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From the Editors: How about that!
For all those who say that the surgeon in the trenches doesn’t have a voice in the world of organized surgery, I have a story or two for you.
About 10 or more years ago, I was at a lovely old hotel in Cooperstown, N.Y., listening to a group of elder rural surgery colleagues hold forth about feeling ignored by the American College of Surgeons and how we should all band together to form a new society of rural surgeons. Like most crowds, they were getting pretty worked up. They were pretty sure such a revolution would solve our problems and we would quit being the Rodney Dangerfields of surgery (not getting any respect, as the great comic used to say).
It took a while – a few years – for the rural surgeons and ACS leadership to get to know each other better. We did, however, get there. An Advisory Council was created with the help of some very heavy hitters not often regarded as rural champions, most of whom had roots in the rural world that helped them understand what this group of surgeons wanted and needed.
Not too much removed from this event, many surgeons were feeling isolated in general due to the many challenges of rural practice familiar to so many of us. ACS leadership sensed that surgeons needed to be connected and with considerable effort they formed listservs and found that they were successful to some degree. So, under Dr. David Hoyt’s guidance a better technology was found, resources were committed, and the ACS Communities was launched. A new era in surgeon-to-surgeon and surgeon-to-leadership communication was born. It was as if we had developed talk radio for surgeons. Some stations were loud, others came in rather softly, but all were on the air. The pulse of the Fellows became audible.
Almost simultaneously, dissatisfaction with Maintenance of Certification grew as surgeons in practice began reaching their second and third recertification and the practice of surgery became ever more specialized. Many surgeons believed that nothing would ever change, that the front-line surgeon didn’t have a chance to affect change, and that the big dogs wouldn’t listen. But the College leadership heard the voices of concern and took steps to support a new approach to certification.
So here we are in 2017, coming off a very successful Clinical Congress. The formerly obscure rural surgeon contingent had several panels on the program. Surgeons practicing in towns as small as 3,000 moderated sessions. Some of those sessions were standing room only. The College assisted (and had for a few years) those rural surgeons in organizing a Rural Surgery Dinner, which filled a restaurant full of surgeons delighted to meet in person surgeons from small communities all over the country. They shared their common experiences and planned for a better tomorrow. Later in the week, the 2nd Vice President-Elect was announced. He is a surgeon from Keokuk, IA, and one of the leaders of the rural surgeon movement within the College, Philip Caropreso, MD, FACS. A new Regent was announced: Gary Timmerman, MD, FACS. Dr. Timmerman started his career in Watertown, S.D., and now runs a rural-based surgery training program.
The Clinical Congress program included many topics and issues that Fellows from every branch of surgery had posted about on the ACS Communities. The American Board of Surgery announced sweeping coming changes to help surgeons move on from an MOC system no one was really happy with to one that has great hope of making ongoing certification more than a hoop to jump through, but instead, a real value to the Diplomate. Sitting on the main committee for the American Board of Surgery’s sprint team on certification is a surgeon from Crockett, Texas, Pat Walker, MD, FACS, who practiced surgery “on the ground” in a small community setting for three decades.
Most of us would agree that rural surgeons are facing truly daunting professional headwinds, despite their critical work in serving rural patients. Yet I have been gladdened at the response and respect that the College leadership has given to rural surgeons in recent years. The outreach by the College to support rural surgeons is part of a broader effort to hear every Fellow and make the College more relevant in the life of hard-working surgeons of every type. Changes in how we retain and improve our certification process in some significant ways came out of College efforts to listen and respond to the concerns of Fellows in the College. These and other initiatives by the College leadership show a degree of farsightedness and caring that should be gratifying to all Fellows.
When Lindsay Fox, MD, FACS, a young rural surgeon in private practice with an 8-week-old baby, receives an award for excellence, moderates her panel at the Clinical Congress to a standing-room-only crowd, and then shares her experience through the Communities, I’d say the American College of Surgeons has done an amazing job in a short period of time to make our organization reflect all of us. As Mel Allen, the voice of the Yankees in their heyday, would say, “How about that!”
Dr. Hughes is clinical professor in the department of surgery and director of medical education at the Kansas University School of Medicine, Salina Campus, and Co-Editor of ACS Surgery News.
For all those who say that the surgeon in the trenches doesn’t have a voice in the world of organized surgery, I have a story or two for you.
About 10 or more years ago, I was at a lovely old hotel in Cooperstown, N.Y., listening to a group of elder rural surgery colleagues hold forth about feeling ignored by the American College of Surgeons and how we should all band together to form a new society of rural surgeons. Like most crowds, they were getting pretty worked up. They were pretty sure such a revolution would solve our problems and we would quit being the Rodney Dangerfields of surgery (not getting any respect, as the great comic used to say).
It took a while – a few years – for the rural surgeons and ACS leadership to get to know each other better. We did, however, get there. An Advisory Council was created with the help of some very heavy hitters not often regarded as rural champions, most of whom had roots in the rural world that helped them understand what this group of surgeons wanted and needed.
Not too much removed from this event, many surgeons were feeling isolated in general due to the many challenges of rural practice familiar to so many of us. ACS leadership sensed that surgeons needed to be connected and with considerable effort they formed listservs and found that they were successful to some degree. So, under Dr. David Hoyt’s guidance a better technology was found, resources were committed, and the ACS Communities was launched. A new era in surgeon-to-surgeon and surgeon-to-leadership communication was born. It was as if we had developed talk radio for surgeons. Some stations were loud, others came in rather softly, but all were on the air. The pulse of the Fellows became audible.
Almost simultaneously, dissatisfaction with Maintenance of Certification grew as surgeons in practice began reaching their second and third recertification and the practice of surgery became ever more specialized. Many surgeons believed that nothing would ever change, that the front-line surgeon didn’t have a chance to affect change, and that the big dogs wouldn’t listen. But the College leadership heard the voices of concern and took steps to support a new approach to certification.
So here we are in 2017, coming off a very successful Clinical Congress. The formerly obscure rural surgeon contingent had several panels on the program. Surgeons practicing in towns as small as 3,000 moderated sessions. Some of those sessions were standing room only. The College assisted (and had for a few years) those rural surgeons in organizing a Rural Surgery Dinner, which filled a restaurant full of surgeons delighted to meet in person surgeons from small communities all over the country. They shared their common experiences and planned for a better tomorrow. Later in the week, the 2nd Vice President-Elect was announced. He is a surgeon from Keokuk, IA, and one of the leaders of the rural surgeon movement within the College, Philip Caropreso, MD, FACS. A new Regent was announced: Gary Timmerman, MD, FACS. Dr. Timmerman started his career in Watertown, S.D., and now runs a rural-based surgery training program.
