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Prophylactic emicizumab cut bleeds by 87% in hemophilia A with inhibitors
Once-weekly prophylactic therapy with emicizumab (ACE910) was associated an 87% lower rate of treated bleeding than no prophylaxis among patients with hemophilia A with inhibitors in the open-label, phase III HAVEN 1 trial.
After a median 24 weeks of treatment (range, 3-48 weeks), the 35 patients who were randomly assigned to prophylactic emicizumab (3.0 mg per kg for 4 weeks, followed by 1.5 mg per kg) had an annualized bleeding rate of 2.9 events, compared with an annualized rate of 23.3 events among the 18 patients who received no prophylaxis. The difference was statistically significant, reported Johannes Oldenburg, MD, PhD, and his associates at the International Society on Thrombosis and Haemostasis congress and simultaneously in the New England Journal of Medicine (N Engl J Med. 2017 Jul 10. doi: 10.1056/NEJMoa1703068).
In addition, 63% of patients who received prophylactic emicizumab had no bleeding events, compared with only 6% of the comparison group, said Dr. Oldenburg of Universitaetsklinikum Bonn, Germany. Emicizumab also was associated with a 79% lower rate of treated bleeds, compared with the historic rate among 24 patients who previously had been on prophylactic bypassing agents (P less than .001). No patient developed detectable antidrug antibodies.
The most common adverse events were injection site reactions (15% of patients), followed by headache, upper respiratory tract infection, arthralgia, and fatigue. Four patients developed thrombotic microangiopathy or cavernous sinus thrombosis and skin necrosis, all of whom had experienced breakthrough bleeding for which they had received multiple infusions of activated prothrombin complex concentrate at doses averaging more than 100 U per kg per day.
Patients with severe hemophilia A typically require prophylactic factor VIII infusions two to three times a week, but 30% develop neutralizing antibodies against factor VIII (inhibitors), which increases care burden, costs, and complication rates.
Emicizumab is a recombinant humanized bispecific monoclonal antibody that restores the function of missing active factor VIII by bridging activated factor IX and factor X, the investigators noted. A phase I study linked once-weekly emicizumab prophylaxis to markedly lower bleeding rates without dose-limiting toxicities (N Engl J Med 2016;374:2044-53). Subsequently, the phase III HAVEN 1 study (NCT02622321) compared once-weekly subcutaneous prophylactic emicizumab with on-demand (episodic) and prophylactic use of bypassing agents (BPAs) in 109 adults and adolescents (12 years and older) with hemophilia A with inhibitors. The primary endpoint was the difference in rates of treated bleeds between the groups. Patients had a median age of 28 years, all were male, and most had severe hemophilia at baseline. They typically had more than nine bleeding events in the 6 months before enrollment, with bleeding in more than one target joint and factor VIII titers of 180 Bethesda units per mL.
HAVEN 1 was funded by F. Hoffmann-La Roche and Chugai Pharmaceutical. Dr. Oldenburg and 13 coinvestigators disclosed ties to Chugai, Roche, and other pharmaceutical companies. The remaining coinvestigator had no disclosures.
The results of this phase III trial are of great importance to patients with for hemophilia A, offering “an elegant new solution for treatment.” Although it is not clear how best to treat the infrequent events of breakthrough bleeding when administering emicizumab, it is evident that repeated high doses of activated prothrombin complex concentrate should be avoided. Also, how to integrate emicizumab prophylaxis with current schedules for the induction of immune tolerance to factor VIII remains to be seen.
Meanwhile, weekly subcutaneous emicizumab prophylaxis offer great reductions in bleeding rates and improve quality of life “for this very challenging patient group.” Additional studies already are underway to ascertain the benefit of emicizumab prophylaxis in children with hemophilia with inhibitors, and a study for patients with hemophilia A without inhibitors is planned.
“These are extraordinary times for innovation in hemophilia therapy, and the introduction of emicizumab represents a major contribution toward achieving an enhanced standard of care for this lifelong bleeding disorder.”
David Lillicrap, MD, is with the department of pathology and molecular medicine at Queen’s University, Kingston, Ontario. He reported having no relevant conflicts of interest. These comments are from his accompanying editorial (N Engl J Med. 2017 June 10. doi: 10.1056/NEJMe1707802).
The results of this phase III trial are of great importance to patients with for hemophilia A, offering “an elegant new solution for treatment.” Although it is not clear how best to treat the infrequent events of breakthrough bleeding when administering emicizumab, it is evident that repeated high doses of activated prothrombin complex concentrate should be avoided. Also, how to integrate emicizumab prophylaxis with current schedules for the induction of immune tolerance to factor VIII remains to be seen.
Meanwhile, weekly subcutaneous emicizumab prophylaxis offer great reductions in bleeding rates and improve quality of life “for this very challenging patient group.” Additional studies already are underway to ascertain the benefit of emicizumab prophylaxis in children with hemophilia with inhibitors, and a study for patients with hemophilia A without inhibitors is planned.
“These are extraordinary times for innovation in hemophilia therapy, and the introduction of emicizumab represents a major contribution toward achieving an enhanced standard of care for this lifelong bleeding disorder.”
David Lillicrap, MD, is with the department of pathology and molecular medicine at Queen’s University, Kingston, Ontario. He reported having no relevant conflicts of interest. These comments are from his accompanying editorial (N Engl J Med. 2017 June 10. doi: 10.1056/NEJMe1707802).
The results of this phase III trial are of great importance to patients with for hemophilia A, offering “an elegant new solution for treatment.” Although it is not clear how best to treat the infrequent events of breakthrough bleeding when administering emicizumab, it is evident that repeated high doses of activated prothrombin complex concentrate should be avoided. Also, how to integrate emicizumab prophylaxis with current schedules for the induction of immune tolerance to factor VIII remains to be seen.
Meanwhile, weekly subcutaneous emicizumab prophylaxis offer great reductions in bleeding rates and improve quality of life “for this very challenging patient group.” Additional studies already are underway to ascertain the benefit of emicizumab prophylaxis in children with hemophilia with inhibitors, and a study for patients with hemophilia A without inhibitors is planned.
“These are extraordinary times for innovation in hemophilia therapy, and the introduction of emicizumab represents a major contribution toward achieving an enhanced standard of care for this lifelong bleeding disorder.”
David Lillicrap, MD, is with the department of pathology and molecular medicine at Queen’s University, Kingston, Ontario. He reported having no relevant conflicts of interest. These comments are from his accompanying editorial (N Engl J Med. 2017 June 10. doi: 10.1056/NEJMe1707802).
Once-weekly prophylactic therapy with emicizumab (ACE910) was associated an 87% lower rate of treated bleeding than no prophylaxis among patients with hemophilia A with inhibitors in the open-label, phase III HAVEN 1 trial.
After a median 24 weeks of treatment (range, 3-48 weeks), the 35 patients who were randomly assigned to prophylactic emicizumab (3.0 mg per kg for 4 weeks, followed by 1.5 mg per kg) had an annualized bleeding rate of 2.9 events, compared with an annualized rate of 23.3 events among the 18 patients who received no prophylaxis. The difference was statistically significant, reported Johannes Oldenburg, MD, PhD, and his associates at the International Society on Thrombosis and Haemostasis congress and simultaneously in the New England Journal of Medicine (N Engl J Med. 2017 Jul 10. doi: 10.1056/NEJMoa1703068).
In addition, 63% of patients who received prophylactic emicizumab had no bleeding events, compared with only 6% of the comparison group, said Dr. Oldenburg of Universitaetsklinikum Bonn, Germany. Emicizumab also was associated with a 79% lower rate of treated bleeds, compared with the historic rate among 24 patients who previously had been on prophylactic bypassing agents (P less than .001). No patient developed detectable antidrug antibodies.
The most common adverse events were injection site reactions (15% of patients), followed by headache, upper respiratory tract infection, arthralgia, and fatigue. Four patients developed thrombotic microangiopathy or cavernous sinus thrombosis and skin necrosis, all of whom had experienced breakthrough bleeding for which they had received multiple infusions of activated prothrombin complex concentrate at doses averaging more than 100 U per kg per day.
Patients with severe hemophilia A typically require prophylactic factor VIII infusions two to three times a week, but 30% develop neutralizing antibodies against factor VIII (inhibitors), which increases care burden, costs, and complication rates.
Emicizumab is a recombinant humanized bispecific monoclonal antibody that restores the function of missing active factor VIII by bridging activated factor IX and factor X, the investigators noted. A phase I study linked once-weekly emicizumab prophylaxis to markedly lower bleeding rates without dose-limiting toxicities (N Engl J Med 2016;374:2044-53). Subsequently, the phase III HAVEN 1 study (NCT02622321) compared once-weekly subcutaneous prophylactic emicizumab with on-demand (episodic) and prophylactic use of bypassing agents (BPAs) in 109 adults and adolescents (12 years and older) with hemophilia A with inhibitors. The primary endpoint was the difference in rates of treated bleeds between the groups. Patients had a median age of 28 years, all were male, and most had severe hemophilia at baseline. They typically had more than nine bleeding events in the 6 months before enrollment, with bleeding in more than one target joint and factor VIII titers of 180 Bethesda units per mL.
HAVEN 1 was funded by F. Hoffmann-La Roche and Chugai Pharmaceutical. Dr. Oldenburg and 13 coinvestigators disclosed ties to Chugai, Roche, and other pharmaceutical companies. The remaining coinvestigator had no disclosures.
Once-weekly prophylactic therapy with emicizumab (ACE910) was associated an 87% lower rate of treated bleeding than no prophylaxis among patients with hemophilia A with inhibitors in the open-label, phase III HAVEN 1 trial.
After a median 24 weeks of treatment (range, 3-48 weeks), the 35 patients who were randomly assigned to prophylactic emicizumab (3.0 mg per kg for 4 weeks, followed by 1.5 mg per kg) had an annualized bleeding rate of 2.9 events, compared with an annualized rate of 23.3 events among the 18 patients who received no prophylaxis. The difference was statistically significant, reported Johannes Oldenburg, MD, PhD, and his associates at the International Society on Thrombosis and Haemostasis congress and simultaneously in the New England Journal of Medicine (N Engl J Med. 2017 Jul 10. doi: 10.1056/NEJMoa1703068).
In addition, 63% of patients who received prophylactic emicizumab had no bleeding events, compared with only 6% of the comparison group, said Dr. Oldenburg of Universitaetsklinikum Bonn, Germany. Emicizumab also was associated with a 79% lower rate of treated bleeds, compared with the historic rate among 24 patients who previously had been on prophylactic bypassing agents (P less than .001). No patient developed detectable antidrug antibodies.
The most common adverse events were injection site reactions (15% of patients), followed by headache, upper respiratory tract infection, arthralgia, and fatigue. Four patients developed thrombotic microangiopathy or cavernous sinus thrombosis and skin necrosis, all of whom had experienced breakthrough bleeding for which they had received multiple infusions of activated prothrombin complex concentrate at doses averaging more than 100 U per kg per day.
Patients with severe hemophilia A typically require prophylactic factor VIII infusions two to three times a week, but 30% develop neutralizing antibodies against factor VIII (inhibitors), which increases care burden, costs, and complication rates.
