Patients at risk of autoimmune connective tissue disease who progressed to actual disease had elevated interferon scores and a family history of autoimmune rheumatic disease, suggesting the interferon scores could be used to predict disease progression, according to results from a prospective, observational study published in Annals of the Rheumatic Diseases.

SOURCE: Yusof MYM et al. Ann Rheum Dis. 21 Jun 2018. doi: 10.1136/annrheumdis-2018-213386.

Patients at risk of autoimmune connective tissue disease who progressed to actual disease had elevated interferon scores and a family history of autoimmune rheumatic disease, suggesting the interferon scores could be used to predict disease progression, according to results from a prospective, observational study published in Annals of the Rheumatic Diseases.

SOURCE: Yusof MYM et al. Ann Rheum Dis. 21 Jun 2018. doi: 10.1136/annrheumdis-2018-213386.

Patients at risk of autoimmune connective tissue disease who progressed to actual disease had elevated interferon scores and a family history of autoimmune rheumatic disease, suggesting the interferon scores could be used to predict disease progression, according to results from a prospective, observational study published in Annals of the Rheumatic Diseases.

SOURCE: Yusof MYM et al. Ann Rheum Dis. 21 Jun 2018. doi: 10.1136/annrheumdis-2018-213386.

In response to alarming racial disparities, New York City announced a new initiative last week to reduce maternal deaths and complications among women of color. Under the new plan, the city will improve the data collection on maternal deaths and complications, fund implicit bias training for medical staff at private and public hospitals, and launch a public awareness campaign.

Over the next three years, the city will spend $12.8 million on the initiative, with the goal of eliminating the black-white racial disparity in deaths related to pregnancy and childbirth and cutting the number of complications in half within five years.

“We recognize these are ambitious goals, but they are not unrealistic,” said Dr. Herminia Palacio, New York City’s deputy mayor for health and human services. “It’s an explicit recognition of the urgency of this issue and puts the goal posts in front of us.”

The city’s health department is targeting nearly two dozen public and private hospitals over four years, focusing on neighborhoods with the highest complication rates, including the South Bronx, North and Central Brooklyn, and East and Central Harlem. Hospital officials will study data from cases that led to bad outcomes, and staff will participate in drills aimed at helping them recognize and treat those complications.

Health department officials approached SUNY Downstate Medical Center in May to serve as a pilot site for many of the new measures.

The Central Brooklyn hospital was featured in the “Lost Mothers” series published by ProPublica and NPR last year as one of the starkest examples of racial disparities among hospitals in three states, according to our analysis of over 1 million births in Florida, Illinois and New York. In the second half of last year, two women, both black, died shortly after delivering at SUNY Downstate from causes that experts have said are preventable. The public, state-run hospital has one of the highest complication rates for hemorrhage in the city.

“We look forward to working with all of our partners to provide quality maternal health care for expectant mothers,” said hospital spokesperson Dawn Skeete-Walker.

“SUNY Downstate serves a unique and diverse population in Brooklyn where many of our expectant mothers are from a variety of different backgrounds, beliefs, and cultures.”

The city will also specifically target its own public hospitals, which are run by NYC Health + Hospitals, training staff on how to better identify and treat hemorrhage and blood clots, two leading causes of maternal death.

The initiative is “aimed at using an approach that encourages folks to have a sense of accountability without finger pointing or blame, and that encourages hospitals to be active participants to identify practices that would benefit from improvement,” said Palacio.

In addition to training, the city’s public hospitals will hire maternal care coordinators who will assist high-risk pregnant women with their appointments, prescriptions and public health benefits. Public hospitals will also work to strengthen prenatal and postpartum care, including conducting hemorrhage assessments, establishing care plans, and providing contraceptive counselling, breastfeeding support and screening for maternal depression.

Starting in 2019, the health department plans to launch a maternal safety public awareness campaign in partnership with grassroots organizations.

“This is a positive first step in really being able to address the concerns of women of color and pregnant women,” said Chanel Porchia-Albert, founder and executive director of Ancient Song Doula Services, which is based in New York City. “There need to be accountability measures that are put in place that stress the community as an active participant and stakeholder.”

The city’s initiative is the latest in a wave of maternal health reforms following the “Lost Mothers” series. Over the past few months, the U.S. Senate has proposed $50 million in funding to reduce maternal deaths, and several states have launched review committees to examine birth outcomes.

As ProPublica and NPR reported, between 700 and 900 women die from causes related to pregnancy and childbirth in the United States every year, and tens of thousands more experience severe complications. The rate of maternal death is substantially higher in the United States than in other affluent nations, and has climbed over the past decade, mostly driven by the outcomes of women of color.

While poverty and inadequate access to health care explain part of the racial disparity in maternal deaths, research has shown that the quality of care at hospitals where black women deliver plays a significant role as well. ProPublica added to research that has found that women who deliver at disproportionately “black-serving” hospitals are more likely to experience serious complications — from emergency hysterectomies to birth-related blood clots — than mothers who deliver at institutions that serve fewer black women.

In New York City, the racial disparity in maternal outcomes is among the largest in the nation, and it’s growing. According to a recent report from New York City’s Department of Health and Mental Hygiene, even as the overall maternal mortality rate across the city has decreased, the gap between black and white mothers has widened.

Regardless of their education, obesity or poverty level, black mothers in New York City are at a higher risk of harm than their white counterparts. Black mothers with a college education fare worse than women of all other races who dropped out of high school. Black women of normal weight have higher rates of harm than obese women of all other races. And black women who reside in the wealthiest neighborhoods have worse outcomes than white, Asian and Hispanic mothers in the poorest ones.

“If you are a poor black woman, you don’t have access to quality OBGYN care, and if you are a wealthy black women, like Serena Williams, you get providers who don’t listen to you when you say you can’t breathe,” said Patricia Loftman, a member of the American College of Nurse Midwives Board of Directors who worked for 30 years as a certified nurse-midwife in Harlem. “The components of this initiative are very aggressive and laudable to the extent that they are forcing hospital departments to talk about implicit bias.”

ProPublica is a Pulitzer Prize-winning investigative newsroom.


 

In response to alarming racial disparities, New York City announced a new initiative last week to reduce maternal deaths and complications among women of color. Under the new plan, the city will improve the data collection on maternal deaths and complications, fund implicit bias training for medical staff at private and public hospitals, and launch a public awareness campaign.

Over the next three years, the city will spend $12.8 million on the initiative, with the goal of eliminating the black-white racial disparity in deaths related to pregnancy and childbirth and cutting the number of complications in half within five years.

“We recognize these are ambitious goals, but they are not unrealistic,” said Dr. Herminia Palacio, New York City’s deputy mayor for health and human services. “It’s an explicit recognition of the urgency of this issue and puts the goal posts in front of us.”

The city’s health department is targeting nearly two dozen public and private hospitals over four years, focusing on neighborhoods with the highest complication rates, including the South Bronx, North and Central Brooklyn, and East and Central Harlem. Hospital officials will study data from cases that led to bad outcomes, and staff will participate in drills aimed at helping them recognize and treat those complications.

Health department officials approached SUNY Downstate Medical Center in May to serve as a pilot site for many of the new measures.

The Central Brooklyn hospital was featured in the “Lost Mothers” series published by ProPublica and NPR last year as one of the starkest examples of racial disparities among hospitals in three states, according to our analysis of over 1 million births in Florida, Illinois and New York. In the second half of last year, two women, both black, died shortly after delivering at SUNY Downstate from causes that experts have said are preventable. The public, state-run hospital has one of the highest complication rates for hemorrhage in the city.

“We look forward to working with all of our partners to provide quality maternal health care for expectant mothers,” said hospital spokesperson Dawn Skeete-Walker.

“SUNY Downstate serves a unique and diverse population in Brooklyn where many of our expectant mothers are from a variety of different backgrounds, beliefs, and cultures.”

The city will also specifically target its own public hospitals, which are run by NYC Health + Hospitals, training staff on how to better identify and treat hemorrhage and blood clots, two leading causes of maternal death.

The initiative is “aimed at using an approach that encourages folks to have a sense of accountability without finger pointing or blame, and that encourages hospitals to be active participants to identify practices that would benefit from improvement,” said Palacio.

In addition to training, the city’s public hospitals will hire maternal care coordinators who will assist high-risk pregnant women with their appointments, prescriptions and public health benefits. Public hospitals will also work to strengthen prenatal and postpartum care, including conducting hemorrhage assessments, establishing care plans, and providing contraceptive counselling, breastfeeding support and screening for maternal depression.

Starting in 2019, the health department plans to launch a maternal safety public awareness campaign in partnership with grassroots organizations.

“This is a positive first step in really being able to address the concerns of women of color and pregnant women,” said Chanel Porchia-Albert, founder and executive director of Ancient Song Doula Services, which is based in New York City. “There need to be accountability measures that are put in place that stress the community as an active participant and stakeholder.”

The city’s initiative is the latest in a wave of maternal health reforms following the “Lost Mothers” series. Over the past few months, the U.S. Senate has proposed $50 million in funding to reduce maternal deaths, and several states have launched review committees to examine birth outcomes.

As ProPublica and NPR reported, between 700 and 900 women die from causes related to pregnancy and childbirth in the United States every year, and tens of thousands more experience severe complications. The rate of maternal death is substantially higher in the United States than in other affluent nations, and has climbed over the past decade, mostly driven by the outcomes of women of color.

While poverty and inadequate access to health care explain part of the racial disparity in maternal deaths, research has shown that the quality of care at hospitals where black women deliver plays a significant role as well. ProPublica added to research that has found that women who deliver at disproportionately “black-serving” hospitals are more likely to experience serious complications — from emergency hysterectomies to birth-related blood clots — than mothers who deliver at institutions that serve fewer black women.

In New York City, the racial disparity in maternal outcomes is among the largest in the nation, and it’s growing. According to a recent report from New York City’s Department of Health and Mental Hygiene, even as the overall maternal mortality rate across the city has decreased, the gap between black and white mothers has widened.

Regardless of their education, obesity or poverty level, black mothers in New York City are at a higher risk of harm than their white counterparts. Black mothers with a college education fare worse than women of all other races who dropped out of high school. Black women of normal weight have higher rates of harm than obese women of all other races. And black women who reside in the wealthiest neighborhoods have worse outcomes than white, Asian and Hispanic mothers in the poorest ones.

