Key clinical point: Treatment with DMT for more than 10 years reduces the risk of confirmed disability progression in MS.

Major finding: Continuous treatment with DMT reduced the risk of 24-month confirmed disability progression by 35%.

Study details: A retrospective analysis of data for 15,602 patients with relapsing-remitting MS.

Disclosures: Two of the researchers are employees of Biogen International, which supported the research. Several investigators received compensation or funding from various pharmaceutical companies.

Citation: Laffaldano P et al. ECTRIMS 2019. Abstract 94.

Key clinical point: Treatment with DMT for more than 10 years reduces the risk of confirmed disability progression in MS.

Major finding: Continuous treatment with DMT reduced the risk of 24-month confirmed disability progression by 35%.

Study details: A retrospective analysis of data for 15,602 patients with relapsing-remitting MS.

Disclosures: Two of the researchers are employees of Biogen International, which supported the research. Several investigators received compensation or funding from various pharmaceutical companies.

Citation: Laffaldano P et al. ECTRIMS 2019. Abstract 94.

Key clinical point: Treatment with DMT for more than 10 years reduces the risk of confirmed disability progression in MS.

Major finding: Continuous treatment with DMT reduced the risk of 24-month confirmed disability progression by 35%.

Study details: A retrospective analysis of data for 15,602 patients with relapsing-remitting MS.

Disclosures: Two of the researchers are employees of Biogen International, which supported the research. Several investigators received compensation or funding from various pharmaceutical companies.

Citation: Laffaldano P et al. ECTRIMS 2019. Abstract 94.

The Food and Drug Administration has alerted health care professionals and patients about a voluntary recall of some prescription ranitidine (Zantac) because of detected N-nitrosodimethylamine (NDMA) levels, according to a news release from the agency.

The recall applies to 14 lots in which NDMA, a probable human carcinogen and nitrosamine impurity formed as a byproduct of several industrial and natural processes, has been detected at levels above those set by the FDA, according to a company announcement on Sept. 23 from Sandoz. According to the announcement, which also specifies the affected lots, the company has not received any reports of adverse events related to use of the products in the recall.

According to the FDA release, so far, only the specified lots of ranitidine are known to be contaminated, and patients can continue taking this stomach acid–reducing histamine₂ blocker from lots that are not affected by the recall.

“When we identify lapses in the quality of drugs that pose potential risks for patients, the FDA makes all efforts to understand the issue and provide our best recommendation to the public as quickly and accurately as possible,” said acting FDA Commissioner Norman E. Sharpless, MD.

As part of this ongoing investigation, the FDA recently posted a testing protocol for detecting NDMA in ranitidine; the agency hopes regulators and industry will use this protocol to begin their own laboratory testing as well and send samples to the FDA for further testing.

More information about the recall, as well as instructions for patients and health care professionals, can be found in the full news release on the FDA website. The agency also encourages any adverse reactions be reported to its MedWatch program.

[email protected]

The Food and Drug Administration has alerted health care professionals and patients about a voluntary recall of some prescription ranitidine (Zantac) because of detected N-nitrosodimethylamine (NDMA) levels, according to a news release from the agency.

The recall applies to 14 lots in which NDMA, a probable human carcinogen and nitrosamine impurity formed as a byproduct of several industrial and natural processes, has been detected at levels above those set by the FDA, according to a company announcement on Sept. 23 from Sandoz. According to the announcement, which also specifies the affected lots, the company has not received any reports of adverse events related to use of the products in the recall.

According to the FDA release, so far, only the specified lots of ranitidine are known to be contaminated, and patients can continue taking this stomach acid–reducing histamine₂ blocker from lots that are not affected by the recall.

“When we identify lapses in the quality of drugs that pose potential risks for patients, the FDA makes all efforts to understand the issue and provide our best recommendation to the public as quickly and accurately as possible,” said acting FDA Commissioner Norman E. Sharpless, MD.

As part of this ongoing investigation, the FDA recently posted a testing protocol for detecting NDMA in ranitidine; the agency hopes regulators and industry will use this protocol to begin their own laboratory testing as well and send samples to the FDA for further testing.

More information about the recall, as well as instructions for patients and health care professionals, can be found in the full news release on the FDA website. The agency also encourages any adverse reactions be reported to its MedWatch program.

[email protected]

The Food and Drug Administration has alerted health care professionals and patients about a voluntary recall of some prescription ranitidine (Zantac) because of detected N-nitrosodimethylamine (NDMA) levels, according to a news release from the agency.

The recall applies to 14 lots in which NDMA, a probable human carcinogen and nitrosamine impurity formed as a byproduct of several industrial and natural processes, has been detected at levels above those set by the FDA, according to a company announcement on Sept. 23 from Sandoz. According to the announcement, which also specifies the affected lots, the company has not received any reports of adverse events related to use of the products in the recall.

According to the FDA release, so far, only the specified lots of ranitidine are known to be contaminated, and patients can continue taking this stomach acid–reducing histamine₂ blocker from lots that are not affected by the recall.

“When we identify lapses in the quality of drugs that pose potential risks for patients, the FDA makes all efforts to understand the issue and provide our best recommendation to the public as quickly and accurately as possible,” said acting FDA Commissioner Norman E. Sharpless, MD.

As part of this ongoing investigation, the FDA recently posted a testing protocol for detecting NDMA in ranitidine; the agency hopes regulators and industry will use this protocol to begin their own laboratory testing as well and send samples to the FDA for further testing.

More information about the recall, as well as instructions for patients and health care professionals, can be found in the full news release on the FDA website. The agency also encourages any adverse reactions be reported to its MedWatch program.

[email protected]

COPENHAGEN – Lumateperone, a novel investigational drug for schizophrenia with a unique triple mechanism of action, showed impressive safety and tolerability while achieving a continuous decline in schizophrenia symptoms over the course of a year in a long-term, open-label study, Suresh Durgam, MD, said at the annual congress of the European College of Neuropsychopharmacology.

Bruce Jancin/MDedge News

Indeed, patients on lumateperone at the 1-year mark showed significant reductions in LDL cholesterol, total cholesterol, serum prolactin, and body weight, compared with baseline values recorded when participants were on various standard-of-care antipsychotics prior to switching. Other cardiometabolic parameters, including fasting blood glucose, insulin, triglycerides, and HDL cholesterol, showed only negligible change over the course of study, according to Dr. Durgam, a psychiatrist and senior vice president for late-stage clinical development and medical affairs at Intra-Cellular Therapies, the New York–based company developing lumateperone as its lead product.

This favorable cardiometabolic profile contrasts sharply with those of currently available antipsychotic agents, many of which worsen cardiometabolic risk factors. That would seem to be a major advantage for lumateperone and is likely to be a factor in the Food and Drug Administration’s ongoing deliberation over the company’s new drug application. The agency has promised a decision on the application by the end of December, Dr. Durgam said.

Intra-Cellular Therapies’ stock price took a hit in July 2019, when the FDA abruptly canceled an advisory committee meeting scheduled to consider lumateperone. The agency sought additional information on animal toxicology studies. Having received it from the company, the FDA now no longer plans to schedule an advisory committee meeting before issuing its marketing approval decision.

Lumateperone is an oral once-daily drug that doesn’t require titration. Its high degree of tolerability is thought to be attributable to the drug’s mechanism of action, which involves simultaneous modulation of three different neurotransmitter pathways: serotonin, dopamine, and glutamate. The drug is a potent serotonin 5-HT_2a antagonist and serotonin reuptake inhibitor, a dopamine D2 presynaptic partial agonist and postsynaptic antagonist, and it also modulates glutamate via activation of the D1 receptor.

Three phase 3, double-blind, placebo-controlled randomized clinical trials of 4-6 weeks duration have been completed in a total of 1,481 patients with acute exacerbation of schizophrenia. Two trials were positive, with lumateperone achieving significantly greater mean reductions in the Positive and Negative Syndrome Scale (PANSS) total score than placebo, while the third was negative, with no significant between-group difference. Of note, the safety profile of lumateperone was indistinguishable from placebo with the sole exception of somnolence, where the 20% incidence was twice that of placebo-treated controls. However, in the open-label program, dosing was switched from morning to evening, with a resultant drop in somnolence to the placebo level, Dr. Durgam said.

The open-label program has two parts. Part 1 was conducted in 302 patients with stable, generally mild schizophrenia symptoms while on risperidone, olanzapine, or various other antipsychotics commonly prescribed in the United States. They were switched to lumateperone at 42 mg once daily for 6 weeks, at which point they demonstrated significant reductions in body weight, serum prolactin, insulin, total cholesterol, and LDL cholesterol. They then were switched back to their former medications, with a resultant worsening of those parameters to prelumateperone levels, providing evidence of a cause-and-effect relationship with cardiometabolic risk factors.

Part 2 of the open-label program is the long-term study, in which 603 patients with stable symptoms on standard-of-care antipsychotics were switched to lumateperone at 42 mg/day, to be followed for 1 year or more. Dr. Durgam presented an interim analysis focused on the first 107 patients to achieve the 1-year treatment milestone. Most were obese at baseline: the group’s mean body mass index was 31.3 kg/m2. They experienced progressive weight loss, with a mean reduction of 1.82 kg on day 175 and 3.16 kg on day 350. About 24% of subjects had a 7% or greater reduction in body weight, while 8% had at least a 7% weight gain. Waist circumference decreased by an average of 5.2 cm from a baseline of 103.2 cm in men and by 1.9 cm in women.

The primary focus of the ongoing long-term study is safety. The most common treatment-emergent adverse events during a full year of therapy were dry mouth, headache, and diarrhea, each occurring in about 7% of patients. Only 0.8% of patients developed extrapyramidal symptoms.

At 150 days of treatment in 340 patients, 30% had achieved a PANSS response, defined as at least a 20% improvement in PANSS total score, compared with baseline. At 300 days in the smaller group who had reached that milestone at the time of the interim analysis, the PANSS response rate had grown to 41%.