Emicizumab is a recombinant humanized bispecific monoclonal antibody that restores the function of missing active factor VIII by bridging activated factor IX and factor X, the investigators noted. A phase I study linked once-weekly emicizumab prophylaxis to markedly lower bleeding rates without dose-limiting toxicities (N Engl J Med 2016;374:2044-53). Subsequently, the phase III HAVEN 1 study (NCT02622321) compared once-weekly subcutaneous prophylactic emicizumab with on-demand (episodic) and prophylactic use of bypassing agents (BPAs) in 109 adults and adolescents (12 years and older) with hemophilia A with inhibitors. The primary endpoint was the difference in rates of treated bleeds between the groups. Patients had a median age of 28 years, all were male, and most had severe hemophilia at baseline. They typically had more than nine bleeding events in the 6 months before enrollment, with bleeding in more than one target joint and factor VIII titers of 180 Bethesda units per mL.
HAVEN 1 was funded by F. Hoffmann-La Roche and Chugai Pharmaceutical. Dr. Oldenburg and 13 coinvestigators disclosed ties to Chugai, Roche, and other pharmaceutical companies. The remaining coinvestigator had no disclosures.
From 2017 ISTH CONGRESS
Key clinical point: .
Major finding: After a median 24 weeks of treatment, the intervention group averaged 2.9 bleeds per year vs. 23.3 events in the control group.
Data source: A phase III randomized multicenter open-label trial of 109 male adolescents and adults with hemophilia A and factor VIII inhibitors.
Disclosures: HAVEN 1 was funded by F. Hoffmann-La Roche and Chugai Pharmaceutical. Dr. Oldenburg and 13 coinvestigators disclosed ties to Chugai, Roche, and other pharmaceutical companies. The remaining coinvestigator had no disclosures.
New one-time treatment for head lice found safe for children
CHICAGO – A novel one-time topical treatment for head lice, abametapir, was well tolerated in children as young as 6 months, according to pooled results from 11 clinical trials.
The pooled safety data included results from 11 clinical trials including 1,372 patients. Of these, 700 were aged 6 months to 17 years, and patients were exposed to the novel metalloproteinase inhibitor for 10-20 minutes.
In examining safety data from the pooled trials, Lydie Hazan, MD, of Axis Clinical Trials and her collaborators found that for pediatric patients, most treatment-emergent adverse events (AEs) were skin and subcutaneous tissue-related. The most common AEs were erythema, rash, a burning sensation on the skin, and contact dermatitis.
Data for the three phase II pharmacokinetic trials, the phase II ovicidal efficacy trial, and the two phase III trials were reported separately by Dr. Hazan and her coauthors in a poster presentation at the World Congress of Pediatric Dermatology. The overall incidence of treatment-emergent AEs in the studies ranged from 20% to 29% for patients in the active arms of the trials. For patients who received the vehicle lotion only, the incidence of AEs ranged from 16% to 57%.
Of the 11 trials, 6 involved pediatric patients, with one phase IIB trial, one phase II ovicidal trial, two maximal-use open-label trials, and two phase III randomized, double-blind, vehicle-controlled trials. Of the 920 patients, in most of the trials they received a 10-minute exposure to the study drug (489 received abametapir lotion 0.74%, 431 received vehicle lotion).
Looking just at the phase III trials, 24% of patients in the abametapir arm reported AEs, while 19% of those receiving vehicle reported any AE.
In the two maximal-use pediatric trials, drug exposure ranged from 3.3 g to 200.8 g; AEs in these two trials occurred in 23% of participants.
Safety data collected for all studies also included vital signs, results of physical exams, and laboratory tests; no “clinically meaningful” changes were seen in any of the trials for any of these values, according to Dr. Hazan and her coauthors.
“AEs were mild, not age-related, and primarily in the system organ class of skin and subcutaneous tissue disorders,” said Dr. Hazan and her coauthors.
Abematapir 0.74% lotion had previously been shown to be an effective ovicidal treatment for head lice when used in a single application; the lotion is intended to be applied at home by the patient or caregiver (J Med Entomol. 2017. 54[1]:167-72).*
Dr. Hazan is employed by Axis clinical trials. Other study authors were employed by Hatchtech, which developed abametapir, and by Promius Pharma/Dr. Reddy’s Laboratories, which plans to market abametapir lotion.
*Correction, 8/7/17: An earlier version of this article had an incorrect citation.
koakes@frontlinemedcom.com
On Twitter @karioakes
CHICAGO – A novel one-time topical treatment for head lice, abametapir, was well tolerated in children as young as 6 months, according to pooled results from 11 clinical trials.
The pooled safety data included results from 11 clinical trials including 1,372 patients. Of these, 700 were aged 6 months to 17 years, and patients were exposed to the novel metalloproteinase inhibitor for 10-20 minutes.
In examining safety data from the pooled trials, Lydie Hazan, MD, of Axis Clinical Trials and her collaborators found that for pediatric patients, most treatment-emergent adverse events (AEs) were skin and subcutaneous tissue-related. The most common AEs were erythema, rash, a burning sensation on the skin, and contact dermatitis.
Data for the three phase II pharmacokinetic trials, the phase II ovicidal efficacy trial, and the two phase III trials were reported separately by Dr. Hazan and her coauthors in a poster presentation at the World Congress of Pediatric Dermatology. The overall incidence of treatment-emergent AEs in the studies ranged from 20% to 29% for patients in the active arms of the trials. For patients who received the vehicle lotion only, the incidence of AEs ranged from 16% to 57%.
Of the 11 trials, 6 involved pediatric patients, with one phase IIB trial, one phase II ovicidal trial, two maximal-use open-label trials, and two phase III randomized, double-blind, vehicle-controlled trials. Of the 920 patients, in most of the trials they received a 10-minute exposure to the study drug (489 received abametapir lotion 0.74%, 431 received vehicle lotion).
Looking just at the phase III trials, 24% of patients in the abametapir arm reported AEs, while 19% of those receiving vehicle reported any AE.
In the two maximal-use pediatric trials, drug exposure ranged from 3.3 g to 200.8 g; AEs in these two trials occurred in 23% of participants.
Safety data collected for all studies also included vital signs, results of physical exams, and laboratory tests; no “clinically meaningful” changes were seen in any of the trials for any of these values, according to Dr. Hazan and her coauthors.
“AEs were mild, not age-related, and primarily in the system organ class of skin and subcutaneous tissue disorders,” said Dr. Hazan and her coauthors.
Abematapir 0.74% lotion had previously been shown to be an effective ovicidal treatment for head lice when used in a single application; the lotion is intended to be applied at home by the patient or caregiver (J Med Entomol. 2017. 54[1]:167-72).*
Dr. Hazan is employed by Axis clinical trials. Other study authors were employed by Hatchtech, which developed abametapir, and by Promius Pharma/Dr. Reddy’s Laboratories, which plans to market abametapir lotion.
*Correction, 8/7/17: An earlier version of this article had an incorrect citation.
koakes@frontlinemedcom.com
On Twitter @karioakes
CHICAGO – A novel one-time topical treatment for head lice, abametapir, was well tolerated in children as young as 6 months, according to pooled results from 11 clinical trials.
The pooled safety data included results from 11 clinical trials including 1,372 patients. Of these, 700 were aged 6 months to 17 years, and patients were exposed to the novel metalloproteinase inhibitor for 10-20 minutes.
In examining safety data from the pooled trials, Lydie Hazan, MD, of Axis Clinical Trials and her collaborators found that for pediatric patients, most treatment-emergent adverse events (AEs) were skin and subcutaneous tissue-related. The most common AEs were erythema, rash, a burning sensation on the skin, and contact dermatitis.
Data for the three phase II pharmacokinetic trials, the phase II ovicidal efficacy trial, and the two phase III trials were reported separately by Dr. Hazan and her coauthors in a poster presentation at the World Congress of Pediatric Dermatology. The overall incidence of treatment-emergent AEs in the studies ranged from 20% to 29% for patients in the active arms of the trials. For patients who received the vehicle lotion only, the incidence of AEs ranged from 16% to 57%.
Of the 11 trials, 6 involved pediatric patients, with one phase IIB trial, one phase II ovicidal trial, two maximal-use open-label trials, and two phase III randomized, double-blind, vehicle-controlled trials. Of the 920 patients, in most of the trials they received a 10-minute exposure to the study drug (489 received abametapir lotion 0.74%, 431 received vehicle lotion).
Looking just at the phase III trials, 24% of patients in the abametapir arm reported AEs, while 19% of those receiving vehicle reported any AE.
In the two maximal-use pediatric trials, drug exposure ranged from 3.3 g to 200.8 g; AEs in these two trials occurred in 23% of participants.
Safety data collected for all studies also included vital signs, results of physical exams, and laboratory tests; no “clinically meaningful” changes were seen in any of the trials for any of these values, according to Dr. Hazan and her coauthors.
“AEs were mild, not age-related, and primarily in the system organ class of skin and subcutaneous tissue disorders,” said Dr. Hazan and her coauthors.
Abematapir 0.74% lotion had previously been shown to be an effective ovicidal treatment for head lice when used in a single application; the lotion is intended to be applied at home by the patient or caregiver (J Med Entomol. 2017. 54[1]:167-72).*
Dr. Hazan is employed by Axis clinical trials. Other study authors were employed by Hatchtech, which developed abametapir, and by Promius Pharma/Dr. Reddy’s Laboratories, which plans to market abametapir lotion.
*Correction, 8/7/17: An earlier version of this article had an incorrect citation.
koakes@frontlinemedcom.com
On Twitter @karioakes
AT WCPD 2017
Key clinical point:
Major finding: In pooled clinical trial data, pediatric patients had adverse events at the same rate as adult patients, with overall rates ranging from 20% to 57%.
Data source: Pooled data from 11 clinical trials including 1,372 patients, 700 of whom were aged 6 months to 17 years.
Disclosures: Dr. Hazan is employed by Axis Clinical Trials. Other study authors were employed by Hatchtech, which developed abametapir, and by Promius Pharma/Dr. Reddy’s Laboratories, which plans to market abametapir lotion.
Look for comorbidities associated with hidradenitis suppurativa
CHICAGO – Hidradenitis suppurativa in children is often associated with comorbidities, especially obesity and endocrine abnormalities, a retrospective review of cases showed.
“When treating hidradenitis suppurativa, it is imperative to not only treat the skin but also to look for associated comorbidities,” Maria del Carmen Liy-Wong, MD, said in an interview in advance of the World Congress for Pediatric Dermatology.
Of the 41 patients, 78% were girls; the mean age of onset was 11 years, and the mean age at diagnosis was 14 years. A positive family history was found in 24% of cases. The most common cutaneous lesions were papules and pustules (51%), followed by scars (39%), and 88% of patients reported associated tenderness and pain.
After using the Hurley severity grade to classify disease severity, the researchers found that 56% of cases were mild, 32% were moderate, and 12% were severe. Comorbidities were identified in 92% of the cases; the most common was obesity (73%), followed by endocrine abnormalities (29%) and menstrual irregularities (20%). The researchers also found that 70% of patients were treated with a combination of topical and systemic antibiotics, and that early onset of disease correlated with more severe disease (P = .03).
Dr. Liy-Wong acknowledged that the study’s retrospective design is a limitation of the analysis, but she said that a prospective evaluation in planned for the near future.
The study was supported in part by a grant from AbbVie. Dr. Liy-Wong reported having no relevant financial disclosures.
dbrunk@frontlinemedcom.com
CHICAGO – Hidradenitis suppurativa in children is often associated with comorbidities, especially obesity and endocrine abnormalities, a retrospective review of cases showed.
