Granuloma annulare (GA) is a granulomatous skin disorder of uncertain etiology. A number of clinical variants exist, most commonly localized annular plaques on the hands or feet, generalized lesions, or subcutaneous nodules in children. Histologically, GA exhibits granulomatous inflammation with either interstitial or palisading lymphocytes and histiocytes with mucin deposition.

Few data exist regarding the epidemiology of GA. Although the pathogenesis of GA is unknown, associations between GA and underlying systemic processes, such as diabetes mellitus, hyperlipidemia, thyroid disease, and human immunodeficiency virus (HIV), have been suggested.

The purpose of this retrospective study was to determine the number of cases of GA seen annually at the Department of Dermatology at the University of Pennsylvania (Philadelphia, Pennsylvania) from 2008 to 2014. Additionally, we reviewed all cases of biopsy-proven GA from 2010 to 2014 and reported the demographics, underlying medical comorbidities, medications, treatments, and outcomes seen in this patient population.

Methods

We identified the number of outpatients presenting with GA annually using PennSeek, a tool developed by the Penn Medicine Data Analytics Center to search electronic medical records (EMRs). We queried the EMR database to determine the number of discrete patients seen at the Department of Dermatology at the University of Pennsylvania annually from 2008 (the year the EMR was established) to 2014. We then used PennSeek to determine the number of patients given a diagnosis of GA annually from 2008 to 2014 based on the International Classification of Diseases, Ninth Revision (ICD-9).

After using PennSeek to identify all patients given the ICD-9 diagnosis of GA from 2008 to 2014, we reviewed the EMRs of these patients to identify cases that were biopsy proven. For the biopsy-proven cases of GA seen at the University of Pennsylvania from 2010 to 2014, we reviewed the EMRs of these patients for clinical characteristics and treatment outcomes. For each case, we recorded the patient’s age, sex, medical comorbidities, GA subtype, and medications.

This study was approved by the University of Pennsylvania’s institutional review board.

Results

On average, the percentage of patients given a diagnosis of GA annually was 0.22% (95% CI, 0.19%-0.24%). A Pearson χ² test was used to determine if any single annual percentage was significantly different from the others. We found a P value of .321, which suggests that the percentage of patients with GA seen annually has been stable from 2008 to 2014 (Figure).

There were 133 cases of biopsy-proven GA that were reviewed for clinical characteristics; of them, 86.5% were female. Thyroid disease was noted in 30.1% of patients, hyperlipidemia in 30.1%, and hematologic malignancies in 3.8%. Type 1 diabetes mellitus was noted in 1.5% of patients. None of the patients were HIV-positive, 1.5% were hepatitis B–positive, and 2.3% were hepatitis C–positive. Of the 133 cases, 64.7% had localized GA and 30.8% had generalized GA. Photosensitive and papular GA were rarer (1.5% and 2.3% of cases, respectively). Use of a selective serotonin reuptake inhibitor (SSRI) was noted in 18.1% of patients; use of a calcium channel blocker was noted in 9.0% (Table 1).

Comment

We attempted to determine the period of prevalence of GA in a tertiary care, university-based referral practice and evaluate disease associations, treatments, and outcomes of patients with biopsy-proven GA. Our calculated period prevalence of GA of 0.22% to 0.27% is consistent with another review, which reported that 0.1% to 0.4% of new patients presenting to a dermatology practice were given a diagnosis of GA.¹ More than 85% of the cases we reviewed were seen in females, a finding that is more heavily skewed compared to prior reports that have suggested a female to male ratio of approximately 1:1 to 2:1.^1-7 Our findings suggest that GA is a female-predominant condition, or women may be more likely to seek evaluation for the condition.

More than 95% of the cases we reviewed were localized (64.7%) or generalized (30.8%) GA, making these variants the most common forms of GA, which is consistent with prior reports.^1-3,8,9 Other varieties of GA—drug induced, patch, perforating, photosensitive, palmar, and papular—appear rare. Because this study was conducted at an adult hospital, subcutaneous GA, which often is seen in children, may be underrepresented. As a retrospective chart review, it is possible that documentation is insufficient to capture each rare variant.

At 1.5%, the prevalence of type 1 diabetes mellitus in our patients is slightly higher than the national average of 0.3%.²⁵ However, based on a Fisher exact test of analysis of proportions, this difference is not statistically significant (P=.106).

At 1.5% and 2.3%, the prevalence of hepatitis B and hepatitis C, respectively, in our patients is slightly higher than the national average of 0.5% and 1%, respectively.²⁶ However, based on a Fisher exact test of analysis of proportions, these differences are not statistically significant (P=.142 and P=.146, respectively).

Given the high prevalence of hyperlipidemia in the United States (31.7%), this disease is not overrepresented in our sample (30.1%), though others have suggested there may be a connection.^27,28 Based on a Fisher exact test, this difference of proportions is not statistically significant (P=.780).

Selective serotonin reuptake inhibitor use is common in the United States; approximately 11% of Americans older than 12 years use an SSRI.²⁹ At 18.1%, the use of SSRIs in our patient group was statistically significantly higher than the national average (Fisher exact test, P=.017), suggesting a possible association between SSRI use and development of GA, warranting further investigation.

The use of calcium channel blockers, interferon, and tumor necrosis factor inhibitors was not significantly associated with GA in our series.

GA Therapy
The most commonly used treatments for GA in our study were topical steroids and intralesional triamcinolone, followed by hydroxychloroquine; all treatments employed exhibited a widely variable response. Assessing treatment response via retrospective chart review is challenging and response rates may not be accurately captured.

Study Limitations
Our study had several limitations. In calculating the period prevalence of GA, our query was limited by the number of years that the EMR has been in place. The number of cases we reviewed for clinical characteristics was limited to 133, as many cases with the ICD-9 diagnosis of GA were not biopsy proven and therefore were not included in our review. Many of the cases we reviewed were lost to follow-up, which prevented us from determining treatment outcomes.

Another weakness of our study was that our query did not provide an estimate of incidence or prevalence of GA overall, as this analysis was not a population-based study. The power of our study was limited by the number of cases of GA seen annually and the number of patients lost to follow-up. Additionally, our study population may only be generalizable to other large academic centers.

Conclusion

This study further solidifies our understanding of the epidemiology of GA and diseases that can be associated with GA. We identified a higher female to male ratio than previous reports, and consistent with prior reports, we noted potential associations with conditions such as thyroid disease and hyperlipidemia. Our population demonstrated higher rates of SSRI use than expected, warranting further investigation. Dermatologists should be aware of potential disease associations with GA, but as a whole we need better data and larger studies to determine the appropriate evaluation and treatment for patients with GA.

Granuloma annulare (GA) is a granulomatous skin disorder of uncertain etiology. A number of clinical variants exist, most commonly localized annular plaques on the hands or feet, generalized lesions, or subcutaneous nodules in children. Histologically, GA exhibits granulomatous inflammation with either interstitial or palisading lymphocytes and histiocytes with mucin deposition.

Few data exist regarding the epidemiology of GA. Although the pathogenesis of GA is unknown, associations between GA and underlying systemic processes, such as diabetes mellitus, hyperlipidemia, thyroid disease, and human immunodeficiency virus (HIV), have been suggested.

The purpose of this retrospective study was to determine the number of cases of GA seen annually at the Department of Dermatology at the University of Pennsylvania (Philadelphia, Pennsylvania) from 2008 to 2014. Additionally, we reviewed all cases of biopsy-proven GA from 2010 to 2014 and reported the demographics, underlying medical comorbidities, medications, treatments, and outcomes seen in this patient population.

Methods

We identified the number of outpatients presenting with GA annually using PennSeek, a tool developed by the Penn Medicine Data Analytics Center to search electronic medical records (EMRs). We queried the EMR database to determine the number of discrete patients seen at the Department of Dermatology at the University of Pennsylvania annually from 2008 (the year the EMR was established) to 2014. We then used PennSeek to determine the number of patients given a diagnosis of GA annually from 2008 to 2014 based on the International Classification of Diseases, Ninth Revision (ICD-9).

After using PennSeek to identify all patients given the ICD-9 diagnosis of GA from 2008 to 2014, we reviewed the EMRs of these patients to identify cases that were biopsy proven. For the biopsy-proven cases of GA seen at the University of Pennsylvania from 2010 to 2014, we reviewed the EMRs of these patients for clinical characteristics and treatment outcomes. For each case, we recorded the patient’s age, sex, medical comorbidities, GA subtype, and medications.

This study was approved by the University of Pennsylvania’s institutional review board.

Results

On average, the percentage of patients given a diagnosis of GA annually was 0.22% (95% CI, 0.19%-0.24%). A Pearson χ² test was used to determine if any single annual percentage was significantly different from the others. We found a P value of .321, which suggests that the percentage of patients with GA seen annually has been stable from 2008 to 2014 (Figure).

There were 133 cases of biopsy-proven GA that were reviewed for clinical characteristics; of them, 86.5% were female. Thyroid disease was noted in 30.1% of patients, hyperlipidemia in 30.1%, and hematologic malignancies in 3.8%. Type 1 diabetes mellitus was noted in 1.5% of patients. None of the patients were HIV-positive, 1.5% were hepatitis B–positive, and 2.3% were hepatitis C–positive. Of the 133 cases, 64.7% had localized GA and 30.8% had generalized GA. Photosensitive and papular GA were rarer (1.5% and 2.3% of cases, respectively). Use of a selective serotonin reuptake inhibitor (SSRI) was noted in 18.1% of patients; use of a calcium channel blocker was noted in 9.0% (Table 1).

Comment

We attempted to determine the period of prevalence of GA in a tertiary care, university-based referral practice and evaluate disease associations, treatments, and outcomes of patients with biopsy-proven GA. Our calculated period prevalence of GA of 0.22% to 0.27% is consistent with another review, which reported that 0.1% to 0.4% of new patients presenting to a dermatology practice were given a diagnosis of GA.¹ More than 85% of the cases we reviewed were seen in females, a finding that is more heavily skewed compared to prior reports that have suggested a female to male ratio of approximately 1:1 to 2:1.^1-7 Our findings suggest that GA is a female-predominant condition, or women may be more likely to seek evaluation for the condition.