Among patients with schizophrenia and comorbid depression as defined by a Calgary Depression Scale for Schizophrenia (CDSS) score of 6 or more at baseline, lumateperone at 42 mg/day improved depressive symptoms, such that 60% of those patients achieved a CDSS response – that is, at least a 50% reduction in the score – by day 75. This finding supports data from earlier short-term studies, and suggests that lumateperone’s multiple mechanisms of action and high tolerability make it a promising candidate for treatment of depression and other symptom domains of schizophrenia that are currently inadequately treated, according to Dr. Durgam.

Dr. Durgam also presented an update on the lumateperone program for bipolar depression, which consists of three phase 3, double-blind, placebo-controlled, 6-week-long clinical trials totaling 1,455 patients. Two have been completed: one positive and the other negative with an unusually high placebo response rate. The ongoing third trial will be the tiebreaker. Safety and tolerability have been as noted in other lumateperone studies.

In the positive trial, the primary efficacy endpoint was change in Montgomery-Åsberg Depression Rating Scale, which improved in lumateperone-treated patients by an average of 16.7 points from a baseline score of just over 30, a significantly better result than the 12.1-point reduction in placebo-treated controls. The treatment benefit was similar in bipolar I and bipolar II patients.

The phase 3 trial* for treatment of agitation in patients with Alzheimer’s disease and other dementias was stopped early for lack of efficacy in an interim analysis. And lumateperone is in ongoing phase 2 trials for sleep disturbances associated with neuropsychiatric disorders. The phase 2 study* in major depressive disorder has been completed.

[email protected]

*This article was updated 9/28/2019.

COPENHAGEN – Lumateperone, a novel investigational drug for schizophrenia with a unique triple mechanism of action, showed impressive safety and tolerability while achieving a continuous decline in schizophrenia symptoms over the course of a year in a long-term, open-label study, Suresh Durgam, MD, said at the annual congress of the European College of Neuropsychopharmacology.

Bruce Jancin/MDedge News

Indeed, patients on lumateperone at the 1-year mark showed significant reductions in LDL cholesterol, total cholesterol, serum prolactin, and body weight, compared with baseline values recorded when participants were on various standard-of-care antipsychotics prior to switching. Other cardiometabolic parameters, including fasting blood glucose, insulin, triglycerides, and HDL cholesterol, showed only negligible change over the course of study, according to Dr. Durgam, a psychiatrist and senior vice president for late-stage clinical development and medical affairs at Intra-Cellular Therapies, the New York–based company developing lumateperone as its lead product.

This favorable cardiometabolic profile contrasts sharply with those of currently available antipsychotic agents, many of which worsen cardiometabolic risk factors. That would seem to be a major advantage for lumateperone and is likely to be a factor in the Food and Drug Administration’s ongoing deliberation over the company’s new drug application. The agency has promised a decision on the application by the end of December, Dr. Durgam said.

Intra-Cellular Therapies’ stock price took a hit in July 2019, when the FDA abruptly canceled an advisory committee meeting scheduled to consider lumateperone. The agency sought additional information on animal toxicology studies. Having received it from the company, the FDA now no longer plans to schedule an advisory committee meeting before issuing its marketing approval decision.

Lumateperone is an oral once-daily drug that doesn’t require titration. Its high degree of tolerability is thought to be attributable to the drug’s mechanism of action, which involves simultaneous modulation of three different neurotransmitter pathways: serotonin, dopamine, and glutamate. The drug is a potent serotonin 5-HT_2a antagonist and serotonin reuptake inhibitor, a dopamine D2 presynaptic partial agonist and postsynaptic antagonist, and it also modulates glutamate via activation of the D1 receptor.

Three phase 3, double-blind, placebo-controlled randomized clinical trials of 4-6 weeks duration have been completed in a total of 1,481 patients with acute exacerbation of schizophrenia. Two trials were positive, with lumateperone achieving significantly greater mean reductions in the Positive and Negative Syndrome Scale (PANSS) total score than placebo, while the third was negative, with no significant between-group difference. Of note, the safety profile of lumateperone was indistinguishable from placebo with the sole exception of somnolence, where the 20% incidence was twice that of placebo-treated controls. However, in the open-label program, dosing was switched from morning to evening, with a resultant drop in somnolence to the placebo level, Dr. Durgam said.

The open-label program has two parts. Part 1 was conducted in 302 patients with stable, generally mild schizophrenia symptoms while on risperidone, olanzapine, or various other antipsychotics commonly prescribed in the United States. They were switched to lumateperone at 42 mg once daily for 6 weeks, at which point they demonstrated significant reductions in body weight, serum prolactin, insulin, total cholesterol, and LDL cholesterol. They then were switched back to their former medications, with a resultant worsening of those parameters to prelumateperone levels, providing evidence of a cause-and-effect relationship with cardiometabolic risk factors.

Part 2 of the open-label program is the long-term study, in which 603 patients with stable symptoms on standard-of-care antipsychotics were switched to lumateperone at 42 mg/day, to be followed for 1 year or more. Dr. Durgam presented an interim analysis focused on the first 107 patients to achieve the 1-year treatment milestone. Most were obese at baseline: the group’s mean body mass index was 31.3 kg/m2. They experienced progressive weight loss, with a mean reduction of 1.82 kg on day 175 and 3.16 kg on day 350. About 24% of subjects had a 7% or greater reduction in body weight, while 8% had at least a 7% weight gain. Waist circumference decreased by an average of 5.2 cm from a baseline of 103.2 cm in men and by 1.9 cm in women.

The primary focus of the ongoing long-term study is safety. The most common treatment-emergent adverse events during a full year of therapy were dry mouth, headache, and diarrhea, each occurring in about 7% of patients. Only 0.8% of patients developed extrapyramidal symptoms.

At 150 days of treatment in 340 patients, 30% had achieved a PANSS response, defined as at least a 20% improvement in PANSS total score, compared with baseline. At 300 days in the smaller group who had reached that milestone at the time of the interim analysis, the PANSS response rate had grown to 41%.

Among patients with schizophrenia and comorbid depression as defined by a Calgary Depression Scale for Schizophrenia (CDSS) score of 6 or more at baseline, lumateperone at 42 mg/day improved depressive symptoms, such that 60% of those patients achieved a CDSS response – that is, at least a 50% reduction in the score – by day 75. This finding supports data from earlier short-term studies, and suggests that lumateperone’s multiple mechanisms of action and high tolerability make it a promising candidate for treatment of depression and other symptom domains of schizophrenia that are currently inadequately treated, according to Dr. Durgam.

Dr. Durgam also presented an update on the lumateperone program for bipolar depression, which consists of three phase 3, double-blind, placebo-controlled, 6-week-long clinical trials totaling 1,455 patients. Two have been completed: one positive and the other negative with an unusually high placebo response rate. The ongoing third trial will be the tiebreaker. Safety and tolerability have been as noted in other lumateperone studies.

In the positive trial, the primary efficacy endpoint was change in Montgomery-Åsberg Depression Rating Scale, which improved in lumateperone-treated patients by an average of 16.7 points from a baseline score of just over 30, a significantly better result than the 12.1-point reduction in placebo-treated controls. The treatment benefit was similar in bipolar I and bipolar II patients.

The phase 3 trial* for treatment of agitation in patients with Alzheimer’s disease and other dementias was stopped early for lack of efficacy in an interim analysis. And lumateperone is in ongoing phase 2 trials for sleep disturbances associated with neuropsychiatric disorders. The phase 2 study* in major depressive disorder has been completed.

[email protected]

*This article was updated 9/28/2019.

COPENHAGEN – Lumateperone, a novel investigational drug for schizophrenia with a unique triple mechanism of action, showed impressive safety and tolerability while achieving a continuous decline in schizophrenia symptoms over the course of a year in a long-term, open-label study, Suresh Durgam, MD, said at the annual congress of the European College of Neuropsychopharmacology.

Bruce Jancin/MDedge News

Indeed, patients on lumateperone at the 1-year mark showed significant reductions in LDL cholesterol, total cholesterol, serum prolactin, and body weight, compared with baseline values recorded when participants were on various standard-of-care antipsychotics prior to switching. Other cardiometabolic parameters, including fasting blood glucose, insulin, triglycerides, and HDL cholesterol, showed only negligible change over the course of study, according to Dr. Durgam, a psychiatrist and senior vice president for late-stage clinical development and medical affairs at Intra-Cellular Therapies, the New York–based company developing lumateperone as its lead product.

This favorable cardiometabolic profile contrasts sharply with those of currently available antipsychotic agents, many of which worsen cardiometabolic risk factors. That would seem to be a major advantage for lumateperone and is likely to be a factor in the Food and Drug Administration’s ongoing deliberation over the company’s new drug application. The agency has promised a decision on the application by the end of December, Dr. Durgam said.

Intra-Cellular Therapies’ stock price took a hit in July 2019, when the FDA abruptly canceled an advisory committee meeting scheduled to consider lumateperone. The agency sought additional information on animal toxicology studies. Having received it from the company, the FDA now no longer plans to schedule an advisory committee meeting before issuing its marketing approval decision.

Lumateperone is an oral once-daily drug that doesn’t require titration. Its high degree of tolerability is thought to be attributable to the drug’s mechanism of action, which involves simultaneous modulation of three different neurotransmitter pathways: serotonin, dopamine, and glutamate. The drug is a potent serotonin 5-HT_2a antagonist and serotonin reuptake inhibitor, a dopamine D2 presynaptic partial agonist and postsynaptic antagonist, and it also modulates glutamate via activation of the D1 receptor.

Three phase 3, double-blind, placebo-controlled randomized clinical trials of 4-6 weeks duration have been completed in a total of 1,481 patients with acute exacerbation of schizophrenia. Two trials were positive, with lumateperone achieving significantly greater mean reductions in the Positive and Negative Syndrome Scale (PANSS) total score than placebo, while the third was negative, with no significant between-group difference. Of note, the safety profile of lumateperone was indistinguishable from placebo with the sole exception of somnolence, where the 20% incidence was twice that of placebo-treated controls. However, in the open-label program, dosing was switched from morning to evening, with a resultant drop in somnolence to the placebo level, Dr. Durgam said.