“When treating hidradenitis suppurativa, it is imperative to not only treat the skin but also to look for associated comorbidities,” Maria del Carmen Liy-Wong, MD, said in an interview in advance of the World Congress for Pediatric Dermatology.
Of the 41 patients, 78% were girls; the mean age of onset was 11 years, and the mean age at diagnosis was 14 years. A positive family history was found in 24% of cases. The most common cutaneous lesions were papules and pustules (51%), followed by scars (39%), and 88% of patients reported associated tenderness and pain.
After using the Hurley severity grade to classify disease severity, the researchers found that 56% of cases were mild, 32% were moderate, and 12% were severe. Comorbidities were identified in 92% of the cases; the most common was obesity (73%), followed by endocrine abnormalities (29%) and menstrual irregularities (20%). The researchers also found that 70% of patients were treated with a combination of topical and systemic antibiotics, and that early onset of disease correlated with more severe disease (P = .03).
Dr. Liy-Wong acknowledged that the study’s retrospective design is a limitation of the analysis, but she said that a prospective evaluation in planned for the near future.
The study was supported in part by a grant from AbbVie. Dr. Liy-Wong reported having no relevant financial disclosures.
dbrunk@frontlinemedcom.com
CHICAGO – Hidradenitis suppurativa in children is often associated with comorbidities, especially obesity and endocrine abnormalities, a retrospective review of cases showed.
“When treating hidradenitis suppurativa, it is imperative to not only treat the skin but also to look for associated comorbidities,” Maria del Carmen Liy-Wong, MD, said in an interview in advance of the World Congress for Pediatric Dermatology.
Of the 41 patients, 78% were girls; the mean age of onset was 11 years, and the mean age at diagnosis was 14 years. A positive family history was found in 24% of cases. The most common cutaneous lesions were papules and pustules (51%), followed by scars (39%), and 88% of patients reported associated tenderness and pain.
After using the Hurley severity grade to classify disease severity, the researchers found that 56% of cases were mild, 32% were moderate, and 12% were severe. Comorbidities were identified in 92% of the cases; the most common was obesity (73%), followed by endocrine abnormalities (29%) and menstrual irregularities (20%). The researchers also found that 70% of patients were treated with a combination of topical and systemic antibiotics, and that early onset of disease correlated with more severe disease (P = .03).
Dr. Liy-Wong acknowledged that the study’s retrospective design is a limitation of the analysis, but she said that a prospective evaluation in planned for the near future.
The study was supported in part by a grant from AbbVie. Dr. Liy-Wong reported having no relevant financial disclosures.
dbrunk@frontlinemedcom.com
AT WCPD 2017
Key clinical point:
Major finding: Comorbidities were identified in 92% of the cases, with obesity (73%) the most common.
Data source: A retrospective review of clinical characteristics, degree of severity, comorbidities, and management of hidradenitis suppurativa in 41 patients followed between January 1995 and January 2015.
Disclosures: Dr. Liy-Wong reported having no relevant financial disclosures.
FDA approves first new drug for sickle cell in nearly 20 years
The approval was based on placebo-controlled phase II and phase III trials suggesting that L-glutamate offered moderate benefit to patients with this rare, serious, and potentially fatal blood disorder.
L-glutamine oral powder will be marketed under the brand name Endari by Emmaus Medical. The FDA granted the approval through its orphan drug pathway, which is reserved for treatments of rare diseases or conditions. The National Institutes of Health estimates that sickle cell disorder affects approximately 100,000 individuals in the United States. Previously, the only drug approved for treating sickle cell disorder was hydroxyurea, which the FDA green-lighted in 1998.
The randomized, placebo-controlled, phase III trial on which the approval of L-glutamine was based (GLUSCC09-01) comprised patients aged 5-58 years with sickle cell disease or beta-0 thalassemia who had at least two episodes of painful crises during the 12 months before screening. A total of 152 patients were randomly assigned to receive oral L-glutamine (0.3 mg/kg per day) for 48 weeks followed by a 3-week tapering period, while 78 patients received placebo. Patients who received L-glutamine averaged three hospital visits for painful crises for which they received parenteral narcotics or ketorolac, while the placebo group averaged four such hospital visits. Additionally, the time to second crisis was delayed by 79 days in the treatment group, compared with the placebo group (hazard ratio, 0.68).
L-glutamine also was associated with fewer hospital days (median 6.5 vs. 11 days) and fewer occurrences of potentially life-threatening acute chest syndrome (8.6% vs. 23.1%), investigators reported to the FDA’s Oncologic Drugs Advisory Committee during a meeting on May 24.
Safety studies of L-glutamine included phase II and phase III data from 187 patients who received L-glutamine and 111 patients who received placebo, the investigators reported. Based on these analyses, rates of sickle cell anemia with crisis were 66% in the treatment population and 72% in placebo recipients. Rates of acute chest syndrome were 7% and 19%, respectively. Treatment-emergent adverse events led patients to drop out of the studies in 2.7% and 0.9% of cases. The most common adverse events of L-glutamine therapy were constipation, nausea, headache, cough, pain in the extremities, back pain, chest pain, and abdominal pain.
The FDA advisory committee voted 10-3 in favor of approving L-glutamate after hearing from industry and FDA representatives, physicians who treat patients with sickle cell disorder, and patients and their family members at the May 24 meeting. “No” voters expressed concerns about differing drop-out rates between the study groups, but other committee members emphasized the severe impact of sickle cell disorder on quality of life and the crucial need for more treatments.
The FDA Orphan Products Grants Program provided some of the funding to develop the drug. The FDA committee members had no relevant conflicts of interests.
The approval was based on placebo-controlled phase II and phase III trials suggesting that L-glutamate offered moderate benefit to patients with this rare, serious, and potentially fatal blood disorder.
L-glutamine oral powder will be marketed under the brand name Endari by Emmaus Medical. The FDA granted the approval through its orphan drug pathway, which is reserved for treatments of rare diseases or conditions. The National Institutes of Health estimates that sickle cell disorder affects approximately 100,000 individuals in the United States. Previously, the only drug approved for treating sickle cell disorder was hydroxyurea, which the FDA green-lighted in 1998.
The randomized, placebo-controlled, phase III trial on which the approval of L-glutamine was based (GLUSCC09-01) comprised patients aged 5-58 years with sickle cell disease or beta-0 thalassemia who had at least two episodes of painful crises during the 12 months before screening. A total of 152 patients were randomly assigned to receive oral L-glutamine (0.3 mg/kg per day) for 48 weeks followed by a 3-week tapering period, while 78 patients received placebo. Patients who received L-glutamine averaged three hospital visits for painful crises for which they received parenteral narcotics or ketorolac, while the placebo group averaged four such hospital visits. Additionally, the time to second crisis was delayed by 79 days in the treatment group, compared with the placebo group (hazard ratio, 0.68).
L-glutamine also was associated with fewer hospital days (median 6.5 vs. 11 days) and fewer occurrences of potentially life-threatening acute chest syndrome (8.6% vs. 23.1%), investigators reported to the FDA’s Oncologic Drugs Advisory Committee during a meeting on May 24.
Safety studies of L-glutamine included phase II and phase III data from 187 patients who received L-glutamine and 111 patients who received placebo, the investigators reported. Based on these analyses, rates of sickle cell anemia with crisis were 66% in the treatment population and 72% in placebo recipients. Rates of acute chest syndrome were 7% and 19%, respectively. Treatment-emergent adverse events led patients to drop out of the studies in 2.7% and 0.9% of cases. The most common adverse events of L-glutamine therapy were constipation, nausea, headache, cough, pain in the extremities, back pain, chest pain, and abdominal pain.
The FDA advisory committee voted 10-3 in favor of approving L-glutamate after hearing from industry and FDA representatives, physicians who treat patients with sickle cell disorder, and patients and their family members at the May 24 meeting. “No” voters expressed concerns about differing drop-out rates between the study groups, but other committee members emphasized the severe impact of sickle cell disorder on quality of life and the crucial need for more treatments.
The FDA Orphan Products Grants Program provided some of the funding to develop the drug. The FDA committee members had no relevant conflicts of interests.
The approval was based on placebo-controlled phase II and phase III trials suggesting that L-glutamate offered moderate benefit to patients with this rare, serious, and potentially fatal blood disorder.
L-glutamine oral powder will be marketed under the brand name Endari by Emmaus Medical. The FDA granted the approval through its orphan drug pathway, which is reserved for treatments of rare diseases or conditions. The National Institutes of Health estimates that sickle cell disorder affects approximately 100,000 individuals in the United States. Previously, the only drug approved for treating sickle cell disorder was hydroxyurea, which the FDA green-lighted in 1998.
The randomized, placebo-controlled, phase III trial on which the approval of L-glutamine was based (GLUSCC09-01) comprised patients aged 5-58 years with sickle cell disease or beta-0 thalassemia who had at least two episodes of painful crises during the 12 months before screening. A total of 152 patients were randomly assigned to receive oral L-glutamine (0.3 mg/kg per day) for 48 weeks followed by a 3-week tapering period, while 78 patients received placebo. Patients who received L-glutamine averaged three hospital visits for painful crises for which they received parenteral narcotics or ketorolac, while the placebo group averaged four such hospital visits. Additionally, the time to second crisis was delayed by 79 days in the treatment group, compared with the placebo group (hazard ratio, 0.68).
L-glutamine also was associated with fewer hospital days (median 6.5 vs. 11 days) and fewer occurrences of potentially life-threatening acute chest syndrome (8.6% vs. 23.1%), investigators reported to the FDA’s Oncologic Drugs Advisory Committee during a meeting on May 24.
Safety studies of L-glutamine included phase II and phase III data from 187 patients who received L-glutamine and 111 patients who received placebo, the investigators reported. Based on these analyses, rates of sickle cell anemia with crisis were 66% in the treatment population and 72% in placebo recipients. Rates of acute chest syndrome were 7% and 19%, respectively. Treatment-emergent adverse events led patients to drop out of the studies in 2.7% and 0.9% of cases. The most common adverse events of L-glutamine therapy were constipation, nausea, headache, cough, pain in the extremities, back pain, chest pain, and abdominal pain.
The FDA advisory committee voted 10-3 in favor of approving L-glutamate after hearing from industry and FDA representatives, physicians who treat patients with sickle cell disorder, and patients and their family members at the May 24 meeting. “No” voters expressed concerns about differing drop-out rates between the study groups, but other committee members emphasized the severe impact of sickle cell disorder on quality of life and the crucial need for more treatments.
The FDA Orphan Products Grants Program provided some of the funding to develop the drug. The FDA committee members had no relevant conflicts of interests.
Pediatrics Committee’s role amplified with subspecialty’s evolution
Editor’s note: Each month, SHM puts the spotlight on some of our most active members who are making substantial contributions to hospital medicine. For more information on how you can lend your expertise to help SHM improve the care of hospitalized patients, log on to www.hospitalmedicine.org/getinvolved.
This month, The Hospitalist spotlights Sandra Gage, MD, PhD, SFHM, associate professor of pediatrics in the section of hospital medicine at the Medical College of Wisconsin, newly appointed chair of SHM’s Pediatrics Committee, and SHM member of almost 20 years.
Why did you choose a career in pediatric hospital medicine, and how did you become an SHM member?
