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PBC incidence remains stable in rural parts of U.S.
The incidence of primary biliary cholangitis (PBC) in rural parts of the midwestern United States has remained stable over the last 2 decades, allowing better prognosis and improved survival rates.
In a population-based cohort study, Rajan Kanth, MD, and his associates researched 79 incident PBC cases observed in the Marshfield Epidemiologic Study Area (MESA) of 24 zip codes in central and northern Wisconsin between 1992 and 2011. The overall age- and sex-standardized PBC incidence rate was 4.9 cases per 100,000 person-years. The annual incidence rate of PBC increased; however, it was not significant (P = .114) during the 20-year study time frame. In women, PBC ranged from a low of 6.9 cases per 100,000 person-years in 1992-1996 to a high of 11.3 cases per 100,000 person-years in 2002-2006. The sex-specific comparisons were not significant at any time during the 5-year period.
After a mean follow-up of 7.3 years, 23 (29%) patients with PBC died. The estimated 10-year survival of PBC cases in MESA was 76%.
Researchers noted the MESA source population grew over the 20-year study time frame, going from a low of 364,722 MESA person-years in 1992-1996 to a high of 409,670 person-years in 2007-2011. The proportion of men and women in MESA were consistent throughout the study, but there was a general population aging trend with a 29% increase in the number of individuals aged 40-69 years in 2007-2011 relative to 1992-1996.
“The overall incidence of PBC in a Midwestern population of the United States has remained relatively stable over the last two decades,” researchers concluded. “Results suggest that the overall incidence of PBC in the United States is not rising quickly, and that patients with PBC have generally improved prognosis and survival.”
Find the full study in Clinical Medicine & Research (2017. doi: 10.3121/cmr.2017.1351).
The incidence of primary biliary cholangitis (PBC) in rural parts of the midwestern United States has remained stable over the last 2 decades, allowing better prognosis and improved survival rates.
In a population-based cohort study, Rajan Kanth, MD, and his associates researched 79 incident PBC cases observed in the Marshfield Epidemiologic Study Area (MESA) of 24 zip codes in central and northern Wisconsin between 1992 and 2011. The overall age- and sex-standardized PBC incidence rate was 4.9 cases per 100,000 person-years. The annual incidence rate of PBC increased; however, it was not significant (P = .114) during the 20-year study time frame. In women, PBC ranged from a low of 6.9 cases per 100,000 person-years in 1992-1996 to a high of 11.3 cases per 100,000 person-years in 2002-2006. The sex-specific comparisons were not significant at any time during the 5-year period.
After a mean follow-up of 7.3 years, 23 (29%) patients with PBC died. The estimated 10-year survival of PBC cases in MESA was 76%.
Researchers noted the MESA source population grew over the 20-year study time frame, going from a low of 364,722 MESA person-years in 1992-1996 to a high of 409,670 person-years in 2007-2011. The proportion of men and women in MESA were consistent throughout the study, but there was a general population aging trend with a 29% increase in the number of individuals aged 40-69 years in 2007-2011 relative to 1992-1996.
“The overall incidence of PBC in a Midwestern population of the United States has remained relatively stable over the last two decades,” researchers concluded. “Results suggest that the overall incidence of PBC in the United States is not rising quickly, and that patients with PBC have generally improved prognosis and survival.”
Find the full study in Clinical Medicine & Research (2017. doi: 10.3121/cmr.2017.1351).
The incidence of primary biliary cholangitis (PBC) in rural parts of the midwestern United States has remained stable over the last 2 decades, allowing better prognosis and improved survival rates.
In a population-based cohort study, Rajan Kanth, MD, and his associates researched 79 incident PBC cases observed in the Marshfield Epidemiologic Study Area (MESA) of 24 zip codes in central and northern Wisconsin between 1992 and 2011. The overall age- and sex-standardized PBC incidence rate was 4.9 cases per 100,000 person-years. The annual incidence rate of PBC increased; however, it was not significant (P = .114) during the 20-year study time frame. In women, PBC ranged from a low of 6.9 cases per 100,000 person-years in 1992-1996 to a high of 11.3 cases per 100,000 person-years in 2002-2006. The sex-specific comparisons were not significant at any time during the 5-year period.
After a mean follow-up of 7.3 years, 23 (29%) patients with PBC died. The estimated 10-year survival of PBC cases in MESA was 76%.
Researchers noted the MESA source population grew over the 20-year study time frame, going from a low of 364,722 MESA person-years in 1992-1996 to a high of 409,670 person-years in 2007-2011. The proportion of men and women in MESA were consistent throughout the study, but there was a general population aging trend with a 29% increase in the number of individuals aged 40-69 years in 2007-2011 relative to 1992-1996.
“The overall incidence of PBC in a Midwestern population of the United States has remained relatively stable over the last two decades,” researchers concluded. “Results suggest that the overall incidence of PBC in the United States is not rising quickly, and that patients with PBC have generally improved prognosis and survival.”
Find the full study in Clinical Medicine & Research (2017. doi: 10.3121/cmr.2017.1351).
FROM CLINICAL MEDICINE & RESEARCH
What’s driving the ‘failure’ of the ACA marketplaces?
Two reports from the Centers for Medicare & Medicaid Services show declines in the number of consumers who are activating the health insurance purchased via an Affordable Care Act exchange, a development Trump administration officials say underlines the failure of the ACA.
As of March 15, 10.3 million people paid premiums to activate coverage they purchased on the exchanges out of 12.2 million who enrolled in plans as of the Jan. 31 deadline for 2017, according to a June 12 report from CMS.
Further, some consumers who began paying premiums stopped.
Two key factors are behind the drop off, according to a second CMS report.
According to a voluntary online survey of consumers who left the exchanges between August 2016 and April 2017, 46% who canceled coverage prior to paying premiums cited cost as the main reason, including 20% who cited increased premiums over the previous year and 17% who claimed ineligibility for financial assistance.
Of those who activated their coverage by paying premiums, half (49%) said they stopped because they became eligible and received coverage elsewhere, mostly through an employer or Medicare. About a quarter (27%) cited affordability as the reason why they dropped coverage.
According to the Commonwealth Fund, CMS officials missed a few big reasons why people did not consistently pay for their coverage: Many were reacting to uncertainty around the Trump administration’s ACA repeal and replace efforts. Others were missed because of policy changes undertaken by the administration.
“One of the things that we know affected enrollment this year was the pullback of outreach efforts in the last weekend of the open enrollment period by the Trump administration,” Sara Collins, PhD, vice president of health care access and coverage at the Commonwealth Fund, said in an interview. “It did have an affect on enrollment and might be part of the reason why we are seeing – compared to last year – a lower effectuate enrollment.”
Other administration actions are taking a toll, Dr. Collins said.
There is a “general uncertainty that the administration is generating with respect to the enforcement of the individual mandate and also the uncertainty that is affecting insurers’ commitment to the marketplaces for 2018 [cost sharing reduction payments],” she said, noting both insurers and consumers are affected by this uncertainty.
While acknowledging that the main reason consumers dropped exchange policies was gaining coverage from source, Dr. Collins noted that “we are in such a strange environment, where it’s not clear what Congress is going to do or what the administration is going to do. It probably has confused the public somewhat about what their options are and maybe a concern even if they stay in a plan whether or not they will continue to get their tax credits. There has just been a general sense of uncertainty that has been created by the Trump administration and Congress in terms of the future of marketplace plans.”
Two reports from the Centers for Medicare & Medicaid Services show declines in the number of consumers who are activating the health insurance purchased via an Affordable Care Act exchange, a development Trump administration officials say underlines the failure of the ACA.
As of March 15, 10.3 million people paid premiums to activate coverage they purchased on the exchanges out of 12.2 million who enrolled in plans as of the Jan. 31 deadline for 2017, according to a June 12 report from CMS.
Further, some consumers who began paying premiums stopped.
Two key factors are behind the drop off, according to a second CMS report.
According to a voluntary online survey of consumers who left the exchanges between August 2016 and April 2017, 46% who canceled coverage prior to paying premiums cited cost as the main reason, including 20% who cited increased premiums over the previous year and 17% who claimed ineligibility for financial assistance.
Of those who activated their coverage by paying premiums, half (49%) said they stopped because they became eligible and received coverage elsewhere, mostly through an employer or Medicare. About a quarter (27%) cited affordability as the reason why they dropped coverage.
According to the Commonwealth Fund, CMS officials missed a few big reasons why people did not consistently pay for their coverage: Many were reacting to uncertainty around the Trump administration’s ACA repeal and replace efforts. Others were missed because of policy changes undertaken by the administration.
“One of the things that we know affected enrollment this year was the pullback of outreach efforts in the last weekend of the open enrollment period by the Trump administration,” Sara Collins, PhD, vice president of health care access and coverage at the Commonwealth Fund, said in an interview. “It did have an affect on enrollment and might be part of the reason why we are seeing – compared to last year – a lower effectuate enrollment.”
Other administration actions are taking a toll, Dr. Collins said.
There is a “general uncertainty that the administration is generating with respect to the enforcement of the individual mandate and also the uncertainty that is affecting insurers’ commitment to the marketplaces for 2018 [cost sharing reduction payments],” she said, noting both insurers and consumers are affected by this uncertainty.
While acknowledging that the main reason consumers dropped exchange policies was gaining coverage from source, Dr. Collins noted that “we are in such a strange environment, where it’s not clear what Congress is going to do or what the administration is going to do. It probably has confused the public somewhat about what their options are and maybe a concern even if they stay in a plan whether or not they will continue to get their tax credits. There has just been a general sense of uncertainty that has been created by the Trump administration and Congress in terms of the future of marketplace plans.”
Two reports from the Centers for Medicare & Medicaid Services show declines in the number of consumers who are activating the health insurance purchased via an Affordable Care Act exchange, a development Trump administration officials say underlines the failure of the ACA.