More than 95% of the cases we reviewed were localized (64.7%) or generalized (30.8%) GA, making these variants the most common forms of GA, which is consistent with prior reports.^1-3,8,9 Other varieties of GA—drug induced, patch, perforating, photosensitive, palmar, and papular—appear rare. Because this study was conducted at an adult hospital, subcutaneous GA, which often is seen in children, may be underrepresented. As a retrospective chart review, it is possible that documentation is insufficient to capture each rare variant.

At 1.5%, the prevalence of type 1 diabetes mellitus in our patients is slightly higher than the national average of 0.3%.²⁵ However, based on a Fisher exact test of analysis of proportions, this difference is not statistically significant (P=.106).

At 1.5% and 2.3%, the prevalence of hepatitis B and hepatitis C, respectively, in our patients is slightly higher than the national average of 0.5% and 1%, respectively.²⁶ However, based on a Fisher exact test of analysis of proportions, these differences are not statistically significant (P=.142 and P=.146, respectively).

Given the high prevalence of hyperlipidemia in the United States (31.7%), this disease is not overrepresented in our sample (30.1%), though others have suggested there may be a connection.^27,28 Based on a Fisher exact test, this difference of proportions is not statistically significant (P=.780).

Selective serotonin reuptake inhibitor use is common in the United States; approximately 11% of Americans older than 12 years use an SSRI.²⁹ At 18.1%, the use of SSRIs in our patient group was statistically significantly higher than the national average (Fisher exact test, P=.017), suggesting a possible association between SSRI use and development of GA, warranting further investigation.

The use of calcium channel blockers, interferon, and tumor necrosis factor inhibitors was not significantly associated with GA in our series.

GA Therapy
The most commonly used treatments for GA in our study were topical steroids and intralesional triamcinolone, followed by hydroxychloroquine; all treatments employed exhibited a widely variable response. Assessing treatment response via retrospective chart review is challenging and response rates may not be accurately captured.

Study Limitations
Our study had several limitations. In calculating the period prevalence of GA, our query was limited by the number of years that the EMR has been in place. The number of cases we reviewed for clinical characteristics was limited to 133, as many cases with the ICD-9 diagnosis of GA were not biopsy proven and therefore were not included in our review. Many of the cases we reviewed were lost to follow-up, which prevented us from determining treatment outcomes.

Another weakness of our study was that our query did not provide an estimate of incidence or prevalence of GA overall, as this analysis was not a population-based study. The power of our study was limited by the number of cases of GA seen annually and the number of patients lost to follow-up. Additionally, our study population may only be generalizable to other large academic centers.

Conclusion

This study further solidifies our understanding of the epidemiology of GA and diseases that can be associated with GA. We identified a higher female to male ratio than previous reports, and consistent with prior reports, we noted potential associations with conditions such as thyroid disease and hyperlipidemia. Our population demonstrated higher rates of SSRI use than expected, warranting further investigation. Dermatologists should be aware of potential disease associations with GA, but as a whole we need better data and larger studies to determine the appropriate evaluation and treatment for patients with GA.

Granuloma annulare (GA) is a granulomatous skin disorder of uncertain etiology. A number of clinical variants exist, most commonly localized annular plaques on the hands or feet, generalized lesions, or subcutaneous nodules in children. Histologically, GA exhibits granulomatous inflammation with either interstitial or palisading lymphocytes and histiocytes with mucin deposition.

Few data exist regarding the epidemiology of GA. Although the pathogenesis of GA is unknown, associations between GA and underlying systemic processes, such as diabetes mellitus, hyperlipidemia, thyroid disease, and human immunodeficiency virus (HIV), have been suggested.

The purpose of this retrospective study was to determine the number of cases of GA seen annually at the Department of Dermatology at the University of Pennsylvania (Philadelphia, Pennsylvania) from 2008 to 2014. Additionally, we reviewed all cases of biopsy-proven GA from 2010 to 2014 and reported the demographics, underlying medical comorbidities, medications, treatments, and outcomes seen in this patient population.

Methods

We identified the number of outpatients presenting with GA annually using PennSeek, a tool developed by the Penn Medicine Data Analytics Center to search electronic medical records (EMRs). We queried the EMR database to determine the number of discrete patients seen at the Department of Dermatology at the University of Pennsylvania annually from 2008 (the year the EMR was established) to 2014. We then used PennSeek to determine the number of patients given a diagnosis of GA annually from 2008 to 2014 based on the International Classification of Diseases, Ninth Revision (ICD-9).

After using PennSeek to identify all patients given the ICD-9 diagnosis of GA from 2008 to 2014, we reviewed the EMRs of these patients to identify cases that were biopsy proven. For the biopsy-proven cases of GA seen at the University of Pennsylvania from 2010 to 2014, we reviewed the EMRs of these patients for clinical characteristics and treatment outcomes. For each case, we recorded the patient’s age, sex, medical comorbidities, GA subtype, and medications.

This study was approved by the University of Pennsylvania’s institutional review board.

Results

On average, the percentage of patients given a diagnosis of GA annually was 0.22% (95% CI, 0.19%-0.24%). A Pearson χ² test was used to determine if any single annual percentage was significantly different from the others. We found a P value of .321, which suggests that the percentage of patients with GA seen annually has been stable from 2008 to 2014 (Figure).

There were 133 cases of biopsy-proven GA that were reviewed for clinical characteristics; of them, 86.5% were female. Thyroid disease was noted in 30.1% of patients, hyperlipidemia in 30.1%, and hematologic malignancies in 3.8%. Type 1 diabetes mellitus was noted in 1.5% of patients. None of the patients were HIV-positive, 1.5% were hepatitis B–positive, and 2.3% were hepatitis C–positive. Of the 133 cases, 64.7% had localized GA and 30.8% had generalized GA. Photosensitive and papular GA were rarer (1.5% and 2.3% of cases, respectively). Use of a selective serotonin reuptake inhibitor (SSRI) was noted in 18.1% of patients; use of a calcium channel blocker was noted in 9.0% (Table 1).

Comment

We attempted to determine the period of prevalence of GA in a tertiary care, university-based referral practice and evaluate disease associations, treatments, and outcomes of patients with biopsy-proven GA. Our calculated period prevalence of GA of 0.22% to 0.27% is consistent with another review, which reported that 0.1% to 0.4% of new patients presenting to a dermatology practice were given a diagnosis of GA.¹ More than 85% of the cases we reviewed were seen in females, a finding that is more heavily skewed compared to prior reports that have suggested a female to male ratio of approximately 1:1 to 2:1.^1-7 Our findings suggest that GA is a female-predominant condition, or women may be more likely to seek evaluation for the condition.

More than 95% of the cases we reviewed were localized (64.7%) or generalized (30.8%) GA, making these variants the most common forms of GA, which is consistent with prior reports.^1-3,8,9 Other varieties of GA—drug induced, patch, perforating, photosensitive, palmar, and papular—appear rare. Because this study was conducted at an adult hospital, subcutaneous GA, which often is seen in children, may be underrepresented. As a retrospective chart review, it is possible that documentation is insufficient to capture each rare variant.

At 1.5%, the prevalence of type 1 diabetes mellitus in our patients is slightly higher than the national average of 0.3%.²⁵ However, based on a Fisher exact test of analysis of proportions, this difference is not statistically significant (P=.106).

At 1.5% and 2.3%, the prevalence of hepatitis B and hepatitis C, respectively, in our patients is slightly higher than the national average of 0.5% and 1%, respectively.²⁶ However, based on a Fisher exact test of analysis of proportions, these differences are not statistically significant (P=.142 and P=.146, respectively).

Given the high prevalence of hyperlipidemia in the United States (31.7%), this disease is not overrepresented in our sample (30.1%), though others have suggested there may be a connection.^27,28 Based on a Fisher exact test, this difference of proportions is not statistically significant (P=.780).

Selective serotonin reuptake inhibitor use is common in the United States; approximately 11% of Americans older than 12 years use an SSRI.²⁹ At 18.1%, the use of SSRIs in our patient group was statistically significantly higher than the national average (Fisher exact test, P=.017), suggesting a possible association between SSRI use and development of GA, warranting further investigation.

The use of calcium channel blockers, interferon, and tumor necrosis factor inhibitors was not significantly associated with GA in our series.

GA Therapy
The most commonly used treatments for GA in our study were topical steroids and intralesional triamcinolone, followed by hydroxychloroquine; all treatments employed exhibited a widely variable response. Assessing treatment response via retrospective chart review is challenging and response rates may not be accurately captured.

Study Limitations
Our study had several limitations. In calculating the period prevalence of GA, our query was limited by the number of years that the EMR has been in place. The number of cases we reviewed for clinical characteristics was limited to 133, as many cases with the ICD-9 diagnosis of GA were not biopsy proven and therefore were not included in our review. Many of the cases we reviewed were lost to follow-up, which prevented us from determining treatment outcomes.

Another weakness of our study was that our query did not provide an estimate of incidence or prevalence of GA overall, as this analysis was not a population-based study. The power of our study was limited by the number of cases of GA seen annually and the number of patients lost to follow-up. Additionally, our study population may only be generalizable to other large academic centers.

Conclusion

This study further solidifies our understanding of the epidemiology of GA and diseases that can be associated with GA. We identified a higher female to male ratio than previous reports, and consistent with prior reports, we noted potential associations with conditions such as thyroid disease and hyperlipidemia. Our population demonstrated higher rates of SSRI use than expected, warranting further investigation. Dermatologists should be aware of potential disease associations with GA, but as a whole we need better data and larger studies to determine the appropriate evaluation and treatment for patients with GA.

WASHINGTON – Oncologists and cardiologists need to work hand-in-hand when managing the care of women with breast cancer whose treatment plan includes cardiotoxic therapies and breast irradiation, reported specialists.

Neil Osterweil/MDedge News

Depending on the cancer subtype, women with breast cancer may receive chemotherapy with a cardiotoxic anthracycline such as doxorubicin or epirubicin, or a HER2-targeted agent such as trastuzumab (Herceptin), pertuzumab (Perjeta), or ado-trastuzumab emtansine (Kadcyla).

“The cardiotoxicity related to breast cancer has been a well publicized issue, and chances are your patients know about it and are concerned as well,” Jennifer E. Liu, MD, director of cardiovascular laboratories at Memorial Sloan Kettering Cancer Center in New York, said at the American College of Cardiology’s Advancing the Cardiovascular Care of the Oncology Patient meeting.
 

Anthracyclines, trastuzumab, and HF

In large adjuvant therapy trials of anthracyclines and trastuzumab in women with breast cancer, doxorubicin alone was associated with an asymptomatic decline in left ventricular ejection fraction (LVEF) of 4% to 11%, and a less than 1% incidence of heart failure (HF), Dr. Liu noted.

