineurs than in the controls, rather than the retinal cone-driven a-wave or the visual evoked potentials that differ most strikingly between the 2 groups.
• Mechanistically, these findings suggest that the inherent hypersensitivity to light among migraine patients may originate in the retinal rods rather than retinal cones or the visual cortex.

Clinically, these findings may explain why migraineurs complain that the light is too bright even when it is dim.

Bernstein CA, N R-R, Noseda R, et al. The migraine eye: distinct rod-driven retinal pathways’ response to dim light challenges the visual cortex hyperexcitability theory. [Published online ahead of print October 29, 2018]. Pain. doi:10.1097/j.pain.0000000000001434.

Patients with migrane are more sensitive to all colors of light during the ictal phase than the during interictal phase, according to a recent study, but control subjects do not experience pain when exposed to different colors of light. In order to identify the origin of this photophobia in migraineurs, researchers compared the electrical waveforms that were generated in the retina and visual cortex of 46 interictal migraineurs to those generated in 42 healthy controls using color-based electroretinography and visual evoked potential paradigms. They found:

• Unexpectedly, it was the amplitude of the retinal rod-driven b-wave, which was consistently larger in the migraineurs than in the controls, rather than the retinal cone-driven a-wave or the visual evoked potentials that differ most strikingly between the 2 groups.
• Mechanistically, these findings suggest that the inherent hypersensitivity to light among migraine patients may originate in the retinal rods rather than retinal cones or the visual cortex.

Clinically, these findings may explain why migraineurs complain that the light is too bright even when it is dim.

Bernstein CA, N R-R, Noseda R, et al. The migraine eye: distinct rod-driven retinal pathways’ response to dim light challenges the visual cortex hyperexcitability theory. [Published online ahead of print October 29, 2018]. Pain. doi:10.1097/j.pain.0000000000001434.

Parental migraine impacts children aged 11 to 17 living in the home, particularly in the domains of global well‐being and the parent/child relationship, according to a recent study. This cross‐sectional observational study included parents who met International Classification of Headache Disorders criteria for migraine and their 11- to 17‐year‐old children currently living with the parent with migraine recruited from neurologist offices and online. Researchers found:

• Children (n=40) reported the greatest impact of their parent’s migraine on the Global Well‐Being and Parent/Child Relationship subscales.
• There were no significant differences between the average child and parent rating of parental migraine impact on children.
• Correlations between parent and child ratings of parental migraine impact were strongest for the Social Impact subscale, and non‐significant for the Parent/Child Relationship and Friends Reactions subscales.

Seng EK, Mauser ED, Marzouk N, Patel ZS, Rosen N, Buse DC. When mom has migraine: An observational study of the impact of parental migraine on adolescent children. [Published online ahead of print October 31, 2018]. Headache. doi:10.1111/head.13433.

Parental migraine impacts children aged 11 to 17 living in the home, particularly in the domains of global well‐being and the parent/child relationship, according to a recent study. This cross‐sectional observational study included parents who met International Classification of Headache Disorders criteria for migraine and their 11- to 17‐year‐old children currently living with the parent with migraine recruited from neurologist offices and online. Researchers found:

• Children (n=40) reported the greatest impact of their parent’s migraine on the Global Well‐Being and Parent/Child Relationship subscales.
• There were no significant differences between the average child and parent rating of parental migraine impact on children.
• Correlations between parent and child ratings of parental migraine impact were strongest for the Social Impact subscale, and non‐significant for the Parent/Child Relationship and Friends Reactions subscales.

Seng EK, Mauser ED, Marzouk N, Patel ZS, Rosen N, Buse DC. When mom has migraine: An observational study of the impact of parental migraine on adolescent children. [Published online ahead of print October 31, 2018]. Headache. doi:10.1111/head.13433.