The open-label program has two parts. Part 1 was conducted in 302 patients with stable, generally mild schizophrenia symptoms while on risperidone, olanzapine, or various other antipsychotics commonly prescribed in the United States. They were switched to lumateperone at 42 mg once daily for 6 weeks, at which point they demonstrated significant reductions in body weight, serum prolactin, insulin, total cholesterol, and LDL cholesterol. They then were switched back to their former medications, with a resultant worsening of those parameters to prelumateperone levels, providing evidence of a cause-and-effect relationship with cardiometabolic risk factors.

Part 2 of the open-label program is the long-term study, in which 603 patients with stable symptoms on standard-of-care antipsychotics were switched to lumateperone at 42 mg/day, to be followed for 1 year or more. Dr. Durgam presented an interim analysis focused on the first 107 patients to achieve the 1-year treatment milestone. Most were obese at baseline: the group’s mean body mass index was 31.3 kg/m2. They experienced progressive weight loss, with a mean reduction of 1.82 kg on day 175 and 3.16 kg on day 350. About 24% of subjects had a 7% or greater reduction in body weight, while 8% had at least a 7% weight gain. Waist circumference decreased by an average of 5.2 cm from a baseline of 103.2 cm in men and by 1.9 cm in women.

The primary focus of the ongoing long-term study is safety. The most common treatment-emergent adverse events during a full year of therapy were dry mouth, headache, and diarrhea, each occurring in about 7% of patients. Only 0.8% of patients developed extrapyramidal symptoms.

At 150 days of treatment in 340 patients, 30% had achieved a PANSS response, defined as at least a 20% improvement in PANSS total score, compared with baseline. At 300 days in the smaller group who had reached that milestone at the time of the interim analysis, the PANSS response rate had grown to 41%.

Among patients with schizophrenia and comorbid depression as defined by a Calgary Depression Scale for Schizophrenia (CDSS) score of 6 or more at baseline, lumateperone at 42 mg/day improved depressive symptoms, such that 60% of those patients achieved a CDSS response – that is, at least a 50% reduction in the score – by day 75. This finding supports data from earlier short-term studies, and suggests that lumateperone’s multiple mechanisms of action and high tolerability make it a promising candidate for treatment of depression and other symptom domains of schizophrenia that are currently inadequately treated, according to Dr. Durgam.

Dr. Durgam also presented an update on the lumateperone program for bipolar depression, which consists of three phase 3, double-blind, placebo-controlled, 6-week-long clinical trials totaling 1,455 patients. Two have been completed: one positive and the other negative with an unusually high placebo response rate. The ongoing third trial will be the tiebreaker. Safety and tolerability have been as noted in other lumateperone studies.

In the positive trial, the primary efficacy endpoint was change in Montgomery-Åsberg Depression Rating Scale, which improved in lumateperone-treated patients by an average of 16.7 points from a baseline score of just over 30, a significantly better result than the 12.1-point reduction in placebo-treated controls. The treatment benefit was similar in bipolar I and bipolar II patients.

The phase 3 trial* for treatment of agitation in patients with Alzheimer’s disease and other dementias was stopped early for lack of efficacy in an interim analysis. And lumateperone is in ongoing phase 2 trials for sleep disturbances associated with neuropsychiatric disorders. The phase 2 study* in major depressive disorder has been completed.

[email protected]

*This article was updated 9/28/2019.

The Food and Drug Administration has approved Jynneos, a live, nonreplicating vaccine based on the vaccinia virus, for smallpox and monkeypox, becoming the first FDA-approved vaccine for the prevention of monkeypox disease.

FDA approval for Jynneos for smallpox is based on results from a clinical trial that compared Jynneos with ACAM2000, a previously FDA-approved smallpox vaccine, in about 400 healthy adults aged 18-42 years. Adults who received Jynneos had a noninferior immune response to those who received ACAM2000. In addition, safety was assessed in 7,800 people who received at least one vaccine dose, with the most commonly reported side effects including pain, redness, swelling, itching, firmness at the injection site, muscle pain, headache, and fatigue.

The effectiveness of Jynneos to prevent monkeypox – a disease similar to but somewhat milder than smallpox caused by the non–U.S.-native monkeypox virus – was inferred from antibody responses of participants in the smallpox clinical trial and from studies on nonhuman primates that showed protection from the monkeypox virus after being vaccinated with Jynneos.

“Routine [smallpox] vaccination of the American public was stopped in 1972 after the disease was eradicated in the U.S. and, as a result, a large proportion of the U.S., as well as the global population has no immunity,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “Although naturally occurring smallpox disease is no longer a global threat, the intentional release of this highly contagious virus could have a devastating effect.”

This vaccine is also part of the Strategic National Stockpile, the nation’s largest supply of potentially lifesaving pharmaceuticals and medical supplies for use in a public health emergency, according to the announcement.

Find the full press release on the FDA website.

[email protected]

The Food and Drug Administration has approved Jynneos, a live, nonreplicating vaccine based on the vaccinia virus, for smallpox and monkeypox, becoming the first FDA-approved vaccine for the prevention of monkeypox disease.

FDA approval for Jynneos for smallpox is based on results from a clinical trial that compared Jynneos with ACAM2000, a previously FDA-approved smallpox vaccine, in about 400 healthy adults aged 18-42 years. Adults who received Jynneos had a noninferior immune response to those who received ACAM2000. In addition, safety was assessed in 7,800 people who received at least one vaccine dose, with the most commonly reported side effects including pain, redness, swelling, itching, firmness at the injection site, muscle pain, headache, and fatigue.

The effectiveness of Jynneos to prevent monkeypox – a disease similar to but somewhat milder than smallpox caused by the non–U.S.-native monkeypox virus – was inferred from antibody responses of participants in the smallpox clinical trial and from studies on nonhuman primates that showed protection from the monkeypox virus after being vaccinated with Jynneos.

“Routine [smallpox] vaccination of the American public was stopped in 1972 after the disease was eradicated in the U.S. and, as a result, a large proportion of the U.S., as well as the global population has no immunity,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “Although naturally occurring smallpox disease is no longer a global threat, the intentional release of this highly contagious virus could have a devastating effect.”

This vaccine is also part of the Strategic National Stockpile, the nation’s largest supply of potentially lifesaving pharmaceuticals and medical supplies for use in a public health emergency, according to the announcement.

Find the full press release on the FDA website.

[email protected]

The Food and Drug Administration has approved Jynneos, a live, nonreplicating vaccine based on the vaccinia virus, for smallpox and monkeypox, becoming the first FDA-approved vaccine for the prevention of monkeypox disease.

FDA approval for Jynneos for smallpox is based on results from a clinical trial that compared Jynneos with ACAM2000, a previously FDA-approved smallpox vaccine, in about 400 healthy adults aged 18-42 years. Adults who received Jynneos had a noninferior immune response to those who received ACAM2000. In addition, safety was assessed in 7,800 people who received at least one vaccine dose, with the most commonly reported side effects including pain, redness, swelling, itching, firmness at the injection site, muscle pain, headache, and fatigue.

The effectiveness of Jynneos to prevent monkeypox – a disease similar to but somewhat milder than smallpox caused by the non–U.S.-native monkeypox virus – was inferred from antibody responses of participants in the smallpox clinical trial and from studies on nonhuman primates that showed protection from the monkeypox virus after being vaccinated with Jynneos.

“Routine [smallpox] vaccination of the American public was stopped in 1972 after the disease was eradicated in the U.S. and, as a result, a large proportion of the U.S., as well as the global population has no immunity,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “Although naturally occurring smallpox disease is no longer a global threat, the intentional release of this highly contagious virus could have a devastating effect.”

This vaccine is also part of the Strategic National Stockpile, the nation’s largest supply of potentially lifesaving pharmaceuticals and medical supplies for use in a public health emergency, according to the announcement.

Find the full press release on the FDA website.

[email protected]

Background: There is increasing concern that the patient experience in the hospital may be associated with post-hospital adverse outcomes, including new or recurrent illnesses after discharge or unplanned return to the hospital or readmission.

Because this is an observational study, causal inferences were not possible; however, hospitalists should keep in mind the possible association of the patient experience and the link to clinical outcomes.

Bottom line: Trauma of hospitalization is common and may be associated with an increased 30-day risk of readmission or ED visit.

Citation: Rawal J et al. Association of the trauma of hospitalization with 30-day readmission or emergency department visit. JAMA Intern Med. 2019;179(1):38-45.

Dr. Wang is an associate professor of medicine in the division of general and hospital medicine at UT Health San Antonio and a hospitalist at South Texas Veterans Health Care System.

Background: There is increasing concern that the patient experience in the hospital may be associated with post-hospital adverse outcomes, including new or recurrent illnesses after discharge or unplanned return to the hospital or readmission.

Because this is an observational study, causal inferences were not possible; however, hospitalists should keep in mind the possible association of the patient experience and the link to clinical outcomes.

Bottom line: Trauma of hospitalization is common and may be associated with an increased 30-day risk of readmission or ED visit.

Citation: Rawal J et al. Association of the trauma of hospitalization with 30-day readmission or emergency department visit. JAMA Intern Med. 2019;179(1):38-45.

Dr. Wang is an associate professor of medicine in the division of general and hospital medicine at UT Health San Antonio and a hospitalist at South Texas Veterans Health Care System.

Background: There is increasing concern that the patient experience in the hospital may be associated with post-hospital adverse outcomes, including new or recurrent illnesses after discharge or unplanned return to the hospital or readmission.

Because this is an observational study, causal inferences were not possible; however, hospitalists should keep in mind the possible association of the patient experience and the link to clinical outcomes.

Bottom line: Trauma of hospitalization is common and may be associated with an increased 30-day risk of readmission or ED visit.

Citation: Rawal J et al. Association of the trauma of hospitalization with 30-day readmission or emergency department visit. JAMA Intern Med. 2019;179(1):38-45.

Dr. Wang is an associate professor of medicine in the division of general and hospital medicine at UT Health San Antonio and a hospitalist at South Texas Veterans Health Care System.

BARCELONA – Further differences in how adults and adolescents with type 2 diabetes respond to glucose and glucagon have been demonstrated by new data from the Restoring Insulin SEcretion (RISE) studies presented at the annual meeting of the European Association for the Study of Diabetes.