The Clinical Congress program included many topics and issues that Fellows from every branch of surgery had posted about on the ACS Communities. The American Board of Surgery announced sweeping coming changes to help surgeons move on from an MOC system no one was really happy with to one that has great hope of making ongoing certification more than a hoop to jump through, but instead, a real value to the Diplomate. Sitting on the main committee for the American Board of Surgery’s sprint team on certification is a surgeon from Crockett, Texas, Pat Walker, MD, FACS, who practiced surgery “on the ground” in a small community setting for three decades.
Most of us would agree that rural surgeons are facing truly daunting professional headwinds, despite their critical work in serving rural patients. Yet I have been gladdened at the response and respect that the College leadership has given to rural surgeons in recent years. The outreach by the College to support rural surgeons is part of a broader effort to hear every Fellow and make the College more relevant in the life of hard-working surgeons of every type. Changes in how we retain and improve our certification process in some significant ways came out of College efforts to listen and respond to the concerns of Fellows in the College. These and other initiatives by the College leadership show a degree of farsightedness and caring that should be gratifying to all Fellows.
When Lindsay Fox, MD, FACS, a young rural surgeon in private practice with an 8-week-old baby, receives an award for excellence, moderates her panel at the Clinical Congress to a standing-room-only crowd, and then shares her experience through the Communities, I’d say the American College of Surgeons has done an amazing job in a short period of time to make our organization reflect all of us. As Mel Allen, the voice of the Yankees in their heyday, would say, “How about that!”
Dr. Hughes is clinical professor in the department of surgery and director of medical education at the Kansas University School of Medicine, Salina Campus, and Co-Editor of ACS Surgery News.
For all those who say that the surgeon in the trenches doesn’t have a voice in the world of organized surgery, I have a story or two for you.
About 10 or more years ago, I was at a lovely old hotel in Cooperstown, N.Y., listening to a group of elder rural surgery colleagues hold forth about feeling ignored by the American College of Surgeons and how we should all band together to form a new society of rural surgeons. Like most crowds, they were getting pretty worked up. They were pretty sure such a revolution would solve our problems and we would quit being the Rodney Dangerfields of surgery (not getting any respect, as the great comic used to say).
It took a while – a few years – for the rural surgeons and ACS leadership to get to know each other better. We did, however, get there. An Advisory Council was created with the help of some very heavy hitters not often regarded as rural champions, most of whom had roots in the rural world that helped them understand what this group of surgeons wanted and needed.
Not too much removed from this event, many surgeons were feeling isolated in general due to the many challenges of rural practice familiar to so many of us. ACS leadership sensed that surgeons needed to be connected and with considerable effort they formed listservs and found that they were successful to some degree. So, under Dr. David Hoyt’s guidance a better technology was found, resources were committed, and the ACS Communities was launched. A new era in surgeon-to-surgeon and surgeon-to-leadership communication was born. It was as if we had developed talk radio for surgeons. Some stations were loud, others came in rather softly, but all were on the air. The pulse of the Fellows became audible.
Almost simultaneously, dissatisfaction with Maintenance of Certification grew as surgeons in practice began reaching their second and third recertification and the practice of surgery became ever more specialized. Many surgeons believed that nothing would ever change, that the front-line surgeon didn’t have a chance to affect change, and that the big dogs wouldn’t listen. But the College leadership heard the voices of concern and took steps to support a new approach to certification.
So here we are in 2017, coming off a very successful Clinical Congress. The formerly obscure rural surgeon contingent had several panels on the program. Surgeons practicing in towns as small as 3,000 moderated sessions. Some of those sessions were standing room only. The College assisted (and had for a few years) those rural surgeons in organizing a Rural Surgery Dinner, which filled a restaurant full of surgeons delighted to meet in person surgeons from small communities all over the country. They shared their common experiences and planned for a better tomorrow. Later in the week, the 2nd Vice President-Elect was announced. He is a surgeon from Keokuk, IA, and one of the leaders of the rural surgeon movement within the College, Philip Caropreso, MD, FACS. A new Regent was announced: Gary Timmerman, MD, FACS. Dr. Timmerman started his career in Watertown, S.D., and now runs a rural-based surgery training program.
The Clinical Congress program included many topics and issues that Fellows from every branch of surgery had posted about on the ACS Communities. The American Board of Surgery announced sweeping coming changes to help surgeons move on from an MOC system no one was really happy with to one that has great hope of making ongoing certification more than a hoop to jump through, but instead, a real value to the Diplomate. Sitting on the main committee for the American Board of Surgery’s sprint team on certification is a surgeon from Crockett, Texas, Pat Walker, MD, FACS, who practiced surgery “on the ground” in a small community setting for three decades.
Most of us would agree that rural surgeons are facing truly daunting professional headwinds, despite their critical work in serving rural patients. Yet I have been gladdened at the response and respect that the College leadership has given to rural surgeons in recent years. The outreach by the College to support rural surgeons is part of a broader effort to hear every Fellow and make the College more relevant in the life of hard-working surgeons of every type. Changes in how we retain and improve our certification process in some significant ways came out of College efforts to listen and respond to the concerns of Fellows in the College. These and other initiatives by the College leadership show a degree of farsightedness and caring that should be gratifying to all Fellows.
When Lindsay Fox, MD, FACS, a young rural surgeon in private practice with an 8-week-old baby, receives an award for excellence, moderates her panel at the Clinical Congress to a standing-room-only crowd, and then shares her experience through the Communities, I’d say the American College of Surgeons has done an amazing job in a short period of time to make our organization reflect all of us. As Mel Allen, the voice of the Yankees in their heyday, would say, “How about that!”
Dr. Hughes is clinical professor in the department of surgery and director of medical education at the Kansas University School of Medicine, Salina Campus, and Co-Editor of ACS Surgery News.
Benralizumab approved for eosinophilic asthma
This is the only respiratory biologic to provide fast and “near-complete depletion of eosinophils within 24 hours,” according to the statement from AstraZeneca.
Similar adverse events were seen in patients who took benralizumab and the placebo. AstraZeneca will market benralizumab under the trade name Fasenra.
“This is an important day for severe, eosinophilic asthma patients who have had limited treatment options for far too long,” said Eugene Bleecker, MD, professor and codirector of genetics, genomics, and precision medicine at the University of Arizona in Tucson, in the statement.
This is the only respiratory biologic to provide fast and “near-complete depletion of eosinophils within 24 hours,” according to the statement from AstraZeneca.
Similar adverse events were seen in patients who took benralizumab and the placebo. AstraZeneca will market benralizumab under the trade name Fasenra.
“This is an important day for severe, eosinophilic asthma patients who have had limited treatment options for far too long,” said Eugene Bleecker, MD, professor and codirector of genetics, genomics, and precision medicine at the University of Arizona in Tucson, in the statement.
