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Is bufexamac worth the risk?
Bufexamac, a nonsteroidal anti-inflammatory drug agent used cutaneously and rectally, is well known globally as an initiator of allergic contact dermatitis. In fact, it has been removed from the European market (except Switzerland) for inducing allergic reactions, and is also banned in Japan, New Zealand, and the United States (where it was never approved).1 This column will primarily discuss recent findings in human trials and weigh in on the issue.
Antioxidant activity
. In 2003, Trommer and Neubert demonstrated that bufexamac displayed antioxidant activity in lipid models and HaCaT keratinocytes, as measured through mass spectrometry.2 In a 2005 in vitro study of the impact of 47 drugs, plant extracts and ingredients, and polysaccharides on lipid peroxidation engendered by UV irradiation, Trommer and Neubert found that bufexamac was among the drugs shown to exhibit antioxidant activity.3
Minor allergen? Worth using?
In a 2009 study on the prevalence and risk factors for allergic contact dermatitis to topical atopic dermatitis (AD) treatments, Mailhol et al. patch tested 641 children with AD using seven then-common ingredients (chlorhexidine, hexamidine, budesonide, tixocortol pivalate, bufexamac, sodium fusidate and with the current emollient used by the child). Bufexamac was identified as an allergen in only 2.5% of the 41 positive patch tests.4
To ban or not to ban
In 2012, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended that the marketing of formulations containing bufexamac be disallowed throughout the European Union because of a tendency toward inducing severe allergic contact dermatitis.5
Given its continuing use in Australia for the local treatment of several dermatoses, Pan and Nixon, in 2012, retrospectively reviewed patch-test data at the Skin and Cancer Foundation Inc. and found 19 cases of positive reactions to bufexamac (5% petrolatum) from 451 people patch tested. In 13 of 19 patients (68%), the reaction to bufexamac was considered to be associated with the identified dermatitis. The authors concluded that allergic contact dermatitis from bufexamac exposure is underreported in the English-language literature and cautioned that physicians should consider bufexamac allergy in patients who have a history of exposure.5
Bufexamac remained available over the counter in topical formulations in Australia as of early 2019. In response, Harris et al. presented several cases of patients who experienced severe skin eruptions after using such preparations in support of their advocacy to the Therapeutic Goods Administration in Australia to ban its use.6
In the middle of that year, Wong et al. reported on the hospitalization of a 41-year-old administrative worker who applied a first aid cream containing bufexamac (5%), lignocaine (1%), and chlorhexidine (0.1%) to a superficial right foot abrasion and who developed facial edema and widespread polymorphic eruptions 2 hours later. The authors suggested that this case reinforced the need to remove bufexamac from the markets where it remains because of the tendency to provoke severe allergic contact dermatoses and lack of efficacy.1
Conclusion
Bufexamac offers the somewhat rare opportunity for advocacy. That is to say, I think there is sufficient evidence to justify the removal of this potent allergen from the market in Australia, Switzerland, and other countries where it may be available.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems LLC. She had no relevant disclosures. Write to her at dermnews@mdedge.com.
References
1. Wong GN et al. Contact Dermatitis. 2019 Jun;80(6):395-7.
2. Trommer H et al. J Pharm Pharmacol. 2003 Oct;55(10):1379-88.
3. Trommer H, Neubert RH. J Pharm Pharm Sci. 2005 Sep 15;8(3):494-506.
4. Mailhol C et al. Allergy. 2009 May;64(5):801-6.
5. Pan Y, Nixon R. Australas J Dermatol. 2012 Aug;53(3):207-10.
6. Harris AG et al. Australas J Dermatol. 2019 Feb;60(1):53-6.
Bufexamac, a nonsteroidal anti-inflammatory drug agent used cutaneously and rectally, is well known globally as an initiator of allergic contact dermatitis. In fact, it has been removed from the European market (except Switzerland) for inducing allergic reactions, and is also banned in Japan, New Zealand, and the United States (where it was never approved).1 This column will primarily discuss recent findings in human trials and weigh in on the issue.
Antioxidant activity
. In 2003, Trommer and Neubert demonstrated that bufexamac displayed antioxidant activity in lipid models and HaCaT keratinocytes, as measured through mass spectrometry.2 In a 2005 in vitro study of the impact of 47 drugs, plant extracts and ingredients, and polysaccharides on lipid peroxidation engendered by UV irradiation, Trommer and Neubert found that bufexamac was among the drugs shown to exhibit antioxidant activity.3
Minor allergen? Worth using?
In a 2009 study on the prevalence and risk factors for allergic contact dermatitis to topical atopic dermatitis (AD) treatments, Mailhol et al. patch tested 641 children with AD using seven then-common ingredients (chlorhexidine, hexamidine, budesonide, tixocortol pivalate, bufexamac, sodium fusidate and with the current emollient used by the child). Bufexamac was identified as an allergen in only 2.5% of the 41 positive patch tests.4
To ban or not to ban
In 2012, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended that the marketing of formulations containing bufexamac be disallowed throughout the European Union because of a tendency toward inducing severe allergic contact dermatitis.5
Given its continuing use in Australia for the local treatment of several dermatoses, Pan and Nixon, in 2012, retrospectively reviewed patch-test data at the Skin and Cancer Foundation Inc. and found 19 cases of positive reactions to bufexamac (5% petrolatum) from 451 people patch tested. In 13 of 19 patients (68%), the reaction to bufexamac was considered to be associated with the identified dermatitis. The authors concluded that allergic contact dermatitis from bufexamac exposure is underreported in the English-language literature and cautioned that physicians should consider bufexamac allergy in patients who have a history of exposure.5
Bufexamac remained available over the counter in topical formulations in Australia as of early 2019. In response, Harris et al. presented several cases of patients who experienced severe skin eruptions after using such preparations in support of their advocacy to the Therapeutic Goods Administration in Australia to ban its use.6
In the middle of that year, Wong et al. reported on the hospitalization of a 41-year-old administrative worker who applied a first aid cream containing bufexamac (5%), lignocaine (1%), and chlorhexidine (0.1%) to a superficial right foot abrasion and who developed facial edema and widespread polymorphic eruptions 2 hours later. The authors suggested that this case reinforced the need to remove bufexamac from the markets where it remains because of the tendency to provoke severe allergic contact dermatoses and lack of efficacy.1
Conclusion
Bufexamac offers the somewhat rare opportunity for advocacy. That is to say, I think there is sufficient evidence to justify the removal of this potent allergen from the market in Australia, Switzerland, and other countries where it may be available.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems LLC. She had no relevant disclosures. Write to her at dermnews@mdedge.com.
References
1. Wong GN et al. Contact Dermatitis. 2019 Jun;80(6):395-7.
2. Trommer H et al. J Pharm Pharmacol. 2003 Oct;55(10):1379-88.
3. Trommer H, Neubert RH. J Pharm Pharm Sci. 2005 Sep 15;8(3):494-506.
4. Mailhol C et al. Allergy. 2009 May;64(5):801-6.
5. Pan Y, Nixon R. Australas J Dermatol. 2012 Aug;53(3):207-10.
6. Harris AG et al. Australas J Dermatol. 2019 Feb;60(1):53-6.
Bufexamac, a nonsteroidal anti-inflammatory drug agent used cutaneously and rectally, is well known globally as an initiator of allergic contact dermatitis. In fact, it has been removed from the European market (except Switzerland) for inducing allergic reactions, and is also banned in Japan, New Zealand, and the United States (where it was never approved).1 This column will primarily discuss recent findings in human trials and weigh in on the issue.
Antioxidant activity
. In 2003, Trommer and Neubert demonstrated that bufexamac displayed antioxidant activity in lipid models and HaCaT keratinocytes, as measured through mass spectrometry.2 In a 2005 in vitro study of the impact of 47 drugs, plant extracts and ingredients, and polysaccharides on lipid peroxidation engendered by UV irradiation, Trommer and Neubert found that bufexamac was among the drugs shown to exhibit antioxidant activity.3
Minor allergen? Worth using?
In a 2009 study on the prevalence and risk factors for allergic contact dermatitis to topical atopic dermatitis (AD) treatments, Mailhol et al. patch tested 641 children with AD using seven then-common ingredients (chlorhexidine, hexamidine, budesonide, tixocortol pivalate, bufexamac, sodium fusidate and with the current emollient used by the child). Bufexamac was identified as an allergen in only 2.5% of the 41 positive patch tests.4
To ban or not to ban
In 2012, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended that the marketing of formulations containing bufexamac be disallowed throughout the European Union because of a tendency toward inducing severe allergic contact dermatitis.5
Given its continuing use in Australia for the local treatment of several dermatoses, Pan and Nixon, in 2012, retrospectively reviewed patch-test data at the Skin and Cancer Foundation Inc. and found 19 cases of positive reactions to bufexamac (5% petrolatum) from 451 people patch tested. In 13 of 19 patients (68%), the reaction to bufexamac was considered to be associated with the identified dermatitis. The authors concluded that allergic contact dermatitis from bufexamac exposure is underreported in the English-language literature and cautioned that physicians should consider bufexamac allergy in patients who have a history of exposure.5
Bufexamac remained available over the counter in topical formulations in Australia as of early 2019. In response, Harris et al. presented several cases of patients who experienced severe skin eruptions after using such preparations in support of their advocacy to the Therapeutic Goods Administration in Australia to ban its use.6
In the middle of that year, Wong et al. reported on the hospitalization of a 41-year-old administrative worker who applied a first aid cream containing bufexamac (5%), lignocaine (1%), and chlorhexidine (0.1%) to a superficial right foot abrasion and who developed facial edema and widespread polymorphic eruptions 2 hours later. The authors suggested that this case reinforced the need to remove bufexamac from the markets where it remains because of the tendency to provoke severe allergic contact dermatoses and lack of efficacy.1
Conclusion
Bufexamac offers the somewhat rare opportunity for advocacy. That is to say, I think there is sufficient evidence to justify the removal of this potent allergen from the market in Australia, Switzerland, and other countries where it may be available.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems LLC. She had no relevant disclosures. Write to her at dermnews@mdedge.com.
References
1. Wong GN et al. Contact Dermatitis. 2019 Jun;80(6):395-7.
2. Trommer H et al. J Pharm Pharmacol. 2003 Oct;55(10):1379-88.
3. Trommer H, Neubert RH. J Pharm Pharm Sci. 2005 Sep 15;8(3):494-506.
4. Mailhol C et al. Allergy. 2009 May;64(5):801-6.
5. Pan Y, Nixon R. Australas J Dermatol. 2012 Aug;53(3):207-10.
6. Harris AG et al. Australas J Dermatol. 2019 Feb;60(1):53-6.
AGA News
Rep. Suzan DelBene (D-Wash.) leads prior authorization reform
As a member of the powerful Ways and Means Committee, which has jurisdiction over the Medicare program, Rep. DelBene has worked closely with the American Gastroenterological Association.
When Rep. DelBene was first elected to Congress in 2012, we met with her to share AGA’s policy priorities. We knew instantly that we had a voice for many of our issues. Rep. DelBene started her career as a young investigator before continuing her education and launching a career in the biotechnology industry. From her firsthand experience, she understands the need for investments in National Institutes of Health research and for access to and coverage of colorectal cancer screenings since a member of her family had the disease.
Since Rep. DelBene has been in office, she has taken the lead on several policy priorities affecting our profession, including patient access and protections and regulatory relief. Rep. DelBene is the lead Democratic sponsor of H.R. 3107, the Improving Seniors’ Timely Access to Care Act, legislation that would streamline prior authorization in Medicare Advantage plans. The legislation hit a milestone of securing 218 cosponsors in the House, which is a majority of the members. We look forward to continuing to work with Rep. DelBene on advancing AGA’s policy priorities.
Featured microbiome investigator: Josephine Ni, MD
We’re checking in with a rising star in microbiome research: Dr. Josephine Ni from the University of Pennsylvania, Philadelphia.
Dr. Ni is an instructor of medicine at the University of Pennsylvania, and 2017 recipient of the AGA–Takeda Pharmaceuticals Research Scholar Award in IBD from the AGA Research Foundation.
Congrats to Dr. Ni! While Dr. Ni’s AGA Research Scholar Award concludes at the end of June 2020, we’re proud to share that she has secured two significant grants to continue her work: an NIH KO8 grant and a Burroughs Welcome Fund Award. We catch up with Dr. Ni in the Q&A below.
How would you sum up your research in one sentence?
I am interested in better understanding bacterial colonization of the healthy and inflamed intestinal tract; specifically, my current research focuses on characterizing the role of biofilm formation on intestinal colonization.
What effect do you hope your research will have on patients?
I hope that my work on understanding intestinal colonization will allow us to engineer the microbiota in predictable ways, which will pave the way to exclude enteropathogens, deliver specific compounds, and prevent dysbiosis.
What inspired you to focus your research career on the gut microbiome?
Being able to use data and observations from patient cohorts to generate research hypotheses and then translate those hypotheses into mouse models to explore mechanisms has been a very gratifying experience that I learned from my mentor, Gary Wu, MD. There is still so much to learn about the effects of the microbiome on intestinal health and I’m excited to be a part of this process.
What recent publication from your lab best represents your work if anyone wants to learn more?
Ni J et al. A role for bacterial urease in gut dysbiosis and Crohn’s disease. Sci Transl Med. 2017 Nov 15;9(416):eaah6888.
Gastroenterology invites submissions for an issue focused on colorectal cancer
Share your innovative basic and clinical research for consideration.
The past decade has seen significant milestones in our understanding of the epidemiology, clinical and genetic risk factors, and underlying biological mechanisms of colorectal cancer. This progress has also emphasized the need for further advances. To this end, Gastroenterology will publish a thematic issue in honor of Colorectal Cancer (CRC) Awareness Month in March 2021. The aim is to cover research highlighting novel pathways with human correlates, discoveries related to clinical interventions, clinical trials, and high-profile epidemiologic studies.
Help drive progress of CRC understanding and care by contributing your work. Enhanced promotion of the full issue and automatic indexing of your article to PubMed will increase the visibility of your research in the scientific community and beyond.
Submit your research through Gastroenterology‘s streamlined submission system: www.editorialmanager.com/gastro by Sept. 30, 2020. Original articles and brief communications are welcome.
For more information, please contact Gastroenterology’s Managing Editor, Christopher Lowe, at clowe@gastro.org.