“If you are a poor black woman, you don’t have access to quality OBGYN care, and if you are a wealthy black women, like Serena Williams, you get providers who don’t listen to you when you say you can’t breathe,” said Patricia Loftman, a member of the American College of Nurse Midwives Board of Directors who worked for 30 years as a certified nurse-midwife in Harlem. “The components of this initiative are very aggressive and laudable to the extent that they are forcing hospital departments to talk about implicit bias.”

ProPublica is a Pulitzer Prize-winning investigative newsroom.


 

In response to alarming racial disparities, New York City announced a new initiative last week to reduce maternal deaths and complications among women of color. Under the new plan, the city will improve the data collection on maternal deaths and complications, fund implicit bias training for medical staff at private and public hospitals, and launch a public awareness campaign.

Over the next three years, the city will spend $12.8 million on the initiative, with the goal of eliminating the black-white racial disparity in deaths related to pregnancy and childbirth and cutting the number of complications in half within five years.

“We recognize these are ambitious goals, but they are not unrealistic,” said Dr. Herminia Palacio, New York City’s deputy mayor for health and human services. “It’s an explicit recognition of the urgency of this issue and puts the goal posts in front of us.”

The city’s health department is targeting nearly two dozen public and private hospitals over four years, focusing on neighborhoods with the highest complication rates, including the South Bronx, North and Central Brooklyn, and East and Central Harlem. Hospital officials will study data from cases that led to bad outcomes, and staff will participate in drills aimed at helping them recognize and treat those complications.

Health department officials approached SUNY Downstate Medical Center in May to serve as a pilot site for many of the new measures.

The Central Brooklyn hospital was featured in the “Lost Mothers” series published by ProPublica and NPR last year as one of the starkest examples of racial disparities among hospitals in three states, according to our analysis of over 1 million births in Florida, Illinois and New York. In the second half of last year, two women, both black, died shortly after delivering at SUNY Downstate from causes that experts have said are preventable. The public, state-run hospital has one of the highest complication rates for hemorrhage in the city.

“We look forward to working with all of our partners to provide quality maternal health care for expectant mothers,” said hospital spokesperson Dawn Skeete-Walker.

“SUNY Downstate serves a unique and diverse population in Brooklyn where many of our expectant mothers are from a variety of different backgrounds, beliefs, and cultures.”

The city will also specifically target its own public hospitals, which are run by NYC Health + Hospitals, training staff on how to better identify and treat hemorrhage and blood clots, two leading causes of maternal death.

The initiative is “aimed at using an approach that encourages folks to have a sense of accountability without finger pointing or blame, and that encourages hospitals to be active participants to identify practices that would benefit from improvement,” said Palacio.

In addition to training, the city’s public hospitals will hire maternal care coordinators who will assist high-risk pregnant women with their appointments, prescriptions and public health benefits. Public hospitals will also work to strengthen prenatal and postpartum care, including conducting hemorrhage assessments, establishing care plans, and providing contraceptive counselling, breastfeeding support and screening for maternal depression.

Starting in 2019, the health department plans to launch a maternal safety public awareness campaign in partnership with grassroots organizations.

“This is a positive first step in really being able to address the concerns of women of color and pregnant women,” said Chanel Porchia-Albert, founder and executive director of Ancient Song Doula Services, which is based in New York City. “There need to be accountability measures that are put in place that stress the community as an active participant and stakeholder.”

The city’s initiative is the latest in a wave of maternal health reforms following the “Lost Mothers” series. Over the past few months, the U.S. Senate has proposed $50 million in funding to reduce maternal deaths, and several states have launched review committees to examine birth outcomes.

As ProPublica and NPR reported, between 700 and 900 women die from causes related to pregnancy and childbirth in the United States every year, and tens of thousands more experience severe complications. The rate of maternal death is substantially higher in the United States than in other affluent nations, and has climbed over the past decade, mostly driven by the outcomes of women of color.

While poverty and inadequate access to health care explain part of the racial disparity in maternal deaths, research has shown that the quality of care at hospitals where black women deliver plays a significant role as well. ProPublica added to research that has found that women who deliver at disproportionately “black-serving” hospitals are more likely to experience serious complications — from emergency hysterectomies to birth-related blood clots — than mothers who deliver at institutions that serve fewer black women.

In New York City, the racial disparity in maternal outcomes is among the largest in the nation, and it’s growing. According to a recent report from New York City’s Department of Health and Mental Hygiene, even as the overall maternal mortality rate across the city has decreased, the gap between black and white mothers has widened.

Regardless of their education, obesity or poverty level, black mothers in New York City are at a higher risk of harm than their white counterparts. Black mothers with a college education fare worse than women of all other races who dropped out of high school. Black women of normal weight have higher rates of harm than obese women of all other races. And black women who reside in the wealthiest neighborhoods have worse outcomes than white, Asian and Hispanic mothers in the poorest ones.

“If you are a poor black woman, you don’t have access to quality OBGYN care, and if you are a wealthy black women, like Serena Williams, you get providers who don’t listen to you when you say you can’t breathe,” said Patricia Loftman, a member of the American College of Nurse Midwives Board of Directors who worked for 30 years as a certified nurse-midwife in Harlem. “The components of this initiative are very aggressive and laudable to the extent that they are forcing hospital departments to talk about implicit bias.”

ProPublica is a Pulitzer Prize-winning investigative newsroom.


 

The Centers for Medicare & Medicaid Services has resumed the risk adjustment payment program from calendar year 2017 and is taking steps to ensure the program’s operation for 2018 and beyond.

CMS posted a final rule on July 24 that reissues, with additional explanation, the risk adjustment methodology that was used to calculate payments made to insurers for 2017.

The risk adjustment payment program uses statewide average premiums to draw money from health insurance plans within a state that have low levels of high-need patients and funnels that money to plans in that state with high amounts of high-need patients as a way to minimize adverse selection and to spread risk.

CMS halted the risk adjustment program earlier in the month following legal action. In January 2018, the U.S. District Court for the District of Massachusetts ruled that the CMS was acting within its authority in promulgating its methodology based on statewide average premiums. A month later, the U.S. District Court for the District of New Mexico ruled that the methodology was invalid and barred the CMS from collecting or making payments, which prompted the agency to temporarily halt the program.

“This final rule will restore operation of the risk adjustment program and mitigate some of the uncertainty caused by the New Mexico litigation,” CMS Administrator Seema Verma said in a statement. “Issuers that had expressed concern about having to withdraw from markets or becoming insolvent should be assured by our actions today.”

CMS said the final rule provides a fuller explanation to support the 2017 risk adjustment methodology. The agency dispensed with the normal notice and comment period before issuing the final rule to help ensure timely payments are made by the program while working to resolve the legal questions. A motion to reconsider was filed in New Mexico on June 21, but a ruling on that is not expected until early September, which prompted the unusual move to issue a final rule without any notice or comment period.

CMS added that there will be a notice of proposed rule making with the normal comment period related to the risk adjustment payments for the 2018 calendar year. The existing rule was also vacated by the New Mexico court. The risk adjustment methodology for 2019 and beyond was finalized in a rule issued on April 17.

[email protected]

The Centers for Medicare & Medicaid Services has resumed the risk adjustment payment program from calendar year 2017 and is taking steps to ensure the program’s operation for 2018 and beyond.

CMS posted a final rule on July 24 that reissues, with additional explanation, the risk adjustment methodology that was used to calculate payments made to insurers for 2017.

The risk adjustment payment program uses statewide average premiums to draw money from health insurance plans within a state that have low levels of high-need patients and funnels that money to plans in that state with high amounts of high-need patients as a way to minimize adverse selection and to spread risk.

CMS halted the risk adjustment program earlier in the month following legal action. In January 2018, the U.S. District Court for the District of Massachusetts ruled that the CMS was acting within its authority in promulgating its methodology based on statewide average premiums. A month later, the U.S. District Court for the District of New Mexico ruled that the methodology was invalid and barred the CMS from collecting or making payments, which prompted the agency to temporarily halt the program.

“This final rule will restore operation of the risk adjustment program and mitigate some of the uncertainty caused by the New Mexico litigation,” CMS Administrator Seema Verma said in a statement. “Issuers that had expressed concern about having to withdraw from markets or becoming insolvent should be assured by our actions today.”

CMS said the final rule provides a fuller explanation to support the 2017 risk adjustment methodology. The agency dispensed with the normal notice and comment period before issuing the final rule to help ensure timely payments are made by the program while working to resolve the legal questions. A motion to reconsider was filed in New Mexico on June 21, but a ruling on that is not expected until early September, which prompted the unusual move to issue a final rule without any notice or comment period.

CMS added that there will be a notice of proposed rule making with the normal comment period related to the risk adjustment payments for the 2018 calendar year. The existing rule was also vacated by the New Mexico court. The risk adjustment methodology for 2019 and beyond was finalized in a rule issued on April 17.

[email protected]

The Centers for Medicare & Medicaid Services has resumed the risk adjustment payment program from calendar year 2017 and is taking steps to ensure the program’s operation for 2018 and beyond.

CMS posted a final rule on July 24 that reissues, with additional explanation, the risk adjustment methodology that was used to calculate payments made to insurers for 2017.

The risk adjustment payment program uses statewide average premiums to draw money from health insurance plans within a state that have low levels of high-need patients and funnels that money to plans in that state with high amounts of high-need patients as a way to minimize adverse selection and to spread risk.

CMS halted the risk adjustment program earlier in the month following legal action. In January 2018, the U.S. District Court for the District of Massachusetts ruled that the CMS was acting within its authority in promulgating its methodology based on statewide average premiums. A month later, the U.S. District Court for the District of New Mexico ruled that the methodology was invalid and barred the CMS from collecting or making payments, which prompted the agency to temporarily halt the program.

“This final rule will restore operation of the risk adjustment program and mitigate some of the uncertainty caused by the New Mexico litigation,” CMS Administrator Seema Verma said in a statement. “Issuers that had expressed concern about having to withdraw from markets or becoming insolvent should be assured by our actions today.”

