User login
SLE: Specialized lupus clinics may offer superior quality of care
Patients with systemic lupus erythematosus (SLE) more often received care consistent with quality measures when they were seen in a specialized lupus clinic than they did in a general rheumatology clinic, according to results of a recent single-center, retrospective study.
Compared with a general rheumatology clinic, the lupus clinic had superior quality measure performance overall and for specific measures related to testing, treatment, and counseling, study authors reported in Arthritis Care & Research.
“Providing quality care in SLE is challenging as patients require ongoing, time consuming, multidisciplinary care,” wrote Shilpa Arora, MD, of John H. Stroger Hospital in Chicago, and her coauthors.
Lupus clinics and other disease-focused clinics at academic centers may provide better patient care by leveraging subspecialists’ current knowledge, experience, care processes, and multidisciplinary networks, according to Dr. Arora and her colleagues.
To assess whether a lupus clinic makes any difference in quality of care, Dr. Arora and her coinvestigators conducted a cross-sectional, retrospective chart review including 150 consecutive patients who received care at Rush University in Chicago.
Of that group of patients, 77 had received care in a subspecialty lupus clinic, and 73 received care at the general rheumatology clinic, according to the report.
Looking at validated quality measures for SLE testing, treatment, and counseling, Dr. Arora and her colleagues found performance was significantly greater overall for the lupus clinic than it was for the general rheumatology clinic (85.8% vs. 70.2%; P = 0.001).
In particular, patients treated at the lupus clinic were significantly more likely to get antiphospholipid antibody testing and bone mineral density testing, they said.
Lupus clinic patients were also more likely to be offered preventive measures, such as sunscreen counseling, cardiovascular disease risk assessment, and prescription of an angiotensin converting enzyme inhibitor when appropriate, they added.
To see whether there was any relationship between patient volume and quality measures, the researchers also looked at the number of SLE patients seen by each rheumatologist.
Dr. Arora and her associates did find a moderate correlation between the number of patients seen per rheumatologist and quality measure performance (rho, 0.48; P less than 0.001).
While this small study suggests subspecialty clinics provide high quality care, the authors said multicenter, prospective studies are needed to evaluate whether they also improve patient outcomes.
“It would be pertinent to see if these efficiencies translate over time to measurable gains in health status and health resource utilizations,” Dr. Arora and her colleagues concluded in their report.
Dr. Arora and her associates said there were no relevant financial disclosures or funding.
SOURCE: Arora S et al. Arthritis Care Res (Hoboken). 2018 Apr 2. doi: 10.1002/acr.23569.
Patients with systemic lupus erythematosus (SLE) more often received care consistent with quality measures when they were seen in a specialized lupus clinic than they did in a general rheumatology clinic, according to results of a recent single-center, retrospective study.
Compared with a general rheumatology clinic, the lupus clinic had superior quality measure performance overall and for specific measures related to testing, treatment, and counseling, study authors reported in Arthritis Care & Research.
“Providing quality care in SLE is challenging as patients require ongoing, time consuming, multidisciplinary care,” wrote Shilpa Arora, MD, of John H. Stroger Hospital in Chicago, and her coauthors.
Lupus clinics and other disease-focused clinics at academic centers may provide better patient care by leveraging subspecialists’ current knowledge, experience, care processes, and multidisciplinary networks, according to Dr. Arora and her colleagues.
To assess whether a lupus clinic makes any difference in quality of care, Dr. Arora and her coinvestigators conducted a cross-sectional, retrospective chart review including 150 consecutive patients who received care at Rush University in Chicago.
Of that group of patients, 77 had received care in a subspecialty lupus clinic, and 73 received care at the general rheumatology clinic, according to the report.
Looking at validated quality measures for SLE testing, treatment, and counseling, Dr. Arora and her colleagues found performance was significantly greater overall for the lupus clinic than it was for the general rheumatology clinic (85.8% vs. 70.2%; P = 0.001).
In particular, patients treated at the lupus clinic were significantly more likely to get antiphospholipid antibody testing and bone mineral density testing, they said.
Lupus clinic patients were also more likely to be offered preventive measures, such as sunscreen counseling, cardiovascular disease risk assessment, and prescription of an angiotensin converting enzyme inhibitor when appropriate, they added.
To see whether there was any relationship between patient volume and quality measures, the researchers also looked at the number of SLE patients seen by each rheumatologist.
Dr. Arora and her associates did find a moderate correlation between the number of patients seen per rheumatologist and quality measure performance (rho, 0.48; P less than 0.001).
While this small study suggests subspecialty clinics provide high quality care, the authors said multicenter, prospective studies are needed to evaluate whether they also improve patient outcomes.
“It would be pertinent to see if these efficiencies translate over time to measurable gains in health status and health resource utilizations,” Dr. Arora and her colleagues concluded in their report.
Dr. Arora and her associates said there were no relevant financial disclosures or funding.
SOURCE: Arora S et al. Arthritis Care Res (Hoboken). 2018 Apr 2. doi: 10.1002/acr.23569.
Patients with systemic lupus erythematosus (SLE) more often received care consistent with quality measures when they were seen in a specialized lupus clinic than they did in a general rheumatology clinic, according to results of a recent single-center, retrospective study.
Compared with a general rheumatology clinic, the lupus clinic had superior quality measure performance overall and for specific measures related to testing, treatment, and counseling, study authors reported in Arthritis Care & Research.
“Providing quality care in SLE is challenging as patients require ongoing, time consuming, multidisciplinary care,” wrote Shilpa Arora, MD, of John H. Stroger Hospital in Chicago, and her coauthors.
Lupus clinics and other disease-focused clinics at academic centers may provide better patient care by leveraging subspecialists’ current knowledge, experience, care processes, and multidisciplinary networks, according to Dr. Arora and her colleagues.
To assess whether a lupus clinic makes any difference in quality of care, Dr. Arora and her coinvestigators conducted a cross-sectional, retrospective chart review including 150 consecutive patients who received care at Rush University in Chicago.
Of that group of patients, 77 had received care in a subspecialty lupus clinic, and 73 received care at the general rheumatology clinic, according to the report.
Looking at validated quality measures for SLE testing, treatment, and counseling, Dr. Arora and her colleagues found performance was significantly greater overall for the lupus clinic than it was for the general rheumatology clinic (85.8% vs. 70.2%; P = 0.001).
In particular, patients treated at the lupus clinic were significantly more likely to get antiphospholipid antibody testing and bone mineral density testing, they said.
Lupus clinic patients were also more likely to be offered preventive measures, such as sunscreen counseling, cardiovascular disease risk assessment, and prescription of an angiotensin converting enzyme inhibitor when appropriate, they added.
To see whether there was any relationship between patient volume and quality measures, the researchers also looked at the number of SLE patients seen by each rheumatologist.
Dr. Arora and her associates did find a moderate correlation between the number of patients seen per rheumatologist and quality measure performance (rho, 0.48; P less than 0.001).
While this small study suggests subspecialty clinics provide high quality care, the authors said multicenter, prospective studies are needed to evaluate whether they also improve patient outcomes.
“It would be pertinent to see if these efficiencies translate over time to measurable gains in health status and health resource utilizations,” Dr. Arora and her colleagues concluded in their report.
Dr. Arora and her associates said there were no relevant financial disclosures or funding.
SOURCE: Arora S et al. Arthritis Care Res (Hoboken). 2018 Apr 2. doi: 10.1002/acr.23569.
FROM ARTHRITIS CARE & RESEARCH
Key clinical point:
Major finding: Quality measure performance in the lupus clinic was superior to that in a general rheumatology clinic (85.8% vs. 70.2%; P = 0.001).
Study details: A cross-sectional, retrospective chart review including 150 consecutive patients who received care at Rush University in Chicago in either the subspecialty lupus clinic or the general rheumatology clinic.
Disclosures: Dr. Arora and her associates said there were no relevant disclosures or funding.
Source: Arora S et al. Arthritis Care Res (Hoboken). 2018 Apr 2. doi: 10.1002/acr.23569.
Healthy lifestyle linked to better colon cancer survival
Having a normal body mass index, being physically active, and eating abundant vegetables, fruits, and whole grains was linked to a significantly reduced risk of death during a prospective cohort study of 992 patients with stage III colon cancer.
After 7 years of median follow-up, patients who most closely followed American Cancer Society Nutrition and Physical Activity Guidelines for Cancer Survivors had a 5-year survival probability of 85%, compared with 76% for patients who were least adherent (absolute risk reduction, 9%). After adjustment for multiple potential confounders, high guideline concordance was associated with a 42% lower risk of death during follow-up, compared with low guideline concordance (hazard ratio, 0.58; 95% confidence interval, 0.34-0.99; P = .01).
The cohort study included individuals with stage 3 colon cancer enrolled in the Cancer and Leukemia Group B (CALGB) 89803 randomized adjuvant chemotherapy trial, which ran from 1999 through 2001. Dr. Van Blarigan and her coinvestigators surveyed and scored each patient according to the ACS guidelines for cancer survivors. Scores ranged from 0 to 6 and increased with healthier behavior. The survival analysis compared individuals scoring 5 or 6 (highest guideline concordance) with those scoring 0 or 1 (lowest guideline concordance).