This is the only respiratory biologic to provide fast and “near-complete depletion of eosinophils within 24 hours,” according to the statement from AstraZeneca.
Similar adverse events were seen in patients who took benralizumab and the placebo. AstraZeneca will market benralizumab under the trade name Fasenra.
“This is an important day for severe, eosinophilic asthma patients who have had limited treatment options for far too long,” said Eugene Bleecker, MD, professor and codirector of genetics, genomics, and precision medicine at the University of Arizona in Tucson, in the statement.
FDA addresses cell-based regenerative medicine in comprehensive new policy
The Food and Drug Administration has announced a new policy that addresses the rapid growth and development of regenerative medicine products, which include novel cellular therapies, with the aim of ensuring their safety and effectiveness.
“The framework – outlined in a suite of four guidance documents – builds upon the FDA’s existing risk-based regulatory approach to more clearly describe what products are regulated as drugs, devices, and/or biological products,” the FDA announced in a statement released on Nov. 16.
He added: “This is no longer the stuff of science fiction. This is the practical promise of modern applications of regenerative medicine.” But, while advances have benefited many patients, he referred to a small number of “unscrupulous actors” that have provided treatments that have harmed patients, which is why stricter FDA enforcement is needed.
Clarification of the existing regulations will “promote responsible and flexible regulation that leverages science to advance public health,” Dr. Gottlieb said during a media briefing held by the FDA to discuss the new framework.
During the briefing, in response to a question concerning adipose tissue injections and their associated risks, Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, explained that the guidance documents will clearly delineate when adipose tissue will be classified as a structural tissue and a stem cell product. If a provider is purveying dangerous products, the FDA can “when necessary, undertake seizures, ask for injunctions, and in some cases when it has been determined that certain violations have occurred even criminal actions can be taken,” he said.
Earlier this year, a report of three patients who had severe visual loss after treatment with intravitreal injections of autologous adipose tissue for age-related macular degeneration was published (N Engl J Med. 2017;376:1047-53).
The new framework is composed of two final guidance documents and two draft guidance documents. The first final guidance document provides details about regulations concerning cell and tissue-based products and when those products are subject to regulation in surgical procedures. The second final guidance document elaborates on the definition of “minimal manipulation” and “homologous use” with the hopes of clarifying what products are subject to regulation. These documents will also explain how the FDA will provide a framework for premarket authorization for cell-based regenerative products.
One draft guidance outlines the FDA’s plan to simplify and expedite the application of the regulatory requirements for devices used in relation to regenerative medicine advanced therapies; the second draft guidance outlines the expedited programs that may be available to sponsors of regenerative therapies.
The Food and Drug Administration has announced a new policy that addresses the rapid growth and development of regenerative medicine products, which include novel cellular therapies, with the aim of ensuring their safety and effectiveness.
“The framework – outlined in a suite of four guidance documents – builds upon the FDA’s existing risk-based regulatory approach to more clearly describe what products are regulated as drugs, devices, and/or biological products,” the FDA announced in a statement released on Nov. 16.
He added: “This is no longer the stuff of science fiction. This is the practical promise of modern applications of regenerative medicine.” But, while advances have benefited many patients, he referred to a small number of “unscrupulous actors” that have provided treatments that have harmed patients, which is why stricter FDA enforcement is needed.
Clarification of the existing regulations will “promote responsible and flexible regulation that leverages science to advance public health,” Dr. Gottlieb said during a media briefing held by the FDA to discuss the new framework.
During the briefing, in response to a question concerning adipose tissue injections and their associated risks, Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, explained that the guidance documents will clearly delineate when adipose tissue will be classified as a structural tissue and a stem cell product. If a provider is purveying dangerous products, the FDA can “when necessary, undertake seizures, ask for injunctions, and in some cases when it has been determined that certain violations have occurred even criminal actions can be taken,” he said.
Earlier this year, a report of three patients who had severe visual loss after treatment with intravitreal injections of autologous adipose tissue for age-related macular degeneration was published (N Engl J Med. 2017;376:1047-53).
The new framework is composed of two final guidance documents and two draft guidance documents. The first final guidance document provides details about regulations concerning cell and tissue-based products and when those products are subject to regulation in surgical procedures. The second final guidance document elaborates on the definition of “minimal manipulation” and “homologous use” with the hopes of clarifying what products are subject to regulation. These documents will also explain how the FDA will provide a framework for premarket authorization for cell-based regenerative products.
One draft guidance outlines the FDA’s plan to simplify and expedite the application of the regulatory requirements for devices used in relation to regenerative medicine advanced therapies; the second draft guidance outlines the expedited programs that may be available to sponsors of regenerative therapies.
The Food and Drug Administration has announced a new policy that addresses the rapid growth and development of regenerative medicine products, which include novel cellular therapies, with the aim of ensuring their safety and effectiveness.
“The framework – outlined in a suite of four guidance documents – builds upon the FDA’s existing risk-based regulatory approach to more clearly describe what products are regulated as drugs, devices, and/or biological products,” the FDA announced in a statement released on Nov. 16.
He added: “This is no longer the stuff of science fiction. This is the practical promise of modern applications of regenerative medicine.” But, while advances have benefited many patients, he referred to a small number of “unscrupulous actors” that have provided treatments that have harmed patients, which is why stricter FDA enforcement is needed.
Clarification of the existing regulations will “promote responsible and flexible regulation that leverages science to advance public health,” Dr. Gottlieb said during a media briefing held by the FDA to discuss the new framework.
During the briefing, in response to a question concerning adipose tissue injections and their associated risks, Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, explained that the guidance documents will clearly delineate when adipose tissue will be classified as a structural tissue and a stem cell product. If a provider is purveying dangerous products, the FDA can “when necessary, undertake seizures, ask for injunctions, and in some cases when it has been determined that certain violations have occurred even criminal actions can be taken,” he said.
Earlier this year, a report of three patients who had severe visual loss after treatment with intravitreal injections of autologous adipose tissue for age-related macular degeneration was published (N Engl J Med. 2017;376:1047-53).
The new framework is composed of two final guidance documents and two draft guidance documents. The first final guidance document provides details about regulations concerning cell and tissue-based products and when those products are subject to regulation in surgical procedures. The second final guidance document elaborates on the definition of “minimal manipulation” and “homologous use” with the hopes of clarifying what products are subject to regulation. These documents will also explain how the FDA will provide a framework for premarket authorization for cell-based regenerative products.
One draft guidance outlines the FDA’s plan to simplify and expedite the application of the regulatory requirements for devices used in relation to regenerative medicine advanced therapies; the second draft guidance outlines the expedited programs that may be available to sponsors of regenerative therapies.
