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Multiple myeloma patients with t(11;14) respond best to venetoclax monotherapy
Phase 1 data on venetoclax monotherapy for relapsed/refractory multiple myeloma, initially presented at the 2016 annual meeting of the American Society of Hematology, have been published in Blood.
Of 66 patients enrolled in the study (NCT01794520), 61% were bortezomib and lenalidomide double refractory, and 46% had t(11;14), said Shaji Kumar, MD, of the Mayo Clinic in Rochester, Minn, and his colleagues.
The overall response rate was 21% (14/66), and 15% achieved very good or better partial responses; 12 of the 14 responses occurred in patients with t(11;14).
(Click here to read the initial report and to view a video of Dr. Kumar discussing the study results at ASH 2016.)
Venetoclax is a selective, orally bioavailable BCL-2 inhibitor that is particularly effective against MM cells harboring t(11;14). Biomarker analysis confirmed that response to venetoclax correlated with higher BCL2:BCL2L1 and BCL2:MCL1 mRNA expression ratios.
The study is sponsored by Abbvie, and Dr. Kumar receives research support from Abbvie.
Phase 1 data on venetoclax monotherapy for relapsed/refractory multiple myeloma, initially presented at the 2016 annual meeting of the American Society of Hematology, have been published in Blood.
Of 66 patients enrolled in the study (NCT01794520), 61% were bortezomib and lenalidomide double refractory, and 46% had t(11;14), said Shaji Kumar, MD, of the Mayo Clinic in Rochester, Minn, and his colleagues.
The overall response rate was 21% (14/66), and 15% achieved very good or better partial responses; 12 of the 14 responses occurred in patients with t(11;14).
(Click here to read the initial report and to view a video of Dr. Kumar discussing the study results at ASH 2016.)
Venetoclax is a selective, orally bioavailable BCL-2 inhibitor that is particularly effective against MM cells harboring t(11;14). Biomarker analysis confirmed that response to venetoclax correlated with higher BCL2:BCL2L1 and BCL2:MCL1 mRNA expression ratios.
The study is sponsored by Abbvie, and Dr. Kumar receives research support from Abbvie.
Phase 1 data on venetoclax monotherapy for relapsed/refractory multiple myeloma, initially presented at the 2016 annual meeting of the American Society of Hematology, have been published in Blood.
Of 66 patients enrolled in the study (NCT01794520), 61% were bortezomib and lenalidomide double refractory, and 46% had t(11;14), said Shaji Kumar, MD, of the Mayo Clinic in Rochester, Minn, and his colleagues.
The overall response rate was 21% (14/66), and 15% achieved very good or better partial responses; 12 of the 14 responses occurred in patients with t(11;14).
(Click here to read the initial report and to view a video of Dr. Kumar discussing the study results at ASH 2016.)
Venetoclax is a selective, orally bioavailable BCL-2 inhibitor that is particularly effective against MM cells harboring t(11;14). Biomarker analysis confirmed that response to venetoclax correlated with higher BCL2:BCL2L1 and BCL2:MCL1 mRNA expression ratios.
The study is sponsored by Abbvie, and Dr. Kumar receives research support from Abbvie.
from blood
Chronic passive exposure to cannabis smoke linked to dependence
Secondhand exposure to cannabis smoke appears linked to signs of cannabis dependence, a researcher said at a Drug Enforcement Agency (DEA) Museum forum on marijuana.
The researcher, Adriaan W. Bruijnzeel, PhD, said at the forum that his team’s work with rats raises the prospect of a link between chronic passive exposure and addiction.
“Immediately after the smoke exposure, you can detect high levels of THC [tetrahydrocannabinol], and then there’s a very quick drop,” Dr. Bruijnzeel, of the department of psychiatry at the University of Florida, Gainesville, said at the Oct. 5 forum at the DEA Museum in Arlington, Va. “Negative mood state associated with the cessation of drug intake helps to maintain the drug addiction.”
In an interview, Mark S. Gold, MD, an expert in addiction who serves as the chair of RiverMend Health’s scientific advisory boards, said Dr. Bruijnzeel’s findings offer lessons for clinicians, particularly for those who treat children.
“Like tobacco smoke, marijuana smoke is an environmental toxin that causes brain changes and addiction,” said Dr. Gold, the 17th Distinguished Alumni Professor at the University of Florida who is also with Washington University in St. Louis. “Second and thirdhand effects of cannabis are important new risks to consider when evaluating the children of marijuana smokers.”
Meanwhile, presenters at the forum, which was webcast, also described marijuana misuse as a threat to general mental health and the adolescent brain, as well as a danger to drivers.
Can preventing cannabis use reduce mental illness? “I think the answer is yes, but the pathway is likely to be fairly complicated and not as straightforward as causation,” said Arpana Agrawal, PhD, a professor of psychiatry at Washington University in St. Louis. “Without a doubt, reduction of cannabis, particularly heavy and persistent use, will likely assist in recovery from psychiatric illness.”
In regard to marijuana’s link to psychosis, in particular, the picture is complex, she said. “There does not appear to be much evidence for a straightforward causal model,” she said. “There’s some evidence of risk in genetically vulnerable individuals, there’s overwhelming support for shared biology; factors other than shared biology are likely to be important. And there’s also some support for increased correlation in the context of high potency use.”
Also, evidence suggests that cannabis is a “reverse gateway” drug among U.S. youth, as well as young people in Australia. “The idea is that youth actually initiate their substance use trajectories with marijuana and then work their way back to nicotine,” Dr. Agrawal said.
A stark warning about marijuana use came from Bertha K. Madras, PhD, professor of psychobiology in the department of psychiatry at Harvard Medical School, Boston; a former deputy director of demand reduction at the Office of National Drug Control Policy; and a member of the President’s Commission on Combating Drug Addiction and the Opioid Crisis, chaired by Gov. Chris Christie (R-N.J.). “We’re not waging a war on drugs,” she said. “We are, in fact, defending our brain, which is the repository of our humanity. And supply reduction, which is what the DEA focuses on to some extent, is a form of prevention. ”
She encouraged adopting a prevention message to discourage all drug use by youth.
Robert L. DuPont, MD, who moderated the forum, said heavy, chronic cannabis users show impairment of psychomotor skills linked to driving for as long as 3 weeks after last use. He also pointed to 2010-2014 data from Washington state that showed increases in the percentages of drivers involved in fatal crashes who tested positive for THC, mainly in addition to alcohol and/or other drugs.
There’s hope that a test will be developed to determine the cannabis tissue level that causes the equivalent impairment as the 0.08 g/dL blood alcohol content standard used to define drunken driving because there is no consistent relationship between THC levels and impairment, said Dr. DuPont, who is the first director of the National Institute on Drug Abuse, the second drug czar, and the president of the Institute for Behavior and Health in Rockville, Md.
Still, several states make driving illegal for drivers with any level of THC and/or THC metabolites, according to the Governors Highway Safety Association. THC can stay in the body for days after marijuana use, while metabolites can remain for weeks, according to the Marijuana Policy Project. An additional 16 states outlaw driving with specific THC levels.
For his part, Dr. DuPont said that, although addressing the opioid epidemic is a top national priority, the legalization of marijuana may be the more enduring threat to the nation’s public health; legalization would make it the third legal drug, joining alcohol and tobacco, which are the two leading causes of illness and death in the country.
“This is the third time in the last 45 years that drugs are front and center” in the United States, Dr. DuPont said. “The first one was heroin addiction related to crime in the early 1970s; the second was the crack epidemic in the late 1980s. In many ways, I think [marijuana is] the more important issue for us.”
Dr. Brijnzeel had no disclosures. Dr. Gold serves as chairman of the scientific advisory boards for RiverMend Health. Dr. Agrawal disclosed NIDA grants. Dr. Madras reported serving on the RiverMend advisory board and working with several organizations, such as the U.S. Department of Justice and the American Bar Association. Dr. DuPont also serves on the RiverMend advisory board.
Secondhand exposure to cannabis smoke appears linked to signs of cannabis dependence, a researcher said at a Drug Enforcement Agency (DEA) Museum forum on marijuana.
The researcher, Adriaan W. Bruijnzeel, PhD, said at the forum that his team’s work with rats raises the prospect of a link between chronic passive exposure and addiction.
“Immediately after the smoke exposure, you can detect high levels of THC [tetrahydrocannabinol], and then there’s a very quick drop,” Dr. Bruijnzeel, of the department of psychiatry at the University of Florida, Gainesville, said at the Oct. 5 forum at the DEA Museum in Arlington, Va. “Negative mood state associated with the cessation of drug intake helps to maintain the drug addiction.”
In an interview, Mark S. Gold, MD, an expert in addiction who serves as the chair of RiverMend Health’s scientific advisory boards, said Dr. Bruijnzeel’s findings offer lessons for clinicians, particularly for those who treat children.
“Like tobacco smoke, marijuana smoke is an environmental toxin that causes brain changes and addiction,” said Dr. Gold, the 17th Distinguished Alumni Professor at the University of Florida who is also with Washington University in St. Louis. “Second and thirdhand effects of cannabis are important new risks to consider when evaluating the children of marijuana smokers.”
Meanwhile, presenters at the forum, which was webcast, also described marijuana misuse as a threat to general mental health and the adolescent brain, as well as a danger to drivers.
Can preventing cannabis use reduce mental illness? “I think the answer is yes, but the pathway is likely to be fairly complicated and not as straightforward as causation,” said Arpana Agrawal, PhD, a professor of psychiatry at Washington University in St. Louis. “Without a doubt, reduction of cannabis, particularly heavy and persistent use, will likely assist in recovery from psychiatric illness.”
In regard to marijuana’s link to psychosis, in particular, the picture is complex, she said. “There does not appear to be much evidence for a straightforward causal model,” she said. “There’s some evidence of risk in genetically vulnerable individuals, there’s overwhelming support for shared biology; factors other than shared biology are likely to be important. And there’s also some support for increased correlation in the context of high potency use.”
Also, evidence suggests that cannabis is a “reverse gateway” drug among U.S. youth, as well as young people in Australia. “The idea is that youth actually initiate their substance use trajectories with marijuana and then work their way back to nicotine,” Dr. Agrawal said.
A stark warning about marijuana use came from Bertha K. Madras, PhD, professor of psychobiology in the department of psychiatry at Harvard Medical School, Boston; a former deputy director of demand reduction at the Office of National Drug Control Policy; and a member of the President’s Commission on Combating Drug Addiction and the Opioid Crisis, chaired by Gov. Chris Christie (R-N.J.). “We’re not waging a war on drugs,” she said. “We are, in fact, defending our brain, which is the repository of our humanity. And supply reduction, which is what the DEA focuses on to some extent, is a form of prevention. ”
She encouraged adopting a prevention message to discourage all drug use by youth.
Robert L. DuPont, MD, who moderated the forum, said heavy, chronic cannabis users show impairment of psychomotor skills linked to driving for as long as 3 weeks after last use. He also pointed to 2010-2014 data from Washington state that showed increases in the percentages of drivers involved in fatal crashes who tested positive for THC, mainly in addition to alcohol and/or other drugs.
There’s hope that a test will be developed to determine the cannabis tissue level that causes the equivalent impairment as the 0.08 g/dL blood alcohol content standard used to define drunken driving because there is no consistent relationship between THC levels and impairment, said Dr. DuPont, who is the first director of the National Institute on Drug Abuse, the second drug czar, and the president of the Institute for Behavior and Health in Rockville, Md.
Still, several states make driving illegal for drivers with any level of THC and/or THC metabolites, according to the Governors Highway Safety Association. THC can stay in the body for days after marijuana use, while metabolites can remain for weeks, according to the Marijuana Policy Project. An additional 16 states outlaw driving with specific THC levels.
For his part, Dr. DuPont said that, although addressing the opioid epidemic is a top national priority, the legalization of marijuana may be the more enduring threat to the nation’s public health; legalization would make it the third legal drug, joining alcohol and tobacco, which are the two leading causes of illness and death in the country.
“This is the third time in the last 45 years that drugs are front and center” in the United States, Dr. DuPont said. “The first one was heroin addiction related to crime in the early 1970s; the second was the crack epidemic in the late 1980s. In many ways, I think [marijuana is] the more important issue for us.”