As of March 15, 10.3 million people paid premiums to activate coverage they purchased on the exchanges out of 12.2 million who enrolled in plans as of the Jan. 31 deadline for 2017, according to a June 12 report from CMS.
Further, some consumers who began paying premiums stopped.
Two key factors are behind the drop off, according to a second CMS report.
According to a voluntary online survey of consumers who left the exchanges between August 2016 and April 2017, 46% who canceled coverage prior to paying premiums cited cost as the main reason, including 20% who cited increased premiums over the previous year and 17% who claimed ineligibility for financial assistance.
Of those who activated their coverage by paying premiums, half (49%) said they stopped because they became eligible and received coverage elsewhere, mostly through an employer or Medicare. About a quarter (27%) cited affordability as the reason why they dropped coverage.
According to the Commonwealth Fund, CMS officials missed a few big reasons why people did not consistently pay for their coverage: Many were reacting to uncertainty around the Trump administration’s ACA repeal and replace efforts. Others were missed because of policy changes undertaken by the administration.
“One of the things that we know affected enrollment this year was the pullback of outreach efforts in the last weekend of the open enrollment period by the Trump administration,” Sara Collins, PhD, vice president of health care access and coverage at the Commonwealth Fund, said in an interview. “It did have an affect on enrollment and might be part of the reason why we are seeing – compared to last year – a lower effectuate enrollment.”
Other administration actions are taking a toll, Dr. Collins said.
There is a “general uncertainty that the administration is generating with respect to the enforcement of the individual mandate and also the uncertainty that is affecting insurers’ commitment to the marketplaces for 2018 [cost sharing reduction payments],” she said, noting both insurers and consumers are affected by this uncertainty.
While acknowledging that the main reason consumers dropped exchange policies was gaining coverage from source, Dr. Collins noted that “we are in such a strange environment, where it’s not clear what Congress is going to do or what the administration is going to do. It probably has confused the public somewhat about what their options are and maybe a concern even if they stay in a plan whether or not they will continue to get their tax credits. There has just been a general sense of uncertainty that has been created by the Trump administration and Congress in terms of the future of marketplace plans.”
CAR T cells plus ibrutinib induce CLL remissions
CHICAGO—Chimeric antigen receptor (CAR) T cells combined with ibrutinib enhance T-cell function and can induce complete remission (CR) in patients with chronic lymphocytic leukemia (CLL), researchers report.
Many CLL patients receive ibrutinib treatment, which is well tolerated, but few patients achieve CR.
Immunotherapy with anti-CD19 CAR T cells has induced CR in 25% - 45% of patients with CLL, Saar Gill, MD, of the University of Pennsylvania in Philadelphia, told Hematology Times, and these CRs tend to be durable.
So investigators conducted a pilot trial in 10 patients to test whether combining anti-CD19 CAR T cells with ibrutinib would enhance the CR rate.
Dr Gill reported the findings of the pilot trial at the ASCO 2017 Annual Meeting (abstract 7509).
The patients must have failed at least 1 regimen before ibrutinib, unless they had del(17)(p13.1) or a TP53 mutation.
T cells were lentivirally transduced to express a CAR that included humanized anti-CD19.
Patients were lymphodepleted 1 week before infusion, and ibrutinib was continued throughout the trial.
After a median follow-up of 6 months, 8 of the 9 evaluable patients show absence of CLL in the bone marrow by flow cytometry or minimal residual disease (MRD) negative, and all remain in marrow CR at last follow-up, Dr Gill said.
Radiologic responses are less clear-cut and may require longer follow-up.
“All but 1 patient achieved MRD with deep sequencing. We have deep response in the bone marrow,” Dr Gill said. He also noted that the treatment was well tolerated.
Cytokine release syndrome (CRS) developed in 9 patients: grade 1 in 2 patients, grade 2 in 6 patients, and grade 3 in 1 patient. One patient developed grade 4 tumor lysis syndrome. Treatment of CRS with the IL-6 receptor antagonist tocilizumab was not required.
There was modest residual splenomegaly in 3 of 5 patients, and adenopathy resolved in 4 of 6 patients, with progression in 1 patient.
Ibrutinib reduced CRS apparently by blocking cytokine production by T cells, said Dr Gill, adding, “The combination led to improved efficacy without increased toxicity.”
Ibrutinib may make CAR T-cell therapy more feasible.
Patients who receive ibrutinib for 6 months have a better T-cell response.
“This opens up future discussions of bringing CAR T-cell therapy earlier into CLL treatment,” said Dr Gill.
He envisions patients receiving ibrutinib for 6 months, which would allow time to manufacture T cells, and then have a T-cell infusion.
“Once patients achieve MRD, then we can discuss the possibility of stopping ibrutinib therapy,” he said.
“Most patients remain on ibrutinib, but longer follow-up may show whether remissions are sustained off ibrutinib.”
The researchers have ongoing plans to treat 25 patients with CTL19 plus ibrutinib in a continuation of this trial.
Dr Gill said longer follow-up will reveal the durability of these results “and could support evaluation of a first-line combination approach in an attempt to obviate the need for chronic therapy.” 
CHICAGO—Chimeric antigen receptor (CAR) T cells combined with ibrutinib enhance T-cell function and can induce complete remission (CR) in patients with chronic lymphocytic leukemia (CLL), researchers report.
Many CLL patients receive ibrutinib treatment, which is well tolerated, but few patients achieve CR.
Immunotherapy with anti-CD19 CAR T cells has induced CR in 25% - 45% of patients with CLL, Saar Gill, MD, of the University of Pennsylvania in Philadelphia, told Hematology Times, and these CRs tend to be durable.
So investigators conducted a pilot trial in 10 patients to test whether combining anti-CD19 CAR T cells with ibrutinib would enhance the CR rate.
Dr Gill reported the findings of the pilot trial at the ASCO 2017 Annual Meeting (abstract 7509).
The patients must have failed at least 1 regimen before ibrutinib, unless they had del(17)(p13.1) or a TP53 mutation.
T cells were lentivirally transduced to express a CAR that included humanized anti-CD19.
Patients were lymphodepleted 1 week before infusion, and ibrutinib was continued throughout the trial.
After a median follow-up of 6 months, 8 of the 9 evaluable patients show absence of CLL in the bone marrow by flow cytometry or minimal residual disease (MRD) negative, and all remain in marrow CR at last follow-up, Dr Gill said.
Radiologic responses are less clear-cut and may require longer follow-up.
“All but 1 patient achieved MRD with deep sequencing. We have deep response in the bone marrow,” Dr Gill said. He also noted that the treatment was well tolerated.
Cytokine release syndrome (CRS) developed in 9 patients: grade 1 in 2 patients, grade 2 in 6 patients, and grade 3 in 1 patient. One patient developed grade 4 tumor lysis syndrome. Treatment of CRS with the IL-6 receptor antagonist tocilizumab was not required.
There was modest residual splenomegaly in 3 of 5 patients, and adenopathy resolved in 4 of 6 patients, with progression in 1 patient.
Ibrutinib reduced CRS apparently by blocking cytokine production by T cells, said Dr Gill, adding, “The combination led to improved efficacy without increased toxicity.”
Ibrutinib may make CAR T-cell therapy more feasible.
Patients who receive ibrutinib for 6 months have a better T-cell response.
“This opens up future discussions of bringing CAR T-cell therapy earlier into CLL treatment,” said Dr Gill.
He envisions patients receiving ibrutinib for 6 months, which would allow time to manufacture T cells, and then have a T-cell infusion.
“Once patients achieve MRD, then we can discuss the possibility of stopping ibrutinib therapy,” he said.
“Most patients remain on ibrutinib, but longer follow-up may show whether remissions are sustained off ibrutinib.”
The researchers have ongoing plans to treat 25 patients with CTL19 plus ibrutinib in a continuation of this trial.
Dr Gill said longer follow-up will reveal the durability of these results “and could support evaluation of a first-line combination approach in an attempt to obviate the need for chronic therapy.”
CHICAGO—Chimeric antigen receptor (CAR) T cells combined with ibrutinib enhance T-cell function and can induce complete remission (CR) in patients with chronic lymphocytic leukemia (CLL), researchers report.
Many CLL patients receive ibrutinib treatment, which is well tolerated, but few patients achieve CR.
Immunotherapy with anti-CD19 CAR T cells has induced CR in 25% - 45% of patients with CLL, Saar Gill, MD, of the University of Pennsylvania in Philadelphia, told Hematology Times, and these CRs tend to be durable.
So investigators conducted a pilot trial in 10 patients to test whether combining anti-CD19 CAR T cells with ibrutinib would enhance the CR rate.
Dr Gill reported the findings of the pilot trial at the ASCO 2017 Annual Meeting (abstract 7509).
The patients must have failed at least 1 regimen before ibrutinib, unless they had del(17)(p13.1) or a TP53 mutation.
T cells were lentivirally transduced to express a CAR that included humanized anti-CD19.
Patients were lymphodepleted 1 week before infusion, and ibrutinib was continued throughout the trial.
After a median follow-up of 6 months, 8 of the 9 evaluable patients show absence of CLL in the bone marrow by flow cytometry or minimal residual disease (MRD) negative, and all remain in marrow CR at last follow-up, Dr Gill said.
Radiologic responses are less clear-cut and may require longer follow-up.
“All but 1 patient achieved MRD with deep sequencing. We have deep response in the bone marrow,” Dr Gill said. He also noted that the treatment was well tolerated.
Cytokine release syndrome (CRS) developed in 9 patients: grade 1 in 2 patients, grade 2 in 6 patients, and grade 3 in 1 patient. One patient developed grade 4 tumor lysis syndrome. Treatment of CRS with the IL-6 receptor antagonist tocilizumab was not required.