Parental migraine impacts children aged 11 to 17 living in the home, particularly in the domains of global well‐being and the parent/child relationship, according to a recent study. This cross‐sectional observational study included parents who met International Classification of Headache Disorders criteria for migraine and their 11- to 17‐year‐old children currently living with the parent with migraine recruited from neurologist offices and online. Researchers found:

• Children (n=40) reported the greatest impact of their parent’s migraine on the Global Well‐Being and Parent/Child Relationship subscales.
• There were no significant differences between the average child and parent rating of parental migraine impact on children.
• Correlations between parent and child ratings of parental migraine impact were strongest for the Social Impact subscale, and non‐significant for the Parent/Child Relationship and Friends Reactions subscales.

Seng EK, Mauser ED, Marzouk N, Patel ZS, Rosen N, Buse DC. When mom has migraine: An observational study of the impact of parental migraine on adolescent children. [Published online ahead of print October 31, 2018]. Headache. doi:10.1111/head.13433.

Headache disorders, and migraine in particular, are important causes of disability worldwide, and deserve greater attention in health policy debates and research resource allocation. This according to a recent investigation that used data from the Global Burden of Diseases, Injuries, and Risk Factors (GBD) 2016 study to provide new estimates for prevalence and years of life lived with disability (YLDs) for migraine and tension-type headache. Prevalence for gender and 5-year age group interval at different time points from 1990 and 2016 in all countries and GBD regions were estimated using a Bayesian meta-regression model. Researchers found:

• Almost 3 billion individuals were estimated to have a migraine or tension-type headache in 2016: 1.89 billion with tension-type headache and 1.04 billion with migraine.
• However, because migraine had a much higher disability weight than tension-type headache, migraine caused 45.1 million and tension-type headache only 7.2 million YLDs globally in 2016.
• The headaches were most burdensome in women between ages 15 and 49 years, with migraine causing 20.3 million and tension-type headache 2.9 million YLDs in 2016, which was 11.2% of all YLDs in this age group and sex.

Stovner LJ, Nichols E, Steiner TJ, et al. GBD 2016 Headache Collaborators. Global, regional, and national burden of migraine and tension-type headache, 1990-2016: A systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018;17(11):954-976. doi:10.1016/S1474-4422(18)30322-3.

Headache disorders, and migraine in particular, are important causes of disability worldwide, and deserve greater attention in health policy debates and research resource allocation. This according to a recent investigation that used data from the Global Burden of Diseases, Injuries, and Risk Factors (GBD) 2016 study to provide new estimates for prevalence and years of life lived with disability (YLDs) for migraine and tension-type headache. Prevalence for gender and 5-year age group interval at different time points from 1990 and 2016 in all countries and GBD regions were estimated using a Bayesian meta-regression model. Researchers found:

• Almost 3 billion individuals were estimated to have a migraine or tension-type headache in 2016: 1.89 billion with tension-type headache and 1.04 billion with migraine.
• However, because migraine had a much higher disability weight than tension-type headache, migraine caused 45.1 million and tension-type headache only 7.2 million YLDs globally in 2016.
• The headaches were most burdensome in women between ages 15 and 49 years, with migraine causing 20.3 million and tension-type headache 2.9 million YLDs in 2016, which was 11.2% of all YLDs in this age group and sex.

Stovner LJ, Nichols E, Steiner TJ, et al. GBD 2016 Headache Collaborators. Global, regional, and national burden of migraine and tension-type headache, 1990-2016: A systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018;17(11):954-976. doi:10.1016/S1474-4422(18)30322-3.