Dr. Brijnzeel had no disclosures. Dr. Gold serves as chairman of the scientific advisory boards for RiverMend Health. Dr. Agrawal disclosed NIDA grants. Dr. Madras reported serving on the RiverMend advisory board and working with several organizations, such as the U.S. Department of Justice and the American Bar Association. Dr. DuPont also serves on the RiverMend advisory board.
Secondhand exposure to cannabis smoke appears linked to signs of cannabis dependence, a researcher said at a Drug Enforcement Agency (DEA) Museum forum on marijuana.
The researcher, Adriaan W. Bruijnzeel, PhD, said at the forum that his team’s work with rats raises the prospect of a link between chronic passive exposure and addiction.
“Immediately after the smoke exposure, you can detect high levels of THC [tetrahydrocannabinol], and then there’s a very quick drop,” Dr. Bruijnzeel, of the department of psychiatry at the University of Florida, Gainesville, said at the Oct. 5 forum at the DEA Museum in Arlington, Va. “Negative mood state associated with the cessation of drug intake helps to maintain the drug addiction.”
In an interview, Mark S. Gold, MD, an expert in addiction who serves as the chair of RiverMend Health’s scientific advisory boards, said Dr. Bruijnzeel’s findings offer lessons for clinicians, particularly for those who treat children.
“Like tobacco smoke, marijuana smoke is an environmental toxin that causes brain changes and addiction,” said Dr. Gold, the 17th Distinguished Alumni Professor at the University of Florida who is also with Washington University in St. Louis. “Second and thirdhand effects of cannabis are important new risks to consider when evaluating the children of marijuana smokers.”
Meanwhile, presenters at the forum, which was webcast, also described marijuana misuse as a threat to general mental health and the adolescent brain, as well as a danger to drivers.
Can preventing cannabis use reduce mental illness? “I think the answer is yes, but the pathway is likely to be fairly complicated and not as straightforward as causation,” said Arpana Agrawal, PhD, a professor of psychiatry at Washington University in St. Louis. “Without a doubt, reduction of cannabis, particularly heavy and persistent use, will likely assist in recovery from psychiatric illness.”
In regard to marijuana’s link to psychosis, in particular, the picture is complex, she said. “There does not appear to be much evidence for a straightforward causal model,” she said. “There’s some evidence of risk in genetically vulnerable individuals, there’s overwhelming support for shared biology; factors other than shared biology are likely to be important. And there’s also some support for increased correlation in the context of high potency use.”
Also, evidence suggests that cannabis is a “reverse gateway” drug among U.S. youth, as well as young people in Australia. “The idea is that youth actually initiate their substance use trajectories with marijuana and then work their way back to nicotine,” Dr. Agrawal said.
A stark warning about marijuana use came from Bertha K. Madras, PhD, professor of psychobiology in the department of psychiatry at Harvard Medical School, Boston; a former deputy director of demand reduction at the Office of National Drug Control Policy; and a member of the President’s Commission on Combating Drug Addiction and the Opioid Crisis, chaired by Gov. Chris Christie (R-N.J.). “We’re not waging a war on drugs,” she said. “We are, in fact, defending our brain, which is the repository of our humanity. And supply reduction, which is what the DEA focuses on to some extent, is a form of prevention. ”
She encouraged adopting a prevention message to discourage all drug use by youth.
Robert L. DuPont, MD, who moderated the forum, said heavy, chronic cannabis users show impairment of psychomotor skills linked to driving for as long as 3 weeks after last use. He also pointed to 2010-2014 data from Washington state that showed increases in the percentages of drivers involved in fatal crashes who tested positive for THC, mainly in addition to alcohol and/or other drugs.
There’s hope that a test will be developed to determine the cannabis tissue level that causes the equivalent impairment as the 0.08 g/dL blood alcohol content standard used to define drunken driving because there is no consistent relationship between THC levels and impairment, said Dr. DuPont, who is the first director of the National Institute on Drug Abuse, the second drug czar, and the president of the Institute for Behavior and Health in Rockville, Md.
Still, several states make driving illegal for drivers with any level of THC and/or THC metabolites, according to the Governors Highway Safety Association. THC can stay in the body for days after marijuana use, while metabolites can remain for weeks, according to the Marijuana Policy Project. An additional 16 states outlaw driving with specific THC levels.
For his part, Dr. DuPont said that, although addressing the opioid epidemic is a top national priority, the legalization of marijuana may be the more enduring threat to the nation’s public health; legalization would make it the third legal drug, joining alcohol and tobacco, which are the two leading causes of illness and death in the country.
“This is the third time in the last 45 years that drugs are front and center” in the United States, Dr. DuPont said. “The first one was heroin addiction related to crime in the early 1970s; the second was the crack epidemic in the late 1980s. In many ways, I think [marijuana is] the more important issue for us.”
Dr. Brijnzeel had no disclosures. Dr. Gold serves as chairman of the scientific advisory boards for RiverMend Health. Dr. Agrawal disclosed NIDA grants. Dr. Madras reported serving on the RiverMend advisory board and working with several organizations, such as the U.S. Department of Justice and the American Bar Association. Dr. DuPont also serves on the RiverMend advisory board.
Tailored approaches to relapsed/recalcitrant myeloma found within NCCN guidelines
SAN FRANCISCO – The approach to relapsed/refractory multiple myeloma (MM) has to be tailored patient by patient based on the biology of the disease, frailty measures, comorbidities, and prior treatment regimens, Natalie Callander, MD, director of the myeloma clinical program at the University of Wisconsin Carbone Cancer Center, Madison, said at the annual congress on Hematologic Malignancies held by the National Comprehensive Cancer Network.
Despite major treatment breakthroughs in recent years and a wide swath of therapeutic options, multiple myeloma is still an incurable disease that eventually relapses in most patients, Dr. Callander, vice chair of the NCCN Multiple Myeloma Panel, said. “If you are having trouble with your relapsed or refractory patients, you’re not alone.”
As a guide to individualize the treatment approach, the NCCN has put together recommendations for patients with relapsed/recalcitrant MM. “Preferred regimens” include bortezomib-lenalidomide-dexamethasone and other well-established combinations supported by evidence from Phase 1 trials. When relapse occurs more than 6 months after primary induction, one option is simply to repeat the induction therapy.
A long list of “other recommended regimens” includes 21 combination options supported by “very strong Phase 2 data,” she said. The NCCN also has a third list of regimens for the most aggressive disease and certain special circumstances. Two powerful combinations that are used to get the disease under control quickly include high-dose cyclophosphamide or dexamethasone/thalidomide/cisplatin/doxorubicin/cyclophosphamide/etoposide, (DT-PACE) with or without bortezomib.
Dr. Callander underscored the importance of differentiating biochemical relapse, such as increases in serum M protein or other indicators, from clinical relapse, such as new soft tissue plasmacytomas or hypercalcemia.
Patients with clinical relapse typically need a quicker and more vigorous therapeutic response, she said. Studies have found that those in biochemical relapse tend to do better than those in symptomatic relapse.
“This whole concept of biochemical versus symptomatic is really important,” Dr. Callander said.
Among the tips she offered for managing patients with relapse, were to perform a repeat bone marrow biopsy with cytogenetics to gauge the presence of high-risk biology, since this category of patients tends to do far worse and to need a more aggressive treatment approach.
“Getting that kind of information with that follow-up bone marrow biopsy might be very important,” she said.
It’s important to be aware of the phenomenon of “light chain escape,” in which patients with relapsed/refractory disease can stop making intact immunoglobulin G. It’s thought to be due to clonal evolution, in which the clone that was making intact immunoglobulin becomes less dominant. These patients tend to do worse than similar patients who don’t exhibit this phenomenon, Dr. Callander said.
Dr. Callander reported no relevant financial disclosures.
SAN FRANCISCO – The approach to relapsed/refractory multiple myeloma (MM) has to be tailored patient by patient based on the biology of the disease, frailty measures, comorbidities, and prior treatment regimens, Natalie Callander, MD, director of the myeloma clinical program at the University of Wisconsin Carbone Cancer Center, Madison, said at the annual congress on Hematologic Malignancies held by the National Comprehensive Cancer Network.
Despite major treatment breakthroughs in recent years and a wide swath of therapeutic options, multiple myeloma is still an incurable disease that eventually relapses in most patients, Dr. Callander, vice chair of the NCCN Multiple Myeloma Panel, said. “If you are having trouble with your relapsed or refractory patients, you’re not alone.”
As a guide to individualize the treatment approach, the NCCN has put together recommendations for patients with relapsed/recalcitrant MM. “Preferred regimens” include bortezomib-lenalidomide-dexamethasone and other well-established combinations supported by evidence from Phase 1 trials. When relapse occurs more than 6 months after primary induction, one option is simply to repeat the induction therapy.
A long list of “other recommended regimens” includes 21 combination options supported by “very strong Phase 2 data,” she said. The NCCN also has a third list of regimens for the most aggressive disease and certain special circumstances. Two powerful combinations that are used to get the disease under control quickly include high-dose cyclophosphamide or dexamethasone/thalidomide/cisplatin/doxorubicin/cyclophosphamide/etoposide, (DT-PACE) with or without bortezomib.
Dr. Callander underscored the importance of differentiating biochemical relapse, such as increases in serum M protein or other indicators, from clinical relapse, such as new soft tissue plasmacytomas or hypercalcemia.
Patients with clinical relapse typically need a quicker and more vigorous therapeutic response, she said. Studies have found that those in biochemical relapse tend to do better than those in symptomatic relapse.
“This whole concept of biochemical versus symptomatic is really important,” Dr. Callander said.
Among the tips she offered for managing patients with relapse, were to perform a repeat bone marrow biopsy with cytogenetics to gauge the presence of high-risk biology, since this category of patients tends to do far worse and to need a more aggressive treatment approach.
“Getting that kind of information with that follow-up bone marrow biopsy might be very important,” she said.
It’s important to be aware of the phenomenon of “light chain escape,” in which patients with relapsed/refractory disease can stop making intact immunoglobulin G. It’s thought to be due to clonal evolution, in which the clone that was making intact immunoglobulin becomes less dominant. These patients tend to do worse than similar patients who don’t exhibit this phenomenon, Dr. Callander said.
Dr. Callander reported no relevant financial disclosures.
SAN FRANCISCO – The approach to relapsed/refractory multiple myeloma (MM) has to be tailored patient by patient based on the biology of the disease, frailty measures, comorbidities, and prior treatment regimens, Natalie Callander, MD, director of the myeloma clinical program at the University of Wisconsin Carbone Cancer Center, Madison, said at the annual congress on Hematologic Malignancies held by the National Comprehensive Cancer Network.
Despite major treatment breakthroughs in recent years and a wide swath of therapeutic options, multiple myeloma is still an incurable disease that eventually relapses in most patients, Dr. Callander, vice chair of the NCCN Multiple Myeloma Panel, said. “If you are having trouble with your relapsed or refractory patients, you’re not alone.”
As a guide to individualize the treatment approach, the NCCN has put together recommendations for patients with relapsed/recalcitrant MM. “Preferred regimens” include bortezomib-lenalidomide-dexamethasone and other well-established combinations supported by evidence from Phase 1 trials. When relapse occurs more than 6 months after primary induction, one option is simply to repeat the induction therapy.
A long list of “other recommended regimens” includes 21 combination options supported by “very strong Phase 2 data,” she said. The NCCN also has a third list of regimens for the most aggressive disease and certain special circumstances. Two powerful combinations that are used to get the disease under control quickly include high-dose cyclophosphamide or dexamethasone/thalidomide/cisplatin/doxorubicin/cyclophosphamide/etoposide, (DT-PACE) with or without bortezomib.
Dr. Callander underscored the importance of differentiating biochemical relapse, such as increases in serum M protein or other indicators, from clinical relapse, such as new soft tissue plasmacytomas or hypercalcemia.
Patients with clinical relapse typically need a quicker and more vigorous therapeutic response, she said. Studies have found that those in biochemical relapse tend to do better than those in symptomatic relapse.
“This whole concept of biochemical versus symptomatic is really important,” Dr. Callander said.