In a comparison of responses to an oral glucose tolerance test (OGTT), youth (n = 85) were more likely than were adults (n = 353) to have a biphasic type of glucose response curve (18.8% vs. 8.2%, respectively), which is considered a more normal response curve. However, that “did not foretell an advantageous outcome to the RISE interventions in the younger age group,” said study investigator Silva Arslanian, MD, of UPMC Children’s Hospital of Pittsburgh.

Fewer youth than adults had an incessant response (10.6% vs. 14.5%, respectively) or monophasic response to an OGTT (70.6% vs. 77.3%), and that was associated with lower beta-cell responses, compared with individuals with monophasic or biphasic glucose curves.

“Irrespective of curve type, insulin sensitivity was lower in youth than in adults,” Dr. Arslanian said. She added that beta-cell responses were greater in youth than in adults, except in youth with the worst incessant-increase curve type. In youth with the incessant-increase glucose curve, there was no evidence of beta-cell hypersecretion, which suggested youth “have more severe beta-cell dysfunction,” compared with adults.

There were also data presented on whether differences in alpha-cell function between youth and adults might be important. Those data showed that although fasting glucagon concentrations did not increase with fasting glucose in youth, they did in adults. It was found that fasting and stimulated glucagon concentrations were lower in youth than in adults, meaning that “alpha-cell function does not explain the beta-cell hyperresponsiveness seen in youth with impaired glucose tolerance or recently diagnosed type 2 diabetes,” reported study investigator Steven Kahn, MD, ChB, of VA Puget Sound Health Care System, University of Washington, Seattle.

M. Alexander Otto/MDedge News

“What was new, however, was that [the beta-cells of] youth were hyperresponsive and were really making large amounts of insulin.” Increased insulin production might be expected when there is insulin resistance, he added, but the level seen was “more than you would expect.” Over time, that might be toxic to the beta cells, and evidence from the earlier TODAY (Treatment Options for Type 2 Diabetes in Adolescents and Youth) studies suggested that the rate of beta-cell dysfunction was more rapid in youth than in adults.

Giving his perspective, as a pediatrician, on the new OGTT analyses from the RISE studies, Dr. Zeitler said that these data showed that the characteristic beta-cell hyperresponsiveness seen in youth “actually disappears as glycemia worsens.” In youth with the incessant glucose response pattern, “it shows that they cannot tolerate glucose, and their glucose levels just go up and up and up” until the beta cells fail.

This is a critical observation, Dr. Zeitler said, noting that it “sort of had to be the case, because sooner or later you had to lose beta cells ... this is probably the point where aggressive therapy is needed ... it was always a bit of a paradox, if these kids have such an aggressive course, how come they were starting out being so hyperresponsive?”

With regard to alpha-cell function, “these are really fresh data. We haven’t really had a long time to think about it,” said Dr. Zeitler. “What I find interesting is that there isn’t alpha-cell glucagon hypersecretion in youth like there is in adults.” That may be because youth are making so much insulin that they are suppressing glucagon production, but that’s not an entirely satisfying answer,” he said.

“The TODAY study demonstrated that diabetes in kids is aggressive; these RISE data now start to put some physiology around that, why is it more aggressive? Hyperresponsiveness, loss of beta-cell function over time, lack of response to intervention, compared with the adults.”

As for the clinical implications, Dr. Zeitler said that this is further evidence that the default approach to treating younger patients with greater caution than adults is perhaps not the best way to treat type 2 diabetes.

“These data are really showing that there is a very important toxic period that is occurring in these kids early on [and] that probably argues for more, not less, aggressive therapy,” than with adults. “Clearly, something is happening that is putting them at really big risk for rapid progression, and that’s your chance to treat much more aggressively, much earlier.”

The RISE studies are sponsored by the RISE Study Group in collaboration with the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Zeitler disclosed that he had acted as a consultant to Boehringer-Ingelheim, Eli Lilly, Daiichi-Sankyo and Merck, Sharp & Dohme, and had received research support from Janssen. Dr. Arslanian stated that she has nothing to disclose. Dr. Khan did not provide any disclosure information.

SOURCES: Arslanian S. EASD 2019, Oral presentation S34.1; Kahn S. EASD 2019, Oral presentation S34.3

BARCELONA – Further differences in how adults and adolescents with type 2 diabetes respond to glucose and glucagon have been demonstrated by new data from the Restoring Insulin SEcretion (RISE) studies presented at the annual meeting of the European Association for the Study of Diabetes.

In a comparison of responses to an oral glucose tolerance test (OGTT), youth (n = 85) were more likely than were adults (n = 353) to have a biphasic type of glucose response curve (18.8% vs. 8.2%, respectively), which is considered a more normal response curve. However, that “did not foretell an advantageous outcome to the RISE interventions in the younger age group,” said study investigator Silva Arslanian, MD, of UPMC Children’s Hospital of Pittsburgh.

Fewer youth than adults had an incessant response (10.6% vs. 14.5%, respectively) or monophasic response to an OGTT (70.6% vs. 77.3%), and that was associated with lower beta-cell responses, compared with individuals with monophasic or biphasic glucose curves.

“Irrespective of curve type, insulin sensitivity was lower in youth than in adults,” Dr. Arslanian said. She added that beta-cell responses were greater in youth than in adults, except in youth with the worst incessant-increase curve type. In youth with the incessant-increase glucose curve, there was no evidence of beta-cell hypersecretion, which suggested youth “have more severe beta-cell dysfunction,” compared with adults.

There were also data presented on whether differences in alpha-cell function between youth and adults might be important. Those data showed that although fasting glucagon concentrations did not increase with fasting glucose in youth, they did in adults. It was found that fasting and stimulated glucagon concentrations were lower in youth than in adults, meaning that “alpha-cell function does not explain the beta-cell hyperresponsiveness seen in youth with impaired glucose tolerance or recently diagnosed type 2 diabetes,” reported study investigator Steven Kahn, MD, ChB, of VA Puget Sound Health Care System, University of Washington, Seattle.

M. Alexander Otto/MDedge News

“What was new, however, was that [the beta-cells of] youth were hyperresponsive and were really making large amounts of insulin.” Increased insulin production might be expected when there is insulin resistance, he added, but the level seen was “more than you would expect.” Over time, that might be toxic to the beta cells, and evidence from the earlier TODAY (Treatment Options for Type 2 Diabetes in Adolescents and Youth) studies suggested that the rate of beta-cell dysfunction was more rapid in youth than in adults.

Giving his perspective, as a pediatrician, on the new OGTT analyses from the RISE studies, Dr. Zeitler said that these data showed that the characteristic beta-cell hyperresponsiveness seen in youth “actually disappears as glycemia worsens.” In youth with the incessant glucose response pattern, “it shows that they cannot tolerate glucose, and their glucose levels just go up and up and up” until the beta cells fail.

This is a critical observation, Dr. Zeitler said, noting that it “sort of had to be the case, because sooner or later you had to lose beta cells ... this is probably the point where aggressive therapy is needed ... it was always a bit of a paradox, if these kids have such an aggressive course, how come they were starting out being so hyperresponsive?”

With regard to alpha-cell function, “these are really fresh data. We haven’t really had a long time to think about it,” said Dr. Zeitler. “What I find interesting is that there isn’t alpha-cell glucagon hypersecretion in youth like there is in adults.” That may be because youth are making so much insulin that they are suppressing glucagon production, but that’s not an entirely satisfying answer,” he said.

“The TODAY study demonstrated that diabetes in kids is aggressive; these RISE data now start to put some physiology around that, why is it more aggressive? Hyperresponsiveness, loss of beta-cell function over time, lack of response to intervention, compared with the adults.”

As for the clinical implications, Dr. Zeitler said that this is further evidence that the default approach to treating younger patients with greater caution than adults is perhaps not the best way to treat type 2 diabetes.

“These data are really showing that there is a very important toxic period that is occurring in these kids early on [and] that probably argues for more, not less, aggressive therapy,” than with adults. “Clearly, something is happening that is putting them at really big risk for rapid progression, and that’s your chance to treat much more aggressively, much earlier.”

The RISE studies are sponsored by the RISE Study Group in collaboration with the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Zeitler disclosed that he had acted as a consultant to Boehringer-Ingelheim, Eli Lilly, Daiichi-Sankyo and Merck, Sharp & Dohme, and had received research support from Janssen. Dr. Arslanian stated that she has nothing to disclose. Dr. Khan did not provide any disclosure information.

SOURCES: Arslanian S. EASD 2019, Oral presentation S34.1; Kahn S. EASD 2019, Oral presentation S34.3

BARCELONA – Further differences in how adults and adolescents with type 2 diabetes respond to glucose and glucagon have been demonstrated by new data from the Restoring Insulin SEcretion (RISE) studies presented at the annual meeting of the European Association for the Study of Diabetes.

In a comparison of responses to an oral glucose tolerance test (OGTT), youth (n = 85) were more likely than were adults (n = 353) to have a biphasic type of glucose response curve (18.8% vs. 8.2%, respectively), which is considered a more normal response curve. However, that “did not foretell an advantageous outcome to the RISE interventions in the younger age group,” said study investigator Silva Arslanian, MD, of UPMC Children’s Hospital of Pittsburgh.

Fewer youth than adults had an incessant response (10.6% vs. 14.5%, respectively) or monophasic response to an OGTT (70.6% vs. 77.3%), and that was associated with lower beta-cell responses, compared with individuals with monophasic or biphasic glucose curves.

“Irrespective of curve type, insulin sensitivity was lower in youth than in adults,” Dr. Arslanian said. She added that beta-cell responses were greater in youth than in adults, except in youth with the worst incessant-increase curve type. In youth with the incessant-increase glucose curve, there was no evidence of beta-cell hypersecretion, which suggested youth “have more severe beta-cell dysfunction,” compared with adults.

There were also data presented on whether differences in alpha-cell function between youth and adults might be important. Those data showed that although fasting glucagon concentrations did not increase with fasting glucose in youth, they did in adults. It was found that fasting and stimulated glucagon concentrations were lower in youth than in adults, meaning that “alpha-cell function does not explain the beta-cell hyperresponsiveness seen in youth with impaired glucose tolerance or recently diagnosed type 2 diabetes,” reported study investigator Steven Kahn, MD, ChB, of VA Puget Sound Health Care System, University of Washington, Seattle.