There was modest residual splenomegaly in 3 of 5 patients, and adenopathy resolved in 4 of 6 patients, with progression in 1 patient.
Ibrutinib reduced CRS apparently by blocking cytokine production by T cells, said Dr Gill, adding, “The combination led to improved efficacy without increased toxicity.”
Ibrutinib may make CAR T-cell therapy more feasible.
Patients who receive ibrutinib for 6 months have a better T-cell response.
“This opens up future discussions of bringing CAR T-cell therapy earlier into CLL treatment,” said Dr Gill.
He envisions patients receiving ibrutinib for 6 months, which would allow time to manufacture T cells, and then have a T-cell infusion.
“Once patients achieve MRD, then we can discuss the possibility of stopping ibrutinib therapy,” he said.
“Most patients remain on ibrutinib, but longer follow-up may show whether remissions are sustained off ibrutinib.”
The researchers have ongoing plans to treat 25 patients with CTL19 plus ibrutinib in a continuation of this trial.
Dr Gill said longer follow-up will reveal the durability of these results “and could support evaluation of a first-line combination approach in an attempt to obviate the need for chronic therapy.”
EASL publishes new PBC guidelines
The European Association for the Study of the Liver has published a new guideline for the diagnosis, treatment, and management of primary biliary cholangitis.
PBC is likely in patients with persistent cholestatic symptoms or who have pruritis and fatigue. A diagnosis of PBC can be made if a patient has elevated alkaline phosphatase and antimitochondrial antibody, although elevated antimitochondrial antibody alone is not enough to diagnose PBC. Liver biopsy is not recommended, and liver imaging is not necessary to prove PBC but can be used to eliminate extrahepatic causes of cholestasis.
Pruritis, fatigue, and sicca complex are the most common symptoms of PBC and can significantly effect quality of life. Pruritis can be treated with cholestyramine or rifampicin. Clinicians should seek out and treat associated and alternate causes of fatigue and advise patients on strategies to avoid compounding fatigue problems. Sicca complex should be treated appropriately and, if patients develop refractory symptoms, referred to a specialist.
Complications of liver disease caused by PBC include osteoporosis, fat-soluble vitamin substitution, hyperlipidemia, varices, hepatocellular carcinoma, and need for liver transplant, though the need for liver transplant in PBC patient has decreased over time.
“Treatment guidelines facilitate a holistic life-long approach to the management of patients with PBC, and care pathways should be developed locally to capture the needs of patients. These can be subject to independent quality evaluation,” EASL concluded.
Find the full clinical guideline in the Journal of Hepatology (2017. doi: 10.1016/j.jhep.2017.03.022).
The European Association for the Study of the Liver has published a new guideline for the diagnosis, treatment, and management of primary biliary cholangitis.
PBC is likely in patients with persistent cholestatic symptoms or who have pruritis and fatigue. A diagnosis of PBC can be made if a patient has elevated alkaline phosphatase and antimitochondrial antibody, although elevated antimitochondrial antibody alone is not enough to diagnose PBC. Liver biopsy is not recommended, and liver imaging is not necessary to prove PBC but can be used to eliminate extrahepatic causes of cholestasis.
Pruritis, fatigue, and sicca complex are the most common symptoms of PBC and can significantly effect quality of life. Pruritis can be treated with cholestyramine or rifampicin. Clinicians should seek out and treat associated and alternate causes of fatigue and advise patients on strategies to avoid compounding fatigue problems. Sicca complex should be treated appropriately and, if patients develop refractory symptoms, referred to a specialist.
Complications of liver disease caused by PBC include osteoporosis, fat-soluble vitamin substitution, hyperlipidemia, varices, hepatocellular carcinoma, and need for liver transplant, though the need for liver transplant in PBC patient has decreased over time.
“Treatment guidelines facilitate a holistic life-long approach to the management of patients with PBC, and care pathways should be developed locally to capture the needs of patients. These can be subject to independent quality evaluation,” EASL concluded.
Find the full clinical guideline in the Journal of Hepatology (2017. doi: 10.1016/j.jhep.2017.03.022).
The European Association for the Study of the Liver has published a new guideline for the diagnosis, treatment, and management of primary biliary cholangitis.
PBC is likely in patients with persistent cholestatic symptoms or who have pruritis and fatigue. A diagnosis of PBC can be made if a patient has elevated alkaline phosphatase and antimitochondrial antibody, although elevated antimitochondrial antibody alone is not enough to diagnose PBC. Liver biopsy is not recommended, and liver imaging is not necessary to prove PBC but can be used to eliminate extrahepatic causes of cholestasis.
Pruritis, fatigue, and sicca complex are the most common symptoms of PBC and can significantly effect quality of life. Pruritis can be treated with cholestyramine or rifampicin. Clinicians should seek out and treat associated and alternate causes of fatigue and advise patients on strategies to avoid compounding fatigue problems. Sicca complex should be treated appropriately and, if patients develop refractory symptoms, referred to a specialist.
Complications of liver disease caused by PBC include osteoporosis, fat-soluble vitamin substitution, hyperlipidemia, varices, hepatocellular carcinoma, and need for liver transplant, though the need for liver transplant in PBC patient has decreased over time.
“Treatment guidelines facilitate a holistic life-long approach to the management of patients with PBC, and care pathways should be developed locally to capture the needs of patients. These can be subject to independent quality evaluation,” EASL concluded.
Find the full clinical guideline in the Journal of Hepatology (2017. doi: 10.1016/j.jhep.2017.03.022).
FROM THE JOURNAL OF HEPATOLOGY
Short-HER trial: DFS is similar, cardiac toxicity lower with short trastuzumab course
CHICAGO – Nine weeks of treatment with trastuzumab resulted in comparable disease-free and overall survival to that seen with the standard 12 months of trastuzumab – with about one-third of the rate of severe cardiac toxicity – in patients with HER2-positive early breast cancer in the Italian phase III multicenter Short-HER study.
The 5-year disease-free survival rate in 626 patients who received 9 weeks of trastuzumab was 87.5%, compared with 85.4% in 627 patients who received 1 year of trastuzumab therapy (hazard ratio, 1.15), Pier F. Conte, MD, reported at the annual meeting of the American Society of Clinical Oncology.
The upper limit of the 90% confidence interval (0.91-1.46) crossed the noninferiority margin set at 1.29 for this frequentist analysis, Dr. Conte of the University of Padova, Italy, said, noting that a subgroup analysis showed that patients with stage III disease and those with four or more positive lymph nodes – who together represented about 15% of the study population – had a disease-free survival advantage with longer treatment (HR, 2.30 and 2.25, respectively), and an interaction test was statistically significant.
However, a preplanned Bayesian analysis showed a 78% probability that the shorter treatment is not inferior to longer treatment for disease-free survival, he said.
The secondary endpoint of overall survival was also similar in the two groups (95.1% vs. 95.0%; HR, 1.06).
As for the secondary endpoint of cardiac events, the rate was 5.1% with shorter treatment vs. 14.4% with longer treatment. Grade 2 cardiac events occurred in 11.2% vs. 3.5% of patients in the treatment arms, respectively, and the grade 3 cardiac vents occurred in 2.7% vs. 1.1%, respectively. The rate of grade 4 events was 0.5% in both groups.
The overall difference between the groups with respect to cardiac events was highly statistically significant in favor of shorter treatment (HR, 0.32), Dr. Conte said.
Multiple studies have demonstrated the superiority of combining trastuzumab and adjuvant chemotherapy for HER2+ early breast cancer, and, following the release of some of those findings at the ASCO annual meeting in 2005, the agent was granted accelerated approval for this indication, Dr. Conte said.
“It was, however, clear that there were a number of reasons to believe that further investigation was appropriate on the optimal duration of trastuzumab duration,” he said, explaining that the same magnitude of benefit was reported by the small FinHER study with 9 weeks of trastuzumab and that clinical data suggest synergism of trastuzumab with chemotherapy.
“Finally, in the real world, there are patients at lower risk of relapse (more node-negative, more small tumors) and at higher risk of cardiac toxicity because of age or comorbidities,” he said. “So, the hypotheses behind the Short-HER [study] was that a shorter duration of trastuzumab administered concomitantly with chemotherapy might produce comparable efficacy with significantly lower toxicities and, of course, costs.”
Short-HER study subjects, who had a mean age of 55 years, had either HER2-positive, node-positive, or high-risk node-negative disease and were randomized to receive either the shorter treatment, including three courses of docetaxel given three times weekly plus trastuzumab given weekly for 9 doses, followed by three courses of 5-fluorouracil/epirubicin/cyclophosphamide, or standard 12-month treatment with four courses of anthracycline-based chemotherapy followed by four courses of docetaxel in combination with trastuzumab given three times weekly, followed by 14 additional courses of trastuzumab given three times weekly (for a total of 18 3-times-weekly doses). Radiation therapy was administered when indicated after chemotherapy, and hormonal therapy was started after completion of chemotherapy in patients with hormone-receptor–positive tumors.
Based on the frequentist analysis, noninferiority of the shorter treatment approach cannot be claimed, but, according to the preplanned Bayesian analysis, noninferiority is likely, Dr. Conte said.
“One year of trastuzumab is still standard. The Short-Her trial, however, reinforces the hypothesis that treatment deescalation retains efficacy with less toxicity. A shorter treatment might be an option for patients at low risk of relapse and/or higher risk of cardiac toxicity,” he said. “Moreover, these results might facilitate trastuzumab to patients in low/middle income countries.”
Individual patient meta-analysis with other trials testing different durations of trastuzumab administration is ongoing, he noted.
