LIVERPOOL, ENGLAND – The investigational cathepsin K inhibitor MIV-711 had positive effects on both bone and cartilage at 6 months in patients with knee osteoarthritis (OA) in a phase 2a study.

The MRI measures of the “area of bone in the medial femur region” and “average cartilage thickness” showed reduced progression with MIV-711 versus placebo.

Sara Freeman/MDedge News

SOURCE: Conaghan P et al. Osteoarthritis Cartilage. 2018 Apr 16:26(1):S25-26. Abstract 29.
 

LIVERPOOL, ENGLAND – The investigational cathepsin K inhibitor MIV-711 had positive effects on both bone and cartilage at 6 months in patients with knee osteoarthritis (OA) in a phase 2a study.

The MRI measures of the “area of bone in the medial femur region” and “average cartilage thickness” showed reduced progression with MIV-711 versus placebo.

Sara Freeman/MDedge News

SOURCE: Conaghan P et al. Osteoarthritis Cartilage. 2018 Apr 16:26(1):S25-26. Abstract 29.
 

LIVERPOOL, ENGLAND – The investigational cathepsin K inhibitor MIV-711 had positive effects on both bone and cartilage at 6 months in patients with knee osteoarthritis (OA) in a phase 2a study.

The MRI measures of the “area of bone in the medial femur region” and “average cartilage thickness” showed reduced progression with MIV-711 versus placebo.

Sara Freeman/MDedge News

SOURCE: Conaghan P et al. Osteoarthritis Cartilage. 2018 Apr 16:26(1):S25-26. Abstract 29.
 

AUSTIN, TEX. – While women may have a plethora of options for care during pregnancy, attention given to women after birth is seriously lacking, with detrimental effect.

Currently, postpartum care is limited to a follow-up appointment 6 weeks after pregnancy, but according to Alison Stuebe, MD, medical director of lactation services at the University of North Carolina, Chapel Hill, there is too much going on in those 6 weeks to continue this model.

To address preferred changes to this system of care, the American College of Obstetricians and Gynecologists recently released a revised committee opinion, which Dr. Stuebe helped create, to provide better care for mothers right after giving birth..

“What we’d like to do with the new committee opinion is move from this one-off visit at 6 weeks where we tell people ‘you’re good to go, you can have sex, get out of my office,’ to a much more comprehensive approach that reaches out to moms in the first couple of weeks,” explained Dr. Stuebe. “Whether that’s by phone, by asynchronous communication, by in-person visit, [the physician] finds out what’s going on, and then makes appropriate recommendations to help her rather than waiting to see what’s left after 6 weeks,” she said at ACOG’s annual clinical and scientific meeting.

Paying for these services is a big barrier right now, said Dr. Stuebe, but some solutions have already shown signs of being cost effective.

One example, in Dr. Stuebe’s hometown of Durham County, N.C., is a program called Durham Connect, which puts nurses in contact with women at 3 weeks postpartum to make assessments of what care the mother needs, and then offers service referrals to help with those needs.

According to Dr. Stuebe, studies have found every dollar invested in the program would save $3 in emergency department visits for children.

As postpartum care evolves, the most important thing is to remember that when it comes to pregnancy and birth, just because the baby is out doesn’t mean the mother can be ignored, she said.

The revised committee opinion states: “The comprehensive postpartum visit should include a full assessment of physical, social, and psychological well-being, including the following domains: mood and emotional well-being; infant care and feeding; sexuality, contraception, and birth spacing; sleep and fatigue; physical recovery from birth; chronic disease management; and health maintenance.”

Dr. Stuebe receives support from Janssen.

[email protected]

AUSTIN, TEX. – While women may have a plethora of options for care during pregnancy, attention given to women after birth is seriously lacking, with detrimental effect.

Currently, postpartum care is limited to a follow-up appointment 6 weeks after pregnancy, but according to Alison Stuebe, MD, medical director of lactation services at the University of North Carolina, Chapel Hill, there is too much going on in those 6 weeks to continue this model.

To address preferred changes to this system of care, the American College of Obstetricians and Gynecologists recently released a revised committee opinion, which Dr. Stuebe helped create, to provide better care for mothers right after giving birth..

“What we’d like to do with the new committee opinion is move from this one-off visit at 6 weeks where we tell people ‘you’re good to go, you can have sex, get out of my office,’ to a much more comprehensive approach that reaches out to moms in the first couple of weeks,” explained Dr. Stuebe. “Whether that’s by phone, by asynchronous communication, by in-person visit, [the physician] finds out what’s going on, and then makes appropriate recommendations to help her rather than waiting to see what’s left after 6 weeks,” she said at ACOG’s annual clinical and scientific meeting.

Paying for these services is a big barrier right now, said Dr. Stuebe, but some solutions have already shown signs of being cost effective.

One example, in Dr. Stuebe’s hometown of Durham County, N.C., is a program called Durham Connect, which puts nurses in contact with women at 3 weeks postpartum to make assessments of what care the mother needs, and then offers service referrals to help with those needs.

According to Dr. Stuebe, studies have found every dollar invested in the program would save $3 in emergency department visits for children.

As postpartum care evolves, the most important thing is to remember that when it comes to pregnancy and birth, just because the baby is out doesn’t mean the mother can be ignored, she said.

The revised committee opinion states: “The comprehensive postpartum visit should include a full assessment of physical, social, and psychological well-being, including the following domains: mood and emotional well-being; infant care and feeding; sexuality, contraception, and birth spacing; sleep and fatigue; physical recovery from birth; chronic disease management; and health maintenance.”

Dr. Stuebe receives support from Janssen.