Among the tips she offered for managing patients with relapse, were to perform a repeat bone marrow biopsy with cytogenetics to gauge the presence of high-risk biology, since this category of patients tends to do far worse and to need a more aggressive treatment approach.
“Getting that kind of information with that follow-up bone marrow biopsy might be very important,” she said.
It’s important to be aware of the phenomenon of “light chain escape,” in which patients with relapsed/refractory disease can stop making intact immunoglobulin G. It’s thought to be due to clonal evolution, in which the clone that was making intact immunoglobulin becomes less dominant. These patients tend to do worse than similar patients who don’t exhibit this phenomenon, Dr. Callander said.
Dr. Callander reported no relevant financial disclosures.
expert analysis AT THE NCCN Hematologic Malignancies Congress
Synbiotic didn’t top placebo for gastrointestinal symptoms in HIV/AIDS
Adding a synbiotic (supplement that contains both pre- and probiotics) to nutritional treatment didn’t significantly beat placebo at reducing gastrointestinal symptoms in patients with HIV/AIDS, a small Brazilian study showed.
The human immunodeficiency virus targets the intestinal immune system, causing gastrointestinal symptoms such as diarrhea, nausea, heartburn, and constipation. Antiretroviral therapy (ART) may exacerbate those symptoms, potentially leading to poor medication adherence and discontinued treatment.
The randomized, double-blind PRECOR-NUT (Treatment With Nutritional Eating Plan and Dietary Fibers in Adult Patients With HIV/AIDS) trial assessed a synbiotic’s ability to reduce gastrointestinal symptoms such as diarrhea and nausea. A total of 64 patients living with HIV/AIDS, taking ART, and experiencing gastrointestinal symptoms were randomized to nutritional treatment paired with either a synbiotic or with placebo. Synbiotic patients took two sachets daily containing fructooligosaccharides, Lactobacillus paracasei, Lactobacillus rhamnosus, Lactobacillus acidophilus, and Bifidobacterium lactis. Both patient groups received nutritional counseling.
Compared with baseline, synbiotic patients saw significant reductions in diarrhea (21.8%), nausea and/or vomiting (28.8%), constipation (13.2%), and dyspepsia (24.5%). Placebo patients saw significant declines from baseline in diarrhea and heartburn (52.8% and 14.8%, respectively).
However, there were no significant differences in symptom reduction between synbiotic and placebo patients for any symptom except heartburn, in which placebo patients experienced a greater decrease.
“Although statistical significance is not observed in some occasions in the present study, the changes in the incidence of gastrointestinal disorders implies substantial benefit for HIV/AIDS patients,” the researchers asserted. The symptom improvements may lead to “better adherence to the pharmacological treatment.”
The Brazilian National Scientific and Technological Development Council and the state of Goias Foundation for Research Support funded the study. SKL Functional Nutrition provided the synbiotic. The study authors had no conflicts of interest.
This story was updated on 10/19/2017.
Adding a synbiotic (supplement that contains both pre- and probiotics) to nutritional treatment didn’t significantly beat placebo at reducing gastrointestinal symptoms in patients with HIV/AIDS, a small Brazilian study showed.
The human immunodeficiency virus targets the intestinal immune system, causing gastrointestinal symptoms such as diarrhea, nausea, heartburn, and constipation. Antiretroviral therapy (ART) may exacerbate those symptoms, potentially leading to poor medication adherence and discontinued treatment.
The randomized, double-blind PRECOR-NUT (Treatment With Nutritional Eating Plan and Dietary Fibers in Adult Patients With HIV/AIDS) trial assessed a synbiotic’s ability to reduce gastrointestinal symptoms such as diarrhea and nausea. A total of 64 patients living with HIV/AIDS, taking ART, and experiencing gastrointestinal symptoms were randomized to nutritional treatment paired with either a synbiotic or with placebo. Synbiotic patients took two sachets daily containing fructooligosaccharides, Lactobacillus paracasei, Lactobacillus rhamnosus, Lactobacillus acidophilus, and Bifidobacterium lactis. Both patient groups received nutritional counseling.
Compared with baseline, synbiotic patients saw significant reductions in diarrhea (21.8%), nausea and/or vomiting (28.8%), constipation (13.2%), and dyspepsia (24.5%). Placebo patients saw significant declines from baseline in diarrhea and heartburn (52.8% and 14.8%, respectively).
However, there were no significant differences in symptom reduction between synbiotic and placebo patients for any symptom except heartburn, in which placebo patients experienced a greater decrease.
“Although statistical significance is not observed in some occasions in the present study, the changes in the incidence of gastrointestinal disorders implies substantial benefit for HIV/AIDS patients,” the researchers asserted. The symptom improvements may lead to “better adherence to the pharmacological treatment.”
The Brazilian National Scientific and Technological Development Council and the state of Goias Foundation for Research Support funded the study. SKL Functional Nutrition provided the synbiotic. The study authors had no conflicts of interest.
This story was updated on 10/19/2017.
Adding a synbiotic (supplement that contains both pre- and probiotics) to nutritional treatment didn’t significantly beat placebo at reducing gastrointestinal symptoms in patients with HIV/AIDS, a small Brazilian study showed.
The human immunodeficiency virus targets the intestinal immune system, causing gastrointestinal symptoms such as diarrhea, nausea, heartburn, and constipation. Antiretroviral therapy (ART) may exacerbate those symptoms, potentially leading to poor medication adherence and discontinued treatment.
The randomized, double-blind PRECOR-NUT (Treatment With Nutritional Eating Plan and Dietary Fibers in Adult Patients With HIV/AIDS) trial assessed a synbiotic’s ability to reduce gastrointestinal symptoms such as diarrhea and nausea. A total of 64 patients living with HIV/AIDS, taking ART, and experiencing gastrointestinal symptoms were randomized to nutritional treatment paired with either a synbiotic or with placebo. Synbiotic patients took two sachets daily containing fructooligosaccharides, Lactobacillus paracasei, Lactobacillus rhamnosus, Lactobacillus acidophilus, and Bifidobacterium lactis. Both patient groups received nutritional counseling.
Compared with baseline, synbiotic patients saw significant reductions in diarrhea (21.8%), nausea and/or vomiting (28.8%), constipation (13.2%), and dyspepsia (24.5%). Placebo patients saw significant declines from baseline in diarrhea and heartburn (52.8% and 14.8%, respectively).
However, there were no significant differences in symptom reduction between synbiotic and placebo patients for any symptom except heartburn, in which placebo patients experienced a greater decrease.
“Although statistical significance is not observed in some occasions in the present study, the changes in the incidence of gastrointestinal disorders implies substantial benefit for HIV/AIDS patients,” the researchers asserted. The symptom improvements may lead to “better adherence to the pharmacological treatment.”
The Brazilian National Scientific and Technological Development Council and the state of Goias Foundation for Research Support funded the study. SKL Functional Nutrition provided the synbiotic. The study authors had no conflicts of interest.
This story was updated on 10/19/2017.
FROM CLINICAL NUTRITION
Key clinical point:
Major finding: Adding a synbiotic to nutritional treatment didn’t significantly beat placebo at reducing gastrointestinal symptoms in patients with HIV/AIDS.
Data source: A randomized, double-blind trial with 64 patients.
Disclosures: The Brazilian National Scientific and Technological Development Council and the state of Goias Foundation for Research Support funded the study. SKL Functional Nutrition provided the synbiotic. The study authors had no conflicts of interest.
Medicare fee schedule: Proposed pay bump falls short of promise
Physicians will likely see a 0.31% uptick in their Medicare payments in 2018 and not the 0.5% promised in the Medicare Access and CHIP Reauthorization Act.
Officials at the Centers for Medicare & Medicaid Services were not able to find adequate funding in so-called misvalued codes to support the larger increase, as required by law, according to the proposed Medicare physician fee schedule for 2018.
Other provisions in the proposed Medicare physician fee schedule may be more palatable than the petite pay raise.
The proposal would roll back data reporting requirements of the Physician Quality Reporting System (PQRS), to better align them with the new Quality Payment Program (QPP), and will waive half of penalties assessed for not meeting PQRS requirements in 2016.
“We are proposing these changes based on stakeholder feedback and to better align with the MIPS [Merit-based Incentive Payment System track of the QPP] data submission requirements for the quality performance category,” according to a CMS fact sheet on the proposed fee schedule.
“This will allow some physicians who attempted to report for the 2016 performance period to avoid penalties and better align PQRS with MIPS as physicians transition to QPP,” officials from the American College of Physicians said in a statement.
Other physician organizations said they believed the proposal did not go far enough.
“While the reductions in penalties represent a move in the right direction, the [American College of Rheumatology] believes CMS should establish a value modifier adjustment of zero for 2018,” ACR officials said in a statement. “This would align with the agency’s policy to ‘zero out’ the impact of the resource use component of the Merit-based Incentive Payment System in 2019, the successor to the value modifier program. This provides additional time to continue refining the cost measures and gives physicians more time to understand the program.”
The proposed fee schedule also would delay implementation of the appropriate use criteria (AUC) for imaging services, a program that would deny payments for imaging services unless the ordering physician consulted the appropriate use criteria.
The American Medical Association “appreciates CMS’ decision to postpone the implementation of this requirement until 2019 and to make the first year an opportunity for testing and education where consultation would not be required as a condition of payment for imaging services,” according to a statement.
“We also applaud the proposed delay in implementing AUC for diagnostic imaging studies,” ACR said in its statement. “We will be gauging the readiness of our members to use clinical support systems. ... We support simplifying and phasing-in the program requirements. The ACR also strongly supports larger exemptions to the program,” such as physicians in small groups and rural and underserved areas.
The proposed fee schedule also seeks feedback from physicians and organizations on how Medicare Part B pays for biosimilars. Under the 2016 fee schedule, the average sales prices (ASPs) for all biosimilar products assigned to the same reference product are included in the same CPT code, meaning the ASPs for all biosimilars of a common reference product are used to determine a single reimbursement rate.
That CMS is looking deeper at this is being seen as a plus.
Biosimilars “tied to the same reference product may not share all indications with one another or the reference product [and] a blended payment model may cause significant confusion in a multitiered biosimilars market that may include both interchangeable and noninterchangeable products,” the Biosimilars Forum said in a statement.
The current situation “may lead to decreased physician confidence in how they are reimbursed and also dramatically reduce the investment in the development of biosimilars and thereby limit treatment options available to patients.”
Both the Biosimilars Forum and the ACR support unique codes for each biosimilar.
“Physicians can better track and monitor their effectiveness and ensure adequate pharmacovigilance in the area of biosimilars” by employing unique codes, according to ACR officials.
“AGA agrees that there should be separate, unique codes for biosimilars; however, we have additional concerns regarding gastroenterological disorders. Specifically, inflammatory bowel disease (IBD) carries unique risks with regard to immunogenicity and currently there is a paucity of clinical data for biosimilars in people with IBD. Real-world use is often the first experience in IBD for these products.”
The fee schedule proposal also would expand the Medicare Diabetes Prevention Program (DPP), currently a demonstration project, taking it nationwide in 2018. The proposal outlines the payment structure and supplier enrollment requirements and compliance standards, as well as beneficiary engagement incentives.
Physicians would be paid based on performance goals being met by patients, including meeting certain numbers of service and maintenance sessions with the program as well as achieving specific weight loss goals. For beneficiaries who are able to lose at least 5% of body weight, physicians could receive up to $810. If that weight loss goal is not achieved, the most a physician could receive is $125, according to a CMS fact sheet. Currently, DPP can be employed only via office visit; however, the proposal would allow virtual make-up sessions.
“The new proposal provides more flexibility to DPP providers in supporting patient engagement and attendance and by making performance-based payments available if patients meet weight-loss targets over longer periods of time,” according to the AMA.
The fee schedule also proposes more telemedicine coverage, specifically for counseling to discuss the need for lung cancer screening, including eligibility determination and shared decision making, as well psychotherapy for crisis, with codes for the first 60 minutes of intervention and a separate code for each additional 30 minutes. Four add-on codes have been proposed to supplement existing codes that cover interactive complexity, chronic care management services, and health risk assessment.