The 91 patients with the highest guideline concordance typically had a BMI of 23 kg/m2 or less, exercised more than 30 metabolic equivalent task hours per week, consumed more than three daily servings of fruits and vegetables, and ate mostly whole (versus refined) grains. In contrast, the 262 patients with the lowest guideline concordance had a median BMI of 33 kg/m2, exercised a median of 2 metabolic equivalent task hours per week, consumed less than two daily servings of fruits and vegetables, and ate mostly refined grains.
A closer look at individual factors linked survival with BMI between 23 kg/m2 and 29.9 kg/m2, with engaging in at least 150 minutes of moderate exercise per week, with consuming at least five daily servings of fruits and vegetables, and with choosing whole grains over refined grains. Although the ACS recommends limiting red or processed meat, this behavior did not show a protective effect, which mirrors findings from a prior study (J Clin Oncol. 2013 Aug 1;31[22]:2773-82). “Higher protein intake may be beneficial for cancer survivors,” the investigators noted.
They also examined alcohol consumption, which the ACS guidelines did not address. Women who consumed more than one alcoholic drink per day and men who consumed more than two drinks per day had a nonsignificantly higher risk of death than abstainers (HR, 1.28; 95% CI, 0.81-2.01). Compared with abstention, low to moderate alcohol consumption was tied to a lower risk of death, but this link also did not reach significance (HR, 0.87; 95% CI, 0.66-1.14).
The National Cancer Institute funded the study. Pharmacia and Upjohn Company (now Pfizer Oncology) provided partial funding for the CALGB 89803/Alliance trial. Dr. Van Blarigan and several of the other investigators were supported by National Cancer Institute awards. No other disclosures were reported.
SOURCE: Van Blarigan EL et al. JAMA Oncol. 2018 Apr 12. doi: 10.1001/jamaoncol.2018.0126.
“If you previously gave [colorectal cancer survivors] vague recommendations about diet and exercise, now you can be more precise and recommend five to six servings per day of fruits and vegetables and 150 minutes per week of exercise,” Michael J. Fisch, MD, MPH; Lorna H. McNeill, PhD, MPH; and Karen M. Basen-Engquist, PhD, MPH, wrote in an accompanying editorial in JAMA Oncology.
Although this was an observational study, the size of the association between survival and high adherence to American Cancer Society Nutrition and Physical Activity Guidelines was “certainly striking,” they wrote.
However, few study patients were younger than 50 years, were nonwhite, or had poor performance status, they noted. Additionally, contemporary adjuvant regimens (FOLFOX and CAPEOX) include oxaliplatin, which can cause chronic neurotoxicities that undermine physical activity.
Nonetheless, the data “strengthen the call to focus on lifestyle changes to extend and improve the lives of cancer survivors,” the editorialists concluded. Although making such changes is “notoriously difficult,” clues may come from six ongoing trials of weight control and physical activity in cancer survivors.
Dr. Fisch, Dr. McNeill, and Dr. Basen-Engquist all are at the University of Texas MD Anderson Cancer Center, Houston. Dr. Fisch also is with AIM Specialty Health, Chicago, Ill.; AIM is a subsidiary of Anthem. No other disclosures were reported. This editorial accompanied the article by Van Blanigan et al. (JAMA Oncology. 2018 Apr 12. doi: 10.1001/jamaoncol.2018.0124 ).
“If you previously gave [colorectal cancer survivors] vague recommendations about diet and exercise, now you can be more precise and recommend five to six servings per day of fruits and vegetables and 150 minutes per week of exercise,” Michael J. Fisch, MD, MPH; Lorna H. McNeill, PhD, MPH; and Karen M. Basen-Engquist, PhD, MPH, wrote in an accompanying editorial in JAMA Oncology.
Although this was an observational study, the size of the association between survival and high adherence to American Cancer Society Nutrition and Physical Activity Guidelines was “certainly striking,” they wrote.
However, few study patients were younger than 50 years, were nonwhite, or had poor performance status, they noted. Additionally, contemporary adjuvant regimens (FOLFOX and CAPEOX) include oxaliplatin, which can cause chronic neurotoxicities that undermine physical activity.
Nonetheless, the data “strengthen the call to focus on lifestyle changes to extend and improve the lives of cancer survivors,” the editorialists concluded. Although making such changes is “notoriously difficult,” clues may come from six ongoing trials of weight control and physical activity in cancer survivors.
Dr. Fisch, Dr. McNeill, and Dr. Basen-Engquist all are at the University of Texas MD Anderson Cancer Center, Houston. Dr. Fisch also is with AIM Specialty Health, Chicago, Ill.; AIM is a subsidiary of Anthem. No other disclosures were reported. This editorial accompanied the article by Van Blanigan et al. (JAMA Oncology. 2018 Apr 12. doi: 10.1001/jamaoncol.2018.0124 ).
“If you previously gave [colorectal cancer survivors] vague recommendations about diet and exercise, now you can be more precise and recommend five to six servings per day of fruits and vegetables and 150 minutes per week of exercise,” Michael J. Fisch, MD, MPH; Lorna H. McNeill, PhD, MPH; and Karen M. Basen-Engquist, PhD, MPH, wrote in an accompanying editorial in JAMA Oncology.
Although this was an observational study, the size of the association between survival and high adherence to American Cancer Society Nutrition and Physical Activity Guidelines was “certainly striking,” they wrote.
However, few study patients were younger than 50 years, were nonwhite, or had poor performance status, they noted. Additionally, contemporary adjuvant regimens (FOLFOX and CAPEOX) include oxaliplatin, which can cause chronic neurotoxicities that undermine physical activity.
Nonetheless, the data “strengthen the call to focus on lifestyle changes to extend and improve the lives of cancer survivors,” the editorialists concluded. Although making such changes is “notoriously difficult,” clues may come from six ongoing trials of weight control and physical activity in cancer survivors.
Dr. Fisch, Dr. McNeill, and Dr. Basen-Engquist all are at the University of Texas MD Anderson Cancer Center, Houston. Dr. Fisch also is with AIM Specialty Health, Chicago, Ill.; AIM is a subsidiary of Anthem. No other disclosures were reported. This editorial accompanied the article by Van Blanigan et al. (JAMA Oncology. 2018 Apr 12. doi: 10.1001/jamaoncol.2018.0124 ).
Having a normal body mass index, being physically active, and eating abundant vegetables, fruits, and whole grains was linked to a significantly reduced risk of death during a prospective cohort study of 992 patients with stage III colon cancer.
After 7 years of median follow-up, patients who most closely followed American Cancer Society Nutrition and Physical Activity Guidelines for Cancer Survivors had a 5-year survival probability of 85%, compared with 76% for patients who were least adherent (absolute risk reduction, 9%). After adjustment for multiple potential confounders, high guideline concordance was associated with a 42% lower risk of death during follow-up, compared with low guideline concordance (hazard ratio, 0.58; 95% confidence interval, 0.34-0.99; P = .01).
The cohort study included individuals with stage 3 colon cancer enrolled in the Cancer and Leukemia Group B (CALGB) 89803 randomized adjuvant chemotherapy trial, which ran from 1999 through 2001. Dr. Van Blarigan and her coinvestigators surveyed and scored each patient according to the ACS guidelines for cancer survivors. Scores ranged from 0 to 6 and increased with healthier behavior. The survival analysis compared individuals scoring 5 or 6 (highest guideline concordance) with those scoring 0 or 1 (lowest guideline concordance).
The 91 patients with the highest guideline concordance typically had a BMI of 23 kg/m2 or less, exercised more than 30 metabolic equivalent task hours per week, consumed more than three daily servings of fruits and vegetables, and ate mostly whole (versus refined) grains. In contrast, the 262 patients with the lowest guideline concordance had a median BMI of 33 kg/m2, exercised a median of 2 metabolic equivalent task hours per week, consumed less than two daily servings of fruits and vegetables, and ate mostly refined grains.
A closer look at individual factors linked survival with BMI between 23 kg/m2 and 29.9 kg/m2, with engaging in at least 150 minutes of moderate exercise per week, with consuming at least five daily servings of fruits and vegetables, and with choosing whole grains over refined grains. Although the ACS recommends limiting red or processed meat, this behavior did not show a protective effect, which mirrors findings from a prior study (J Clin Oncol. 2013 Aug 1;31[22]:2773-82). “Higher protein intake may be beneficial for cancer survivors,” the investigators noted.
They also examined alcohol consumption, which the ACS guidelines did not address. Women who consumed more than one alcoholic drink per day and men who consumed more than two drinks per day had a nonsignificantly higher risk of death than abstainers (HR, 1.28; 95% CI, 0.81-2.01). Compared with abstention, low to moderate alcohol consumption was tied to a lower risk of death, but this link also did not reach significance (HR, 0.87; 95% CI, 0.66-1.14).
The National Cancer Institute funded the study. Pharmacia and Upjohn Company (now Pfizer Oncology) provided partial funding for the CALGB 89803/Alliance trial. Dr. Van Blarigan and several of the other investigators were supported by National Cancer Institute awards. No other disclosures were reported.
SOURCE: Van Blarigan EL et al. JAMA Oncol. 2018 Apr 12. doi: 10.1001/jamaoncol.2018.0126.
Having a normal body mass index, being physically active, and eating abundant vegetables, fruits, and whole grains was linked to a significantly reduced risk of death during a prospective cohort study of 992 patients with stage III colon cancer.