[email protected]

AUSTIN, TEX. – While women may have a plethora of options for care during pregnancy, attention given to women after birth is seriously lacking, with detrimental effect.

Currently, postpartum care is limited to a follow-up appointment 6 weeks after pregnancy, but according to Alison Stuebe, MD, medical director of lactation services at the University of North Carolina, Chapel Hill, there is too much going on in those 6 weeks to continue this model.

To address preferred changes to this system of care, the American College of Obstetricians and Gynecologists recently released a revised committee opinion, which Dr. Stuebe helped create, to provide better care for mothers right after giving birth..

“What we’d like to do with the new committee opinion is move from this one-off visit at 6 weeks where we tell people ‘you’re good to go, you can have sex, get out of my office,’ to a much more comprehensive approach that reaches out to moms in the first couple of weeks,” explained Dr. Stuebe. “Whether that’s by phone, by asynchronous communication, by in-person visit, [the physician] finds out what’s going on, and then makes appropriate recommendations to help her rather than waiting to see what’s left after 6 weeks,” she said at ACOG’s annual clinical and scientific meeting.

Paying for these services is a big barrier right now, said Dr. Stuebe, but some solutions have already shown signs of being cost effective.

One example, in Dr. Stuebe’s hometown of Durham County, N.C., is a program called Durham Connect, which puts nurses in contact with women at 3 weeks postpartum to make assessments of what care the mother needs, and then offers service referrals to help with those needs.

According to Dr. Stuebe, studies have found every dollar invested in the program would save $3 in emergency department visits for children.

As postpartum care evolves, the most important thing is to remember that when it comes to pregnancy and birth, just because the baby is out doesn’t mean the mother can be ignored, she said.

The revised committee opinion states: “The comprehensive postpartum visit should include a full assessment of physical, social, and psychological well-being, including the following domains: mood and emotional well-being; infant care and feeding; sexuality, contraception, and birth spacing; sleep and fatigue; physical recovery from birth; chronic disease management; and health maintenance.”

Dr. Stuebe receives support from Janssen.

[email protected]

For adults with serious illness, consulting with a palliative care team within 3 days of hospital admission significantly reduced hospital costs, according to findings from a systematic review and meta-analysis.

In a pooled analysis of six cohort studies, average cost savings per admission were $3,237 (95% confidence interval, –$3,581 to −$2,893) overall, $4,251 for patients with cancer, and $2,105 for patients with other serious illnesses (all P values less than .001), reported Peter May, PhD, of Trinity College Dublin, and his associates.

In this latter group, prompt palliative care consultations saved more when patients had at least four comorbidities rather than two or fewer comorbidities, the reviewers wrote. The report was published in JAMA Internal Medicine.

About one in four Medicare beneficiaries dies in acute care hospitals, often after weeks of intensive, costly care that may not reflect personal wishes, according to an earlier study (JAMA. 2013;309:470-7). Economic studies have tried to pinpoint the cost savings of palliative care. These studies have found it important to consider both the clinical characteristics of patients and the amount of time between admission and palliative consultations, the reviewers noted. However, heterogeneity among older studies had precluded pooled analyses.

The six studies in this meta-analysis were identified by a search of Embase, PsycINFO, CENTRAL, PubMed, CINAHL, and EconLit databases for economic studies of hospital-based palliative care consultations. The studies were published between 2008 and 2017 and included 133,118 adults with cancer, chronic obstructive pulmonary disease, major organ failure, AIDS/HIV, or serious neurodegenerative disease. Patients tended to be in their 60s and were usually Medicare beneficiaries, although one study focused only on Medicaid enrollees. Forty-one percent of patients had a primary diagnosis of cancer, and 93% were discharged alive. Most also had at least two comorbidities. Only 3.6% received a palliative care consultation (range, 2.2% to 22.3%).

The link that they found between more comorbidities and greater cost savings “is the reverse of prior research that assumed that long-stay, high-cost hospitalized patients could not have their care trajectories affected by palliative care,” the researchers wrote. “Current palliative care provision in the United States is characterized by widespread understaffing. Our results suggest that acute care hospitals may be able to reduce costs for this population by increasing palliative care capacity to meet national guidelines.”

Dr. May received grant support from The Atlantic Philanthropies. The reviewers reported having no conflicts of interest.

SOURCE: May P et al. JAMA Intern Med. 2018 Apr 30. doi: 10.1001/jamainternmed.2018.0750.

For adults with serious illness, consulting with a palliative care team within 3 days of hospital admission significantly reduced hospital costs, according to findings from a systematic review and meta-analysis.

In a pooled analysis of six cohort studies, average cost savings per admission were $3,237 (95% confidence interval, –$3,581 to −$2,893) overall, $4,251 for patients with cancer, and $2,105 for patients with other serious illnesses (all P values less than .001), reported Peter May, PhD, of Trinity College Dublin, and his associates.

In this latter group, prompt palliative care consultations saved more when patients had at least four comorbidities rather than two or fewer comorbidities, the reviewers wrote. The report was published in JAMA Internal Medicine.

About one in four Medicare beneficiaries dies in acute care hospitals, often after weeks of intensive, costly care that may not reflect personal wishes, according to an earlier study (JAMA. 2013;309:470-7). Economic studies have tried to pinpoint the cost savings of palliative care. These studies have found it important to consider both the clinical characteristics of patients and the amount of time between admission and palliative consultations, the reviewers noted. However, heterogeneity among older studies had precluded pooled analyses.