For clinicians providing behavioral health services, CMS is proposing an increased payment for providing face-to-face office-based services that better reflects overhead expenses.
The final rule is expected in early November.
Physicians will likely see a 0.31% uptick in their Medicare payments in 2018 and not the 0.5% promised in the Medicare Access and CHIP Reauthorization Act.
Officials at the Centers for Medicare & Medicaid Services were not able to find adequate funding in so-called misvalued codes to support the larger increase, as required by law, according to the proposed Medicare physician fee schedule for 2018.
Other provisions in the proposed Medicare physician fee schedule may be more palatable than the petite pay raise.
The proposal would roll back data reporting requirements of the Physician Quality Reporting System (PQRS), to better align them with the new Quality Payment Program (QPP), and will waive half of penalties assessed for not meeting PQRS requirements in 2016.
“We are proposing these changes based on stakeholder feedback and to better align with the MIPS [Merit-based Incentive Payment System track of the QPP] data submission requirements for the quality performance category,” according to a CMS fact sheet on the proposed fee schedule.
“This will allow some physicians who attempted to report for the 2016 performance period to avoid penalties and better align PQRS with MIPS as physicians transition to QPP,” officials from the American College of Physicians said in a statement.
Other physician organizations said they believed the proposal did not go far enough.
“While the reductions in penalties represent a move in the right direction, the [American College of Rheumatology] believes CMS should establish a value modifier adjustment of zero for 2018,” ACR officials said in a statement. “This would align with the agency’s policy to ‘zero out’ the impact of the resource use component of the Merit-based Incentive Payment System in 2019, the successor to the value modifier program. This provides additional time to continue refining the cost measures and gives physicians more time to understand the program.”
The proposed fee schedule also would delay implementation of the appropriate use criteria (AUC) for imaging services, a program that would deny payments for imaging services unless the ordering physician consulted the appropriate use criteria.
The American Medical Association “appreciates CMS’ decision to postpone the implementation of this requirement until 2019 and to make the first year an opportunity for testing and education where consultation would not be required as a condition of payment for imaging services,” according to a statement.
“We also applaud the proposed delay in implementing AUC for diagnostic imaging studies,” ACR said in its statement. “We will be gauging the readiness of our members to use clinical support systems. ... We support simplifying and phasing-in the program requirements. The ACR also strongly supports larger exemptions to the program,” such as physicians in small groups and rural and underserved areas.
The proposed fee schedule also seeks feedback from physicians and organizations on how Medicare Part B pays for biosimilars. Under the 2016 fee schedule, the average sales prices (ASPs) for all biosimilar products assigned to the same reference product are included in the same CPT code, meaning the ASPs for all biosimilars of a common reference product are used to determine a single reimbursement rate.
That CMS is looking deeper at this is being seen as a plus.
Biosimilars “tied to the same reference product may not share all indications with one another or the reference product [and] a blended payment model may cause significant confusion in a multitiered biosimilars market that may include both interchangeable and noninterchangeable products,” the Biosimilars Forum said in a statement.
The current situation “may lead to decreased physician confidence in how they are reimbursed and also dramatically reduce the investment in the development of biosimilars and thereby limit treatment options available to patients.”
Both the Biosimilars Forum and the ACR support unique codes for each biosimilar.
“Physicians can better track and monitor their effectiveness and ensure adequate pharmacovigilance in the area of biosimilars” by employing unique codes, according to ACR officials.
“AGA agrees that there should be separate, unique codes for biosimilars; however, we have additional concerns regarding gastroenterological disorders. Specifically, inflammatory bowel disease (IBD) carries unique risks with regard to immunogenicity and currently there is a paucity of clinical data for biosimilars in people with IBD. Real-world use is often the first experience in IBD for these products.”
The fee schedule proposal also would expand the Medicare Diabetes Prevention Program (DPP), currently a demonstration project, taking it nationwide in 2018. The proposal outlines the payment structure and supplier enrollment requirements and compliance standards, as well as beneficiary engagement incentives.
Physicians would be paid based on performance goals being met by patients, including meeting certain numbers of service and maintenance sessions with the program as well as achieving specific weight loss goals. For beneficiaries who are able to lose at least 5% of body weight, physicians could receive up to $810. If that weight loss goal is not achieved, the most a physician could receive is $125, according to a CMS fact sheet. Currently, DPP can be employed only via office visit; however, the proposal would allow virtual make-up sessions.
“The new proposal provides more flexibility to DPP providers in supporting patient engagement and attendance and by making performance-based payments available if patients meet weight-loss targets over longer periods of time,” according to the AMA.
The fee schedule also proposes more telemedicine coverage, specifically for counseling to discuss the need for lung cancer screening, including eligibility determination and shared decision making, as well psychotherapy for crisis, with codes for the first 60 minutes of intervention and a separate code for each additional 30 minutes. Four add-on codes have been proposed to supplement existing codes that cover interactive complexity, chronic care management services, and health risk assessment.
For clinicians providing behavioral health services, CMS is proposing an increased payment for providing face-to-face office-based services that better reflects overhead expenses.
The final rule is expected in early November.
Physicians will likely see a 0.31% uptick in their Medicare payments in 2018 and not the 0.5% promised in the Medicare Access and CHIP Reauthorization Act.
Officials at the Centers for Medicare & Medicaid Services were not able to find adequate funding in so-called misvalued codes to support the larger increase, as required by law, according to the proposed Medicare physician fee schedule for 2018.
Other provisions in the proposed Medicare physician fee schedule may be more palatable than the petite pay raise.
The proposal would roll back data reporting requirements of the Physician Quality Reporting System (PQRS), to better align them with the new Quality Payment Program (QPP), and will waive half of penalties assessed for not meeting PQRS requirements in 2016.
“We are proposing these changes based on stakeholder feedback and to better align with the MIPS [Merit-based Incentive Payment System track of the QPP] data submission requirements for the quality performance category,” according to a CMS fact sheet on the proposed fee schedule.
“This will allow some physicians who attempted to report for the 2016 performance period to avoid penalties and better align PQRS with MIPS as physicians transition to QPP,” officials from the American College of Physicians said in a statement.
Other physician organizations said they believed the proposal did not go far enough.
“While the reductions in penalties represent a move in the right direction, the [American College of Rheumatology] believes CMS should establish a value modifier adjustment of zero for 2018,” ACR officials said in a statement. “This would align with the agency’s policy to ‘zero out’ the impact of the resource use component of the Merit-based Incentive Payment System in 2019, the successor to the value modifier program. This provides additional time to continue refining the cost measures and gives physicians more time to understand the program.”
The proposed fee schedule also would delay implementation of the appropriate use criteria (AUC) for imaging services, a program that would deny payments for imaging services unless the ordering physician consulted the appropriate use criteria.
The American Medical Association “appreciates CMS’ decision to postpone the implementation of this requirement until 2019 and to make the first year an opportunity for testing and education where consultation would not be required as a condition of payment for imaging services,” according to a statement.
“We also applaud the proposed delay in implementing AUC for diagnostic imaging studies,” ACR said in its statement. “We will be gauging the readiness of our members to use clinical support systems. ... We support simplifying and phasing-in the program requirements. The ACR also strongly supports larger exemptions to the program,” such as physicians in small groups and rural and underserved areas.
The proposed fee schedule also seeks feedback from physicians and organizations on how Medicare Part B pays for biosimilars. Under the 2016 fee schedule, the average sales prices (ASPs) for all biosimilar products assigned to the same reference product are included in the same CPT code, meaning the ASPs for all biosimilars of a common reference product are used to determine a single reimbursement rate.
That CMS is looking deeper at this is being seen as a plus.
Biosimilars “tied to the same reference product may not share all indications with one another or the reference product [and] a blended payment model may cause significant confusion in a multitiered biosimilars market that may include both interchangeable and noninterchangeable products,” the Biosimilars Forum said in a statement.
The current situation “may lead to decreased physician confidence in how they are reimbursed and also dramatically reduce the investment in the development of biosimilars and thereby limit treatment options available to patients.”
Both the Biosimilars Forum and the ACR support unique codes for each biosimilar.
“Physicians can better track and monitor their effectiveness and ensure adequate pharmacovigilance in the area of biosimilars” by employing unique codes, according to ACR officials.
“AGA agrees that there should be separate, unique codes for biosimilars; however, we have additional concerns regarding gastroenterological disorders. Specifically, inflammatory bowel disease (IBD) carries unique risks with regard to immunogenicity and currently there is a paucity of clinical data for biosimilars in people with IBD. Real-world use is often the first experience in IBD for these products.”
The fee schedule proposal also would expand the Medicare Diabetes Prevention Program (DPP), currently a demonstration project, taking it nationwide in 2018. The proposal outlines the payment structure and supplier enrollment requirements and compliance standards, as well as beneficiary engagement incentives.
Physicians would be paid based on performance goals being met by patients, including meeting certain numbers of service and maintenance sessions with the program as well as achieving specific weight loss goals. For beneficiaries who are able to lose at least 5% of body weight, physicians could receive up to $810. If that weight loss goal is not achieved, the most a physician could receive is $125, according to a CMS fact sheet. Currently, DPP can be employed only via office visit; however, the proposal would allow virtual make-up sessions.
“The new proposal provides more flexibility to DPP providers in supporting patient engagement and attendance and by making performance-based payments available if patients meet weight-loss targets over longer periods of time,” according to the AMA.
The fee schedule also proposes more telemedicine coverage, specifically for counseling to discuss the need for lung cancer screening, including eligibility determination and shared decision making, as well psychotherapy for crisis, with codes for the first 60 minutes of intervention and a separate code for each additional 30 minutes. Four add-on codes have been proposed to supplement existing codes that cover interactive complexity, chronic care management services, and health risk assessment.
For clinicians providing behavioral health services, CMS is proposing an increased payment for providing face-to-face office-based services that better reflects overhead expenses.
The final rule is expected in early November.
Genital psoriasis is the worst: Patients sound off
GENEVA – The great majority of patients with genital psoriasis say their symptoms in the genital area are worse than elsewhere on the body, Kim A. Meeuwis, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
She presented a qualitative study in which 20 patients with longstanding genital psoriasis sounded off, sharing their perspectives on the disease in one-on-one, semistructured, face-to-face interviews.
Genital psoriasis is common. Epidemiologic studies show 30%-60% of psoriasis patients experience genital involvement at some point in the course of their disease. Yet patients seldom discuss their genital psoriasis with their physicians, and the patient perspective on how the experience of genital psoriasis differs from that of having psoriasis at other locations has been addressed only sparsely in the literature. This lack of attention was the impetus for the current study, she explained.
The 20 participants in the study had an average 18-year history of plaque psoriasis, with an average 7.5-year history of genital involvement. The genital psoriasis was rated moderate or severe in 70% of subjects at the time of the study.
The most commonly reported symptoms of genital psoriasis were itch and discomfort, each of which was cited by all study participants. This was followed by erythema, cited by 95%; stinging and burning, also cited by 95%; pain, cited by 85%; scaling, by 75%; and cracking, by 30%.
Of the patients in the study, 85% reported that their pain and/or discomfort were worse in the genital area than at other sites, and 10% said they were highly self-conscious about their genital psoriasis because others had misidentified them as having a sexually transmitted infection.
Since this was a qualitative study, Dr. Meeuwis provided representative quotes from several patients, including one who asserted, “I really only have discomfort on my psoriasis on the rest of my body ... in my genitals is the only place that actually has pain, or the itching is ... really, really bad.”
Dr. Meeuwis said the study results hold an important lesson for physicians who treat psoriasis: “Due to differences in patient experiences between genital and nongenital skin, it’s really important to make time for the specific evaluation of genital involvement in taking care of patients with psoriasis – and to be sure to ask about it.”
Dr. Meeuwis reported serving as a consultant to Eli Lilly, which sponsored the study, as well as being on an advisory board to Beiersdorf.
GENEVA – The great majority of patients with genital psoriasis say their symptoms in the genital area are worse than elsewhere on the body, Kim A. Meeuwis, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
She presented a qualitative study in which 20 patients with longstanding genital psoriasis sounded off, sharing their perspectives on the disease in one-on-one, semistructured, face-to-face interviews.