I would say that pediatric hospital medicine chose me. After obtaining a degree in physical therapy and spending five years treating children with a variety of neurological and neurodevelopmental disorders, I went back to school to get my MD and a PhD in neurobiology, thinking that I would specialize in either pediatric neurology or pediatric physical medicine and rehabilitation.
I always had an interest in treating children but never considered general pediatrics because spending my time in the outpatient clinic setting had little appeal for me. This was before the concept of being a “hospitalist” was widespread – and even before the phrase was coined – but there were a few providers in my academic pediatric group who focused on inpatient care. The pace, variety and challenge of treating hospitalized children was exactly what I was looking for, and, following completion of my pediatric residency, I slowly became a full-time hospitalist.
What is the Pediatrics Committee currently working on, and what do you hope to accomplish during your term as Committee Chair?
With subspecialty status coming soon, rapidly expanding interest in the profession and the introduction of hospitalists into more areas of care, the landscape of pediatric hospital medicine is ever-changing. This amplifies the importance of the Pediatrics Committee’s role. The overall goals of the committee are to promote the growth and development of pediatric hospital medicine as a field and to provide educational and practical resources for individual practitioners.
The 2017-2018 committee comprises enthusiastic members from a wide variety of practice settings. At our first meeting in May, we formulated many exciting and innovative ideas to achieve our goals. As we continue to narrow down our approach and finalize our tasks for the year, we are also beginning to determine the content for the pediatric track at HM18. An example of a project the committee has executed in the past is the development of hospitalist-specific American Board of Pediatrics Maintenance of Certification modules for the SHM Learning Portal. In addition, the 2017 Pediatric Hospital Medicine (PHM) meeting is hosted by SHM this July in Nashville, and many Pediatrics Committee members are hard at work on finalizing those plans.
How has the PHM meeting evolved since its inception, and what value do you find in attending?
I have been an attendee of PHM many times over the years. The meeting has grown from a small group of no more than 100 individuals in a few hotel meeting rooms to more than 1,000 attendees and a wide variety of tracks and offerings. The growth of this meeting is truly reflective of the growth of our subspecialty, and the meeting brings together practitioners, both old and new, in an atmosphere full of innovations and ideas. Like SHM’s annual meeting, the PHM meeting is a great place for learning, sharing, and networking.
What advice do you have for fellow pediatric hospitalists during this transformational time in health care?
The direction of health care has provided fodder for lively discussion since I started my career 20 years ago. The nature of the practice of medicine is evolving, and, as physicians, we must be adept at navigating the changing climate while maintaining our goal of providing excellent care for our patients. As hospitalists, we have the opportunity to be in the forefront of the changes that will impact hospital care and utilization.
Whether our work is done at a local or a national level, as a group or as individuals, I believe that hospitalists will have an active role in directing the course of the future of medicine. We spend much of our clinical time advocating for our patients, but your experience is important and your voice can make an important contribution to the direction of health care for one child or for all children. Whether it is in the hospital hallway or on the Hill, continue to strive to do what you already do best.
Felicia Steele is SHM’s communications coordinator.
Editor’s note: Each month, SHM puts the spotlight on some of our most active members who are making substantial contributions to hospital medicine. For more information on how you can lend your expertise to help SHM improve the care of hospitalized patients, log on to www.hospitalmedicine.org/getinvolved.
This month, The Hospitalist spotlights Sandra Gage, MD, PhD, SFHM, associate professor of pediatrics in the section of hospital medicine at the Medical College of Wisconsin, newly appointed chair of SHM’s Pediatrics Committee, and SHM member of almost 20 years.
Why did you choose a career in pediatric hospital medicine, and how did you become an SHM member?
I would say that pediatric hospital medicine chose me. After obtaining a degree in physical therapy and spending five years treating children with a variety of neurological and neurodevelopmental disorders, I went back to school to get my MD and a PhD in neurobiology, thinking that I would specialize in either pediatric neurology or pediatric physical medicine and rehabilitation.
I always had an interest in treating children but never considered general pediatrics because spending my time in the outpatient clinic setting had little appeal for me. This was before the concept of being a “hospitalist” was widespread – and even before the phrase was coined – but there were a few providers in my academic pediatric group who focused on inpatient care. The pace, variety and challenge of treating hospitalized children was exactly what I was looking for, and, following completion of my pediatric residency, I slowly became a full-time hospitalist.
What is the Pediatrics Committee currently working on, and what do you hope to accomplish during your term as Committee Chair?
With subspecialty status coming soon, rapidly expanding interest in the profession and the introduction of hospitalists into more areas of care, the landscape of pediatric hospital medicine is ever-changing. This amplifies the importance of the Pediatrics Committee’s role. The overall goals of the committee are to promote the growth and development of pediatric hospital medicine as a field and to provide educational and practical resources for individual practitioners.
The 2017-2018 committee comprises enthusiastic members from a wide variety of practice settings. At our first meeting in May, we formulated many exciting and innovative ideas to achieve our goals. As we continue to narrow down our approach and finalize our tasks for the year, we are also beginning to determine the content for the pediatric track at HM18. An example of a project the committee has executed in the past is the development of hospitalist-specific American Board of Pediatrics Maintenance of Certification modules for the SHM Learning Portal. In addition, the 2017 Pediatric Hospital Medicine (PHM) meeting is hosted by SHM this July in Nashville, and many Pediatrics Committee members are hard at work on finalizing those plans.
How has the PHM meeting evolved since its inception, and what value do you find in attending?
I have been an attendee of PHM many times over the years. The meeting has grown from a small group of no more than 100 individuals in a few hotel meeting rooms to more than 1,000 attendees and a wide variety of tracks and offerings. The growth of this meeting is truly reflective of the growth of our subspecialty, and the meeting brings together practitioners, both old and new, in an atmosphere full of innovations and ideas. Like SHM’s annual meeting, the PHM meeting is a great place for learning, sharing, and networking.
What advice do you have for fellow pediatric hospitalists during this transformational time in health care?
The direction of health care has provided fodder for lively discussion since I started my career 20 years ago. The nature of the practice of medicine is evolving, and, as physicians, we must be adept at navigating the changing climate while maintaining our goal of providing excellent care for our patients. As hospitalists, we have the opportunity to be in the forefront of the changes that will impact hospital care and utilization.
Whether our work is done at a local or a national level, as a group or as individuals, I believe that hospitalists will have an active role in directing the course of the future of medicine. We spend much of our clinical time advocating for our patients, but your experience is important and your voice can make an important contribution to the direction of health care for one child or for all children. Whether it is in the hospital hallway or on the Hill, continue to strive to do what you already do best.
Felicia Steele is SHM’s communications coordinator.
Editor’s note: Each month, SHM puts the spotlight on some of our most active members who are making substantial contributions to hospital medicine. For more information on how you can lend your expertise to help SHM improve the care of hospitalized patients, log on to www.hospitalmedicine.org/getinvolved.
This month, The Hospitalist spotlights Sandra Gage, MD, PhD, SFHM, associate professor of pediatrics in the section of hospital medicine at the Medical College of Wisconsin, newly appointed chair of SHM’s Pediatrics Committee, and SHM member of almost 20 years.
Why did you choose a career in pediatric hospital medicine, and how did you become an SHM member?
I would say that pediatric hospital medicine chose me. After obtaining a degree in physical therapy and spending five years treating children with a variety of neurological and neurodevelopmental disorders, I went back to school to get my MD and a PhD in neurobiology, thinking that I would specialize in either pediatric neurology or pediatric physical medicine and rehabilitation.
I always had an interest in treating children but never considered general pediatrics because spending my time in the outpatient clinic setting had little appeal for me. This was before the concept of being a “hospitalist” was widespread – and even before the phrase was coined – but there were a few providers in my academic pediatric group who focused on inpatient care. The pace, variety and challenge of treating hospitalized children was exactly what I was looking for, and, following completion of my pediatric residency, I slowly became a full-time hospitalist.
What is the Pediatrics Committee currently working on, and what do you hope to accomplish during your term as Committee Chair?
With subspecialty status coming soon, rapidly expanding interest in the profession and the introduction of hospitalists into more areas of care, the landscape of pediatric hospital medicine is ever-changing. This amplifies the importance of the Pediatrics Committee’s role. The overall goals of the committee are to promote the growth and development of pediatric hospital medicine as a field and to provide educational and practical resources for individual practitioners.
The 2017-2018 committee comprises enthusiastic members from a wide variety of practice settings. At our first meeting in May, we formulated many exciting and innovative ideas to achieve our goals. As we continue to narrow down our approach and finalize our tasks for the year, we are also beginning to determine the content for the pediatric track at HM18. An example of a project the committee has executed in the past is the development of hospitalist-specific American Board of Pediatrics Maintenance of Certification modules for the SHM Learning Portal. In addition, the 2017 Pediatric Hospital Medicine (PHM) meeting is hosted by SHM this July in Nashville, and many Pediatrics Committee members are hard at work on finalizing those plans.
How has the PHM meeting evolved since its inception, and what value do you find in attending?
I have been an attendee of PHM many times over the years. The meeting has grown from a small group of no more than 100 individuals in a few hotel meeting rooms to more than 1,000 attendees and a wide variety of tracks and offerings. The growth of this meeting is truly reflective of the growth of our subspecialty, and the meeting brings together practitioners, both old and new, in an atmosphere full of innovations and ideas. Like SHM’s annual meeting, the PHM meeting is a great place for learning, sharing, and networking.
What advice do you have for fellow pediatric hospitalists during this transformational time in health care?
The direction of health care has provided fodder for lively discussion since I started my career 20 years ago. The nature of the practice of medicine is evolving, and, as physicians, we must be adept at navigating the changing climate while maintaining our goal of providing excellent care for our patients. As hospitalists, we have the opportunity to be in the forefront of the changes that will impact hospital care and utilization.
Whether our work is done at a local or a national level, as a group or as individuals, I believe that hospitalists will have an active role in directing the course of the future of medicine. We spend much of our clinical time advocating for our patients, but your experience is important and your voice can make an important contribution to the direction of health care for one child or for all children. Whether it is in the hospital hallway or on the Hill, continue to strive to do what you already do best.
Felicia Steele is SHM’s communications coordinator.
Mapping the genomic landscape of T-ALL
Researchers say they have uncovered new details of the genomic landscape of T-lineage acute lymphoblastic leukemia (T-ALL).
The team believes their findings will aid the development of drugs to target newly discovered mutations and enable researchers to engineer better mouse models to probe the leukemia’s aberrant biological machinery.
Charles Mullighan, MD, MBBS, of St. Jude Children’s Research Hospital in Memphis, Tennessee, and his colleagues conducted this research and reported their findings in Nature Genetics.
“This first comprehensive and systematic analysis in a large group of patients revealed many new mutations that are biologically significant as well as new drug targets that could be clinically important,” Dr Mullighan said.
“Leukemias typically arise from multiple genetic changes that work together. Most previous studies have not had the breadth of genomic data in enough patients to identify the constellations of mutations and recognize their associations.”
Dr Mullighan and his colleagues sequenced the genomes of 264 children and young adults with T-ALL. This revealed 106 driver genes, half of which had not been identified in childhood T-ALL.
“We went into this study knowing that we didn’t know the full genomic landscape of T-ALL,” said Stephen Hunger, MD, of the Children’s Hospital of Philadelphia in Pennsylvania.