AGA journals select editorial fellows for 2020-2021 academic year
The AGA journals Gastroenterology, Clinical Gastroenterology and Hepatology (CGH), and Cellular and Molecular Gastroenterology and Hepatology (CMGH) recently selected the recipients of their editorial fellowships, which runs from July 2020 through June 2021. The editorial fellowship program is in its fourth year.
The editorial fellows for each journal are:
Gastroenterology
Ruben Colman, MD
Cincinnati Children’s Hospital Medical Center
John Gubatan, MD
Stanford (Calif.) University Medical Center
CGH
Blake Jones, MD
University of Colorado at Denver, Aurora
Nikhil Thiruvengadam, MD
University of California, San Francisco
CMGH
Samuel Hinman, PhD
University of Washington, Seattle
The editorial fellows will be mentored on the journals’ editorial processes, including peer review and the publication process from manuscript submission to acceptance. They will participate in discussions and conferences with the boards of editors and work closely with the AGA editorial staff. Additionally, the fellows will participate in AGA’s new reviewer education program and will also be offered the opportunity to contribute content to their respective journals.
The journals’ board of editors and editorial staff congratulate the fellows and are excited to work with them over the next year.
AGA welcomes new president, M. Bishr Omary, MD, PhD, AGAF
M. Bishr Omary, MD, PhD, AGAF, will begin his term as the 115th president of the AGA Institute on June 1, 2020.
Dr. Omary, an international leader in GI biology and physiology, currently serves as senior vice chancellor for academic affairs and research for Rutgers Biomedical and Health Sciences schools, centers, and institutes at Rutgers University, Newark, N.J.
Eldest of three siblings, Dr. Omary was born and raised to Syrian parents in New York. After his father obtained his MS degree in political science from Columbia University in New York, the family returned to Damascus, Syria, where his father worked in the Ministry of Urban Planning. The family emigrated to the United States in 1968.
“I am eternally grateful to my parents from whom I learned the meaning of hard work and unconditional love. The opportunities in the U.S. open so many doors, compared with many other countries, including Syria then and especially now given the ongoing 9-year civil war that has ravaged the country,” shared Dr. Omary.
When asked about how he will approach his presidency during a global COVID-19 pandemic, Dr. Omary expressed his commitment to urgently working with and for patients, as well as our community of gastroenterologists, researchers, trainees, and other AGA members, to overcome the disruptions created by the pandemic and ultimately be in a better place than we were before. Dr. Omary holds steadfast to AGA’s vision, a world free from digestive diseases.
Dr. Omary’s primary focus, as an internationally recognized biomedical investigator, is understanding the mechanism and developing therapies for several diseases including lipodystrophies, acute liver failure, and porphyrias. He served as chief of gastroenterology and hepatology at Stanford University, then chair of physiology and chief scientific officer while at the University of Michigan, Ann Arbor, before moving to Rutgers.
Dr. Omary has been a long-time AGA leader, most notably chairing the AGA Institute Research Awards Panel and serving as senior associate editor (2006-2011) then editor in chief (2011-2016) of Gastroenterology, AGA’s premier journal.
Dr. Omary has been on the AGA Governing Board for 2 years as vice president then president-elect; his term as AGA president concludes May 2021.
Rep. Suzan DelBene (D-Wash.) leads prior authorization reform
As a member of the powerful Ways and Means Committee, which has jurisdiction over the Medicare program, Rep. DelBene has worked closely with the American Gastroenterological Association.
When Rep. DelBene was first elected to Congress in 2012, we met with her to share AGA’s policy priorities. We knew instantly that we had a voice for many of our issues. Rep. DelBene started her career as a young investigator before continuing her education and launching a career in the biotechnology industry. From her firsthand experience, she understands the need for investments in National Institutes of Health research and for access to and coverage of colorectal cancer screenings since a member of her family had the disease.
Since Rep. DelBene has been in office, she has taken the lead on several policy priorities affecting our profession, including patient access and protections and regulatory relief. Rep. DelBene is the lead Democratic sponsor of H.R. 3107, the Improving Seniors’ Timely Access to Care Act, legislation that would streamline prior authorization in Medicare Advantage plans. The legislation hit a milestone of securing 218 cosponsors in the House, which is a majority of the members. We look forward to continuing to work with Rep. DelBene on advancing AGA’s policy priorities.
Featured microbiome investigator: Josephine Ni, MD
We’re checking in with a rising star in microbiome research: Dr. Josephine Ni from the University of Pennsylvania, Philadelphia.
Dr. Ni is an instructor of medicine at the University of Pennsylvania, and 2017 recipient of the AGA–Takeda Pharmaceuticals Research Scholar Award in IBD from the AGA Research Foundation.
Congrats to Dr. Ni! While Dr. Ni’s AGA Research Scholar Award concludes at the end of June 2020, we’re proud to share that she has secured two significant grants to continue her work: an NIH KO8 grant and a Burroughs Welcome Fund Award. We catch up with Dr. Ni in the Q&A below.
How would you sum up your research in one sentence?
I am interested in better understanding bacterial colonization of the healthy and inflamed intestinal tract; specifically, my current research focuses on characterizing the role of biofilm formation on intestinal colonization.
What effect do you hope your research will have on patients?
I hope that my work on understanding intestinal colonization will allow us to engineer the microbiota in predictable ways, which will pave the way to exclude enteropathogens, deliver specific compounds, and prevent dysbiosis.
What inspired you to focus your research career on the gut microbiome?
Being able to use data and observations from patient cohorts to generate research hypotheses and then translate those hypotheses into mouse models to explore mechanisms has been a very gratifying experience that I learned from my mentor, Gary Wu, MD. There is still so much to learn about the effects of the microbiome on intestinal health and I’m excited to be a part of this process.
What recent publication from your lab best represents your work if anyone wants to learn more?
Ni J et al. A role for bacterial urease in gut dysbiosis and Crohn’s disease. Sci Transl Med. 2017 Nov 15;9(416):eaah6888.
Gastroenterology invites submissions for an issue focused on colorectal cancer
Share your innovative basic and clinical research for consideration.
The past decade has seen significant milestones in our understanding of the epidemiology, clinical and genetic risk factors, and underlying biological mechanisms of colorectal cancer. This progress has also emphasized the need for further advances. To this end, Gastroenterology will publish a thematic issue in honor of Colorectal Cancer (CRC) Awareness Month in March 2021. The aim is to cover research highlighting novel pathways with human correlates, discoveries related to clinical interventions, clinical trials, and high-profile epidemiologic studies.
Help drive progress of CRC understanding and care by contributing your work. Enhanced promotion of the full issue and automatic indexing of your article to PubMed will increase the visibility of your research in the scientific community and beyond.
Submit your research through Gastroenterology‘s streamlined submission system: www.editorialmanager.com/gastro by Sept. 30, 2020. Original articles and brief communications are welcome.
For more information, please contact Gastroenterology’s Managing Editor, Christopher Lowe, at clowe@gastro.org.
AGA journals select editorial fellows for 2020-2021 academic year
The AGA journals Gastroenterology, Clinical Gastroenterology and Hepatology (CGH), and Cellular and Molecular Gastroenterology and Hepatology (CMGH) recently selected the recipients of their editorial fellowships, which runs from July 2020 through June 2021. The editorial fellowship program is in its fourth year.
The editorial fellows for each journal are:
Gastroenterology
Ruben Colman, MD
Cincinnati Children’s Hospital Medical Center
John Gubatan, MD
Stanford (Calif.) University Medical Center
CGH
Blake Jones, MD
University of Colorado at Denver, Aurora
Nikhil Thiruvengadam, MD
University of California, San Francisco
CMGH
Samuel Hinman, PhD
University of Washington, Seattle
The editorial fellows will be mentored on the journals’ editorial processes, including peer review and the publication process from manuscript submission to acceptance. They will participate in discussions and conferences with the boards of editors and work closely with the AGA editorial staff. Additionally, the fellows will participate in AGA’s new reviewer education program and will also be offered the opportunity to contribute content to their respective journals.
The journals’ board of editors and editorial staff congratulate the fellows and are excited to work with them over the next year.
AGA welcomes new president, M. Bishr Omary, MD, PhD, AGAF
M. Bishr Omary, MD, PhD, AGAF, will begin his term as the 115th president of the AGA Institute on June 1, 2020.
Dr. Omary, an international leader in GI biology and physiology, currently serves as senior vice chancellor for academic affairs and research for Rutgers Biomedical and Health Sciences schools, centers, and institutes at Rutgers University, Newark, N.J.
Eldest of three siblings, Dr. Omary was born and raised to Syrian parents in New York. After his father obtained his MS degree in political science from Columbia University in New York, the family returned to Damascus, Syria, where his father worked in the Ministry of Urban Planning. The family emigrated to the United States in 1968.
“I am eternally grateful to my parents from whom I learned the meaning of hard work and unconditional love. The opportunities in the U.S. open so many doors, compared with many other countries, including Syria then and especially now given the ongoing 9-year civil war that has ravaged the country,” shared Dr. Omary.
When asked about how he will approach his presidency during a global COVID-19 pandemic, Dr. Omary expressed his commitment to urgently working with and for patients, as well as our community of gastroenterologists, researchers, trainees, and other AGA members, to overcome the disruptions created by the pandemic and ultimately be in a better place than we were before. Dr. Omary holds steadfast to AGA’s vision, a world free from digestive diseases.
Dr. Omary’s primary focus, as an internationally recognized biomedical investigator, is understanding the mechanism and developing therapies for several diseases including lipodystrophies, acute liver failure, and porphyrias. He served as chief of gastroenterology and hepatology at Stanford University, then chair of physiology and chief scientific officer while at the University of Michigan, Ann Arbor, before moving to Rutgers.
Dr. Omary has been a long-time AGA leader, most notably chairing the AGA Institute Research Awards Panel and serving as senior associate editor (2006-2011) then editor in chief (2011-2016) of Gastroenterology, AGA’s premier journal.
Dr. Omary has been on the AGA Governing Board for 2 years as vice president then president-elect; his term as AGA president concludes May 2021.
Rep. Suzan DelBene (D-Wash.) leads prior authorization reform
As a member of the powerful Ways and Means Committee, which has jurisdiction over the Medicare program, Rep. DelBene has worked closely with the American Gastroenterological Association.
When Rep. DelBene was first elected to Congress in 2012, we met with her to share AGA’s policy priorities. We knew instantly that we had a voice for many of our issues. Rep. DelBene started her career as a young investigator before continuing her education and launching a career in the biotechnology industry. From her firsthand experience, she understands the need for investments in National Institutes of Health research and for access to and coverage of colorectal cancer screenings since a member of her family had the disease.
Since Rep. DelBene has been in office, she has taken the lead on several policy priorities affecting our profession, including patient access and protections and regulatory relief. Rep. DelBene is the lead Democratic sponsor of H.R. 3107, the Improving Seniors’ Timely Access to Care Act, legislation that would streamline prior authorization in Medicare Advantage plans. The legislation hit a milestone of securing 218 cosponsors in the House, which is a majority of the members. We look forward to continuing to work with Rep. DelBene on advancing AGA’s policy priorities.
Featured microbiome investigator: Josephine Ni, MD
We’re checking in with a rising star in microbiome research: Dr. Josephine Ni from the University of Pennsylvania, Philadelphia.
Dr. Ni is an instructor of medicine at the University of Pennsylvania, and 2017 recipient of the AGA–Takeda Pharmaceuticals Research Scholar Award in IBD from the AGA Research Foundation.
Congrats to Dr. Ni! While Dr. Ni’s AGA Research Scholar Award concludes at the end of June 2020, we’re proud to share that she has secured two significant grants to continue her work: an NIH KO8 grant and a Burroughs Welcome Fund Award. We catch up with Dr. Ni in the Q&A below.
How would you sum up your research in one sentence?
I am interested in better understanding bacterial colonization of the healthy and inflamed intestinal tract; specifically, my current research focuses on characterizing the role of biofilm formation on intestinal colonization.
What effect do you hope your research will have on patients?
I hope that my work on understanding intestinal colonization will allow us to engineer the microbiota in predictable ways, which will pave the way to exclude enteropathogens, deliver specific compounds, and prevent dysbiosis.
What inspired you to focus your research career on the gut microbiome?
Being able to use data and observations from patient cohorts to generate research hypotheses and then translate those hypotheses into mouse models to explore mechanisms has been a very gratifying experience that I learned from my mentor, Gary Wu, MD. There is still so much to learn about the effects of the microbiome on intestinal health and I’m excited to be a part of this process.
What recent publication from your lab best represents your work if anyone wants to learn more?
Ni J et al. A role for bacterial urease in gut dysbiosis and Crohn’s disease. Sci Transl Med. 2017 Nov 15;9(416):eaah6888.
Gastroenterology invites submissions for an issue focused on colorectal cancer
Share your innovative basic and clinical research for consideration.
The past decade has seen significant milestones in our understanding of the epidemiology, clinical and genetic risk factors, and underlying biological mechanisms of colorectal cancer. This progress has also emphasized the need for further advances. To this end, Gastroenterology will publish a thematic issue in honor of Colorectal Cancer (CRC) Awareness Month in March 2021. The aim is to cover research highlighting novel pathways with human correlates, discoveries related to clinical interventions, clinical trials, and high-profile epidemiologic studies.
Help drive progress of CRC understanding and care by contributing your work. Enhanced promotion of the full issue and automatic indexing of your article to PubMed will increase the visibility of your research in the scientific community and beyond.
Submit your research through Gastroenterology‘s streamlined submission system: www.editorialmanager.com/gastro by Sept. 30, 2020. Original articles and brief communications are welcome.
For more information, please contact Gastroenterology’s Managing Editor, Christopher Lowe, at clowe@gastro.org.
AGA journals select editorial fellows for 2020-2021 academic year
The AGA journals Gastroenterology, Clinical Gastroenterology and Hepatology (CGH), and Cellular and Molecular Gastroenterology and Hepatology (CMGH) recently selected the recipients of their editorial fellowships, which runs from July 2020 through June 2021. The editorial fellowship program is in its fourth year.
The editorial fellows for each journal are:
Gastroenterology
Ruben Colman, MD
Cincinnati Children’s Hospital Medical Center
John Gubatan, MD
Stanford (Calif.) University Medical Center
CGH
Blake Jones, MD
University of Colorado at Denver, Aurora
Nikhil Thiruvengadam, MD
University of California, San Francisco
CMGH
Samuel Hinman, PhD
University of Washington, Seattle
The editorial fellows will be mentored on the journals’ editorial processes, including peer review and the publication process from manuscript submission to acceptance. They will participate in discussions and conferences with the boards of editors and work closely with the AGA editorial staff. Additionally, the fellows will participate in AGA’s new reviewer education program and will also be offered the opportunity to contribute content to their respective journals.