After 7 years of median follow-up, patients who most closely followed American Cancer Society Nutrition and Physical Activity Guidelines for Cancer Survivors had a 5-year survival probability of 85%, compared with 76% for patients who were least adherent (absolute risk reduction, 9%). After adjustment for multiple potential confounders, high guideline concordance was associated with a 42% lower risk of death during follow-up, compared with low guideline concordance (hazard ratio, 0.58; 95% confidence interval, 0.34-0.99; P = .01).
The cohort study included individuals with stage 3 colon cancer enrolled in the Cancer and Leukemia Group B (CALGB) 89803 randomized adjuvant chemotherapy trial, which ran from 1999 through 2001. Dr. Van Blarigan and her coinvestigators surveyed and scored each patient according to the ACS guidelines for cancer survivors. Scores ranged from 0 to 6 and increased with healthier behavior. The survival analysis compared individuals scoring 5 or 6 (highest guideline concordance) with those scoring 0 or 1 (lowest guideline concordance).
The 91 patients with the highest guideline concordance typically had a BMI of 23 kg/m2 or less, exercised more than 30 metabolic equivalent task hours per week, consumed more than three daily servings of fruits and vegetables, and ate mostly whole (versus refined) grains. In contrast, the 262 patients with the lowest guideline concordance had a median BMI of 33 kg/m2, exercised a median of 2 metabolic equivalent task hours per week, consumed less than two daily servings of fruits and vegetables, and ate mostly refined grains.
A closer look at individual factors linked survival with BMI between 23 kg/m2 and 29.9 kg/m2, with engaging in at least 150 minutes of moderate exercise per week, with consuming at least five daily servings of fruits and vegetables, and with choosing whole grains over refined grains. Although the ACS recommends limiting red or processed meat, this behavior did not show a protective effect, which mirrors findings from a prior study (J Clin Oncol. 2013 Aug 1;31[22]:2773-82). “Higher protein intake may be beneficial for cancer survivors,” the investigators noted.
They also examined alcohol consumption, which the ACS guidelines did not address. Women who consumed more than one alcoholic drink per day and men who consumed more than two drinks per day had a nonsignificantly higher risk of death than abstainers (HR, 1.28; 95% CI, 0.81-2.01). Compared with abstention, low to moderate alcohol consumption was tied to a lower risk of death, but this link also did not reach significance (HR, 0.87; 95% CI, 0.66-1.14).
The National Cancer Institute funded the study. Pharmacia and Upjohn Company (now Pfizer Oncology) provided partial funding for the CALGB 89803/Alliance trial. Dr. Van Blarigan and several of the other investigators were supported by National Cancer Institute awards. No other disclosures were reported.
SOURCE: Van Blarigan EL et al. JAMA Oncol. 2018 Apr 12. doi: 10.1001/jamaoncol.2018.0126.
FROM JAMA ONCOLOGY
Key clinical point:
Major finding: Five-year survival probability was 85% for highly guideline-adherent patients and 76% for patients with low adherence (absolute risk reduction, 9%).
Study details: Prospective cohort study of 992 patients with stage III colon cancer.
Disclosures: The National Cancer Institute funded the study. Pharmacia and Upjohn Company (now Pfizer Oncology) partially funded the CALGB 89803/Alliance trial. Dr. Van Blarigan and several of the other investigators were supported by National Cancer Institute awards. No other disclosures were reported.
Source: Van Blarigan EL et al. JAMA Oncol. 2018 Apr 12. doi: 10.1001/jamaoncol.2018.0126.
Advanced practice nurses and physician assistants are not the same
Looking across a hospital ward, emergency department, or primary care clinic aligned side by side, you may not see any differences between an advanced practice nurse (APN) or physician assistant (PA). However, if you took a closer look at their education programs and credentialing, you would find considerable differences.
Although both professions hold advanced degrees, the approach to patient care differs, as well as the training they receive, including different models of practice. The APN is trained according to the nursing model, while the PA attends programs that are more in line with the medical model. The APN has a patient-centered model, while the PA adheres to a disease-centered model. Consequently, their approach to caring for the same patient population differs in viewpoint and philosophy.
Entry into the APN programs requires a nursing degree or related field from an accredited college or university. The curriculum includes coursework in health care policy, advocacy, outcomes, advanced assessment, diagnosis, and practice skills as well as, pharmacology, pathophysiology, and a final capstone project.
There are six specialty APN tracks including pediatrics, women’s/gender health, family practice, adult-gerontology, psychiatric, and neonatal. Additionally, there are three additional advanced practice registered nurses tracks: certified nurse anesthesia, certified nurse midwife, and clinical nurse leader. In addition to academic hours, there is a minimum of 1,000 supervised, direct patient care clinical hours in a variety of locations covering all populations specific to the identified specialty.
The Bureau of Labor Statistics defines the role of physician assistant as follows: “Physician assistants practice medicine under the supervision of physicians and surgeons. PAs are formally trained to provide diagnostic, therapeutic, and preventive health care services, as delegated by a physician.” The physician assistant program is a master’s prepared education.
School requirements include completing 2 years of pre-physician assistant undergraduate studies prior to applying to the School of Biomedical Sciences. Many programs have a 200-hour health care experience requirement, which can be either paid or unpaid. However, unlike the APN program, this is not required by all PA programs, but it is strongly encouraged.
Accredited PA programs require completing a 3-year graduate program that includes clinical rotations and results in a Master of Science in Physician Assistant Studies. Physician assistant programs typically involve 1,000 classroom hours and 2,000 or more hours in a clinical setting. The course work focuses on biochemistry, pathology, anatomy and physiology, ethics, and biology.
Both the APN and PA practices are regulated by the state through licensure laws and policy that determine the scope of practice and allow prescriptive authority.
Both programs began in 1965 in response to a shortage of primary care physicians, yet each program took a different route to address this need. According to the May 2017 Bureau of Labor Statistics, there were more than 109,000 physician assistants and more than 166,000 nurse practitioners practicing in the United States.
With the enactment of the Affordable Care Act in 2010, the mandate for APN’s and PA’s to lead patient-centered medical homes continued to grow to meet the demand. Both roles provide direct patient care under the sponsorship of a physician, yet both roles have gained a greater level of independence as state and federal requirements have relaxed restrictive physician collaboration and oversight rules, which has allowed both roles to practice at the highest level of their training. These relaxed restrictions come at a time when a growing physician shortage is met by increased demands placed on the health care system.
Ms. Thew is a certified family nurse practitioner in the division of adolescent medicine at the Medical College of Wisconsin, Milwaukee. Email her at [email protected]
Looking across a hospital ward, emergency department, or primary care clinic aligned side by side, you may not see any differences between an advanced practice nurse (APN) or physician assistant (PA). However, if you took a closer look at their education programs and credentialing, you would find considerable differences.
Although both professions hold advanced degrees, the approach to patient care differs, as well as the training they receive, including different models of practice. The APN is trained according to the nursing model, while the PA attends programs that are more in line with the medical model. The APN has a patient-centered model, while the PA adheres to a disease-centered model. Consequently, their approach to caring for the same patient population differs in viewpoint and philosophy.
Entry into the APN programs requires a nursing degree or related field from an accredited college or university. The curriculum includes coursework in health care policy, advocacy, outcomes, advanced assessment, diagnosis, and practice skills as well as, pharmacology, pathophysiology, and a final capstone project.
There are six specialty APN tracks including pediatrics, women’s/gender health, family practice, adult-gerontology, psychiatric, and neonatal. Additionally, there are three additional advanced practice registered nurses tracks: certified nurse anesthesia, certified nurse midwife, and clinical nurse leader. In addition to academic hours, there is a minimum of 1,000 supervised, direct patient care clinical hours in a variety of locations covering all populations specific to the identified specialty.
The Bureau of Labor Statistics defines the role of physician assistant as follows: “Physician assistants practice medicine under the supervision of physicians and surgeons. PAs are formally trained to provide diagnostic, therapeutic, and preventive health care services, as delegated by a physician.” The physician assistant program is a master’s prepared education.
School requirements include completing 2 years of pre-physician assistant undergraduate studies prior to applying to the School of Biomedical Sciences. Many programs have a 200-hour health care experience requirement, which can be either paid or unpaid. However, unlike the APN program, this is not required by all PA programs, but it is strongly encouraged.
Accredited PA programs require completing a 3-year graduate program that includes clinical rotations and results in a Master of Science in Physician Assistant Studies. Physician assistant programs typically involve 1,000 classroom hours and 2,000 or more hours in a clinical setting. The course work focuses on biochemistry, pathology, anatomy and physiology, ethics, and biology.
Both the APN and PA practices are regulated by the state through licensure laws and policy that determine the scope of practice and allow prescriptive authority.
Both programs began in 1965 in response to a shortage of primary care physicians, yet each program took a different route to address this need. According to the May 2017 Bureau of Labor Statistics, there were more than 109,000 physician assistants and more than 166,000 nurse practitioners practicing in the United States.
With the enactment of the Affordable Care Act in 2010, the mandate for APN’s and PA’s to lead patient-centered medical homes continued to grow to meet the demand. Both roles provide direct patient care under the sponsorship of a physician, yet both roles have gained a greater level of independence as state and federal requirements have relaxed restrictive physician collaboration and oversight rules, which has allowed both roles to practice at the highest level of their training. These relaxed restrictions come at a time when a growing physician shortage is met by increased demands placed on the health care system.