The Short-HER study was funded by the Italian Drug Agency, and drugs and insurance coverage were supplied by the National Health System. The study was sponsored by the University of Modena & Regio Emilia and the University of Padova. Dr. Conte has served on the speakers’ bureau for AstraZeneca, Lilly, Novartis, and Roche/Genentech and has received research funding and/or travel or other expenses from AstraZeneca, Celgene, and Novartis.
CHICAGO – Nine weeks of treatment with trastuzumab resulted in comparable disease-free and overall survival to that seen with the standard 12 months of trastuzumab – with about one-third of the rate of severe cardiac toxicity – in patients with HER2-positive early breast cancer in the Italian phase III multicenter Short-HER study.
The 5-year disease-free survival rate in 626 patients who received 9 weeks of trastuzumab was 87.5%, compared with 85.4% in 627 patients who received 1 year of trastuzumab therapy (hazard ratio, 1.15), Pier F. Conte, MD, reported at the annual meeting of the American Society of Clinical Oncology.
The upper limit of the 90% confidence interval (0.91-1.46) crossed the noninferiority margin set at 1.29 for this frequentist analysis, Dr. Conte of the University of Padova, Italy, said, noting that a subgroup analysis showed that patients with stage III disease and those with four or more positive lymph nodes – who together represented about 15% of the study population – had a disease-free survival advantage with longer treatment (HR, 2.30 and 2.25, respectively), and an interaction test was statistically significant.
However, a preplanned Bayesian analysis showed a 78% probability that the shorter treatment is not inferior to longer treatment for disease-free survival, he said.
The secondary endpoint of overall survival was also similar in the two groups (95.1% vs. 95.0%; HR, 1.06).
As for the secondary endpoint of cardiac events, the rate was 5.1% with shorter treatment vs. 14.4% with longer treatment. Grade 2 cardiac events occurred in 11.2% vs. 3.5% of patients in the treatment arms, respectively, and the grade 3 cardiac vents occurred in 2.7% vs. 1.1%, respectively. The rate of grade 4 events was 0.5% in both groups.
The overall difference between the groups with respect to cardiac events was highly statistically significant in favor of shorter treatment (HR, 0.32), Dr. Conte said.
Multiple studies have demonstrated the superiority of combining trastuzumab and adjuvant chemotherapy for HER2+ early breast cancer, and, following the release of some of those findings at the ASCO annual meeting in 2005, the agent was granted accelerated approval for this indication, Dr. Conte said.
“It was, however, clear that there were a number of reasons to believe that further investigation was appropriate on the optimal duration of trastuzumab duration,” he said, explaining that the same magnitude of benefit was reported by the small FinHER study with 9 weeks of trastuzumab and that clinical data suggest synergism of trastuzumab with chemotherapy.
“Finally, in the real world, there are patients at lower risk of relapse (more node-negative, more small tumors) and at higher risk of cardiac toxicity because of age or comorbidities,” he said. “So, the hypotheses behind the Short-HER [study] was that a shorter duration of trastuzumab administered concomitantly with chemotherapy might produce comparable efficacy with significantly lower toxicities and, of course, costs.”
Short-HER study subjects, who had a mean age of 55 years, had either HER2-positive, node-positive, or high-risk node-negative disease and were randomized to receive either the shorter treatment, including three courses of docetaxel given three times weekly plus trastuzumab given weekly for 9 doses, followed by three courses of 5-fluorouracil/epirubicin/cyclophosphamide, or standard 12-month treatment with four courses of anthracycline-based chemotherapy followed by four courses of docetaxel in combination with trastuzumab given three times weekly, followed by 14 additional courses of trastuzumab given three times weekly (for a total of 18 3-times-weekly doses). Radiation therapy was administered when indicated after chemotherapy, and hormonal therapy was started after completion of chemotherapy in patients with hormone-receptor–positive tumors.
Based on the frequentist analysis, noninferiority of the shorter treatment approach cannot be claimed, but, according to the preplanned Bayesian analysis, noninferiority is likely, Dr. Conte said.
“One year of trastuzumab is still standard. The Short-Her trial, however, reinforces the hypothesis that treatment deescalation retains efficacy with less toxicity. A shorter treatment might be an option for patients at low risk of relapse and/or higher risk of cardiac toxicity,” he said. “Moreover, these results might facilitate trastuzumab to patients in low/middle income countries.”
Individual patient meta-analysis with other trials testing different durations of trastuzumab administration is ongoing, he noted.
The Short-HER study was funded by the Italian Drug Agency, and drugs and insurance coverage were supplied by the National Health System. The study was sponsored by the University of Modena & Regio Emilia and the University of Padova. Dr. Conte has served on the speakers’ bureau for AstraZeneca, Lilly, Novartis, and Roche/Genentech and has received research funding and/or travel or other expenses from AstraZeneca, Celgene, and Novartis.
CHICAGO – Nine weeks of treatment with trastuzumab resulted in comparable disease-free and overall survival to that seen with the standard 12 months of trastuzumab – with about one-third of the rate of severe cardiac toxicity – in patients with HER2-positive early breast cancer in the Italian phase III multicenter Short-HER study.
The 5-year disease-free survival rate in 626 patients who received 9 weeks of trastuzumab was 87.5%, compared with 85.4% in 627 patients who received 1 year of trastuzumab therapy (hazard ratio, 1.15), Pier F. Conte, MD, reported at the annual meeting of the American Society of Clinical Oncology.
The upper limit of the 90% confidence interval (0.91-1.46) crossed the noninferiority margin set at 1.29 for this frequentist analysis, Dr. Conte of the University of Padova, Italy, said, noting that a subgroup analysis showed that patients with stage III disease and those with four or more positive lymph nodes – who together represented about 15% of the study population – had a disease-free survival advantage with longer treatment (HR, 2.30 and 2.25, respectively), and an interaction test was statistically significant.
However, a preplanned Bayesian analysis showed a 78% probability that the shorter treatment is not inferior to longer treatment for disease-free survival, he said.
The secondary endpoint of overall survival was also similar in the two groups (95.1% vs. 95.0%; HR, 1.06).
As for the secondary endpoint of cardiac events, the rate was 5.1% with shorter treatment vs. 14.4% with longer treatment. Grade 2 cardiac events occurred in 11.2% vs. 3.5% of patients in the treatment arms, respectively, and the grade 3 cardiac vents occurred in 2.7% vs. 1.1%, respectively. The rate of grade 4 events was 0.5% in both groups.
The overall difference between the groups with respect to cardiac events was highly statistically significant in favor of shorter treatment (HR, 0.32), Dr. Conte said.
Multiple studies have demonstrated the superiority of combining trastuzumab and adjuvant chemotherapy for HER2+ early breast cancer, and, following the release of some of those findings at the ASCO annual meeting in 2005, the agent was granted accelerated approval for this indication, Dr. Conte said.
“It was, however, clear that there were a number of reasons to believe that further investigation was appropriate on the optimal duration of trastuzumab duration,” he said, explaining that the same magnitude of benefit was reported by the small FinHER study with 9 weeks of trastuzumab and that clinical data suggest synergism of trastuzumab with chemotherapy.
“Finally, in the real world, there are patients at lower risk of relapse (more node-negative, more small tumors) and at higher risk of cardiac toxicity because of age or comorbidities,” he said. “So, the hypotheses behind the Short-HER [study] was that a shorter duration of trastuzumab administered concomitantly with chemotherapy might produce comparable efficacy with significantly lower toxicities and, of course, costs.”
Short-HER study subjects, who had a mean age of 55 years, had either HER2-positive, node-positive, or high-risk node-negative disease and were randomized to receive either the shorter treatment, including three courses of docetaxel given three times weekly plus trastuzumab given weekly for 9 doses, followed by three courses of 5-fluorouracil/epirubicin/cyclophosphamide, or standard 12-month treatment with four courses of anthracycline-based chemotherapy followed by four courses of docetaxel in combination with trastuzumab given three times weekly, followed by 14 additional courses of trastuzumab given three times weekly (for a total of 18 3-times-weekly doses). Radiation therapy was administered when indicated after chemotherapy, and hormonal therapy was started after completion of chemotherapy in patients with hormone-receptor–positive tumors.
Based on the frequentist analysis, noninferiority of the shorter treatment approach cannot be claimed, but, according to the preplanned Bayesian analysis, noninferiority is likely, Dr. Conte said.
“One year of trastuzumab is still standard. The Short-Her trial, however, reinforces the hypothesis that treatment deescalation retains efficacy with less toxicity. A shorter treatment might be an option for patients at low risk of relapse and/or higher risk of cardiac toxicity,” he said. “Moreover, these results might facilitate trastuzumab to patients in low/middle income countries.”
Individual patient meta-analysis with other trials testing different durations of trastuzumab administration is ongoing, he noted.
The Short-HER study was funded by the Italian Drug Agency, and drugs and insurance coverage were supplied by the National Health System. The study was sponsored by the University of Modena & Regio Emilia and the University of Padova. Dr. Conte has served on the speakers’ bureau for AstraZeneca, Lilly, Novartis, and Roche/Genentech and has received research funding and/or travel or other expenses from AstraZeneca, Celgene, and Novartis.
AT ASCO 2017
Key clinical point:
Major finding: The 5-year disease-free survival rates were 87.5% and 85.4% with 9 weeks, vs. 1 year, of trastuzumab (HR, 1.15).
Data source: The phase III Short-HER study of 1,253 patients.
Disclosures: The Short-HER study was funded by the Italian Drug Agency, and drugs and insurance coverage were supplied by the National Health System. The study was sponsored by the University of Modena & Regio Emilia and the University of Padova. Dr. Conte has served on the speakers’ bureau for AstraZeneca, Lilly, Novartis, and Roche/Genentech and has received research funding and/or travel or other expenses from AstraZeneca, Celgene, and Novartis.