The journals’ board of editors and editorial staff congratulate the fellows and are excited to work with them over the next year.
AGA welcomes new president, M. Bishr Omary, MD, PhD, AGAF
M. Bishr Omary, MD, PhD, AGAF, will begin his term as the 115th president of the AGA Institute on June 1, 2020.
Dr. Omary, an international leader in GI biology and physiology, currently serves as senior vice chancellor for academic affairs and research for Rutgers Biomedical and Health Sciences schools, centers, and institutes at Rutgers University, Newark, N.J.
Eldest of three siblings, Dr. Omary was born and raised to Syrian parents in New York. After his father obtained his MS degree in political science from Columbia University in New York, the family returned to Damascus, Syria, where his father worked in the Ministry of Urban Planning. The family emigrated to the United States in 1968.
“I am eternally grateful to my parents from whom I learned the meaning of hard work and unconditional love. The opportunities in the U.S. open so many doors, compared with many other countries, including Syria then and especially now given the ongoing 9-year civil war that has ravaged the country,” shared Dr. Omary.
When asked about how he will approach his presidency during a global COVID-19 pandemic, Dr. Omary expressed his commitment to urgently working with and for patients, as well as our community of gastroenterologists, researchers, trainees, and other AGA members, to overcome the disruptions created by the pandemic and ultimately be in a better place than we were before. Dr. Omary holds steadfast to AGA’s vision, a world free from digestive diseases.
Dr. Omary’s primary focus, as an internationally recognized biomedical investigator, is understanding the mechanism and developing therapies for several diseases including lipodystrophies, acute liver failure, and porphyrias. He served as chief of gastroenterology and hepatology at Stanford University, then chair of physiology and chief scientific officer while at the University of Michigan, Ann Arbor, before moving to Rutgers.
Dr. Omary has been a long-time AGA leader, most notably chairing the AGA Institute Research Awards Panel and serving as senior associate editor (2006-2011) then editor in chief (2011-2016) of Gastroenterology, AGA’s premier journal.
Dr. Omary has been on the AGA Governing Board for 2 years as vice president then president-elect; his term as AGA president concludes May 2021.
FDA approves Tremfya (guselkumab) for psoriatic arthritis
, according to a July 14 announcement from its manufacturer, Janssen.
The FDA’s approval marks the second indication for guselkumab, which was first approved for adults with plaque psoriasis in 2017.
The agency based its approval on two pivotal phase 3 clinical trials, DISCOVER-1 and DISCOVER-2, which tested the biologic in 1,120 adults with active PsA who were naive to biologics (both trials) or had an inadequate response or intolerance to one or two tumor necrosis factor inhibitors (in about 30% of patients in DISCOVER-1). Part of this pretrial standard treatment could include at least 4 months of Otezla (apremilast), at least 3 months of nonbiologic disease-modifying antirheumatic drugs (DMARDs), or at least 4 weeks of NSAIDs. In both trials, about 58% of patients took methotrexate.
Participants who took guselkumab achieved 20% improvement in American College of Rheumatology response criteria at week 24 at rates of 52% in DISCOVER-1 and 64% in DISCOVER-2, whereas placebo-treated patients had rates of 22% and 33%, respectively.
Guselkumab improved patients’ other symptoms, including skin manifestations of psoriasis, physical functioning, enthesitis, dactylitis, and fatigue, according to the Janssen release.
Guselkumab, a fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23, is administered as a 100-mg subcutaneous injection every 8 weeks, following two starter doses at weeks 0 and 4, and can be used alone or in combination with a conventional DMARD.
In guselkumab clinical trials of patients with PsA, a minority had bronchitis or a decreased neutrophil count, but the safety profile was otherwise generally consistent with what has been seen in patients with plaque psoriasis, according to the company release. Other common side effects described in 1% or more of patients have included upper respiratory infections, headache, injection-site reactions, arthralgia, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections.
, according to a July 14 announcement from its manufacturer, Janssen.
The FDA’s approval marks the second indication for guselkumab, which was first approved for adults with plaque psoriasis in 2017.
The agency based its approval on two pivotal phase 3 clinical trials, DISCOVER-1 and DISCOVER-2, which tested the biologic in 1,120 adults with active PsA who were naive to biologics (both trials) or had an inadequate response or intolerance to one or two tumor necrosis factor inhibitors (in about 30% of patients in DISCOVER-1). Part of this pretrial standard treatment could include at least 4 months of Otezla (apremilast), at least 3 months of nonbiologic disease-modifying antirheumatic drugs (DMARDs), or at least 4 weeks of NSAIDs. In both trials, about 58% of patients took methotrexate.
Participants who took guselkumab achieved 20% improvement in American College of Rheumatology response criteria at week 24 at rates of 52% in DISCOVER-1 and 64% in DISCOVER-2, whereas placebo-treated patients had rates of 22% and 33%, respectively.
Guselkumab improved patients’ other symptoms, including skin manifestations of psoriasis, physical functioning, enthesitis, dactylitis, and fatigue, according to the Janssen release.
Guselkumab, a fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23, is administered as a 100-mg subcutaneous injection every 8 weeks, following two starter doses at weeks 0 and 4, and can be used alone or in combination with a conventional DMARD.
In guselkumab clinical trials of patients with PsA, a minority had bronchitis or a decreased neutrophil count, but the safety profile was otherwise generally consistent with what has been seen in patients with plaque psoriasis, according to the company release. Other common side effects described in 1% or more of patients have included upper respiratory infections, headache, injection-site reactions, arthralgia, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections.
, according to a July 14 announcement from its manufacturer, Janssen.
The FDA’s approval marks the second indication for guselkumab, which was first approved for adults with plaque psoriasis in 2017.
The agency based its approval on two pivotal phase 3 clinical trials, DISCOVER-1 and DISCOVER-2, which tested the biologic in 1,120 adults with active PsA who were naive to biologics (both trials) or had an inadequate response or intolerance to one or two tumor necrosis factor inhibitors (in about 30% of patients in DISCOVER-1). Part of this pretrial standard treatment could include at least 4 months of Otezla (apremilast), at least 3 months of nonbiologic disease-modifying antirheumatic drugs (DMARDs), or at least 4 weeks of NSAIDs. In both trials, about 58% of patients took methotrexate.
Participants who took guselkumab achieved 20% improvement in American College of Rheumatology response criteria at week 24 at rates of 52% in DISCOVER-1 and 64% in DISCOVER-2, whereas placebo-treated patients had rates of 22% and 33%, respectively.
Guselkumab improved patients’ other symptoms, including skin manifestations of psoriasis, physical functioning, enthesitis, dactylitis, and fatigue, according to the Janssen release.
Guselkumab, a fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23, is administered as a 100-mg subcutaneous injection every 8 weeks, following two starter doses at weeks 0 and 4, and can be used alone or in combination with a conventional DMARD.
In guselkumab clinical trials of patients with PsA, a minority had bronchitis or a decreased neutrophil count, but the safety profile was otherwise generally consistent with what has been seen in patients with plaque psoriasis, according to the company release. Other common side effects described in 1% or more of patients have included upper respiratory infections, headache, injection-site reactions, arthralgia, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections.
The public’s trust in science
Having been a bench research scientist 30 years ago, I am flabbergasted at what is and is not currently possible. In a few weeks, scientists sequenced a novel coronavirus and used the genetic sequence to select candidate molecules for a vaccine. But we still can’t reliably say how much protection a cloth mask provides. Worse yet, even if/when we could reliably quantify contagion, it isn’t clear that the public will believe us anyhow.
The good news is that the public worldwide did believe scientists about the threat of a pandemic and the need to flatten the curve. Saving lives has not been about the strength of an antibiotic or the skill in managing a ventilator, but the credibility of medical scientists. The degree of acceptance was variable and subject to a variety of delays caused by regional politicians, but The bad news is that the public’s trust in that scientific advice has waned, the willingness to accept onerous restrictions has fatigued, and the cooperation for maintaining these social changes is evaporating.
I will leave pontificating about the spread of COVID-19 to other experts in other forums. My focus is on the public’s trust in the professionalism of physicians, nurses, medical scientists, and the health care industry as a whole. That trust has been our most valuable tool in fighting the pandemic so far. There have been situations in which weaknesses in modern science have let society down during the pandemic of the century. In my February 2020 column, at the beginning of the outbreak, a month before it was declared a pandemic, when its magnitude was still unclear, I emphasized the importance of having a trusted scientific spokesperson providing timely, accurate information to the public. That, obviously, did not happen in the United States and the degree of the ensuing disaster is still to be revealed.
Scientists have made some wrong decisions about this novel threat. The advice on masks is an illustrative example. For many years, infection control nurses have insisted that medical students wear a mask to protect themselves, even if they were observing rounds from just inside the doorway of a room of a baby with bronchiolitis. The landfills are full of briefly worn surgical masks. Now the story goes: Surgical masks don’t protect staff; they protect others. Changes like that contribute to a credibility gap.
For 3 months, there was conflicting advice about the appropriateness of masks. In early March 2020, some health care workers were disciplined for wearing personal masks. Now, most scientists recommend the public use masks to reduce contagion. Significant subgroups in the U.S. population have refused, mostly to signal their contrarian politics. In June there was an anecdote of a success story from the Show Me state of Missouri, where a mask is credited for preventing an outbreak from a sick hair stylist.
It is hard to find something more reliable than an anecdote. On June 1, a meta-analysis funded by the World Health Organization was published online by Lancet. It supports the idea that masks are beneficial. It is mostly forest plots, so you can try to interpret it yourself. There were 172 observational studies in the systematic review, and the meta-analysis contains 44 relevant comparative studies and 0 randomized controlled trials. Most of those forest plots have an I2 of 75% or worse, which to me indicates that they are not much more reliable than a good anecdote. My primary conclusion was that modern academic science, in an era with a shortage of toilet paper, should convert to printing on soft tissue paper.
It is important to note that the guesstimated overall benefit of cloth masks was a relative risk of 0.30. That benefit is easily nullified if the false security of a mask causes people to congregate together in groups three times larger or for three times more minutes. N95 masks were more effective.
A different article was published in PNAS on June 11. Its senior author was awarded the Nobel Prize in Chemistry in 1995. That article touted the benefits of masks. The article is facing heavy criticism for flaws in methodology and flaws in the peer review process. A long list of signatories have joined a letter asking for the article’s retraction.
This article, when combined with the two instances of prominent articles being retracted in the prior month by the New England Journal of Medicine and The Lancet, is accumulating evidence the peer review system is not working as intended.
There are many heroes in this pandemic, from the frontline health care workers in hotspots to the grocery workers and cleaning staff. There is hope, indeed some faith, that medical scientists in the foreseeable future will provide treatments and a vaccine for this viral plague. This month, the credibility of scientists again plays a major role as communities respond to outbreaks related to reopening the economy. Let’s celebrate the victories, resolve to fix the impure system, and restore a high level of public trust in science. Lives depend on it.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no relevant financial disclosures. Email him at pdnews@mdedge.com.
Having been a bench research scientist 30 years ago, I am flabbergasted at what is and is not currently possible. In a few weeks, scientists sequenced a novel coronavirus and used the genetic sequence to select candidate molecules for a vaccine. But we still can’t reliably say how much protection a cloth mask provides. Worse yet, even if/when we could reliably quantify contagion, it isn’t clear that the public will believe us anyhow.
The good news is that the public worldwide did believe scientists about the threat of a pandemic and the need to flatten the curve. Saving lives has not been about the strength of an antibiotic or the skill in managing a ventilator, but the credibility of medical scientists. The degree of acceptance was variable and subject to a variety of delays caused by regional politicians, but The bad news is that the public’s trust in that scientific advice has waned, the willingness to accept onerous restrictions has fatigued, and the cooperation for maintaining these social changes is evaporating.
I will leave pontificating about the spread of COVID-19 to other experts in other forums. My focus is on the public’s trust in the professionalism of physicians, nurses, medical scientists, and the health care industry as a whole. That trust has been our most valuable tool in fighting the pandemic so far. There have been situations in which weaknesses in modern science have let society down during the pandemic of the century. In my February 2020 column, at the beginning of the outbreak, a month before it was declared a pandemic, when its magnitude was still unclear, I emphasized the importance of having a trusted scientific spokesperson providing timely, accurate information to the public. That, obviously, did not happen in the United States and the degree of the ensuing disaster is still to be revealed.
Scientists have made some wrong decisions about this novel threat. The advice on masks is an illustrative example. For many years, infection control nurses have insisted that medical students wear a mask to protect themselves, even if they were observing rounds from just inside the doorway of a room of a baby with bronchiolitis. The landfills are full of briefly worn surgical masks. Now the story goes: Surgical masks don’t protect staff; they protect others. Changes like that contribute to a credibility gap.
For 3 months, there was conflicting advice about the appropriateness of masks. In early March 2020, some health care workers were disciplined for wearing personal masks. Now, most scientists recommend the public use masks to reduce contagion. Significant subgroups in the U.S. population have refused, mostly to signal their contrarian politics. In June there was an anecdote of a success story from the Show Me state of Missouri, where a mask is credited for preventing an outbreak from a sick hair stylist.
It is hard to find something more reliable than an anecdote. On June 1, a meta-analysis funded by the World Health Organization was published online by Lancet. It supports the idea that masks are beneficial. It is mostly forest plots, so you can try to interpret it yourself. There were 172 observational studies in the systematic review, and the meta-analysis contains 44 relevant comparative studies and 0 randomized controlled trials. Most of those forest plots have an I2 of 75% or worse, which to me indicates that they are not much more reliable than a good anecdote. My primary conclusion was that modern academic science, in an era with a shortage of toilet paper, should convert to printing on soft tissue paper.
It is important to note that the guesstimated overall benefit of cloth masks was a relative risk of 0.30. That benefit is easily nullified if the false security of a mask causes people to congregate together in groups three times larger or for three times more minutes. N95 masks were more effective.
A different article was published in PNAS on June 11. Its senior author was awarded the Nobel Prize in Chemistry in 1995. That article touted the benefits of masks. The article is facing heavy criticism for flaws in methodology and flaws in the peer review process. A long list of signatories have joined a letter asking for the article’s retraction.