“But we were surprised that over half of the new targets and mutations were previously unrecognized. It was particularly unexpected and very striking that some mutations were exclusively found in some subtypes of T-ALL but not others.”
The researchers’ analysis confirmed that T-ALL was driven by mutations in known signaling pathways, including JAK-STAT, Ras, and PTEN-PI3K. However, the study also revealed new mutations in those known pathways.
In addition, the researchers identified cases in which the same T-ALL subtype had mutations in different pathways triggered by the same founding mutation.
“We believe this finding suggests we can target such subtypes with an inhibitor drug for one of the pathways, and it’s likely to be effective,” Dr Mullighan said.
He and his colleagues also believe the mutations uncovered in this study will enable researchers to create mouse models that more accurately reflect human T-ALL.
“We now have a launching pad, if you will, to design mouse models that include multiple genetic mutations to more faithfully reflect the leukemias we see in humans,” Dr Mullighan said.
Data from this study are available to researchers through the St. Jude PeCan data portal and the TARGET Data Matrix. 
Researchers say they have uncovered new details of the genomic landscape of T-lineage acute lymphoblastic leukemia (T-ALL).
The team believes their findings will aid the development of drugs to target newly discovered mutations and enable researchers to engineer better mouse models to probe the leukemia’s aberrant biological machinery.
Charles Mullighan, MD, MBBS, of St. Jude Children’s Research Hospital in Memphis, Tennessee, and his colleagues conducted this research and reported their findings in Nature Genetics.
“This first comprehensive and systematic analysis in a large group of patients revealed many new mutations that are biologically significant as well as new drug targets that could be clinically important,” Dr Mullighan said.
“Leukemias typically arise from multiple genetic changes that work together. Most previous studies have not had the breadth of genomic data in enough patients to identify the constellations of mutations and recognize their associations.”
Dr Mullighan and his colleagues sequenced the genomes of 264 children and young adults with T-ALL. This revealed 106 driver genes, half of which had not been identified in childhood T-ALL.
“We went into this study knowing that we didn’t know the full genomic landscape of T-ALL,” said Stephen Hunger, MD, of the Children’s Hospital of Philadelphia in Pennsylvania.
“But we were surprised that over half of the new targets and mutations were previously unrecognized. It was particularly unexpected and very striking that some mutations were exclusively found in some subtypes of T-ALL but not others.”
The researchers’ analysis confirmed that T-ALL was driven by mutations in known signaling pathways, including JAK-STAT, Ras, and PTEN-PI3K. However, the study also revealed new mutations in those known pathways.
In addition, the researchers identified cases in which the same T-ALL subtype had mutations in different pathways triggered by the same founding mutation.
“We believe this finding suggests we can target such subtypes with an inhibitor drug for one of the pathways, and it’s likely to be effective,” Dr Mullighan said.
He and his colleagues also believe the mutations uncovered in this study will enable researchers to create mouse models that more accurately reflect human T-ALL.
“We now have a launching pad, if you will, to design mouse models that include multiple genetic mutations to more faithfully reflect the leukemias we see in humans,” Dr Mullighan said.
Data from this study are available to researchers through the St. Jude PeCan data portal and the TARGET Data Matrix.
Researchers say they have uncovered new details of the genomic landscape of T-lineage acute lymphoblastic leukemia (T-ALL).
The team believes their findings will aid the development of drugs to target newly discovered mutations and enable researchers to engineer better mouse models to probe the leukemia’s aberrant biological machinery.
Charles Mullighan, MD, MBBS, of St. Jude Children’s Research Hospital in Memphis, Tennessee, and his colleagues conducted this research and reported their findings in Nature Genetics.
“This first comprehensive and systematic analysis in a large group of patients revealed many new mutations that are biologically significant as well as new drug targets that could be clinically important,” Dr Mullighan said.
“Leukemias typically arise from multiple genetic changes that work together. Most previous studies have not had the breadth of genomic data in enough patients to identify the constellations of mutations and recognize their associations.”
Dr Mullighan and his colleagues sequenced the genomes of 264 children and young adults with T-ALL. This revealed 106 driver genes, half of which had not been identified in childhood T-ALL.
“We went into this study knowing that we didn’t know the full genomic landscape of T-ALL,” said Stephen Hunger, MD, of the Children’s Hospital of Philadelphia in Pennsylvania.
“But we were surprised that over half of the new targets and mutations were previously unrecognized. It was particularly unexpected and very striking that some mutations were exclusively found in some subtypes of T-ALL but not others.”
The researchers’ analysis confirmed that T-ALL was driven by mutations in known signaling pathways, including JAK-STAT, Ras, and PTEN-PI3K. However, the study also revealed new mutations in those known pathways.
In addition, the researchers identified cases in which the same T-ALL subtype had mutations in different pathways triggered by the same founding mutation.
“We believe this finding suggests we can target such subtypes with an inhibitor drug for one of the pathways, and it’s likely to be effective,” Dr Mullighan said.
He and his colleagues also believe the mutations uncovered in this study will enable researchers to create mouse models that more accurately reflect human T-ALL.
“We now have a launching pad, if you will, to design mouse models that include multiple genetic mutations to more faithfully reflect the leukemias we see in humans,” Dr Mullighan said.
Data from this study are available to researchers through the St. Jude PeCan data portal and the TARGET Data Matrix.
Coaching ‘No’
In a recent column entitled “To the limit,” I tried to make the case that the negative consequences of permissive parenting are numerous enough to warrant the attention of primary care pediatricians and family physicians. The evidence linking atypical sensory adaptation, behavior difficulties, sleep deprivation, and obesity to a permissive parenting style is just beginning to appear in the literature, but the numbers are in sync with the anecdotal observations of many experienced pediatricians like me. In that previous column,
First, let me make it clear that I don’t consider parenting style to be a topic that needs to occur on the checklist of every patient at every health maintenance visit. You already are overburdened with the demands of experts who have lobbied to have their favorite hot button issues included in your 15 minutes of face-to-face time with your young patients.
We also must accept our limited role as advisors. There are many ways to skin a cat and to raise a child. Homogeneity is not our goal. We must respect the cultural and philosophical differences that exist in our society. However, in my opinion, the unhealthy consequences of permissive parenting deserve a sensitive attempt at education and some gentle anticipatory guidance ... hopefully without an aroma of condescension.
The opportunities for our input begin in the first few months of life when parents are faced with the difficult questions of whether it is safe and appropriate to allow their infant to cry himself to sleep and whether a mom must allow her infant to use her breast as a pacifier. With the transition to solid food comes the challenge of how to manage the inevitable rejection of new tastes, colors, and textures. Of course, most parents find these issues challenging, but to what degree a parent can internalize your reassurance and advice is a good reflection on where he or she sits on the permissive to authoritarian spectrum of parenting.
With an infant’s rapidly advancing motor skills comes the question of when, where, and how to create boundaries to keep the child safe ... and to protect the environment from the surprisingly destructive power of an inquisitive toddler. Here the permissive parent will be continually challenged when he or she finds that simply saying “No” or “Don’t” doesn’t always work ... to some extent because, up to this point, the child has never encountered a situation in which s/he hasn’t gotten what s/he wants.
This is not an issue in which we should allow ourselves to get bogged down in circuitous philosophical arguments. We must keep our advice practical and focused on issues of safety and health. I have found that a significant number of permissive parents can learn the difficult skill of saying “No” to their children. It takes time, but it is time well spent.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@frontlinemedcom.com.
In a recent column entitled “To the limit,” I tried to make the case that the negative consequences of permissive parenting are numerous enough to warrant the attention of primary care pediatricians and family physicians. The evidence linking atypical sensory adaptation, behavior difficulties, sleep deprivation, and obesity to a permissive parenting style is just beginning to appear in the literature, but the numbers are in sync with the anecdotal observations of many experienced pediatricians like me. In that previous column,
First, let me make it clear that I don’t consider parenting style to be a topic that needs to occur on the checklist of every patient at every health maintenance visit. You already are overburdened with the demands of experts who have lobbied to have their favorite hot button issues included in your 15 minutes of face-to-face time with your young patients.
We also must accept our limited role as advisors. There are many ways to skin a cat and to raise a child. Homogeneity is not our goal. We must respect the cultural and philosophical differences that exist in our society. However, in my opinion, the unhealthy consequences of permissive parenting deserve a sensitive attempt at education and some gentle anticipatory guidance ... hopefully without an aroma of condescension.
The opportunities for our input begin in the first few months of life when parents are faced with the difficult questions of whether it is safe and appropriate to allow their infant to cry himself to sleep and whether a mom must allow her infant to use her breast as a pacifier. With the transition to solid food comes the challenge of how to manage the inevitable rejection of new tastes, colors, and textures. Of course, most parents find these issues challenging, but to what degree a parent can internalize your reassurance and advice is a good reflection on where he or she sits on the permissive to authoritarian spectrum of parenting.
With an infant’s rapidly advancing motor skills comes the question of when, where, and how to create boundaries to keep the child safe ... and to protect the environment from the surprisingly destructive power of an inquisitive toddler. Here the permissive parent will be continually challenged when he or she finds that simply saying “No” or “Don’t” doesn’t always work ... to some extent because, up to this point, the child has never encountered a situation in which s/he hasn’t gotten what s/he wants.
This is not an issue in which we should allow ourselves to get bogged down in circuitous philosophical arguments. We must keep our advice practical and focused on issues of safety and health. I have found that a significant number of permissive parents can learn the difficult skill of saying “No” to their children. It takes time, but it is time well spent.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@frontlinemedcom.com.
In a recent column entitled “To the limit,” I tried to make the case that the negative consequences of permissive parenting are numerous enough to warrant the attention of primary care pediatricians and family physicians. The evidence linking atypical sensory adaptation, behavior difficulties, sleep deprivation, and obesity to a permissive parenting style is just beginning to appear in the literature, but the numbers are in sync with the anecdotal observations of many experienced pediatricians like me. In that previous column,
First, let me make it clear that I don’t consider parenting style to be a topic that needs to occur on the checklist of every patient at every health maintenance visit. You already are overburdened with the demands of experts who have lobbied to have their favorite hot button issues included in your 15 minutes of face-to-face time with your young patients.
We also must accept our limited role as advisors. There are many ways to skin a cat and to raise a child. Homogeneity is not our goal. We must respect the cultural and philosophical differences that exist in our society. However, in my opinion, the unhealthy consequences of permissive parenting deserve a sensitive attempt at education and some gentle anticipatory guidance ... hopefully without an aroma of condescension.
The opportunities for our input begin in the first few months of life when parents are faced with the difficult questions of whether it is safe and appropriate to allow their infant to cry himself to sleep and whether a mom must allow her infant to use her breast as a pacifier. With the transition to solid food comes the challenge of how to manage the inevitable rejection of new tastes, colors, and textures. Of course, most parents find these issues challenging, but to what degree a parent can internalize your reassurance and advice is a good reflection on where he or she sits on the permissive to authoritarian spectrum of parenting.
With an infant’s rapidly advancing motor skills comes the question of when, where, and how to create boundaries to keep the child safe ... and to protect the environment from the surprisingly destructive power of an inquisitive toddler. Here the permissive parent will be continually challenged when he or she finds that simply saying “No” or “Don’t” doesn’t always work ... to some extent because, up to this point, the child has never encountered a situation in which s/he hasn’t gotten what s/he wants.