The six studies in this meta-analysis were identified by a search of Embase, PsycINFO, CENTRAL, PubMed, CINAHL, and EconLit databases for economic studies of hospital-based palliative care consultations. The studies were published between 2008 and 2017 and included 133,118 adults with cancer, chronic obstructive pulmonary disease, major organ failure, AIDS/HIV, or serious neurodegenerative disease. Patients tended to be in their 60s and were usually Medicare beneficiaries, although one study focused only on Medicaid enrollees. Forty-one percent of patients had a primary diagnosis of cancer, and 93% were discharged alive. Most also had at least two comorbidities. Only 3.6% received a palliative care consultation (range, 2.2% to 22.3%).

The link that they found between more comorbidities and greater cost savings “is the reverse of prior research that assumed that long-stay, high-cost hospitalized patients could not have their care trajectories affected by palliative care,” the researchers wrote. “Current palliative care provision in the United States is characterized by widespread understaffing. Our results suggest that acute care hospitals may be able to reduce costs for this population by increasing palliative care capacity to meet national guidelines.”

Dr. May received grant support from The Atlantic Philanthropies. The reviewers reported having no conflicts of interest.

SOURCE: May P et al. JAMA Intern Med. 2018 Apr 30. doi: 10.1001/jamainternmed.2018.0750.

For adults with serious illness, consulting with a palliative care team within 3 days of hospital admission significantly reduced hospital costs, according to findings from a systematic review and meta-analysis.

In a pooled analysis of six cohort studies, average cost savings per admission were $3,237 (95% confidence interval, –$3,581 to −$2,893) overall, $4,251 for patients with cancer, and $2,105 for patients with other serious illnesses (all P values less than .001), reported Peter May, PhD, of Trinity College Dublin, and his associates.

In this latter group, prompt palliative care consultations saved more when patients had at least four comorbidities rather than two or fewer comorbidities, the reviewers wrote. The report was published in JAMA Internal Medicine.

About one in four Medicare beneficiaries dies in acute care hospitals, often after weeks of intensive, costly care that may not reflect personal wishes, according to an earlier study (JAMA. 2013;309:470-7). Economic studies have tried to pinpoint the cost savings of palliative care. These studies have found it important to consider both the clinical characteristics of patients and the amount of time between admission and palliative consultations, the reviewers noted. However, heterogeneity among older studies had precluded pooled analyses.

The six studies in this meta-analysis were identified by a search of Embase, PsycINFO, CENTRAL, PubMed, CINAHL, and EconLit databases for economic studies of hospital-based palliative care consultations. The studies were published between 2008 and 2017 and included 133,118 adults with cancer, chronic obstructive pulmonary disease, major organ failure, AIDS/HIV, or serious neurodegenerative disease. Patients tended to be in their 60s and were usually Medicare beneficiaries, although one study focused only on Medicaid enrollees. Forty-one percent of patients had a primary diagnosis of cancer, and 93% were discharged alive. Most also had at least two comorbidities. Only 3.6% received a palliative care consultation (range, 2.2% to 22.3%).

The link that they found between more comorbidities and greater cost savings “is the reverse of prior research that assumed that long-stay, high-cost hospitalized patients could not have their care trajectories affected by palliative care,” the researchers wrote. “Current palliative care provision in the United States is characterized by widespread understaffing. Our results suggest that acute care hospitals may be able to reduce costs for this population by increasing palliative care capacity to meet national guidelines.”

Dr. May received grant support from The Atlantic Philanthropies. The reviewers reported having no conflicts of interest.

SOURCE: May P et al. JAMA Intern Med. 2018 Apr 30. doi: 10.1001/jamainternmed.2018.0750.

Learn about emerging vascular science, engage with researchers, network with colleagues, and support your peers at VRIC, our ‘Annual Meeting’ for basic and translational vascular researchers. Online registration has ended by attendees can register in person the day of the conference. VRIC 2018 will be held at the Hilton San Francisco Union Square, on May 9. Learn more and find the program schedule here.

Learn about emerging vascular science, engage with researchers, network with colleagues, and support your peers at VRIC, our ‘Annual Meeting’ for basic and translational vascular researchers. Online registration has ended by attendees can register in person the day of the conference. VRIC 2018 will be held at the Hilton San Francisco Union Square, on May 9. Learn more and find the program schedule here.

Learn about emerging vascular science, engage with researchers, network with colleagues, and support your peers at VRIC, our ‘Annual Meeting’ for basic and translational vascular researchers. Online registration has ended by attendees can register in person the day of the conference. VRIC 2018 will be held at the Hilton San Francisco Union Square, on May 9. Learn more and find the program schedule here.

Among patients with metastatic melanoma, detectable circulating levels of BRAF^V600 mutated circulating tumor DNA and elevated levels of circulating hepatocyte growth factor separately predicted significantly worse survival, regardless of treatment.

After adjusting for lactate dehydrogenase, ECOG (Eastern Cooperative Oncology Group) status, disease stage, and treatment, hazard ratios for overall survival were 1.75 (95% confidence interval, 1.35-2.28) for detectable versus undetectable circulating tumor DNA (ctDNA) and 1.24 (95% CI, 1.00-1.53) for high versus low circulating hepatocyte growth factor (cHGF), reported William Lu, PhD, of Genentech in South San Francisco, with his associates. Their retrospective, exploratory analysis of the phase 3 BRIM-3 trial was published in JCO Precision Oncology.

BRIM-3 was a multicenter, open-label trial of 675 patients with previously untreated unresectable stage IIIC or stage IV melanoma that tested positive for the BRAF^V600 mutation. Patients received either vemurafenib or dacarbazine therapy.