Hypertonic saline for bronchiolitis found ineffective in large RCT study
MADRID – Giving nebulized hypertonic saline (NHS) to infants who present to pediatric emergency departments with a first episode of moderate to severe acute bronchiolitis did not reduce their hospitalization rate in the randomized, multicenter, double-blind GUERANDE trial.
Moreover, mild adverse events – mainly worsening cough – were significantly more frequent in the NHS recipients than in controls given nebulized normal saline, Christele Gras-le Guen, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
Some previous studies have suggested a modest benefit, but they were underpowered to draw meaningful conclusions. GUERANDE, a 777-patient randomized trial conducted in 24 French pediatric emergency departments, was the first quality study large enough to determine whether the therapy results in fewer hospital admissions, she said.
In GUERANDE, infants with a first episode of acute bronchiolitis were given two 20-minute nebulizations of 3% hypertonic saline or 0.9% normal saline 20 minutes apart.
The primary outcome was the rate of hospital admission within 24 hours after enrollment. The rate was 48% in the NHS group and 52% in controls, a nonsignificant difference which shrunk even more after controlling for age, oxygen saturation, and respiratory syncytial virus infection status.
No serious adverse events occurred in GUERANDE. However, the rate of mild adverse events was 9% in the NHS group, significantly higher than the 4% rate in controls. Notably, cough without respiratory distress occurred 30 times in 26 infants in the NHS group, compared with 4 times in 3 control subjects.
Dr. Gras-le Guin reported having no financial conflicts regarding the GUERANDE study, funded by the French Health Ministry.
MADRID – Giving nebulized hypertonic saline (NHS) to infants who present to pediatric emergency departments with a first episode of moderate to severe acute bronchiolitis did not reduce their hospitalization rate in the randomized, multicenter, double-blind GUERANDE trial.
Moreover, mild adverse events – mainly worsening cough – were significantly more frequent in the NHS recipients than in controls given nebulized normal saline, Christele Gras-le Guen, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
Some previous studies have suggested a modest benefit, but they were underpowered to draw meaningful conclusions. GUERANDE, a 777-patient randomized trial conducted in 24 French pediatric emergency departments, was the first quality study large enough to determine whether the therapy results in fewer hospital admissions, she said.
In GUERANDE, infants with a first episode of acute bronchiolitis were given two 20-minute nebulizations of 3% hypertonic saline or 0.9% normal saline 20 minutes apart.
The primary outcome was the rate of hospital admission within 24 hours after enrollment. The rate was 48% in the NHS group and 52% in controls, a nonsignificant difference which shrunk even more after controlling for age, oxygen saturation, and respiratory syncytial virus infection status.
No serious adverse events occurred in GUERANDE. However, the rate of mild adverse events was 9% in the NHS group, significantly higher than the 4% rate in controls. Notably, cough without respiratory distress occurred 30 times in 26 infants in the NHS group, compared with 4 times in 3 control subjects.
Dr. Gras-le Guin reported having no financial conflicts regarding the GUERANDE study, funded by the French Health Ministry.
MADRID – Giving nebulized hypertonic saline (NHS) to infants who present to pediatric emergency departments with a first episode of moderate to severe acute bronchiolitis did not reduce their hospitalization rate in the randomized, multicenter, double-blind GUERANDE trial.
Moreover, mild adverse events – mainly worsening cough – were significantly more frequent in the NHS recipients than in controls given nebulized normal saline, Christele Gras-le Guen, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
Some previous studies have suggested a modest benefit, but they were underpowered to draw meaningful conclusions. GUERANDE, a 777-patient randomized trial conducted in 24 French pediatric emergency departments, was the first quality study large enough to determine whether the therapy results in fewer hospital admissions, she said.
In GUERANDE, infants with a first episode of acute bronchiolitis were given two 20-minute nebulizations of 3% hypertonic saline or 0.9% normal saline 20 minutes apart.
The primary outcome was the rate of hospital admission within 24 hours after enrollment. The rate was 48% in the NHS group and 52% in controls, a nonsignificant difference which shrunk even more after controlling for age, oxygen saturation, and respiratory syncytial virus infection status.
No serious adverse events occurred in GUERANDE. However, the rate of mild adverse events was 9% in the NHS group, significantly higher than the 4% rate in controls. Notably, cough without respiratory distress occurred 30 times in 26 infants in the NHS group, compared with 4 times in 3 control subjects.
Dr. Gras-le Guin reported having no financial conflicts regarding the GUERANDE study, funded by the French Health Ministry.
AT ESPID 2017
Key clinical point:
Major finding: The rate of hospitalization following administration of nebulized hypertonic saline to infants with a first episode of acute bronchiolitis was 48%, not significantly different from the 52% rate in controls.
Data source: This was a randomized, multicenter, double-blind, controlled clinical trial including 777 infants with acute bronchiolitis.
Disclosures: The GUERANDE study was funded by the French Health Ministry. The presenter reported having no financial conflicts.
VIDEO: Troponin acts as atherosclerotic biomarker in patients with lupus
MADRID – Measuring levels of troponin, a well-known cardiac biomarker, could help identify patients with systemic lupus erythematosus (SLE) at particularly high risk for cardiovascular (CV) events, according to the results of a cross-sectional study presented at the European Congress of Rheumatology.
Karim Sacré, MD, presented the findings of the study that looked for possible biomarkers of atherosclerosis in patients with SLE and provide preliminary evidence that high-sensitivity troponin T (HS-cTnT) was predictive regardless of whether or not patients already had visible atherosclerotic plaques on vascular ultrasound.
“Patients with SLE have been known to be at risk for cardiovascular disease for at least a decade,” Dr. Sacré of Bichat Hospital, University of Paris-Diderot, France, said in an interview at the meeting. Today, SLE is considered an independent risk factor for CV events, much like diabetes, he added.
However, determining which patients with lupus will and which will not develop cardiac problems is still tricky in routine practice. This is because the traditional ways of assessing CV events do not fully account for the increased risk seen in lupus patients. Indeed, the Framingham risk score, which is based on several risk factors such as tobacco use, hypertension, and dyslipidemia, has been shown to underestimate the cardiovascular risk of lupus patients, he observed.
“So, we need something that will help clinicians to better define the real risk of cardiovascular disease in such populations,” he said at an earlier press conference.
Thus, the objective of the study he presented was to try to find a biomarker in the blood that might aid clinicians in identifying which patients who had SLE and no obvious cardiac symptoms might be at risk for future CV events.
The study involved 63 patients with SLE who were consecutively recruited and 18 individuals without SLE who were used as controls. None had any symptoms of cardiovascular disease at recruitment, and all were assessed prospectively by vascular ultrasound for the presence of atherosclerotic plaques in the carotid artery.
The concentration of HS-cTnT was measured in the serum by using an electrochemiluminescence method, which could detect a concentration level greater than 3 ng/L .
At recruitment, the Framingham risk score was low (2.1) in both patients and controls, none of whom showed any signs of already having cardiovascular disease. The results of the carotid ultrasound, however, showed a different story for the SLE patients, with 23 (36.5%) identified as having carotid plaques, compared with just 2 (11.1%) of the control group.
Serum HS-cTNT could be detected in more SLE patients than controls (58.7% vs. 33.3%; P = .057), and the SLE patients who had detectable levels were nine times more likely than controls to have a carotid plaque, Dr. Sacré reported, although the 95% confidence interval was wide (1.55 to 90.07; P = .033).
Interestingly, a higher percentage of SLE patients with carotid plaques than those without had detectable HS-cTNT (87% vs. 42.5%; P less than .001). Conversely, more patients with detectable HS-cTnT than without had a carotid plaque (54.5% vs. 11.5%; P less than .001).
In multivariate analyses, only SLE status and age were significantly associated with having carotid plaques, and body mass index and HS-cTnT (P = .033) were statistically associated with the presence of carotid plaques in SLE patients.
The research is, of course, preliminary, Dr. Sacré emphasized, and further investigation is needed. The study looked at subclinical disease rather than actual CV events, and that is something to look at next in a larger cohort of patients with a longer follow-up period, he said.
Dr. Sacré disclosed that he had received support for travel to the EULAR Congress from Roche Diagnostics France.
*This story was updated 6/20/2017.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
MADRID – Measuring levels of troponin, a well-known cardiac biomarker, could help identify patients with systemic lupus erythematosus (SLE) at particularly high risk for cardiovascular (CV) events, according to the results of a cross-sectional study presented at the European Congress of Rheumatology.
Karim Sacré, MD, presented the findings of the study that looked for possible biomarkers of atherosclerosis in patients with SLE and provide preliminary evidence that high-sensitivity troponin T (HS-cTnT) was predictive regardless of whether or not patients already had visible atherosclerotic plaques on vascular ultrasound.
“Patients with SLE have been known to be at risk for cardiovascular disease for at least a decade,” Dr. Sacré of Bichat Hospital, University of Paris-Diderot, France, said in an interview at the meeting. Today, SLE is considered an independent risk factor for CV events, much like diabetes, he added.
However, determining which patients with lupus will and which will not develop cardiac problems is still tricky in routine practice. This is because the traditional ways of assessing CV events do not fully account for the increased risk seen in lupus patients. Indeed, the Framingham risk score, which is based on several risk factors such as tobacco use, hypertension, and dyslipidemia, has been shown to underestimate the cardiovascular risk of lupus patients, he observed.
“So, we need something that will help clinicians to better define the real risk of cardiovascular disease in such populations,” he said at an earlier press conference.
Thus, the objective of the study he presented was to try to find a biomarker in the blood that might aid clinicians in identifying which patients who had SLE and no obvious cardiac symptoms might be at risk for future CV events.
The study involved 63 patients with SLE who were consecutively recruited and 18 individuals without SLE who were used as controls. None had any symptoms of cardiovascular disease at recruitment, and all were assessed prospectively by vascular ultrasound for the presence of atherosclerotic plaques in the carotid artery.