When patients received an anthracycline followed by trastuzumab, the incidence of asymptomatic LVEF decline ranged from 4% to 19%, the incidence of clinical HF was 2% to 4%, and the rate of trastuzumab interruption for cardiac adverse events ranged from 5% to 18%.

In comparison, in trials with trastuzumab in combination therapy that did not contain an anthracycline, the risk of cardiovascular complications was lower, with asymptomatic decline in LVEF ranging from 3.2% to 9.4%, and class III/IV HF occurring in just 0.5% of patients. In trials combining trastuzumab and pertuzumab, there were no increases in cardiac toxicity over trastuzumab alone.

Although with longer follow-up, the approximately 4% rate of HF in patients treated with anthracycline-based chemotherapy, paclitaxel, and trastuzumab in the NSABP B-31 trial has not changed significantly; retrospective claims-based studies reflecting daily practice have shown significantly higher rates of HF and or cardiomyopathy, Dr. Liu said.

She cited a 2012 study showing that among 45,537 women with a mean age of 76 years who were treated for breast cancer, the 3-year incidence rates of HF and/or cardiomyopathy were 32% for patients treated with trastuzumab alone, and 41.9% for those treated with an anthracycline followed by trastuzumab. Other, smaller studies also showed lower but significantly elevated risks for the drugs.

The discrepancy between clinical trial and “real world” results may be chalked up to the fact that claims-based data rely on diagnostic codes that may not accurately reflect the actual cardiac diagnosis, and by the fact that clinical trials have strict entry criteria that exclude patients with cardiovascular disease, she said.
 

Radiation risks

Radiation therapy is associated with a more than 7% increase in major coronary events per Gy of mean heart dose, Dr. Liu noted, citing a 2013 study (N Engl J Med. 2013;368:987-98).

Paul Nguyen, MD, a radiation oncologist at the Dana-Farber/Brigham and Women’s Cancer Center in Boston, said that risk factors for radiation-induced heart disease include anterior or left chest irradiation, cumulative doses above 30 Gy, patient age younger than 50 years, doses of more than 2 Gy per fraction, presence and extent of tumor in or near the heart, lack of radiation shielding, concomitant chemotherapy (especially with anthracyclines), and preexisting cardiovascular disease or risk factors.

Neil Osterweil/MDedge News

Treatment options for LVEF decline

The package insert for trastuzumab recommends withholding the drug for a minimum of 4 weeks if the patient has a 16% or greater decline in LVEF from baseline, or a 10% or greater decline from baseline to below the lower limit of normal. The insert recommends LVEF monitoring every 3 or 4 weeks, and says that trastuzumab can be resumed if LVEF improves to above the lower limit of normal with an absolute decrease from baseline of not more than 15%. The insert also states, however, that “the safety of continuation or resumption of trastuzumab in patients with trastuzumab induced LV dysfunction has never been studied, “ Dr. Liu noted.

She cited an American Society of Clinical Oncology guideline on the prevention and monitoring of cardiac dysfunction in survivors of adult cancers, which states in part that the decision to continue or discontinue cancer therapy in patients with evidence of cardiac dysfunction “made by the oncologist, should be informed by close collaboration with a cardiologist, fully evaluating the clinical circumstances and considering the risks and benefits of continuation of therapy responsible for the cardiac dysfunction.”

“I want to emphasize the importance of accepting and managing cardiovascular risk in patients priors to and during potentially cardiotoxic therapy. To optimize cardiologic and oncologic outcomes, we need to avoid or minimize treatment interruptions of life-saving therapy, and mitigate cardiac events with aggressive cardiovascular risk-factor modification,” Dr. Liu said.

She called for development of better risk stratification tools to tailor cardiac surveillance during therapy, based on both patient-specific and treatment-specific risk factors.

Dr. Liu reported nothing to disclose. Dr. Nguyen reported consulting fees/honoraria from Astellas, Augmenix, Blue Earth Diagnostics. Cota, Dendreon, Ferring Pharmaceuticals. GenomeDx, Janssen, and Nanobiotix.

WASHINGTON – Oncologists and cardiologists need to work hand-in-hand when managing the care of women with breast cancer whose treatment plan includes cardiotoxic therapies and breast irradiation, reported specialists.

Neil Osterweil/MDedge News

Depending on the cancer subtype, women with breast cancer may receive chemotherapy with a cardiotoxic anthracycline such as doxorubicin or epirubicin, or a HER2-targeted agent such as trastuzumab (Herceptin), pertuzumab (Perjeta), or ado-trastuzumab emtansine (Kadcyla).

“The cardiotoxicity related to breast cancer has been a well publicized issue, and chances are your patients know about it and are concerned as well,” Jennifer E. Liu, MD, director of cardiovascular laboratories at Memorial Sloan Kettering Cancer Center in New York, said at the American College of Cardiology’s Advancing the Cardiovascular Care of the Oncology Patient meeting.
 

Anthracyclines, trastuzumab, and HF

In large adjuvant therapy trials of anthracyclines and trastuzumab in women with breast cancer, doxorubicin alone was associated with an asymptomatic decline in left ventricular ejection fraction (LVEF) of 4% to 11%, and a less than 1% incidence of heart failure (HF), Dr. Liu noted.

When patients received an anthracycline followed by trastuzumab, the incidence of asymptomatic LVEF decline ranged from 4% to 19%, the incidence of clinical HF was 2% to 4%, and the rate of trastuzumab interruption for cardiac adverse events ranged from 5% to 18%.

In comparison, in trials with trastuzumab in combination therapy that did not contain an anthracycline, the risk of cardiovascular complications was lower, with asymptomatic decline in LVEF ranging from 3.2% to 9.4%, and class III/IV HF occurring in just 0.5% of patients. In trials combining trastuzumab and pertuzumab, there were no increases in cardiac toxicity over trastuzumab alone.

Although with longer follow-up, the approximately 4% rate of HF in patients treated with anthracycline-based chemotherapy, paclitaxel, and trastuzumab in the NSABP B-31 trial has not changed significantly; retrospective claims-based studies reflecting daily practice have shown significantly higher rates of HF and or cardiomyopathy, Dr. Liu said.

She cited a 2012 study showing that among 45,537 women with a mean age of 76 years who were treated for breast cancer, the 3-year incidence rates of HF and/or cardiomyopathy were 32% for patients treated with trastuzumab alone, and 41.9% for those treated with an anthracycline followed by trastuzumab. Other, smaller studies also showed lower but significantly elevated risks for the drugs.

The discrepancy between clinical trial and “real world” results may be chalked up to the fact that claims-based data rely on diagnostic codes that may not accurately reflect the actual cardiac diagnosis, and by the fact that clinical trials have strict entry criteria that exclude patients with cardiovascular disease, she said.
 

Radiation risks

Radiation therapy is associated with a more than 7% increase in major coronary events per Gy of mean heart dose, Dr. Liu noted, citing a 2013 study (N Engl J Med. 2013;368:987-98).

Paul Nguyen, MD, a radiation oncologist at the Dana-Farber/Brigham and Women’s Cancer Center in Boston, said that risk factors for radiation-induced heart disease include anterior or left chest irradiation, cumulative doses above 30 Gy, patient age younger than 50 years, doses of more than 2 Gy per fraction, presence and extent of tumor in or near the heart, lack of radiation shielding, concomitant chemotherapy (especially with anthracyclines), and preexisting cardiovascular disease or risk factors.

Neil Osterweil/MDedge News

Treatment options for LVEF decline

The package insert for trastuzumab recommends withholding the drug for a minimum of 4 weeks if the patient has a 16% or greater decline in LVEF from baseline, or a 10% or greater decline from baseline to below the lower limit of normal. The insert recommends LVEF monitoring every 3 or 4 weeks, and says that trastuzumab can be resumed if LVEF improves to above the lower limit of normal with an absolute decrease from baseline of not more than 15%. The insert also states, however, that “the safety of continuation or resumption of trastuzumab in patients with trastuzumab induced LV dysfunction has never been studied, “ Dr. Liu noted.

She cited an American Society of Clinical Oncology guideline on the prevention and monitoring of cardiac dysfunction in survivors of adult cancers, which states in part that the decision to continue or discontinue cancer therapy in patients with evidence of cardiac dysfunction “made by the oncologist, should be informed by close collaboration with a cardiologist, fully evaluating the clinical circumstances and considering the risks and benefits of continuation of therapy responsible for the cardiac dysfunction.”

“I want to emphasize the importance of accepting and managing cardiovascular risk in patients priors to and during potentially cardiotoxic therapy. To optimize cardiologic and oncologic outcomes, we need to avoid or minimize treatment interruptions of life-saving therapy, and mitigate cardiac events with aggressive cardiovascular risk-factor modification,” Dr. Liu said.

She called for development of better risk stratification tools to tailor cardiac surveillance during therapy, based on both patient-specific and treatment-specific risk factors.

Dr. Liu reported nothing to disclose. Dr. Nguyen reported consulting fees/honoraria from Astellas, Augmenix, Blue Earth Diagnostics. Cota, Dendreon, Ferring Pharmaceuticals. GenomeDx, Janssen, and Nanobiotix.

WASHINGTON – Oncologists and cardiologists need to work hand-in-hand when managing the care of women with breast cancer whose treatment plan includes cardiotoxic therapies and breast irradiation, reported specialists.

Neil Osterweil/MDedge News

Depending on the cancer subtype, women with breast cancer may receive chemotherapy with a cardiotoxic anthracycline such as doxorubicin or epirubicin, or a HER2-targeted agent such as trastuzumab (Herceptin), pertuzumab (Perjeta), or ado-trastuzumab emtansine (Kadcyla).

“The cardiotoxicity related to breast cancer has been a well publicized issue, and chances are your patients know about it and are concerned as well,” Jennifer E. Liu, MD, director of cardiovascular laboratories at Memorial Sloan Kettering Cancer Center in New York, said at the American College of Cardiology’s Advancing the Cardiovascular Care of the Oncology Patient meeting.
 

Anthracyclines, trastuzumab, and HF

In large adjuvant therapy trials of anthracyclines and trastuzumab in women with breast cancer, doxorubicin alone was associated with an asymptomatic decline in left ventricular ejection fraction (LVEF) of 4% to 11%, and a less than 1% incidence of heart failure (HF), Dr. Liu noted.