CMS said the final rule provides a fuller explanation to support the 2017 risk adjustment methodology. The agency dispensed with the normal notice and comment period before issuing the final rule to help ensure timely payments are made by the program while working to resolve the legal questions. A motion to reconsider was filed in New Mexico on June 21, but a ruling on that is not expected until early September, which prompted the unusual move to issue a final rule without any notice or comment period.

CMS added that there will be a notice of proposed rule making with the normal comment period related to the risk adjustment payments for the 2018 calendar year. The existing rule was also vacated by the New Mexico court. The risk adjustment methodology for 2019 and beyond was finalized in a rule issued on April 17.

[email protected]

MALMO, SWEDEN – Four doses of hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus/Haemophilus influenza type b vaccine given in infancy provides reassuringly long-lasting immune memory against hepatitis B among 14- to 15-year-olds, Tino F. Schwarz, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.

He presented the fourth and final study in a series evaluating the antibody persistence and immune memory against hepatitis B (HBV) in recipients of the complete four-dose series of hexavalent DTPa-HBV-IPV/Hib vaccine in infancy. Because exposure to HBV can increase during adolescence, it was essential to determine whether antibody persistence is maintained, explained Dr. Schwarz of Juliusspital Hospital in Wurzburg, Germany.

“As expected, we saw a decrease in anti-HBs [hepatitis B surface antigen] antibody levels over the years, with persistent seroprotection in 85% of children at age 4-5 years, 72% at 7-8 years, 61% at 12-13 years, and now 54% of adolescents at 14-15 years. But we could demonstrate a very strong anamnestic response in the trial. This is good information. It clearly shows that, in patients who are exposed to hepatitis B, we can certainly guarantee that they are protected. It’s a good result for public health. The vaccine is a very robust vaccine which induces a very strong response over the years. It can be boosted, but from an immunologic point of view it is not required,” he said.

The multicenter study included 268 adolescents aged 14-15 years who had received the four-dose hexavalent vaccine series in infancy. Their antibody persistence against anti-HBs was measured, then measured once again 1 month after receiving a challenge dose of monovalent HBV vaccine.

Prechallenge, 105 of the teens were seronegative, 144 were seroprotected as defined by an anti-HBs concentration of at least 10 mIU/mL, and 19 had low seropositivity marked by an antibody level of 6 to less than 10 mIU/mL. Yet 1 month after the booster, which was intended to mimic the impact of real-world exposure to HBV, 83% of the initially seronegative subjects had an anti-HBs concentration of 10 mIU/mL or more, and 67% of them had a level of at least 100 mIU/mL.

“We saw a clear fantastic anamnestic response,” Dr. Schwarz declared.

Overall, 93% of study participants seroconverted, and 87% of them had anti-HBs titers of 100 mIU/mL, “which is the level we’d like to achieve in vaccinees,” he observed.

The booster monovalent HBV vaccine was well tolerated, with one-third of subjects complaining of mild local injection site pain and 30% noting fatigue. But in response to a question posed by session chair Ronald de Groot, MD, emeritus professor of pediatrics at Radboud University in Nijmegen, the Netherlands, Dr. Schwarz said these study results indicate there’s no need for routine boosting in healthy adolescents such as those in the trial. Immunocompromised individuals might be a different story, but they weren’t investigated.

But what about in physicians and surgeons, where protection against HBV infection is essential? Dr. de Groot asked.

“In Germany, we require a titer of 100 mIU/mL or more in medical staff, but we’re quite alone in Europe. Other countries do not require booster vaccination for medical staff. The data we’ve shown here is quite reassuring: If you get exposed, you in effect get a booster. It’s complicated to test surgeons in their offices; better to just rely on the anamnestic response that we’ve demonstrated,” Dr. Schwarz replied.

He reported serving as a consultant to GlaxoSmithKline, which funded the study, as well as to Pfizer and Sanofi Pasteur.

[email protected]

MALMO, SWEDEN – Four doses of hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus/Haemophilus influenza type b vaccine given in infancy provides reassuringly long-lasting immune memory against hepatitis B among 14- to 15-year-olds, Tino F. Schwarz, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.

He presented the fourth and final study in a series evaluating the antibody persistence and immune memory against hepatitis B (HBV) in recipients of the complete four-dose series of hexavalent DTPa-HBV-IPV/Hib vaccine in infancy. Because exposure to HBV can increase during adolescence, it was essential to determine whether antibody persistence is maintained, explained Dr. Schwarz of Juliusspital Hospital in Wurzburg, Germany.

“As expected, we saw a decrease in anti-HBs [hepatitis B surface antigen] antibody levels over the years, with persistent seroprotection in 85% of children at age 4-5 years, 72% at 7-8 years, 61% at 12-13 years, and now 54% of adolescents at 14-15 years. But we could demonstrate a very strong anamnestic response in the trial. This is good information. It clearly shows that, in patients who are exposed to hepatitis B, we can certainly guarantee that they are protected. It’s a good result for public health. The vaccine is a very robust vaccine which induces a very strong response over the years. It can be boosted, but from an immunologic point of view it is not required,” he said.

The multicenter study included 268 adolescents aged 14-15 years who had received the four-dose hexavalent vaccine series in infancy. Their antibody persistence against anti-HBs was measured, then measured once again 1 month after receiving a challenge dose of monovalent HBV vaccine.

Prechallenge, 105 of the teens were seronegative, 144 were seroprotected as defined by an anti-HBs concentration of at least 10 mIU/mL, and 19 had low seropositivity marked by an antibody level of 6 to less than 10 mIU/mL. Yet 1 month after the booster, which was intended to mimic the impact of real-world exposure to HBV, 83% of the initially seronegative subjects had an anti-HBs concentration of 10 mIU/mL or more, and 67% of them had a level of at least 100 mIU/mL.

“We saw a clear fantastic anamnestic response,” Dr. Schwarz declared.

Overall, 93% of study participants seroconverted, and 87% of them had anti-HBs titers of 100 mIU/mL, “which is the level we’d like to achieve in vaccinees,” he observed.

The booster monovalent HBV vaccine was well tolerated, with one-third of subjects complaining of mild local injection site pain and 30% noting fatigue. But in response to a question posed by session chair Ronald de Groot, MD, emeritus professor of pediatrics at Radboud University in Nijmegen, the Netherlands, Dr. Schwarz said these study results indicate there’s no need for routine boosting in healthy adolescents such as those in the trial. Immunocompromised individuals might be a different story, but they weren’t investigated.

But what about in physicians and surgeons, where protection against HBV infection is essential? Dr. de Groot asked.

“In Germany, we require a titer of 100 mIU/mL or more in medical staff, but we’re quite alone in Europe. Other countries do not require booster vaccination for medical staff. The data we’ve shown here is quite reassuring: If you get exposed, you in effect get a booster. It’s complicated to test surgeons in their offices; better to just rely on the anamnestic response that we’ve demonstrated,” Dr. Schwarz replied.

He reported serving as a consultant to GlaxoSmithKline, which funded the study, as well as to Pfizer and Sanofi Pasteur.

[email protected]

MALMO, SWEDEN – Four doses of hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus/Haemophilus influenza type b vaccine given in infancy provides reassuringly long-lasting immune memory against hepatitis B among 14- to 15-year-olds, Tino F. Schwarz, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.

He presented the fourth and final study in a series evaluating the antibody persistence and immune memory against hepatitis B (HBV) in recipients of the complete four-dose series of hexavalent DTPa-HBV-IPV/Hib vaccine in infancy. Because exposure to HBV can increase during adolescence, it was essential to determine whether antibody persistence is maintained, explained Dr. Schwarz of Juliusspital Hospital in Wurzburg, Germany.

“As expected, we saw a decrease in anti-HBs [hepatitis B surface antigen] antibody levels over the years, with persistent seroprotection in 85% of children at age 4-5 years, 72% at 7-8 years, 61% at 12-13 years, and now 54% of adolescents at 14-15 years. But we could demonstrate a very strong anamnestic response in the trial. This is good information. It clearly shows that, in patients who are exposed to hepatitis B, we can certainly guarantee that they are protected. It’s a good result for public health. The vaccine is a very robust vaccine which induces a very strong response over the years. It can be boosted, but from an immunologic point of view it is not required,” he said.

The multicenter study included 268 adolescents aged 14-15 years who had received the four-dose hexavalent vaccine series in infancy. Their antibody persistence against anti-HBs was measured, then measured once again 1 month after receiving a challenge dose of monovalent HBV vaccine.

Prechallenge, 105 of the teens were seronegative, 144 were seroprotected as defined by an anti-HBs concentration of at least 10 mIU/mL, and 19 had low seropositivity marked by an antibody level of 6 to less than 10 mIU/mL. Yet 1 month after the booster, which was intended to mimic the impact of real-world exposure to HBV, 83% of the initially seronegative subjects had an anti-HBs concentration of 10 mIU/mL or more, and 67% of them had a level of at least 100 mIU/mL.

“We saw a clear fantastic anamnestic response,” Dr. Schwarz declared.

Overall, 93% of study participants seroconverted, and 87% of them had anti-HBs titers of 100 mIU/mL, “which is the level we’d like to achieve in vaccinees,” he observed.

The booster monovalent HBV vaccine was well tolerated, with one-third of subjects complaining of mild local injection site pain and 30% noting fatigue. But in response to a question posed by session chair Ronald de Groot, MD, emeritus professor of pediatrics at Radboud University in Nijmegen, the Netherlands, Dr. Schwarz said these study results indicate there’s no need for routine boosting in healthy adolescents such as those in the trial. Immunocompromised individuals might be a different story, but they weren’t investigated.

But what about in physicians and surgeons, where protection against HBV infection is essential? Dr. de Groot asked.

“In Germany, we require a titer of 100 mIU/mL or more in medical staff, but we’re quite alone in Europe. Other countries do not require booster vaccination for medical staff. The data we’ve shown here is quite reassuring: If you get exposed, you in effect get a booster. It’s complicated to test surgeons in their offices; better to just rely on the anamnestic response that we’ve demonstrated,” Dr. Schwarz replied.

He reported serving as a consultant to GlaxoSmithKline, which funded the study, as well as to Pfizer and Sanofi Pasteur.