The concentration of HS-cTnT was measured in the serum by using an electrochemiluminescence method, which could detect a concentration level greater than 3 ng/L .
At recruitment, the Framingham risk score was low (2.1) in both patients and controls, none of whom showed any signs of already having cardiovascular disease. The results of the carotid ultrasound, however, showed a different story for the SLE patients, with 23 (36.5%) identified as having carotid plaques, compared with just 2 (11.1%) of the control group.
Serum HS-cTNT could be detected in more SLE patients than controls (58.7% vs. 33.3%; P = .057), and the SLE patients who had detectable levels were nine times more likely than controls to have a carotid plaque, Dr. Sacré reported, although the 95% confidence interval was wide (1.55 to 90.07; P = .033).
Interestingly, a higher percentage of SLE patients with carotid plaques than those without had detectable HS-cTNT (87% vs. 42.5%; P less than .001). Conversely, more patients with detectable HS-cTnT than without had a carotid plaque (54.5% vs. 11.5%; P less than .001).
In multivariate analyses, only SLE status and age were significantly associated with having carotid plaques, and body mass index and HS-cTnT (P = .033) were statistically associated with the presence of carotid plaques in SLE patients.
The research is, of course, preliminary, Dr. Sacré emphasized, and further investigation is needed. The study looked at subclinical disease rather than actual CV events, and that is something to look at next in a larger cohort of patients with a longer follow-up period, he said.
Dr. Sacré disclosed that he had received support for travel to the EULAR Congress from Roche Diagnostics France.
*This story was updated 6/20/2017.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
MADRID – Measuring levels of troponin, a well-known cardiac biomarker, could help identify patients with systemic lupus erythematosus (SLE) at particularly high risk for cardiovascular (CV) events, according to the results of a cross-sectional study presented at the European Congress of Rheumatology.
Karim Sacré, MD, presented the findings of the study that looked for possible biomarkers of atherosclerosis in patients with SLE and provide preliminary evidence that high-sensitivity troponin T (HS-cTnT) was predictive regardless of whether or not patients already had visible atherosclerotic plaques on vascular ultrasound.
“Patients with SLE have been known to be at risk for cardiovascular disease for at least a decade,” Dr. Sacré of Bichat Hospital, University of Paris-Diderot, France, said in an interview at the meeting. Today, SLE is considered an independent risk factor for CV events, much like diabetes, he added.
However, determining which patients with lupus will and which will not develop cardiac problems is still tricky in routine practice. This is because the traditional ways of assessing CV events do not fully account for the increased risk seen in lupus patients. Indeed, the Framingham risk score, which is based on several risk factors such as tobacco use, hypertension, and dyslipidemia, has been shown to underestimate the cardiovascular risk of lupus patients, he observed.
“So, we need something that will help clinicians to better define the real risk of cardiovascular disease in such populations,” he said at an earlier press conference.
Thus, the objective of the study he presented was to try to find a biomarker in the blood that might aid clinicians in identifying which patients who had SLE and no obvious cardiac symptoms might be at risk for future CV events.
The study involved 63 patients with SLE who were consecutively recruited and 18 individuals without SLE who were used as controls. None had any symptoms of cardiovascular disease at recruitment, and all were assessed prospectively by vascular ultrasound for the presence of atherosclerotic plaques in the carotid artery.
The concentration of HS-cTnT was measured in the serum by using an electrochemiluminescence method, which could detect a concentration level greater than 3 ng/L .
At recruitment, the Framingham risk score was low (2.1) in both patients and controls, none of whom showed any signs of already having cardiovascular disease. The results of the carotid ultrasound, however, showed a different story for the SLE patients, with 23 (36.5%) identified as having carotid plaques, compared with just 2 (11.1%) of the control group.
Serum HS-cTNT could be detected in more SLE patients than controls (58.7% vs. 33.3%; P = .057), and the SLE patients who had detectable levels were nine times more likely than controls to have a carotid plaque, Dr. Sacré reported, although the 95% confidence interval was wide (1.55 to 90.07; P = .033).
Interestingly, a higher percentage of SLE patients with carotid plaques than those without had detectable HS-cTNT (87% vs. 42.5%; P less than .001). Conversely, more patients with detectable HS-cTnT than without had a carotid plaque (54.5% vs. 11.5%; P less than .001).
In multivariate analyses, only SLE status and age were significantly associated with having carotid plaques, and body mass index and HS-cTnT (P = .033) were statistically associated with the presence of carotid plaques in SLE patients.
The research is, of course, preliminary, Dr. Sacré emphasized, and further investigation is needed. The study looked at subclinical disease rather than actual CV events, and that is something to look at next in a larger cohort of patients with a longer follow-up period, he said.
Dr. Sacré disclosed that he had received support for travel to the EULAR Congress from Roche Diagnostics France.
*This story was updated 6/20/2017.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT THE EULAR 2017 CONGRESS
Measles immunization is a major challenge in HIV-infected children
MADRID – Impaired response to measles immunization is common in HIV-infected children, and revaccination – while an important strategy – helps only some of them, Ruth del Valle, MD, said at the annual meeting of the European Society for Paediatric Infectious Diseases.
The key predictor of an impaired response to measles immunization appears to be a CD4/CD8 cell ratio of less than 1.0, added Dr. del Valle of Infant Sofia University Hospital in Madrid.
Of note, 48% of the children had a CD4/CD8 ratio of less than 1.0 at baseline. This ratio is gaining credence as a predictor of HIV-positive patients’ immunologic response to a variety of vaccines: most recently, in Dr. del Valle’s study, to measles vaccine and, in two earlier studies published in 2016, to yellow fever vaccine (PLoS Negl Trop Dis. 2016 Dec 12;10[12]:e0005219) and hepatitis B vaccine (Vaccine. 2016 Apr 7;34[16]:1889-95).
In Dr. del Valle’s study, only 52% of HIV-positive children developed protective antibody levels following completion of the standard two-dose MMR schedule. In accord with current Paediatric European Network for Treatment of AIDS (PENTA) guidelines, 41 unresponsive patients then received a booster MMR dose (HIV Med. 2012 Jul;13[6]:333-6). Of the 41, 10 (24%) did not respond to the booster dose, either. Thus, the final measles protection rate in this study was only 77%.
These study findings highlight the importance of routinely testing measles vaccine response in HIV-infected children in clinical practice, she noted.
The CD4/CD8 ratio was 1.3 in good responders to measles immunization and 0.9 in nonresponders. In a multivariate analysis, a CD4/CD8 ratio of less than 1.0 conferred a 3.2 times increased risk of impaired response to the measles vaccine.
Dr. del Valle and her coinvestigators in CORISPES (the Spanish Cohort of HIV-infected Children) plan further studies to determine the duration of protection against measles in those patients who responded to the booster dose.
Session cochair Nigel Klein, MD, commented that Dr. del Valle’s study is “one of a number of reports that HIV-infected children, as they get older, are predisposed to getting infections that we should be able to prevent.”
“I think we don’t know best how to manage this population of patients. You can give more vaccinations, but, as Dr. del Valle has shown, not all of them will respond. And I think this study is further evidence that the better we can maintain our children’s immune systems by treating early, the better our chances of getting good responses when we vaccinate,” said Dr. Klein, professor of pediatric infectious diseases and immunology at Great Ormond Street Children’s Hospital and University College London.
Dr. del Valle reported having no relevant financial disclosures.
MADRID – Impaired response to measles immunization is common in HIV-infected children, and revaccination – while an important strategy – helps only some of them, Ruth del Valle, MD, said at the annual meeting of the European Society for Paediatric Infectious Diseases.
The key predictor of an impaired response to measles immunization appears to be a CD4/CD8 cell ratio of less than 1.0, added Dr. del Valle of Infant Sofia University Hospital in Madrid.
Of note, 48% of the children had a CD4/CD8 ratio of less than 1.0 at baseline. This ratio is gaining credence as a predictor of HIV-positive patients’ immunologic response to a variety of vaccines: most recently, in Dr. del Valle’s study, to measles vaccine and, in two earlier studies published in 2016, to yellow fever vaccine (PLoS Negl Trop Dis. 2016 Dec 12;10[12]:e0005219) and hepatitis B vaccine (Vaccine. 2016 Apr 7;34[16]:1889-95).
In Dr. del Valle’s study, only 52% of HIV-positive children developed protective antibody levels following completion of the standard two-dose MMR schedule. In accord with current Paediatric European Network for Treatment of AIDS (PENTA) guidelines, 41 unresponsive patients then received a booster MMR dose (HIV Med. 2012 Jul;13[6]:333-6). Of the 41, 10 (24%) did not respond to the booster dose, either. Thus, the final measles protection rate in this study was only 77%.
These study findings highlight the importance of routinely testing measles vaccine response in HIV-infected children in clinical practice, she noted.
The CD4/CD8 ratio was 1.3 in good responders to measles immunization and 0.9 in nonresponders. In a multivariate analysis, a CD4/CD8 ratio of less than 1.0 conferred a 3.2 times increased risk of impaired response to the measles vaccine.
Dr. del Valle and her coinvestigators in CORISPES (the Spanish Cohort of HIV-infected Children) plan further studies to determine the duration of protection against measles in those patients who responded to the booster dose.
Session cochair Nigel Klein, MD, commented that Dr. del Valle’s study is “one of a number of reports that HIV-infected children, as they get older, are predisposed to getting infections that we should be able to prevent.”
“I think we don’t know best how to manage this population of patients. You can give more vaccinations, but, as Dr. del Valle has shown, not all of them will respond. And I think this study is further evidence that the better we can maintain our children’s immune systems by treating early, the better our chances of getting good responses when we vaccinate,” said Dr. Klein, professor of pediatric infectious diseases and immunology at Great Ormond Street Children’s Hospital and University College London.