Ms. Thew is a certified family nurse practitioner in the division of adolescent medicine at the Medical College of Wisconsin, Milwaukee. Email her at [email protected]
Looking across a hospital ward, emergency department, or primary care clinic aligned side by side, you may not see any differences between an advanced practice nurse (APN) or physician assistant (PA). However, if you took a closer look at their education programs and credentialing, you would find considerable differences.
Although both professions hold advanced degrees, the approach to patient care differs, as well as the training they receive, including different models of practice. The APN is trained according to the nursing model, while the PA attends programs that are more in line with the medical model. The APN has a patient-centered model, while the PA adheres to a disease-centered model. Consequently, their approach to caring for the same patient population differs in viewpoint and philosophy.
Entry into the APN programs requires a nursing degree or related field from an accredited college or university. The curriculum includes coursework in health care policy, advocacy, outcomes, advanced assessment, diagnosis, and practice skills as well as, pharmacology, pathophysiology, and a final capstone project.
There are six specialty APN tracks including pediatrics, women’s/gender health, family practice, adult-gerontology, psychiatric, and neonatal. Additionally, there are three additional advanced practice registered nurses tracks: certified nurse anesthesia, certified nurse midwife, and clinical nurse leader. In addition to academic hours, there is a minimum of 1,000 supervised, direct patient care clinical hours in a variety of locations covering all populations specific to the identified specialty.
The Bureau of Labor Statistics defines the role of physician assistant as follows: “Physician assistants practice medicine under the supervision of physicians and surgeons. PAs are formally trained to provide diagnostic, therapeutic, and preventive health care services, as delegated by a physician.” The physician assistant program is a master’s prepared education.
School requirements include completing 2 years of pre-physician assistant undergraduate studies prior to applying to the School of Biomedical Sciences. Many programs have a 200-hour health care experience requirement, which can be either paid or unpaid. However, unlike the APN program, this is not required by all PA programs, but it is strongly encouraged.
Accredited PA programs require completing a 3-year graduate program that includes clinical rotations and results in a Master of Science in Physician Assistant Studies. Physician assistant programs typically involve 1,000 classroom hours and 2,000 or more hours in a clinical setting. The course work focuses on biochemistry, pathology, anatomy and physiology, ethics, and biology.
Both the APN and PA practices are regulated by the state through licensure laws and policy that determine the scope of practice and allow prescriptive authority.
Both programs began in 1965 in response to a shortage of primary care physicians, yet each program took a different route to address this need. According to the May 2017 Bureau of Labor Statistics, there were more than 109,000 physician assistants and more than 166,000 nurse practitioners practicing in the United States.
With the enactment of the Affordable Care Act in 2010, the mandate for APN’s and PA’s to lead patient-centered medical homes continued to grow to meet the demand. Both roles provide direct patient care under the sponsorship of a physician, yet both roles have gained a greater level of independence as state and federal requirements have relaxed restrictive physician collaboration and oversight rules, which has allowed both roles to practice at the highest level of their training. These relaxed restrictions come at a time when a growing physician shortage is met by increased demands placed on the health care system.
Ms. Thew is a certified family nurse practitioner in the division of adolescent medicine at the Medical College of Wisconsin, Milwaukee. Email her at [email protected]
Surgical excision essential in severe hidradenitis suppurativa
KAUAI, HAWAII – Medical therapy alone is never sufficient in Hurley stage III hidradenitis suppurativa (HS), Iltefat H. Hamzavi, MD, observed at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
“Even with the advances in biologics and antibiotic therapy, you still have to excise once you’re in full-blown Hurley stage III disease. Surgery has to be part of your protocol,” according to Dr. Hamzavi, a dermatologist at Henry Ford Hospital in Detroit, which runs one of the nation’s largest hidradenitis suppurativa clinics, with roughly 1,600 patients.
“Of course we’re biased. But until the data can set us free, you’re stuck with me,” the dermatologist quipped.
A core principle of the Henry Ford algorithm is this: “Medical therapy [for patients with advanced HS] stabilizes them and reduces their draining and pain, then you try to bring them back to a lower stage with surgical options,” he explained.
Although other HS staging systems exist, Dr. Hamzavi and his colleagues rely on the Hurley staging system to guide their treatment. Basically, Hurley stage I consists of follicular nodules and abscesses. When the nodules connect to form sinus tracts with scarring, that’s stage II. And if the sinus tracts interconnect throughout an entire area, that’s stage III.
Hurley stage I
First-line treatment of localized Hurley stage I disease at Henry Ford is a 10% topical benzoyl peroxide wash left on for 5 minutes before bathing, followed by postbathing topical clindamycin 1% lotion or solution applied to the nodules. If this maintenance regimen isn’t sufficient to prevent formation of new and worsening nodules, Dr. Hamzavi supplements it with up to three once-monthly 1064-nm Nd:YAG laser sessions aimed at follicular ablation. It’s a laser application he and his colleagues pioneered (Dermatol Surg. 2009 Aug;35[8]:1188-98). They subsequently documented the histopathologic basis of the procedure’s efficacy, which entails selective thermolysis of follicles, destruction of inflammatory lesions in the superficial to mid-dermis, followed by fibrosis and scarring (Arch Dermatol. 2011 Jan;147[1]:21-8).
In generalized Hurley stage I HS, the Henry Ford approach is to supplement the topical regimen and laser sessions with oral doxycycline at 100-150 mg daily for 1-6 months.
“The theory here is this is a dysbiotic event. The antibiotics reduce commensal bacteria, which ultimately reduces the reactive inflammatory response. But when you stop the antibiotics, the inflammatory response returns. So antibiotics can help stabilize the disease state but really can’t reverse the disease state. For that we have to turn to ablative treatment options: laser, surgery,” the dermatologist continued.
Hurley stage II
“At this point you’re looking at procedures,” according to Dr. Hamzavi. “Once you have sinus tracts it’s critical to remove them.”
The treatment backbone in stage II disease is 8-10 weeks of oral clindamycin and rifampin, both at 300 mg twice daily.
“This is one of the fundamental building blocks of HS clinics throughout the world,” he noted.
Clostridium difficile infection is exceedingly rare in HS patients on this regimen, for reasons still unclear.
If this dual-antibiotic regimen doesn’t dramatically reduce drainage and pain, he adds levofloxacin at 500 mg twice daily for up to 2 weeks in an effort to calm down unstable, decompensating disease.
Dapsone at 50-150 mg/day for up to 12 weeks is an additional option. It’s most useful in patients with nodules that are disproportionately painful, in Dr. Hamzavi’s experience.
Deroofing is a simple procedure that should be considered for all sinus tracts. It entails numbing the area with a ring block then introducing a curette or surgical probe into the sinus tract to open it up and get rid of the gelatinous material within. Dutch investigators have detailed the technique (J Am Acad Dermatol. 2010 Sep;63[3]:475-80).
Tumor necrosis factor–inhibitor therapy has been a major advance in Hurley stage II and III disease. “It doesn’t work in everybody, but a lot of patients can be stabilized,” Dr. Hamzavi observed.
Efficacy has been amply demonstrated for adalimumab (Humira) and infliximab (Remicade). In Dr. Hamzavi’s experience infliximab works better, probably because it offers more dosing options.
Assuming medical therapy has resulted in disease stabilization, CO2 laser excision of sinus tracts under local anesthesia can then be employed as an office procedure to turn back the clock and return to an earlier stage of disease. Dermatologists at the Cleveland Clinic have described the technique in detail (Dermatol Surg. 2010 Feb;36[2]:208-13).
Hurley stage III
If biologic therapy doesn’t bring disease stabilization, the patient is likely headed for surgical excision using the CO2 laser. The Henry Ford team favors a specific regimen of surgical preparation using wide-spectrum antibiotics. The program begins with 6 weeks of IV ertapenem at 1 g/day delivered by a peripherally inserted central catheter managed by infectious disease colleagues.
“IV ertapenem is a drug you may not know much about. We find it works really well as a great way to bridge patients towards surgery,” the dermatologist explained.
The IV ertapenem is followed by 6 weeks of oral triple therapy with rifampin, moxifloxacin, and metronidazole then another 6 weeks of rifampin plus moxifloxacin. Next it’s surgical excision time.
Lifestyle modification
Lifestyle modification deserves to be a major priority in all HS patients, regardless of Hurley stage. Smoking cessation results in significantly greater likelihood of favorable response to first-line therapy. In obese patients, greater than 15% weight loss has been associated with significant reduction in disease severity. A sartorial shift to loose-fitting clothing can quiet down skin lesions through decreased friction and pressure. And proper utilization of warm compression will rapidly decrease acute lesional pain.
Dr. Hamzavi and his coinvestigators have described the Henry Ford Hospital treatment algorithm in a review of HS published in an open-access journal meant to serve as a resource for patients and physicians alike (F1000Res. 2017 Jul 28;6:1272. doi: 10.12688/f1000research.11337.1. eCollection 2017).
He reported serving as a consultant to AbbVie, Incyte, and UCB.
The Global Academy for Medical Education/SDEF and this news organization are owned by the same parent company.