[email protected]

ORLANDO – Widespread implementation of enhanced recovery protocols at the state level resulted in a significant reduction in length of stay and complications in patients undergoing elective colectomy, an analysis shows.

The benefits were particularly pronounced in the subset of patients undergoing laparoscopic colectomy in the retrospective analysis, which included data for treated at four institutions in the Virginia Surgical Quality Collaborative Workgroup.

While the benefits of enhanced recovery after surgery (ERAS) are well known, most of the published data has come from single-institution experiences, according to investigator Traci L. Hedrick, MD, FACS, of the University of Virginia, Charlottesville.

At the American College of Surgeons Quality and Safety Conference, Dr. Hedrick presented risk-adjusted National Surgical Quality Improvement Program (NSQIP) data for 2,971 consecutive procedures during 2012-2016 at the University of Virginia, Winchester Medical Center, Carilion Clinic, and Inova Fairfax.

“Institutions came and went from the collaborative during this time period, so we focused on those institutions that maintained in the collaborative throughout the entire study protocol,” Dr. Hedrick said in her presentation.

Of the 2,971 procedures, about half (1,460) were performed after implementation of enhanced recovery protocols. Laparoscopic and open procedures were analyzed separately due to a substantial shift toward laparoscopic procedures, mainly during the 2012-2014 period, Dr. Hedrick said.

Among laparoscopic cases, there was a significant 1-day reduction in median length of stay, dropping from 4 days for pre–enhanced recovery protocol cases to 3 days for post–enhanced recovery protocol cases, Dr. Hedrick reported.

Observed morbidity also dropped significantly from 14.8% to 8.9% for the pre– and post–enhanced recovery cases, and the readmission rate fell significantly from 13% to 8.8%.

For open cases, there was a significant 1-day drop in median length of stay, from 4 to 3 days, but no significant differences in observed morbidity or readmission rates, according to Dr. Hedrick.

“As more of the patients were done laparoscopically, that really selected out the more complicated patients that were undergoing open procedures,” she said.

The protocols implemented by institutions in the Virginia collaborative group were generally uniform in important tenants of enhanced recovery, such as opioid minimization and avoidance of fasting, but specific elements were left up to each institution to improve buy-in, according to Dr. Hedrick.

“A lot of our protocols are very similar, particularly with regards to the order set,” Dr. Hedrick explained, “[but] I really am a firm believer in not being very strict about exactly what to use, because it’s so dependent on preference at the local level.”

The Virginia Surgical Quality Collaborative Workgroup is one of 20 regional ACS NSQIP collaboratives with the objective of improving surgical outcomes through multi-institutional collaboration, Dr. Hedrick said.

Dr. Hedrick and her coinvestigators had no relevant disclosures to report.

ORLANDO – Widespread implementation of enhanced recovery protocols at the state level resulted in a significant reduction in length of stay and complications in patients undergoing elective colectomy, an analysis shows.

The benefits were particularly pronounced in the subset of patients undergoing laparoscopic colectomy in the retrospective analysis, which included data for treated at four institutions in the Virginia Surgical Quality Collaborative Workgroup.

While the benefits of enhanced recovery after surgery (ERAS) are well known, most of the published data has come from single-institution experiences, according to investigator Traci L. Hedrick, MD, FACS, of the University of Virginia, Charlottesville.

At the American College of Surgeons Quality and Safety Conference, Dr. Hedrick presented risk-adjusted National Surgical Quality Improvement Program (NSQIP) data for 2,971 consecutive procedures during 2012-2016 at the University of Virginia, Winchester Medical Center, Carilion Clinic, and Inova Fairfax.

“Institutions came and went from the collaborative during this time period, so we focused on those institutions that maintained in the collaborative throughout the entire study protocol,” Dr. Hedrick said in her presentation.

Of the 2,971 procedures, about half (1,460) were performed after implementation of enhanced recovery protocols. Laparoscopic and open procedures were analyzed separately due to a substantial shift toward laparoscopic procedures, mainly during the 2012-2014 period, Dr. Hedrick said.

Among laparoscopic cases, there was a significant 1-day reduction in median length of stay, dropping from 4 days for pre–enhanced recovery protocol cases to 3 days for post–enhanced recovery protocol cases, Dr. Hedrick reported.

Observed morbidity also dropped significantly from 14.8% to 8.9% for the pre– and post–enhanced recovery cases, and the readmission rate fell significantly from 13% to 8.8%.

For open cases, there was a significant 1-day drop in median length of stay, from 4 to 3 days, but no significant differences in observed morbidity or readmission rates, according to Dr. Hedrick.

“As more of the patients were done laparoscopically, that really selected out the more complicated patients that were undergoing open procedures,” she said.

The protocols implemented by institutions in the Virginia collaborative group were generally uniform in important tenants of enhanced recovery, such as opioid minimization and avoidance of fasting, but specific elements were left up to each institution to improve buy-in, according to Dr. Hedrick.

“A lot of our protocols are very similar, particularly with regards to the order set,” Dr. Hedrick explained, “[but] I really am a firm believer in not being very strict about exactly what to use, because it’s so dependent on preference at the local level.”

The Virginia Surgical Quality Collaborative Workgroup is one of 20 regional ACS NSQIP collaboratives with the objective of improving surgical outcomes through multi-institutional collaboration, Dr. Hedrick said.

Dr. Hedrick and her coinvestigators had no relevant disclosures to report.

ORLANDO – Widespread implementation of enhanced recovery protocols at the state level resulted in a significant reduction in length of stay and complications in patients undergoing elective colectomy, an analysis shows.

The benefits were particularly pronounced in the subset of patients undergoing laparoscopic colectomy in the retrospective analysis, which included data for treated at four institutions in the Virginia Surgical Quality Collaborative Workgroup.

While the benefits of enhanced recovery after surgery (ERAS) are well known, most of the published data has come from single-institution experiences, according to investigator Traci L. Hedrick, MD, FACS, of the University of Virginia, Charlottesville.

At the American College of Surgeons Quality and Safety Conference, Dr. Hedrick presented risk-adjusted National Surgical Quality Improvement Program (NSQIP) data for 2,971 consecutive procedures during 2012-2016 at the University of Virginia, Winchester Medical Center, Carilion Clinic, and Inova Fairfax.

“Institutions came and went from the collaborative during this time period, so we focused on those institutions that maintained in the collaborative throughout the entire study protocol,” Dr. Hedrick said in her presentation.

Of the 2,971 procedures, about half (1,460) were performed after implementation of enhanced recovery protocols. Laparoscopic and open procedures were analyzed separately due to a substantial shift toward laparoscopic procedures, mainly during the 2012-2014 period, Dr. Hedrick said.

Among laparoscopic cases, there was a significant 1-day reduction in median length of stay, dropping from 4 days for pre–enhanced recovery protocol cases to 3 days for post–enhanced recovery protocol cases, Dr. Hedrick reported.

Observed morbidity also dropped significantly from 14.8% to 8.9% for the pre– and post–enhanced recovery cases, and the readmission rate fell significantly from 13% to 8.8%.

For open cases, there was a significant 1-day drop in median length of stay, from 4 to 3 days, but no significant differences in observed morbidity or readmission rates, according to Dr. Hedrick.

“As more of the patients were done laparoscopically, that really selected out the more complicated patients that were undergoing open procedures,” she said.

The protocols implemented by institutions in the Virginia collaborative group were generally uniform in important tenants of enhanced recovery, such as opioid minimization and avoidance of fasting, but specific elements were left up to each institution to improve buy-in, according to Dr. Hedrick.

“A lot of our protocols are very similar, particularly with regards to the order set,” Dr. Hedrick explained, “[but] I really am a firm believer in not being very strict about exactly what to use, because it’s so dependent on preference at the local level.”

The Virginia Surgical Quality Collaborative Workgroup is one of 20 regional ACS NSQIP collaboratives with the objective of improving surgical outcomes through multi-institutional collaboration, Dr. Hedrick said.

Dr. Hedrick and her coinvestigators had no relevant disclosures to report.

ORLANDO – The inferior outcomes associated with right-sided colon cancers might be mitigated if a higher lymph node harvest is obtained, a retrospective study suggested.

jacoblund/Thinkstock

Among patients with right-sided cancers, the rate of survival improved when 22 or more lymph nodes were harvested during operations, according to the study results presented at the American College of Surgeons Quality and Safety Conference.

“These data may provide indirect evidence for complete mesocolic excision to obtain a higher lymph node harvest to improve survival,” said investigator Arman Erkan, MD, of the Center for Colon and Rectal Surgery at Florida Hospital Orlando, in an oral abstract presentation.

This study adds new perspective on recent studies that have also demonstrated worse outcomes for right-sided versus left-sided tumors, which may be related to differences in levels of vascular ligation and nodal harvest. In addition, many studies to date have been limited in their ability to evaluate that hypothesis because of small sample size or other factors, he said in his presentation.

Accordingly, Dr. Erkan and his colleagues queried the National Cancer Database for colectomies for nonmetastatic colon adenocarcinoma occurring between 2004 and 2014, evaluating a total of 504,958 patient records, of which 273,198 were for right-sided tumors. To minimize bias, they used propensity score matching, leaving 148,540 patients in each group for the primary analysis.

Right-sided tumors were associated with inferior 5-year survival for patients with stage II and III disease (P less than .001 for right vs. left in both analyses), the investigators found.

In multivariate analysis, they found a significant interaction between right-sided tumors and a lymph node harvest of greater than 22 nodes toward increased survival, with a hazard ratio of 0.87 (95% confidence interval, 0.84-0.90). “This indicates that survival after right-sided resections can be improved if more than 22 nodes are harvested during the surgery,” Dr. Erkan said.

The difference was most pronounced in stage III of the disease, he added.

Study coauthor Lawrence Lee, MD, a colorectal surgeon at McGill University, said in a related press release that the study findings might prompt surgeons to reevaluate the types of procedures they perform in patients with right-sided tumors. “These patients may need a more extensive resection than is considered to be standard for them.”

Dr. Erkan, Dr. Lee, and other coinvestigators reported no conflicts of interest related to their research.

Help your patients better prepare for their colonoscopy by using AGA patient education materials: https://www.gastro.org/practice-guidance/gi-patient-center/topic/colonoscopy.