Dr. del Valle reported having no relevant financial disclosures.
MADRID – Impaired response to measles immunization is common in HIV-infected children, and revaccination – while an important strategy – helps only some of them, Ruth del Valle, MD, said at the annual meeting of the European Society for Paediatric Infectious Diseases.
The key predictor of an impaired response to measles immunization appears to be a CD4/CD8 cell ratio of less than 1.0, added Dr. del Valle of Infant Sofia University Hospital in Madrid.
Of note, 48% of the children had a CD4/CD8 ratio of less than 1.0 at baseline. This ratio is gaining credence as a predictor of HIV-positive patients’ immunologic response to a variety of vaccines: most recently, in Dr. del Valle’s study, to measles vaccine and, in two earlier studies published in 2016, to yellow fever vaccine (PLoS Negl Trop Dis. 2016 Dec 12;10[12]:e0005219) and hepatitis B vaccine (Vaccine. 2016 Apr 7;34[16]:1889-95).
In Dr. del Valle’s study, only 52% of HIV-positive children developed protective antibody levels following completion of the standard two-dose MMR schedule. In accord with current Paediatric European Network for Treatment of AIDS (PENTA) guidelines, 41 unresponsive patients then received a booster MMR dose (HIV Med. 2012 Jul;13[6]:333-6). Of the 41, 10 (24%) did not respond to the booster dose, either. Thus, the final measles protection rate in this study was only 77%.
These study findings highlight the importance of routinely testing measles vaccine response in HIV-infected children in clinical practice, she noted.
The CD4/CD8 ratio was 1.3 in good responders to measles immunization and 0.9 in nonresponders. In a multivariate analysis, a CD4/CD8 ratio of less than 1.0 conferred a 3.2 times increased risk of impaired response to the measles vaccine.
Dr. del Valle and her coinvestigators in CORISPES (the Spanish Cohort of HIV-infected Children) plan further studies to determine the duration of protection against measles in those patients who responded to the booster dose.
Session cochair Nigel Klein, MD, commented that Dr. del Valle’s study is “one of a number of reports that HIV-infected children, as they get older, are predisposed to getting infections that we should be able to prevent.”
“I think we don’t know best how to manage this population of patients. You can give more vaccinations, but, as Dr. del Valle has shown, not all of them will respond. And I think this study is further evidence that the better we can maintain our children’s immune systems by treating early, the better our chances of getting good responses when we vaccinate,” said Dr. Klein, professor of pediatric infectious diseases and immunology at Great Ormond Street Children’s Hospital and University College London.
Dr. del Valle reported having no relevant financial disclosures.
AT ESPID 2017
Key clinical point:
Major finding: After two doses of MMR and, if needed, a third booster dose, 23% of a group of HIV-infected children remained unprotected against measles.
Data source: This multicenter study included 120 HIV-infected Spanish children who received two doses of the MMR vaccine and, if still unprotected against measles, a booster dose.
Disclosures: Dr. del Valle reported having no relevant financial disclosures.
Cancer, heart disease increase MRSA mortality
Cancer, heart, and neurologic disease are associated with significantly higher 30-day mortality from methicillin-resistant Staphylococcus aureus (MRSA), according to a study that also showed mortality rates have changed little in 9 years.
A retrospective study of 1,168 patients, who were admitted to four Michigan hospitals with MRSA over a period of 9 years, showed an overall 30-day mortality of 16% (Int J Infect Dis. 2017 May 19. doi: 10.1016/j.ijid.2017.05.010).
“Notably, with time, we found no improvement in overall mortality over time despite advancement in antimicrobial treatment,” wrote Pedro Ayau, MD, of the Universidad Francisco Marroquin in Guatemala City and his coauthors. “Thus far, the role of different antimicrobial agents against MRSA infection in clinical settings is uncertain.”
Patients with cancer showed the highest 30-day mortality risk from MRSA infection (odds ratio, 2.29; P = .001). Heart disease increased the mortality risk by 78%, neurologic disease by 65%, and nursing home residence by 66%. A Charlson index score greater than 3 was associated with an 88% increase in 30-day mortality.
Age was also an independent risk factor, with each additional year of age associated with a 2.9% increase in the odds of 30-day mortality, even after accounting for other variables.
The authors found evidence of a protective effect associated with diabetes and peripheral vascular disease, with a decrease in 30-day mortality of 40% and 47%, respectively. Although this was an unexpected finding, it was likely related to the source of the infection, they said.
“Patients with [peripheral vascular disease] and diabetes are usually less acutely ill and present with skin/wound infections, which are more easily managed, and started earlier on appropriate antibiotic treatment,” the investigators wrote.
Patients who were readmitted had an 88% lower risk of 30-day mortality. The authors suggested this may be because these patients would likely have received earlier and better management of the infection.
There was also a relationship between the source of infection and mortality. Patients infected from an indwelling central venous catheter had a 61% lower 30-day mortality. Those with skin or wound infections had a 52% lower mortality, and those with genitourinary infection had a 60% lower mortality.
In contrast to other studies, the researchers did not see any significant increase in 30-day mortality with persistent bacteremia.
Two authors declared research grants from the pharmaceutical industries.
Cancer, heart, and neurologic disease are associated with significantly higher 30-day mortality from methicillin-resistant Staphylococcus aureus (MRSA), according to a study that also showed mortality rates have changed little in 9 years.
A retrospective study of 1,168 patients, who were admitted to four Michigan hospitals with MRSA over a period of 9 years, showed an overall 30-day mortality of 16% (Int J Infect Dis. 2017 May 19. doi: 10.1016/j.ijid.2017.05.010).
“Notably, with time, we found no improvement in overall mortality over time despite advancement in antimicrobial treatment,” wrote Pedro Ayau, MD, of the Universidad Francisco Marroquin in Guatemala City and his coauthors. “Thus far, the role of different antimicrobial agents against MRSA infection in clinical settings is uncertain.”
Patients with cancer showed the highest 30-day mortality risk from MRSA infection (odds ratio, 2.29; P = .001). Heart disease increased the mortality risk by 78%, neurologic disease by 65%, and nursing home residence by 66%. A Charlson index score greater than 3 was associated with an 88% increase in 30-day mortality.
Age was also an independent risk factor, with each additional year of age associated with a 2.9% increase in the odds of 30-day mortality, even after accounting for other variables.
The authors found evidence of a protective effect associated with diabetes and peripheral vascular disease, with a decrease in 30-day mortality of 40% and 47%, respectively. Although this was an unexpected finding, it was likely related to the source of the infection, they said.
“Patients with [peripheral vascular disease] and diabetes are usually less acutely ill and present with skin/wound infections, which are more easily managed, and started earlier on appropriate antibiotic treatment,” the investigators wrote.
Patients who were readmitted had an 88% lower risk of 30-day mortality. The authors suggested this may be because these patients would likely have received earlier and better management of the infection.
There was also a relationship between the source of infection and mortality. Patients infected from an indwelling central venous catheter had a 61% lower 30-day mortality. Those with skin or wound infections had a 52% lower mortality, and those with genitourinary infection had a 60% lower mortality.
In contrast to other studies, the researchers did not see any significant increase in 30-day mortality with persistent bacteremia.
Two authors declared research grants from the pharmaceutical industries.
Cancer, heart, and neurologic disease are associated with significantly higher 30-day mortality from methicillin-resistant Staphylococcus aureus (MRSA), according to a study that also showed mortality rates have changed little in 9 years.
A retrospective study of 1,168 patients, who were admitted to four Michigan hospitals with MRSA over a period of 9 years, showed an overall 30-day mortality of 16% (Int J Infect Dis. 2017 May 19. doi: 10.1016/j.ijid.2017.05.010).
“Notably, with time, we found no improvement in overall mortality over time despite advancement in antimicrobial treatment,” wrote Pedro Ayau, MD, of the Universidad Francisco Marroquin in Guatemala City and his coauthors. “Thus far, the role of different antimicrobial agents against MRSA infection in clinical settings is uncertain.”
Patients with cancer showed the highest 30-day mortality risk from MRSA infection (odds ratio, 2.29; P = .001). Heart disease increased the mortality risk by 78%, neurologic disease by 65%, and nursing home residence by 66%. A Charlson index score greater than 3 was associated with an 88% increase in 30-day mortality.
Age was also an independent risk factor, with each additional year of age associated with a 2.9% increase in the odds of 30-day mortality, even after accounting for other variables.
The authors found evidence of a protective effect associated with diabetes and peripheral vascular disease, with a decrease in 30-day mortality of 40% and 47%, respectively. Although this was an unexpected finding, it was likely related to the source of the infection, they said.
“Patients with [peripheral vascular disease] and diabetes are usually less acutely ill and present with skin/wound infections, which are more easily managed, and started earlier on appropriate antibiotic treatment,” the investigators wrote.
Patients who were readmitted had an 88% lower risk of 30-day mortality. The authors suggested this may be because these patients would likely have received earlier and better management of the infection.
There was also a relationship between the source of infection and mortality. Patients infected from an indwelling central venous catheter had a 61% lower 30-day mortality. Those with skin or wound infections had a 52% lower mortality, and those with genitourinary infection had a 60% lower mortality.
In contrast to other studies, the researchers did not see any significant increase in 30-day mortality with persistent bacteremia.
Two authors declared research grants from the pharmaceutical industries.
FROM INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES
Key clinical point:
Major finding: Cancer is associated with a more than twofold increase in 30-day mortality from MRSA.
Data source: A 9-year retrospective study of 1,168 patients with MRSA infection.
Disclosures: Two authors declared research grants from the pharmaceutical industry.