When patients received an anthracycline followed by trastuzumab, the incidence of asymptomatic LVEF decline ranged from 4% to 19%, the incidence of clinical HF was 2% to 4%, and the rate of trastuzumab interruption for cardiac adverse events ranged from 5% to 18%.

In comparison, in trials with trastuzumab in combination therapy that did not contain an anthracycline, the risk of cardiovascular complications was lower, with asymptomatic decline in LVEF ranging from 3.2% to 9.4%, and class III/IV HF occurring in just 0.5% of patients. In trials combining trastuzumab and pertuzumab, there were no increases in cardiac toxicity over trastuzumab alone.

Although with longer follow-up, the approximately 4% rate of HF in patients treated with anthracycline-based chemotherapy, paclitaxel, and trastuzumab in the NSABP B-31 trial has not changed significantly; retrospective claims-based studies reflecting daily practice have shown significantly higher rates of HF and or cardiomyopathy, Dr. Liu said.

She cited a 2012 study showing that among 45,537 women with a mean age of 76 years who were treated for breast cancer, the 3-year incidence rates of HF and/or cardiomyopathy were 32% for patients treated with trastuzumab alone, and 41.9% for those treated with an anthracycline followed by trastuzumab. Other, smaller studies also showed lower but significantly elevated risks for the drugs.

The discrepancy between clinical trial and “real world” results may be chalked up to the fact that claims-based data rely on diagnostic codes that may not accurately reflect the actual cardiac diagnosis, and by the fact that clinical trials have strict entry criteria that exclude patients with cardiovascular disease, she said.
 

Radiation risks

Radiation therapy is associated with a more than 7% increase in major coronary events per Gy of mean heart dose, Dr. Liu noted, citing a 2013 study (N Engl J Med. 2013;368:987-98).

Paul Nguyen, MD, a radiation oncologist at the Dana-Farber/Brigham and Women’s Cancer Center in Boston, said that risk factors for radiation-induced heart disease include anterior or left chest irradiation, cumulative doses above 30 Gy, patient age younger than 50 years, doses of more than 2 Gy per fraction, presence and extent of tumor in or near the heart, lack of radiation shielding, concomitant chemotherapy (especially with anthracyclines), and preexisting cardiovascular disease or risk factors.

Neil Osterweil/MDedge News

Treatment options for LVEF decline

The package insert for trastuzumab recommends withholding the drug for a minimum of 4 weeks if the patient has a 16% or greater decline in LVEF from baseline, or a 10% or greater decline from baseline to below the lower limit of normal. The insert recommends LVEF monitoring every 3 or 4 weeks, and says that trastuzumab can be resumed if LVEF improves to above the lower limit of normal with an absolute decrease from baseline of not more than 15%. The insert also states, however, that “the safety of continuation or resumption of trastuzumab in patients with trastuzumab induced LV dysfunction has never been studied, “ Dr. Liu noted.

She cited an American Society of Clinical Oncology guideline on the prevention and monitoring of cardiac dysfunction in survivors of adult cancers, which states in part that the decision to continue or discontinue cancer therapy in patients with evidence of cardiac dysfunction “made by the oncologist, should be informed by close collaboration with a cardiologist, fully evaluating the clinical circumstances and considering the risks and benefits of continuation of therapy responsible for the cardiac dysfunction.”

“I want to emphasize the importance of accepting and managing cardiovascular risk in patients priors to and during potentially cardiotoxic therapy. To optimize cardiologic and oncologic outcomes, we need to avoid or minimize treatment interruptions of life-saving therapy, and mitigate cardiac events with aggressive cardiovascular risk-factor modification,” Dr. Liu said.

She called for development of better risk stratification tools to tailor cardiac surveillance during therapy, based on both patient-specific and treatment-specific risk factors.

Dr. Liu reported nothing to disclose. Dr. Nguyen reported consulting fees/honoraria from Astellas, Augmenix, Blue Earth Diagnostics. Cota, Dendreon, Ferring Pharmaceuticals. GenomeDx, Janssen, and Nanobiotix.

A new single-surgeon study suggests that the experience gained from performing more than 60 robot-assisted thoracoscopic (RATS) pulmonary lobectomies could allow surgeons to reach “mastery” and shave about 90 minutes off adjusted operating time.

Master Video/Shutterstock

The findings provide “further support to the adaptation of formalized robotic training and credentialing procedures,” wrote the authors of the retrospective, single-center study, which was presented at the 2018 Academic Surgical Congress and published in Surgery.

According to the study authors, advantages of robotic surgery, compared with thoracoscopic surgery, include “3-dimensional visualization, enhanced maneuverability in small spaces, and the ease of the hilar and mediastinal dissection. Disadvantages include the lack of haptic feedback, increased cost, and increased operative time.”

In the new study, the authors, led by thoracic surgeon Brian N. Arnold, MD, of Yale University, New Haven, Conn., attempted to quantify the learning curve in RATS pulmonary lobectomies by using a more “statistically rigorous” technique than previous studies.

The study tracked 101 of 116 consecutive patients who underwent RATS pulmonary lobectomy at a single unnamed center from 2010 to 2016. Some patients, such as those who underwent a right middle lobectomy that is considered an easier procedure, were excluded. All patients were treated by the same unidentified surgeon.

Researchers identified three phases of the RATS learning curve: cases 1-22, cases 23-63, and cases 64-101.

On average, the patients were aged 69 years; 52% were female. Overall, a third of the patients developed complications.

After controlling for various factors, the researchers found that adjusted operating time and estimated blood loss were statistically different between the first and second phases (P less than .05 and P = .016, respectively). They were also different between the first and third phases (P less than .05 and P = .006, respectively).

Specifically, operating time in the first phase was a mean of 256 minutes versus 195 minutes in the second phase (P = .0002) and 168 minutes in the third phase (P less than .0001). Blood loss was 200 mL (interquartile range, 150-300 mL) in the first phase versus 150 mL (IQR, 75-200 mL; P = .0219) in the second phase and 150 mL (IQR, 100-150 mL; P = .0096) in the third phase.

The researchers found no statistically significant evidence that the surgeon’s growing experience affected length of stay, postoperative complications, chest tube duration, or conversion rate. No patients died within 30 or 90 days.

The researchers also compared operating time, length of stay, and complication rate in the RATS procedures with those in video-assisted thoracoscopic (VATS) lobectomies performed at the same institution from 2008 to 2014. There was only a statistically significant difference in mean operating time (RATS, 319 minutes; VATS, 253 minutes; P less than .001)

The study authors noted that the surgeon had extensive previous experience with VATS procedures. “Therefore, for better or for worse, the results may not apply to surgeons without this experience who move from open surgery to robotic surgery.”

Study funding and disclosures were not reported.

SOURCE: Arnold BN et al. Surgery. 2019 Feb;165(2):450-4.

A new single-surgeon study suggests that the experience gained from performing more than 60 robot-assisted thoracoscopic (RATS) pulmonary lobectomies could allow surgeons to reach “mastery” and shave about 90 minutes off adjusted operating time.

Master Video/Shutterstock

The findings provide “further support to the adaptation of formalized robotic training and credentialing procedures,” wrote the authors of the retrospective, single-center study, which was presented at the 2018 Academic Surgical Congress and published in Surgery.

According to the study authors, advantages of robotic surgery, compared with thoracoscopic surgery, include “3-dimensional visualization, enhanced maneuverability in small spaces, and the ease of the hilar and mediastinal dissection. Disadvantages include the lack of haptic feedback, increased cost, and increased operative time.”

In the new study, the authors, led by thoracic surgeon Brian N. Arnold, MD, of Yale University, New Haven, Conn., attempted to quantify the learning curve in RATS pulmonary lobectomies by using a more “statistically rigorous” technique than previous studies.

The study tracked 101 of 116 consecutive patients who underwent RATS pulmonary lobectomy at a single unnamed center from 2010 to 2016. Some patients, such as those who underwent a right middle lobectomy that is considered an easier procedure, were excluded. All patients were treated by the same unidentified surgeon.

Researchers identified three phases of the RATS learning curve: cases 1-22, cases 23-63, and cases 64-101.

On average, the patients were aged 69 years; 52% were female. Overall, a third of the patients developed complications.

After controlling for various factors, the researchers found that adjusted operating time and estimated blood loss were statistically different between the first and second phases (P less than .05 and P = .016, respectively). They were also different between the first and third phases (P less than .05 and P = .006, respectively).

Specifically, operating time in the first phase was a mean of 256 minutes versus 195 minutes in the second phase (P = .0002) and 168 minutes in the third phase (P less than .0001). Blood loss was 200 mL (interquartile range, 150-300 mL) in the first phase versus 150 mL (IQR, 75-200 mL; P = .0219) in the second phase and 150 mL (IQR, 100-150 mL; P = .0096) in the third phase.

The researchers found no statistically significant evidence that the surgeon’s growing experience affected length of stay, postoperative complications, chest tube duration, or conversion rate. No patients died within 30 or 90 days.

The researchers also compared operating time, length of stay, and complication rate in the RATS procedures with those in video-assisted thoracoscopic (VATS) lobectomies performed at the same institution from 2008 to 2014. There was only a statistically significant difference in mean operating time (RATS, 319 minutes; VATS, 253 minutes; P less than .001)

The study authors noted that the surgeon had extensive previous experience with VATS procedures. “Therefore, for better or for worse, the results may not apply to surgeons without this experience who move from open surgery to robotic surgery.”

Study funding and disclosures were not reported.

SOURCE: Arnold BN et al. Surgery. 2019 Feb;165(2):450-4.

A new single-surgeon study suggests that the experience gained from performing more than 60 robot-assisted thoracoscopic (RATS) pulmonary lobectomies could allow surgeons to reach “mastery” and shave about 90 minutes off adjusted operating time.

Master Video/Shutterstock

The findings provide “further support to the adaptation of formalized robotic training and credentialing procedures,” wrote the authors of the retrospective, single-center study, which was presented at the 2018 Academic Surgical Congress and published in Surgery.

According to the study authors, advantages of robotic surgery, compared with thoracoscopic surgery, include “3-dimensional visualization, enhanced maneuverability in small spaces, and the ease of the hilar and mediastinal dissection. Disadvantages include the lack of haptic feedback, increased cost, and increased operative time.”