ORLANDO – The inferior outcomes associated with right-sided colon cancers might be mitigated if a higher lymph node harvest is obtained, a retrospective study suggested.

jacoblund/Thinkstock

Among patients with right-sided cancers, the rate of survival improved when 22 or more lymph nodes were harvested during operations, according to the study results presented at the American College of Surgeons Quality and Safety Conference.

“These data may provide indirect evidence for complete mesocolic excision to obtain a higher lymph node harvest to improve survival,” said investigator Arman Erkan, MD, of the Center for Colon and Rectal Surgery at Florida Hospital Orlando, in an oral abstract presentation.

This study adds new perspective on recent studies that have also demonstrated worse outcomes for right-sided versus left-sided tumors, which may be related to differences in levels of vascular ligation and nodal harvest. In addition, many studies to date have been limited in their ability to evaluate that hypothesis because of small sample size or other factors, he said in his presentation.

Accordingly, Dr. Erkan and his colleagues queried the National Cancer Database for colectomies for nonmetastatic colon adenocarcinoma occurring between 2004 and 2014, evaluating a total of 504,958 patient records, of which 273,198 were for right-sided tumors. To minimize bias, they used propensity score matching, leaving 148,540 patients in each group for the primary analysis.

Right-sided tumors were associated with inferior 5-year survival for patients with stage II and III disease (P less than .001 for right vs. left in both analyses), the investigators found.

In multivariate analysis, they found a significant interaction between right-sided tumors and a lymph node harvest of greater than 22 nodes toward increased survival, with a hazard ratio of 0.87 (95% confidence interval, 0.84-0.90). “This indicates that survival after right-sided resections can be improved if more than 22 nodes are harvested during the surgery,” Dr. Erkan said.

The difference was most pronounced in stage III of the disease, he added.

Study coauthor Lawrence Lee, MD, a colorectal surgeon at McGill University, said in a related press release that the study findings might prompt surgeons to reevaluate the types of procedures they perform in patients with right-sided tumors. “These patients may need a more extensive resection than is considered to be standard for them.”

Dr. Erkan, Dr. Lee, and other coinvestigators reported no conflicts of interest related to their research.

Help your patients better prepare for their colonoscopy by using AGA patient education materials: https://www.gastro.org/practice-guidance/gi-patient-center/topic/colonoscopy.

ORLANDO – The inferior outcomes associated with right-sided colon cancers might be mitigated if a higher lymph node harvest is obtained, a retrospective study suggested.

jacoblund/Thinkstock

Among patients with right-sided cancers, the rate of survival improved when 22 or more lymph nodes were harvested during operations, according to the study results presented at the American College of Surgeons Quality and Safety Conference.

“These data may provide indirect evidence for complete mesocolic excision to obtain a higher lymph node harvest to improve survival,” said investigator Arman Erkan, MD, of the Center for Colon and Rectal Surgery at Florida Hospital Orlando, in an oral abstract presentation.

This study adds new perspective on recent studies that have also demonstrated worse outcomes for right-sided versus left-sided tumors, which may be related to differences in levels of vascular ligation and nodal harvest. In addition, many studies to date have been limited in their ability to evaluate that hypothesis because of small sample size or other factors, he said in his presentation.

Accordingly, Dr. Erkan and his colleagues queried the National Cancer Database for colectomies for nonmetastatic colon adenocarcinoma occurring between 2004 and 2014, evaluating a total of 504,958 patient records, of which 273,198 were for right-sided tumors. To minimize bias, they used propensity score matching, leaving 148,540 patients in each group for the primary analysis.

Right-sided tumors were associated with inferior 5-year survival for patients with stage II and III disease (P less than .001 for right vs. left in both analyses), the investigators found.

In multivariate analysis, they found a significant interaction between right-sided tumors and a lymph node harvest of greater than 22 nodes toward increased survival, with a hazard ratio of 0.87 (95% confidence interval, 0.84-0.90). “This indicates that survival after right-sided resections can be improved if more than 22 nodes are harvested during the surgery,” Dr. Erkan said.

The difference was most pronounced in stage III of the disease, he added.

Study coauthor Lawrence Lee, MD, a colorectal surgeon at McGill University, said in a related press release that the study findings might prompt surgeons to reevaluate the types of procedures they perform in patients with right-sided tumors. “These patients may need a more extensive resection than is considered to be standard for them.”

Dr. Erkan, Dr. Lee, and other coinvestigators reported no conflicts of interest related to their research.

Help your patients better prepare for their colonoscopy by using AGA patient education materials: https://www.gastro.org/practice-guidance/gi-patient-center/topic/colonoscopy.

CHICAGO – A dendritic cell vaccine improved progression-free survival when administered sequentially after chemotherapy in patients with epithelial ovarian carcinoma who have undergone primary debulking surgery, according to interim findings from a randomized, phase 2, open-label trial.

Of 99 patients enrolled in the international, multicenter trial between November 2013 and March 2016, 92 received at least one dose of therapy and had a postbaseline endpoint assessment (the modified intention-to-treat population). Median progression-free survival was 18.3 months in the 31 patients who received autologous dendritic cell vaccine (DCVAC) given concomitantly with chemotherapy (group A), 24.3 months in the 30 patients who received DCVAC given sequentially as maintenance therapy after chemotherapy (group B), and 18.6 months in the 31 controls who received chemotherapy alone (group C), Lukas Rob, MD, reported at the annual meeting of the American Society of Clinical Oncology.

“When DCVAC was administered as maintenance [therapy] after the chemotherapy, the time to disease progression was prolonged by almost 6 months. Based on the hazard ratio, there was a 57% decrease in the hazard of progression in favor of arm B,” said Dr. Rob, of University Hospital Kralovske Vinohrady, Prague.

Compared with group C, progression-free survival hazard ratios were 0.64 and 0.43 in the modified intention-to-treat population in groups A and B, respectively, he said.

“These results are statistically significant and the clinical benefit is even more significant in patients who received more doses of DCVAC,” he added, explaining that the hazard ratios for patients in groups A and B who received at least eight doses of DCVAC and/or three cycles of chemotherapy (the per protocol population, including 87 patients) were 1.01 and 0.32, respectively.

Although the overall survival data in this study is immature, there is “a strong trend in favor of DCVAC in the maintenance treatment arm,” he said.

Study participants had FIGO stage III epithelial ovarian cancer (EOC) and a performance status score of 0-2. All had undergone primary debulking surgery and had less than 1 cm maximal residuum and no prior systemic therapy. Patients were randomized up to 6 weeks after surgery. Chemotherapy in all three groups included six cycles of carboplatin and paclitaxel, and DCVAC was given at doses of 1 x 107 dendritic cells per dose for a planned 10 doses.

Most patients with EOC – about 70% of those with stage III/IV disease – relapse after optimal debulking surgery and chemotherapy.

“There is no doubt that we need a new treatment modality,” he said. Because autologous DCVAC can present tumor antigens to elicit a durable immune response, he and his colleagues hypothesized that adding DCVAC to chemotherapy could improve outcomes – either when used concomitantly to target tumor-induced immune suppression and allowing for partial recovery of the immune system after each cycle, or when used sequentially as maintenance therapy, as minimal tumor burden after chemotherapy would provide optimal conditions for immune stimulation and the immune system would be fully recovered after completing cytotoxic therapy.

The treatments in this study were well tolerated; no grade 3 or greater adverse events were related solely to DCVAC, and the vaccine did not worsen the side effects of chemotherapy, Dr. Rob said.

The findings suggested that sequential DCVAC after chemotherapy in patients with EOC is a promising maintenance treatment option that can delay disease progression, he concluded, noting that “due to the excellent result in the maintenance arm we decided ... to enroll more patients in arms B and C to increase the power of this study.”

Additionally, a phase 3 trial is planned and enrollment should begin in early 2019, he said.

Dr. Rob reported having no disclosures.

SOURCE: Rob L et al. ASCO 2018, Abstract 5509.

CHICAGO – A dendritic cell vaccine improved progression-free survival when administered sequentially after chemotherapy in patients with epithelial ovarian carcinoma who have undergone primary debulking surgery, according to interim findings from a randomized, phase 2, open-label trial.

Of 99 patients enrolled in the international, multicenter trial between November 2013 and March 2016, 92 received at least one dose of therapy and had a postbaseline endpoint assessment (the modified intention-to-treat population). Median progression-free survival was 18.3 months in the 31 patients who received autologous dendritic cell vaccine (DCVAC) given concomitantly with chemotherapy (group A), 24.3 months in the 30 patients who received DCVAC given sequentially as maintenance therapy after chemotherapy (group B), and 18.6 months in the 31 controls who received chemotherapy alone (group C), Lukas Rob, MD, reported at the annual meeting of the American Society of Clinical Oncology.

“When DCVAC was administered as maintenance [therapy] after the chemotherapy, the time to disease progression was prolonged by almost 6 months. Based on the hazard ratio, there was a 57% decrease in the hazard of progression in favor of arm B,” said Dr. Rob, of University Hospital Kralovske Vinohrady, Prague.

Compared with group C, progression-free survival hazard ratios were 0.64 and 0.43 in the modified intention-to-treat population in groups A and B, respectively, he said.

“These results are statistically significant and the clinical benefit is even more significant in patients who received more doses of DCVAC,” he added, explaining that the hazard ratios for patients in groups A and B who received at least eight doses of DCVAC and/or three cycles of chemotherapy (the per protocol population, including 87 patients) were 1.01 and 0.32, respectively.

Although the overall survival data in this study is immature, there is “a strong trend in favor of DCVAC in the maintenance treatment arm,” he said.

Study participants had FIGO stage III epithelial ovarian cancer (EOC) and a performance status score of 0-2. All had undergone primary debulking surgery and had less than 1 cm maximal residuum and no prior systemic therapy. Patients were randomized up to 6 weeks after surgery. Chemotherapy in all three groups included six cycles of carboplatin and paclitaxel, and DCVAC was given at doses of 1 x 107 dendritic cells per dose for a planned 10 doses.

Most patients with EOC – about 70% of those with stage III/IV disease – relapse after optimal debulking surgery and chemotherapy.