M. Alexander Otto/MDedge News

“What was new, however, was that [the beta-cells of] youth were hyperresponsive and were really making large amounts of insulin.” Increased insulin production might be expected when there is insulin resistance, he added, but the level seen was “more than you would expect.” Over time, that might be toxic to the beta cells, and evidence from the earlier TODAY (Treatment Options for Type 2 Diabetes in Adolescents and Youth) studies suggested that the rate of beta-cell dysfunction was more rapid in youth than in adults.

Giving his perspective, as a pediatrician, on the new OGTT analyses from the RISE studies, Dr. Zeitler said that these data showed that the characteristic beta-cell hyperresponsiveness seen in youth “actually disappears as glycemia worsens.” In youth with the incessant glucose response pattern, “it shows that they cannot tolerate glucose, and their glucose levels just go up and up and up” until the beta cells fail.

This is a critical observation, Dr. Zeitler said, noting that it “sort of had to be the case, because sooner or later you had to lose beta cells ... this is probably the point where aggressive therapy is needed ... it was always a bit of a paradox, if these kids have such an aggressive course, how come they were starting out being so hyperresponsive?”

With regard to alpha-cell function, “these are really fresh data. We haven’t really had a long time to think about it,” said Dr. Zeitler. “What I find interesting is that there isn’t alpha-cell glucagon hypersecretion in youth like there is in adults.” That may be because youth are making so much insulin that they are suppressing glucagon production, but that’s not an entirely satisfying answer,” he said.

“The TODAY study demonstrated that diabetes in kids is aggressive; these RISE data now start to put some physiology around that, why is it more aggressive? Hyperresponsiveness, loss of beta-cell function over time, lack of response to intervention, compared with the adults.”

As for the clinical implications, Dr. Zeitler said that this is further evidence that the default approach to treating younger patients with greater caution than adults is perhaps not the best way to treat type 2 diabetes.

“These data are really showing that there is a very important toxic period that is occurring in these kids early on [and] that probably argues for more, not less, aggressive therapy,” than with adults. “Clearly, something is happening that is putting them at really big risk for rapid progression, and that’s your chance to treat much more aggressively, much earlier.”

The RISE studies are sponsored by the RISE Study Group in collaboration with the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Zeitler disclosed that he had acted as a consultant to Boehringer-Ingelheim, Eli Lilly, Daiichi-Sankyo and Merck, Sharp & Dohme, and had received research support from Janssen. Dr. Arslanian stated that she has nothing to disclose. Dr. Khan did not provide any disclosure information.

SOURCES: Arslanian S. EASD 2019, Oral presentation S34.1; Kahn S. EASD 2019, Oral presentation S34.3

The biologic drug anakinra appears to be effective in treating children with secondary hemophagocytic lymphohistiocytosis (sHLH)/macrophage activation syndrome (MAS), a dangerous “cytokine storm” that can emerge from infections, cancer, and rheumatic diseases.

Children with systematic juvenile idiopathic arthritis (sJIA) and sHLH/MAS are especially good candidates for treatment with the interleukin-1 receptor antagonist anakinra (Kineret), in whom its safety and benefits have been more widely explored than in pediatric patients with sHLH/MAS related to non-sJIA underlying conditions.

In a study published in Arthritis & Rheumatology, Esraa Eloseily, MD, and colleagues at the University of Alabama at Birmingham, looked at hospitalization records for 44 children (mean age, 10 years; n = 25 females) with sHLH/MAS. The children in the study had heterogeneous underlying conditions including leukemias, infections, and rheumatic diseases. About one-third of patients had no known rheumatic or autoimmune disorder.

Dr. Eloseily and colleagues found that early initiation of anakinra (within 5 days of hospitalization) was significantly associated with improved survival across the cohort, for which mortality was 27%. Thrombocytopenia (less than 100,000/mcL) and STXBP2 mutations were both seen significantly associated with mortality.

Patients with blood cancers – even those in remission at the time of treatment – did poorly. None of the three patients in the cohort with leukemia survived.

Importantly, no deaths were seen among the 13 patients with underlying SJIA who were treated with anakinra, suggesting particular benefit for this patient group.

“In addition to the 10% risk of developing overt MAS as part of sJIA, another 30%-40% of sJIA patients may have occult or subclinical MAS during a disease flare that can eventually lead to overt MAS,” Dr. Eloseily and colleagues wrote. “This association of MAS with sJIA suggested that anakinra would also be a valuable treatment for sJIA-MAS.”

The investigators acknowledged that their study was limited by its retrospective design and “nonuniform approach to therapy, lack of treatment controls, and variable follow-up period.” The authors also acknowledged the potential for selection bias favoring anakinra use in patients who are less severely ill.

In a comment accompanying Dr. Eloseily and colleagues’ study, Sarah Nikiforow, MD, PhD, of the Dana-Farber Cancer Institute in Boston, and Nancy Berliner, MD, of Brigham & Women’s Hospital in Boston, urged clinicians not to interpret the study results as supporting anakinra as “a carte blanche approach to hyperinflammatory syndromes.”

While the study supported the use of anakinra in sJIA with MAS or sHLH, “we posit that patients [with sHLH/MAS] in sepsis, cytokine release syndrome following chimeric antigen receptor T-cell therapy, and other hyperinflammatory syndromes still require individualized approaches to therapy,” Dr. Nikiforow and Dr. Berliner wrote, adding that, “in several studies and anecdotally in our institutional practice, cytotoxic chemotherapy was/is preferred over biologic agents in patients with evidence of more severe inflammatory activity.”

Outside sJIA, Dr. Nikiforow and Dr. Berliner wrote, “early anakinra therapy should be extended to treatment of other forms of sHLH with extreme caution. Specifically, the authors’ suggestion that cytotoxic therapy should be ‘considered’ only after anakinra therapy may be dangerous for some patients.”

Two of Dr. Eloseily’s coinvestigators reported financial and research support from Sobi, the manufacturer of anakinra. No other conflicts of interest were reported.

SOURCES: Eloseily E et al. Arthritis Rheumatol. 2019 Sep 12. doi: 10.1002/art.41103; Nikiforow S, Berliner N. Arthritis Rheumatol. 2019 Sep 16. doi: 10.1002/art.41106.

The biologic drug anakinra appears to be effective in treating children with secondary hemophagocytic lymphohistiocytosis (sHLH)/macrophage activation syndrome (MAS), a dangerous “cytokine storm” that can emerge from infections, cancer, and rheumatic diseases.

Children with systematic juvenile idiopathic arthritis (sJIA) and sHLH/MAS are especially good candidates for treatment with the interleukin-1 receptor antagonist anakinra (Kineret), in whom its safety and benefits have been more widely explored than in pediatric patients with sHLH/MAS related to non-sJIA underlying conditions.

In a study published in Arthritis & Rheumatology, Esraa Eloseily, MD, and colleagues at the University of Alabama at Birmingham, looked at hospitalization records for 44 children (mean age, 10 years; n = 25 females) with sHLH/MAS. The children in the study had heterogeneous underlying conditions including leukemias, infections, and rheumatic diseases. About one-third of patients had no known rheumatic or autoimmune disorder.

Dr. Eloseily and colleagues found that early initiation of anakinra (within 5 days of hospitalization) was significantly associated with improved survival across the cohort, for which mortality was 27%. Thrombocytopenia (less than 100,000/mcL) and STXBP2 mutations were both seen significantly associated with mortality.

Patients with blood cancers – even those in remission at the time of treatment – did poorly. None of the three patients in the cohort with leukemia survived.

Importantly, no deaths were seen among the 13 patients with underlying SJIA who were treated with anakinra, suggesting particular benefit for this patient group.

“In addition to the 10% risk of developing overt MAS as part of sJIA, another 30%-40% of sJIA patients may have occult or subclinical MAS during a disease flare that can eventually lead to overt MAS,” Dr. Eloseily and colleagues wrote. “This association of MAS with sJIA suggested that anakinra would also be a valuable treatment for sJIA-MAS.”

The investigators acknowledged that their study was limited by its retrospective design and “nonuniform approach to therapy, lack of treatment controls, and variable follow-up period.” The authors also acknowledged the potential for selection bias favoring anakinra use in patients who are less severely ill.

In a comment accompanying Dr. Eloseily and colleagues’ study, Sarah Nikiforow, MD, PhD, of the Dana-Farber Cancer Institute in Boston, and Nancy Berliner, MD, of Brigham & Women’s Hospital in Boston, urged clinicians not to interpret the study results as supporting anakinra as “a carte blanche approach to hyperinflammatory syndromes.”

While the study supported the use of anakinra in sJIA with MAS or sHLH, “we posit that patients [with sHLH/MAS] in sepsis, cytokine release syndrome following chimeric antigen receptor T-cell therapy, and other hyperinflammatory syndromes still require individualized approaches to therapy,” Dr. Nikiforow and Dr. Berliner wrote, adding that, “in several studies and anecdotally in our institutional practice, cytotoxic chemotherapy was/is preferred over biologic agents in patients with evidence of more severe inflammatory activity.”

Outside sJIA, Dr. Nikiforow and Dr. Berliner wrote, “early anakinra therapy should be extended to treatment of other forms of sHLH with extreme caution. Specifically, the authors’ suggestion that cytotoxic therapy should be ‘considered’ only after anakinra therapy may be dangerous for some patients.”

Two of Dr. Eloseily’s coinvestigators reported financial and research support from Sobi, the manufacturer of anakinra. No other conflicts of interest were reported.

SOURCES: Eloseily E et al. Arthritis Rheumatol. 2019 Sep 12. doi: 10.1002/art.41103; Nikiforow S, Berliner N. Arthritis Rheumatol. 2019 Sep 16. doi: 10.1002/art.41106.

The biologic drug anakinra appears to be effective in treating children with secondary hemophagocytic lymphohistiocytosis (sHLH)/macrophage activation syndrome (MAS), a dangerous “cytokine storm” that can emerge from infections, cancer, and rheumatic diseases.

Children with systematic juvenile idiopathic arthritis (sJIA) and sHLH/MAS are especially good candidates for treatment with the interleukin-1 receptor antagonist anakinra (Kineret), in whom its safety and benefits have been more widely explored than in pediatric patients with sHLH/MAS related to non-sJIA underlying conditions.