Headache disorders, and migraine in particular, are important causes of disability worldwide, and deserve greater attention in health policy debates and research resource allocation. This according to a recent investigation that used data from the Global Burden of Diseases, Injuries, and Risk Factors (GBD) 2016 study to provide new estimates for prevalence and years of life lived with disability (YLDs) for migraine and tension-type headache. Prevalence for gender and 5-year age group interval at different time points from 1990 and 2016 in all countries and GBD regions were estimated using a Bayesian meta-regression model. Researchers found:

• Almost 3 billion individuals were estimated to have a migraine or tension-type headache in 2016: 1.89 billion with tension-type headache and 1.04 billion with migraine.
• However, because migraine had a much higher disability weight than tension-type headache, migraine caused 45.1 million and tension-type headache only 7.2 million YLDs globally in 2016.
• The headaches were most burdensome in women between ages 15 and 49 years, with migraine causing 20.3 million and tension-type headache 2.9 million YLDs in 2016, which was 11.2% of all YLDs in this age group and sex.

Stovner LJ, Nichols E, Steiner TJ, et al. GBD 2016 Headache Collaborators. Global, regional, and national burden of migraine and tension-type headache, 1990-2016: A systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018;17(11):954-976. doi:10.1016/S1474-4422(18)30322-3.

Although ambulatory EEGs (aEEGs) can help distinguish epileptic attacks from non-epileptic attacks, they have their limitations. A recent retrospective review of EEG procedure notes from the Stanford Comprehensive Epilepsy Center has found that they rarely yield useful information beyond 24 hours duration.

• Stanford researchers analyzed 358 adult aEEG readings from 2010 to 2017 and found epileptiform discharges or epileptic seizures in 101 of the readings (28%).
• The analysis compared detection rates for 20-30 hours, 30-50 hours, and 50-76 hours and found little difference.
• Epilepsy seizures were observed in 11%, 7%, and 10% respectively for the 3 duration periods.
• An analysis of the epileptiform abnormalities revealed no significant differences in detection rates for the 3 duration periods.
• Among aEEGs that were ordered to characterize suspected events, however, 72 hours was the best option because it generated a higher rate of capture.

Kuo J, Lee-Messer C, Le S. Optimal recording duration of ambulatory EEG (aEEG). Epilepsy Res. 2018;149:9-12.

Although ambulatory EEGs (aEEGs) can help distinguish epileptic attacks from non-epileptic attacks, they have their limitations. A recent retrospective review of EEG procedure notes from the Stanford Comprehensive Epilepsy Center has found that they rarely yield useful information beyond 24 hours duration.

• Stanford researchers analyzed 358 adult aEEG readings from 2010 to 2017 and found epileptiform discharges or epileptic seizures in 101 of the readings (28%).
• The analysis compared detection rates for 20-30 hours, 30-50 hours, and 50-76 hours and found little difference.
• Epilepsy seizures were observed in 11%, 7%, and 10% respectively for the 3 duration periods.
• An analysis of the epileptiform abnormalities revealed no significant differences in detection rates for the 3 duration periods.
• Among aEEGs that were ordered to characterize suspected events, however, 72 hours was the best option because it generated a higher rate of capture.

Kuo J, Lee-Messer C, Le S. Optimal recording duration of ambulatory EEG (aEEG). Epilepsy Res. 2018;149:9-12.

Although ambulatory EEGs (aEEGs) can help distinguish epileptic attacks from non-epileptic attacks, they have their limitations. A recent retrospective review of EEG procedure notes from the Stanford Comprehensive Epilepsy Center has found that they rarely yield useful information beyond 24 hours duration.

• Stanford researchers analyzed 358 adult aEEG readings from 2010 to 2017 and found epileptiform discharges or epileptic seizures in 101 of the readings (28%).
• The analysis compared detection rates for 20-30 hours, 30-50 hours, and 50-76 hours and found little difference.
• Epilepsy seizures were observed in 11%, 7%, and 10% respectively for the 3 duration periods.
• An analysis of the epileptiform abnormalities revealed no significant differences in detection rates for the 3 duration periods.
• Among aEEGs that were ordered to characterize suspected events, however, 72 hours was the best option because it generated a higher rate of capture.

Kuo J, Lee-Messer C, Le S. Optimal recording duration of ambulatory EEG (aEEG). Epilepsy Res. 2018;149:9-12.