“There is no doubt that we need a new treatment modality,” he said. Because autologous DCVAC can present tumor antigens to elicit a durable immune response, he and his colleagues hypothesized that adding DCVAC to chemotherapy could improve outcomes – either when used concomitantly to target tumor-induced immune suppression and allowing for partial recovery of the immune system after each cycle, or when used sequentially as maintenance therapy, as minimal tumor burden after chemotherapy would provide optimal conditions for immune stimulation and the immune system would be fully recovered after completing cytotoxic therapy.

The treatments in this study were well tolerated; no grade 3 or greater adverse events were related solely to DCVAC, and the vaccine did not worsen the side effects of chemotherapy, Dr. Rob said.

The findings suggested that sequential DCVAC after chemotherapy in patients with EOC is a promising maintenance treatment option that can delay disease progression, he concluded, noting that “due to the excellent result in the maintenance arm we decided ... to enroll more patients in arms B and C to increase the power of this study.”

Additionally, a phase 3 trial is planned and enrollment should begin in early 2019, he said.

Dr. Rob reported having no disclosures.

SOURCE: Rob L et al. ASCO 2018, Abstract 5509.

CHICAGO – A dendritic cell vaccine improved progression-free survival when administered sequentially after chemotherapy in patients with epithelial ovarian carcinoma who have undergone primary debulking surgery, according to interim findings from a randomized, phase 2, open-label trial.

Of 99 patients enrolled in the international, multicenter trial between November 2013 and March 2016, 92 received at least one dose of therapy and had a postbaseline endpoint assessment (the modified intention-to-treat population). Median progression-free survival was 18.3 months in the 31 patients who received autologous dendritic cell vaccine (DCVAC) given concomitantly with chemotherapy (group A), 24.3 months in the 30 patients who received DCVAC given sequentially as maintenance therapy after chemotherapy (group B), and 18.6 months in the 31 controls who received chemotherapy alone (group C), Lukas Rob, MD, reported at the annual meeting of the American Society of Clinical Oncology.

“When DCVAC was administered as maintenance [therapy] after the chemotherapy, the time to disease progression was prolonged by almost 6 months. Based on the hazard ratio, there was a 57% decrease in the hazard of progression in favor of arm B,” said Dr. Rob, of University Hospital Kralovske Vinohrady, Prague.

Compared with group C, progression-free survival hazard ratios were 0.64 and 0.43 in the modified intention-to-treat population in groups A and B, respectively, he said.

“These results are statistically significant and the clinical benefit is even more significant in patients who received more doses of DCVAC,” he added, explaining that the hazard ratios for patients in groups A and B who received at least eight doses of DCVAC and/or three cycles of chemotherapy (the per protocol population, including 87 patients) were 1.01 and 0.32, respectively.

Although the overall survival data in this study is immature, there is “a strong trend in favor of DCVAC in the maintenance treatment arm,” he said.

Study participants had FIGO stage III epithelial ovarian cancer (EOC) and a performance status score of 0-2. All had undergone primary debulking surgery and had less than 1 cm maximal residuum and no prior systemic therapy. Patients were randomized up to 6 weeks after surgery. Chemotherapy in all three groups included six cycles of carboplatin and paclitaxel, and DCVAC was given at doses of 1 x 107 dendritic cells per dose for a planned 10 doses.

Most patients with EOC – about 70% of those with stage III/IV disease – relapse after optimal debulking surgery and chemotherapy.

“There is no doubt that we need a new treatment modality,” he said. Because autologous DCVAC can present tumor antigens to elicit a durable immune response, he and his colleagues hypothesized that adding DCVAC to chemotherapy could improve outcomes – either when used concomitantly to target tumor-induced immune suppression and allowing for partial recovery of the immune system after each cycle, or when used sequentially as maintenance therapy, as minimal tumor burden after chemotherapy would provide optimal conditions for immune stimulation and the immune system would be fully recovered after completing cytotoxic therapy.

The treatments in this study were well tolerated; no grade 3 or greater adverse events were related solely to DCVAC, and the vaccine did not worsen the side effects of chemotherapy, Dr. Rob said.

The findings suggested that sequential DCVAC after chemotherapy in patients with EOC is a promising maintenance treatment option that can delay disease progression, he concluded, noting that “due to the excellent result in the maintenance arm we decided ... to enroll more patients in arms B and C to increase the power of this study.”

Additionally, a phase 3 trial is planned and enrollment should begin in early 2019, he said.

Dr. Rob reported having no disclosures.

SOURCE: Rob L et al. ASCO 2018, Abstract 5509.

Laboratory work revealed a normal CBC and differential, an elevated C-reactive protein (CRP) and sedimentation rate (ESR), negative antistreptolysin O (ASO) titers, negative pregnancy test, a normal urinalysis, and negative blood, throat, and urine cultures. A chest x-ray also was negative as well as angiotensin-converting enzyme (ACE) levels. Tuberculosis interferon-gamma release essay was negative.

The patient was diagnosed with erythema nodosum (EN), based on physical exam and history of the lesions. In her particular case, infectious causes including streptococcus infection, tuberculosis, and coccidioidomycosis were ruled out. There were no x-ray findings that suggested sarcoidosis and her ACE level was within normal limits. The pregnancy test also was negative. Given her recent start on OCs, this was thought to be the cause of the lesions.

She was treated with elevation, compression stockings, and NSAIDs and discontinuation of OCs. The lesions resolved after 6 weeks leaving bruiselike patches (erythema contusiformis).

EN is a delayed-type hypersensitivity reaction, causing inflammation on the fat (panniculitis) most commonly on the shins, but it can also occur on the arms, face, neck, and thighs. It is the most common type of panniculitis and is usually seen more often in women from the second to fourth decade of life. Erythematous tender nodules in crops commonly located on the shins are the characteristic physical finding. Systemic symptoms can occur including fever, malaise, and joint pain. The lesions usually last up to 6-8 weeks and may leave bruiselike patches or postinflammatory hyperpigmentation that can take months to improve.¹

The diagnosis of EN usually is made by physical examination and natural history. In unusual severe cases or lesions in atypical locations, a skin biopsy is indicated. Histologic examination of one of the lesions reveals a septal panniculitis without vasculitis. Miescher’s radial granulomas (grouped macrophages around neutrophils or septa-like spaces) often are present and are a characteristic feature of EN.

EN can be triggered by different types of infections such as streptococcus, mycoplasma, tuberculosis, or bacterial gastroenteritis; medications such as OCs, sulfonamides, iodides, penicillin, or bromides; medical conditions that include inflammatory bowel disease, pregnancy, or sarcoidosis; or neutrophilic dermatosis and malignancy such as leukemia and Hodgkin disease.^2,3 A third of the cases are idiopathic. In children, streptococcal infections are responsible for most cases of EN.⁴

Recommended work-up to investigate possible triggers includes a CBC with differential, sedimentation rate, CRP, ASO titers or anti-DNase B titers, tuberculin skin test or interferon-gamma TB test and a chest X ray. If there are any other symptoms, physical signs, or risk factors are present for the other not so common causes, further ancillary testing may be warranted.

Erythematous nodules and papules on the shin in children are commonly caused by arthropod bites also known as papular urticaria. These lesions are pruritic rather than tender and usually respond to topical corticosteroids and oral antihistamines. Subcutaneous bacterial, fungal, or atypical mycobacterial infections can present with tender nodules that can ulcerate and drain on the shins, feet, or any other body part. These patients may have a history of immunodeficiency and usually systemic symptoms of infection are present. Cutaneous polyarteritis nodosa (PAN) also can present with tender nodules on the legs but these lesions usually necrose and ulcerate and may be associated with livedo racemosa, a transient or persistent, blotchy, reddish-blue to purple, netlike cyanotic pattern. On pathology, PAN presents with necrotizing medium vessel vasculitis. Malignant nodules also can occur on the shin. Pathology will show atypical cells. Other forms of panniculitis, such as erythema induratum and pancreatic panniculitis, can present with tender nodules but these lesions usually occur on the calves and ulcerate.

Management of EN starts with treating the underlying infection or stopping the causative medication. Initial measures include bed rest, leg elevation, compression bandages, and NSAIDs. Potassium iodide is a very effective therapy as it may control the symptoms within 24 hours. When there is no response to the above, or the patient has severe symptoms, a short course of systemic glucocorticoids can be started. Other medications for recalcitrant or recurrent lesions include colchicine, dapsone, or hydroxychloroquine.
 

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego.

References

1. Panniculitis, in “Dermatology,” 3rd ed. (Philadelphia: Elsevier Saunders, 2012, p. 1641).

2. Arthritis Rheum. 2000 Mar;43(3):584-92.

3. J Clin Oncol. 2007 Sep 1;25(25):4011-2.

4. Turk J Pediatr. 2014 Mar-Apr;56(2):144-9.

Laboratory work revealed a normal CBC and differential, an elevated C-reactive protein (CRP) and sedimentation rate (ESR), negative antistreptolysin O (ASO) titers, negative pregnancy test, a normal urinalysis, and negative blood, throat, and urine cultures. A chest x-ray also was negative as well as angiotensin-converting enzyme (ACE) levels. Tuberculosis interferon-gamma release essay was negative.

The patient was diagnosed with erythema nodosum (EN), based on physical exam and history of the lesions. In her particular case, infectious causes including streptococcus infection, tuberculosis, and coccidioidomycosis were ruled out. There were no x-ray findings that suggested sarcoidosis and her ACE level was within normal limits. The pregnancy test also was negative. Given her recent start on OCs, this was thought to be the cause of the lesions.

She was treated with elevation, compression stockings, and NSAIDs and discontinuation of OCs. The lesions resolved after 6 weeks leaving bruiselike patches (erythema contusiformis).

EN is a delayed-type hypersensitivity reaction, causing inflammation on the fat (panniculitis) most commonly on the shins, but it can also occur on the arms, face, neck, and thighs. It is the most common type of panniculitis and is usually seen more often in women from the second to fourth decade of life. Erythematous tender nodules in crops commonly located on the shins are the characteristic physical finding. Systemic symptoms can occur including fever, malaise, and joint pain. The lesions usually last up to 6-8 weeks and may leave bruiselike patches or postinflammatory hyperpigmentation that can take months to improve.¹

The diagnosis of EN usually is made by physical examination and natural history. In unusual severe cases or lesions in atypical locations, a skin biopsy is indicated. Histologic examination of one of the lesions reveals a septal panniculitis without vasculitis. Miescher’s radial granulomas (grouped macrophages around neutrophils or septa-like spaces) often are present and are a characteristic feature of EN.