FROM an FDA MEDIA BRIEFING
Career (of your dreams) advice for young MIGS surgeons
From the 46th AAGL Global Congress on MIGS
From the 46th AAGL Global Congress on MIGS
From the 46th AAGL Global Congress on MIGS
AGA launches new registry to track patient outcomes
The AGA Center for GI Innovation and Technology is excited to announce a new clinical research registry to track and evaluate patient outcomes after trans-oral endoscopic suturing procedures.
The Prospective Registry for Trans-Oral Suturing Applications (“Endoscopic Suturing Registry”) will collect real-world data related to the safety and effectiveness of procedures done with Apollo Endosurgery’s OverStitch™ Endoscopic Suturing System. Jennifer Maranki, MD, director of endoscopy, Penn State Milton S. Hershey School of Medicine, and Brian Dunkin, MD, head of endoscopic surgery and medical director, Houston Methodist Institute for Technology, Innovation and Education, will serve as principal investigators for the Endoscopic Suturing Registry. The Registry will begin collecting patient data in early 2018.
We asked Michael Kochman, MD, AGAF, past chair of the AGA Center for GI Innovation and Technology and director of the Center for Endoscopic Innovation, Research and Training at the University of Pennsylvania, to weigh in on the value of this new registry.
“Flexible endoscopic suturing is an important tool for the treatment of a number of GI disorders. As these procedures become more routine in GI and surgery practices across the country, the real-world data AGA will collect through the Endoscopic Suturing Registry will guide all stakeholders in making informed decisions around the continued adoption of these procedures in clinical practice.”
Learn more about AGA’s registry initiative at www.gastro.org/patient-care/registries-studies.
The AGA Center for GI Innovation and Technology is excited to announce a new clinical research registry to track and evaluate patient outcomes after trans-oral endoscopic suturing procedures.
The Prospective Registry for Trans-Oral Suturing Applications (“Endoscopic Suturing Registry”) will collect real-world data related to the safety and effectiveness of procedures done with Apollo Endosurgery’s OverStitch™ Endoscopic Suturing System. Jennifer Maranki, MD, director of endoscopy, Penn State Milton S. Hershey School of Medicine, and Brian Dunkin, MD, head of endoscopic surgery and medical director, Houston Methodist Institute for Technology, Innovation and Education, will serve as principal investigators for the Endoscopic Suturing Registry. The Registry will begin collecting patient data in early 2018.
We asked Michael Kochman, MD, AGAF, past chair of the AGA Center for GI Innovation and Technology and director of the Center for Endoscopic Innovation, Research and Training at the University of Pennsylvania, to weigh in on the value of this new registry.
“Flexible endoscopic suturing is an important tool for the treatment of a number of GI disorders. As these procedures become more routine in GI and surgery practices across the country, the real-world data AGA will collect through the Endoscopic Suturing Registry will guide all stakeholders in making informed decisions around the continued adoption of these procedures in clinical practice.”
Learn more about AGA’s registry initiative at www.gastro.org/patient-care/registries-studies.
The AGA Center for GI Innovation and Technology is excited to announce a new clinical research registry to track and evaluate patient outcomes after trans-oral endoscopic suturing procedures.
The Prospective Registry for Trans-Oral Suturing Applications (“Endoscopic Suturing Registry”) will collect real-world data related to the safety and effectiveness of procedures done with Apollo Endosurgery’s OverStitch™ Endoscopic Suturing System. Jennifer Maranki, MD, director of endoscopy, Penn State Milton S. Hershey School of Medicine, and Brian Dunkin, MD, head of endoscopic surgery and medical director, Houston Methodist Institute for Technology, Innovation and Education, will serve as principal investigators for the Endoscopic Suturing Registry. The Registry will begin collecting patient data in early 2018.
We asked Michael Kochman, MD, AGAF, past chair of the AGA Center for GI Innovation and Technology and director of the Center for Endoscopic Innovation, Research and Training at the University of Pennsylvania, to weigh in on the value of this new registry.
“Flexible endoscopic suturing is an important tool for the treatment of a number of GI disorders. As these procedures become more routine in GI and surgery practices across the country, the real-world data AGA will collect through the Endoscopic Suturing Registry will guide all stakeholders in making informed decisions around the continued adoption of these procedures in clinical practice.”
Learn more about AGA’s registry initiative at www.gastro.org/patient-care/registries-studies.
PCVs may reduce AOM severity, although they do not decrease incidence
Use of the 7-valent pneumococcal conjugate vaccine (PCV7) may have had a part in reducing the incidence of severe middle ear inflammation of acute otitis media (AOM) in Japanese children, decreasing the rate of myringotomies for AOM, said Atsushi Sasaki, of the Hiroshima (Japan) University, and associates.
To assess whether use of PCV7 and then PCV13 affected AOM incidence, the investigators looked at the incidence of visits to medical institutions (VtMI) due to all-cause AOM in children younger than 15 years in the Japan Medical Data Center Claims Database between January 2005 and December 2015. Data for children aged 10 years to younger than 15 years served as the control. The rate of myringotomies for AOM (MyfA) from January 2007 to December 2015 also was assessed.
Numerous other studies have “concluded that the preventive effect of PCV7 against AOM was very modest,” the researchers said. “In contrast, our study proposes the hypothesis that PCV7 use in 1-year-olds may contribute to the decreased incidence of severe middle ear inflammation of AOM. When evaluating the effectiveness of PCV, measures to evaluate severity may be as important as evaluating disease prevention.”
Read more in Auris Nasus Larynx (2017 Nov 1. doi: 10.1016/j.anl.2017.10.006).
Use of the 7-valent pneumococcal conjugate vaccine (PCV7) may have had a part in reducing the incidence of severe middle ear inflammation of acute otitis media (AOM) in Japanese children, decreasing the rate of myringotomies for AOM, said Atsushi Sasaki, of the Hiroshima (Japan) University, and associates.
To assess whether use of PCV7 and then PCV13 affected AOM incidence, the investigators looked at the incidence of visits to medical institutions (VtMI) due to all-cause AOM in children younger than 15 years in the Japan Medical Data Center Claims Database between January 2005 and December 2015. Data for children aged 10 years to younger than 15 years served as the control. The rate of myringotomies for AOM (MyfA) from January 2007 to December 2015 also was assessed.
Numerous other studies have “concluded that the preventive effect of PCV7 against AOM was very modest,” the researchers said. “In contrast, our study proposes the hypothesis that PCV7 use in 1-year-olds may contribute to the decreased incidence of severe middle ear inflammation of AOM. When evaluating the effectiveness of PCV, measures to evaluate severity may be as important as evaluating disease prevention.”