KAUAI, HAWAII – Medical therapy alone is never sufficient in Hurley stage III hidradenitis suppurativa (HS), Iltefat H. Hamzavi, MD, observed at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
“Even with the advances in biologics and antibiotic therapy, you still have to excise once you’re in full-blown Hurley stage III disease. Surgery has to be part of your protocol,” according to Dr. Hamzavi, a dermatologist at Henry Ford Hospital in Detroit, which runs one of the nation’s largest hidradenitis suppurativa clinics, with roughly 1,600 patients.
“Of course we’re biased. But until the data can set us free, you’re stuck with me,” the dermatologist quipped.
A core principle of the Henry Ford algorithm is this: “Medical therapy [for patients with advanced HS] stabilizes them and reduces their draining and pain, then you try to bring them back to a lower stage with surgical options,” he explained.
Although other HS staging systems exist, Dr. Hamzavi and his colleagues rely on the Hurley staging system to guide their treatment. Basically, Hurley stage I consists of follicular nodules and abscesses. When the nodules connect to form sinus tracts with scarring, that’s stage II. And if the sinus tracts interconnect throughout an entire area, that’s stage III.
Hurley stage I
First-line treatment of localized Hurley stage I disease at Henry Ford is a 10% topical benzoyl peroxide wash left on for 5 minutes before bathing, followed by postbathing topical clindamycin 1% lotion or solution applied to the nodules. If this maintenance regimen isn’t sufficient to prevent formation of new and worsening nodules, Dr. Hamzavi supplements it with up to three once-monthly 1064-nm Nd:YAG laser sessions aimed at follicular ablation. It’s a laser application he and his colleagues pioneered (Dermatol Surg. 2009 Aug;35[8]:1188-98). They subsequently documented the histopathologic basis of the procedure’s efficacy, which entails selective thermolysis of follicles, destruction of inflammatory lesions in the superficial to mid-dermis, followed by fibrosis and scarring (Arch Dermatol. 2011 Jan;147[1]:21-8).
In generalized Hurley stage I HS, the Henry Ford approach is to supplement the topical regimen and laser sessions with oral doxycycline at 100-150 mg daily for 1-6 months.
“The theory here is this is a dysbiotic event. The antibiotics reduce commensal bacteria, which ultimately reduces the reactive inflammatory response. But when you stop the antibiotics, the inflammatory response returns. So antibiotics can help stabilize the disease state but really can’t reverse the disease state. For that we have to turn to ablative treatment options: laser, surgery,” the dermatologist continued.
Hurley stage II
“At this point you’re looking at procedures,” according to Dr. Hamzavi. “Once you have sinus tracts it’s critical to remove them.”
The treatment backbone in stage II disease is 8-10 weeks of oral clindamycin and rifampin, both at 300 mg twice daily.
“This is one of the fundamental building blocks of HS clinics throughout the world,” he noted.
Clostridium difficile infection is exceedingly rare in HS patients on this regimen, for reasons still unclear.
If this dual-antibiotic regimen doesn’t dramatically reduce drainage and pain, he adds levofloxacin at 500 mg twice daily for up to 2 weeks in an effort to calm down unstable, decompensating disease.
Dapsone at 50-150 mg/day for up to 12 weeks is an additional option. It’s most useful in patients with nodules that are disproportionately painful, in Dr. Hamzavi’s experience.
Deroofing is a simple procedure that should be considered for all sinus tracts. It entails numbing the area with a ring block then introducing a curette or surgical probe into the sinus tract to open it up and get rid of the gelatinous material within. Dutch investigators have detailed the technique (J Am Acad Dermatol. 2010 Sep;63[3]:475-80).
Tumor necrosis factor–inhibitor therapy has been a major advance in Hurley stage II and III disease. “It doesn’t work in everybody, but a lot of patients can be stabilized,” Dr. Hamzavi observed.
Efficacy has been amply demonstrated for adalimumab (Humira) and infliximab (Remicade). In Dr. Hamzavi’s experience infliximab works better, probably because it offers more dosing options.
Assuming medical therapy has resulted in disease stabilization, CO2 laser excision of sinus tracts under local anesthesia can then be employed as an office procedure to turn back the clock and return to an earlier stage of disease. Dermatologists at the Cleveland Clinic have described the technique in detail (Dermatol Surg. 2010 Feb;36[2]:208-13).
Hurley stage III
If biologic therapy doesn’t bring disease stabilization, the patient is likely headed for surgical excision using the CO2 laser. The Henry Ford team favors a specific regimen of surgical preparation using wide-spectrum antibiotics. The program begins with 6 weeks of IV ertapenem at 1 g/day delivered by a peripherally inserted central catheter managed by infectious disease colleagues.
“IV ertapenem is a drug you may not know much about. We find it works really well as a great way to bridge patients towards surgery,” the dermatologist explained.
The IV ertapenem is followed by 6 weeks of oral triple therapy with rifampin, moxifloxacin, and metronidazole then another 6 weeks of rifampin plus moxifloxacin. Next it’s surgical excision time.
Lifestyle modification
Lifestyle modification deserves to be a major priority in all HS patients, regardless of Hurley stage. Smoking cessation results in significantly greater likelihood of favorable response to first-line therapy. In obese patients, greater than 15% weight loss has been associated with significant reduction in disease severity. A sartorial shift to loose-fitting clothing can quiet down skin lesions through decreased friction and pressure. And proper utilization of warm compression will rapidly decrease acute lesional pain.
Dr. Hamzavi and his coinvestigators have described the Henry Ford Hospital treatment algorithm in a review of HS published in an open-access journal meant to serve as a resource for patients and physicians alike (F1000Res. 2017 Jul 28;6:1272. doi: 10.12688/f1000research.11337.1. eCollection 2017).
He reported serving as a consultant to AbbVie, Incyte, and UCB.
The Global Academy for Medical Education/SDEF and this news organization are owned by the same parent company.
KAUAI, HAWAII – Medical therapy alone is never sufficient in Hurley stage III hidradenitis suppurativa (HS), Iltefat H. Hamzavi, MD, observed at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
“Even with the advances in biologics and antibiotic therapy, you still have to excise once you’re in full-blown Hurley stage III disease. Surgery has to be part of your protocol,” according to Dr. Hamzavi, a dermatologist at Henry Ford Hospital in Detroit, which runs one of the nation’s largest hidradenitis suppurativa clinics, with roughly 1,600 patients.
“Of course we’re biased. But until the data can set us free, you’re stuck with me,” the dermatologist quipped.
A core principle of the Henry Ford algorithm is this: “Medical therapy [for patients with advanced HS] stabilizes them and reduces their draining and pain, then you try to bring them back to a lower stage with surgical options,” he explained.
Although other HS staging systems exist, Dr. Hamzavi and his colleagues rely on the Hurley staging system to guide their treatment. Basically, Hurley stage I consists of follicular nodules and abscesses. When the nodules connect to form sinus tracts with scarring, that’s stage II. And if the sinus tracts interconnect throughout an entire area, that’s stage III.
Hurley stage I
First-line treatment of localized Hurley stage I disease at Henry Ford is a 10% topical benzoyl peroxide wash left on for 5 minutes before bathing, followed by postbathing topical clindamycin 1% lotion or solution applied to the nodules. If this maintenance regimen isn’t sufficient to prevent formation of new and worsening nodules, Dr. Hamzavi supplements it with up to three once-monthly 1064-nm Nd:YAG laser sessions aimed at follicular ablation. It’s a laser application he and his colleagues pioneered (Dermatol Surg. 2009 Aug;35[8]:1188-98). They subsequently documented the histopathologic basis of the procedure’s efficacy, which entails selective thermolysis of follicles, destruction of inflammatory lesions in the superficial to mid-dermis, followed by fibrosis and scarring (Arch Dermatol. 2011 Jan;147[1]:21-8).
In generalized Hurley stage I HS, the Henry Ford approach is to supplement the topical regimen and laser sessions with oral doxycycline at 100-150 mg daily for 1-6 months.
“The theory here is this is a dysbiotic event. The antibiotics reduce commensal bacteria, which ultimately reduces the reactive inflammatory response. But when you stop the antibiotics, the inflammatory response returns. So antibiotics can help stabilize the disease state but really can’t reverse the disease state. For that we have to turn to ablative treatment options: laser, surgery,” the dermatologist continued.
Hurley stage II
“At this point you’re looking at procedures,” according to Dr. Hamzavi. “Once you have sinus tracts it’s critical to remove them.”
The treatment backbone in stage II disease is 8-10 weeks of oral clindamycin and rifampin, both at 300 mg twice daily.
“This is one of the fundamental building blocks of HS clinics throughout the world,” he noted.
Clostridium difficile infection is exceedingly rare in HS patients on this regimen, for reasons still unclear.
If this dual-antibiotic regimen doesn’t dramatically reduce drainage and pain, he adds levofloxacin at 500 mg twice daily for up to 2 weeks in an effort to calm down unstable, decompensating disease.
Dapsone at 50-150 mg/day for up to 12 weeks is an additional option. It’s most useful in patients with nodules that are disproportionately painful, in Dr. Hamzavi’s experience.