EN can be triggered by different types of infections such as streptococcus, mycoplasma, tuberculosis, or bacterial gastroenteritis; medications such as OCs, sulfonamides, iodides, penicillin, or bromides; medical conditions that include inflammatory bowel disease, pregnancy, or sarcoidosis; or neutrophilic dermatosis and malignancy such as leukemia and Hodgkin disease.^2,3 A third of the cases are idiopathic. In children, streptococcal infections are responsible for most cases of EN.⁴

Recommended work-up to investigate possible triggers includes a CBC with differential, sedimentation rate, CRP, ASO titers or anti-DNase B titers, tuberculin skin test or interferon-gamma TB test and a chest X ray. If there are any other symptoms, physical signs, or risk factors are present for the other not so common causes, further ancillary testing may be warranted.

Erythematous nodules and papules on the shin in children are commonly caused by arthropod bites also known as papular urticaria. These lesions are pruritic rather than tender and usually respond to topical corticosteroids and oral antihistamines. Subcutaneous bacterial, fungal, or atypical mycobacterial infections can present with tender nodules that can ulcerate and drain on the shins, feet, or any other body part. These patients may have a history of immunodeficiency and usually systemic symptoms of infection are present. Cutaneous polyarteritis nodosa (PAN) also can present with tender nodules on the legs but these lesions usually necrose and ulcerate and may be associated with livedo racemosa, a transient or persistent, blotchy, reddish-blue to purple, netlike cyanotic pattern. On pathology, PAN presents with necrotizing medium vessel vasculitis. Malignant nodules also can occur on the shin. Pathology will show atypical cells. Other forms of panniculitis, such as erythema induratum and pancreatic panniculitis, can present with tender nodules but these lesions usually occur on the calves and ulcerate.

Management of EN starts with treating the underlying infection or stopping the causative medication. Initial measures include bed rest, leg elevation, compression bandages, and NSAIDs. Potassium iodide is a very effective therapy as it may control the symptoms within 24 hours. When there is no response to the above, or the patient has severe symptoms, a short course of systemic glucocorticoids can be started. Other medications for recalcitrant or recurrent lesions include colchicine, dapsone, or hydroxychloroquine.
 

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego.

References

1. Panniculitis, in “Dermatology,” 3rd ed. (Philadelphia: Elsevier Saunders, 2012, p. 1641).

2. Arthritis Rheum. 2000 Mar;43(3):584-92.

3. J Clin Oncol. 2007 Sep 1;25(25):4011-2.

4. Turk J Pediatr. 2014 Mar-Apr;56(2):144-9.

Laboratory work revealed a normal CBC and differential, an elevated C-reactive protein (CRP) and sedimentation rate (ESR), negative antistreptolysin O (ASO) titers, negative pregnancy test, a normal urinalysis, and negative blood, throat, and urine cultures. A chest x-ray also was negative as well as angiotensin-converting enzyme (ACE) levels. Tuberculosis interferon-gamma release essay was negative.

The patient was diagnosed with erythema nodosum (EN), based on physical exam and history of the lesions. In her particular case, infectious causes including streptococcus infection, tuberculosis, and coccidioidomycosis were ruled out. There were no x-ray findings that suggested sarcoidosis and her ACE level was within normal limits. The pregnancy test also was negative. Given her recent start on OCs, this was thought to be the cause of the lesions.

She was treated with elevation, compression stockings, and NSAIDs and discontinuation of OCs. The lesions resolved after 6 weeks leaving bruiselike patches (erythema contusiformis).

EN is a delayed-type hypersensitivity reaction, causing inflammation on the fat (panniculitis) most commonly on the shins, but it can also occur on the arms, face, neck, and thighs. It is the most common type of panniculitis and is usually seen more often in women from the second to fourth decade of life. Erythematous tender nodules in crops commonly located on the shins are the characteristic physical finding. Systemic symptoms can occur including fever, malaise, and joint pain. The lesions usually last up to 6-8 weeks and may leave bruiselike patches or postinflammatory hyperpigmentation that can take months to improve.¹

The diagnosis of EN usually is made by physical examination and natural history. In unusual severe cases or lesions in atypical locations, a skin biopsy is indicated. Histologic examination of one of the lesions reveals a septal panniculitis without vasculitis. Miescher’s radial granulomas (grouped macrophages around neutrophils or septa-like spaces) often are present and are a characteristic feature of EN.

EN can be triggered by different types of infections such as streptococcus, mycoplasma, tuberculosis, or bacterial gastroenteritis; medications such as OCs, sulfonamides, iodides, penicillin, or bromides; medical conditions that include inflammatory bowel disease, pregnancy, or sarcoidosis; or neutrophilic dermatosis and malignancy such as leukemia and Hodgkin disease.^2,3 A third of the cases are idiopathic. In children, streptococcal infections are responsible for most cases of EN.⁴

Recommended work-up to investigate possible triggers includes a CBC with differential, sedimentation rate, CRP, ASO titers or anti-DNase B titers, tuberculin skin test or interferon-gamma TB test and a chest X ray. If there are any other symptoms, physical signs, or risk factors are present for the other not so common causes, further ancillary testing may be warranted.

Erythematous nodules and papules on the shin in children are commonly caused by arthropod bites also known as papular urticaria. These lesions are pruritic rather than tender and usually respond to topical corticosteroids and oral antihistamines. Subcutaneous bacterial, fungal, or atypical mycobacterial infections can present with tender nodules that can ulcerate and drain on the shins, feet, or any other body part. These patients may have a history of immunodeficiency and usually systemic symptoms of infection are present. Cutaneous polyarteritis nodosa (PAN) also can present with tender nodules on the legs but these lesions usually necrose and ulcerate and may be associated with livedo racemosa, a transient or persistent, blotchy, reddish-blue to purple, netlike cyanotic pattern. On pathology, PAN presents with necrotizing medium vessel vasculitis. Malignant nodules also can occur on the shin. Pathology will show atypical cells. Other forms of panniculitis, such as erythema induratum and pancreatic panniculitis, can present with tender nodules but these lesions usually occur on the calves and ulcerate.

Management of EN starts with treating the underlying infection or stopping the causative medication. Initial measures include bed rest, leg elevation, compression bandages, and NSAIDs. Potassium iodide is a very effective therapy as it may control the symptoms within 24 hours. When there is no response to the above, or the patient has severe symptoms, a short course of systemic glucocorticoids can be started. Other medications for recalcitrant or recurrent lesions include colchicine, dapsone, or hydroxychloroquine.
 

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego.

References

1. Panniculitis, in “Dermatology,” 3rd ed. (Philadelphia: Elsevier Saunders, 2012, p. 1641).

2. Arthritis Rheum. 2000 Mar;43(3):584-92.

3. J Clin Oncol. 2007 Sep 1;25(25):4011-2.

4. Turk J Pediatr. 2014 Mar-Apr;56(2):144-9.

Mature cystic teratoma of the ovary invading the rectum

The patient was diagnosed with an ovarian dermoid cyst that was fistulating into the rectum. In view of these findings, a decision was made for surgical intervention to remove this lesion. A diagnostic laparoscopy, robotic-assisted left ­salpingo-oopherectomy, excision of cystorectal fistula, proctotomy, and primary repair of the rectal defect was performed. Intraoperative findings include a large left ovarian dermoid cyst with sebaceous content and hair fistulating into the upper rectum just above the rectovaginal pouch, and was adherent to surrounding structures. After excision of the fistula, the anterior rectal wall defect measured 1.5 cm and was closed primarily. Histology revealed a mature cystic teratoma and a fistula tract in the rectum; no malignant features were found. The patient had an uneventful recovery and was well at follow-up.

Mature cystic teratomas of the ovary, also referred to as ovarian dermoid cysts, are benign germ cell tumors of the ovary. These account for 10%-20% of all ovarian neoplasms.¹ These are commonly asymptomatic and are found incidentally on imaging studies performed for other indications.² Complications of these tumors include torsion (16%), rupture (0.5%), and malignant degeneration (2%-6%).³ Rectal invasion via fistulation by these lesions are rare; to date, six cases of colorectal involvement by mature cystic teratomas of the ovary are reported in the literature. These fistulas are a result of rupture of the cyst into the pouch of Douglas, which leads to an intense inflammatory response that results in fistulation, rather than freely into the peritoneum.³ These are therefore undetected until symptoms such as diarrhea or passage of cystic contents (mucus, hair, teeth) develop. The management of mature cystic teratomas of the ovary with symptoms or complications commonly involves surgical intervention to resect the involved ovary and address other pathology.

References

1. Rajaganeshan R., Wang H., Abouleid A., et al. Conservative surgery in the management of a benign ovarian cystic teratoma presenting as a rectal mass: a case report. Ann R Coll Surg Engl. 2001;93 e46-8.

2. Wichremasinghe D., Samarasekera D. A benign teratoma of the ovary fistulating into the rectum. Ceylon Med J. 2010;55:133.

3. Stern J.L., Buscema J., Rosenshein N.B., et al. Spontaneous rupture of benign cystic teratomas. Obstet Gynecol. 1981;57:363-6.
 

[email protected]

Mature cystic teratoma of the ovary invading the rectum

The patient was diagnosed with an ovarian dermoid cyst that was fistulating into the rectum. In view of these findings, a decision was made for surgical intervention to remove this lesion. A diagnostic laparoscopy, robotic-assisted left ­salpingo-oopherectomy, excision of cystorectal fistula, proctotomy, and primary repair of the rectal defect was performed. Intraoperative findings include a large left ovarian dermoid cyst with sebaceous content and hair fistulating into the upper rectum just above the rectovaginal pouch, and was adherent to surrounding structures. After excision of the fistula, the anterior rectal wall defect measured 1.5 cm and was closed primarily. Histology revealed a mature cystic teratoma and a fistula tract in the rectum; no malignant features were found. The patient had an uneventful recovery and was well at follow-up.