Read more in Auris Nasus Larynx (2017 Nov 1. doi: 10.1016/j.anl.2017.10.006).
Use of the 7-valent pneumococcal conjugate vaccine (PCV7) may have had a part in reducing the incidence of severe middle ear inflammation of acute otitis media (AOM) in Japanese children, decreasing the rate of myringotomies for AOM, said Atsushi Sasaki, of the Hiroshima (Japan) University, and associates.
To assess whether use of PCV7 and then PCV13 affected AOM incidence, the investigators looked at the incidence of visits to medical institutions (VtMI) due to all-cause AOM in children younger than 15 years in the Japan Medical Data Center Claims Database between January 2005 and December 2015. Data for children aged 10 years to younger than 15 years served as the control. The rate of myringotomies for AOM (MyfA) from January 2007 to December 2015 also was assessed.
Numerous other studies have “concluded that the preventive effect of PCV7 against AOM was very modest,” the researchers said. “In contrast, our study proposes the hypothesis that PCV7 use in 1-year-olds may contribute to the decreased incidence of severe middle ear inflammation of AOM. When evaluating the effectiveness of PCV, measures to evaluate severity may be as important as evaluating disease prevention.”
Read more in Auris Nasus Larynx (2017 Nov 1. doi: 10.1016/j.anl.2017.10.006).
FROM AURIS NASUS LARYNX
Health care panhandlers: A symptom of our system’s baked-in pressures?
A few nights a week after work I have to stop by the store for this or that.
In the last 1-2 months there’s always been a couple at the parking lot exit, both in wheelchairs, with a big sign asking for money to help one of them beat cancer. They even have the amount listed.
But, by the same token, they could be quite legitimate. The American health care system is full of cracks that seriously ill people can slip through. One recent survey found that about 30% of Americans had trouble paying their medical bills.
It’s easy to look at people like this and think, “I’ll never let that happen to me.” We assume they must be smokers, or irresponsible spenders, or some other reason that makes us feel we won’t stumble into the same pitfalls. That’s reassuring, and sometimes true, but not always. And probably more often than we want to realize.
The world is full of people and families devastated by bad luck. Through no fault of their own, they develop a terrible medical condition or suffer grievous injuries, and suddenly, decent, hard-working, previously healthy people are facing foreclosure and financial ruin. It could, quite literally, be any of us.
Case in point: My family has good insurance and has averaged $10,000 in out-of-pocket medical expenses per year for the last several years. That’s for routine stuff: meeting deductibles, copays on medications, tests, and doctor visits, a few ER trips, etc. The only real “surprise” in there was when my wife broke her leg and needed surgery.
If the panhandlers really did have legitimate medical issues, I might be willing to help out. I give to charity. My grandmother and parents stressed that value to me, and I try to teach it to my kids. But, sadly, we live in a world full of con artists who try to make money by taking advantage of caring peoples’ feelings. Look at all the scams that immediately cropped up following the recent hurricane and wildfire disasters. Without knowing the truth, I’d rather give to an organization like the Salvation Army or Red Cross, hoping they have more experience than I do in sorting out who’s really in need.
As a doctor, I also try to justify it by thinking about how much care I do for “free.” This includes uninsured hospital patients we all see on call, knowing we’ll end up writing their bill off as a loss, and bounced checks for copays and deductible portions that we know we’ll never see.
But, no matter how I try to rationalize it, it still bothers me when I see them sitting there as I leave the store. I don’t know if they’re legitimate. But if they are, they aren’t alone, and there’s something seriously wrong with our health care system.
[polldaddy:9876776]
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
A few nights a week after work I have to stop by the store for this or that.
In the last 1-2 months there’s always been a couple at the parking lot exit, both in wheelchairs, with a big sign asking for money to help one of them beat cancer. They even have the amount listed.
But, by the same token, they could be quite legitimate. The American health care system is full of cracks that seriously ill people can slip through. One recent survey found that about 30% of Americans had trouble paying their medical bills.
It’s easy to look at people like this and think, “I’ll never let that happen to me.” We assume they must be smokers, or irresponsible spenders, or some other reason that makes us feel we won’t stumble into the same pitfalls. That’s reassuring, and sometimes true, but not always. And probably more often than we want to realize.
The world is full of people and families devastated by bad luck. Through no fault of their own, they develop a terrible medical condition or suffer grievous injuries, and suddenly, decent, hard-working, previously healthy people are facing foreclosure and financial ruin. It could, quite literally, be any of us.
Case in point: My family has good insurance and has averaged $10,000 in out-of-pocket medical expenses per year for the last several years. That’s for routine stuff: meeting deductibles, copays on medications, tests, and doctor visits, a few ER trips, etc. The only real “surprise” in there was when my wife broke her leg and needed surgery.
If the panhandlers really did have legitimate medical issues, I might be willing to help out. I give to charity. My grandmother and parents stressed that value to me, and I try to teach it to my kids. But, sadly, we live in a world full of con artists who try to make money by taking advantage of caring peoples’ feelings. Look at all the scams that immediately cropped up following the recent hurricane and wildfire disasters. Without knowing the truth, I’d rather give to an organization like the Salvation Army or Red Cross, hoping they have more experience than I do in sorting out who’s really in need.
As a doctor, I also try to justify it by thinking about how much care I do for “free.” This includes uninsured hospital patients we all see on call, knowing we’ll end up writing their bill off as a loss, and bounced checks for copays and deductible portions that we know we’ll never see.
But, no matter how I try to rationalize it, it still bothers me when I see them sitting there as I leave the store. I don’t know if they’re legitimate. But if they are, they aren’t alone, and there’s something seriously wrong with our health care system.
[polldaddy:9876776]
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
A few nights a week after work I have to stop by the store for this or that.
In the last 1-2 months there’s always been a couple at the parking lot exit, both in wheelchairs, with a big sign asking for money to help one of them beat cancer. They even have the amount listed.
But, by the same token, they could be quite legitimate. The American health care system is full of cracks that seriously ill people can slip through. One recent survey found that about 30% of Americans had trouble paying their medical bills.
It’s easy to look at people like this and think, “I’ll never let that happen to me.” We assume they must be smokers, or irresponsible spenders, or some other reason that makes us feel we won’t stumble into the same pitfalls. That’s reassuring, and sometimes true, but not always. And probably more often than we want to realize.
The world is full of people and families devastated by bad luck. Through no fault of their own, they develop a terrible medical condition or suffer grievous injuries, and suddenly, decent, hard-working, previously healthy people are facing foreclosure and financial ruin. It could, quite literally, be any of us.