Genital psoriasis is common. Epidemiologic studies show 30%-60% of psoriasis patients experience genital involvement at some point in the course of their disease. Yet patients seldom discuss their genital psoriasis with their physicians, and the patient perspective on how the experience of genital psoriasis differs from that of having psoriasis at other locations has been addressed only sparsely in the literature. This lack of attention was the impetus for the current study, she explained.
The 20 participants in the study had an average 18-year history of plaque psoriasis, with an average 7.5-year history of genital involvement. The genital psoriasis was rated moderate or severe in 70% of subjects at the time of the study.
The most commonly reported symptoms of genital psoriasis were itch and discomfort, each of which was cited by all study participants. This was followed by erythema, cited by 95%; stinging and burning, also cited by 95%; pain, cited by 85%; scaling, by 75%; and cracking, by 30%.
Of the patients in the study, 85% reported that their pain and/or discomfort were worse in the genital area than at other sites, and 10% said they were highly self-conscious about their genital psoriasis because others had misidentified them as having a sexually transmitted infection.
Since this was a qualitative study, Dr. Meeuwis provided representative quotes from several patients, including one who asserted, “I really only have discomfort on my psoriasis on the rest of my body ... in my genitals is the only place that actually has pain, or the itching is ... really, really bad.”
Dr. Meeuwis said the study results hold an important lesson for physicians who treat psoriasis: “Due to differences in patient experiences between genital and nongenital skin, it’s really important to make time for the specific evaluation of genital involvement in taking care of patients with psoriasis – and to be sure to ask about it.”
Dr. Meeuwis reported serving as a consultant to Eli Lilly, which sponsored the study, as well as being on an advisory board to Beiersdorf.
GENEVA – The great majority of patients with genital psoriasis say their symptoms in the genital area are worse than elsewhere on the body, Kim A. Meeuwis, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
She presented a qualitative study in which 20 patients with longstanding genital psoriasis sounded off, sharing their perspectives on the disease in one-on-one, semistructured, face-to-face interviews.
Genital psoriasis is common. Epidemiologic studies show 30%-60% of psoriasis patients experience genital involvement at some point in the course of their disease. Yet patients seldom discuss their genital psoriasis with their physicians, and the patient perspective on how the experience of genital psoriasis differs from that of having psoriasis at other locations has been addressed only sparsely in the literature. This lack of attention was the impetus for the current study, she explained.
The 20 participants in the study had an average 18-year history of plaque psoriasis, with an average 7.5-year history of genital involvement. The genital psoriasis was rated moderate or severe in 70% of subjects at the time of the study.
The most commonly reported symptoms of genital psoriasis were itch and discomfort, each of which was cited by all study participants. This was followed by erythema, cited by 95%; stinging and burning, also cited by 95%; pain, cited by 85%; scaling, by 75%; and cracking, by 30%.
Of the patients in the study, 85% reported that their pain and/or discomfort were worse in the genital area than at other sites, and 10% said they were highly self-conscious about their genital psoriasis because others had misidentified them as having a sexually transmitted infection.
Since this was a qualitative study, Dr. Meeuwis provided representative quotes from several patients, including one who asserted, “I really only have discomfort on my psoriasis on the rest of my body ... in my genitals is the only place that actually has pain, or the itching is ... really, really bad.”
Dr. Meeuwis said the study results hold an important lesson for physicians who treat psoriasis: “Due to differences in patient experiences between genital and nongenital skin, it’s really important to make time for the specific evaluation of genital involvement in taking care of patients with psoriasis – and to be sure to ask about it.”
Dr. Meeuwis reported serving as a consultant to Eli Lilly, which sponsored the study, as well as being on an advisory board to Beiersdorf.
AT THE EADV CONGRESS
Key clinical point:
Major finding: Of the participants in a study of genital psoriasis, 100% reported that a hallmark of their genital disease was itching and discomfort.
Data source: A qualitative study that involved one-on-one interviews with 20 patients with genital psoriasis, who shared their experiences as to how genital involvement differs from their psoriasis elsewhere.
Disclosures: The study was sponsored by Eli Lilly. The presenter reported serving as a consultant to the company.
Advance care planning benefit presents challenges
When Donna Sweet, MD, sees patients for routine exams, death and dying are often the furthest thing from their minds. Regardless of age or health status, however, Dr. Sweet regularly asks patients about end-of-life care and whether they’ve considered their options.
In the past, physicians had to be creative in how they coded for such conversations, but Medicare’s newish advance care planning benefit is changing that.
Staring in 2016, the Centers for Medicare & Medicaid Services began reimbursing physicians for advance care planning discussions with the approval of two new codes: 99497 and 99498. The codes pay about $86 for the first 30-minutes of a face-to-face conversation with a patient, family member, and/or surrogate and about $75 for additional sessions. Services can be furnished in both inpatient and ambulatory settings, and payment is not limited to particular physician specialties.
Dr. Sweet said that she uses these codes a couple times a week when patients visit for reasons such as routine hypertension or diabetes exams or annual Medicare wellness visits. To broach the subject, Dr. Sweet said it helps to have literature about advance care planning in the room that patients can review.
“It’s just a matter of bringing it up,” she said. “Considering some of the other codes, the advance care planning code is really pretty simple.”
However, doctors like Dr. Sweet appear to be in the minority when it comes to providing this service. Of the nearly 57 million beneficiaries enrolled in Medicare at the end of 2016, only about 1% received advance care planning sessions, according to analysis of Medicare data posted by Kaiser Health News. Nationwide, health providers submitted about $93 million in charges, of which $43 million was paid by Medicare.
Challenges deter conversations
During a recent visit with a 72-year-old cancer patient, Bridget Fahy, MD, a surgical oncologist at the University of New Mexico, Albuquerque, spent time discussing advance directives and the importance of naming a surrogate decision maker. Dr. Fahy had treated the patient for two different cancers over the course of 4 years, and he was now diagnosed with a third, she recalled during an interview. Figuring out an advance care plan, though, proved complicated: The man was not married, had no children, and had no family members who lived in the state.
Although Dr. Fahy was aware of the Medicare advance care planning codes, she did not bill the session as such.
“Even in the course of having that conversation, I’m more apt to bill on time than I am specifically to meet the Medicare requirements for the documentation for [the benefit],” she said.
“There are two pieces required to take advantage of the advance care planning benefit code: having the conversation and documenting it,” Dr. Fahy noted. “What I write at the end of a resident note or an advanced practice provider note is going to be more focused on the counseling I had with the patient about their condition, the evaluation, and what the treatment plan is going to be. For surgeons to utilize the advance care planning codes, they have to have knowledge of the code, which many do not; they must know the requirements for documenting the conversation; and they have to have the time needed to have the conversation while also addressing all of the surgery-specific issues that need to be covered during the visit. There are a number of hurdles to overcome.”
Danielle B. Scheurer, MD, a hospitalist and chief quality officer at the Medical University of South Carolina, Charleston, said that she, too, has not used advance care planning codes. The reimbursement tool is a positive step forward, she said, but so far, it’s not an easy insert into a hospitalist’s practice.
“It’s not top of mind as far as a billing practice,” she said. “It’s not built into the typical work flow. Obviously, it’s not every patient, it’s not everyday, so you have to remember to put it into your work flow. That’s probably the biggest barrier for most hospitalists: either not knowing about it at all or not yet figuring out how to weave it into what they already do.”
Overcoming hurdles through experience
Using the advance care planning benefit has been easier said than done in his practice, according to Carl R. Olden, MD, a family physician in Yakima, Wash. The logistics of scheduling and patient reluctance are contributing to low usage of the new codes, said Dr. Olden, a member of the American Academy of Family Physicians board of directors.
Between Sept. 1, 2016, and Aug. 31, 2017, the family medicine, primary care, internal medicine, and pulmonary medicine members of Dr. Olden’s network who provide end-of-life counseling submitted billing for a total of 106,160 Medicare visits. Of those visits, the 99497 code was submitted only 32 times, according to data provided by Dr. Olden.
At Dr. Olden’s 16-physician practice, there are no registered nurses to help set up and start Medicare wellness visits, which the advance care planning session benefit is designed to fit within, he said.
“Most of those Medicare wellness visits are driven by having a registered nurse do most of the work,” he said. “[For us] to schedule a wellness visit, it’s mostly physician work and to do a 30-minute wellness visit, most of us can see three patients in that 30-minute slot, so it ends up not being very cost effective.”
“Most of my Medicare patients are folks that have four to five chronic medical conditions, and for them to make a 30-minute visit to the office and not talk about any of those conditions but to talk about home safety and advance directives and fall prevention, it’s hard for them to understand that,” he said.
Dr. Newman stresses that while the billing approach takes time to learn, the codes can be weaved into regular practice with some preparation and planning. At her practice, she primarily uses the codes for patients with challenging changes in their health status, sometimes setting up meetings in advance and, other times, conducting a spur-of-the-moment conversation.
“It’s a wonderful benefit,” she said. “I’m not surprised it’s taking awhile to take hold. The reason is you have to prepare for these visits. It takes preparation, including a chart review.”
A common misconception is that the visit must be scheduled separately and cannot be added to another visit, she said. Doctors can bill the advance care planning codes on the same day as an evaluation and management service. For instance, if a patient is accompanied by a family member and seen for routine follow-up, the physician can discuss the medical conditions first and later have a discussion about advance care planning. When billing, the physician can then use an evaluation and management code for the part of the visit related to the patient’s medical conditions and also bill for the advance care planning discussion using the new Medicare codes, Dr. Newman said.
“You’re allowed to use a modifier to attach to it to get paid for both on the same day,” she said. She suggested checking local Medicare policy for the use of the appropriate modifier, usually 26. “One thing that’s important to understand is there’s a lot of short discussions about advanced care planning that doesn’t fit the code. So if a patient wants to have a 5-minute conversation – that happens a lot – these will not be billable or counted under this new benefit. Fifteen minutes is the least amount of time that qualifies for 99497.”
Dr. Sweet said that she expects greater use of the codes as more doctors become aware of how they can be used.
“Once people use it a time or two, they will use it a lot more,” Dr. Sweet said. “It takes time to change, and it takes time to make time to do the things we need to do. But especially, as we move into high-value care, something like this hopefully, [doctors] will embrace.”
agallegos@frontlinemedcom.com
On Twitter @legal_med
When Donna Sweet, MD, sees patients for routine exams, death and dying are often the furthest thing from their minds. Regardless of age or health status, however, Dr. Sweet regularly asks patients about end-of-life care and whether they’ve considered their options.
In the past, physicians had to be creative in how they coded for such conversations, but Medicare’s newish advance care planning benefit is changing that.
Staring in 2016, the Centers for Medicare & Medicaid Services began reimbursing physicians for advance care planning discussions with the approval of two new codes: 99497 and 99498. The codes pay about $86 for the first 30-minutes of a face-to-face conversation with a patient, family member, and/or surrogate and about $75 for additional sessions. Services can be furnished in both inpatient and ambulatory settings, and payment is not limited to particular physician specialties.
Dr. Sweet said that she uses these codes a couple times a week when patients visit for reasons such as routine hypertension or diabetes exams or annual Medicare wellness visits. To broach the subject, Dr. Sweet said it helps to have literature about advance care planning in the room that patients can review.
“It’s just a matter of bringing it up,” she said. “Considering some of the other codes, the advance care planning code is really pretty simple.”
However, doctors like Dr. Sweet appear to be in the minority when it comes to providing this service. Of the nearly 57 million beneficiaries enrolled in Medicare at the end of 2016, only about 1% received advance care planning sessions, according to analysis of Medicare data posted by Kaiser Health News. Nationwide, health providers submitted about $93 million in charges, of which $43 million was paid by Medicare.
Challenges deter conversations
During a recent visit with a 72-year-old cancer patient, Bridget Fahy, MD, a surgical oncologist at the University of New Mexico, Albuquerque, spent time discussing advance directives and the importance of naming a surrogate decision maker. Dr. Fahy had treated the patient for two different cancers over the course of 4 years, and he was now diagnosed with a third, she recalled during an interview. Figuring out an advance care plan, though, proved complicated: The man was not married, had no children, and had no family members who lived in the state.