Mature cystic teratomas of the ovary, also referred to as ovarian dermoid cysts, are benign germ cell tumors of the ovary. These account for 10%-20% of all ovarian neoplasms.¹ These are commonly asymptomatic and are found incidentally on imaging studies performed for other indications.² Complications of these tumors include torsion (16%), rupture (0.5%), and malignant degeneration (2%-6%).³ Rectal invasion via fistulation by these lesions are rare; to date, six cases of colorectal involvement by mature cystic teratomas of the ovary are reported in the literature. These fistulas are a result of rupture of the cyst into the pouch of Douglas, which leads to an intense inflammatory response that results in fistulation, rather than freely into the peritoneum.³ These are therefore undetected until symptoms such as diarrhea or passage of cystic contents (mucus, hair, teeth) develop. The management of mature cystic teratomas of the ovary with symptoms or complications commonly involves surgical intervention to resect the involved ovary and address other pathology.

References

1. Rajaganeshan R., Wang H., Abouleid A., et al. Conservative surgery in the management of a benign ovarian cystic teratoma presenting as a rectal mass: a case report. Ann R Coll Surg Engl. 2001;93 e46-8.

2. Wichremasinghe D., Samarasekera D. A benign teratoma of the ovary fistulating into the rectum. Ceylon Med J. 2010;55:133.

3. Stern J.L., Buscema J., Rosenshein N.B., et al. Spontaneous rupture of benign cystic teratomas. Obstet Gynecol. 1981;57:363-6.
 

[email protected]

Mature cystic teratoma of the ovary invading the rectum

The patient was diagnosed with an ovarian dermoid cyst that was fistulating into the rectum. In view of these findings, a decision was made for surgical intervention to remove this lesion. A diagnostic laparoscopy, robotic-assisted left ­salpingo-oopherectomy, excision of cystorectal fistula, proctotomy, and primary repair of the rectal defect was performed. Intraoperative findings include a large left ovarian dermoid cyst with sebaceous content and hair fistulating into the upper rectum just above the rectovaginal pouch, and was adherent to surrounding structures. After excision of the fistula, the anterior rectal wall defect measured 1.5 cm and was closed primarily. Histology revealed a mature cystic teratoma and a fistula tract in the rectum; no malignant features were found. The patient had an uneventful recovery and was well at follow-up.

Mature cystic teratomas of the ovary, also referred to as ovarian dermoid cysts, are benign germ cell tumors of the ovary. These account for 10%-20% of all ovarian neoplasms.¹ These are commonly asymptomatic and are found incidentally on imaging studies performed for other indications.² Complications of these tumors include torsion (16%), rupture (0.5%), and malignant degeneration (2%-6%).³ Rectal invasion via fistulation by these lesions are rare; to date, six cases of colorectal involvement by mature cystic teratomas of the ovary are reported in the literature. These fistulas are a result of rupture of the cyst into the pouch of Douglas, which leads to an intense inflammatory response that results in fistulation, rather than freely into the peritoneum.³ These are therefore undetected until symptoms such as diarrhea or passage of cystic contents (mucus, hair, teeth) develop. The management of mature cystic teratomas of the ovary with symptoms or complications commonly involves surgical intervention to resect the involved ovary and address other pathology.

References

1. Rajaganeshan R., Wang H., Abouleid A., et al. Conservative surgery in the management of a benign ovarian cystic teratoma presenting as a rectal mass: a case report. Ann R Coll Surg Engl. 2001;93 e46-8.

2. Wichremasinghe D., Samarasekera D. A benign teratoma of the ovary fistulating into the rectum. Ceylon Med J. 2010;55:133.

3. Stern J.L., Buscema J., Rosenshein N.B., et al. Spontaneous rupture of benign cystic teratomas. Obstet Gynecol. 1981;57:363-6.
 

[email protected]

In patients with seropositive rheumatoid arthritis, seroconversion within the first year of treatment is not associated with long-term sustained drug-free remission (SDFR), according to results of a randomized, treat-to-target study of patients with early RA.

Suze777/Thinkstock

“The clinical significance of seroconversion in RA and especially its relationship with long-term SDFR, an approximation of disease ‘cure’ of RA, is a topic of major interest,” wrote Emma C. de Moel, of the department of rheumatology at Leiden (Netherlands) University Medical Center, and her coauthors.

“Previous studies found no association of seroconversion with remission or radiographic damage,” the investigators wrote in Annals of the Rheumatic Diseases. “We here investigated the association between seroconversion and ... SDFR and found no association.”

The study involved 381 patients with early RA (less than 2 years) from the IMPROVED trial who were treated with methotrexate and high-dose prednisone. At baseline and 12 months, 14 RA-associated autoantibodies were measured by ELISA, including anti-CCP2 and rheumatoid factor. Patients were monitored for long-term SDFR, defined as remission lasting longer than 1 year, beginning at any time, and persisting until the maximum follow-up of 5 years.

An association between seroconversion and SDFR was not found. At 12 months, 6 of 170 patients (3.5%) had seroconverted all autoantibodies to negative, and 2 of these 6 patients achieved SDFR, compared with 19 of 164 seropositive patients (11.6%) who achieved SDFR without seroconversion (P = .11). Additionally, neither the proportion of autoantibodies converted to negative nor relative decreases in autoantibody levels were associated with SDFR.

“It appears that seroconversion (as measured by current standards) does not identify a group of patients in ... true immunological remission, and is not superior to signals of low inflammatory load (e.g. by DAS 6) for predicting successful drug tapering,” the investigators concluded. “Future studies are needed to identify whether other immunological parameters such as the numbers or phenotype of circulating autoreactive B or T cells might be a better reflection of disease persistence and markers for immunological remission.”

The study was funded by ZonMw (the Netherlands Organization for Health Research and Development)-consortium Molecular Diagnostics in RA (MODIRA).

SOURCE: de Moel EC et al. Ann Rheum Dis. 2018 Jul 25. doi: 10.1136/annrheumdis-2018-213823.

In patients with seropositive rheumatoid arthritis, seroconversion within the first year of treatment is not associated with long-term sustained drug-free remission (SDFR), according to results of a randomized, treat-to-target study of patients with early RA.

Suze777/Thinkstock

“The clinical significance of seroconversion in RA and especially its relationship with long-term SDFR, an approximation of disease ‘cure’ of RA, is a topic of major interest,” wrote Emma C. de Moel, of the department of rheumatology at Leiden (Netherlands) University Medical Center, and her coauthors.

“Previous studies found no association of seroconversion with remission or radiographic damage,” the investigators wrote in Annals of the Rheumatic Diseases. “We here investigated the association between seroconversion and ... SDFR and found no association.”

The study involved 381 patients with early RA (less than 2 years) from the IMPROVED trial who were treated with methotrexate and high-dose prednisone. At baseline and 12 months, 14 RA-associated autoantibodies were measured by ELISA, including anti-CCP2 and rheumatoid factor. Patients were monitored for long-term SDFR, defined as remission lasting longer than 1 year, beginning at any time, and persisting until the maximum follow-up of 5 years.

An association between seroconversion and SDFR was not found. At 12 months, 6 of 170 patients (3.5%) had seroconverted all autoantibodies to negative, and 2 of these 6 patients achieved SDFR, compared with 19 of 164 seropositive patients (11.6%) who achieved SDFR without seroconversion (P = .11). Additionally, neither the proportion of autoantibodies converted to negative nor relative decreases in autoantibody levels were associated with SDFR.

“It appears that seroconversion (as measured by current standards) does not identify a group of patients in ... true immunological remission, and is not superior to signals of low inflammatory load (e.g. by DAS 6) for predicting successful drug tapering,” the investigators concluded. “Future studies are needed to identify whether other immunological parameters such as the numbers or phenotype of circulating autoreactive B or T cells might be a better reflection of disease persistence and markers for immunological remission.”

The study was funded by ZonMw (the Netherlands Organization for Health Research and Development)-consortium Molecular Diagnostics in RA (MODIRA).

SOURCE: de Moel EC et al. Ann Rheum Dis. 2018 Jul 25. doi: 10.1136/annrheumdis-2018-213823.

In patients with seropositive rheumatoid arthritis, seroconversion within the first year of treatment is not associated with long-term sustained drug-free remission (SDFR), according to results of a randomized, treat-to-target study of patients with early RA.

Suze777/Thinkstock

“The clinical significance of seroconversion in RA and especially its relationship with long-term SDFR, an approximation of disease ‘cure’ of RA, is a topic of major interest,” wrote Emma C. de Moel, of the department of rheumatology at Leiden (Netherlands) University Medical Center, and her coauthors.

“Previous studies found no association of seroconversion with remission or radiographic damage,” the investigators wrote in Annals of the Rheumatic Diseases. “We here investigated the association between seroconversion and ... SDFR and found no association.”

The study involved 381 patients with early RA (less than 2 years) from the IMPROVED trial who were treated with methotrexate and high-dose prednisone. At baseline and 12 months, 14 RA-associated autoantibodies were measured by ELISA, including anti-CCP2 and rheumatoid factor. Patients were monitored for long-term SDFR, defined as remission lasting longer than 1 year, beginning at any time, and persisting until the maximum follow-up of 5 years.

An association between seroconversion and SDFR was not found. At 12 months, 6 of 170 patients (3.5%) had seroconverted all autoantibodies to negative, and 2 of these 6 patients achieved SDFR, compared with 19 of 164 seropositive patients (11.6%) who achieved SDFR without seroconversion (P = .11). Additionally, neither the proportion of autoantibodies converted to negative nor relative decreases in autoantibody levels were associated with SDFR.

“It appears that seroconversion (as measured by current standards) does not identify a group of patients in ... true immunological remission, and is not superior to signals of low inflammatory load (e.g. by DAS 6) for predicting successful drug tapering,” the investigators concluded. “Future studies are needed to identify whether other immunological parameters such as the numbers or phenotype of circulating autoreactive B or T cells might be a better reflection of disease persistence and markers for immunological remission.”

The study was funded by ZonMw (the Netherlands Organization for Health Research and Development)-consortium Molecular Diagnostics in RA (MODIRA).

SOURCE: de Moel EC et al. Ann Rheum Dis. 2018 Jul 25. doi: 10.1136/annrheumdis-2018-213823.