This is not an issue in which we should allow ourselves to get bogged down in circuitous philosophical arguments. We must keep our advice practical and focused on issues of safety and health. I have found that a significant number of permissive parents can learn the difficult skill of saying “No” to their children. It takes time, but it is time well spent.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@frontlinemedcom.com.
To the limit
Do you believe that children whose parents can make and enforce rules are more likely to thrive than those children whose parents are hesitant to set limits? If you don’t see limit setting as a critical function of parenting, you and I are not only marching to different drummers, we aren’t even in the same parade.
You may be tempted to write me off as just another old school ranter because I believe that limit setting is one of the cornerstones of parenting. But, let’s look at some of the evidence. There are several studies demonstrating that children whose parents set bedtimes get more sleep. One recent survey also found that teenagers who got more sleep as a result of enforced bedtimes functioned better in school (Sleep. 2011 Jun 1;34[6]:797-800).
An important question is whether permissive parenting is a problem that warrants our concern as pediatricians. We always are on alert for the red flags of abusive parenting, and, obviously, failure to intervene in cases of abuse can be disastrous. However, if we can believe the results from the studies that have already been completed, it seems pretty clear that permissive parenting can spawn behavioral problems, sleep problems, and the myriad of downstream effects that can result from sleep deprivation. And I haven’t even touched on the possible relationship between permissive parenting and the obesity epidemic.
If we still consider ourselves the preventive medicine specialists, shouldn’t pediatricians and family medicine physicians be more invested in minimizing the unhealthy consequences of permissive parenting? If we can agree on a firm “Yes!” the next question is, When and how should we address the issue?
A more nuanced discussion can be the germ of a future Letters from Maine, but the short answer is that we need to sound as nonjudgmental as possible as we present our case for limit setting. We need to start early before the die is cast, and we should be better about publicizing our supporting evidence. Setting a bedtime can begin in the first 6 months of life. Helping parents learn to say, “No, we aren’t going to feed you only what you like to eat!” can start as an infant makes what can be an unsettling transition to solid food.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.”
Do you believe that children whose parents can make and enforce rules are more likely to thrive than those children whose parents are hesitant to set limits? If you don’t see limit setting as a critical function of parenting, you and I are not only marching to different drummers, we aren’t even in the same parade.
You may be tempted to write me off as just another old school ranter because I believe that limit setting is one of the cornerstones of parenting. But, let’s look at some of the evidence. There are several studies demonstrating that children whose parents set bedtimes get more sleep. One recent survey also found that teenagers who got more sleep as a result of enforced bedtimes functioned better in school (Sleep. 2011 Jun 1;34[6]:797-800).
An important question is whether permissive parenting is a problem that warrants our concern as pediatricians. We always are on alert for the red flags of abusive parenting, and, obviously, failure to intervene in cases of abuse can be disastrous. However, if we can believe the results from the studies that have already been completed, it seems pretty clear that permissive parenting can spawn behavioral problems, sleep problems, and the myriad of downstream effects that can result from sleep deprivation. And I haven’t even touched on the possible relationship between permissive parenting and the obesity epidemic.
If we still consider ourselves the preventive medicine specialists, shouldn’t pediatricians and family medicine physicians be more invested in minimizing the unhealthy consequences of permissive parenting? If we can agree on a firm “Yes!” the next question is, When and how should we address the issue?
A more nuanced discussion can be the germ of a future Letters from Maine, but the short answer is that we need to sound as nonjudgmental as possible as we present our case for limit setting. We need to start early before the die is cast, and we should be better about publicizing our supporting evidence. Setting a bedtime can begin in the first 6 months of life. Helping parents learn to say, “No, we aren’t going to feed you only what you like to eat!” can start as an infant makes what can be an unsettling transition to solid food.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.”
Do you believe that children whose parents can make and enforce rules are more likely to thrive than those children whose parents are hesitant to set limits? If you don’t see limit setting as a critical function of parenting, you and I are not only marching to different drummers, we aren’t even in the same parade.
You may be tempted to write me off as just another old school ranter because I believe that limit setting is one of the cornerstones of parenting. But, let’s look at some of the evidence. There are several studies demonstrating that children whose parents set bedtimes get more sleep. One recent survey also found that teenagers who got more sleep as a result of enforced bedtimes functioned better in school (Sleep. 2011 Jun 1;34[6]:797-800).
An important question is whether permissive parenting is a problem that warrants our concern as pediatricians. We always are on alert for the red flags of abusive parenting, and, obviously, failure to intervene in cases of abuse can be disastrous. However, if we can believe the results from the studies that have already been completed, it seems pretty clear that permissive parenting can spawn behavioral problems, sleep problems, and the myriad of downstream effects that can result from sleep deprivation. And I haven’t even touched on the possible relationship between permissive parenting and the obesity epidemic.
If we still consider ourselves the preventive medicine specialists, shouldn’t pediatricians and family medicine physicians be more invested in minimizing the unhealthy consequences of permissive parenting? If we can agree on a firm “Yes!” the next question is, When and how should we address the issue?
A more nuanced discussion can be the germ of a future Letters from Maine, but the short answer is that we need to sound as nonjudgmental as possible as we present our case for limit setting. We need to start early before the die is cast, and we should be better about publicizing our supporting evidence. Setting a bedtime can begin in the first 6 months of life. Helping parents learn to say, “No, we aren’t going to feed you only what you like to eat!” can start as an infant makes what can be an unsettling transition to solid food.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.”
Teen suicide risk significant among screened nonresponders
SAN FRANCISCO – Teens who answered “no response” for one or more questions during a standard suicide screening in the ED typically have a risk of suicide nearly on par with those who answered “yes” to at least one question, results of a study showed.
“Risk for suicidality was substantial among both groups,” Tricia Hengehold of the University of Cincinnati reported at the Pediatric Academic Societies meeting. “About half of each group fit the medium-risk category, although the yes group had more teens in the high-risk category comparatively.”
In their study, she and her coinvestigators compared all teens who answered yes or no response (NR) to any question on the Ask Suicide-Screening Questions (ASQ). A total of 3,386 adolescents, aged 12-17 years, were screened when each presented to the ED with a complaint other than a psychiatric one. The data came from a preexisting study not initially designed for studying nonresponders.
The majority of teens (93%) answered no to all ASQ questions: 5% answered yes to at least one ASQ question, regardless of other answers, and 2% answered no response on at least one of the ASQ questions, but did not answer yes to any of them.
The average age of participants was 14 years among all response groups, but females were overrepresented in the yes and NR groups: 74% of females answered yes to one of the ASQ questions, compared with just 26% of males. Similarly, 79% of females were classified as nonresponders, vs. 21% of males. In the negative screen group, however, females (54%) and males (46%) were much more evenly represented.
Patients who answered yes or NR also were more likely to have Medicaid or Medicare than commercial insurance or a self-pay arrangement. Within the yes group, 56% had public insurance, and 39% had private insurance. In the NR group, 43% had public insurance, and 53% had private insurance.
Any teens who answered yes or NR should have undergone evaluation by a mental health professional, but those answering yes were more likely to get this evaluation than nonresponders. Nearly all (93%) of those answering yes received the evaluation, compared with 79% of nonresponders. Yet half of the nonresponders who were evaluated were recommended for further follow-up, not far behind the 65% recommended from among the yes group.
A clinically significant risk of suicide existed among 93% of those answering yes and 85% of nonresponders, the investigators found. About a third (33%) of the yes group were classified as high risk – suicidal ideation within the past week or no treatment after a previous attempt – while 16% of the nonresponders were.
“The NR group was more often in an earlier stage of change than the yes group, presenting with a greater percentage of teens in the precontemplation category,” Ms. Hengehold said. The precontemplation category, which included 27% of the NR group and 17% of the yes group, referred to teens who did not believe they would benefit from working with a mental health professional.
The contemplation category referred to teens who said they were still thinking about whether to meet with a mental health professional or that they would seek treatment if their suicidality worsened. This category included 9% of yes responders and 14% of nonresponders.
A higher proportion of yes responders (56%) than nonresponders (41%) had reached the preparation stage, which meant they had agreed to set up treatment or had received a referral within a month after their ED visit. A similar percentage of yes responders and nonresponders were currently in treatment, seeing a mental health professional intermittently, or had successfully received therapy.
“The sociodemographic characteristics of teens that endorse a no response are very similar to those of positive endorsers,” she concluded. She noted the potential importance of including an NR option on suicide-screening instruments.
Although nonresponders had clinically significant mental health concerns that indicated a need for further evaluation, these adolescents were less ready to engage in mental health services than those answering yes.
“This may be important when designing suicide risk interventions for each group,” she reported.
The research was funded by the National Institutes of Health. Ms. Hengehold and her associates reported no relevant financial disclosures.
SAN FRANCISCO – Teens who answered “no response” for one or more questions during a standard suicide screening in the ED typically have a risk of suicide nearly on par with those who answered “yes” to at least one question, results of a study showed.
“Risk for suicidality was substantial among both groups,” Tricia Hengehold of the University of Cincinnati reported at the Pediatric Academic Societies meeting. “About half of each group fit the medium-risk category, although the yes group had more teens in the high-risk category comparatively.”
In their study, she and her coinvestigators compared all teens who answered yes or no response (NR) to any question on the Ask Suicide-Screening Questions (ASQ). A total of 3,386 adolescents, aged 12-17 years, were screened when each presented to the ED with a complaint other than a psychiatric one. The data came from a preexisting study not initially designed for studying nonresponders.
The majority of teens (93%) answered no to all ASQ questions: 5% answered yes to at least one ASQ question, regardless of other answers, and 2% answered no response on at least one of the ASQ questions, but did not answer yes to any of them.
The average age of participants was 14 years among all response groups, but females were overrepresented in the yes and NR groups: 74% of females answered yes to one of the ASQ questions, compared with just 26% of males. Similarly, 79% of females were classified as nonresponders, vs. 21% of males. In the negative screen group, however, females (54%) and males (46%) were much more evenly represented.
Patients who answered yes or NR also were more likely to have Medicaid or Medicare than commercial insurance or a self-pay arrangement. Within the yes group, 56% had public insurance, and 39% had private insurance. In the NR group, 43% had public insurance, and 53% had private insurance.
Any teens who answered yes or NR should have undergone evaluation by a mental health professional, but those answering yes were more likely to get this evaluation than nonresponders. Nearly all (93%) of those answering yes received the evaluation, compared with 79% of nonresponders. Yet half of the nonresponders who were evaluated were recommended for further follow-up, not far behind the 65% recommended from among the yes group.
A clinically significant risk of suicide existed among 93% of those answering yes and 85% of nonresponders, the investigators found. About a third (33%) of the yes group were classified as high risk – suicidal ideation within the past week or no treatment after a previous attempt – while 16% of the nonresponders were.
“The NR group was more often in an earlier stage of change than the yes group, presenting with a greater percentage of teens in the precontemplation category,” Ms. Hengehold said. The precontemplation category, which included 27% of the NR group and 17% of the yes group, referred to teens who did not believe they would benefit from working with a mental health professional.
The contemplation category referred to teens who said they were still thinking about whether to meet with a mental health professional or that they would seek treatment if their suicidality worsened. This category included 9% of yes responders and 14% of nonresponders.
A higher proportion of yes responders (56%) than nonresponders (41%) had reached the preparation stage, which meant they had agreed to set up treatment or had received a referral within a month after their ED visit. A similar percentage of yes responders and nonresponders were currently in treatment, seeing a mental health professional intermittently, or had successfully received therapy.