Although Dr. Fahy was aware of the Medicare advance care planning codes, she did not bill the session as such.
“Even in the course of having that conversation, I’m more apt to bill on time than I am specifically to meet the Medicare requirements for the documentation for [the benefit],” she said.
“There are two pieces required to take advantage of the advance care planning benefit code: having the conversation and documenting it,” Dr. Fahy noted. “What I write at the end of a resident note or an advanced practice provider note is going to be more focused on the counseling I had with the patient about their condition, the evaluation, and what the treatment plan is going to be. For surgeons to utilize the advance care planning codes, they have to have knowledge of the code, which many do not; they must know the requirements for documenting the conversation; and they have to have the time needed to have the conversation while also addressing all of the surgery-specific issues that need to be covered during the visit. There are a number of hurdles to overcome.”
Danielle B. Scheurer, MD, a hospitalist and chief quality officer at the Medical University of South Carolina, Charleston, said that she, too, has not used advance care planning codes. The reimbursement tool is a positive step forward, she said, but so far, it’s not an easy insert into a hospitalist’s practice.
“It’s not top of mind as far as a billing practice,” she said. “It’s not built into the typical work flow. Obviously, it’s not every patient, it’s not everyday, so you have to remember to put it into your work flow. That’s probably the biggest barrier for most hospitalists: either not knowing about it at all or not yet figuring out how to weave it into what they already do.”
Overcoming hurdles through experience
Using the advance care planning benefit has been easier said than done in his practice, according to Carl R. Olden, MD, a family physician in Yakima, Wash. The logistics of scheduling and patient reluctance are contributing to low usage of the new codes, said Dr. Olden, a member of the American Academy of Family Physicians board of directors.
Between Sept. 1, 2016, and Aug. 31, 2017, the family medicine, primary care, internal medicine, and pulmonary medicine members of Dr. Olden’s network who provide end-of-life counseling submitted billing for a total of 106,160 Medicare visits. Of those visits, the 99497 code was submitted only 32 times, according to data provided by Dr. Olden.
At Dr. Olden’s 16-physician practice, there are no registered nurses to help set up and start Medicare wellness visits, which the advance care planning session benefit is designed to fit within, he said.
“Most of those Medicare wellness visits are driven by having a registered nurse do most of the work,” he said. “[For us] to schedule a wellness visit, it’s mostly physician work and to do a 30-minute wellness visit, most of us can see three patients in that 30-minute slot, so it ends up not being very cost effective.”
“Most of my Medicare patients are folks that have four to five chronic medical conditions, and for them to make a 30-minute visit to the office and not talk about any of those conditions but to talk about home safety and advance directives and fall prevention, it’s hard for them to understand that,” he said.
Dr. Newman stresses that while the billing approach takes time to learn, the codes can be weaved into regular practice with some preparation and planning. At her practice, she primarily uses the codes for patients with challenging changes in their health status, sometimes setting up meetings in advance and, other times, conducting a spur-of-the-moment conversation.
“It’s a wonderful benefit,” she said. “I’m not surprised it’s taking awhile to take hold. The reason is you have to prepare for these visits. It takes preparation, including a chart review.”
A common misconception is that the visit must be scheduled separately and cannot be added to another visit, she said. Doctors can bill the advance care planning codes on the same day as an evaluation and management service. For instance, if a patient is accompanied by a family member and seen for routine follow-up, the physician can discuss the medical conditions first and later have a discussion about advance care planning. When billing, the physician can then use an evaluation and management code for the part of the visit related to the patient’s medical conditions and also bill for the advance care planning discussion using the new Medicare codes, Dr. Newman said.
“You’re allowed to use a modifier to attach to it to get paid for both on the same day,” she said. She suggested checking local Medicare policy for the use of the appropriate modifier, usually 26. “One thing that’s important to understand is there’s a lot of short discussions about advanced care planning that doesn’t fit the code. So if a patient wants to have a 5-minute conversation – that happens a lot – these will not be billable or counted under this new benefit. Fifteen minutes is the least amount of time that qualifies for 99497.”
Dr. Sweet said that she expects greater use of the codes as more doctors become aware of how they can be used.
“Once people use it a time or two, they will use it a lot more,” Dr. Sweet said. “It takes time to change, and it takes time to make time to do the things we need to do. But especially, as we move into high-value care, something like this hopefully, [doctors] will embrace.”
agallegos@frontlinemedcom.com
On Twitter @legal_med
When Donna Sweet, MD, sees patients for routine exams, death and dying are often the furthest thing from their minds. Regardless of age or health status, however, Dr. Sweet regularly asks patients about end-of-life care and whether they’ve considered their options.
In the past, physicians had to be creative in how they coded for such conversations, but Medicare’s newish advance care planning benefit is changing that.
Staring in 2016, the Centers for Medicare & Medicaid Services began reimbursing physicians for advance care planning discussions with the approval of two new codes: 99497 and 99498. The codes pay about $86 for the first 30-minutes of a face-to-face conversation with a patient, family member, and/or surrogate and about $75 for additional sessions. Services can be furnished in both inpatient and ambulatory settings, and payment is not limited to particular physician specialties.
Dr. Sweet said that she uses these codes a couple times a week when patients visit for reasons such as routine hypertension or diabetes exams or annual Medicare wellness visits. To broach the subject, Dr. Sweet said it helps to have literature about advance care planning in the room that patients can review.
“It’s just a matter of bringing it up,” she said. “Considering some of the other codes, the advance care planning code is really pretty simple.”
However, doctors like Dr. Sweet appear to be in the minority when it comes to providing this service. Of the nearly 57 million beneficiaries enrolled in Medicare at the end of 2016, only about 1% received advance care planning sessions, according to analysis of Medicare data posted by Kaiser Health News. Nationwide, health providers submitted about $93 million in charges, of which $43 million was paid by Medicare.
Challenges deter conversations
During a recent visit with a 72-year-old cancer patient, Bridget Fahy, MD, a surgical oncologist at the University of New Mexico, Albuquerque, spent time discussing advance directives and the importance of naming a surrogate decision maker. Dr. Fahy had treated the patient for two different cancers over the course of 4 years, and he was now diagnosed with a third, she recalled during an interview. Figuring out an advance care plan, though, proved complicated: The man was not married, had no children, and had no family members who lived in the state.
Although Dr. Fahy was aware of the Medicare advance care planning codes, she did not bill the session as such.
“Even in the course of having that conversation, I’m more apt to bill on time than I am specifically to meet the Medicare requirements for the documentation for [the benefit],” she said.
“There are two pieces required to take advantage of the advance care planning benefit code: having the conversation and documenting it,” Dr. Fahy noted. “What I write at the end of a resident note or an advanced practice provider note is going to be more focused on the counseling I had with the patient about their condition, the evaluation, and what the treatment plan is going to be. For surgeons to utilize the advance care planning codes, they have to have knowledge of the code, which many do not; they must know the requirements for documenting the conversation; and they have to have the time needed to have the conversation while also addressing all of the surgery-specific issues that need to be covered during the visit. There are a number of hurdles to overcome.”
Danielle B. Scheurer, MD, a hospitalist and chief quality officer at the Medical University of South Carolina, Charleston, said that she, too, has not used advance care planning codes. The reimbursement tool is a positive step forward, she said, but so far, it’s not an easy insert into a hospitalist’s practice.
“It’s not top of mind as far as a billing practice,” she said. “It’s not built into the typical work flow. Obviously, it’s not every patient, it’s not everyday, so you have to remember to put it into your work flow. That’s probably the biggest barrier for most hospitalists: either not knowing about it at all or not yet figuring out how to weave it into what they already do.”
Overcoming hurdles through experience
Using the advance care planning benefit has been easier said than done in his practice, according to Carl R. Olden, MD, a family physician in Yakima, Wash. The logistics of scheduling and patient reluctance are contributing to low usage of the new codes, said Dr. Olden, a member of the American Academy of Family Physicians board of directors.
Between Sept. 1, 2016, and Aug. 31, 2017, the family medicine, primary care, internal medicine, and pulmonary medicine members of Dr. Olden’s network who provide end-of-life counseling submitted billing for a total of 106,160 Medicare visits. Of those visits, the 99497 code was submitted only 32 times, according to data provided by Dr. Olden.
At Dr. Olden’s 16-physician practice, there are no registered nurses to help set up and start Medicare wellness visits, which the advance care planning session benefit is designed to fit within, he said.
“Most of those Medicare wellness visits are driven by having a registered nurse do most of the work,” he said. “[For us] to schedule a wellness visit, it’s mostly physician work and to do a 30-minute wellness visit, most of us can see three patients in that 30-minute slot, so it ends up not being very cost effective.”
“Most of my Medicare patients are folks that have four to five chronic medical conditions, and for them to make a 30-minute visit to the office and not talk about any of those conditions but to talk about home safety and advance directives and fall prevention, it’s hard for them to understand that,” he said.
Dr. Newman stresses that while the billing approach takes time to learn, the codes can be weaved into regular practice with some preparation and planning. At her practice, she primarily uses the codes for patients with challenging changes in their health status, sometimes setting up meetings in advance and, other times, conducting a spur-of-the-moment conversation.
“It’s a wonderful benefit,” she said. “I’m not surprised it’s taking awhile to take hold. The reason is you have to prepare for these visits. It takes preparation, including a chart review.”
A common misconception is that the visit must be scheduled separately and cannot be added to another visit, she said. Doctors can bill the advance care planning codes on the same day as an evaluation and management service. For instance, if a patient is accompanied by a family member and seen for routine follow-up, the physician can discuss the medical conditions first and later have a discussion about advance care planning. When billing, the physician can then use an evaluation and management code for the part of the visit related to the patient’s medical conditions and also bill for the advance care planning discussion using the new Medicare codes, Dr. Newman said.
“You’re allowed to use a modifier to attach to it to get paid for both on the same day,” she said. She suggested checking local Medicare policy for the use of the appropriate modifier, usually 26. “One thing that’s important to understand is there’s a lot of short discussions about advanced care planning that doesn’t fit the code. So if a patient wants to have a 5-minute conversation – that happens a lot – these will not be billable or counted under this new benefit. Fifteen minutes is the least amount of time that qualifies for 99497.”
Dr. Sweet said that she expects greater use of the codes as more doctors become aware of how they can be used.
“Once people use it a time or two, they will use it a lot more,” Dr. Sweet said. “It takes time to change, and it takes time to make time to do the things we need to do. But especially, as we move into high-value care, something like this hopefully, [doctors] will embrace.”
agallegos@frontlinemedcom.com
On Twitter @legal_med
Ixekizumab has profound impact on genital psoriasis
GENEVA – The interleukin-17A inhibitor ixekizumab provided rapid clearance of genital psoriasis in a phase 3b clinical trial, with significant improvement seen as early as week 1, Caitriona Ryan, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
The highly targeted monoclonal antibody also improved the intense itching that’s a particularly prominent feature of genital psoriasis.
“Genital psoriasis is a hidden part of psoriasis. Unfortunately, as dermatologists we do a bad job of evaluating our patients for it. They are ashamed and embarrassed to bring up the topic with their dermatologists. Hopefully, this study will create some awareness around the topic,” she said.
This was the first-ever randomized trial to evaluate the effect of a biologic agent specifically on genital psoriasis. It was also the first study of a biologic in psoriasis patients with less than 10% body surface area involved.
“That’s a very important thing,” according to the dermatologist. “There are lots of patients with genital psoriasis who have less than 10% body surface area involved and therefore don’t qualify for biologic therapy, even though their genital psoriasis can be incredibly debilitating.”
The 12-week, multicenter, double-blind trial included 149 patients with a baseline static Physician’s Global Assessment of Genitalia (sPGA-G) score of at least 3 on a 0-5 scale. All participants had failed to respond to at least one topical therapy for their genital psoriasis, such as a corticosteroid, a calcineurin inhibitor, or a vitamin D analog. The subjects averaged a 16-year history of psoriasis and a 9-year history of genital psoriasis. Thirty-eight percent of participants had an involved body surface area of at least 1% but less than 10%.