This article, when combined with the two instances of prominent articles being retracted in the prior month by the New England Journal of Medicine and The Lancet, is accumulating evidence the peer review system is not working as intended.
There are many heroes in this pandemic, from the frontline health care workers in hotspots to the grocery workers and cleaning staff. There is hope, indeed some faith, that medical scientists in the foreseeable future will provide treatments and a vaccine for this viral plague. This month, the credibility of scientists again plays a major role as communities respond to outbreaks related to reopening the economy. Let’s celebrate the victories, resolve to fix the impure system, and restore a high level of public trust in science. Lives depend on it.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no relevant financial disclosures. Email him at pdnews@mdedge.com.
Having been a bench research scientist 30 years ago, I am flabbergasted at what is and is not currently possible. In a few weeks, scientists sequenced a novel coronavirus and used the genetic sequence to select candidate molecules for a vaccine. But we still can’t reliably say how much protection a cloth mask provides. Worse yet, even if/when we could reliably quantify contagion, it isn’t clear that the public will believe us anyhow.
The good news is that the public worldwide did believe scientists about the threat of a pandemic and the need to flatten the curve. Saving lives has not been about the strength of an antibiotic or the skill in managing a ventilator, but the credibility of medical scientists. The degree of acceptance was variable and subject to a variety of delays caused by regional politicians, but The bad news is that the public’s trust in that scientific advice has waned, the willingness to accept onerous restrictions has fatigued, and the cooperation for maintaining these social changes is evaporating.
I will leave pontificating about the spread of COVID-19 to other experts in other forums. My focus is on the public’s trust in the professionalism of physicians, nurses, medical scientists, and the health care industry as a whole. That trust has been our most valuable tool in fighting the pandemic so far. There have been situations in which weaknesses in modern science have let society down during the pandemic of the century. In my February 2020 column, at the beginning of the outbreak, a month before it was declared a pandemic, when its magnitude was still unclear, I emphasized the importance of having a trusted scientific spokesperson providing timely, accurate information to the public. That, obviously, did not happen in the United States and the degree of the ensuing disaster is still to be revealed.
Scientists have made some wrong decisions about this novel threat. The advice on masks is an illustrative example. For many years, infection control nurses have insisted that medical students wear a mask to protect themselves, even if they were observing rounds from just inside the doorway of a room of a baby with bronchiolitis. The landfills are full of briefly worn surgical masks. Now the story goes: Surgical masks don’t protect staff; they protect others. Changes like that contribute to a credibility gap.
For 3 months, there was conflicting advice about the appropriateness of masks. In early March 2020, some health care workers were disciplined for wearing personal masks. Now, most scientists recommend the public use masks to reduce contagion. Significant subgroups in the U.S. population have refused, mostly to signal their contrarian politics. In June there was an anecdote of a success story from the Show Me state of Missouri, where a mask is credited for preventing an outbreak from a sick hair stylist.
It is hard to find something more reliable than an anecdote. On June 1, a meta-analysis funded by the World Health Organization was published online by Lancet. It supports the idea that masks are beneficial. It is mostly forest plots, so you can try to interpret it yourself. There were 172 observational studies in the systematic review, and the meta-analysis contains 44 relevant comparative studies and 0 randomized controlled trials. Most of those forest plots have an I2 of 75% or worse, which to me indicates that they are not much more reliable than a good anecdote. My primary conclusion was that modern academic science, in an era with a shortage of toilet paper, should convert to printing on soft tissue paper.
It is important to note that the guesstimated overall benefit of cloth masks was a relative risk of 0.30. That benefit is easily nullified if the false security of a mask causes people to congregate together in groups three times larger or for three times more minutes. N95 masks were more effective.
A different article was published in PNAS on June 11. Its senior author was awarded the Nobel Prize in Chemistry in 1995. That article touted the benefits of masks. The article is facing heavy criticism for flaws in methodology and flaws in the peer review process. A long list of signatories have joined a letter asking for the article’s retraction.
This article, when combined with the two instances of prominent articles being retracted in the prior month by the New England Journal of Medicine and The Lancet, is accumulating evidence the peer review system is not working as intended.
There are many heroes in this pandemic, from the frontline health care workers in hotspots to the grocery workers and cleaning staff. There is hope, indeed some faith, that medical scientists in the foreseeable future will provide treatments and a vaccine for this viral plague. This month, the credibility of scientists again plays a major role as communities respond to outbreaks related to reopening the economy. Let’s celebrate the victories, resolve to fix the impure system, and restore a high level of public trust in science. Lives depend on it.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no relevant financial disclosures. Email him at pdnews@mdedge.com.
Real-time, computer-aided detection system significantly improved adenoma detection
A real-time, computer-aided detection system using artificial intelligence significantly improved adenoma detection during high-definition colonoscopy in a multicenter, randomized clinical trial.
The adenoma detection rate was 55% in the intervention group and 40% in the control group, Alessandro Repici, MD, PhD, and his associates wrote in Gastroenterology. Improved detection of smaller adenomas explained the difference. After age, sex, and indication for colonoscopy were controlled for, computer-aided detection (CADe) increased the probability of adenoma detection by 30% (risk ratio, 1.30; 95% confidence interval, 1.14-1.45).
The CADe system did not increase the likelihood of resecting non-neoplastic lesions (26% versus 29% in the control group), said Dr. Repici, of Humanitas Research Hospital in Milano, Italy. “The per-protocol analysis produced similar results,” he and his associates wrote. “The substantial improvement for adenoma detection rate and mean number of adenomas per colonoscopy, without increasing the removal of nonneoplastic lesions, is likely to improve the quality of colonoscopy without affecting its efficiency.”
Screening colonoscopies miss about 25% of adenomas, increasing patients’ risk for colorectal cancer. Although real-time CADe systems can identify colorectal neoplasias, comprehensive studies of the effect of CADe systems on adenoma detection and other colonoscopy quality measures are lacking.
The study included 685 adults from three centers in Italy who underwent screening colonoscopies for colorectal cancer, postpolypectomy surveillance, or workup based on a positive fecal immunochemical test or signs and symptoms of colorectal cancer. Patients were randomly assigned on a one-to-one basis to receive high-definition colonoscopies with or without the CADe system, which consists of an artificial intelligence–based medical device (GI Genius, Medtronic) that processes colonoscopy images in real time and superimposes a green box over suspected lesions. Six experienced endoscopists performed the colonoscopies; the minimum withdrawal time was 6 minutes, and histopathology was the reference standard.
The average number of adenomas detected per colonoscopy was 1.1 (standard deviation, 0.5) in the CADe group and 0.7 (SD, 1.2) in the control group, for an incidence rate ratio of 1.46 (95% CI, 1.15-1.86). The CADe system also significantly improved the detection of adenomas measuring 5 mm or less (34% vs. 27% in the control group; RR, 1.26; 95% CI, 1.01-1.52) and adenomas measuring 6-9 mm (11% vs. 6%, respectively; RR, 1.78; 95% CI, 1.09-2.86). Detection of larger adenomas did not significantly differ between groups. These findings did not vary based on adenoma morphology (polypoid or nonpolypoid) or location (proximal or distal colon), the researchers said.
Detection of multiple adenomas also was higher in the intervention group than in the control group (23% vs. 15%, respectively; RR, 1.50; 95% CI, 1.19-1.95). There were no significant differences in the detection of sessile serrated lesions (7% and 5%) and nonneoplastic lesions (20% and 17%). Average withdrawal times did not significantly differ between groups (417 seconds for CADe and 435 seconds for the control group).
The CADe system is a convolutional neural network that was trained and validated using a series of more than 2,600 histologically confirmed polyps from 840 participants in a prior clinical trial (Gastroenterology 2019;156:2198-207.e1). The system takes an average of 1.5 microseconds to output processed images.
“The addition of real-time CADe to colonoscopy resulted in a 30% and 46% relative increase in adenoma detection rate and the average number of adenomas detected per colonoscopy, demonstrating its efficacy in improving the detection of colorectal neoplasia at screening and diagnostic colonoscopy,” the investigators wrote. “[The s]afety of CADe was demonstrated by the lack of increase of both useless resections and withdrawal time, as well as by the exclusion of any underskilling in the study period.”
Medtronic loaned the equipment for the study. Dr. Repici and the senior author disclosed consulting fees from Medtronic.
SOURCE: Repici A et al. Gastroenterology. 2020 May 3. doi: 10.1053/j.gastro.2020.04.062.
A real-time, computer-aided detection system using artificial intelligence significantly improved adenoma detection during high-definition colonoscopy in a multicenter, randomized clinical trial.
The adenoma detection rate was 55% in the intervention group and 40% in the control group, Alessandro Repici, MD, PhD, and his associates wrote in Gastroenterology. Improved detection of smaller adenomas explained the difference. After age, sex, and indication for colonoscopy were controlled for, computer-aided detection (CADe) increased the probability of adenoma detection by 30% (risk ratio, 1.30; 95% confidence interval, 1.14-1.45).
The CADe system did not increase the likelihood of resecting non-neoplastic lesions (26% versus 29% in the control group), said Dr. Repici, of Humanitas Research Hospital in Milano, Italy. “The per-protocol analysis produced similar results,” he and his associates wrote. “The substantial improvement for adenoma detection rate and mean number of adenomas per colonoscopy, without increasing the removal of nonneoplastic lesions, is likely to improve the quality of colonoscopy without affecting its efficiency.”
Screening colonoscopies miss about 25% of adenomas, increasing patients’ risk for colorectal cancer. Although real-time CADe systems can identify colorectal neoplasias, comprehensive studies of the effect of CADe systems on adenoma detection and other colonoscopy quality measures are lacking.
The study included 685 adults from three centers in Italy who underwent screening colonoscopies for colorectal cancer, postpolypectomy surveillance, or workup based on a positive fecal immunochemical test or signs and symptoms of colorectal cancer. Patients were randomly assigned on a one-to-one basis to receive high-definition colonoscopies with or without the CADe system, which consists of an artificial intelligence–based medical device (GI Genius, Medtronic) that processes colonoscopy images in real time and superimposes a green box over suspected lesions. Six experienced endoscopists performed the colonoscopies; the minimum withdrawal time was 6 minutes, and histopathology was the reference standard.
The average number of adenomas detected per colonoscopy was 1.1 (standard deviation, 0.5) in the CADe group and 0.7 (SD, 1.2) in the control group, for an incidence rate ratio of 1.46 (95% CI, 1.15-1.86). The CADe system also significantly improved the detection of adenomas measuring 5 mm or less (34% vs. 27% in the control group; RR, 1.26; 95% CI, 1.01-1.52) and adenomas measuring 6-9 mm (11% vs. 6%, respectively; RR, 1.78; 95% CI, 1.09-2.86). Detection of larger adenomas did not significantly differ between groups. These findings did not vary based on adenoma morphology (polypoid or nonpolypoid) or location (proximal or distal colon), the researchers said.
Detection of multiple adenomas also was higher in the intervention group than in the control group (23% vs. 15%, respectively; RR, 1.50; 95% CI, 1.19-1.95). There were no significant differences in the detection of sessile serrated lesions (7% and 5%) and nonneoplastic lesions (20% and 17%). Average withdrawal times did not significantly differ between groups (417 seconds for CADe and 435 seconds for the control group).
The CADe system is a convolutional neural network that was trained and validated using a series of more than 2,600 histologically confirmed polyps from 840 participants in a prior clinical trial (Gastroenterology 2019;156:2198-207.e1). The system takes an average of 1.5 microseconds to output processed images.
“The addition of real-time CADe to colonoscopy resulted in a 30% and 46% relative increase in adenoma detection rate and the average number of adenomas detected per colonoscopy, demonstrating its efficacy in improving the detection of colorectal neoplasia at screening and diagnostic colonoscopy,” the investigators wrote. “[The s]afety of CADe was demonstrated by the lack of increase of both useless resections and withdrawal time, as well as by the exclusion of any underskilling in the study period.”
Medtronic loaned the equipment for the study. Dr. Repici and the senior author disclosed consulting fees from Medtronic.
SOURCE: Repici A et al. Gastroenterology. 2020 May 3. doi: 10.1053/j.gastro.2020.04.062.
A real-time, computer-aided detection system using artificial intelligence significantly improved adenoma detection during high-definition colonoscopy in a multicenter, randomized clinical trial.
The adenoma detection rate was 55% in the intervention group and 40% in the control group, Alessandro Repici, MD, PhD, and his associates wrote in Gastroenterology. Improved detection of smaller adenomas explained the difference. After age, sex, and indication for colonoscopy were controlled for, computer-aided detection (CADe) increased the probability of adenoma detection by 30% (risk ratio, 1.30; 95% confidence interval, 1.14-1.45).
The CADe system did not increase the likelihood of resecting non-neoplastic lesions (26% versus 29% in the control group), said Dr. Repici, of Humanitas Research Hospital in Milano, Italy. “The per-protocol analysis produced similar results,” he and his associates wrote. “The substantial improvement for adenoma detection rate and mean number of adenomas per colonoscopy, without increasing the removal of nonneoplastic lesions, is likely to improve the quality of colonoscopy without affecting its efficiency.”
Screening colonoscopies miss about 25% of adenomas, increasing patients’ risk for colorectal cancer. Although real-time CADe systems can identify colorectal neoplasias, comprehensive studies of the effect of CADe systems on adenoma detection and other colonoscopy quality measures are lacking.
The study included 685 adults from three centers in Italy who underwent screening colonoscopies for colorectal cancer, postpolypectomy surveillance, or workup based on a positive fecal immunochemical test or signs and symptoms of colorectal cancer. Patients were randomly assigned on a one-to-one basis to receive high-definition colonoscopies with or without the CADe system, which consists of an artificial intelligence–based medical device (GI Genius, Medtronic) that processes colonoscopy images in real time and superimposes a green box over suspected lesions. Six experienced endoscopists performed the colonoscopies; the minimum withdrawal time was 6 minutes, and histopathology was the reference standard.
The average number of adenomas detected per colonoscopy was 1.1 (standard deviation, 0.5) in the CADe group and 0.7 (SD, 1.2) in the control group, for an incidence rate ratio of 1.46 (95% CI, 1.15-1.86). The CADe system also significantly improved the detection of adenomas measuring 5 mm or less (34% vs. 27% in the control group; RR, 1.26; 95% CI, 1.01-1.52) and adenomas measuring 6-9 mm (11% vs. 6%, respectively; RR, 1.78; 95% CI, 1.09-2.86). Detection of larger adenomas did not significantly differ between groups. These findings did not vary based on adenoma morphology (polypoid or nonpolypoid) or location (proximal or distal colon), the researchers said.