In the new study, the authors, led by thoracic surgeon Brian N. Arnold, MD, of Yale University, New Haven, Conn., attempted to quantify the learning curve in RATS pulmonary lobectomies by using a more “statistically rigorous” technique than previous studies.

The study tracked 101 of 116 consecutive patients who underwent RATS pulmonary lobectomy at a single unnamed center from 2010 to 2016. Some patients, such as those who underwent a right middle lobectomy that is considered an easier procedure, were excluded. All patients were treated by the same unidentified surgeon.

Researchers identified three phases of the RATS learning curve: cases 1-22, cases 23-63, and cases 64-101.

On average, the patients were aged 69 years; 52% were female. Overall, a third of the patients developed complications.

After controlling for various factors, the researchers found that adjusted operating time and estimated blood loss were statistically different between the first and second phases (P less than .05 and P = .016, respectively). They were also different between the first and third phases (P less than .05 and P = .006, respectively).

Specifically, operating time in the first phase was a mean of 256 minutes versus 195 minutes in the second phase (P = .0002) and 168 minutes in the third phase (P less than .0001). Blood loss was 200 mL (interquartile range, 150-300 mL) in the first phase versus 150 mL (IQR, 75-200 mL; P = .0219) in the second phase and 150 mL (IQR, 100-150 mL; P = .0096) in the third phase.

The researchers found no statistically significant evidence that the surgeon’s growing experience affected length of stay, postoperative complications, chest tube duration, or conversion rate. No patients died within 30 or 90 days.

The researchers also compared operating time, length of stay, and complication rate in the RATS procedures with those in video-assisted thoracoscopic (VATS) lobectomies performed at the same institution from 2008 to 2014. There was only a statistically significant difference in mean operating time (RATS, 319 minutes; VATS, 253 minutes; P less than .001)

The study authors noted that the surgeon had extensive previous experience with VATS procedures. “Therefore, for better or for worse, the results may not apply to surgeons without this experience who move from open surgery to robotic surgery.”

Study funding and disclosures were not reported.

SOURCE: Arnold BN et al. Surgery. 2019 Feb;165(2):450-4.

The Food and Drug Administration issued a letter on Feb. 4, 2019, to health care providers regarding interim results from a postapproval study for Abiomed’s Impella RP System because these results appear to have a higher mortality rate than was seen in premarket clinical studies.

The Impella RP system was approved in 2017 to help patients maintain stable heart function for up to 14 days without open chest surgery. As a condition of its approval, the FDA mandated Abiomed to perform a postapproval study (PAS); this study reflects use in a broader population than the premarket studies, which adhered to stricter inclusion and exclusion criteria.

Earlier in January, Abiomed submitted data to the FDA suggesting that differences in preimplant characteristics between patients in the PAS and those in the premarket clinical studies may explain the difference in mortality. Specifically, 16 of the 23 patients enrolled in the PAS would not have met the enrollment criteria for the premarket clinical studies because they were in cardiogenic shock for longer than 48 hours, experienced an in-hospital cardiac arrest, were treated with an intra-aortic balloon pump, or suffered a preimplant hypoxic or ischemic neurologic event.

“Although the FDA is concerned about the high mortality rate from the interim PAS results,” they wrote in the letter, which is available on the FDA website, “we believe that, when the device is used for the currently approved indication in appropriately selected patients, the benefits of the Impella RP system continue to outweigh the risks.”

[email protected]

The Food and Drug Administration issued a letter on Feb. 4, 2019, to health care providers regarding interim results from a postapproval study for Abiomed’s Impella RP System because these results appear to have a higher mortality rate than was seen in premarket clinical studies.

The Impella RP system was approved in 2017 to help patients maintain stable heart function for up to 14 days without open chest surgery. As a condition of its approval, the FDA mandated Abiomed to perform a postapproval study (PAS); this study reflects use in a broader population than the premarket studies, which adhered to stricter inclusion and exclusion criteria.

Earlier in January, Abiomed submitted data to the FDA suggesting that differences in preimplant characteristics between patients in the PAS and those in the premarket clinical studies may explain the difference in mortality. Specifically, 16 of the 23 patients enrolled in the PAS would not have met the enrollment criteria for the premarket clinical studies because they were in cardiogenic shock for longer than 48 hours, experienced an in-hospital cardiac arrest, were treated with an intra-aortic balloon pump, or suffered a preimplant hypoxic or ischemic neurologic event.

“Although the FDA is concerned about the high mortality rate from the interim PAS results,” they wrote in the letter, which is available on the FDA website, “we believe that, when the device is used for the currently approved indication in appropriately selected patients, the benefits of the Impella RP system continue to outweigh the risks.”

[email protected]

The Food and Drug Administration issued a letter on Feb. 4, 2019, to health care providers regarding interim results from a postapproval study for Abiomed’s Impella RP System because these results appear to have a higher mortality rate than was seen in premarket clinical studies.

The Impella RP system was approved in 2017 to help patients maintain stable heart function for up to 14 days without open chest surgery. As a condition of its approval, the FDA mandated Abiomed to perform a postapproval study (PAS); this study reflects use in a broader population than the premarket studies, which adhered to stricter inclusion and exclusion criteria.

Earlier in January, Abiomed submitted data to the FDA suggesting that differences in preimplant characteristics between patients in the PAS and those in the premarket clinical studies may explain the difference in mortality. Specifically, 16 of the 23 patients enrolled in the PAS would not have met the enrollment criteria for the premarket clinical studies because they were in cardiogenic shock for longer than 48 hours, experienced an in-hospital cardiac arrest, were treated with an intra-aortic balloon pump, or suffered a preimplant hypoxic or ischemic neurologic event.

“Although the FDA is concerned about the high mortality rate from the interim PAS results,” they wrote in the letter, which is available on the FDA website, “we believe that, when the device is used for the currently approved indication in appropriately selected patients, the benefits of the Impella RP system continue to outweigh the risks.”

[email protected]

Family histories of psoriasis and of psoriatic arthritis have different effects on skin phenotypes, disease severity, and musculoskeletal features, the results of a retrospective cohort study suggest.

A family history of psoriasis was associated with younger onset of psoriatic disease and the presence of enthesitis, while by contrast, a family history of psoriatic arthritis (PsA) was associated with lower risk of plaque psoriasis and higher risk of deformities, according to Dilek Solmaz, MD, of the University of Ottawa and her coauthors, who reported their findings in Arthritis Care & Research.

“The link between family history of psoriasis/psoriatic arthritis and pustular/plaque phenotypes may point to a different genetic background and pathogenic mechanisms in these subsets,” the investigators wrote.

Most, if not all, previous studies evaluating family history have grouped psoriasis and PsA together, according to Dr. Solmaz and her colleagues, rather than looking at the individual effects of psoriasis or PsA family history that may lead to unique disease phenotypes, as was done in the present study.


The investigators based their retrospective analysis on patients recruited in a longitudinal, multicenter database in Turkey and Canada. The mean age of patients in the study was 48 years; nearly 65% were female.

Out of 1,393 patients in the database, 444 had a family history of psoriasis or PsA. That included 335 patients with a psoriasis-only family history and 74 with a family history of PsA; another 35 patients weren’t sure about having a family history of PsA or psoriasis and were left out of the analysis.

Plaque psoriasis was more common in individuals with a family history of only psoriasis, while pustular psoriasis was more common in those with a PsA family history, the investigators reported.

In multivariate analyses, having a family member with psoriasis was a risk factor for younger age of psoriasis onset (odds ratio, 0.976; 95% confidence interval, 0.964-0.989; P less than .001) as well as a higher risk for enthesitis (OR, 1.931; 95% CI, 1.276-2.922; P = .002) when compared against patients without a family history of psoriasis.

Patients with a family history of PsA were more likely to have deformities (OR, 2.557; 95% CI, 1.250-5.234; P less than .010) and lower risk of plaque-type psoriasis (OR, 0.417; 95% CI, 0.213-0.816; P less than .011) than patients without a family history of PsA.

Disease onset was earlier among patients with a family history of psoriasis at a mean of 28.1 years versus 31.9 years for those with a family history of PsA (P less than .001).

Dr. Solmaz and her colleagues reported no conflicts of interest related to the research, which was supported in part by the Turkish Society for Rheumatology, the Scientific and Technological Research Council of Turkey, and Union Chimique Belge.

SOURCE: Solmaz D et al. Arthritis Care Res (Hoboken). 2019 Jan 25. doi: 10.1002/acr.23836.

Family histories of psoriasis and of psoriatic arthritis have different effects on skin phenotypes, disease severity, and musculoskeletal features, the results of a retrospective cohort study suggest.

A family history of psoriasis was associated with younger onset of psoriatic disease and the presence of enthesitis, while by contrast, a family history of psoriatic arthritis (PsA) was associated with lower risk of plaque psoriasis and higher risk of deformities, according to Dilek Solmaz, MD, of the University of Ottawa and her coauthors, who reported their findings in Arthritis Care & Research.

“The link between family history of psoriasis/psoriatic arthritis and pustular/plaque phenotypes may point to a different genetic background and pathogenic mechanisms in these subsets,” the investigators wrote.

Most, if not all, previous studies evaluating family history have grouped psoriasis and PsA together, according to Dr. Solmaz and her colleagues, rather than looking at the individual effects of psoriasis or PsA family history that may lead to unique disease phenotypes, as was done in the present study.


The investigators based their retrospective analysis on patients recruited in a longitudinal, multicenter database in Turkey and Canada. The mean age of patients in the study was 48 years; nearly 65% were female.

Out of 1,393 patients in the database, 444 had a family history of psoriasis or PsA. That included 335 patients with a psoriasis-only family history and 74 with a family history of PsA; another 35 patients weren’t sure about having a family history of PsA or psoriasis and were left out of the analysis.

Plaque psoriasis was more common in individuals with a family history of only psoriasis, while pustular psoriasis was more common in those with a PsA family history, the investigators reported.

In multivariate analyses, having a family member with psoriasis was a risk factor for younger age of psoriasis onset (odds ratio, 0.976; 95% confidence interval, 0.964-0.989; P less than .001) as well as a higher risk for enthesitis (OR, 1.931; 95% CI, 1.276-2.922; P = .002) when compared against patients without a family history of psoriasis.

Patients with a family history of PsA were more likely to have deformities (OR, 2.557; 95% CI, 1.250-5.234; P less than .010) and lower risk of plaque-type psoriasis (OR, 0.417; 95% CI, 0.213-0.816; P less than .011) than patients without a family history of PsA.