In a study published in Arthritis & Rheumatology, Esraa Eloseily, MD, and colleagues at the University of Alabama at Birmingham, looked at hospitalization records for 44 children (mean age, 10 years; n = 25 females) with sHLH/MAS. The children in the study had heterogeneous underlying conditions including leukemias, infections, and rheumatic diseases. About one-third of patients had no known rheumatic or autoimmune disorder.

Dr. Eloseily and colleagues found that early initiation of anakinra (within 5 days of hospitalization) was significantly associated with improved survival across the cohort, for which mortality was 27%. Thrombocytopenia (less than 100,000/mcL) and STXBP2 mutations were both seen significantly associated with mortality.

Patients with blood cancers – even those in remission at the time of treatment – did poorly. None of the three patients in the cohort with leukemia survived.

Importantly, no deaths were seen among the 13 patients with underlying SJIA who were treated with anakinra, suggesting particular benefit for this patient group.

“In addition to the 10% risk of developing overt MAS as part of sJIA, another 30%-40% of sJIA patients may have occult or subclinical MAS during a disease flare that can eventually lead to overt MAS,” Dr. Eloseily and colleagues wrote. “This association of MAS with sJIA suggested that anakinra would also be a valuable treatment for sJIA-MAS.”

The investigators acknowledged that their study was limited by its retrospective design and “nonuniform approach to therapy, lack of treatment controls, and variable follow-up period.” The authors also acknowledged the potential for selection bias favoring anakinra use in patients who are less severely ill.

In a comment accompanying Dr. Eloseily and colleagues’ study, Sarah Nikiforow, MD, PhD, of the Dana-Farber Cancer Institute in Boston, and Nancy Berliner, MD, of Brigham & Women’s Hospital in Boston, urged clinicians not to interpret the study results as supporting anakinra as “a carte blanche approach to hyperinflammatory syndromes.”

While the study supported the use of anakinra in sJIA with MAS or sHLH, “we posit that patients [with sHLH/MAS] in sepsis, cytokine release syndrome following chimeric antigen receptor T-cell therapy, and other hyperinflammatory syndromes still require individualized approaches to therapy,” Dr. Nikiforow and Dr. Berliner wrote, adding that, “in several studies and anecdotally in our institutional practice, cytotoxic chemotherapy was/is preferred over biologic agents in patients with evidence of more severe inflammatory activity.”

Outside sJIA, Dr. Nikiforow and Dr. Berliner wrote, “early anakinra therapy should be extended to treatment of other forms of sHLH with extreme caution. Specifically, the authors’ suggestion that cytotoxic therapy should be ‘considered’ only after anakinra therapy may be dangerous for some patients.”

Two of Dr. Eloseily’s coinvestigators reported financial and research support from Sobi, the manufacturer of anakinra. No other conflicts of interest were reported.

SOURCES: Eloseily E et al. Arthritis Rheumatol. 2019 Sep 12. doi: 10.1002/art.41103; Nikiforow S, Berliner N. Arthritis Rheumatol. 2019 Sep 16. doi: 10.1002/art.41106.

Nearly half of children with atopic dermatitis (AD) were not getting their medications as prescribed, according to a survey of parents of children with AD.

Perceived effectiveness was the main driver of this variation, Alan Schwartz PhD, and Korey Capozza, MPH, wrote in the study, published in Pediatric Dermatology.

“Responses suggest parents may be willing to use therapies with concerning side effects if they can see a clear benefit for their child’s eczema, but when anticipated improvements fail to materialize, they may change their usage, usually in the direction of using less medication or stopping,” observed Dr. Schwartz, of the University of Illinois, Chicago, and Ms. Capozza, of Global Parents for Eczema Research.

“Addressing expectations related to effectiveness, rather than concerns about medication use, may thus be more likely to lead to taking medication as directed.”

The researchers posted a 15-question survey on the Facebook page of Global Parents for Eczema Research, an international coalition of parents of children with AD. During the month that the survey was posted, 86 parents completed it; questions pertained to adherence to medications and reasons for changing treatments. The mean age of their children was 6 years, most (about 83%) had moderate or severe eczema, and about half lived in the United States.

More than half (55%) reported using the AD medications as directed. But 30% said they took or applied less than prescribed, 13% had stopped the prescribed medication altogether, and 2% took or applied more (or more often) than prescribed.

There were several reasons stated for this variance. Concern over side effects was the most common (46%) reason for not using medications as directed. The next most common reasons were that the child’s symptoms went away (28%); or the “medication was not helping or was not helping as much,” in 23%.

A lack of physician trust or not agreeing with the physician’s recommendations accounted for 18% of the concerns. The remainder thought it wasn’t important to take the medication as prescribed, it was inconvenient or too time consuming, that they forgot, it was too expensive, or they were confused about the directions.

To the question asking “What would have made you more likely to use the medication as prescribed?” the most common answer was a clearer indication of effectiveness (56%). The next most common was “access to research or evidence about benefit and side effect profile” (14%).

A good relationship between the physician and patient was associated with taking medication as directed

“Improvement in adherence to topical treatments among children with AD could yield large gains in quality-of-life improvements and reduce exposure to costlier and potentially more toxic systemic agents,” the authors noted. “Given the large, documented gains in disease improvement, and even remission, achieved with interventions that address adherence among patients with other chronic diseases, strategies that address the underlying causes for poor adherence among parents of children with atopic dermatitis stand to provide a significant, untapped benefit.”

No financial disclosures were noted.

[email protected]

SOURCE: Pediatr Dermatol. 2019 Aug 28. doi: 10.1111/pde.13991.

Nearly half of children with atopic dermatitis (AD) were not getting their medications as prescribed, according to a survey of parents of children with AD.

Perceived effectiveness was the main driver of this variation, Alan Schwartz PhD, and Korey Capozza, MPH, wrote in the study, published in Pediatric Dermatology.

“Responses suggest parents may be willing to use therapies with concerning side effects if they can see a clear benefit for their child’s eczema, but when anticipated improvements fail to materialize, they may change their usage, usually in the direction of using less medication or stopping,” observed Dr. Schwartz, of the University of Illinois, Chicago, and Ms. Capozza, of Global Parents for Eczema Research.

“Addressing expectations related to effectiveness, rather than concerns about medication use, may thus be more likely to lead to taking medication as directed.”

The researchers posted a 15-question survey on the Facebook page of Global Parents for Eczema Research, an international coalition of parents of children with AD. During the month that the survey was posted, 86 parents completed it; questions pertained to adherence to medications and reasons for changing treatments. The mean age of their children was 6 years, most (about 83%) had moderate or severe eczema, and about half lived in the United States.

More than half (55%) reported using the AD medications as directed. But 30% said they took or applied less than prescribed, 13% had stopped the prescribed medication altogether, and 2% took or applied more (or more often) than prescribed.

There were several reasons stated for this variance. Concern over side effects was the most common (46%) reason for not using medications as directed. The next most common reasons were that the child’s symptoms went away (28%); or the “medication was not helping or was not helping as much,” in 23%.

A lack of physician trust or not agreeing with the physician’s recommendations accounted for 18% of the concerns. The remainder thought it wasn’t important to take the medication as prescribed, it was inconvenient or too time consuming, that they forgot, it was too expensive, or they were confused about the directions.

To the question asking “What would have made you more likely to use the medication as prescribed?” the most common answer was a clearer indication of effectiveness (56%). The next most common was “access to research or evidence about benefit and side effect profile” (14%).

A good relationship between the physician and patient was associated with taking medication as directed

“Improvement in adherence to topical treatments among children with AD could yield large gains in quality-of-life improvements and reduce exposure to costlier and potentially more toxic systemic agents,” the authors noted. “Given the large, documented gains in disease improvement, and even remission, achieved with interventions that address adherence among patients with other chronic diseases, strategies that address the underlying causes for poor adherence among parents of children with atopic dermatitis stand to provide a significant, untapped benefit.”

No financial disclosures were noted.

[email protected]

SOURCE: Pediatr Dermatol. 2019 Aug 28. doi: 10.1111/pde.13991.

Nearly half of children with atopic dermatitis (AD) were not getting their medications as prescribed, according to a survey of parents of children with AD.

Perceived effectiveness was the main driver of this variation, Alan Schwartz PhD, and Korey Capozza, MPH, wrote in the study, published in Pediatric Dermatology.

“Responses suggest parents may be willing to use therapies with concerning side effects if they can see a clear benefit for their child’s eczema, but when anticipated improvements fail to materialize, they may change their usage, usually in the direction of using less medication or stopping,” observed Dr. Schwartz, of the University of Illinois, Chicago, and Ms. Capozza, of Global Parents for Eczema Research.

“Addressing expectations related to effectiveness, rather than concerns about medication use, may thus be more likely to lead to taking medication as directed.”

The researchers posted a 15-question survey on the Facebook page of Global Parents for Eczema Research, an international coalition of parents of children with AD. During the month that the survey was posted, 86 parents completed it; questions pertained to adherence to medications and reasons for changing treatments. The mean age of their children was 6 years, most (about 83%) had moderate or severe eczema, and about half lived in the United States.

More than half (55%) reported using the AD medications as directed. But 30% said they took or applied less than prescribed, 13% had stopped the prescribed medication altogether, and 2% took or applied more (or more often) than prescribed.

There were several reasons stated for this variance. Concern over side effects was the most common (46%) reason for not using medications as directed. The next most common reasons were that the child’s symptoms went away (28%); or the “medication was not helping or was not helping as much,” in 23%.

A lack of physician trust or not agreeing with the physician’s recommendations accounted for 18% of the concerns. The remainder thought it wasn’t important to take the medication as prescribed, it was inconvenient or too time consuming, that they forgot, it was too expensive, or they were confused about the directions.

To the question asking “What would have made you more likely to use the medication as prescribed?” the most common answer was a clearer indication of effectiveness (56%). The next most common was “access to research or evidence about benefit and side effect profile” (14%).