Detection of multiple adenomas also was higher in the intervention group than in the control group (23% vs. 15%, respectively; RR, 1.50; 95% CI, 1.19-1.95). There were no significant differences in the detection of sessile serrated lesions (7% and 5%) and nonneoplastic lesions (20% and 17%). Average withdrawal times did not significantly differ between groups (417 seconds for CADe and 435 seconds for the control group).
The CADe system is a convolutional neural network that was trained and validated using a series of more than 2,600 histologically confirmed polyps from 840 participants in a prior clinical trial (Gastroenterology 2019;156:2198-207.e1). The system takes an average of 1.5 microseconds to output processed images.
“The addition of real-time CADe to colonoscopy resulted in a 30% and 46% relative increase in adenoma detection rate and the average number of adenomas detected per colonoscopy, demonstrating its efficacy in improving the detection of colorectal neoplasia at screening and diagnostic colonoscopy,” the investigators wrote. “[The s]afety of CADe was demonstrated by the lack of increase of both useless resections and withdrawal time, as well as by the exclusion of any underskilling in the study period.”
Medtronic loaned the equipment for the study. Dr. Repici and the senior author disclosed consulting fees from Medtronic.
SOURCE: Repici A et al. Gastroenterology. 2020 May 3. doi: 10.1053/j.gastro.2020.04.062.
FROM GASTROENTEROLOGY
High-def chromoendoscopy better for detecting dysplasias in patients with IBD
High-definition chromoendoscopy significantly outperformed high-definition white-light endoscopy for detecting dysplastic lesions in patients with inflammatory bowel disease, according to the findings of a single-center prospective randomized trial.
In the intention-to-diagnose analysis, rates of dysplasia detection were 11% for high-definition chromoendoscopy and 5% for high-definition white-light endoscopy (P = .032). The per-protocol analysis produced a similar result (12% vs. 5%, respectively; P = .027). High-definition chromoendoscopy also detected significantly more dysplastic lesions per 10 minutes of colonoscope withdrawal time in the per-protocol analysis, although the difference did not reach statistical significance in the intention-to-diagnose analysis.
Overall, the findings “support the use of chromoendoscopy for surveillance of patients with inflammatory bowel diseases,” Bjarki Alexandersson, a PhD student at Karolinska University Hospital in Solna, Stockholm, and his associates wrote in Clinical Gastroenterology and Hepatology. Patients with inflammatory bowel disease are at increased risk for colorectal cancer. Most guidelines support chromoendoscopy for the surveillance of these patients, as do the results of two recent meta-analyses in which chromoendoscopy detected significantly more dysplasias among patients with inflammatory bowel disease than did white light endoscopy. However, in subgroup analyses of these studies, the difference only emerged when comparing chromoendoscopy with standard (not high-definition) white-light endoscopy. “Thus, the evidence in support of chromoendoscopy using high-definition endoscopes is weak,” the researchers wrote.
For the study, they prospectively enrolled 305 patients with ulcerative colitis or Crohn’s disease who were referred for surveillance colonoscopy at an academic hospital in Sweden from March 2011 through April 2016. Participants were randomly assigned to receive either high-definition chromoendoscopy with indigo carmine (152 patients) or high-definition white-light endoscopy (153 patients).
In the intention-to-diagnose analysis, dysplasias were detected in 17 (11%) patients evaluated by high-definition chromoendoscopy, compared with 7 (5%) patients evaluated by high-definition white-light endoscopy (P = .032). After excluding 20 patients for inadequate bowel preparation, 18 patients for protocol violations, and 4 patients for incomplete colonoscopies, the per-protocol population consisted of 263 patients. Dysplasias were detected in 12% of patients evaluated by high-definition chromoendoscopy and in 5% of those evaluated by high-definition white-light endoscopy (P = .027).
All patients also had 32 samples collected by random biopsy, which used to be standard for detecting dysplasia in inflammatory bowel disease but has become more controversial in the era of video endoscopy, the researchers noted. In all, random biopsy evaluation identified dysplasias in nine patients, including six in the high-definition chromoendoscopy group and three in the high-definition white-light endoscopy group. Random biopsies were low-yield, identifying dysplasias in 0.092% of all specimens and 3% of colonoscopies. However, 20% of patients with dysplasias were identified only through random biopsy. This finding resembles that of another recent randomized trial in which 13% of patients with inflammatory bowel disease had dysplasias detected only through random biopsy (Gut. 2018;67:616-24), the researchers noted.
They also evaluated the number of macroscopic dysplastic lesions identified for every 10 minutes of colonoscope withdrawal time. These numbers were not significantly different in the intention-to-diagnose analysis (0.066 lesions in the high-definition chromoendoscopy group vs. 0.027 lesions in the high-definition white-light endoscopy group; P = .056). However, the per-protocol analysis revealed a significant difference (0.073 vs. 0.029 dysplastic lesions, respectively; P = .031).
“Based on our findings, we recommend the use of high-definition chromoendoscopy in inflammatory bowel disease surveillance,” the researchers concluded. They acknowledged several limitations: the study included patients from only one center, most dyplastic lesions were small and, thus, had an unclear natural history, and the endoscopists included both experts and nonexperts.
The Stockholm City Council provided funding. The researchers reported having no conflicts of interest.
SOURCE: Alexandersson B et al. Clin Gastroenterol Hepatol. 2020 Apr 27. doi: 10.1016/j.cgh.2020.04.049.
High-definition chromoendoscopy significantly outperformed high-definition white-light endoscopy for detecting dysplastic lesions in patients with inflammatory bowel disease, according to the findings of a single-center prospective randomized trial.
In the intention-to-diagnose analysis, rates of dysplasia detection were 11% for high-definition chromoendoscopy and 5% for high-definition white-light endoscopy (P = .032). The per-protocol analysis produced a similar result (12% vs. 5%, respectively; P = .027). High-definition chromoendoscopy also detected significantly more dysplastic lesions per 10 minutes of colonoscope withdrawal time in the per-protocol analysis, although the difference did not reach statistical significance in the intention-to-diagnose analysis.
Overall, the findings “support the use of chromoendoscopy for surveillance of patients with inflammatory bowel diseases,” Bjarki Alexandersson, a PhD student at Karolinska University Hospital in Solna, Stockholm, and his associates wrote in Clinical Gastroenterology and Hepatology. Patients with inflammatory bowel disease are at increased risk for colorectal cancer. Most guidelines support chromoendoscopy for the surveillance of these patients, as do the results of two recent meta-analyses in which chromoendoscopy detected significantly more dysplasias among patients with inflammatory bowel disease than did white light endoscopy. However, in subgroup analyses of these studies, the difference only emerged when comparing chromoendoscopy with standard (not high-definition) white-light endoscopy. “Thus, the evidence in support of chromoendoscopy using high-definition endoscopes is weak,” the researchers wrote.
For the study, they prospectively enrolled 305 patients with ulcerative colitis or Crohn’s disease who were referred for surveillance colonoscopy at an academic hospital in Sweden from March 2011 through April 2016. Participants were randomly assigned to receive either high-definition chromoendoscopy with indigo carmine (152 patients) or high-definition white-light endoscopy (153 patients).
In the intention-to-diagnose analysis, dysplasias were detected in 17 (11%) patients evaluated by high-definition chromoendoscopy, compared with 7 (5%) patients evaluated by high-definition white-light endoscopy (P = .032). After excluding 20 patients for inadequate bowel preparation, 18 patients for protocol violations, and 4 patients for incomplete colonoscopies, the per-protocol population consisted of 263 patients. Dysplasias were detected in 12% of patients evaluated by high-definition chromoendoscopy and in 5% of those evaluated by high-definition white-light endoscopy (P = .027).
All patients also had 32 samples collected by random biopsy, which used to be standard for detecting dysplasia in inflammatory bowel disease but has become more controversial in the era of video endoscopy, the researchers noted. In all, random biopsy evaluation identified dysplasias in nine patients, including six in the high-definition chromoendoscopy group and three in the high-definition white-light endoscopy group. Random biopsies were low-yield, identifying dysplasias in 0.092% of all specimens and 3% of colonoscopies. However, 20% of patients with dysplasias were identified only through random biopsy. This finding resembles that of another recent randomized trial in which 13% of patients with inflammatory bowel disease had dysplasias detected only through random biopsy (Gut. 2018;67:616-24), the researchers noted.
They also evaluated the number of macroscopic dysplastic lesions identified for every 10 minutes of colonoscope withdrawal time. These numbers were not significantly different in the intention-to-diagnose analysis (0.066 lesions in the high-definition chromoendoscopy group vs. 0.027 lesions in the high-definition white-light endoscopy group; P = .056). However, the per-protocol analysis revealed a significant difference (0.073 vs. 0.029 dysplastic lesions, respectively; P = .031).
“Based on our findings, we recommend the use of high-definition chromoendoscopy in inflammatory bowel disease surveillance,” the researchers concluded. They acknowledged several limitations: the study included patients from only one center, most dyplastic lesions were small and, thus, had an unclear natural history, and the endoscopists included both experts and nonexperts.
The Stockholm City Council provided funding. The researchers reported having no conflicts of interest.
SOURCE: Alexandersson B et al. Clin Gastroenterol Hepatol. 2020 Apr 27. doi: 10.1016/j.cgh.2020.04.049.
High-definition chromoendoscopy significantly outperformed high-definition white-light endoscopy for detecting dysplastic lesions in patients with inflammatory bowel disease, according to the findings of a single-center prospective randomized trial.
In the intention-to-diagnose analysis, rates of dysplasia detection were 11% for high-definition chromoendoscopy and 5% for high-definition white-light endoscopy (P = .032). The per-protocol analysis produced a similar result (12% vs. 5%, respectively; P = .027). High-definition chromoendoscopy also detected significantly more dysplastic lesions per 10 minutes of colonoscope withdrawal time in the per-protocol analysis, although the difference did not reach statistical significance in the intention-to-diagnose analysis.
Overall, the findings “support the use of chromoendoscopy for surveillance of patients with inflammatory bowel diseases,” Bjarki Alexandersson, a PhD student at Karolinska University Hospital in Solna, Stockholm, and his associates wrote in Clinical Gastroenterology and Hepatology. Patients with inflammatory bowel disease are at increased risk for colorectal cancer. Most guidelines support chromoendoscopy for the surveillance of these patients, as do the results of two recent meta-analyses in which chromoendoscopy detected significantly more dysplasias among patients with inflammatory bowel disease than did white light endoscopy. However, in subgroup analyses of these studies, the difference only emerged when comparing chromoendoscopy with standard (not high-definition) white-light endoscopy. “Thus, the evidence in support of chromoendoscopy using high-definition endoscopes is weak,” the researchers wrote.
For the study, they prospectively enrolled 305 patients with ulcerative colitis or Crohn’s disease who were referred for surveillance colonoscopy at an academic hospital in Sweden from March 2011 through April 2016. Participants were randomly assigned to receive either high-definition chromoendoscopy with indigo carmine (152 patients) or high-definition white-light endoscopy (153 patients).
In the intention-to-diagnose analysis, dysplasias were detected in 17 (11%) patients evaluated by high-definition chromoendoscopy, compared with 7 (5%) patients evaluated by high-definition white-light endoscopy (P = .032). After excluding 20 patients for inadequate bowel preparation, 18 patients for protocol violations, and 4 patients for incomplete colonoscopies, the per-protocol population consisted of 263 patients. Dysplasias were detected in 12% of patients evaluated by high-definition chromoendoscopy and in 5% of those evaluated by high-definition white-light endoscopy (P = .027).
All patients also had 32 samples collected by random biopsy, which used to be standard for detecting dysplasia in inflammatory bowel disease but has become more controversial in the era of video endoscopy, the researchers noted. In all, random biopsy evaluation identified dysplasias in nine patients, including six in the high-definition chromoendoscopy group and three in the high-definition white-light endoscopy group. Random biopsies were low-yield, identifying dysplasias in 0.092% of all specimens and 3% of colonoscopies. However, 20% of patients with dysplasias were identified only through random biopsy. This finding resembles that of another recent randomized trial in which 13% of patients with inflammatory bowel disease had dysplasias detected only through random biopsy (Gut. 2018;67:616-24), the researchers noted.
They also evaluated the number of macroscopic dysplastic lesions identified for every 10 minutes of colonoscope withdrawal time. These numbers were not significantly different in the intention-to-diagnose analysis (0.066 lesions in the high-definition chromoendoscopy group vs. 0.027 lesions in the high-definition white-light endoscopy group; P = .056). However, the per-protocol analysis revealed a significant difference (0.073 vs. 0.029 dysplastic lesions, respectively; P = .031).
“Based on our findings, we recommend the use of high-definition chromoendoscopy in inflammatory bowel disease surveillance,” the researchers concluded. They acknowledged several limitations: the study included patients from only one center, most dyplastic lesions were small and, thus, had an unclear natural history, and the endoscopists included both experts and nonexperts.
The Stockholm City Council provided funding. The researchers reported having no conflicts of interest.
SOURCE: Alexandersson B et al. Clin Gastroenterol Hepatol. 2020 Apr 27. doi: 10.1016/j.cgh.2020.04.049.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Analysis of early onset cancers suggests need for genetic testing
according to a presentation at the AACR virtual meeting II.
Investigators analyzed blood samples from 1,201 patients who were aged 18-39 years when diagnosed with a solid tumor malignancy.
In this group, there were 877 patients with early onset cancers, defined as cancers for which 39 years of age is greater than 1 standard deviation below the mean age of diagnosis for the cancer type.
The remaining 324 patients had young adult cancers, defined as cancers for which 39 years of age is less than 1 standard deviation below the mean age of diagnosis.
The most common early onset cancers were breast, colorectal, kidney, pancreas, and ovarian cancer.
The most common young adult cancers were sarcoma, brain cancer, and testicular cancer, as expected, said investigator Zsofia K. Stadler, MD, of Memorial Sloan Kettering Cancer Center in New York.
Dr. Stadler and colleagues performed next-generation sequencing of the patient samples using a panel of up to 88 genes previously implicated in cancer predisposition. This revealed a significantly higher prevalence of germline mutations in patients with early onset cancers than in those with young adult cancers – 21% and 13%, respectively (P = .002).