Disease onset was earlier among patients with a family history of psoriasis at a mean of 28.1 years versus 31.9 years for those with a family history of PsA (P less than .001).

Dr. Solmaz and her colleagues reported no conflicts of interest related to the research, which was supported in part by the Turkish Society for Rheumatology, the Scientific and Technological Research Council of Turkey, and Union Chimique Belge.

SOURCE: Solmaz D et al. Arthritis Care Res (Hoboken). 2019 Jan 25. doi: 10.1002/acr.23836.

Family histories of psoriasis and of psoriatic arthritis have different effects on skin phenotypes, disease severity, and musculoskeletal features, the results of a retrospective cohort study suggest.

A family history of psoriasis was associated with younger onset of psoriatic disease and the presence of enthesitis, while by contrast, a family history of psoriatic arthritis (PsA) was associated with lower risk of plaque psoriasis and higher risk of deformities, according to Dilek Solmaz, MD, of the University of Ottawa and her coauthors, who reported their findings in Arthritis Care & Research.

“The link between family history of psoriasis/psoriatic arthritis and pustular/plaque phenotypes may point to a different genetic background and pathogenic mechanisms in these subsets,” the investigators wrote.

Most, if not all, previous studies evaluating family history have grouped psoriasis and PsA together, according to Dr. Solmaz and her colleagues, rather than looking at the individual effects of psoriasis or PsA family history that may lead to unique disease phenotypes, as was done in the present study.


The investigators based their retrospective analysis on patients recruited in a longitudinal, multicenter database in Turkey and Canada. The mean age of patients in the study was 48 years; nearly 65% were female.

Out of 1,393 patients in the database, 444 had a family history of psoriasis or PsA. That included 335 patients with a psoriasis-only family history and 74 with a family history of PsA; another 35 patients weren’t sure about having a family history of PsA or psoriasis and were left out of the analysis.

Plaque psoriasis was more common in individuals with a family history of only psoriasis, while pustular psoriasis was more common in those with a PsA family history, the investigators reported.

In multivariate analyses, having a family member with psoriasis was a risk factor for younger age of psoriasis onset (odds ratio, 0.976; 95% confidence interval, 0.964-0.989; P less than .001) as well as a higher risk for enthesitis (OR, 1.931; 95% CI, 1.276-2.922; P = .002) when compared against patients without a family history of psoriasis.

Patients with a family history of PsA were more likely to have deformities (OR, 2.557; 95% CI, 1.250-5.234; P less than .010) and lower risk of plaque-type psoriasis (OR, 0.417; 95% CI, 0.213-0.816; P less than .011) than patients without a family history of PsA.

Disease onset was earlier among patients with a family history of psoriasis at a mean of 28.1 years versus 31.9 years for those with a family history of PsA (P less than .001).

Dr. Solmaz and her colleagues reported no conflicts of interest related to the research, which was supported in part by the Turkish Society for Rheumatology, the Scientific and Technological Research Council of Turkey, and Union Chimique Belge.

SOURCE: Solmaz D et al. Arthritis Care Res (Hoboken). 2019 Jan 25. doi: 10.1002/acr.23836.

In this episode, Gary H. Lyman, MD (https://bitly.is/2UJzUly) joins David Henry, MD, (http://bit.ly/2MFDfzm) to talk about biosimilars. 

Dr. Lyman talks about the definition of biosimilars, how they are made, which are approved, and which ones are on the market. 

He also talks about extrapolation and interchangeability as well as where some biosimilars stand in both ASCO and NCCN guidelines for patients who are going into supportive care. 

And Ilana Yurkiewicz, MD (https://stanford.io/2RXPixR), talks about what the word "cure" means to you compared to what it means to patients in a world with OS, PFS, DFS, CR, etc. (26:35). 

Subscribe here:

Apple Podcasts
Google Podcasts

Show Notes

By Hitomi Hosoya, MD, PhD

- Biosimilars are biologic products that are highly similar to the reference products with no clinically meaningful difference in terms of safety, efficacy, purity, and potency.

- Unlike “generic” products, biosimilars are produced in living systems, therefore they cannot be replicated identically. 

- The Food and Drug Administration encourages companies to produce biosimilars as a patent expires on the original product.

- For approval, the FDA requires largely preclinical data; amino acid sequence and molecular structures, pharmacodynamics and pharmacokinetic data in animal models and humans. Also, no greater immunogenicity should be demonstrated.

- Large randomized trials are not usually required for approval of biosimilars as there is already data on the original product. Post-marketing surveillance is important.

- 14 biosimilars have already been approved by the FDA.

- Interchangeable designation of biosimilars is yet to come.

- At this early stage of biosimilar marketing, we see a 10%-11% cost reduction. This is expected to increase as the market expands.

References:

 JAMA Oncol.2018 Feb 1;4(2):241-247

 JCSO 2018;16(6):e283-e289.

Contact us: [email protected]

MDedge Hematology/Oncology Twitter: @MDedgeHemOnc

Ilana Yurkiewicz Twitter: @ilanayurkiewicz

In this episode, Gary H. Lyman, MD (https://bitly.is/2UJzUly) joins David Henry, MD, (http://bit.ly/2MFDfzm) to talk about biosimilars. 

Dr. Lyman talks about the definition of biosimilars, how they are made, which are approved, and which ones are on the market. 

He also talks about extrapolation and interchangeability as well as where some biosimilars stand in both ASCO and NCCN guidelines for patients who are going into supportive care. 

And Ilana Yurkiewicz, MD (https://stanford.io/2RXPixR), talks about what the word "cure" means to you compared to what it means to patients in a world with OS, PFS, DFS, CR, etc. (26:35). 

Subscribe here:

Apple Podcasts
Google Podcasts

Show Notes

By Hitomi Hosoya, MD, PhD

- Biosimilars are biologic products that are highly similar to the reference products with no clinically meaningful difference in terms of safety, efficacy, purity, and potency.

- Unlike “generic” products, biosimilars are produced in living systems, therefore they cannot be replicated identically. 

- The Food and Drug Administration encourages companies to produce biosimilars as a patent expires on the original product.

- For approval, the FDA requires largely preclinical data; amino acid sequence and molecular structures, pharmacodynamics and pharmacokinetic data in animal models and humans. Also, no greater immunogenicity should be demonstrated.

- Large randomized trials are not usually required for approval of biosimilars as there is already data on the original product. Post-marketing surveillance is important.

- 14 biosimilars have already been approved by the FDA.

- Interchangeable designation of biosimilars is yet to come.

- At this early stage of biosimilar marketing, we see a 10%-11% cost reduction. This is expected to increase as the market expands.

References:

 JAMA Oncol.2018 Feb 1;4(2):241-247

 JCSO 2018;16(6):e283-e289.

Contact us: [email protected]

MDedge Hematology/Oncology Twitter: @MDedgeHemOnc

Ilana Yurkiewicz Twitter: @ilanayurkiewicz

In this episode, Gary H. Lyman, MD (https://bitly.is/2UJzUly) joins David Henry, MD, (http://bit.ly/2MFDfzm) to talk about biosimilars. 

Dr. Lyman talks about the definition of biosimilars, how they are made, which are approved, and which ones are on the market. 

He also talks about extrapolation and interchangeability as well as where some biosimilars stand in both ASCO and NCCN guidelines for patients who are going into supportive care. 

And Ilana Yurkiewicz, MD (https://stanford.io/2RXPixR), talks about what the word "cure" means to you compared to what it means to patients in a world with OS, PFS, DFS, CR, etc. (26:35). 

Subscribe here:

Apple Podcasts
Google Podcasts

Show Notes

By Hitomi Hosoya, MD, PhD

- Biosimilars are biologic products that are highly similar to the reference products with no clinically meaningful difference in terms of safety, efficacy, purity, and potency.

- Unlike “generic” products, biosimilars are produced in living systems, therefore they cannot be replicated identically. 

- The Food and Drug Administration encourages companies to produce biosimilars as a patent expires on the original product.

- For approval, the FDA requires largely preclinical data; amino acid sequence and molecular structures, pharmacodynamics and pharmacokinetic data in animal models and humans. Also, no greater immunogenicity should be demonstrated.

- Large randomized trials are not usually required for approval of biosimilars as there is already data on the original product. Post-marketing surveillance is important.

- 14 biosimilars have already been approved by the FDA.

- Interchangeable designation of biosimilars is yet to come.

- At this early stage of biosimilar marketing, we see a 10%-11% cost reduction. This is expected to increase as the market expands.

References:

 JAMA Oncol.2018 Feb 1;4(2):241-247

 JCSO 2018;16(6):e283-e289.

Contact us: [email protected]

MDedge Hematology/Oncology Twitter: @MDedgeHemOnc

Ilana Yurkiewicz Twitter: @ilanayurkiewicz

HIV/AIDs, pediatric cancer research, abortion, prescription drug prices, and preexisting conditions were among the health care highlights in President Donald Trump’s second State of the Union Address. Also today, public health experts have attributed to the opioid epidemic the recent alarming rise in the rate of hepatitis C virus infection. medical advice prompts unneeded emergency visits by patients with atrial fibrillation, and legal marijuana may complicate substance use disorder treatment in adolescents.

Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify

HIV/AIDs, pediatric cancer research, abortion, prescription drug prices, and preexisting conditions were among the health care highlights in President Donald Trump’s second State of the Union Address. Also today, public health experts have attributed to the opioid epidemic the recent alarming rise in the rate of hepatitis C virus infection. medical advice prompts unneeded emergency visits by patients with atrial fibrillation, and legal marijuana may complicate substance use disorder treatment in adolescents.

Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify

HIV/AIDs, pediatric cancer research, abortion, prescription drug prices, and preexisting conditions were among the health care highlights in President Donald Trump’s second State of the Union Address. Also today, public health experts have attributed to the opioid epidemic the recent alarming rise in the rate of hepatitis C virus infection. medical advice prompts unneeded emergency visits by patients with atrial fibrillation, and legal marijuana may complicate substance use disorder treatment in adolescents.

Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify

The opioid emergency claims > 130 lives every day, says Health Resources and Services Administration (HRSA) Administrator George Sigounas, MS, PhD. By strengthening the health workforce, HRSA hopes to ensure that there are enough clinicians to cope with the growing epidemic.