Patients were randomized to ixekizumab (Taltz) given in the usual way – a subcutaneous loading dose of 160 mg, followed by repeat 80-mg injections every 2 weeks – or placebo.
The primary study endpoint was achievement of an sPGA-G score of 0 or 1, meaning clear or almost clear, as assessed by blinded investigators. At the 12-week mark, the rate was 73% in the ixekizumab group and 8% in controls. The sPGA-G score already differed significantly between the two study arms at the first assessment, after 1 week. The treatment success rate was closely similar in patients with or without at least 10% total body surface area involved.
A key secondary endpoint concerned sexual health. Among patients who at baseline indicated that in the past week, their genital psoriasis “sometimes,” “often,” or “always” limited the frequency of their sexual activity, at week 12, 78% of those in the ixekizumab group answered the same question on the Sexual Frequency Questionnaire “never” or “rarely,” compared with 21% of controls.
“This is huge. It’s such an important part of our patients’ lives, and there was a big difference by week 1,” Dr. Ryan noted.
On another secondary endpoint, 60% of the ixekizumab group reported at least a 3-point improvement in the 0-10 Genital Itch Numeric Rating Scale at week 12, compared with 8% of controls, with a statistically significant difference apparent at week 2.
“Itch is the most frequently reported symptom in our patients with genital psoriasis, and it seems to be much more impactful than itch from psoriasis elsewhere,” Dr. Ryan commented.
The side effect profile of ixekizumab was the same as has been seen in larger, longer-term studies. There were no serious ixekizumab-related adverse events, and no cases of candidiasis.
The study was sponsored by Eli Lilly. Dr. Ryan reported serving as an advisory board member to and/or receiving honoraria from that company and more than half a dozen other pharmaceutical companies.
GENEVA – The interleukin-17A inhibitor ixekizumab provided rapid clearance of genital psoriasis in a phase 3b clinical trial, with significant improvement seen as early as week 1, Caitriona Ryan, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
The highly targeted monoclonal antibody also improved the intense itching that’s a particularly prominent feature of genital psoriasis.
“Genital psoriasis is a hidden part of psoriasis. Unfortunately, as dermatologists we do a bad job of evaluating our patients for it. They are ashamed and embarrassed to bring up the topic with their dermatologists. Hopefully, this study will create some awareness around the topic,” she said.
This was the first-ever randomized trial to evaluate the effect of a biologic agent specifically on genital psoriasis. It was also the first study of a biologic in psoriasis patients with less than 10% body surface area involved.
“That’s a very important thing,” according to the dermatologist. “There are lots of patients with genital psoriasis who have less than 10% body surface area involved and therefore don’t qualify for biologic therapy, even though their genital psoriasis can be incredibly debilitating.”
The 12-week, multicenter, double-blind trial included 149 patients with a baseline static Physician’s Global Assessment of Genitalia (sPGA-G) score of at least 3 on a 0-5 scale. All participants had failed to respond to at least one topical therapy for their genital psoriasis, such as a corticosteroid, a calcineurin inhibitor, or a vitamin D analog. The subjects averaged a 16-year history of psoriasis and a 9-year history of genital psoriasis. Thirty-eight percent of participants had an involved body surface area of at least 1% but less than 10%.
Patients were randomized to ixekizumab (Taltz) given in the usual way – a subcutaneous loading dose of 160 mg, followed by repeat 80-mg injections every 2 weeks – or placebo.
The primary study endpoint was achievement of an sPGA-G score of 0 or 1, meaning clear or almost clear, as assessed by blinded investigators. At the 12-week mark, the rate was 73% in the ixekizumab group and 8% in controls. The sPGA-G score already differed significantly between the two study arms at the first assessment, after 1 week. The treatment success rate was closely similar in patients with or without at least 10% total body surface area involved.
A key secondary endpoint concerned sexual health. Among patients who at baseline indicated that in the past week, their genital psoriasis “sometimes,” “often,” or “always” limited the frequency of their sexual activity, at week 12, 78% of those in the ixekizumab group answered the same question on the Sexual Frequency Questionnaire “never” or “rarely,” compared with 21% of controls.
“This is huge. It’s such an important part of our patients’ lives, and there was a big difference by week 1,” Dr. Ryan noted.
On another secondary endpoint, 60% of the ixekizumab group reported at least a 3-point improvement in the 0-10 Genital Itch Numeric Rating Scale at week 12, compared with 8% of controls, with a statistically significant difference apparent at week 2.
“Itch is the most frequently reported symptom in our patients with genital psoriasis, and it seems to be much more impactful than itch from psoriasis elsewhere,” Dr. Ryan commented.
The side effect profile of ixekizumab was the same as has been seen in larger, longer-term studies. There were no serious ixekizumab-related adverse events, and no cases of candidiasis.
The study was sponsored by Eli Lilly. Dr. Ryan reported serving as an advisory board member to and/or receiving honoraria from that company and more than half a dozen other pharmaceutical companies.
GENEVA – The interleukin-17A inhibitor ixekizumab provided rapid clearance of genital psoriasis in a phase 3b clinical trial, with significant improvement seen as early as week 1, Caitriona Ryan, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
The highly targeted monoclonal antibody also improved the intense itching that’s a particularly prominent feature of genital psoriasis.
“Genital psoriasis is a hidden part of psoriasis. Unfortunately, as dermatologists we do a bad job of evaluating our patients for it. They are ashamed and embarrassed to bring up the topic with their dermatologists. Hopefully, this study will create some awareness around the topic,” she said.
This was the first-ever randomized trial to evaluate the effect of a biologic agent specifically on genital psoriasis. It was also the first study of a biologic in psoriasis patients with less than 10% body surface area involved.
“That’s a very important thing,” according to the dermatologist. “There are lots of patients with genital psoriasis who have less than 10% body surface area involved and therefore don’t qualify for biologic therapy, even though their genital psoriasis can be incredibly debilitating.”
The 12-week, multicenter, double-blind trial included 149 patients with a baseline static Physician’s Global Assessment of Genitalia (sPGA-G) score of at least 3 on a 0-5 scale. All participants had failed to respond to at least one topical therapy for their genital psoriasis, such as a corticosteroid, a calcineurin inhibitor, or a vitamin D analog. The subjects averaged a 16-year history of psoriasis and a 9-year history of genital psoriasis. Thirty-eight percent of participants had an involved body surface area of at least 1% but less than 10%.
Patients were randomized to ixekizumab (Taltz) given in the usual way – a subcutaneous loading dose of 160 mg, followed by repeat 80-mg injections every 2 weeks – or placebo.
The primary study endpoint was achievement of an sPGA-G score of 0 or 1, meaning clear or almost clear, as assessed by blinded investigators. At the 12-week mark, the rate was 73% in the ixekizumab group and 8% in controls. The sPGA-G score already differed significantly between the two study arms at the first assessment, after 1 week. The treatment success rate was closely similar in patients with or without at least 10% total body surface area involved.
A key secondary endpoint concerned sexual health. Among patients who at baseline indicated that in the past week, their genital psoriasis “sometimes,” “often,” or “always” limited the frequency of their sexual activity, at week 12, 78% of those in the ixekizumab group answered the same question on the Sexual Frequency Questionnaire “never” or “rarely,” compared with 21% of controls.
“This is huge. It’s such an important part of our patients’ lives, and there was a big difference by week 1,” Dr. Ryan noted.
On another secondary endpoint, 60% of the ixekizumab group reported at least a 3-point improvement in the 0-10 Genital Itch Numeric Rating Scale at week 12, compared with 8% of controls, with a statistically significant difference apparent at week 2.
“Itch is the most frequently reported symptom in our patients with genital psoriasis, and it seems to be much more impactful than itch from psoriasis elsewhere,” Dr. Ryan commented.
The side effect profile of ixekizumab was the same as has been seen in larger, longer-term studies. There were no serious ixekizumab-related adverse events, and no cases of candidiasis.
The study was sponsored by Eli Lilly. Dr. Ryan reported serving as an advisory board member to and/or receiving honoraria from that company and more than half a dozen other pharmaceutical companies.
AT THE EADV CONGRESS
Key clinical point: First-ever trial of a biologic agent in genital psoriasis shows heartening results.
Major finding: 73% of patients with moderate to severe genital psoriasis were clear or almost clear of their genital disease after 12 weeks of ixekizumab, vs. 8% of controls.
Data source: This was a randomized, double-blind, placebo-controlled, multicenter, 12-week clinical trial in 149 patients with moderate to severe genital psoriasis.
Disclosures: The study was sponsored by Eli Lilly. The presenter reported serving as an advisory board member to and/or receiving honoraria from that company and more than half a dozen other pharmaceutical companies.
Connect with the CHEST Foundation at CHEST 2017
Be sure to check out our ever-growing presence at CHEST 2017, showcasing the numerous ways we support CHEST members, patients, and the community. Have time for a break or interested in networking with leaders in CHEST medicine? Stop by one of our many open invitation activities listed below to learn more about how the CHEST Foundation can support you in your efforts to champion lung health through clinical research grants, community service, and patient education.
SATURDAY OCTOBER 28
2:00 PM – 4:00 PM (Open Invitation)
Nathan Phillips Square
100 Queen St W, Toronto, ON M5H 2N2, Canada
SUNDAY OCTOBER 29
9:00 AM - 5:00 PM
Donor Lounge
Convention Center, 803B
3:15 PM - 4:15 PM
Foundation Session: Severe Asthma Care at Its Best: Shared Decision Making
Convention Center, 716A
4:30 PM - 5:30 PM
Foundation Session: No Money, No Mission: Tips for Getting Your Grant Funded
Convention Center, 716B
MONDAY OCTOBER 30
9:00 AM - 5:00 PM
Convention Center, 803B
8:45 AM – 10:00 AM
Opening Session/CHEST Foundation
Awards Convocation
Convention Center, Hall G, Level 800
6:30 PM - 8:00 PM
Boehringer Ingelheim and CHEST Foundation Patient Engagement Summit
Sheraton, Grand Ballroom Centre
8:00 PM – 10:00 PM
Young Professionals Reception
(RSVP chestfoundation.org/youngprofessionals)
225 Richmond St W Suite 100
Toronto, ON M5V 1W2, Canada
TUESDAY OCTOBER 31
9:00 AM - 5:00 PM
Donor Lounge
Convention Center, 803B
WEDNESDAY NOVEMBER 1
9:00 AM - 12:00 PM
Donor Lounge
Convention Center, 803B
ADD YOUR VOICE
and champion lung health at the Actelion Booth #1322. For every addition to the graffiti wall, Actelion will donate $25 to the CHEST Foundation.
Thank you for your support of the CHEST Foundation and our mission of championing lung health!
Be sure to check out our ever-growing presence at CHEST 2017, showcasing the numerous ways we support CHEST members, patients, and the community. Have time for a break or interested in networking with leaders in CHEST medicine? Stop by one of our many open invitation activities listed below to learn more about how the CHEST Foundation can support you in your efforts to champion lung health through clinical research grants, community service, and patient education.
SATURDAY OCTOBER 28
2:00 PM – 4:00 PM (Open Invitation)
Nathan Phillips Square
100 Queen St W, Toronto, ON M5H 2N2, Canada
SUNDAY OCTOBER 29
9:00 AM - 5:00 PM
Donor Lounge
Convention Center, 803B
3:15 PM - 4:15 PM
Foundation Session: Severe Asthma Care at Its Best: Shared Decision Making
Convention Center, 716A
4:30 PM - 5:30 PM
Foundation Session: No Money, No Mission: Tips for Getting Your Grant Funded
Convention Center, 716B
MONDAY OCTOBER 30
9:00 AM - 5:00 PM
Convention Center, 803B
8:45 AM – 10:00 AM
Opening Session/CHEST Foundation
Awards Convocation
Convention Center, Hall G, Level 800
6:30 PM - 8:00 PM
Boehringer Ingelheim and CHEST Foundation Patient Engagement Summit
Sheraton, Grand Ballroom Centre
8:00 PM – 10:00 PM
Young Professionals Reception
(RSVP chestfoundation.org/youngprofessionals)
225 Richmond St W Suite 100
Toronto, ON M5V 1W2, Canada
TUESDAY OCTOBER 31
9:00 AM - 5:00 PM
Donor Lounge
Convention Center, 803B
WEDNESDAY NOVEMBER 1
9:00 AM - 12:00 PM
Donor Lounge
Convention Center, 803B
ADD YOUR VOICE
and champion lung health at the Actelion Booth #1322. For every addition to the graffiti wall, Actelion will donate $25 to the CHEST Foundation.