A good relationship between the physician and patient was associated with taking medication as directed

“Improvement in adherence to topical treatments among children with AD could yield large gains in quality-of-life improvements and reduce exposure to costlier and potentially more toxic systemic agents,” the authors noted. “Given the large, documented gains in disease improvement, and even remission, achieved with interventions that address adherence among patients with other chronic diseases, strategies that address the underlying causes for poor adherence among parents of children with atopic dermatitis stand to provide a significant, untapped benefit.”

No financial disclosures were noted.

[email protected]

SOURCE: Pediatr Dermatol. 2019 Aug 28. doi: 10.1111/pde.13991.

PARIS – A massive randomized trial that included all New Zealanders with a suspected acute coronary syndrome during a 2-year period has provided definitive evidence that giving high-flow supplemental oxygen to those who are nonhypoxemic is of no clinical benefit, although it wasn’t harmful, either.

Vidyard Video

“Patients who have a normal blood oxygen saturation level are very unlikely to benefit from supplemental oxygen,” Ralph Stewart, MbChB, said in presenting the results of the NZOTACS (New Zealand Oxygen Therapy in Acute Coronary Syndromes) trial at the annual congress of the European Society of Cardiology.

“It’s amazing that oxygen has been used in patients with suspected heart attack for over 50 years, and during that time there’s never been definite evidence that it improves outcomes. And more recently some have even suggested giving high-level oxygen might actually cause harm,” observed Dr. Stewart, a cardiologist at Auckland City Hospital and the University of Auckland (New Zealand).

The primary outcome in NZOTACS was 30-day all-cause mortality. In the overall study population, the rate was 3.0% in the group assigned to the routine high-flow oxygen protocol and closely similar at 3.1% in those randomized to the conservative oxygen strategy. And there was reassuringly no signal that the liberal oxygen protocol caused any harm.

To conduct this cluster randomized crossover trial, Dr. Stewart and his coinvestigators divided New Zealand into quadrants and, taking advantage of the coordinated health care systems operative in the nation of 4.8 million, they arranged for all ambulances, emergency departments, and hospitals in each geographic region to utilize each supplemental oxygen strategy for a total of 12 months.

In the liberal oxygen strategy, patients with suspected ACS on the basis of ischemic chest pain or ECG changes received high-flow oxygen by face mask at 6-8 L/min regardless of their blood oxygen saturation (SaO₂) level. The oxygen was stopped only upon clinical resolution of myocardial ischemia. In contrast, in the low-oxygen protocol, supplemental oxygen was reserved for patients with an initial SaO₂ below 90%, with a target SaO₂ of 90%-94%.

Roughly 90% of the nearly 41,000 study participants had a normal SaO₂ of 90% or more. Their 30-day mortality was 2.1% with the high-oxygen protocol and similar at 1.9% with the conservative oxygen protocol.

In contrast, there was a suggestion of benefit for the routine liberal oxygen strategy in the subgroup of patients with ST-elevation MI. Their 30-day mortality was 8.8% with high-flow oxygen and 10.6% with the conservative oxygen protocol. The resultant 19% relative risk reduction barely missed statistical significance. There was also a trend for possible benefit of routine high-flow oxygen in the roughly 12% of NZOTACS participants with an SaO₂ below 95%, a lower bar than the 90% SaO₂ that defines hypoxemia. Their death rate at 30 days was 10.1% if they got supplemental oxygen and 11.1% if they only received oxygen in the event their SaO₂ was below 90%. But these exploratory findings must be viewed as hypothesis-generating, and a large confirmatory study would be required, Dr. Stewart noted.

Discussant Robin Hofmann, MD, PhD, commented that, based on the NZOTACS results, he believes a couple of changes to the current ESC guidelines on management of ACS are in order. The guidelines now state that oxygen is indicated in patients with suspected ACS and hypoxemia as defined by an SaO₂ below 90%, giving that recommendation a Class I Level of Evidence C. That should now be upgraded to the strongest-possible Class I A recommendation, according to Dr. Hofmann, a cardiologist at the Karolinska Institute in Stockholm.

The ESC guidelines also state that oxygen isn’t routinely recommended in patients with an SaO₂ of 90% or more, rating that guidance Class III B. On the basis of NZOTACS coupled with earlier far smaller studies, that should be changed to a Class III A recommendation, meaning simply don’t do it. The hint provided by NZOTACS of a possible small benefit for oxygen in patients with an SaO₂ below 95% isn’t strong enough evidence to carry the day, in Dr. Hofmann’s view.

Dr. Stewart and Dr. Hofmann reported having no financial conflicts of interest. The NZOTACS trial was funded by the National Heart Foundation of New Zealand.

[email protected]

SOURCE: Stewart R. ESC 2019, Hotline Session 2.

PARIS – A massive randomized trial that included all New Zealanders with a suspected acute coronary syndrome during a 2-year period has provided definitive evidence that giving high-flow supplemental oxygen to those who are nonhypoxemic is of no clinical benefit, although it wasn’t harmful, either.

Vidyard Video

“Patients who have a normal blood oxygen saturation level are very unlikely to benefit from supplemental oxygen,” Ralph Stewart, MbChB, said in presenting the results of the NZOTACS (New Zealand Oxygen Therapy in Acute Coronary Syndromes) trial at the annual congress of the European Society of Cardiology.

“It’s amazing that oxygen has been used in patients with suspected heart attack for over 50 years, and during that time there’s never been definite evidence that it improves outcomes. And more recently some have even suggested giving high-level oxygen might actually cause harm,” observed Dr. Stewart, a cardiologist at Auckland City Hospital and the University of Auckland (New Zealand).

The primary outcome in NZOTACS was 30-day all-cause mortality. In the overall study population, the rate was 3.0% in the group assigned to the routine high-flow oxygen protocol and closely similar at 3.1% in those randomized to the conservative oxygen strategy. And there was reassuringly no signal that the liberal oxygen protocol caused any harm.

To conduct this cluster randomized crossover trial, Dr. Stewart and his coinvestigators divided New Zealand into quadrants and, taking advantage of the coordinated health care systems operative in the nation of 4.8 million, they arranged for all ambulances, emergency departments, and hospitals in each geographic region to utilize each supplemental oxygen strategy for a total of 12 months.

In the liberal oxygen strategy, patients with suspected ACS on the basis of ischemic chest pain or ECG changes received high-flow oxygen by face mask at 6-8 L/min regardless of their blood oxygen saturation (SaO₂) level. The oxygen was stopped only upon clinical resolution of myocardial ischemia. In contrast, in the low-oxygen protocol, supplemental oxygen was reserved for patients with an initial SaO₂ below 90%, with a target SaO₂ of 90%-94%.

Roughly 90% of the nearly 41,000 study participants had a normal SaO₂ of 90% or more. Their 30-day mortality was 2.1% with the high-oxygen protocol and similar at 1.9% with the conservative oxygen protocol.

In contrast, there was a suggestion of benefit for the routine liberal oxygen strategy in the subgroup of patients with ST-elevation MI. Their 30-day mortality was 8.8% with high-flow oxygen and 10.6% with the conservative oxygen protocol. The resultant 19% relative risk reduction barely missed statistical significance. There was also a trend for possible benefit of routine high-flow oxygen in the roughly 12% of NZOTACS participants with an SaO₂ below 95%, a lower bar than the 90% SaO₂ that defines hypoxemia. Their death rate at 30 days was 10.1% if they got supplemental oxygen and 11.1% if they only received oxygen in the event their SaO₂ was below 90%. But these exploratory findings must be viewed as hypothesis-generating, and a large confirmatory study would be required, Dr. Stewart noted.

Discussant Robin Hofmann, MD, PhD, commented that, based on the NZOTACS results, he believes a couple of changes to the current ESC guidelines on management of ACS are in order. The guidelines now state that oxygen is indicated in patients with suspected ACS and hypoxemia as defined by an SaO₂ below 90%, giving that recommendation a Class I Level of Evidence C. That should now be upgraded to the strongest-possible Class I A recommendation, according to Dr. Hofmann, a cardiologist at the Karolinska Institute in Stockholm.

The ESC guidelines also state that oxygen isn’t routinely recommended in patients with an SaO₂ of 90% or more, rating that guidance Class III B. On the basis of NZOTACS coupled with earlier far smaller studies, that should be changed to a Class III A recommendation, meaning simply don’t do it. The hint provided by NZOTACS of a possible small benefit for oxygen in patients with an SaO₂ below 95% isn’t strong enough evidence to carry the day, in Dr. Hofmann’s view.

Dr. Stewart and Dr. Hofmann reported having no financial conflicts of interest. The NZOTACS trial was funded by the National Heart Foundation of New Zealand.

[email protected]

SOURCE: Stewart R. ESC 2019, Hotline Session 2.

PARIS – A massive randomized trial that included all New Zealanders with a suspected acute coronary syndrome during a 2-year period has provided definitive evidence that giving high-flow supplemental oxygen to those who are nonhypoxemic is of no clinical benefit, although it wasn’t harmful, either.

Vidyard Video

“Patients who have a normal blood oxygen saturation level are very unlikely to benefit from supplemental oxygen,” Ralph Stewart, MbChB, said in presenting the results of the NZOTACS (New Zealand Oxygen Therapy in Acute Coronary Syndromes) trial at the annual congress of the European Society of Cardiology.

“It’s amazing that oxygen has been used in patients with suspected heart attack for over 50 years, and during that time there’s never been definite evidence that it improves outcomes. And more recently some have even suggested giving high-level oxygen might actually cause harm,” observed Dr. Stewart, a cardiologist at Auckland City Hospital and the University of Auckland (New Zealand).

The primary outcome in NZOTACS was 30-day all-cause mortality. In the overall study population, the rate was 3.0% in the group assigned to the routine high-flow oxygen protocol and closely similar at 3.1% in those randomized to the conservative oxygen strategy. And there was reassuringly no signal that the liberal oxygen protocol caused any harm.

To conduct this cluster randomized crossover trial, Dr. Stewart and his coinvestigators divided New Zealand into quadrants and, taking advantage of the coordinated health care systems operative in the nation of 4.8 million, they arranged for all ambulances, emergency departments, and hospitals in each geographic region to utilize each supplemental oxygen strategy for a total of 12 months.