That is why, in December 2018, HRSA launched a program that Sigounas says is “critical to HHS’ response to the opioid crisis.” The new National Health Service Corps (NHSC) Substance Use Disorder (SUD) Workforce Loan Repayment Program (LRP) will provide eligible health care clinicians with student loan repayment assistance in exchange for service in underserved communities.

A clinician may be awarded up to $75,000 for 3 years of full-time service at an NHSC-approved SUD site and $37,500 for part-time. Eligible providers use evidence-based treatment models to treat SUDs and must be trained and licensed to provide SUD treatment at NHSC-approved facilities. Qualification criteria are available at https://nhsc.hrsa.gov/loan-repayment/nhsc-sud-workforce-loan-repayment-program.html.

Clinicians also can apply to the NHSC Loan Repayment Program for primary care, dental, and behavioral health professionals. If accepted, they may receive up to $50,000 for 2 years of full-time service, $25,000 for part-time.

Military reservists also are eligible to participate in either the NHSC LRP or the NHSC Students to Service Loan Repayment Program. (Military training or service will not satisfy the NHSC service commitment.) More information is available at https://nhsc.hrsa.gov/loan-repayment/military-reservists.html.

Clinicians can only apply for 1 program. Sigounas says, “I am grateful to the clinicians who will apply and are looking to make a positive impact on patients, caregivers, and hard-hit communities throughout the country.”

The opioid emergency claims > 130 lives every day, says Health Resources and Services Administration (HRSA) Administrator George Sigounas, MS, PhD. By strengthening the health workforce, HRSA hopes to ensure that there are enough clinicians to cope with the growing epidemic.

That is why, in December 2018, HRSA launched a program that Sigounas says is “critical to HHS’ response to the opioid crisis.” The new National Health Service Corps (NHSC) Substance Use Disorder (SUD) Workforce Loan Repayment Program (LRP) will provide eligible health care clinicians with student loan repayment assistance in exchange for service in underserved communities.

A clinician may be awarded up to $75,000 for 3 years of full-time service at an NHSC-approved SUD site and $37,500 for part-time. Eligible providers use evidence-based treatment models to treat SUDs and must be trained and licensed to provide SUD treatment at NHSC-approved facilities. Qualification criteria are available at https://nhsc.hrsa.gov/loan-repayment/nhsc-sud-workforce-loan-repayment-program.html.

Clinicians also can apply to the NHSC Loan Repayment Program for primary care, dental, and behavioral health professionals. If accepted, they may receive up to $50,000 for 2 years of full-time service, $25,000 for part-time.

Military reservists also are eligible to participate in either the NHSC LRP or the NHSC Students to Service Loan Repayment Program. (Military training or service will not satisfy the NHSC service commitment.) More information is available at https://nhsc.hrsa.gov/loan-repayment/military-reservists.html.

Clinicians can only apply for 1 program. Sigounas says, “I am grateful to the clinicians who will apply and are looking to make a positive impact on patients, caregivers, and hard-hit communities throughout the country.”

The opioid emergency claims > 130 lives every day, says Health Resources and Services Administration (HRSA) Administrator George Sigounas, MS, PhD. By strengthening the health workforce, HRSA hopes to ensure that there are enough clinicians to cope with the growing epidemic.

That is why, in December 2018, HRSA launched a program that Sigounas says is “critical to HHS’ response to the opioid crisis.” The new National Health Service Corps (NHSC) Substance Use Disorder (SUD) Workforce Loan Repayment Program (LRP) will provide eligible health care clinicians with student loan repayment assistance in exchange for service in underserved communities.

A clinician may be awarded up to $75,000 for 3 years of full-time service at an NHSC-approved SUD site and $37,500 for part-time. Eligible providers use evidence-based treatment models to treat SUDs and must be trained and licensed to provide SUD treatment at NHSC-approved facilities. Qualification criteria are available at https://nhsc.hrsa.gov/loan-repayment/nhsc-sud-workforce-loan-repayment-program.html.

Clinicians also can apply to the NHSC Loan Repayment Program for primary care, dental, and behavioral health professionals. If accepted, they may receive up to $50,000 for 2 years of full-time service, $25,000 for part-time.

Military reservists also are eligible to participate in either the NHSC LRP or the NHSC Students to Service Loan Repayment Program. (Military training or service will not satisfy the NHSC service commitment.) More information is available at https://nhsc.hrsa.gov/loan-repayment/military-reservists.html.

Clinicians can only apply for 1 program. Sigounas says, “I am grateful to the clinicians who will apply and are looking to make a positive impact on patients, caregivers, and hard-hit communities throughout the country.”

Due to the dark and rapidly growing nodule, the FP immediately worried about melanoma.

He thought that he should biopsy the entire lesion with an elliptical excision, so he scheduled the patient for a biopsy during some protected surgical time later that week. The patient did not show up for this appointment. Several calls were placed, and she returned for the biopsy the following week. The FP performed a narrow margin (2 mm) elliptical excision oriented to match the lymphatic drainage of the arm. He closed the excision with a 2-layer closure. (See the Watch & Learn video on elliptical excision.) The pathology report confirmed that it was a nodular melanoma that was 8 mm in depth. This was clearly an aggressive tumor, so the patient was referred to Surgical Oncology for sentinel lymph node biopsy. One node was positive for metastasis.

After a wide excision with 2 cm margins by Surgical Oncology, the patient underwent a course of chemotherapy and remained disease free 2 years later. She was carefully monitored for metastasis and new primary lesions by a multidisciplinary team that included family medicine, dermatology, and oncology.

While this FP handled the case in an excellent matter, he was fortunate to have the skills and time to be able to perform a full elliptical excision. It’s important to note that a 6 mm punch biopsy or a deep shave biopsy (saucerization) at the base of the thickest portion of this tumor would almost certainly have provided the same diagnosis of melanoma and at least showed that the tumor was thicker than 4 mm (an important cut-off for management). This could have been done on the day of original presentation and might have avoided the problem of the patient not showing up for the next appointment or a long delay to see a dermatologist.

FPs should be empowered to perform biopsies on the most worrisome of lesions as these biopsies can save lives. While incomplete sampling can result in false negative results and misdiagnosis, the protection against this is to not accept a benign pathology report in what appears to be an obvious malignancy. If this occurs, the next step is always complete excision. Having options and understanding potential sampling errors can help FPs diagnose patients more rapidly. This is essential when cancers are rapidly growing and delays of months for surgical appointments or referrals to specialists can worsen a prognosis.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Melanoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine. 3rd ed. New York, NY: McGraw-Hill; 2019:1112-1123.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com

Due to the dark and rapidly growing nodule, the FP immediately worried about melanoma.

He thought that he should biopsy the entire lesion with an elliptical excision, so he scheduled the patient for a biopsy during some protected surgical time later that week. The patient did not show up for this appointment. Several calls were placed, and she returned for the biopsy the following week. The FP performed a narrow margin (2 mm) elliptical excision oriented to match the lymphatic drainage of the arm. He closed the excision with a 2-layer closure. (See the Watch & Learn video on elliptical excision.) The pathology report confirmed that it was a nodular melanoma that was 8 mm in depth. This was clearly an aggressive tumor, so the patient was referred to Surgical Oncology for sentinel lymph node biopsy. One node was positive for metastasis.

After a wide excision with 2 cm margins by Surgical Oncology, the patient underwent a course of chemotherapy and remained disease free 2 years later. She was carefully monitored for metastasis and new primary lesions by a multidisciplinary team that included family medicine, dermatology, and oncology.

While this FP handled the case in an excellent matter, he was fortunate to have the skills and time to be able to perform a full elliptical excision. It’s important to note that a 6 mm punch biopsy or a deep shave biopsy (saucerization) at the base of the thickest portion of this tumor would almost certainly have provided the same diagnosis of melanoma and at least showed that the tumor was thicker than 4 mm (an important cut-off for management). This could have been done on the day of original presentation and might have avoided the problem of the patient not showing up for the next appointment or a long delay to see a dermatologist.

FPs should be empowered to perform biopsies on the most worrisome of lesions as these biopsies can save lives. While incomplete sampling can result in false negative results and misdiagnosis, the protection against this is to not accept a benign pathology report in what appears to be an obvious malignancy. If this occurs, the next step is always complete excision. Having options and understanding potential sampling errors can help FPs diagnose patients more rapidly. This is essential when cancers are rapidly growing and delays of months for surgical appointments or referrals to specialists can worsen a prognosis.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Melanoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine. 3rd ed. New York, NY: McGraw-Hill; 2019:1112-1123.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com

Due to the dark and rapidly growing nodule, the FP immediately worried about melanoma.

He thought that he should biopsy the entire lesion with an elliptical excision, so he scheduled the patient for a biopsy during some protected surgical time later that week. The patient did not show up for this appointment. Several calls were placed, and she returned for the biopsy the following week. The FP performed a narrow margin (2 mm) elliptical excision oriented to match the lymphatic drainage of the arm. He closed the excision with a 2-layer closure. (See the Watch & Learn video on elliptical excision.) The pathology report confirmed that it was a nodular melanoma that was 8 mm in depth. This was clearly an aggressive tumor, so the patient was referred to Surgical Oncology for sentinel lymph node biopsy. One node was positive for metastasis.

After a wide excision with 2 cm margins by Surgical Oncology, the patient underwent a course of chemotherapy and remained disease free 2 years later. She was carefully monitored for metastasis and new primary lesions by a multidisciplinary team that included family medicine, dermatology, and oncology.

While this FP handled the case in an excellent matter, he was fortunate to have the skills and time to be able to perform a full elliptical excision. It’s important to note that a 6 mm punch biopsy or a deep shave biopsy (saucerization) at the base of the thickest portion of this tumor would almost certainly have provided the same diagnosis of melanoma and at least showed that the tumor was thicker than 4 mm (an important cut-off for management). This could have been done on the day of original presentation and might have avoided the problem of the patient not showing up for the next appointment or a long delay to see a dermatologist.

FPs should be empowered to perform biopsies on the most worrisome of lesions as these biopsies can save lives. While incomplete sampling can result in false negative results and misdiagnosis, the protection against this is to not accept a benign pathology report in what appears to be an obvious malignancy. If this occurs, the next step is always complete excision. Having options and understanding potential sampling errors can help FPs diagnose patients more rapidly. This is essential when cancers are rapidly growing and delays of months for surgical appointments or referrals to specialists can worsen a prognosis.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Melanoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine. 3rd ed. New York, NY: McGraw-Hill; 2019:1112-1123.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com

Around three-quarters of people with type 2 diabetes mellitus (T2DM) who undergo Roux-en-Y gastric bypass experience remission of their disease within a year of the surgery, according to published findings from a population-based observational study. However, one in four of those people will have relapsed by 5 years, the authors noted.