In patients with only high- and moderate-risk cancer susceptibility genes, the prevalence was 15% in the early onset group and 10% in the young adult group (P = .01). “Among the early onset cancer group, pancreas, breast, and kidney cancer patients harbored the highest rates of germline mutations,” Dr. Stadler said, noting that the spectrum of mutated genes differed in early onset and young adult cancer patients.
“In early onset patients, the most commonly mutated genes were BRCA1 and BRCA2 [4.9%], Lynch syndrome genes [2.2%], ATM [1.6%], and CHECK2 [1.7%],” Dr. Stadler said. “On the other hand, in young adults, TP53 mutations [2.2%], and SDHA and SDHB mutations dominated [1.9%], with the majority of mutations occurring in sarcoma patients.”
These findings suggest the prevalence of inherited cancer susceptibility syndromes in young adults with cancer is not uniform.
“We found a very high prevalence of germline mutations in young patients with cancer types that typically present at later ages,” Dr. Stadler said, referring to the early onset patients.
Conversely, the young adult cancer patients had a prevalence and spectrum of mutations more similar to what is seen in pediatric cancer populations, she noted.
The findings are surprising, according to AACR past president Elaine R. Mardis, PhD, of The Ohio State University in Columbus.
Dr. Mardis said the results show that, in young adults with early onset cancers, “the germline prevalence of these mutations is significantly higher than we had previously thought.”
“Although representing only about 4% of all cancers, young adults with cancer ... face unique challenges,” Dr. Stadler said. “Identifying whether a young patient’s cancer occurred in the setting of an inherited cancer predisposition syndrome is especially important in this patient population.”
Such knowledge “can significantly impact the risk of second primary cancers and the need for increased surveillance measures or even risk-reducing surgeries,” Dr. Stadler explained. She added that it can also have implications for identifying at-risk family members, such as younger siblings or children who should pursue genetic testing and appropriate prevention measures.
“Our results suggest that, among patients with early onset cancer, the increased prevalence of germline mutations supports a role for genetic testing, irrespective of tumor type,” Dr. Stadler said.
This study was partially funded by the Precision, Interception and Prevention Program, the Robert and Katie Niehaus Center for Inherited Cancer Genomics, the Marie-Josee and Henry R. Kravis Center for Molecular Oncology, and a National Cancer Institute Cancer Center Core Grant. Dr. Stadler reported that an immediate family member serves as a consultant in ophthalmology for Allergan, Adverum Biotechnologies, Alimera Sciences, BioMarin, Fortress Biotech, Genentech/Roche, Novartis, Optos, Regeneron, Regenxbio, and Spark Therapeutics. Dr. Mardis disclosed relationships with Qiagen NV, Pact Pharma LLC, Moderna Inc., and Interpreta LLC.
SOURCE: Stadler Z et al. AACR 2020, Abstract 1122.
according to a presentation at the AACR virtual meeting II.
Investigators analyzed blood samples from 1,201 patients who were aged 18-39 years when diagnosed with a solid tumor malignancy.
In this group, there were 877 patients with early onset cancers, defined as cancers for which 39 years of age is greater than 1 standard deviation below the mean age of diagnosis for the cancer type.
The remaining 324 patients had young adult cancers, defined as cancers for which 39 years of age is less than 1 standard deviation below the mean age of diagnosis.
The most common early onset cancers were breast, colorectal, kidney, pancreas, and ovarian cancer.
The most common young adult cancers were sarcoma, brain cancer, and testicular cancer, as expected, said investigator Zsofia K. Stadler, MD, of Memorial Sloan Kettering Cancer Center in New York.
Dr. Stadler and colleagues performed next-generation sequencing of the patient samples using a panel of up to 88 genes previously implicated in cancer predisposition. This revealed a significantly higher prevalence of germline mutations in patients with early onset cancers than in those with young adult cancers – 21% and 13%, respectively (P = .002).
In patients with only high- and moderate-risk cancer susceptibility genes, the prevalence was 15% in the early onset group and 10% in the young adult group (P = .01). “Among the early onset cancer group, pancreas, breast, and kidney cancer patients harbored the highest rates of germline mutations,” Dr. Stadler said, noting that the spectrum of mutated genes differed in early onset and young adult cancer patients.
“In early onset patients, the most commonly mutated genes were BRCA1 and BRCA2 [4.9%], Lynch syndrome genes [2.2%], ATM [1.6%], and CHECK2 [1.7%],” Dr. Stadler said. “On the other hand, in young adults, TP53 mutations [2.2%], and SDHA and SDHB mutations dominated [1.9%], with the majority of mutations occurring in sarcoma patients.”
These findings suggest the prevalence of inherited cancer susceptibility syndromes in young adults with cancer is not uniform.
“We found a very high prevalence of germline mutations in young patients with cancer types that typically present at later ages,” Dr. Stadler said, referring to the early onset patients.
Conversely, the young adult cancer patients had a prevalence and spectrum of mutations more similar to what is seen in pediatric cancer populations, she noted.
The findings are surprising, according to AACR past president Elaine R. Mardis, PhD, of The Ohio State University in Columbus.
Dr. Mardis said the results show that, in young adults with early onset cancers, “the germline prevalence of these mutations is significantly higher than we had previously thought.”
“Although representing only about 4% of all cancers, young adults with cancer ... face unique challenges,” Dr. Stadler said. “Identifying whether a young patient’s cancer occurred in the setting of an inherited cancer predisposition syndrome is especially important in this patient population.”
Such knowledge “can significantly impact the risk of second primary cancers and the need for increased surveillance measures or even risk-reducing surgeries,” Dr. Stadler explained. She added that it can also have implications for identifying at-risk family members, such as younger siblings or children who should pursue genetic testing and appropriate prevention measures.
“Our results suggest that, among patients with early onset cancer, the increased prevalence of germline mutations supports a role for genetic testing, irrespective of tumor type,” Dr. Stadler said.
This study was partially funded by the Precision, Interception and Prevention Program, the Robert and Katie Niehaus Center for Inherited Cancer Genomics, the Marie-Josee and Henry R. Kravis Center for Molecular Oncology, and a National Cancer Institute Cancer Center Core Grant. Dr. Stadler reported that an immediate family member serves as a consultant in ophthalmology for Allergan, Adverum Biotechnologies, Alimera Sciences, BioMarin, Fortress Biotech, Genentech/Roche, Novartis, Optos, Regeneron, Regenxbio, and Spark Therapeutics. Dr. Mardis disclosed relationships with Qiagen NV, Pact Pharma LLC, Moderna Inc., and Interpreta LLC.
SOURCE: Stadler Z et al. AACR 2020, Abstract 1122.
according to a presentation at the AACR virtual meeting II.
Investigators analyzed blood samples from 1,201 patients who were aged 18-39 years when diagnosed with a solid tumor malignancy.
In this group, there were 877 patients with early onset cancers, defined as cancers for which 39 years of age is greater than 1 standard deviation below the mean age of diagnosis for the cancer type.
The remaining 324 patients had young adult cancers, defined as cancers for which 39 years of age is less than 1 standard deviation below the mean age of diagnosis.
The most common early onset cancers were breast, colorectal, kidney, pancreas, and ovarian cancer.
The most common young adult cancers were sarcoma, brain cancer, and testicular cancer, as expected, said investigator Zsofia K. Stadler, MD, of Memorial Sloan Kettering Cancer Center in New York.
Dr. Stadler and colleagues performed next-generation sequencing of the patient samples using a panel of up to 88 genes previously implicated in cancer predisposition. This revealed a significantly higher prevalence of germline mutations in patients with early onset cancers than in those with young adult cancers – 21% and 13%, respectively (P = .002).
In patients with only high- and moderate-risk cancer susceptibility genes, the prevalence was 15% in the early onset group and 10% in the young adult group (P = .01). “Among the early onset cancer group, pancreas, breast, and kidney cancer patients harbored the highest rates of germline mutations,” Dr. Stadler said, noting that the spectrum of mutated genes differed in early onset and young adult cancer patients.
“In early onset patients, the most commonly mutated genes were BRCA1 and BRCA2 [4.9%], Lynch syndrome genes [2.2%], ATM [1.6%], and CHECK2 [1.7%],” Dr. Stadler said. “On the other hand, in young adults, TP53 mutations [2.2%], and SDHA and SDHB mutations dominated [1.9%], with the majority of mutations occurring in sarcoma patients.”
These findings suggest the prevalence of inherited cancer susceptibility syndromes in young adults with cancer is not uniform.
“We found a very high prevalence of germline mutations in young patients with cancer types that typically present at later ages,” Dr. Stadler said, referring to the early onset patients.
Conversely, the young adult cancer patients had a prevalence and spectrum of mutations more similar to what is seen in pediatric cancer populations, she noted.
The findings are surprising, according to AACR past president Elaine R. Mardis, PhD, of The Ohio State University in Columbus.
Dr. Mardis said the results show that, in young adults with early onset cancers, “the germline prevalence of these mutations is significantly higher than we had previously thought.”
“Although representing only about 4% of all cancers, young adults with cancer ... face unique challenges,” Dr. Stadler said. “Identifying whether a young patient’s cancer occurred in the setting of an inherited cancer predisposition syndrome is especially important in this patient population.”
Such knowledge “can significantly impact the risk of second primary cancers and the need for increased surveillance measures or even risk-reducing surgeries,” Dr. Stadler explained. She added that it can also have implications for identifying at-risk family members, such as younger siblings or children who should pursue genetic testing and appropriate prevention measures.
“Our results suggest that, among patients with early onset cancer, the increased prevalence of germline mutations supports a role for genetic testing, irrespective of tumor type,” Dr. Stadler said.
This study was partially funded by the Precision, Interception and Prevention Program, the Robert and Katie Niehaus Center for Inherited Cancer Genomics, the Marie-Josee and Henry R. Kravis Center for Molecular Oncology, and a National Cancer Institute Cancer Center Core Grant. Dr. Stadler reported that an immediate family member serves as a consultant in ophthalmology for Allergan, Adverum Biotechnologies, Alimera Sciences, BioMarin, Fortress Biotech, Genentech/Roche, Novartis, Optos, Regeneron, Regenxbio, and Spark Therapeutics. Dr. Mardis disclosed relationships with Qiagen NV, Pact Pharma LLC, Moderna Inc., and Interpreta LLC.
SOURCE: Stadler Z et al. AACR 2020, Abstract 1122.
FROM AACR 2020
Acetaminophen beats fentanyl in STEMI
Swapping out intravenous fentanyl in favor of IV acetaminophen in patients with ST-elevation MI (STEMI) provides comparable pain relief but with desirably higher blood levels of ticagrelor both immediately after primary percutaneous intervention and 1 hour post procedure.
That’s according to results of the Dutch ON-TIME 3 trial, presented by Anne H. Tavenier, MD, at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.
“Our trial results have implications for the prehospital treatment of STEMI patients,” said Dr. Tavenier, a cardiologist at the Isala Clinic in Zwolle, the Netherlands.
The explanation for the success of this novel STEMI pain management strategy? The synthetic opioid fentanyl impairs gastrointestinal absorption of oral P2Y12 receptor antagonists such as ticagrelor. Opiates do so as well, whereas acetaminophen does not, she explained.
The potent platelet inhibition provided by oral P2Y12 inhibitors is crucial to successful primary PCI for STEMI. But these platelet inhibitory effects are inherently slowed in STEMI patients owing to hemodynamic changes and delayed GI absorption. And even though both American College of Cardiology/American Heart Association and European Society of Cardiology guidelines recommend the use of opioids for pain control in STEMI patients, the fact is that these medications further delay the absorption of oral P2Y12 inhibitors. And this delay is further exacerbated by the nausea and vomiting which are common side effects of IV fentanyl, she continued.
The impetus for the ON-TIME 3 trial was straightforward, the cardiologist said: “For years, STEMI patients have been treated with morphine or morphinelike drugs like fentanyl because of pain or sympathetic stress. To date, trials investigating alternative analgesics to opioids have been scarce.”
ON-TIME 3 was a multicenter, open-label, phase 4 clinical trial in which 195 STEMI patients with a self-reported pain score of at least 4 on a 0-10 scale received crushed ticagrelor in the ambulance along with either 1,000 mg of IV acetaminophen or fentanyl at 1-2 mcg/kg.
Ticagrelor blood levels were significantly higher in the IV acetaminophen group when measured just prior to primary PCI (151 ng/mL versus 60 ng/mL in the IV fentanyl group; immediately after PCI (326 versus 115 ng/mL), and 1 hour post PCI (488 versus 372 ng/mL).
However, there was no significant between-group difference in levels of platelet reactivity units measured immediately after primary PCI, Dr. Tavenier added.
Discussant Christoph K. Naber, MD, PhD, confessed that prior to ON-TIME 3 he was unaware that administering opioids to STEMI patients results in delayed absorption of oral P2Y12 inhibitors. Upon delving into the literature, however, he found that this is indeed a well-documented problem.
“The open question I have about this very elegant trial is whether the increased P2Y12 levels will translate into a measurable difference in clinical outcomes,” said Dr. Naber, an interventional cardiologist at the Wilhemshaven (Germany) Clinic.
The answer to that question would require a larger, longer-term trial. And he’s disinclined to wait around for that to happen.
“I think when we look at the risk balance, the risk of switching from an opioid to acetaminophen, if it works for the patient, is rather low. So this might be something to introduce in my practice,” the cardiologist said.
Dr. Tavenier and Dr. Naber reported having no financial conflicts of interest.
SOURCE: Tavenier AH. EuroPCR 2020.
Swapping out intravenous fentanyl in favor of IV acetaminophen in patients with ST-elevation MI (STEMI) provides comparable pain relief but with desirably higher blood levels of ticagrelor both immediately after primary percutaneous intervention and 1 hour post procedure.
That’s according to results of the Dutch ON-TIME 3 trial, presented by Anne H. Tavenier, MD, at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.
“Our trial results have implications for the prehospital treatment of STEMI patients,” said Dr. Tavenier, a cardiologist at the Isala Clinic in Zwolle, the Netherlands.
The explanation for the success of this novel STEMI pain management strategy? The synthetic opioid fentanyl impairs gastrointestinal absorption of oral P2Y12 receptor antagonists such as ticagrelor. Opiates do so as well, whereas acetaminophen does not, she explained.