Baseline ctDNA, baseline cHGF, and ECOG performance status most strongly predicted overall survival, said the investigators. Patients whose mutant ctDNA fraction exceeded 0.039 had an 11.5-month shorter median overall survival on vemurafenib (P less than .001) and a 13.9-month shorter median overall survival on dacarbazine (P less than .001) than patients whose mutant ctDNA fraction was less than 0.039, they explained. Similarly, median overall survival times were 5.4 months shorter for vemurafenib (P = .002) and 12.3 months shorter for dacarbazine (P less than .001) when patients had high (more than 438 pg/mL) versus low circulating cHGF.

Median overall survival for vemurafenib was shortest (7.3 months) in the subgroup of 64 patients with detectable BRAF^V600 ctDNA and elevated cHGF, according to the researchers. In contrast, median overall survival for vemurafenib was longest (22.0 months) when patients had undetectable ctDNA and an ECOG status of 0.

“Although similar studies have been performed, to our knowledge, our study is unique in its size and in its design as a randomized trial,” Dr. Lu and associates concluded. “The biomarkers in this study can be readily acquired and measured, and require only small volumes of plasma.” They suggested validating the findings in a separate dataset.

F. Hoffman-La Roche provided funding. Roche Molecular Systems makes the Cobas 4800 BRAF^V600 Mutation Test used in the study. Dr. Lu disclosed employment and research funding from Genentech/Roche.

SOURCE: Lu W et al. JCO Precis Oncol. 2018 Apr 25. doi: 10.1200/PO.17.00168.

Among patients with metastatic melanoma, detectable circulating levels of BRAF^V600 mutated circulating tumor DNA and elevated levels of circulating hepatocyte growth factor separately predicted significantly worse survival, regardless of treatment.

After adjusting for lactate dehydrogenase, ECOG (Eastern Cooperative Oncology Group) status, disease stage, and treatment, hazard ratios for overall survival were 1.75 (95% confidence interval, 1.35-2.28) for detectable versus undetectable circulating tumor DNA (ctDNA) and 1.24 (95% CI, 1.00-1.53) for high versus low circulating hepatocyte growth factor (cHGF), reported William Lu, PhD, of Genentech in South San Francisco, with his associates. Their retrospective, exploratory analysis of the phase 3 BRIM-3 trial was published in JCO Precision Oncology.

BRIM-3 was a multicenter, open-label trial of 675 patients with previously untreated unresectable stage IIIC or stage IV melanoma that tested positive for the BRAF^V600 mutation. Patients received either vemurafenib or dacarbazine therapy.

Baseline ctDNA, baseline cHGF, and ECOG performance status most strongly predicted overall survival, said the investigators. Patients whose mutant ctDNA fraction exceeded 0.039 had an 11.5-month shorter median overall survival on vemurafenib (P less than .001) and a 13.9-month shorter median overall survival on dacarbazine (P less than .001) than patients whose mutant ctDNA fraction was less than 0.039, they explained. Similarly, median overall survival times were 5.4 months shorter for vemurafenib (P = .002) and 12.3 months shorter for dacarbazine (P less than .001) when patients had high (more than 438 pg/mL) versus low circulating cHGF.

Median overall survival for vemurafenib was shortest (7.3 months) in the subgroup of 64 patients with detectable BRAF^V600 ctDNA and elevated cHGF, according to the researchers. In contrast, median overall survival for vemurafenib was longest (22.0 months) when patients had undetectable ctDNA and an ECOG status of 0.

“Although similar studies have been performed, to our knowledge, our study is unique in its size and in its design as a randomized trial,” Dr. Lu and associates concluded. “The biomarkers in this study can be readily acquired and measured, and require only small volumes of plasma.” They suggested validating the findings in a separate dataset.

F. Hoffman-La Roche provided funding. Roche Molecular Systems makes the Cobas 4800 BRAF^V600 Mutation Test used in the study. Dr. Lu disclosed employment and research funding from Genentech/Roche.

SOURCE: Lu W et al. JCO Precis Oncol. 2018 Apr 25. doi: 10.1200/PO.17.00168.

Among patients with metastatic melanoma, detectable circulating levels of BRAF^V600 mutated circulating tumor DNA and elevated levels of circulating hepatocyte growth factor separately predicted significantly worse survival, regardless of treatment.

After adjusting for lactate dehydrogenase, ECOG (Eastern Cooperative Oncology Group) status, disease stage, and treatment, hazard ratios for overall survival were 1.75 (95% confidence interval, 1.35-2.28) for detectable versus undetectable circulating tumor DNA (ctDNA) and 1.24 (95% CI, 1.00-1.53) for high versus low circulating hepatocyte growth factor (cHGF), reported William Lu, PhD, of Genentech in South San Francisco, with his associates. Their retrospective, exploratory analysis of the phase 3 BRIM-3 trial was published in JCO Precision Oncology.

BRIM-3 was a multicenter, open-label trial of 675 patients with previously untreated unresectable stage IIIC or stage IV melanoma that tested positive for the BRAF^V600 mutation. Patients received either vemurafenib or dacarbazine therapy.

Baseline ctDNA, baseline cHGF, and ECOG performance status most strongly predicted overall survival, said the investigators. Patients whose mutant ctDNA fraction exceeded 0.039 had an 11.5-month shorter median overall survival on vemurafenib (P less than .001) and a 13.9-month shorter median overall survival on dacarbazine (P less than .001) than patients whose mutant ctDNA fraction was less than 0.039, they explained. Similarly, median overall survival times were 5.4 months shorter for vemurafenib (P = .002) and 12.3 months shorter for dacarbazine (P less than .001) when patients had high (more than 438 pg/mL) versus low circulating cHGF.

Median overall survival for vemurafenib was shortest (7.3 months) in the subgroup of 64 patients with detectable BRAF^V600 ctDNA and elevated cHGF, according to the researchers. In contrast, median overall survival for vemurafenib was longest (22.0 months) when patients had undetectable ctDNA and an ECOG status of 0.