Case in point: My family has good insurance and has averaged $10,000 in out-of-pocket medical expenses per year for the last several years. That’s for routine stuff: meeting deductibles, copays on medications, tests, and doctor visits, a few ER trips, etc. The only real “surprise” in there was when my wife broke her leg and needed surgery.
If the panhandlers really did have legitimate medical issues, I might be willing to help out. I give to charity. My grandmother and parents stressed that value to me, and I try to teach it to my kids. But, sadly, we live in a world full of con artists who try to make money by taking advantage of caring peoples’ feelings. Look at all the scams that immediately cropped up following the recent hurricane and wildfire disasters. Without knowing the truth, I’d rather give to an organization like the Salvation Army or Red Cross, hoping they have more experience than I do in sorting out who’s really in need.
As a doctor, I also try to justify it by thinking about how much care I do for “free.” This includes uninsured hospital patients we all see on call, knowing we’ll end up writing their bill off as a loss, and bounced checks for copays and deductible portions that we know we’ll never see.
But, no matter how I try to rationalize it, it still bothers me when I see them sitting there as I leave the store. I don’t know if they’re legitimate. But if they are, they aren’t alone, and there’s something seriously wrong with our health care system.
[polldaddy:9876776]
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Closing the colonoscopy loophole
What is the colonoscopy loophole?
The Affordable Care Act covers screening colonoscopies at no cost to patients as long as no polyps are found. As Dr. Siddique explains in her article, finding a polyp changes the billing code to a therapeutic colonoscopy, a reclassification that changes the procedure from a diagnostic screening to an intervention. And this means a bill is generated. This reclassification directly affects those covered by Medicare and not commercial insurers.
AGA leaders urge Congress to correct this problem
Dr. Siddique – a member of the AGA Trainee and Early Career Committee and AGA Clinical Guidelines Committee – joined other AGA leaders for AGA Advocacy Day in late September where they spoke directly to lawmakers about patients who are blindsided by this regulation. AGA supports closing this loophole to ensure patients continue to have access to quality care and preventative screenings. We encourage all members to continue to share their patient stories, like Dr. Siddique has, to help raise awareness of this issue.
AGA can help you advocate for GI
Watch an AGA webinar at www.gastro.org/webinars/CongressionalMeeting (login required) to learn more about how to set up congressional meetings in your district, or contact Navneet Buttar, AGA government and political affairs manager, at [email protected] or 240-482-3221.
What is the colonoscopy loophole?
The Affordable Care Act covers screening colonoscopies at no cost to patients as long as no polyps are found. As Dr. Siddique explains in her article, finding a polyp changes the billing code to a therapeutic colonoscopy, a reclassification that changes the procedure from a diagnostic screening to an intervention. And this means a bill is generated. This reclassification directly affects those covered by Medicare and not commercial insurers.
AGA leaders urge Congress to correct this problem
Dr. Siddique – a member of the AGA Trainee and Early Career Committee and AGA Clinical Guidelines Committee – joined other AGA leaders for AGA Advocacy Day in late September where they spoke directly to lawmakers about patients who are blindsided by this regulation. AGA supports closing this loophole to ensure patients continue to have access to quality care and preventative screenings. We encourage all members to continue to share their patient stories, like Dr. Siddique has, to help raise awareness of this issue.
AGA can help you advocate for GI
Watch an AGA webinar at www.gastro.org/webinars/CongressionalMeeting (login required) to learn more about how to set up congressional meetings in your district, or contact Navneet Buttar, AGA government and political affairs manager, at [email protected] or 240-482-3221.
What is the colonoscopy loophole?
The Affordable Care Act covers screening colonoscopies at no cost to patients as long as no polyps are found. As Dr. Siddique explains in her article, finding a polyp changes the billing code to a therapeutic colonoscopy, a reclassification that changes the procedure from a diagnostic screening to an intervention. And this means a bill is generated. This reclassification directly affects those covered by Medicare and not commercial insurers.
AGA leaders urge Congress to correct this problem
Dr. Siddique – a member of the AGA Trainee and Early Career Committee and AGA Clinical Guidelines Committee – joined other AGA leaders for AGA Advocacy Day in late September where they spoke directly to lawmakers about patients who are blindsided by this regulation. AGA supports closing this loophole to ensure patients continue to have access to quality care and preventative screenings. We encourage all members to continue to share their patient stories, like Dr. Siddique has, to help raise awareness of this issue.
AGA can help you advocate for GI
Watch an AGA webinar at www.gastro.org/webinars/CongressionalMeeting (login required) to learn more about how to set up congressional meetings in your district, or contact Navneet Buttar, AGA government and political affairs manager, at [email protected] or 240-482-3221.
Serlopitant is itching to quell chronic pruritus
GENEVA – Serlopitant, a novel once-daily oral neurokinin-1 receptor antagonist, brought significant improvement for patients with treatment-resistant chronic pruritus as early as day 2, in a phase 2 randomized trial, Paul Kwon, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
In a separate phase 2 study presented at the congress, serlopitant showed strong efficacy in patients with prurigo nodularis.
Serlopitant is an oral small molecule with high selectivity for the neurokinin-1 receptor (NK1R). At the 5-mg dose, the drug occupies more than 90% of CNS NK1Rs. The NK1R is the primary receptor for substance P, and thus plays an important role in pruritus signaling.
Chronic pruritus is an often-debilitating condition that can have a multitude of causes. It’s associated with increased rates of anxiety, depression, and sleep deprivation. Existing treatments often fail to provide adequate relief from the severe chronic itching, or they are associated with safety or tolerability issues.
“Chronic pruritus can disrupt quality of life to a level comparable to chronic pain,” the dermatologist observed. “I think we in the medical community are hearing more and more about treatment for chronic pruritus as being a major unmet medical need.”
Dr. Kwon noted that investigators at Emory University in Atlanta have found that the quality of life disruption imposed by chronic pruritus is comparable to that of chronic pain (Arch Dermatol. 2011 Oct;147[10]:1153-6).
The phase 2, randomized, double-blind, placebo-controlled, 6-week trial comprised 257 patients with chronic pruritus at 25 U.S. centers. All were non- or inadequate responders to topical corticosteroids or oral antihistamines. This was essentially an all-comers study that was not restricted to patients with any particular specific cause of their chronic itch. They had to have severe chronic pruritus, as defined by a baseline self-rated pruritus visual analogue score of at least 7 on a 0-10 scale. Patients were randomized to once-daily oral serlopitant at 0.25 mg, 1 mg, or 5 mg, or to placebo.
The primary endpoint was change in mean visual analogue score from baseline to week 6. The serlopitant 1-mg and 5-mg groups reported mean 41.4% and 42.5% reductions, respectively, which were significantly better than the 28.3% reduction in controls.