“The sociodemographic characteristics of teens that endorse a no response are very similar to those of positive endorsers,” she concluded. She noted the potential importance of including an NR option on suicide-screening instruments.
Although nonresponders had clinically significant mental health concerns that indicated a need for further evaluation, these adolescents were less ready to engage in mental health services than those answering yes.
“This may be important when designing suicide risk interventions for each group,” she reported.
The research was funded by the National Institutes of Health. Ms. Hengehold and her associates reported no relevant financial disclosures.
SAN FRANCISCO – Teens who answered “no response” for one or more questions during a standard suicide screening in the ED typically have a risk of suicide nearly on par with those who answered “yes” to at least one question, results of a study showed.
“Risk for suicidality was substantial among both groups,” Tricia Hengehold of the University of Cincinnati reported at the Pediatric Academic Societies meeting. “About half of each group fit the medium-risk category, although the yes group had more teens in the high-risk category comparatively.”
In their study, she and her coinvestigators compared all teens who answered yes or no response (NR) to any question on the Ask Suicide-Screening Questions (ASQ). A total of 3,386 adolescents, aged 12-17 years, were screened when each presented to the ED with a complaint other than a psychiatric one. The data came from a preexisting study not initially designed for studying nonresponders.
The majority of teens (93%) answered no to all ASQ questions: 5% answered yes to at least one ASQ question, regardless of other answers, and 2% answered no response on at least one of the ASQ questions, but did not answer yes to any of them.
The average age of participants was 14 years among all response groups, but females were overrepresented in the yes and NR groups: 74% of females answered yes to one of the ASQ questions, compared with just 26% of males. Similarly, 79% of females were classified as nonresponders, vs. 21% of males. In the negative screen group, however, females (54%) and males (46%) were much more evenly represented.
Patients who answered yes or NR also were more likely to have Medicaid or Medicare than commercial insurance or a self-pay arrangement. Within the yes group, 56% had public insurance, and 39% had private insurance. In the NR group, 43% had public insurance, and 53% had private insurance.
Any teens who answered yes or NR should have undergone evaluation by a mental health professional, but those answering yes were more likely to get this evaluation than nonresponders. Nearly all (93%) of those answering yes received the evaluation, compared with 79% of nonresponders. Yet half of the nonresponders who were evaluated were recommended for further follow-up, not far behind the 65% recommended from among the yes group.
A clinically significant risk of suicide existed among 93% of those answering yes and 85% of nonresponders, the investigators found. About a third (33%) of the yes group were classified as high risk – suicidal ideation within the past week or no treatment after a previous attempt – while 16% of the nonresponders were.
“The NR group was more often in an earlier stage of change than the yes group, presenting with a greater percentage of teens in the precontemplation category,” Ms. Hengehold said. The precontemplation category, which included 27% of the NR group and 17% of the yes group, referred to teens who did not believe they would benefit from working with a mental health professional.
The contemplation category referred to teens who said they were still thinking about whether to meet with a mental health professional or that they would seek treatment if their suicidality worsened. This category included 9% of yes responders and 14% of nonresponders.
A higher proportion of yes responders (56%) than nonresponders (41%) had reached the preparation stage, which meant they had agreed to set up treatment or had received a referral within a month after their ED visit. A similar percentage of yes responders and nonresponders were currently in treatment, seeing a mental health professional intermittently, or had successfully received therapy.
“The sociodemographic characteristics of teens that endorse a no response are very similar to those of positive endorsers,” she concluded. She noted the potential importance of including an NR option on suicide-screening instruments.
Although nonresponders had clinically significant mental health concerns that indicated a need for further evaluation, these adolescents were less ready to engage in mental health services than those answering yes.
“This may be important when designing suicide risk interventions for each group,” she reported.
The research was funded by the National Institutes of Health. Ms. Hengehold and her associates reported no relevant financial disclosures.
AT PAS 17
Key clinical point:
Major finding: Eighty-five percent of teens who were nonresponders on at least one suicide-screening question had a clinically significant risk of suicide, compared with 93% of those answering yes.
Data source: The findings are based on an analysis of responses from 3,386 adolescents screened for suicidality during a nonpsychiatric emergency department visit.
Disclosures: The research was funded by the National Institutes of Health. Ms. Hengehold and her associates reported no relevant financial disclosures.
How to raise HPV vaccine rates: Work together
Despite widespread availability of the human papillomavirus vaccine over the last 11 years, vaccination rates continue to lag behind national targets and are far behind other vaccines routinely administered in adolescence, such as the meningococcal and tetanus vaccines.
Better collaboration among pediatricians and obstetrician-gynecologists to promote the HPV vaccine may be one answer to turning the tide, said David W. Kimberlin, MD, codirector of the division of pediatric infectious diseases at the University of Alabama at Birmingham and president of the Pediatric Infectious Diseases Society.
As of 2015, just 63% of eligible U.S. girls completed the first dose of the HPV vaccination, 52% completed two doses, and 42% finished the three-dose series, according to a recent “Call to Action” paper in the American Journal of Obstetrics and Gynecology (doi: 10.1016/j.ajog.2017.02.026). Although the HPV vaccine has been recommended for boys since 2011, just half of eligible boys completed the first dose, 39% completed two doses, and 28% finished the full series. By contrast, 86% of adolescents received the tetanus, diphtheria, and acellular pertussis vaccine, and 81% received the first dose of the meningococcal vaccine. The federal government’s Office of Disease Prevention and Health Promotion aims for an 80% HPV vaccination completion rate for girls and boys aged 13-15 years by 2020.
[polldaddy:{"method":"iframe","type":"survey","src":"//newspolls2017.polldaddy.com/s/how-to-raise-hpv-vaccine-rates?iframe=1"}]The CDC now recommends that 11- to 12-year-olds get two doses of the HPV vaccine, rather than three, with the second dose given 6-12 months after the first (MMWR. 2016;65:1405-8).
The common ways in which the HPV vaccine is introduced to parents likely contributes to the low vaccination rates, said Beth Auslander, PhD, a clinical psychologist and associate professor in the department of pediatrics at the University of Texas Medical Branch in Galveston. Some pediatricians may tell parents about school-mandated vaccines first and then as a side note, mention the HPV vaccine.
“The way it’s presented at times is being separate from the other vaccines,” Dr. Auslander said. “Sometimes it sounds optional.”
Parents often are uncertain about the safety and efficacy of the HPV vaccine, she added, and some wrongly assume the vaccine will lead to sexual activity among their children.
“Sometimes it can take a little longer to talk about,” Dr. Yoost said in an interview. “A lot of times, parents will bring up questions or concerns about the HPV vaccine. If physicians aren’t comfortable talking about those topics, they may not give the best recommendation. Pediatricians are not dealing with cervical cancer, so they may have a harder time recommending a vaccine based on outcomes they don’t deal with.”
Ob.gyns. are in a unique position to reach out to their pediatric counterparts and discuss strategies for catching more patients eligible for the HPV vaccine, said Sarah Dilley, MD, a gynecologic oncology fellow at the University of Alabama at Birmingham and the lead author of the recent Call to Action paper.
“We offer a unique perspective in that we are treating the conditions that the HPV vaccine is preventing, so we have more of a sense of urgency and an understanding of why that is so important,” Dr. Dilley said in an interview. “Obviously, pediatricians understand this as well, but it’s not something they see every day in their practice. We, as ob.gyns., have the opportunity to talk to our pediatric colleagues about the importance and really how devastating these conditions can be and how important it is to prevent them.”
In the recent paper, Dr. Dilley and her colleagues recommend that ob.gyns. speak to pediatricians and primary care physicians in their community to promote the vaccine and encourage them to view the Centers for Disease Control and Prevention’s You Are the Key presentation. The CDC resources include tips for how to discuss the burden of HPV-related diseases and effective communication with parents, an update on state vaccination rates, and the latest HPV vaccination recommendations.
Dr. Dilley encourages ob.gyns. and pediatricians to find different opportunities and venues to discuss the HPV vaccine. Ask about the pediatrician’s current approach to the vaccine, the doctor’s communication with parents, and how such practices could be improved, she said.
“People like to hear from their colleagues,” Dr. Dilley said. “Hearing from ob.gyns. [about] their experiences could be really helpful, whether it’s doing lunch and learns, formal education, grand rounds, or even more informal talks at the hospital.”
Ob.gyns. and pediatricians also need to better coordinate their messaging so that there is more consistent emphasis during each patient encounter about the need of the HPV vaccination, Dr. Kimberlin said. There needs to be a renewed focus on the vaccine as a cancer vaccination, he said.
“The nuances of HPV and the way that HPV is acquired, namely sexually transmitted, has taken too much of a front row consideration in the conversations that parents sometimes want to have with their child’s health care providers,” Dr. Kimberlin said. “We have to stress this is a cancer vaccine. This is a vaccine that prevents the deaths of thousands of women and men. We simply need to get that message out more forcefully.”
In addition, there’s a need for joint action to debunk myths about the vaccine and work toward eliminating the stigma surrounding it, Dr. Dilley said.
“I talk to a lot parents about the HPV vaccine and there’s so much misinformation online,” she said. “But a lot of patients do look at websites of their ob.gyn. or their pediatrician, [and] if they see something reputable coming from one of those sites, they might listen. We have a lot of patients who are mothers or grandmothers of kids; that’s also an opportunity for us to say, ‘Hey while we’re screening you for cervical cancer, let’s talk about the HPV vaccine.’ That’s a really good opportunity to help our [pediatric] colleagues out.”
5 steps to increase HPV vaccination
Melissa Kottke, MD, director of the Jane Fonda Center for Adolescent Reproductive Health at Emory University offered her practice steps for increased HPV vaccination rates.
1. Be clear about your recommendation. For example, “I recommend the HPV vaccine. It can help prevent cancer.”
3. Educate the entire clinical team (front desk staff, nursing, medical assistants, etc.) about the HPV vaccine so there is consistent messaging and delivery.
4. Establish streamlined systems. The vaccine recommendation, order, and follow-up should be streamlined and automated, if possible. Systems should also ensure documentation of vaccine receipt.
5. Make time for conversations with patients who are mothers and grandmothers. Recommend the HPV vaccine for males and females aged 9-26 years old. Encourage parents/grandparents to follow-up with the child’s doctor or offer to provide the vaccine in your office.
*This story was updated 8/22/2017.
agallegos@frontlinemedcom.com
On Twitter @legal_med
Despite widespread availability of the human papillomavirus vaccine over the last 11 years, vaccination rates continue to lag behind national targets and are far behind other vaccines routinely administered in adolescence, such as the meningococcal and tetanus vaccines.
Better collaboration among pediatricians and obstetrician-gynecologists to promote the HPV vaccine may be one answer to turning the tide, said David W. Kimberlin, MD, codirector of the division of pediatric infectious diseases at the University of Alabama at Birmingham and president of the Pediatric Infectious Diseases Society.
As of 2015, just 63% of eligible U.S. girls completed the first dose of the HPV vaccination, 52% completed two doses, and 42% finished the three-dose series, according to a recent “Call to Action” paper in the American Journal of Obstetrics and Gynecology (doi: 10.1016/j.ajog.2017.02.026). Although the HPV vaccine has been recommended for boys since 2011, just half of eligible boys completed the first dose, 39% completed two doses, and 28% finished the full series. By contrast, 86% of adolescents received the tetanus, diphtheria, and acellular pertussis vaccine, and 81% received the first dose of the meningococcal vaccine. The federal government’s Office of Disease Prevention and Health Promotion aims for an 80% HPV vaccination completion rate for girls and boys aged 13-15 years by 2020.