“Although similar studies have been performed, to our knowledge, our study is unique in its size and in its design as a randomized trial,” Dr. Lu and associates concluded. “The biomarkers in this study can be readily acquired and measured, and require only small volumes of plasma.” They suggested validating the findings in a separate dataset.

F. Hoffman-La Roche provided funding. Roche Molecular Systems makes the Cobas 4800 BRAF^V600 Mutation Test used in the study. Dr. Lu disclosed employment and research funding from Genentech/Roche.

SOURCE: Lu W et al. JCO Precis Oncol. 2018 Apr 25. doi: 10.1200/PO.17.00168.

Female physicians face an enduring wage gap. A metabolic syndrome scoring system predicts cardiovascular disease risk in type 2 diabetes. A national suicide hotline could become a reality. And anticholinergics’ link to dementia calls for vigilance in elderly patients.

Listen to the MDedge Daily News podcast for all the details on today’s top news.


 

Female physicians face an enduring wage gap. A metabolic syndrome scoring system predicts cardiovascular disease risk in type 2 diabetes. A national suicide hotline could become a reality. And anticholinergics’ link to dementia calls for vigilance in elderly patients.

Listen to the MDedge Daily News podcast for all the details on today’s top news.


 

Female physicians face an enduring wage gap. A metabolic syndrome scoring system predicts cardiovascular disease risk in type 2 diabetes. A national suicide hotline could become a reality. And anticholinergics’ link to dementia calls for vigilance in elderly patients.

Listen to the MDedge Daily News podcast for all the details on today’s top news.


 

In 2015, young people aged 13- 24 years accounted for > 1 in 5 new HIV diagnoses in the US. Young people aged 15-24 years also account for half of all new sexually transmitted disease infections. Many of those high-risk youth are caught in the juvenile justice system, where they experience more mental illness, substance abuse, and STDs than their peers in the general population.

It is a challenge to identify and implement effective prevention strategies for these young people, but a study at the University of Illinois shows potential. PHAT Life: Preventing HIV/AIDS Among Teens uses role-playing, videos, games, and skill-building exercises to promote knowledge about HIV/AIDS, positive coping, and problem-solving skills.

The study was conducted with 310 urban teens, mostly African American boys, on probation in Chicago’s Cook County, the second-largest county justice system in the US. The participants were assigned to PHAT Life or an equally intensive health information program. Both 2-week programs consisted of 8 90- to 120-minute sessions, delivered at detention-alternative after-school programs.

The study measured the degree of condom use and number of sexual partners in the 6 months before and after the intervention. Among participants who reported the highest-risk sexual behavior at baseline, those assigned to PHAT Life were over 4 times more likely than those in the control group to report a reduction in number of sexual partners and more consistent condom use. Of those who reported having had sex before age 12, the PHAT Life participants reported significantly fewer sexual partners after the intervention.

“Uniquely tailored interventions like PHAT Life … are essential to mitigate young offenders’ poor long-term trajectories,” says Geri Donenberg, PhD, study leader.

The next step, the researchers say, is to identify how best to disseminate PHAT Life resources to ensure it’s self-sustaining in the juvenile justice system.

In 2015, young people aged 13- 24 years accounted for > 1 in 5 new HIV diagnoses in the US. Young people aged 15-24 years also account for half of all new sexually transmitted disease infections. Many of those high-risk youth are caught in the juvenile justice system, where they experience more mental illness, substance abuse, and STDs than their peers in the general population.

It is a challenge to identify and implement effective prevention strategies for these young people, but a study at the University of Illinois shows potential. PHAT Life: Preventing HIV/AIDS Among Teens uses role-playing, videos, games, and skill-building exercises to promote knowledge about HIV/AIDS, positive coping, and problem-solving skills.

The study was conducted with 310 urban teens, mostly African American boys, on probation in Chicago’s Cook County, the second-largest county justice system in the US. The participants were assigned to PHAT Life or an equally intensive health information program. Both 2-week programs consisted of 8 90- to 120-minute sessions, delivered at detention-alternative after-school programs.

The study measured the degree of condom use and number of sexual partners in the 6 months before and after the intervention. Among participants who reported the highest-risk sexual behavior at baseline, those assigned to PHAT Life were over 4 times more likely than those in the control group to report a reduction in number of sexual partners and more consistent condom use. Of those who reported having had sex before age 12, the PHAT Life participants reported significantly fewer sexual partners after the intervention.

“Uniquely tailored interventions like PHAT Life … are essential to mitigate young offenders’ poor long-term trajectories,” says Geri Donenberg, PhD, study leader.

The next step, the researchers say, is to identify how best to disseminate PHAT Life resources to ensure it’s self-sustaining in the juvenile justice system.

In 2015, young people aged 13- 24 years accounted for > 1 in 5 new HIV diagnoses in the US. Young people aged 15-24 years also account for half of all new sexually transmitted disease infections. Many of those high-risk youth are caught in the juvenile justice system, where they experience more mental illness, substance abuse, and STDs than their peers in the general population.

It is a challenge to identify and implement effective prevention strategies for these young people, but a study at the University of Illinois shows potential. PHAT Life: Preventing HIV/AIDS Among Teens uses role-playing, videos, games, and skill-building exercises to promote knowledge about HIV/AIDS, positive coping, and problem-solving skills.

The study was conducted with 310 urban teens, mostly African American boys, on probation in Chicago’s Cook County, the second-largest county justice system in the US. The participants were assigned to PHAT Life or an equally intensive health information program. Both 2-week programs consisted of 8 90- to 120-minute sessions, delivered at detention-alternative after-school programs.