In the liberal oxygen strategy, patients with suspected ACS on the basis of ischemic chest pain or ECG changes received high-flow oxygen by face mask at 6-8 L/min regardless of their blood oxygen saturation (SaO₂) level. The oxygen was stopped only upon clinical resolution of myocardial ischemia. In contrast, in the low-oxygen protocol, supplemental oxygen was reserved for patients with an initial SaO₂ below 90%, with a target SaO₂ of 90%-94%.

Roughly 90% of the nearly 41,000 study participants had a normal SaO₂ of 90% or more. Their 30-day mortality was 2.1% with the high-oxygen protocol and similar at 1.9% with the conservative oxygen protocol.

In contrast, there was a suggestion of benefit for the routine liberal oxygen strategy in the subgroup of patients with ST-elevation MI. Their 30-day mortality was 8.8% with high-flow oxygen and 10.6% with the conservative oxygen protocol. The resultant 19% relative risk reduction barely missed statistical significance. There was also a trend for possible benefit of routine high-flow oxygen in the roughly 12% of NZOTACS participants with an SaO₂ below 95%, a lower bar than the 90% SaO₂ that defines hypoxemia. Their death rate at 30 days was 10.1% if they got supplemental oxygen and 11.1% if they only received oxygen in the event their SaO₂ was below 90%. But these exploratory findings must be viewed as hypothesis-generating, and a large confirmatory study would be required, Dr. Stewart noted.

Discussant Robin Hofmann, MD, PhD, commented that, based on the NZOTACS results, he believes a couple of changes to the current ESC guidelines on management of ACS are in order. The guidelines now state that oxygen is indicated in patients with suspected ACS and hypoxemia as defined by an SaO₂ below 90%, giving that recommendation a Class I Level of Evidence C. That should now be upgraded to the strongest-possible Class I A recommendation, according to Dr. Hofmann, a cardiologist at the Karolinska Institute in Stockholm.

The ESC guidelines also state that oxygen isn’t routinely recommended in patients with an SaO₂ of 90% or more, rating that guidance Class III B. On the basis of NZOTACS coupled with earlier far smaller studies, that should be changed to a Class III A recommendation, meaning simply don’t do it. The hint provided by NZOTACS of a possible small benefit for oxygen in patients with an SaO₂ below 95% isn’t strong enough evidence to carry the day, in Dr. Hofmann’s view.

Dr. Stewart and Dr. Hofmann reported having no financial conflicts of interest. The NZOTACS trial was funded by the National Heart Foundation of New Zealand.

[email protected]

SOURCE: Stewart R. ESC 2019, Hotline Session 2.

Personality quizzes abound on the Internet these days; you can find out everything from which Disney Princess you are to what type of fruit you would be. But there is a serious case to be made for how your personality type influences your work. It affects how you manage others, develop leadership skills, approach conflict resolution, and manage change.¹ Understanding your personality type assists in identifying your strengths, weaknesses, and areas in need of development.

My personality type is ENTP: someone who is “resourceful in solving new and challenging problems.”1 At many points in my career, I found myself in a leadership role. But truthfully, I never set out to be a leader—my career goals set me on that path. You might call me an “accidental leader.”

Recall my story about the founding of the American Academy of Nurse Practitioners (AANP; see Part 2): In the beginning, we were all encouraged to contribute whatever time and energy we could to getting the organization off the ground. I had plenty of time and energy to give. I saw the need for an NP-dedicated organization as a challenge. While I did not know my personality type at the time, I understood that I had a drive to meet challenges—those arising from the status quo and those of moving the vision for this new organization forward.

Our leadership skills are derived from everyday experiences—both the good and the bad. But we only grow if we study the consequences of those experiences to gain insights and to find new ways to manage ourselves and the team.² Understanding your own personality and skills helps you better appreciate the differences in those you lead and understand how to direct or utilize their particular skills.

Each team member brings a set of skills, range of ideas, and problem-solving approaches to a unique situation. You should identify your team members’ strengths and promote a culture in which the whole team feels comfortable, confident, supported, and encouraged to contribute.³

How do you do that? By initiating and maintaining effective working relationships within the team and demonstrating skills in care coordination and delegation. Everyone benefits when each team member’s unique abilities are used to progress toward the goal.

In my experience, a team is most effective when the leader

• knows each team members’ professional and personal goals
• sets real priorities and commitments
• establishes clear direction
• builds rapport
• is fair with everyone
• shares knowledge and resources
• mentors others to become effective leaders.

Continue to: Another thing that the most effective leaders do is...

Another thing that the most effective leaders do is manage their time and conserve their energy and focus. Think in both short- and long-term goals. Leaders are ordinary people with extraordinary determination, but they know when to stop working and how to recharge their batteries.^3,4

It is also important for leaders to acknowledge their accomplishments. All too often, we downplay the contributions we have made, the barriers we have overcome, and the sacrifices we have made to get to where we are today. Our accomplishments add to our body of experience and serve as the foundation for our growth.

Contrary to popular belief, leaders can be made. Anybody can be a leader. One just has to take the time to understand the commitment and the responsibilities. Leadership is a function of who you are, what you can do, and how you do it. Find a mission that ignites your passion, and go for it!

Personality quizzes abound on the Internet these days; you can find out everything from which Disney Princess you are to what type of fruit you would be. But there is a serious case to be made for how your personality type influences your work. It affects how you manage others, develop leadership skills, approach conflict resolution, and manage change.¹ Understanding your personality type assists in identifying your strengths, weaknesses, and areas in need of development.

My personality type is ENTP: someone who is “resourceful in solving new and challenging problems.”1 At many points in my career, I found myself in a leadership role. But truthfully, I never set out to be a leader—my career goals set me on that path. You might call me an “accidental leader.”

Recall my story about the founding of the American Academy of Nurse Practitioners (AANP; see Part 2): In the beginning, we were all encouraged to contribute whatever time and energy we could to getting the organization off the ground. I had plenty of time and energy to give. I saw the need for an NP-dedicated organization as a challenge. While I did not know my personality type at the time, I understood that I had a drive to meet challenges—those arising from the status quo and those of moving the vision for this new organization forward.

Our leadership skills are derived from everyday experiences—both the good and the bad. But we only grow if we study the consequences of those experiences to gain insights and to find new ways to manage ourselves and the team.² Understanding your own personality and skills helps you better appreciate the differences in those you lead and understand how to direct or utilize their particular skills.

Each team member brings a set of skills, range of ideas, and problem-solving approaches to a unique situation. You should identify your team members’ strengths and promote a culture in which the whole team feels comfortable, confident, supported, and encouraged to contribute.³

How do you do that? By initiating and maintaining effective working relationships within the team and demonstrating skills in care coordination and delegation. Everyone benefits when each team member’s unique abilities are used to progress toward the goal.

In my experience, a team is most effective when the leader

• knows each team members’ professional and personal goals
• sets real priorities and commitments
• establishes clear direction
• builds rapport
• is fair with everyone
• shares knowledge and resources
• mentors others to become effective leaders.

Continue to: Another thing that the most effective leaders do is...

Another thing that the most effective leaders do is manage their time and conserve their energy and focus. Think in both short- and long-term goals. Leaders are ordinary people with extraordinary determination, but they know when to stop working and how to recharge their batteries.^3,4

It is also important for leaders to acknowledge their accomplishments. All too often, we downplay the contributions we have made, the barriers we have overcome, and the sacrifices we have made to get to where we are today. Our accomplishments add to our body of experience and serve as the foundation for our growth.

Contrary to popular belief, leaders can be made. Anybody can be a leader. One just has to take the time to understand the commitment and the responsibilities. Leadership is a function of who you are, what you can do, and how you do it. Find a mission that ignites your passion, and go for it!

Personality quizzes abound on the Internet these days; you can find out everything from which Disney Princess you are to what type of fruit you would be. But there is a serious case to be made for how your personality type influences your work. It affects how you manage others, develop leadership skills, approach conflict resolution, and manage change.¹ Understanding your personality type assists in identifying your strengths, weaknesses, and areas in need of development.

My personality type is ENTP: someone who is “resourceful in solving new and challenging problems.”1 At many points in my career, I found myself in a leadership role. But truthfully, I never set out to be a leader—my career goals set me on that path. You might call me an “accidental leader.”

Recall my story about the founding of the American Academy of Nurse Practitioners (AANP; see Part 2): In the beginning, we were all encouraged to contribute whatever time and energy we could to getting the organization off the ground. I had plenty of time and energy to give. I saw the need for an NP-dedicated organization as a challenge. While I did not know my personality type at the time, I understood that I had a drive to meet challenges—those arising from the status quo and those of moving the vision for this new organization forward.

Our leadership skills are derived from everyday experiences—both the good and the bad. But we only grow if we study the consequences of those experiences to gain insights and to find new ways to manage ourselves and the team.² Understanding your own personality and skills helps you better appreciate the differences in those you lead and understand how to direct or utilize their particular skills.

Each team member brings a set of skills, range of ideas, and problem-solving approaches to a unique situation. You should identify your team members’ strengths and promote a culture in which the whole team feels comfortable, confident, supported, and encouraged to contribute.³

How do you do that? By initiating and maintaining effective working relationships within the team and demonstrating skills in care coordination and delegation. Everyone benefits when each team member’s unique abilities are used to progress toward the goal.

In my experience, a team is most effective when the leader

• knows each team members’ professional and personal goals
• sets real priorities and commitments
• establishes clear direction
• builds rapport
• is fair with everyone
• shares knowledge and resources
• mentors others to become effective leaders.

Continue to: Another thing that the most effective leaders do is...

Another thing that the most effective leaders do is manage their time and conserve their energy and focus. Think in both short- and long-term goals. Leaders are ordinary people with extraordinary determination, but they know when to stop working and how to recharge their batteries.^3,4

It is also important for leaders to acknowledge their accomplishments. All too often, we downplay the contributions we have made, the barriers we have overcome, and the sacrifices we have made to get to where we are today. Our accomplishments add to our body of experience and serve as the foundation for our growth.

Contrary to popular belief, leaders can be made. Anybody can be a leader. One just has to take the time to understand the commitment and the responsibilities. Leadership is a function of who you are, what you can do, and how you do it. Find a mission that ignites your passion, and go for it!