Want to take action on health care legislation? Here’s how
The U.S. House of Representatives recently passed a revised version of the American Health Care Act (AHCA), which the nonpartisan Congressional Budget Office concluded would result in 14 million people losing coverage by 2018 and 23 million people losing coverage by 2026.
The American Congress of Obstetricians and Gynecologists is opposed to this bill and has stated that it will leave Americans “worse off than they are today” by cutting Medicaid, eliminating Medicaid expansion, allowing states to opt out of covering essential benefits like maternity care, and weakening protections for people with preexisting conditions.
[polldaddy:9770191]
State level
At the state level, the best person to contact is your ACOG section chairman, who can then direct you to your state’s legislative chairman. The legislative chairman will provide you with information on legislative actions that have been taken by the section. If you are interested in women’s health legislation, there may be an advocacy list to join that will provide legislative alerts. You may even choose to tweet about the alerts.
Often the state legislative chairman will send out information about an upcoming bill and ask for ACOG members to provide testimony. If there is a bill of particular interest, you can offer to testify either in person or submit written testimony. Often talking points are made available to help in the preparation of testimony.
Many states also have a Lobby Day, a day when members of the ob.gyn. community meet at the state house to advocate for or oppose legislation. This action can be easier than providing testimony because the time and date are predictable, while legislative hearings may not be.
There is a great deal that can be done at the state level in support of women’s health. Perhaps your state does not have a maternal mortality committee, perhaps there needs to be funding for vaccinations, or perhaps you want to support legislation that continues to provide health care for women even if the AHCA becomes law.
National action
Legislative action at the national level mirrors that at the state level, but it is coordinated by the ACOG Government Affairs Department. Contact this department via acog.org. One option is to become an advocate and receive legislative alerts. This alert system informs ACOG members about congressional actions and gives you the option to directly contact your members of Congress through email with a specific message. Some physicians may prefer to send an email different than the one provided by ACOG, while others may tweet using hashtags like #obgynaction or #docs4coverage.
You may prefer to contact your member of Congress by phone. The U.S. Capitol Switchboard number is 202-224-3121. Phone calls typically are taken by staff members. It is reasonable to ask for a staff member who handles the issue you wish to discuss. This person may be referred to as the L.A. (legislative assistant). Inform the staff member that you are a constituent and you would like to leave a brief message for the Senator or Representative. Your comments may be as brief as stating that you support or oppose a particular piece of legislation. As with the letter, you should state the reasons for your opinion and may include a short personal story. If you do not already know it, you should ask for the lawmaker’s position on the bill.
An ideal method of interacting with members of Congress is through town hall meetings. These meetings typically are posted on the member’s website and hearing from constituents in person can have a tremendous impact on legislators. Letters to the Editor, interviews with journalists, and advocating for candidates are also options to consider. In such cases, consider contacting the ACOG Government Affairs Department. They can provide helpful dos and don’ts before an interview is scheduled or an article is written.
Health care policymaking that is not based on scientific or medical evidence is dangerous for our patients. We, as their physicians, need to advocate on their behalf. Stay or get involved to help ensure that our patients can get the health care they need when they need it.
Dr. Bohon is an ob.gyn. in private practice in Washington, and an ACOG state legislative chair from the District of Columbia. She is a member of the Ob.Gyn. News Editorial Advisory Board. Dr. Bohon reported having no relevant financial disclosures.
The U.S. House of Representatives recently passed a revised version of the American Health Care Act (AHCA), which the nonpartisan Congressional Budget Office concluded would result in 14 million people losing coverage by 2018 and 23 million people losing coverage by 2026.
The American Congress of Obstetricians and Gynecologists is opposed to this bill and has stated that it will leave Americans “worse off than they are today” by cutting Medicaid, eliminating Medicaid expansion, allowing states to opt out of covering essential benefits like maternity care, and weakening protections for people with preexisting conditions.
[polldaddy:9770191]
State level
At the state level, the best person to contact is your ACOG section chairman, who can then direct you to your state’s legislative chairman. The legislative chairman will provide you with information on legislative actions that have been taken by the section. If you are interested in women’s health legislation, there may be an advocacy list to join that will provide legislative alerts. You may even choose to tweet about the alerts.
Often the state legislative chairman will send out information about an upcoming bill and ask for ACOG members to provide testimony. If there is a bill of particular interest, you can offer to testify either in person or submit written testimony. Often talking points are made available to help in the preparation of testimony.
Many states also have a Lobby Day, a day when members of the ob.gyn. community meet at the state house to advocate for or oppose legislation. This action can be easier than providing testimony because the time and date are predictable, while legislative hearings may not be.
There is a great deal that can be done at the state level in support of women’s health. Perhaps your state does not have a maternal mortality committee, perhaps there needs to be funding for vaccinations, or perhaps you want to support legislation that continues to provide health care for women even if the AHCA becomes law.
National action
Legislative action at the national level mirrors that at the state level, but it is coordinated by the ACOG Government Affairs Department. Contact this department via acog.org. One option is to become an advocate and receive legislative alerts. This alert system informs ACOG members about congressional actions and gives you the option to directly contact your members of Congress through email with a specific message. Some physicians may prefer to send an email different than the one provided by ACOG, while others may tweet using hashtags like #obgynaction or #docs4coverage.
You may prefer to contact your member of Congress by phone. The U.S. Capitol Switchboard number is 202-224-3121. Phone calls typically are taken by staff members. It is reasonable to ask for a staff member who handles the issue you wish to discuss. This person may be referred to as the L.A. (legislative assistant). Inform the staff member that you are a constituent and you would like to leave a brief message for the Senator or Representative. Your comments may be as brief as stating that you support or oppose a particular piece of legislation. As with the letter, you should state the reasons for your opinion and may include a short personal story. If you do not already know it, you should ask for the lawmaker’s position on the bill.
An ideal method of interacting with members of Congress is through town hall meetings. These meetings typically are posted on the member’s website and hearing from constituents in person can have a tremendous impact on legislators. Letters to the Editor, interviews with journalists, and advocating for candidates are also options to consider. In such cases, consider contacting the ACOG Government Affairs Department. They can provide helpful dos and don’ts before an interview is scheduled or an article is written.
Health care policymaking that is not based on scientific or medical evidence is dangerous for our patients. We, as their physicians, need to advocate on their behalf. Stay or get involved to help ensure that our patients can get the health care they need when they need it.
Dr. Bohon is an ob.gyn. in private practice in Washington, and an ACOG state legislative chair from the District of Columbia. She is a member of the Ob.Gyn. News Editorial Advisory Board. Dr. Bohon reported having no relevant financial disclosures.
The U.S. House of Representatives recently passed a revised version of the American Health Care Act (AHCA), which the nonpartisan Congressional Budget Office concluded would result in 14 million people losing coverage by 2018 and 23 million people losing coverage by 2026.
The American Congress of Obstetricians and Gynecologists is opposed to this bill and has stated that it will leave Americans “worse off than they are today” by cutting Medicaid, eliminating Medicaid expansion, allowing states to opt out of covering essential benefits like maternity care, and weakening protections for people with preexisting conditions.
[polldaddy:9770191]
State level
At the state level, the best person to contact is your ACOG section chairman, who can then direct you to your state’s legislative chairman. The legislative chairman will provide you with information on legislative actions that have been taken by the section. If you are interested in women’s health legislation, there may be an advocacy list to join that will provide legislative alerts. You may even choose to tweet about the alerts.
Often the state legislative chairman will send out information about an upcoming bill and ask for ACOG members to provide testimony. If there is a bill of particular interest, you can offer to testify either in person or submit written testimony. Often talking points are made available to help in the preparation of testimony.
Many states also have a Lobby Day, a day when members of the ob.gyn. community meet at the state house to advocate for or oppose legislation. This action can be easier than providing testimony because the time and date are predictable, while legislative hearings may not be.
There is a great deal that can be done at the state level in support of women’s health. Perhaps your state does not have a maternal mortality committee, perhaps there needs to be funding for vaccinations, or perhaps you want to support legislation that continues to provide health care for women even if the AHCA becomes law.
National action
Legislative action at the national level mirrors that at the state level, but it is coordinated by the ACOG Government Affairs Department. Contact this department via acog.org. One option is to become an advocate and receive legislative alerts. This alert system informs ACOG members about congressional actions and gives you the option to directly contact your members of Congress through email with a specific message. Some physicians may prefer to send an email different than the one provided by ACOG, while others may tweet using hashtags like #obgynaction or #docs4coverage.
You may prefer to contact your member of Congress by phone. The U.S. Capitol Switchboard number is 202-224-3121. Phone calls typically are taken by staff members. It is reasonable to ask for a staff member who handles the issue you wish to discuss. This person may be referred to as the L.A. (legislative assistant). Inform the staff member that you are a constituent and you would like to leave a brief message for the Senator or Representative. Your comments may be as brief as stating that you support or oppose a particular piece of legislation. As with the letter, you should state the reasons for your opinion and may include a short personal story. If you do not already know it, you should ask for the lawmaker’s position on the bill.
An ideal method of interacting with members of Congress is through town hall meetings. These meetings typically are posted on the member’s website and hearing from constituents in person can have a tremendous impact on legislators. Letters to the Editor, interviews with journalists, and advocating for candidates are also options to consider. In such cases, consider contacting the ACOG Government Affairs Department. They can provide helpful dos and don’ts before an interview is scheduled or an article is written.
Health care policymaking that is not based on scientific or medical evidence is dangerous for our patients. We, as their physicians, need to advocate on their behalf. Stay or get involved to help ensure that our patients can get the health care they need when they need it.
Dr. Bohon is an ob.gyn. in private practice in Washington, and an ACOG state legislative chair from the District of Columbia. She is a member of the Ob.Gyn. News Editorial Advisory Board. Dr. Bohon reported having no relevant financial disclosures.