The study measured the degree of condom use and number of sexual partners in the 6 months before and after the intervention. Among participants who reported the highest-risk sexual behavior at baseline, those assigned to PHAT Life were over 4 times more likely than those in the control group to report a reduction in number of sexual partners and more consistent condom use. Of those who reported having had sex before age 12, the PHAT Life participants reported significantly fewer sexual partners after the intervention.

“Uniquely tailored interventions like PHAT Life … are essential to mitigate young offenders’ poor long-term trajectories,” says Geri Donenberg, PhD, study leader.

The next step, the researchers say, is to identify how best to disseminate PHAT Life resources to ensure it’s self-sustaining in the juvenile justice system.

Image by Difu Wu

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended changes to the marketing authorization for dasatinib (Sprycel).

The CHMP is recommending approval for dasatinib as a treatment for pediatric patients with newly diagnosed, Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP) or Ph+ CML-CP that is resistant or intolerant to prior therapy, including imatinib.

The CHMP has also recommended approval of a new formulation of dasatinib—a powder for oral suspension (PFOS)—for use in pediatric patients.

Dasatinib is already approved in the European Union to treat adults with:

• Newly diagnosed Ph+ CML-CP
• Chronic, accelerated, or blast phase CML with resistance or intolerance to prior therapy, including imatinib
• Ph+ acute lymphoblastic leukemia and lymphoid blast CML with resistance or intolerance to prior therapy.

The CHMP’s opinion on dasatinib for pediatric patients will be reviewed by the European Commission (EC).

If the EC agrees with the CHMP, the commission will grant a centralized marketing authorization that will be valid in the European Union. Norway, Iceland, and Liechtenstein will make corresponding decisions on the basis of the EC’s decision.

The EC typically makes a decision within 67 days of the CHMP’s recommendation.

The CHMP’s opinion on dasatinib for pediatric patients is supported by 2 studies. Results from the phase 1 study (NCT00306202) were published in the Journal of Clinical Oncology in 2013. Phase 2 (NCT00777036) results were published in the same journal this year.

Phase 1

The phase 1 trial included 17 patients with CML-CP, all of whom had received prior imatinib.

Eleven patients received dasatinib at a starting dose of 60 mg/m² once daily, and 6 received the drug at a starting dose of 80 mg/m² once daily. Dose escalation was allowed based on tolerance and response. The median duration of treatment was 24.1 months (range, 2.3 to 50.6 months).

The 60 mg/m² starting dose appeared more tolerable than 80 mg/m² dose.

Drug-related adverse events (AEs) occurring in at least 20% of patients included neutropenia (82.4%), anemia (70.6%), thrombocytopenia (64.7%), nausea (29.4%), headache (35.3%), diarrhea (23.5%), and pain in extremity (23.5%). Grade 3-4 AEs included neutropenia (23.5%), thrombocytopenia (11.8%), and headache (5.9%). There were no drug-related deaths.

Ninety-four percent of patients achieved a complete hematologic response (CHR), 88% had a major cytogenetic response (MCyR), 82% had a complete cytogenetic response (CCyR), 47% had a major molecular response (MMR), and 24% had a complete molecular response (CMR).

Patients who received the lower starting dose of dasatinib had lower rates of cumulative CCyR (72.7% vs 100%) and CHR (90.9% vs 100%) but higher rates of cumulative MMR (54.5% vs 33.3%) and CMR (27.3% vs 16.7).

The median progression-free survival (PFS) and overall survival (OS) had not been reached at last follow-up. At 24 months, the estimated PFS was 61%, and the estimated OS was 88%.

Phase 2

The phase 2 trial included 29 patients with imatinib-resistant/intolerant CML-CP and 84 with newly diagnosed CML-CP.

The previously treated patients received dasatinib tablets. Newly diagnosed patients were treated with dasatinib tablets (n=51) or PFOS (n=33). Patients who started on PFOS could switch to tablets after receiving PFOS for at least 1 year. Sixty-seven percent of patients on PFOS switched to tablets due to patient preference.

The average daily dose of dasatinib was 58.18 mg/m² in the previously treated patients and 59.84 mg/m² in the newly diagnosed patients (for both tablets and PFOS). The median duration of treatment was 49.91 months (range, 1.9 to 90.2) and 42.30 months (range, 0.1 to 75.2), respectively.

Rates of confirmed CHR (at any time) were 93% in the previously treated patients and 96% in the newly diagnosed patients.

At 12 months, previously treated patients had an MMR rate of 41% and a CMR rate of 7%. In newly diagnosed patients, MMR was 52%, and CMR was 8%.

At 24 months, previously treated patients had an MMR rate of 55% and a CMR rate of 17%. In the newly diagnosed patients, MMR was 70%, and CMR was 21%.

The rate of MCyR at any time was 89.7% in all previously treated patients and 90% when the researchers excluded patients with MCyR or unknown cytogenetic status at baseline.

The rate of CCyR at any time was 94% in all newly diagnosed patients and 93.9% when the researchers excluded patients with CCyR or unknown cytogenetic status at baseline.

The median PFS and OS had not been reached at last follow-up. The estimated 48-month PFS was 78% in the previously treated patients and 93% in the newly diagnosed patients. The estimated 48-month OS was 96% and 100%, respectively.

Dasatinib-related AEs occurring in at least 10% of the previously treated patients included nausea/vomiting (31%), myalgia/arthralgia (17%), fatigue (14%), rash (14%), diarrhea (14%), hemorrhage (10%), bone growth and development events (10%), and shortness of breath (10%).