Deroofing is a simple procedure that should be considered for all sinus tracts. It entails numbing the area with a ring block then introducing a curette or surgical probe into the sinus tract to open it up and get rid of the gelatinous material within. Dutch investigators have detailed the technique (J Am Acad Dermatol. 2010 Sep;63[3]:475-80).
Tumor necrosis factor–inhibitor therapy has been a major advance in Hurley stage II and III disease. “It doesn’t work in everybody, but a lot of patients can be stabilized,” Dr. Hamzavi observed.
Efficacy has been amply demonstrated for adalimumab (Humira) and infliximab (Remicade). In Dr. Hamzavi’s experience infliximab works better, probably because it offers more dosing options.
Assuming medical therapy has resulted in disease stabilization, CO2 laser excision of sinus tracts under local anesthesia can then be employed as an office procedure to turn back the clock and return to an earlier stage of disease. Dermatologists at the Cleveland Clinic have described the technique in detail (Dermatol Surg. 2010 Feb;36[2]:208-13).
Hurley stage III
If biologic therapy doesn’t bring disease stabilization, the patient is likely headed for surgical excision using the CO2 laser. The Henry Ford team favors a specific regimen of surgical preparation using wide-spectrum antibiotics. The program begins with 6 weeks of IV ertapenem at 1 g/day delivered by a peripherally inserted central catheter managed by infectious disease colleagues.
“IV ertapenem is a drug you may not know much about. We find it works really well as a great way to bridge patients towards surgery,” the dermatologist explained.
The IV ertapenem is followed by 6 weeks of oral triple therapy with rifampin, moxifloxacin, and metronidazole then another 6 weeks of rifampin plus moxifloxacin. Next it’s surgical excision time.
Lifestyle modification
Lifestyle modification deserves to be a major priority in all HS patients, regardless of Hurley stage. Smoking cessation results in significantly greater likelihood of favorable response to first-line therapy. In obese patients, greater than 15% weight loss has been associated with significant reduction in disease severity. A sartorial shift to loose-fitting clothing can quiet down skin lesions through decreased friction and pressure. And proper utilization of warm compression will rapidly decrease acute lesional pain.
Dr. Hamzavi and his coinvestigators have described the Henry Ford Hospital treatment algorithm in a review of HS published in an open-access journal meant to serve as a resource for patients and physicians alike (F1000Res. 2017 Jul 28;6:1272. doi: 10.12688/f1000research.11337.1. eCollection 2017).
He reported serving as a consultant to AbbVie, Incyte, and UCB.
The Global Academy for Medical Education/SDEF and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM SDEF HAWAII DERMATOLOGY SEMINAR
How to avoid severe diarrhea from apremilast
KAUAI, HAWAII – Physicians have become much more cognizant of severe diarrhea and nausea as potential side effects of apremilast since the Food and Drug Administration–approved change in the warnings and precautions section of the drug’s labeling in June 2017. Jashin J. Wu, MD, director of the psoriasis clinic at Kaiser Permanente Los Angeles Medical Center, has a tip for avoiding these problems: Delay up-titrating.
“In my opinion, that may be too quick of an up-titration. I tell patients that, if they feel the GI issues are still a problem for them on day 6, they should take 30 mg just once a day for the first 1-2 months. After that we’ll see how they’re doing, and if they feel they can make the jump to twice a day, then they can go for it. Of course, I also tell them that maybe their psoriasis will not clear as well as if they’d been on apremilast twice a day right from day 6, but if they’re able to tolerate it and can continue to take it, they can improve while they’re on it,” the dermatologist said at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
Dr. Wu presented an update on recent developments regarding the newest oral drugs for psoriasis and one of the oldest: apremilast and methotrexate, respectively.
Apremilast
The revised warning label highlighting the risks of severe diarrhea and nausea associated with the oral phosphodiesterase-4 inhibitor says that most such events have occurred within the first few weeks of therapy. The guidance also notes that patients who reduced the dosage or discontinued treatment outright generally improved rapidly.
“I see this in a lot of my patients. They have to go to the bathroom pretty often. It’s actually unusual for me for a patient not to have any GI issues at all,” according to Dr. Wu.
He shared a number of other fresh insights into apremilast’s safety and efficacy derived from recent studies.
Efficacy appears to increase at least out to 1 year
A report from the phase 3b, randomized, placebo-controlled, 250-patient LIBERATE trial showed that the week 16 PASI 75 response rate was 39.8% with apremilast, 48.2% with etanercept (Enbrel), and 11.9% with placebo. After week 16, everyone switched to apremilast. The PASI 75 rate in patients on apremilast all along climbed from 39.8% at week 16 to 52.7% at week 52. That result was in the same ballpark as the 57% rate in those switched from etanercept to apremilast and the 53.4% PASI 75 rate at week 52 in patients switched from placebo to apremilast (J Eur Acad Dermatol Venereol. 2017 Mar;31[3]:507-17).
“It was interesting to see that, as the study continued on for 1 year, the PASI 75 rate continued to improve. That’s worth noting: In general, I tell patients you have to be on a drug for about 3 months before we’re going to say if it worked or not, and that’s true even with drugs for other conditions, like doxycycline for acne. But this study seems to indicate that you have much better improvement at the 1-year point, and that’s not so much true for the biologics,” the dermatologist observed.
Safety to 3 years looks reassuringly good: 3-year follow-up of the 1,184-patient, phase 3, randomized, controlled ESTEEM 1 and 2 trials provided by far the longest look to date at apremilast’s safety. There were no surprises, no serious opportunistic infections, and no significant changes in laboratory values (J Am Acad Dermatol. 2017 Aug;77[2]:310-17.e1).
Of note, 21.9% of patients on apremilast lost more than 5% of their baseline body weight. Most of the weight loss occurred during year 1 of treatment and mostly in patients with a higher baseline body mass index.
“It seems like apremilast is definitely a good option if patients can tolerate the GI upset,” Dr. Wu said.
Apremilast can safely and effectively be combined with other psoriasis therapies: Dermatologists at the University of Toronto reported on a retrospective analysis of 81 biologic-naive psoriasis patients treated with apremilast in combination with methotrexate, acitretin (Soriatane), cyclosporine, narrowband UVB, etanercept, infliximab (Remicade), adalimumab (Humira), and/or ustekinumab (Stelara). Of these patients, 81% achieved a PASI 75 response at week 12 (J Cutan Med Surg. 2016 Jul;20[4]:313-6).
“That’s pretty good. It’s certainly better than apremilast by itself. So if you can get the payer to cover a combination of apremilast and something else, it may help get to PASI 75,” Dr. Wu noted.
Session chair Craig L. Leonardi, MD, said he hasn’t had any luck in going that route.
“The insurance industry just won’t give me apremilast in combination with a biologic drug. Even though it makes complete sense to use it in place of methotrexate with a biologic, I just can’t get it,” according to Dr. Leonardi, a dermatologist at Saint Louis University.
“I don’t have those limitations at Kaiser,” according to Dr. Wu. “I personally have only used apremilast and methotrexate and apremilast and acitretin in combination. I just want to be kind to Kaiser and not give two branded medications to a patient, but I certainly think it’s a feasible option.”
Methotrexate
A simple response prediction rule: Kenneth B. Gordon, MD, professor and chair of dermatology at the Medical College of Wisconsin in Milwaukee, and his coinvestigators at AbbVie developed a methotrexate response/nonresponse prediction rule using data on 110 participants in the phase 3 CHAMPION trial. Then they validated the rule in the phase 3 M10-255 trial. They found that a PASI 25 response to methotrexate at week 4 was associated with an 8.9-fold increased likelihood of a week-16 PASI 75 response. Patients with a predicted response probability of less than 30% were asked to discontinue the drug; their week 16 PASI 75 rate was only 21.1%, compared with a 65.8% response rate in patients with a prediction rating (J Am Acad Dermatol. 2017 Dec;77[6]:1030-7).
“Four weeks of methotrexate may be sufficient to determine the long-term response. It may not be necessary to put them on the drug for 3 months,” Dr. Wu commented.
Subcutaneous methotrexate: European investigators demonstrated that an intensified dosing schedule of subcutaneous methotrexate was safe and effective for treatment of moderate to severe plaque psoriasis in the 52-week, phase 3, randomized, 16-center, double-blind, 120-patient, placebo-controlled METOP study.
The intensified subcutaneous regimen consisted of 17.5 mg/week initially, escalated to 22.5 mg/week after 8 weeks if a patient hadn’t achieved at least a PASI 50 response at that point. The primary outcome, the PASI 75 response at week 16, was 41% in the subcutaneous methotrexate group and 10% in controls, with a maximum PASI 75 rate of 51% seen beginning at week 24. The week 4 and 8 PASI 50 rates were 50% and 58%, respectively, with methotrexate versus 3% and 17% in placebo-treated controls. The subcutaneous regimen was generally well tolerated, with no serious infections or malignancies arising during 52 weeks (Lancet. 2017 Feb 4;389[10068]:528-37).
Dr. Wu reported receiving research funding from AbbVie, Amgen, Eli Lilly, Janssen, Novartis, and Regeneron.
The Global Academy for Medical Education/SDEF and this news organization are owned by the same parent company.
KAUAI, HAWAII – Physicians have become much more cognizant of severe diarrhea and nausea as potential side effects of apremilast since the Food and Drug Administration–approved change in the warnings and precautions section of the drug’s labeling in June 2017. Jashin J. Wu, MD, director of the psoriasis clinic at Kaiser Permanente Los Angeles Medical Center, has a tip for avoiding these problems: Delay up-titrating.