The potent platelet inhibition provided by oral P2Y12 inhibitors is crucial to successful primary PCI for STEMI. But these platelet inhibitory effects are inherently slowed in STEMI patients owing to hemodynamic changes and delayed GI absorption. And even though both American College of Cardiology/American Heart Association and European Society of Cardiology guidelines recommend the use of opioids for pain control in STEMI patients, the fact is that these medications further delay the absorption of oral P2Y12 inhibitors. And this delay is further exacerbated by the nausea and vomiting which are common side effects of IV fentanyl, she continued.
The impetus for the ON-TIME 3 trial was straightforward, the cardiologist said: “For years, STEMI patients have been treated with morphine or morphinelike drugs like fentanyl because of pain or sympathetic stress. To date, trials investigating alternative analgesics to opioids have been scarce.”
ON-TIME 3 was a multicenter, open-label, phase 4 clinical trial in which 195 STEMI patients with a self-reported pain score of at least 4 on a 0-10 scale received crushed ticagrelor in the ambulance along with either 1,000 mg of IV acetaminophen or fentanyl at 1-2 mcg/kg.
Ticagrelor blood levels were significantly higher in the IV acetaminophen group when measured just prior to primary PCI (151 ng/mL versus 60 ng/mL in the IV fentanyl group; immediately after PCI (326 versus 115 ng/mL), and 1 hour post PCI (488 versus 372 ng/mL).
However, there was no significant between-group difference in levels of platelet reactivity units measured immediately after primary PCI, Dr. Tavenier added.
Discussant Christoph K. Naber, MD, PhD, confessed that prior to ON-TIME 3 he was unaware that administering opioids to STEMI patients results in delayed absorption of oral P2Y12 inhibitors. Upon delving into the literature, however, he found that this is indeed a well-documented problem.
“The open question I have about this very elegant trial is whether the increased P2Y12 levels will translate into a measurable difference in clinical outcomes,” said Dr. Naber, an interventional cardiologist at the Wilhemshaven (Germany) Clinic.
The answer to that question would require a larger, longer-term trial. And he’s disinclined to wait around for that to happen.
“I think when we look at the risk balance, the risk of switching from an opioid to acetaminophen, if it works for the patient, is rather low. So this might be something to introduce in my practice,” the cardiologist said.
Dr. Tavenier and Dr. Naber reported having no financial conflicts of interest.
SOURCE: Tavenier AH. EuroPCR 2020.
Swapping out intravenous fentanyl in favor of IV acetaminophen in patients with ST-elevation MI (STEMI) provides comparable pain relief but with desirably higher blood levels of ticagrelor both immediately after primary percutaneous intervention and 1 hour post procedure.
That’s according to results of the Dutch ON-TIME 3 trial, presented by Anne H. Tavenier, MD, at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.
“Our trial results have implications for the prehospital treatment of STEMI patients,” said Dr. Tavenier, a cardiologist at the Isala Clinic in Zwolle, the Netherlands.
The explanation for the success of this novel STEMI pain management strategy? The synthetic opioid fentanyl impairs gastrointestinal absorption of oral P2Y12 receptor antagonists such as ticagrelor. Opiates do so as well, whereas acetaminophen does not, she explained.
The potent platelet inhibition provided by oral P2Y12 inhibitors is crucial to successful primary PCI for STEMI. But these platelet inhibitory effects are inherently slowed in STEMI patients owing to hemodynamic changes and delayed GI absorption. And even though both American College of Cardiology/American Heart Association and European Society of Cardiology guidelines recommend the use of opioids for pain control in STEMI patients, the fact is that these medications further delay the absorption of oral P2Y12 inhibitors. And this delay is further exacerbated by the nausea and vomiting which are common side effects of IV fentanyl, she continued.
The impetus for the ON-TIME 3 trial was straightforward, the cardiologist said: “For years, STEMI patients have been treated with morphine or morphinelike drugs like fentanyl because of pain or sympathetic stress. To date, trials investigating alternative analgesics to opioids have been scarce.”
ON-TIME 3 was a multicenter, open-label, phase 4 clinical trial in which 195 STEMI patients with a self-reported pain score of at least 4 on a 0-10 scale received crushed ticagrelor in the ambulance along with either 1,000 mg of IV acetaminophen or fentanyl at 1-2 mcg/kg.
Ticagrelor blood levels were significantly higher in the IV acetaminophen group when measured just prior to primary PCI (151 ng/mL versus 60 ng/mL in the IV fentanyl group; immediately after PCI (326 versus 115 ng/mL), and 1 hour post PCI (488 versus 372 ng/mL).
However, there was no significant between-group difference in levels of platelet reactivity units measured immediately after primary PCI, Dr. Tavenier added.
Discussant Christoph K. Naber, MD, PhD, confessed that prior to ON-TIME 3 he was unaware that administering opioids to STEMI patients results in delayed absorption of oral P2Y12 inhibitors. Upon delving into the literature, however, he found that this is indeed a well-documented problem.
“The open question I have about this very elegant trial is whether the increased P2Y12 levels will translate into a measurable difference in clinical outcomes,” said Dr. Naber, an interventional cardiologist at the Wilhemshaven (Germany) Clinic.
The answer to that question would require a larger, longer-term trial. And he’s disinclined to wait around for that to happen.
“I think when we look at the risk balance, the risk of switching from an opioid to acetaminophen, if it works for the patient, is rather low. So this might be something to introduce in my practice,” the cardiologist said.
Dr. Tavenier and Dr. Naber reported having no financial conflicts of interest.
SOURCE: Tavenier AH. EuroPCR 2020.
REPORTING FROM EUROPCR 2020
PASDAS beats DAS28 in measuring psoriatic arthritis treat-to-target success
Measuring success with a treat-to-target strategy in psoriatic arthritis patients proved to be more comprehensive with the Psoriatic Arthritis Disease Activity Score (PASDAS) than it was with the Disease Activity Score in 28 joints (DAS28), according to findings from a prospective cohort study.
Fewer patients had a low disease activity score according to DAS28, and a higher percentage of patients deemed adequately treated according to DAS28 were found to have residual disease activity, compared with the number of patients so categorized according to PASDAS, researcher Michelle Mulder reported in her presentation of the study at the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).
“PASDAS implementation in a tightly monitored PsA [psoriatic arthritis] cohort suggests relevant residual disease burden, even though DAS28 was measured at every visit previously,” said Ms. Mulder, an MD/PhD student at Sint Maartenskliniek in Nijmegen, The Netherlands.
The presentation was convincing to Philip Helliwell, MD, PhD, who is a professor of clinical rheumatology at Leeds (England) University, and was also one of the developers of PASDAS. “We know it can be used in clinical practice with a certain amount of organization and clinical staff to help you,” he said during another presentation at GRAPPA.
Treat to target is a widely accepted therapeutic strategy. It’s particularly common in rheumatoid arthritis, but increasing evidence suggests that it improves patient outcomes in psoriatic arthritis. DAS28 is frequently used in treat-to-target approaches in rheumatoid arthritis, and often gets applied to psoriatic arthritis since rheumatologists are already comfortable with it, according to Ms. Mulder. “However, DAS28 has shown some limitations when used in psoriatic arthritis. For example, its joint count is limited to only 28 joints, and it does not take all PsA domains into account,” she said.
DAS28 was previously used at Sint Maartenskliniek in combination with psoriatic arthritis–specific assessment recommendations, but the institution opted in 2019 to switch to PASDAS, which was developed by GRAPPA and the European League Against Rheumatism. “To better adhere to international PsA guidelines, we chose to implement PASDAS in our cohort with the assumption that it might improve patient care,” Ms. Mulder said.
With DAS28, clinicians measured the C-reactive protein (CRP) and Patient Global Visual Analog Scale (VAS) domains and were advised to examine 28 joints for tender and swollen joint count domains. Under the PASDAS guidance, clinicians examined 68 joints for tenderness, 66 joints for swelling, CRP, Patient Global VAS, Physician Global VAS, Leeds Enthesitis Index, dactylitis, and the 12-item Short Form Physical Composite Scale. They also examined the skin, nails, and axial disease.
To examine the effects of the switch from DAS28 to PASDAS, the researchers compared outcomes in 855 patients before and after the change during March to December 2019. The mean age of patients was 55 years, and 46% were female. The mean disease duration was 10 years, and the mean PASDAS score was 3.1. A total of 96% of participants were negative for anti-cyclic citrullinated peptide. Overall, 30% had arthritis, 9% had axial disease, 3% had dactylitis, 21% had enthesitis, 51% had skin disease, and 42% had nail disease.
About three-quarters (77.4%) of patients reached the threshold of low disease activity (LDA) according to the DAS28 measure, while 53.1% did so using the PASDAS. High disease activity occurred in 7.8% of patients according to DAS28, compared with 2.7% as measured by PASDAS. Patients who reached only the DAS28 LDA target but not the PASDAS target, compared with patients who reached the LDA target in both measures, had significantly worse counts for swelling in 66 joints (0.7 vs. 0.2; P < .001) and tenderness in 68 joints (2.1 vs. 0.7; P < .001), as well as worse scores for enthesitis (0.5 vs. 0.1; P < .001), dactylitis (4% vs. 1%; P = .005), patient global VAS (44.0 vs. 14.4; P < .001), Health Assessment Questionnaire (0.8 vs. 0.4; P < .001) and Patient Acceptable Symptom State (unacceptable score in 17% vs. 3%; P < .001).
Ms. Mulder acknowledged that PASDAS imposes a significant burden on clinicians, and noted that Sint Maartenskliniek created patient infrastructure to handle the load. “It’s very important that you set up your clinic in a specific way. When the patient comes in, we draw blood immediately and we ask them to fill in the questionnaires, and then they go to a specialized nurse who measures all the different components of the PASDAS. It took a lot of time to train the specialized nurses and to implement the PASDAS score in our electronic health records. After we did those things, it was quite easy because we have this whole setup. It takes time and it is difficult, but it is definitely possible to do it,” Ms. Mulder said during a live Q&A following her prerecorded presentation.
The study received no funding. Ms. Mulder had no relevant financial disclosures. Dr. Helliwell has financial ties to AbbVie, Amgen, Celgen, Galapagos, Janssen, Novartis, Pfizer, and UCB.
SOURCE: Mulder M et al. GRAPPA 2020 Virtual Annual Meeting.
Measuring success with a treat-to-target strategy in psoriatic arthritis patients proved to be more comprehensive with the Psoriatic Arthritis Disease Activity Score (PASDAS) than it was with the Disease Activity Score in 28 joints (DAS28), according to findings from a prospective cohort study.
Fewer patients had a low disease activity score according to DAS28, and a higher percentage of patients deemed adequately treated according to DAS28 were found to have residual disease activity, compared with the number of patients so categorized according to PASDAS, researcher Michelle Mulder reported in her presentation of the study at the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).
“PASDAS implementation in a tightly monitored PsA [psoriatic arthritis] cohort suggests relevant residual disease burden, even though DAS28 was measured at every visit previously,” said Ms. Mulder, an MD/PhD student at Sint Maartenskliniek in Nijmegen, The Netherlands.
The presentation was convincing to Philip Helliwell, MD, PhD, who is a professor of clinical rheumatology at Leeds (England) University, and was also one of the developers of PASDAS. “We know it can be used in clinical practice with a certain amount of organization and clinical staff to help you,” he said during another presentation at GRAPPA.
Treat to target is a widely accepted therapeutic strategy. It’s particularly common in rheumatoid arthritis, but increasing evidence suggests that it improves patient outcomes in psoriatic arthritis. DAS28 is frequently used in treat-to-target approaches in rheumatoid arthritis, and often gets applied to psoriatic arthritis since rheumatologists are already comfortable with it, according to Ms. Mulder. “However, DAS28 has shown some limitations when used in psoriatic arthritis. For example, its joint count is limited to only 28 joints, and it does not take all PsA domains into account,” she said.
DAS28 was previously used at Sint Maartenskliniek in combination with psoriatic arthritis–specific assessment recommendations, but the institution opted in 2019 to switch to PASDAS, which was developed by GRAPPA and the European League Against Rheumatism. “To better adhere to international PsA guidelines, we chose to implement PASDAS in our cohort with the assumption that it might improve patient care,” Ms. Mulder said.
With DAS28, clinicians measured the C-reactive protein (CRP) and Patient Global Visual Analog Scale (VAS) domains and were advised to examine 28 joints for tender and swollen joint count domains. Under the PASDAS guidance, clinicians examined 68 joints for tenderness, 66 joints for swelling, CRP, Patient Global VAS, Physician Global VAS, Leeds Enthesitis Index, dactylitis, and the 12-item Short Form Physical Composite Scale. They also examined the skin, nails, and axial disease.
To examine the effects of the switch from DAS28 to PASDAS, the researchers compared outcomes in 855 patients before and after the change during March to December 2019. The mean age of patients was 55 years, and 46% were female. The mean disease duration was 10 years, and the mean PASDAS score was 3.1. A total of 96% of participants were negative for anti-cyclic citrullinated peptide. Overall, 30% had arthritis, 9% had axial disease, 3% had dactylitis, 21% had enthesitis, 51% had skin disease, and 42% had nail disease.
About three-quarters (77.4%) of patients reached the threshold of low disease activity (LDA) according to the DAS28 measure, while 53.1% did so using the PASDAS. High disease activity occurred in 7.8% of patients according to DAS28, compared with 2.7% as measured by PASDAS. Patients who reached only the DAS28 LDA target but not the PASDAS target, compared with patients who reached the LDA target in both measures, had significantly worse counts for swelling in 66 joints (0.7 vs. 0.2; P < .001) and tenderness in 68 joints (2.1 vs. 0.7; P < .001), as well as worse scores for enthesitis (0.5 vs. 0.1; P < .001), dactylitis (4% vs. 1%; P = .005), patient global VAS (44.0 vs. 14.4; P < .001), Health Assessment Questionnaire (0.8 vs. 0.4; P < .001) and Patient Acceptable Symptom State (unacceptable score in 17% vs. 3%; P < .001).
Ms. Mulder acknowledged that PASDAS imposes a significant burden on clinicians, and noted that Sint Maartenskliniek created patient infrastructure to handle the load. “It’s very important that you set up your clinic in a specific way. When the patient comes in, we draw blood immediately and we ask them to fill in the questionnaires, and then they go to a specialized nurse who measures all the different components of the PASDAS. It took a lot of time to train the specialized nurses and to implement the PASDAS score in our electronic health records. After we did those things, it was quite easy because we have this whole setup. It takes time and it is difficult, but it is definitely possible to do it,” Ms. Mulder said during a live Q&A following her prerecorded presentation.