“It seems that the drug is working in a broad set of subjects,” Dr. Kwon said. “It is not entirely shutting off itch in significant numbers, but the majority of patients appear to be deriving benefit from serlopitant.”
He highlighted the rapidity with which chronic pruritus responded to serlopitant. The first dose was taken on the evening of day 1. The next day, the 1-mg serlopitant group already showed a significantly greater improvement than did placebo-treated controls. The day after that, so did the 5-mg group. Those between-group differences grew steadily larger throughout the 6-week study period.
That rapid response is clinically highly relevant, because numerous studies have demonstrated that fast onset of therapeutic effect improves patient satisfaction, quality of life, and compliance with treatment for a variety of medical conditions, he said.
Dr. Kwon characterized the safety profile of serlopitant in the trial as “fairly robust,” with only mild or moderate treatment-emergent adverse events being seen. Diarrhea and somnolence were the only adverse events more common with serlopitant than placebo, and their incidence was in the mid single digits.
“We have not uncovered any significant safety signal in this study,” Dr. Kwon declared.
Also at the EADV Congress, Sonja Ständer, MD, presented a phase 2 study of serlopitant in patients with prurigo nodularis. The randomized, double-blind, 8-week, 127-patient trial was conducted at 15 sites in Germany, where patients were randomized to once-daily serlopitant at 5 mg or placebo. All participants had a baseline pruritus VAS of 7 or more. Thirty percent of patients had more than a 10-year history of prurigo nodularis, and 24% had the condition for 5-10 years.
The primary endpoint was the difference from baseline to weeks 4 and 8 in the average pruritus VAS over the previous 24 hours. The baseline score was 7.9. The serlopitant group averaged a 1.0-point greater reduction, compared with controls, at week 4, and a 1.7-point greater decrease at week 8.
Multiple other measures of pruritus serving as secondary endpoints consistently showed significantly greater improvement in the serlopitant group. For example, at the week 8 assessment, 54% of serlopitant-treated patients reported no or only mild itch, compared with 29% of controls. And two-thirds of the serlopitant group reported some degree of improvement in the severity of their eruptive papulonodular lesions at week 8, versus 40% of controls, according to Dr. Ständer, professor of dermatology and neurodermatology and head of the Center for Chronic Pruritus at the University of Münster (Germany).
Of note, nasopharyngitis occurred in 17.2% of the serlopitant group and in 3.2% of controls. Diarrhea was also more common in the serlopitant group, by a margin of 10.9% versus 4.8%.
Dr. Kwon said additional phase 2 as well as phase 3 randomized trials of serlopitant are in the works for both chronic pruritus and prurigo nodularis. The drug is also under study for chronic itch due to other specific etiologies, as well as for refractory chronic cough.
Menlo Therapeutics sponsored the study. Dr. Kwon is a Menlo Therapeutics officer. Dr. Ständer, who was also principal investigator in the chronic pruritus trial, reported having no financial conflicts of interest.
GENEVA – Serlopitant, a novel once-daily oral neurokinin-1 receptor antagonist, brought significant improvement for patients with treatment-resistant chronic pruritus as early as day 2, in a phase 2 randomized trial, Paul Kwon, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
In a separate phase 2 study presented at the congress, serlopitant showed strong efficacy in patients with prurigo nodularis.
Serlopitant is an oral small molecule with high selectivity for the neurokinin-1 receptor (NK1R). At the 5-mg dose, the drug occupies more than 90% of CNS NK1Rs. The NK1R is the primary receptor for substance P, and thus plays an important role in pruritus signaling.
Chronic pruritus is an often-debilitating condition that can have a multitude of causes. It’s associated with increased rates of anxiety, depression, and sleep deprivation. Existing treatments often fail to provide adequate relief from the severe chronic itching, or they are associated with safety or tolerability issues.
“Chronic pruritus can disrupt quality of life to a level comparable to chronic pain,” the dermatologist observed. “I think we in the medical community are hearing more and more about treatment for chronic pruritus as being a major unmet medical need.”
Dr. Kwon noted that investigators at Emory University in Atlanta have found that the quality of life disruption imposed by chronic pruritus is comparable to that of chronic pain (Arch Dermatol. 2011 Oct;147[10]:1153-6).
The phase 2, randomized, double-blind, placebo-controlled, 6-week trial comprised 257 patients with chronic pruritus at 25 U.S. centers. All were non- or inadequate responders to topical corticosteroids or oral antihistamines. This was essentially an all-comers study that was not restricted to patients with any particular specific cause of their chronic itch. They had to have severe chronic pruritus, as defined by a baseline self-rated pruritus visual analogue score of at least 7 on a 0-10 scale. Patients were randomized to once-daily oral serlopitant at 0.25 mg, 1 mg, or 5 mg, or to placebo.
The primary endpoint was change in mean visual analogue score from baseline to week 6. The serlopitant 1-mg and 5-mg groups reported mean 41.4% and 42.5% reductions, respectively, which were significantly better than the 28.3% reduction in controls.
“It seems that the drug is working in a broad set of subjects,” Dr. Kwon said. “It is not entirely shutting off itch in significant numbers, but the majority of patients appear to be deriving benefit from serlopitant.”
He highlighted the rapidity with which chronic pruritus responded to serlopitant. The first dose was taken on the evening of day 1. The next day, the 1-mg serlopitant group already showed a significantly greater improvement than did placebo-treated controls. The day after that, so did the 5-mg group. Those between-group differences grew steadily larger throughout the 6-week study period.
That rapid response is clinically highly relevant, because numerous studies have demonstrated that fast onset of therapeutic effect improves patient satisfaction, quality of life, and compliance with treatment for a variety of medical conditions, he said.
Dr. Kwon characterized the safety profile of serlopitant in the trial as “fairly robust,” with only mild or moderate treatment-emergent adverse events being seen. Diarrhea and somnolence were the only adverse events more common with serlopitant than placebo, and their incidence was in the mid single digits.
“We have not uncovered any significant safety signal in this study,” Dr. Kwon declared.
Also at the EADV Congress, Sonja Ständer, MD, presented a phase 2 study of serlopitant in patients with prurigo nodularis. The randomized, double-blind, 8-week, 127-patient trial was conducted at 15 sites in Germany, where patients were randomized to once-daily serlopitant at 5 mg or placebo. All participants had a baseline pruritus VAS of 7 or more. Thirty percent of patients had more than a 10-year history of prurigo nodularis, and 24% had the condition for 5-10 years.
The primary endpoint was the difference from baseline to weeks 4 and 8 in the average pruritus VAS over the previous 24 hours. The baseline score was 7.9. The serlopitant group averaged a 1.0-point greater reduction, compared with controls, at week 4, and a 1.7-point greater decrease at week 8.