Dasatinib-related AEs occurring in at least 10% of the newly diagnosed patients included nausea/vomiting (20%), myalgia/arthralgia (10%), fatigue (11%), rash (19%), diarrhea (18%), and hemorrhage (10%).

Image by Difu Wu

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended changes to the marketing authorization for dasatinib (Sprycel).

The CHMP is recommending approval for dasatinib as a treatment for pediatric patients with newly diagnosed, Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP) or Ph+ CML-CP that is resistant or intolerant to prior therapy, including imatinib.

The CHMP has also recommended approval of a new formulation of dasatinib—a powder for oral suspension (PFOS)—for use in pediatric patients.

Dasatinib is already approved in the European Union to treat adults with:

• Newly diagnosed Ph+ CML-CP
• Chronic, accelerated, or blast phase CML with resistance or intolerance to prior therapy, including imatinib
• Ph+ acute lymphoblastic leukemia and lymphoid blast CML with resistance or intolerance to prior therapy.

The CHMP’s opinion on dasatinib for pediatric patients will be reviewed by the European Commission (EC).

If the EC agrees with the CHMP, the commission will grant a centralized marketing authorization that will be valid in the European Union. Norway, Iceland, and Liechtenstein will make corresponding decisions on the basis of the EC’s decision.

The EC typically makes a decision within 67 days of the CHMP’s recommendation.

The CHMP’s opinion on dasatinib for pediatric patients is supported by 2 studies. Results from the phase 1 study (NCT00306202) were published in the Journal of Clinical Oncology in 2013. Phase 2 (NCT00777036) results were published in the same journal this year.

Phase 1

The phase 1 trial included 17 patients with CML-CP, all of whom had received prior imatinib.

Eleven patients received dasatinib at a starting dose of 60 mg/m² once daily, and 6 received the drug at a starting dose of 80 mg/m² once daily. Dose escalation was allowed based on tolerance and response. The median duration of treatment was 24.1 months (range, 2.3 to 50.6 months).

The 60 mg/m² starting dose appeared more tolerable than 80 mg/m² dose.

Drug-related adverse events (AEs) occurring in at least 20% of patients included neutropenia (82.4%), anemia (70.6%), thrombocytopenia (64.7%), nausea (29.4%), headache (35.3%), diarrhea (23.5%), and pain in extremity (23.5%). Grade 3-4 AEs included neutropenia (23.5%), thrombocytopenia (11.8%), and headache (5.9%). There were no drug-related deaths.

Ninety-four percent of patients achieved a complete hematologic response (CHR), 88% had a major cytogenetic response (MCyR), 82% had a complete cytogenetic response (CCyR), 47% had a major molecular response (MMR), and 24% had a complete molecular response (CMR).

Patients who received the lower starting dose of dasatinib had lower rates of cumulative CCyR (72.7% vs 100%) and CHR (90.9% vs 100%) but higher rates of cumulative MMR (54.5% vs 33.3%) and CMR (27.3% vs 16.7).

The median progression-free survival (PFS) and overall survival (OS) had not been reached at last follow-up. At 24 months, the estimated PFS was 61%, and the estimated OS was 88%.

Phase 2

The phase 2 trial included 29 patients with imatinib-resistant/intolerant CML-CP and 84 with newly diagnosed CML-CP.

The previously treated patients received dasatinib tablets. Newly diagnosed patients were treated with dasatinib tablets (n=51) or PFOS (n=33). Patients who started on PFOS could switch to tablets after receiving PFOS for at least 1 year. Sixty-seven percent of patients on PFOS switched to tablets due to patient preference.

The average daily dose of dasatinib was 58.18 mg/m² in the previously treated patients and 59.84 mg/m² in the newly diagnosed patients (for both tablets and PFOS). The median duration of treatment was 49.91 months (range, 1.9 to 90.2) and 42.30 months (range, 0.1 to 75.2), respectively.

Rates of confirmed CHR (at any time) were 93% in the previously treated patients and 96% in the newly diagnosed patients.

At 12 months, previously treated patients had an MMR rate of 41% and a CMR rate of 7%. In newly diagnosed patients, MMR was 52%, and CMR was 8%.

At 24 months, previously treated patients had an MMR rate of 55% and a CMR rate of 17%. In the newly diagnosed patients, MMR was 70%, and CMR was 21%.

The rate of MCyR at any time was 89.7% in all previously treated patients and 90% when the researchers excluded patients with MCyR or unknown cytogenetic status at baseline.

The rate of CCyR at any time was 94% in all newly diagnosed patients and 93.9% when the researchers excluded patients with CCyR or unknown cytogenetic status at baseline.

The median PFS and OS had not been reached at last follow-up. The estimated 48-month PFS was 78% in the previously treated patients and 93% in the newly diagnosed patients. The estimated 48-month OS was 96% and 100%, respectively.

Dasatinib-related AEs occurring in at least 10% of the previously treated patients included nausea/vomiting (31%), myalgia/arthralgia (17%), fatigue (14%), rash (14%), diarrhea (14%), hemorrhage (10%), bone growth and development events (10%), and shortness of breath (10%).

Dasatinib-related AEs occurring in at least 10% of the newly diagnosed patients included nausea/vomiting (20%), myalgia/arthralgia (10%), fatigue (11%), rash (19%), diarrhea (18%), and hemorrhage (10%).

Image by Difu Wu

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended changes to the marketing authorization for dasatinib (Sprycel).

The CHMP is recommending approval for dasatinib as a treatment for pediatric patients with newly diagnosed, Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP) or Ph+ CML-CP that is resistant or intolerant to prior therapy, including imatinib.

The CHMP has also recommended approval of a new formulation of dasatinib—a powder for oral suspension (PFOS)—for use in pediatric patients.