Thank you for your support of the CHEST Foundation and our mission of championing lung health!
Be sure to check out our ever-growing presence at CHEST 2017, showcasing the numerous ways we support CHEST members, patients, and the community. Have time for a break or interested in networking with leaders in CHEST medicine? Stop by one of our many open invitation activities listed below to learn more about how the CHEST Foundation can support you in your efforts to champion lung health through clinical research grants, community service, and patient education.
SATURDAY OCTOBER 28
2:00 PM – 4:00 PM (Open Invitation)
Nathan Phillips Square
100 Queen St W, Toronto, ON M5H 2N2, Canada
SUNDAY OCTOBER 29
9:00 AM - 5:00 PM
Donor Lounge
Convention Center, 803B
3:15 PM - 4:15 PM
Foundation Session: Severe Asthma Care at Its Best: Shared Decision Making
Convention Center, 716A
4:30 PM - 5:30 PM
Foundation Session: No Money, No Mission: Tips for Getting Your Grant Funded
Convention Center, 716B
MONDAY OCTOBER 30
9:00 AM - 5:00 PM
Convention Center, 803B
8:45 AM – 10:00 AM
Opening Session/CHEST Foundation
Awards Convocation
Convention Center, Hall G, Level 800
6:30 PM - 8:00 PM
Boehringer Ingelheim and CHEST Foundation Patient Engagement Summit
Sheraton, Grand Ballroom Centre
8:00 PM – 10:00 PM
Young Professionals Reception
(RSVP chestfoundation.org/youngprofessionals)
225 Richmond St W Suite 100
Toronto, ON M5V 1W2, Canada
TUESDAY OCTOBER 31
9:00 AM - 5:00 PM
Donor Lounge
Convention Center, 803B
WEDNESDAY NOVEMBER 1
9:00 AM - 12:00 PM
Donor Lounge
Convention Center, 803B
ADD YOUR VOICE
and champion lung health at the Actelion Booth #1322. For every addition to the graffiti wall, Actelion will donate $25 to the CHEST Foundation.
Thank you for your support of the CHEST Foundation and our mission of championing lung health!
Trump order allows end-around ACA rules
An executive order signed by President Donald J. Trump aims to expand health care coverage options, primarily for small businesses.
The order includes three key provisions.
First, it allows small businesses to band together to buy insurance collectively for their workers and allows plans to be sold across state lines, in theory extending the buying power that comes with a larger base of employees to smaller businesses.
Employers participating in association health plans “cannot exclude any employee from joining the plan and cannot develop premiums based on health condition,” according to a White House statement on the executive order.
Second, the executive order allows broader use of limited duration health insurance – short-term policies that are not intended to be comprehensive offerings and are not subject to Affordable Care Act coverage requirements.
These plans “typically feature broad provider networks and high coverage limits,” according to the White House statement. The plans are geared toward “people between jobs, people in counties with only a single insurer offering exchange plans, people with limited coverage networks, and people who missed the open enrollment period but still want insurance,” according to the executive order.
Association health plans and the short-term, limited duration insurance will not need to fully cover the ACA’s essential health benefits package; instead, they are intended to be alternatives to “expensive, mandate-laden [ACA] insurance,” according to the executive order.
Third, the order directs the secretaries of Health & Human Services, Treasury, and Labor to “explore how they can allow more businesses to use tax-free health reimbursement arrangements, or HRAs, to compensate their employees for their health care expenses,” according to the White House statement.
HRAs allow employers to cover select items, such as copayments, deductibles, and other items, that are not covered by the insurance plan offered to employees.
“With these actions, we are moving toward lower costs and more options in the health care market and taking crucial steps toward saving the American people from the nightmare of Obamacare,” President Trump said, adding that the White House will continue to put pressure on Congress to finish repeal and replace activities. He also said that Congress will be pursuing block grants, presumably for Medicaid, which he said he had the votes to accomplish.
The action taken today by the White House is already receiving pushback.
The American College of Physicians “has said repeatedly that any attempts by Congress to ‘repeal and replace’ the ACA must first do no harm to patients,” Susan Thompson Hingle, MD, chair of the American College of Physicians Board of Regents, said in a statement. “This executive order utterly fails that test.”
Under the association health plans “small employers would be allowed to purchase health plans that do not meet the ACA’s requirement to provide essential health benefits,” Dr. Hingle noted. “This means that plans would no longer have to cover medical patients needs; plans could choose not to cover pregnancy, maternity, and newborn care, or even chemotherapy. This would also mean that the ACA’s prohibition on annual and lifetime limits on coverage would no longer apply to any service an employer decides is not essential. These changes would be devastating for patients who need access to the ‘nonessential’ services, leaving them with potentially millions of dollars in out-of-pocket costs despite being insured.”
Association health plans also could further destabilize the individual market if healthy workers – who currently may have purchased coverage on the individual market – shifted to less comprehensive association health plans, leaving even fewer healthy individuals in the individual market. “Insurers will be forced to either leave the markets in droves or charge much higher premiums.”
The rules may not be able to provide the relief that President Trump has promised, according to Julius Hobson, a Washington-based health care lobbyist
“The changes that he is talking about are going to require departments and agencies to promulgate rules. They just simply can’t do that by fiat,” Mr. Hobson said in an interview. “I am not sure that we will see an immediate impact on the executive order. ... When you get down to the nitty-gritty of implementation, we could be a bit away from seeing anything that actually has impact.”
An executive order signed by President Donald J. Trump aims to expand health care coverage options, primarily for small businesses.
The order includes three key provisions.
First, it allows small businesses to band together to buy insurance collectively for their workers and allows plans to be sold across state lines, in theory extending the buying power that comes with a larger base of employees to smaller businesses.
Employers participating in association health plans “cannot exclude any employee from joining the plan and cannot develop premiums based on health condition,” according to a White House statement on the executive order.
Second, the executive order allows broader use of limited duration health insurance – short-term policies that are not intended to be comprehensive offerings and are not subject to Affordable Care Act coverage requirements.
These plans “typically feature broad provider networks and high coverage limits,” according to the White House statement. The plans are geared toward “people between jobs, people in counties with only a single insurer offering exchange plans, people with limited coverage networks, and people who missed the open enrollment period but still want insurance,” according to the executive order.
Association health plans and the short-term, limited duration insurance will not need to fully cover the ACA’s essential health benefits package; instead, they are intended to be alternatives to “expensive, mandate-laden [ACA] insurance,” according to the executive order.
Third, the order directs the secretaries of Health & Human Services, Treasury, and Labor to “explore how they can allow more businesses to use tax-free health reimbursement arrangements, or HRAs, to compensate their employees for their health care expenses,” according to the White House statement.
HRAs allow employers to cover select items, such as copayments, deductibles, and other items, that are not covered by the insurance plan offered to employees.
“With these actions, we are moving toward lower costs and more options in the health care market and taking crucial steps toward saving the American people from the nightmare of Obamacare,” President Trump said, adding that the White House will continue to put pressure on Congress to finish repeal and replace activities. He also said that Congress will be pursuing block grants, presumably for Medicaid, which he said he had the votes to accomplish.
The action taken today by the White House is already receiving pushback.
The American College of Physicians “has said repeatedly that any attempts by Congress to ‘repeal and replace’ the ACA must first do no harm to patients,” Susan Thompson Hingle, MD, chair of the American College of Physicians Board of Regents, said in a statement. “This executive order utterly fails that test.”
Under the association health plans “small employers would be allowed to purchase health plans that do not meet the ACA’s requirement to provide essential health benefits,” Dr. Hingle noted. “This means that plans would no longer have to cover medical patients needs; plans could choose not to cover pregnancy, maternity, and newborn care, or even chemotherapy. This would also mean that the ACA’s prohibition on annual and lifetime limits on coverage would no longer apply to any service an employer decides is not essential. These changes would be devastating for patients who need access to the ‘nonessential’ services, leaving them with potentially millions of dollars in out-of-pocket costs despite being insured.”
Association health plans also could further destabilize the individual market if healthy workers – who currently may have purchased coverage on the individual market – shifted to less comprehensive association health plans, leaving even fewer healthy individuals in the individual market. “Insurers will be forced to either leave the markets in droves or charge much higher premiums.”
The rules may not be able to provide the relief that President Trump has promised, according to Julius Hobson, a Washington-based health care lobbyist
“The changes that he is talking about are going to require departments and agencies to promulgate rules. They just simply can’t do that by fiat,” Mr. Hobson said in an interview. “I am not sure that we will see an immediate impact on the executive order. ... When you get down to the nitty-gritty of implementation, we could be a bit away from seeing anything that actually has impact.”
An executive order signed by President Donald J. Trump aims to expand health care coverage options, primarily for small businesses.
The order includes three key provisions.
First, it allows small businesses to band together to buy insurance collectively for their workers and allows plans to be sold across state lines, in theory extending the buying power that comes with a larger base of employees to smaller businesses.
Employers participating in association health plans “cannot exclude any employee from joining the plan and cannot develop premiums based on health condition,” according to a White House statement on the executive order.
Second, the executive order allows broader use of limited duration health insurance – short-term policies that are not intended to be comprehensive offerings and are not subject to Affordable Care Act coverage requirements.
These plans “typically feature broad provider networks and high coverage limits,” according to the White House statement. The plans are geared toward “people between jobs, people in counties with only a single insurer offering exchange plans, people with limited coverage networks, and people who missed the open enrollment period but still want insurance,” according to the executive order.
Association health plans and the short-term, limited duration insurance will not need to fully cover the ACA’s essential health benefits package; instead, they are intended to be alternatives to “expensive, mandate-laden [ACA] insurance,” according to the executive order.
Third, the order directs the secretaries of Health & Human Services, Treasury, and Labor to “explore how they can allow more businesses to use tax-free health reimbursement arrangements, or HRAs, to compensate their employees for their health care expenses,” according to the White House statement.
HRAs allow employers to cover select items, such as copayments, deductibles, and other items, that are not covered by the insurance plan offered to employees.
“With these actions, we are moving toward lower costs and more options in the health care market and taking crucial steps toward saving the American people from the nightmare of Obamacare,” President Trump said, adding that the White House will continue to put pressure on Congress to finish repeal and replace activities. He also said that Congress will be pursuing block grants, presumably for Medicaid, which he said he had the votes to accomplish.
The action taken today by the White House is already receiving pushback.
The American College of Physicians “has said repeatedly that any attempts by Congress to ‘repeal and replace’ the ACA must first do no harm to patients,” Susan Thompson Hingle, MD, chair of the American College of Physicians Board of Regents, said in a statement. “This executive order utterly fails that test.”
Under the association health plans “small employers would be allowed to purchase health plans that do not meet the ACA’s requirement to provide essential health benefits,” Dr. Hingle noted. “This means that plans would no longer have to cover medical patients needs; plans could choose not to cover pregnancy, maternity, and newborn care, or even chemotherapy. This would also mean that the ACA’s prohibition on annual and lifetime limits on coverage would no longer apply to any service an employer decides is not essential. These changes would be devastating for patients who need access to the ‘nonessential’ services, leaving them with potentially millions of dollars in out-of-pocket costs despite being insured.”
Association health plans also could further destabilize the individual market if healthy workers – who currently may have purchased coverage on the individual market – shifted to less comprehensive association health plans, leaving even fewer healthy individuals in the individual market. “Insurers will be forced to either leave the markets in droves or charge much higher premiums.”
The rules may not be able to provide the relief that President Trump has promised, according to Julius Hobson, a Washington-based health care lobbyist
“The changes that he is talking about are going to require departments and agencies to promulgate rules. They just simply can’t do that by fiat,” Mr. Hobson said in an interview. “I am not sure that we will see an immediate impact on the executive order. ... When you get down to the nitty-gritty of implementation, we could be a bit away from seeing anything that actually has impact.”