The study received no funding. Ms. Mulder had no relevant financial disclosures. Dr. Helliwell has financial ties to AbbVie, Amgen, Celgen, Galapagos, Janssen, Novartis, Pfizer, and UCB.
SOURCE: Mulder M et al. GRAPPA 2020 Virtual Annual Meeting.
Measuring success with a treat-to-target strategy in psoriatic arthritis patients proved to be more comprehensive with the Psoriatic Arthritis Disease Activity Score (PASDAS) than it was with the Disease Activity Score in 28 joints (DAS28), according to findings from a prospective cohort study.
Fewer patients had a low disease activity score according to DAS28, and a higher percentage of patients deemed adequately treated according to DAS28 were found to have residual disease activity, compared with the number of patients so categorized according to PASDAS, researcher Michelle Mulder reported in her presentation of the study at the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).
“PASDAS implementation in a tightly monitored PsA [psoriatic arthritis] cohort suggests relevant residual disease burden, even though DAS28 was measured at every visit previously,” said Ms. Mulder, an MD/PhD student at Sint Maartenskliniek in Nijmegen, The Netherlands.
The presentation was convincing to Philip Helliwell, MD, PhD, who is a professor of clinical rheumatology at Leeds (England) University, and was also one of the developers of PASDAS. “We know it can be used in clinical practice with a certain amount of organization and clinical staff to help you,” he said during another presentation at GRAPPA.
Treat to target is a widely accepted therapeutic strategy. It’s particularly common in rheumatoid arthritis, but increasing evidence suggests that it improves patient outcomes in psoriatic arthritis. DAS28 is frequently used in treat-to-target approaches in rheumatoid arthritis, and often gets applied to psoriatic arthritis since rheumatologists are already comfortable with it, according to Ms. Mulder. “However, DAS28 has shown some limitations when used in psoriatic arthritis. For example, its joint count is limited to only 28 joints, and it does not take all PsA domains into account,” she said.
DAS28 was previously used at Sint Maartenskliniek in combination with psoriatic arthritis–specific assessment recommendations, but the institution opted in 2019 to switch to PASDAS, which was developed by GRAPPA and the European League Against Rheumatism. “To better adhere to international PsA guidelines, we chose to implement PASDAS in our cohort with the assumption that it might improve patient care,” Ms. Mulder said.
With DAS28, clinicians measured the C-reactive protein (CRP) and Patient Global Visual Analog Scale (VAS) domains and were advised to examine 28 joints for tender and swollen joint count domains. Under the PASDAS guidance, clinicians examined 68 joints for tenderness, 66 joints for swelling, CRP, Patient Global VAS, Physician Global VAS, Leeds Enthesitis Index, dactylitis, and the 12-item Short Form Physical Composite Scale. They also examined the skin, nails, and axial disease.
To examine the effects of the switch from DAS28 to PASDAS, the researchers compared outcomes in 855 patients before and after the change during March to December 2019. The mean age of patients was 55 years, and 46% were female. The mean disease duration was 10 years, and the mean PASDAS score was 3.1. A total of 96% of participants were negative for anti-cyclic citrullinated peptide. Overall, 30% had arthritis, 9% had axial disease, 3% had dactylitis, 21% had enthesitis, 51% had skin disease, and 42% had nail disease.
About three-quarters (77.4%) of patients reached the threshold of low disease activity (LDA) according to the DAS28 measure, while 53.1% did so using the PASDAS. High disease activity occurred in 7.8% of patients according to DAS28, compared with 2.7% as measured by PASDAS. Patients who reached only the DAS28 LDA target but not the PASDAS target, compared with patients who reached the LDA target in both measures, had significantly worse counts for swelling in 66 joints (0.7 vs. 0.2; P < .001) and tenderness in 68 joints (2.1 vs. 0.7; P < .001), as well as worse scores for enthesitis (0.5 vs. 0.1; P < .001), dactylitis (4% vs. 1%; P = .005), patient global VAS (44.0 vs. 14.4; P < .001), Health Assessment Questionnaire (0.8 vs. 0.4; P < .001) and Patient Acceptable Symptom State (unacceptable score in 17% vs. 3%; P < .001).
Ms. Mulder acknowledged that PASDAS imposes a significant burden on clinicians, and noted that Sint Maartenskliniek created patient infrastructure to handle the load. “It’s very important that you set up your clinic in a specific way. When the patient comes in, we draw blood immediately and we ask them to fill in the questionnaires, and then they go to a specialized nurse who measures all the different components of the PASDAS. It took a lot of time to train the specialized nurses and to implement the PASDAS score in our electronic health records. After we did those things, it was quite easy because we have this whole setup. It takes time and it is difficult, but it is definitely possible to do it,” Ms. Mulder said during a live Q&A following her prerecorded presentation.
The study received no funding. Ms. Mulder had no relevant financial disclosures. Dr. Helliwell has financial ties to AbbVie, Amgen, Celgen, Galapagos, Janssen, Novartis, Pfizer, and UCB.
SOURCE: Mulder M et al. GRAPPA 2020 Virtual Annual Meeting.
FROM GRAPPA 2020 VIRTUAL ANNUAL MEETING
COVID-19 symptoms can linger for months
Clinicians and researchers have focused on the acute phase of COVID-19 infection, but it’s increasingly clear that some recovered patients discharged from acute care need continued monitoring for long-lasting effects, a study has found.
In a research letter published online July 9 in JAMA, Angelo Carfi, MD, and colleagues from the Gemelli Against COVID-19 Post–Acute Care Study Group in Rome, report that
Postdischarge assessments of patients who met criteria for SARS-CoV-2 negativity, including a reverse transcriptase–polymerase chain reaction test, were conducted from April 21 to May 29. Among the results:
- Only 12.6% of the 143 patients were completely free of any COVID-19 symptom
- About 32% of patients had one or two symptoms and 55% had three or more
- None had fever or other signs and symptoms of acute illness
- About 53% of patients still had fatigue, 43.4% had dyspnea, 27.3% had joint pain, and had 21.7% chest pain
- About 44% reported worsened quality of life on the EuroQol visual analog scale.
The sample cohort, assessed in a COVID-19 patient service recently established at the Fondazione Policlinico Universitario Agostino Gemelli had a mean age of 56.5 years and 37% were women. The mean length of hospital stay was 13.5 days. During their hospitalization, 72.7% of patients showed evidence of interstitial pneumonia. Noninvasive ventilation was given to 14.7% of patients and 4.9% received invasive ventilation.
The reality of lingering symptoms has led Dr. Carfi’s clinic to schedule a final “wrap-up visit” for patients after full assessment. “On that occasion the doctor prescribes anything necessary to correct the anomalies found during the full evaluation,” Dr. Carfi, a geriatrician at the Gemelli clinic, said in an interview. “These usually include vitamin supplementation and, in selected cases, a new drug prescription such as a blood thinner if necessary.”
Patients can also enroll in a training program in which breathing status is monitored.
In North America, doctors are also addressing the reality that the road to recovery can be a long and upward one, with persistent symptoms worse than those seen with acute influenza infection. “We see patients who were first diagnosed in March or April and still have symptoms in July,” said Zijian Chen, MD, an endocrinologist and medical director of Mount Sinai Health System’s Center for Post-COVID Care in New York.
“Persistent symptoms are much worse for COVID patients than flu patients. Even flu patients who spent time in the intensive care unit recover fully, and we can optimize their breathing before discharge,” Dr. Chen said in an interview.
As in the Italian study, Dr. Chen sees patients with COVID-19 who have ongoing shortness of breath, some requiring supplemental oxygen, or with persistent chest pain on exertion, blood clotting problems, poor concentration, gastrointestinal distress, and reduced muscle strength and impaired grasping power. He doesn’t rule out permanent lung damage in some. “Even asymptomatic individuals already show lung scarring on imaging,” he said.
The Mount Sinai program provides specialized interdisciplinary management that may include CT scans, endoscopy, and drugs such as respiratory medications or anticoagulants. It also offers training to combat the fatigue and deconditioning caused by the infection, symptoms that are not medically treatable but impact quality of life.
“These patients do get better, but I expect they may still have symptoms requiring monitoring after a year,” Dr. Chen said.
The study received no specific funding. Dr. Carfi and colleagues have disclosed no relevant financial relationships. Dr. Chen has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Clinicians and researchers have focused on the acute phase of COVID-19 infection, but it’s increasingly clear that some recovered patients discharged from acute care need continued monitoring for long-lasting effects, a study has found.
In a research letter published online July 9 in JAMA, Angelo Carfi, MD, and colleagues from the Gemelli Against COVID-19 Post–Acute Care Study Group in Rome, report that
Postdischarge assessments of patients who met criteria for SARS-CoV-2 negativity, including a reverse transcriptase–polymerase chain reaction test, were conducted from April 21 to May 29. Among the results:
- Only 12.6% of the 143 patients were completely free of any COVID-19 symptom
- About 32% of patients had one or two symptoms and 55% had three or more
- None had fever or other signs and symptoms of acute illness
- About 53% of patients still had fatigue, 43.4% had dyspnea, 27.3% had joint pain, and had 21.7% chest pain
- About 44% reported worsened quality of life on the EuroQol visual analog scale.
The sample cohort, assessed in a COVID-19 patient service recently established at the Fondazione Policlinico Universitario Agostino Gemelli had a mean age of 56.5 years and 37% were women. The mean length of hospital stay was 13.5 days. During their hospitalization, 72.7% of patients showed evidence of interstitial pneumonia. Noninvasive ventilation was given to 14.7% of patients and 4.9% received invasive ventilation.
The reality of lingering symptoms has led Dr. Carfi’s clinic to schedule a final “wrap-up visit” for patients after full assessment. “On that occasion the doctor prescribes anything necessary to correct the anomalies found during the full evaluation,” Dr. Carfi, a geriatrician at the Gemelli clinic, said in an interview. “These usually include vitamin supplementation and, in selected cases, a new drug prescription such as a blood thinner if necessary.”
Patients can also enroll in a training program in which breathing status is monitored.
In North America, doctors are also addressing the reality that the road to recovery can be a long and upward one, with persistent symptoms worse than those seen with acute influenza infection. “We see patients who were first diagnosed in March or April and still have symptoms in July,” said Zijian Chen, MD, an endocrinologist and medical director of Mount Sinai Health System’s Center for Post-COVID Care in New York.
“Persistent symptoms are much worse for COVID patients than flu patients. Even flu patients who spent time in the intensive care unit recover fully, and we can optimize their breathing before discharge,” Dr. Chen said in an interview.
As in the Italian study, Dr. Chen sees patients with COVID-19 who have ongoing shortness of breath, some requiring supplemental oxygen, or with persistent chest pain on exertion, blood clotting problems, poor concentration, gastrointestinal distress, and reduced muscle strength and impaired grasping power. He doesn’t rule out permanent lung damage in some. “Even asymptomatic individuals already show lung scarring on imaging,” he said.
The Mount Sinai program provides specialized interdisciplinary management that may include CT scans, endoscopy, and drugs such as respiratory medications or anticoagulants. It also offers training to combat the fatigue and deconditioning caused by the infection, symptoms that are not medically treatable but impact quality of life.
“These patients do get better, but I expect they may still have symptoms requiring monitoring after a year,” Dr. Chen said.
The study received no specific funding. Dr. Carfi and colleagues have disclosed no relevant financial relationships. Dr. Chen has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Clinicians and researchers have focused on the acute phase of COVID-19 infection, but it’s increasingly clear that some recovered patients discharged from acute care need continued monitoring for long-lasting effects, a study has found.
In a research letter published online July 9 in JAMA, Angelo Carfi, MD, and colleagues from the Gemelli Against COVID-19 Post–Acute Care Study Group in Rome, report that
Postdischarge assessments of patients who met criteria for SARS-CoV-2 negativity, including a reverse transcriptase–polymerase chain reaction test, were conducted from April 21 to May 29. Among the results:
- Only 12.6% of the 143 patients were completely free of any COVID-19 symptom
- About 32% of patients had one or two symptoms and 55% had three or more
- None had fever or other signs and symptoms of acute illness
- About 53% of patients still had fatigue, 43.4% had dyspnea, 27.3% had joint pain, and had 21.7% chest pain
- About 44% reported worsened quality of life on the EuroQol visual analog scale.
The sample cohort, assessed in a COVID-19 patient service recently established at the Fondazione Policlinico Universitario Agostino Gemelli had a mean age of 56.5 years and 37% were women. The mean length of hospital stay was 13.5 days. During their hospitalization, 72.7% of patients showed evidence of interstitial pneumonia. Noninvasive ventilation was given to 14.7% of patients and 4.9% received invasive ventilation.
The reality of lingering symptoms has led Dr. Carfi’s clinic to schedule a final “wrap-up visit” for patients after full assessment. “On that occasion the doctor prescribes anything necessary to correct the anomalies found during the full evaluation,” Dr. Carfi, a geriatrician at the Gemelli clinic, said in an interview. “These usually include vitamin supplementation and, in selected cases, a new drug prescription such as a blood thinner if necessary.”
Patients can also enroll in a training program in which breathing status is monitored.
In North America, doctors are also addressing the reality that the road to recovery can be a long and upward one, with persistent symptoms worse than those seen with acute influenza infection. “We see patients who were first diagnosed in March or April and still have symptoms in July,” said Zijian Chen, MD, an endocrinologist and medical director of Mount Sinai Health System’s Center for Post-COVID Care in New York.
“Persistent symptoms are much worse for COVID patients than flu patients. Even flu patients who spent time in the intensive care unit recover fully, and we can optimize their breathing before discharge,” Dr. Chen said in an interview.
As in the Italian study, Dr. Chen sees patients with COVID-19 who have ongoing shortness of breath, some requiring supplemental oxygen, or with persistent chest pain on exertion, blood clotting problems, poor concentration, gastrointestinal distress, and reduced muscle strength and impaired grasping power. He doesn’t rule out permanent lung damage in some. “Even asymptomatic individuals already show lung scarring on imaging,” he said.
The Mount Sinai program provides specialized interdisciplinary management that may include CT scans, endoscopy, and drugs such as respiratory medications or anticoagulants. It also offers training to combat the fatigue and deconditioning caused by the infection, symptoms that are not medically treatable but impact quality of life.
“These patients do get better, but I expect they may still have symptoms requiring monitoring after a year,” Dr. Chen said.
The study received no specific funding. Dr. Carfi and colleagues have disclosed no relevant financial relationships. Dr. Chen has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.