Dasatinib is already approved in the European Union to treat adults with:

• Newly diagnosed Ph+ CML-CP
• Chronic, accelerated, or blast phase CML with resistance or intolerance to prior therapy, including imatinib
• Ph+ acute lymphoblastic leukemia and lymphoid blast CML with resistance or intolerance to prior therapy.

The CHMP’s opinion on dasatinib for pediatric patients will be reviewed by the European Commission (EC).

If the EC agrees with the CHMP, the commission will grant a centralized marketing authorization that will be valid in the European Union. Norway, Iceland, and Liechtenstein will make corresponding decisions on the basis of the EC’s decision.

The EC typically makes a decision within 67 days of the CHMP’s recommendation.

The CHMP’s opinion on dasatinib for pediatric patients is supported by 2 studies. Results from the phase 1 study (NCT00306202) were published in the Journal of Clinical Oncology in 2013. Phase 2 (NCT00777036) results were published in the same journal this year.

Phase 1

The phase 1 trial included 17 patients with CML-CP, all of whom had received prior imatinib.

Eleven patients received dasatinib at a starting dose of 60 mg/m² once daily, and 6 received the drug at a starting dose of 80 mg/m² once daily. Dose escalation was allowed based on tolerance and response. The median duration of treatment was 24.1 months (range, 2.3 to 50.6 months).

The 60 mg/m² starting dose appeared more tolerable than 80 mg/m² dose.

Drug-related adverse events (AEs) occurring in at least 20% of patients included neutropenia (82.4%), anemia (70.6%), thrombocytopenia (64.7%), nausea (29.4%), headache (35.3%), diarrhea (23.5%), and pain in extremity (23.5%). Grade 3-4 AEs included neutropenia (23.5%), thrombocytopenia (11.8%), and headache (5.9%). There were no drug-related deaths.

Ninety-four percent of patients achieved a complete hematologic response (CHR), 88% had a major cytogenetic response (MCyR), 82% had a complete cytogenetic response (CCyR), 47% had a major molecular response (MMR), and 24% had a complete molecular response (CMR).

Patients who received the lower starting dose of dasatinib had lower rates of cumulative CCyR (72.7% vs 100%) and CHR (90.9% vs 100%) but higher rates of cumulative MMR (54.5% vs 33.3%) and CMR (27.3% vs 16.7).

The median progression-free survival (PFS) and overall survival (OS) had not been reached at last follow-up. At 24 months, the estimated PFS was 61%, and the estimated OS was 88%.

Phase 2

The phase 2 trial included 29 patients with imatinib-resistant/intolerant CML-CP and 84 with newly diagnosed CML-CP.

The previously treated patients received dasatinib tablets. Newly diagnosed patients were treated with dasatinib tablets (n=51) or PFOS (n=33). Patients who started on PFOS could switch to tablets after receiving PFOS for at least 1 year. Sixty-seven percent of patients on PFOS switched to tablets due to patient preference.

The average daily dose of dasatinib was 58.18 mg/m² in the previously treated patients and 59.84 mg/m² in the newly diagnosed patients (for both tablets and PFOS). The median duration of treatment was 49.91 months (range, 1.9 to 90.2) and 42.30 months (range, 0.1 to 75.2), respectively.

Rates of confirmed CHR (at any time) were 93% in the previously treated patients and 96% in the newly diagnosed patients.

At 12 months, previously treated patients had an MMR rate of 41% and a CMR rate of 7%. In newly diagnosed patients, MMR was 52%, and CMR was 8%.

At 24 months, previously treated patients had an MMR rate of 55% and a CMR rate of 17%. In the newly diagnosed patients, MMR was 70%, and CMR was 21%.

The rate of MCyR at any time was 89.7% in all previously treated patients and 90% when the researchers excluded patients with MCyR or unknown cytogenetic status at baseline.

The rate of CCyR at any time was 94% in all newly diagnosed patients and 93.9% when the researchers excluded patients with CCyR or unknown cytogenetic status at baseline.

The median PFS and OS had not been reached at last follow-up. The estimated 48-month PFS was 78% in the previously treated patients and 93% in the newly diagnosed patients. The estimated 48-month OS was 96% and 100%, respectively.

Dasatinib-related AEs occurring in at least 10% of the previously treated patients included nausea/vomiting (31%), myalgia/arthralgia (17%), fatigue (14%), rash (14%), diarrhea (14%), hemorrhage (10%), bone growth and development events (10%), and shortness of breath (10%).

Dasatinib-related AEs occurring in at least 10% of the newly diagnosed patients included nausea/vomiting (20%), myalgia/arthralgia (10%), fatigue (11%), rash (19%), diarrhea (18%), and hemorrhage (10%).

Clinical question: Are patient perceptions of care during index hospitalization associated with likelihood of 30-day readmission?

Background: Hospital readmissions are costly (more than $40 billion annually) and common. Nearly one readmission in five is thought to be preventable. While many risk-prediction models exist, few incorporate patient perceptions during the index hospitalization or factors associated with patient experience.

Clinical question: Are patient perceptions of care during index hospitalization associated with likelihood of 30-day readmission?

Background: Hospital readmissions are costly (more than $40 billion annually) and common. Nearly one readmission in five is thought to be preventable. While many risk-prediction models exist, few incorporate patient perceptions during the index hospitalization or factors associated with patient experience.

Clinical question: Are patient perceptions of care during index hospitalization associated with likelihood of 30-day readmission?

Background: Hospital readmissions are costly (more than $40 billion annually) and common. Nearly one readmission in five is thought to be preventable. While many risk-prediction models exist, few incorporate patient perceptions during the index hospitalization or factors associated with patient experience.