Multiple other measures of pruritus serving as secondary endpoints consistently showed significantly greater improvement in the serlopitant group. For example, at the week 8 assessment, 54% of serlopitant-treated patients reported no or only mild itch, compared with 29% of controls. And two-thirds of the serlopitant group reported some degree of improvement in the severity of their eruptive papulonodular lesions at week 8, versus 40% of controls, according to Dr. Ständer, professor of dermatology and neurodermatology and head of the Center for Chronic Pruritus at the University of Münster (Germany).
Of note, nasopharyngitis occurred in 17.2% of the serlopitant group and in 3.2% of controls. Diarrhea was also more common in the serlopitant group, by a margin of 10.9% versus 4.8%.
Dr. Kwon said additional phase 2 as well as phase 3 randomized trials of serlopitant are in the works for both chronic pruritus and prurigo nodularis. The drug is also under study for chronic itch due to other specific etiologies, as well as for refractory chronic cough.
Menlo Therapeutics sponsored the study. Dr. Kwon is a Menlo Therapeutics officer. Dr. Ständer, who was also principal investigator in the chronic pruritus trial, reported having no financial conflicts of interest.
GENEVA – Serlopitant, a novel once-daily oral neurokinin-1 receptor antagonist, brought significant improvement for patients with treatment-resistant chronic pruritus as early as day 2, in a phase 2 randomized trial, Paul Kwon, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
In a separate phase 2 study presented at the congress, serlopitant showed strong efficacy in patients with prurigo nodularis.
Serlopitant is an oral small molecule with high selectivity for the neurokinin-1 receptor (NK1R). At the 5-mg dose, the drug occupies more than 90% of CNS NK1Rs. The NK1R is the primary receptor for substance P, and thus plays an important role in pruritus signaling.
Chronic pruritus is an often-debilitating condition that can have a multitude of causes. It’s associated with increased rates of anxiety, depression, and sleep deprivation. Existing treatments often fail to provide adequate relief from the severe chronic itching, or they are associated with safety or tolerability issues.
“Chronic pruritus can disrupt quality of life to a level comparable to chronic pain,” the dermatologist observed. “I think we in the medical community are hearing more and more about treatment for chronic pruritus as being a major unmet medical need.”
Dr. Kwon noted that investigators at Emory University in Atlanta have found that the quality of life disruption imposed by chronic pruritus is comparable to that of chronic pain (Arch Dermatol. 2011 Oct;147[10]:1153-6).
The phase 2, randomized, double-blind, placebo-controlled, 6-week trial comprised 257 patients with chronic pruritus at 25 U.S. centers. All were non- or inadequate responders to topical corticosteroids or oral antihistamines. This was essentially an all-comers study that was not restricted to patients with any particular specific cause of their chronic itch. They had to have severe chronic pruritus, as defined by a baseline self-rated pruritus visual analogue score of at least 7 on a 0-10 scale. Patients were randomized to once-daily oral serlopitant at 0.25 mg, 1 mg, or 5 mg, or to placebo.
The primary endpoint was change in mean visual analogue score from baseline to week 6. The serlopitant 1-mg and 5-mg groups reported mean 41.4% and 42.5% reductions, respectively, which were significantly better than the 28.3% reduction in controls.
“It seems that the drug is working in a broad set of subjects,” Dr. Kwon said. “It is not entirely shutting off itch in significant numbers, but the majority of patients appear to be deriving benefit from serlopitant.”
He highlighted the rapidity with which chronic pruritus responded to serlopitant. The first dose was taken on the evening of day 1. The next day, the 1-mg serlopitant group already showed a significantly greater improvement than did placebo-treated controls. The day after that, so did the 5-mg group. Those between-group differences grew steadily larger throughout the 6-week study period.
That rapid response is clinically highly relevant, because numerous studies have demonstrated that fast onset of therapeutic effect improves patient satisfaction, quality of life, and compliance with treatment for a variety of medical conditions, he said.
Dr. Kwon characterized the safety profile of serlopitant in the trial as “fairly robust,” with only mild or moderate treatment-emergent adverse events being seen. Diarrhea and somnolence were the only adverse events more common with serlopitant than placebo, and their incidence was in the mid single digits.
“We have not uncovered any significant safety signal in this study,” Dr. Kwon declared.
Also at the EADV Congress, Sonja Ständer, MD, presented a phase 2 study of serlopitant in patients with prurigo nodularis. The randomized, double-blind, 8-week, 127-patient trial was conducted at 15 sites in Germany, where patients were randomized to once-daily serlopitant at 5 mg or placebo. All participants had a baseline pruritus VAS of 7 or more. Thirty percent of patients had more than a 10-year history of prurigo nodularis, and 24% had the condition for 5-10 years.
The primary endpoint was the difference from baseline to weeks 4 and 8 in the average pruritus VAS over the previous 24 hours. The baseline score was 7.9. The serlopitant group averaged a 1.0-point greater reduction, compared with controls, at week 4, and a 1.7-point greater decrease at week 8.
Multiple other measures of pruritus serving as secondary endpoints consistently showed significantly greater improvement in the serlopitant group. For example, at the week 8 assessment, 54% of serlopitant-treated patients reported no or only mild itch, compared with 29% of controls. And two-thirds of the serlopitant group reported some degree of improvement in the severity of their eruptive papulonodular lesions at week 8, versus 40% of controls, according to Dr. Ständer, professor of dermatology and neurodermatology and head of the Center for Chronic Pruritus at the University of Münster (Germany).
Of note, nasopharyngitis occurred in 17.2% of the serlopitant group and in 3.2% of controls. Diarrhea was also more common in the serlopitant group, by a margin of 10.9% versus 4.8%.
Dr. Kwon said additional phase 2 as well as phase 3 randomized trials of serlopitant are in the works for both chronic pruritus and prurigo nodularis. The drug is also under study for chronic itch due to other specific etiologies, as well as for refractory chronic cough.
Menlo Therapeutics sponsored the study. Dr. Kwon is a Menlo Therapeutics officer. Dr. Ständer, who was also principal investigator in the chronic pruritus trial, reported having no financial conflicts of interest.
AT THE EADV CONGRESS
Key clinical point:
Major finding: Mean self-rated pruritus scores fell by 41% and 43% from baseline to week 6 in patients on serlopitant at 1 mg/day and 5 mg/day, compared with 28% in placebo-treated controls.
Data source: A randomized, double-blind, multicenter, placebo-controlled, 6-week, phase 2 clinical trial comprising 257 patients with treatment-resistant chronic pruritus.
Disclosures: Menlo Therapeutics sponsored the study. Dr. Kwon is a Menlo Therapeutics officer. Dr. Ständer reported having no financial conflicts of interest.