Researchers looked at the effect of Roux-en-Y gastric bypass (RYGB) in 1,111 individuals with T2DM, compared with 1,074 controls who also had T2DM but did not undergo gastric bypass.

By 6 months after surgery, 65% of those who had undergone RYGB met the criteria for remission – defined as no use of glucose-lowering drugs and an HbA_1c below 48 mmol/mol (less than 6.5%) or metformin monotherapy with HbA_1c below 42 mmol/mol (less than 6.0%).

By 1 year, 74% of those who had surgery had achieved remission, and 73% of those remained in remission 5 years after surgery. However, at 2 years, 6% of those who had achieved remission in the first year had already relapsed; by 3 years, 12% had relapsed; and by 4 years, 18% had relapsed. By 5 years after surgery, a total of 27% of those who originally achieved remission in the first year had relapsed.

The overall prevalence of remission remained at 70% for every 6-month period during the duration of the study, which suggests that, although some achieved remission early and then relapsed, others achieved remission later.

Individuals who were aged 50-60 years were 12% less likely to achieve remission, compared with those who were younger than 40 years, whereas those aged 60 years or more were 17% less likely to achieve remission.

A longer duration of diabetes was also associated with a lower likelihood of achieving remission after RYGB; individuals who had had diabetes for 8 years or more had a 27% lower likelihood of remission, compared with those who had had the disease for less than 2 years.

A higher HbA_1c (greater than 53 mmol/mol) was associated with a 19% lower likelihood of remission, and individuals using insulin had a 43% lower likelihood of remission.

“Overall, our findings add evidence to the importance of regular check-ups following RYGB, despite initial diabetes remission, and also suggest that timing of RYGB is important (i.e., consider RYGB while there are still functional pancreatic beta cells),” wrote Lene R. Madsen, MD, from the department of endocrinology and internal medicine at Aarhus (Denmark) University Hospital and her colleagues.

The study also examined the effect of RYGB on microvascular and macrovascular diabetes complications. This revealed that the incidence of diabetic retinopathy was nearly halved among individuals who had undergone gastric bypass, the incidence of hospital-coded diabetic kidney disease was 46% lower, and the incidence of diabetic neuropathy was 16% lower.

In particular, individuals who achieved remission in the first year after surgery had a 57% lower incidence of microvascular events, compared with those who did not have surgery.

The authors noted that individuals who did not reach the threshold for diabetes remission after surgery still showed signs of better glycemic control, compared with individuals who had not undergone surgery.

“This aligns with the theory of ‘metabolic memory’ introduced by Coleman et al. [Diabetes Care. 2016;39(8):1400-07], suggesting that time spent in diabetes remission after RYGB is not spent in vain when it comes to reducing the risk of subsequent microvascular complications,” they wrote.

The surgery was also associated with a 46% reduction in the incidence of ischemic heart disease. In the first 30 days after surgery, 7.5% of patients were readmitted to hospital for any surgical complication, but the 90-day mortality rate after surgery was less than 0.5%.

The study was supported by the Health Research Fund of Central Denmark, the Novo Nordisk Foundation, and the A.P. Møller Foundation. The authors reported no conflicts of interest.

SOURCE: Madsen LR et al. Diabetologia. 2019, Feb 6. doi: 10.1007/s00125-019-4816-2.

Around three-quarters of people with type 2 diabetes mellitus (T2DM) who undergo Roux-en-Y gastric bypass experience remission of their disease within a year of the surgery, according to published findings from a population-based observational study. However, one in four of those people will have relapsed by 5 years, the authors noted.

Researchers looked at the effect of Roux-en-Y gastric bypass (RYGB) in 1,111 individuals with T2DM, compared with 1,074 controls who also had T2DM but did not undergo gastric bypass.

By 6 months after surgery, 65% of those who had undergone RYGB met the criteria for remission – defined as no use of glucose-lowering drugs and an HbA_1c below 48 mmol/mol (less than 6.5%) or metformin monotherapy with HbA_1c below 42 mmol/mol (less than 6.0%).

By 1 year, 74% of those who had surgery had achieved remission, and 73% of those remained in remission 5 years after surgery. However, at 2 years, 6% of those who had achieved remission in the first year had already relapsed; by 3 years, 12% had relapsed; and by 4 years, 18% had relapsed. By 5 years after surgery, a total of 27% of those who originally achieved remission in the first year had relapsed.

The overall prevalence of remission remained at 70% for every 6-month period during the duration of the study, which suggests that, although some achieved remission early and then relapsed, others achieved remission later.

Individuals who were aged 50-60 years were 12% less likely to achieve remission, compared with those who were younger than 40 years, whereas those aged 60 years or more were 17% less likely to achieve remission.

A longer duration of diabetes was also associated with a lower likelihood of achieving remission after RYGB; individuals who had had diabetes for 8 years or more had a 27% lower likelihood of remission, compared with those who had had the disease for less than 2 years.

A higher HbA_1c (greater than 53 mmol/mol) was associated with a 19% lower likelihood of remission, and individuals using insulin had a 43% lower likelihood of remission.

“Overall, our findings add evidence to the importance of regular check-ups following RYGB, despite initial diabetes remission, and also suggest that timing of RYGB is important (i.e., consider RYGB while there are still functional pancreatic beta cells),” wrote Lene R. Madsen, MD, from the department of endocrinology and internal medicine at Aarhus (Denmark) University Hospital and her colleagues.

The study also examined the effect of RYGB on microvascular and macrovascular diabetes complications. This revealed that the incidence of diabetic retinopathy was nearly halved among individuals who had undergone gastric bypass, the incidence of hospital-coded diabetic kidney disease was 46% lower, and the incidence of diabetic neuropathy was 16% lower.

In particular, individuals who achieved remission in the first year after surgery had a 57% lower incidence of microvascular events, compared with those who did not have surgery.

The authors noted that individuals who did not reach the threshold for diabetes remission after surgery still showed signs of better glycemic control, compared with individuals who had not undergone surgery.

“This aligns with the theory of ‘metabolic memory’ introduced by Coleman et al. [Diabetes Care. 2016;39(8):1400-07], suggesting that time spent in diabetes remission after RYGB is not spent in vain when it comes to reducing the risk of subsequent microvascular complications,” they wrote.

The surgery was also associated with a 46% reduction in the incidence of ischemic heart disease. In the first 30 days after surgery, 7.5% of patients were readmitted to hospital for any surgical complication, but the 90-day mortality rate after surgery was less than 0.5%.

The study was supported by the Health Research Fund of Central Denmark, the Novo Nordisk Foundation, and the A.P. Møller Foundation. The authors reported no conflicts of interest.

SOURCE: Madsen LR et al. Diabetologia. 2019, Feb 6. doi: 10.1007/s00125-019-4816-2.

Around three-quarters of people with type 2 diabetes mellitus (T2DM) who undergo Roux-en-Y gastric bypass experience remission of their disease within a year of the surgery, according to published findings from a population-based observational study. However, one in four of those people will have relapsed by 5 years, the authors noted.

Researchers looked at the effect of Roux-en-Y gastric bypass (RYGB) in 1,111 individuals with T2DM, compared with 1,074 controls who also had T2DM but did not undergo gastric bypass.

By 6 months after surgery, 65% of those who had undergone RYGB met the criteria for remission – defined as no use of glucose-lowering drugs and an HbA_1c below 48 mmol/mol (less than 6.5%) or metformin monotherapy with HbA_1c below 42 mmol/mol (less than 6.0%).

By 1 year, 74% of those who had surgery had achieved remission, and 73% of those remained in remission 5 years after surgery. However, at 2 years, 6% of those who had achieved remission in the first year had already relapsed; by 3 years, 12% had relapsed; and by 4 years, 18% had relapsed. By 5 years after surgery, a total of 27% of those who originally achieved remission in the first year had relapsed.

The overall prevalence of remission remained at 70% for every 6-month period during the duration of the study, which suggests that, although some achieved remission early and then relapsed, others achieved remission later.

Individuals who were aged 50-60 years were 12% less likely to achieve remission, compared with those who were younger than 40 years, whereas those aged 60 years or more were 17% less likely to achieve remission.

A longer duration of diabetes was also associated with a lower likelihood of achieving remission after RYGB; individuals who had had diabetes for 8 years or more had a 27% lower likelihood of remission, compared with those who had had the disease for less than 2 years.

A higher HbA_1c (greater than 53 mmol/mol) was associated with a 19% lower likelihood of remission, and individuals using insulin had a 43% lower likelihood of remission.

“Overall, our findings add evidence to the importance of regular check-ups following RYGB, despite initial diabetes remission, and also suggest that timing of RYGB is important (i.e., consider RYGB while there are still functional pancreatic beta cells),” wrote Lene R. Madsen, MD, from the department of endocrinology and internal medicine at Aarhus (Denmark) University Hospital and her colleagues.

The study also examined the effect of RYGB on microvascular and macrovascular diabetes complications. This revealed that the incidence of diabetic retinopathy was nearly halved among individuals who had undergone gastric bypass, the incidence of hospital-coded diabetic kidney disease was 46% lower, and the incidence of diabetic neuropathy was 16% lower.

In particular, individuals who achieved remission in the first year after surgery had a 57% lower incidence of microvascular events, compared with those who did not have surgery.

The authors noted that individuals who did not reach the threshold for diabetes remission after surgery still showed signs of better glycemic control, compared with individuals who had not undergone surgery.

“This aligns with the theory of ‘metabolic memory’ introduced by Coleman et al. [Diabetes Care. 2016;39(8):1400-07], suggesting that time spent in diabetes remission after RYGB is not spent in vain when it comes to reducing the risk of subsequent microvascular complications,” they wrote.

The surgery was also associated with a 46% reduction in the incidence of ischemic heart disease. In the first 30 days after surgery, 7.5% of patients were readmitted to hospital for any surgical complication, but the 90-day mortality rate after surgery was less than 0.5%.

The study was supported by the Health Research Fund of Central Denmark, the Novo Nordisk Foundation, and the A.P. Møller Foundation. The authors reported no conflicts of interest.

SOURCE: Madsen LR et al. Diabetologia. 2019, Feb 6. doi: 10.1007/s00125-019-4816-2.