[polldaddy:{"method":"iframe","type":"survey","src":"//newspolls2017.polldaddy.com/s/how-to-raise-hpv-vaccine-rates?iframe=1"}]The CDC now recommends that 11- to 12-year-olds get two doses of the HPV vaccine, rather than three, with the second dose given 6-12 months after the first (MMWR. 2016;65:1405-8).
The common ways in which the HPV vaccine is introduced to parents likely contributes to the low vaccination rates, said Beth Auslander, PhD, a clinical psychologist and associate professor in the department of pediatrics at the University of Texas Medical Branch in Galveston. Some pediatricians may tell parents about school-mandated vaccines first and then as a side note, mention the HPV vaccine.
“The way it’s presented at times is being separate from the other vaccines,” Dr. Auslander said. “Sometimes it sounds optional.”
Parents often are uncertain about the safety and efficacy of the HPV vaccine, she added, and some wrongly assume the vaccine will lead to sexual activity among their children.
“Sometimes it can take a little longer to talk about,” Dr. Yoost said in an interview. “A lot of times, parents will bring up questions or concerns about the HPV vaccine. If physicians aren’t comfortable talking about those topics, they may not give the best recommendation. Pediatricians are not dealing with cervical cancer, so they may have a harder time recommending a vaccine based on outcomes they don’t deal with.”
Ob.gyns. are in a unique position to reach out to their pediatric counterparts and discuss strategies for catching more patients eligible for the HPV vaccine, said Sarah Dilley, MD, a gynecologic oncology fellow at the University of Alabama at Birmingham and the lead author of the recent Call to Action paper.
“We offer a unique perspective in that we are treating the conditions that the HPV vaccine is preventing, so we have more of a sense of urgency and an understanding of why that is so important,” Dr. Dilley said in an interview. “Obviously, pediatricians understand this as well, but it’s not something they see every day in their practice. We, as ob.gyns., have the opportunity to talk to our pediatric colleagues about the importance and really how devastating these conditions can be and how important it is to prevent them.”
In the recent paper, Dr. Dilley and her colleagues recommend that ob.gyns. speak to pediatricians and primary care physicians in their community to promote the vaccine and encourage them to view the Centers for Disease Control and Prevention’s You Are the Key presentation. The CDC resources include tips for how to discuss the burden of HPV-related diseases and effective communication with parents, an update on state vaccination rates, and the latest HPV vaccination recommendations.
Dr. Dilley encourages ob.gyns. and pediatricians to find different opportunities and venues to discuss the HPV vaccine. Ask about the pediatrician’s current approach to the vaccine, the doctor’s communication with parents, and how such practices could be improved, she said.
“People like to hear from their colleagues,” Dr. Dilley said. “Hearing from ob.gyns. [about] their experiences could be really helpful, whether it’s doing lunch and learns, formal education, grand rounds, or even more informal talks at the hospital.”
Ob.gyns. and pediatricians also need to better coordinate their messaging so that there is more consistent emphasis during each patient encounter about the need of the HPV vaccination, Dr. Kimberlin said. There needs to be a renewed focus on the vaccine as a cancer vaccination, he said.
“The nuances of HPV and the way that HPV is acquired, namely sexually transmitted, has taken too much of a front row consideration in the conversations that parents sometimes want to have with their child’s health care providers,” Dr. Kimberlin said. “We have to stress this is a cancer vaccine. This is a vaccine that prevents the deaths of thousands of women and men. We simply need to get that message out more forcefully.”
In addition, there’s a need for joint action to debunk myths about the vaccine and work toward eliminating the stigma surrounding it, Dr. Dilley said.
“I talk to a lot parents about the HPV vaccine and there’s so much misinformation online,” she said. “But a lot of patients do look at websites of their ob.gyn. or their pediatrician, [and] if they see something reputable coming from one of those sites, they might listen. We have a lot of patients who are mothers or grandmothers of kids; that’s also an opportunity for us to say, ‘Hey while we’re screening you for cervical cancer, let’s talk about the HPV vaccine.’ That’s a really good opportunity to help our [pediatric] colleagues out.”
5 steps to increase HPV vaccination
Melissa Kottke, MD, director of the Jane Fonda Center for Adolescent Reproductive Health at Emory University offered her practice steps for increased HPV vaccination rates.
1. Be clear about your recommendation. For example, “I recommend the HPV vaccine. It can help prevent cancer.”
3. Educate the entire clinical team (front desk staff, nursing, medical assistants, etc.) about the HPV vaccine so there is consistent messaging and delivery.
4. Establish streamlined systems. The vaccine recommendation, order, and follow-up should be streamlined and automated, if possible. Systems should also ensure documentation of vaccine receipt.
5. Make time for conversations with patients who are mothers and grandmothers. Recommend the HPV vaccine for males and females aged 9-26 years old. Encourage parents/grandparents to follow-up with the child’s doctor or offer to provide the vaccine in your office.
*This story was updated 8/22/2017.
agallegos@frontlinemedcom.com
On Twitter @legal_med
Despite widespread availability of the human papillomavirus vaccine over the last 11 years, vaccination rates continue to lag behind national targets and are far behind other vaccines routinely administered in adolescence, such as the meningococcal and tetanus vaccines.
Better collaboration among pediatricians and obstetrician-gynecologists to promote the HPV vaccine may be one answer to turning the tide, said David W. Kimberlin, MD, codirector of the division of pediatric infectious diseases at the University of Alabama at Birmingham and president of the Pediatric Infectious Diseases Society.
As of 2015, just 63% of eligible U.S. girls completed the first dose of the HPV vaccination, 52% completed two doses, and 42% finished the three-dose series, according to a recent “Call to Action” paper in the American Journal of Obstetrics and Gynecology (doi: 10.1016/j.ajog.2017.02.026). Although the HPV vaccine has been recommended for boys since 2011, just half of eligible boys completed the first dose, 39% completed two doses, and 28% finished the full series. By contrast, 86% of adolescents received the tetanus, diphtheria, and acellular pertussis vaccine, and 81% received the first dose of the meningococcal vaccine. The federal government’s Office of Disease Prevention and Health Promotion aims for an 80% HPV vaccination completion rate for girls and boys aged 13-15 years by 2020.
[polldaddy:{"method":"iframe","type":"survey","src":"//newspolls2017.polldaddy.com/s/how-to-raise-hpv-vaccine-rates?iframe=1"}]The CDC now recommends that 11- to 12-year-olds get two doses of the HPV vaccine, rather than three, with the second dose given 6-12 months after the first (MMWR. 2016;65:1405-8).
The common ways in which the HPV vaccine is introduced to parents likely contributes to the low vaccination rates, said Beth Auslander, PhD, a clinical psychologist and associate professor in the department of pediatrics at the University of Texas Medical Branch in Galveston. Some pediatricians may tell parents about school-mandated vaccines first and then as a side note, mention the HPV vaccine.
“The way it’s presented at times is being separate from the other vaccines,” Dr. Auslander said. “Sometimes it sounds optional.”
Parents often are uncertain about the safety and efficacy of the HPV vaccine, she added, and some wrongly assume the vaccine will lead to sexual activity among their children.
“Sometimes it can take a little longer to talk about,” Dr. Yoost said in an interview. “A lot of times, parents will bring up questions or concerns about the HPV vaccine. If physicians aren’t comfortable talking about those topics, they may not give the best recommendation. Pediatricians are not dealing with cervical cancer, so they may have a harder time recommending a vaccine based on outcomes they don’t deal with.”
Ob.gyns. are in a unique position to reach out to their pediatric counterparts and discuss strategies for catching more patients eligible for the HPV vaccine, said Sarah Dilley, MD, a gynecologic oncology fellow at the University of Alabama at Birmingham and the lead author of the recent Call to Action paper.
“We offer a unique perspective in that we are treating the conditions that the HPV vaccine is preventing, so we have more of a sense of urgency and an understanding of why that is so important,” Dr. Dilley said in an interview. “Obviously, pediatricians understand this as well, but it’s not something they see every day in their practice. We, as ob.gyns., have the opportunity to talk to our pediatric colleagues about the importance and really how devastating these conditions can be and how important it is to prevent them.”
In the recent paper, Dr. Dilley and her colleagues recommend that ob.gyns. speak to pediatricians and primary care physicians in their community to promote the vaccine and encourage them to view the Centers for Disease Control and Prevention’s You Are the Key presentation. The CDC resources include tips for how to discuss the burden of HPV-related diseases and effective communication with parents, an update on state vaccination rates, and the latest HPV vaccination recommendations.
Dr. Dilley encourages ob.gyns. and pediatricians to find different opportunities and venues to discuss the HPV vaccine. Ask about the pediatrician’s current approach to the vaccine, the doctor’s communication with parents, and how such practices could be improved, she said.
“People like to hear from their colleagues,” Dr. Dilley said. “Hearing from ob.gyns. [about] their experiences could be really helpful, whether it’s doing lunch and learns, formal education, grand rounds, or even more informal talks at the hospital.”
Ob.gyns. and pediatricians also need to better coordinate their messaging so that there is more consistent emphasis during each patient encounter about the need of the HPV vaccination, Dr. Kimberlin said. There needs to be a renewed focus on the vaccine as a cancer vaccination, he said.
“The nuances of HPV and the way that HPV is acquired, namely sexually transmitted, has taken too much of a front row consideration in the conversations that parents sometimes want to have with their child’s health care providers,” Dr. Kimberlin said. “We have to stress this is a cancer vaccine. This is a vaccine that prevents the deaths of thousands of women and men. We simply need to get that message out more forcefully.”
In addition, there’s a need for joint action to debunk myths about the vaccine and work toward eliminating the stigma surrounding it, Dr. Dilley said.
“I talk to a lot parents about the HPV vaccine and there’s so much misinformation online,” she said. “But a lot of patients do look at websites of their ob.gyn. or their pediatrician, [and] if they see something reputable coming from one of those sites, they might listen. We have a lot of patients who are mothers or grandmothers of kids; that’s also an opportunity for us to say, ‘Hey while we’re screening you for cervical cancer, let’s talk about the HPV vaccine.’ That’s a really good opportunity to help our [pediatric] colleagues out.”
5 steps to increase HPV vaccination
Melissa Kottke, MD, director of the Jane Fonda Center for Adolescent Reproductive Health at Emory University offered her practice steps for increased HPV vaccination rates.
1. Be clear about your recommendation. For example, “I recommend the HPV vaccine. It can help prevent cancer.”
3. Educate the entire clinical team (front desk staff, nursing, medical assistants, etc.) about the HPV vaccine so there is consistent messaging and delivery.
4. Establish streamlined systems. The vaccine recommendation, order, and follow-up should be streamlined and automated, if possible. Systems should also ensure documentation of vaccine receipt.
5. Make time for conversations with patients who are mothers and grandmothers. Recommend the HPV vaccine for males and females aged 9-26 years old. Encourage parents/grandparents to follow-up with the child’s doctor or offer to provide the vaccine in your office.
*This story was updated 8/22/2017.
agallegos@frontlinemedcom.com
On Twitter @legal_med