“In my opinion, that may be too quick of an up-titration. I tell patients that, if they feel the GI issues are still a problem for them on day 6, they should take 30 mg just once a day for the first 1-2 months. After that we’ll see how they’re doing, and if they feel they can make the jump to twice a day, then they can go for it. Of course, I also tell them that maybe their psoriasis will not clear as well as if they’d been on apremilast twice a day right from day 6, but if they’re able to tolerate it and can continue to take it, they can improve while they’re on it,” the dermatologist said at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
Dr. Wu presented an update on recent developments regarding the newest oral drugs for psoriasis and one of the oldest: apremilast and methotrexate, respectively.
Apremilast
The revised warning label highlighting the risks of severe diarrhea and nausea associated with the oral phosphodiesterase-4 inhibitor says that most such events have occurred within the first few weeks of therapy. The guidance also notes that patients who reduced the dosage or discontinued treatment outright generally improved rapidly.
“I see this in a lot of my patients. They have to go to the bathroom pretty often. It’s actually unusual for me for a patient not to have any GI issues at all,” according to Dr. Wu.
He shared a number of other fresh insights into apremilast’s safety and efficacy derived from recent studies.
Efficacy appears to increase at least out to 1 year
A report from the phase 3b, randomized, placebo-controlled, 250-patient LIBERATE trial showed that the week 16 PASI 75 response rate was 39.8% with apremilast, 48.2% with etanercept (Enbrel), and 11.9% with placebo. After week 16, everyone switched to apremilast. The PASI 75 rate in patients on apremilast all along climbed from 39.8% at week 16 to 52.7% at week 52. That result was in the same ballpark as the 57% rate in those switched from etanercept to apremilast and the 53.4% PASI 75 rate at week 52 in patients switched from placebo to apremilast (J Eur Acad Dermatol Venereol. 2017 Mar;31[3]:507-17).
“It was interesting to see that, as the study continued on for 1 year, the PASI 75 rate continued to improve. That’s worth noting: In general, I tell patients you have to be on a drug for about 3 months before we’re going to say if it worked or not, and that’s true even with drugs for other conditions, like doxycycline for acne. But this study seems to indicate that you have much better improvement at the 1-year point, and that’s not so much true for the biologics,” the dermatologist observed.
Safety to 3 years looks reassuringly good: 3-year follow-up of the 1,184-patient, phase 3, randomized, controlled ESTEEM 1 and 2 trials provided by far the longest look to date at apremilast’s safety. There were no surprises, no serious opportunistic infections, and no significant changes in laboratory values (J Am Acad Dermatol. 2017 Aug;77[2]:310-17.e1).
Of note, 21.9% of patients on apremilast lost more than 5% of their baseline body weight. Most of the weight loss occurred during year 1 of treatment and mostly in patients with a higher baseline body mass index.
“It seems like apremilast is definitely a good option if patients can tolerate the GI upset,” Dr. Wu said.
Apremilast can safely and effectively be combined with other psoriasis therapies: Dermatologists at the University of Toronto reported on a retrospective analysis of 81 biologic-naive psoriasis patients treated with apremilast in combination with methotrexate, acitretin (Soriatane), cyclosporine, narrowband UVB, etanercept, infliximab (Remicade), adalimumab (Humira), and/or ustekinumab (Stelara). Of these patients, 81% achieved a PASI 75 response at week 12 (J Cutan Med Surg. 2016 Jul;20[4]:313-6).
“That’s pretty good. It’s certainly better than apremilast by itself. So if you can get the payer to cover a combination of apremilast and something else, it may help get to PASI 75,” Dr. Wu noted.
Session chair Craig L. Leonardi, MD, said he hasn’t had any luck in going that route.
“The insurance industry just won’t give me apremilast in combination with a biologic drug. Even though it makes complete sense to use it in place of methotrexate with a biologic, I just can’t get it,” according to Dr. Leonardi, a dermatologist at Saint Louis University.
“I don’t have those limitations at Kaiser,” according to Dr. Wu. “I personally have only used apremilast and methotrexate and apremilast and acitretin in combination. I just want to be kind to Kaiser and not give two branded medications to a patient, but I certainly think it’s a feasible option.”
Methotrexate
A simple response prediction rule: Kenneth B. Gordon, MD, professor and chair of dermatology at the Medical College of Wisconsin in Milwaukee, and his coinvestigators at AbbVie developed a methotrexate response/nonresponse prediction rule using data on 110 participants in the phase 3 CHAMPION trial. Then they validated the rule in the phase 3 M10-255 trial. They found that a PASI 25 response to methotrexate at week 4 was associated with an 8.9-fold increased likelihood of a week-16 PASI 75 response. Patients with a predicted response probability of less than 30% were asked to discontinue the drug; their week 16 PASI 75 rate was only 21.1%, compared with a 65.8% response rate in patients with a prediction rating (J Am Acad Dermatol. 2017 Dec;77[6]:1030-7).
“Four weeks of methotrexate may be sufficient to determine the long-term response. It may not be necessary to put them on the drug for 3 months,” Dr. Wu commented.
Subcutaneous methotrexate: European investigators demonstrated that an intensified dosing schedule of subcutaneous methotrexate was safe and effective for treatment of moderate to severe plaque psoriasis in the 52-week, phase 3, randomized, 16-center, double-blind, 120-patient, placebo-controlled METOP study.
The intensified subcutaneous regimen consisted of 17.5 mg/week initially, escalated to 22.5 mg/week after 8 weeks if a patient hadn’t achieved at least a PASI 50 response at that point. The primary outcome, the PASI 75 response at week 16, was 41% in the subcutaneous methotrexate group and 10% in controls, with a maximum PASI 75 rate of 51% seen beginning at week 24. The week 4 and 8 PASI 50 rates were 50% and 58%, respectively, with methotrexate versus 3% and 17% in placebo-treated controls. The subcutaneous regimen was generally well tolerated, with no serious infections or malignancies arising during 52 weeks (Lancet. 2017 Feb 4;389[10068]:528-37).
Dr. Wu reported receiving research funding from AbbVie, Amgen, Eli Lilly, Janssen, Novartis, and Regeneron.
The Global Academy for Medical Education/SDEF and this news organization are owned by the same parent company.
KAUAI, HAWAII – Physicians have become much more cognizant of severe diarrhea and nausea as potential side effects of apremilast since the Food and Drug Administration–approved change in the warnings and precautions section of the drug’s labeling in June 2017. Jashin J. Wu, MD, director of the psoriasis clinic at Kaiser Permanente Los Angeles Medical Center, has a tip for avoiding these problems: Delay up-titrating.
“In my opinion, that may be too quick of an up-titration. I tell patients that, if they feel the GI issues are still a problem for them on day 6, they should take 30 mg just once a day for the first 1-2 months. After that we’ll see how they’re doing, and if they feel they can make the jump to twice a day, then they can go for it. Of course, I also tell them that maybe their psoriasis will not clear as well as if they’d been on apremilast twice a day right from day 6, but if they’re able to tolerate it and can continue to take it, they can improve while they’re on it,” the dermatologist said at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
Dr. Wu presented an update on recent developments regarding the newest oral drugs for psoriasis and one of the oldest: apremilast and methotrexate, respectively.
Apremilast
The revised warning label highlighting the risks of severe diarrhea and nausea associated with the oral phosphodiesterase-4 inhibitor says that most such events have occurred within the first few weeks of therapy. The guidance also notes that patients who reduced the dosage or discontinued treatment outright generally improved rapidly.
“I see this in a lot of my patients. They have to go to the bathroom pretty often. It’s actually unusual for me for a patient not to have any GI issues at all,” according to Dr. Wu.
He shared a number of other fresh insights into apremilast’s safety and efficacy derived from recent studies.
Efficacy appears to increase at least out to 1 year
A report from the phase 3b, randomized, placebo-controlled, 250-patient LIBERATE trial showed that the week 16 PASI 75 response rate was 39.8% with apremilast, 48.2% with etanercept (Enbrel), and 11.9% with placebo. After week 16, everyone switched to apremilast. The PASI 75 rate in patients on apremilast all along climbed from 39.8% at week 16 to 52.7% at week 52. That result was in the same ballpark as the 57% rate in those switched from etanercept to apremilast and the 53.4% PASI 75 rate at week 52 in patients switched from placebo to apremilast (J Eur Acad Dermatol Venereol. 2017 Mar;31[3]:507-17).
“It was interesting to see that, as the study continued on for 1 year, the PASI 75 rate continued to improve. That’s worth noting: In general, I tell patients you have to be on a drug for about 3 months before we’re going to say if it worked or not, and that’s true even with drugs for other conditions, like doxycycline for acne. But this study seems to indicate that you have much better improvement at the 1-year point, and that’s not so much true for the biologics,” the dermatologist observed.
Safety to 3 years looks reassuringly good: 3-year follow-up of the 1,184-patient, phase 3, randomized, controlled ESTEEM 1 and 2 trials provided by far the longest look to date at apremilast’s safety. There were no surprises, no serious opportunistic infections, and no significant changes in laboratory values (J Am Acad Dermatol. 2017 Aug;77[2]:310-17.e1).
Of note, 21.9% of patients on apremilast lost more than 5% of their baseline body weight. Most of the weight loss occurred during year 1 of treatment and mostly in patients with a higher baseline body mass index.
“It seems like apremilast is definitely a good option if patients can tolerate the GI upset,” Dr. Wu said.
Apremilast can safely and effectively be combined with other psoriasis therapies: Dermatologists at the University of Toronto reported on a retrospective analysis of 81 biologic-naive psoriasis patients treated with apremilast in combination with methotrexate, acitretin (Soriatane), cyclosporine, narrowband UVB, etanercept, infliximab (Remicade), adalimumab (Humira), and/or ustekinumab (Stelara). Of these patients, 81% achieved a PASI 75 response at week 12 (J Cutan Med Surg. 2016 Jul;20[4]:313-6).
“That’s pretty good. It’s certainly better than apremilast by itself. So if you can get the payer to cover a combination of apremilast and something else, it may help get to PASI 75,” Dr. Wu noted.
Session chair Craig L. Leonardi, MD, said he hasn’t had any luck in going that route.
“The insurance industry just won’t give me apremilast in combination with a biologic drug. Even though it makes complete sense to use it in place of methotrexate with a biologic, I just can’t get it,” according to Dr. Leonardi, a dermatologist at Saint Louis University.
“I don’t have those limitations at Kaiser,” according to Dr. Wu. “I personally have only used apremilast and methotrexate and apremilast and acitretin in combination. I just want to be kind to Kaiser and not give two branded medications to a patient, but I certainly think it’s a feasible option.”
Methotrexate
A simple response prediction rule: Kenneth B. Gordon, MD, professor and chair of dermatology at the Medical College of Wisconsin in Milwaukee, and his coinvestigators at AbbVie developed a methotrexate response/nonresponse prediction rule using data on 110 participants in the phase 3 CHAMPION trial. Then they validated the rule in the phase 3 M10-255 trial. They found that a PASI 25 response to methotrexate at week 4 was associated with an 8.9-fold increased likelihood of a week-16 PASI 75 response. Patients with a predicted response probability of less than 30% were asked to discontinue the drug; their week 16 PASI 75 rate was only 21.1%, compared with a 65.8% response rate in patients with a prediction rating (J Am Acad Dermatol. 2017 Dec;77[6]:1030-7).
“Four weeks of methotrexate may be sufficient to determine the long-term response. It may not be necessary to put them on the drug for 3 months,” Dr. Wu commented.
Subcutaneous methotrexate: European investigators demonstrated that an intensified dosing schedule of subcutaneous methotrexate was safe and effective for treatment of moderate to severe plaque psoriasis in the 52-week, phase 3, randomized, 16-center, double-blind, 120-patient, placebo-controlled METOP study.
The intensified subcutaneous regimen consisted of 17.5 mg/week initially, escalated to 22.5 mg/week after 8 weeks if a patient hadn’t achieved at least a PASI 50 response at that point. The primary outcome, the PASI 75 response at week 16, was 41% in the subcutaneous methotrexate group and 10% in controls, with a maximum PASI 75 rate of 51% seen beginning at week 24. The week 4 and 8 PASI 50 rates were 50% and 58%, respectively, with methotrexate versus 3% and 17% in placebo-treated controls. The subcutaneous regimen was generally well tolerated, with no serious infections or malignancies arising during 52 weeks (Lancet. 2017 Feb 4;389[10068]:528-37).
Dr. Wu reported receiving research funding from AbbVie, Amgen, Eli Lilly, Janssen, Novartis, and Regeneron.
The Global Academy for Medical Education/SDEF and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM SDEF HAWAII DERMATOLOGY SEMINAR
2 in 1: Rosacea-like demodicosis, papulopustular rosacea may be phenotypes of same disease
according to the authors of a retrospective study.
Currently, there is a lack of consensus among physicians and health care organizations on how Demodex mites affect the development of rosacea. Many experts separate rosacea into two camps: PPR not caused by Demodex and rosacea-like demodicosis caused by Demodex.
During each evaluation session, each patient underwent two consecutive standardized skin surface biopsies (SSSBs), a small 1 square centimeter sample of the horny skin layer and the follicular content, on each cheek. The first sample, SSSB1, was a superficial sample, and SSSB2, the second sample, was a deep sample. The sum of the two samples, SSSB1+2, also was noted.
During the same session, patients had Demodex densities (Dds) measured. To avoid any confounding factors that could affect facial skin symptoms, Dr. Forton and Dr. de Maertelaer evaluated a subgroup of 132 patients who had not been treated in the previous 3 months and had no other facial dermatoses, such as acne vulgaris and seborrheic dermatitis.
The study revealed that, among the 242 patients in the primary analysis group, those with persistent erythema had higher Dds than did those without and the differences were statistically significant when comparing SSSB2 (208 D/cm2 vs. 130 D/cm2; P = 0.031) and SSB1+2 (298 D/cm2 vs. 191 D/cm2; P = 0.025), respectively.
This pattern of greater Dds density among patients with persistent erythema, compared with patients without, also held true among the subgroup of 132 patients who had not received any recent dermatological treatments, but the difference was not statistically significant. Nonetheless, patients with follicular scales did have greater SSSBs than did those without follicular scales.
As part of the study, Dr. Forton and Dr. de Maertelaer analyzed the findings of a case report of a 19-year-old woman who had a facial papulopustular eruption that had been present for 1 year. She had two SSSBs taken on each cheek: the right had follicular scales and papulopustules, and the left was clinically normal. This revealed that she had much higher Dds on the affected cheek than on the clinically normal one (108 and 216 D/cm2 vs. 12 and 20 D/cm2). She was subsequently diagnosed with rosacea-like demodicosis.
After treating the areas with acaricidal ointment, the symptoms improved. But 27 months after stopping maintenance treatments, the facial eruptions reappeared, and the papulopustules were larger than during her original consultation, leading to the diagnosis of PPR. This time, the Dds was high on both cheeks but responded to acaricidal treatment, which indicates that her eruptions were caused Demodex mites.
“All our observations, therefore, highlight the nosological confusion that persists between PPR and rosacea-like demodicosis and the need to update the consensus concerning the definition and classification of rosacea. Moreover, they suggest that PPR and rosacea-like demodicosis may be phenotypes of the same disease,” wrote Dr. Forton and Dr. de Maertelaer. “This concept is supported by our case report, with many features indicating that the second presentation was an evolution of the first.”
They cautioned that their research is not definitive but should provide strong evidence that PPR and rosacea-like demodicosis are the same disease.
“While our observations do not prove a causative role of Demodex in rosacea, they nevertheless support the idea that PPR and rosacea-like demodicosis should no longer be considered as two separate entities but, rather, as two phenotypes of the same disease,” they wrote. “As such, the definition of rosacea subtype II (PPR) should be reconsidered and simplified to include all patients with central face papulopustules – with or without persistent erythema – and thus also patients with ‘rosacea-like demodicosis,’ which is a term that should therefore disappear.”
This study received no external funding. Dr. Forton works for Galderma as a consultant. Dr. de Maertelaer had no conflicts of interest to declare.
SOURCE: Forton F et al. J Eur Acad Dermatol Venereol. 2018 Feb 25. doi: 10.1111/jdv.14885.
according to the authors of a retrospective study.
Currently, there is a lack of consensus among physicians and health care organizations on how Demodex mites affect the development of rosacea. Many experts separate rosacea into two camps: PPR not caused by Demodex and rosacea-like demodicosis caused by Demodex.
During each evaluation session, each patient underwent two consecutive standardized skin surface biopsies (SSSBs), a small 1 square centimeter sample of the horny skin layer and the follicular content, on each cheek. The first sample, SSSB1, was a superficial sample, and SSSB2, the second sample, was a deep sample. The sum of the two samples, SSSB1+2, also was noted.
During the same session, patients had Demodex densities (Dds) measured. To avoid any confounding factors that could affect facial skin symptoms, Dr. Forton and Dr. de Maertelaer evaluated a subgroup of 132 patients who had not been treated in the previous 3 months and had no other facial dermatoses, such as acne vulgaris and seborrheic dermatitis.
The study revealed that, among the 242 patients in the primary analysis group, those with persistent erythema had higher Dds than did those without and the differences were statistically significant when comparing SSSB2 (208 D/cm2 vs. 130 D/cm2; P = 0.031) and SSB1+2 (298 D/cm2 vs. 191 D/cm2; P = 0.025), respectively.
This pattern of greater Dds density among patients with persistent erythema, compared with patients without, also held true among the subgroup of 132 patients who had not received any recent dermatological treatments, but the difference was not statistically significant. Nonetheless, patients with follicular scales did have greater SSSBs than did those without follicular scales.
As part of the study, Dr. Forton and Dr. de Maertelaer analyzed the findings of a case report of a 19-year-old woman who had a facial papulopustular eruption that had been present for 1 year. She had two SSSBs taken on each cheek: the right had follicular scales and papulopustules, and the left was clinically normal. This revealed that she had much higher Dds on the affected cheek than on the clinically normal one (108 and 216 D/cm2 vs. 12 and 20 D/cm2). She was subsequently diagnosed with rosacea-like demodicosis.
After treating the areas with acaricidal ointment, the symptoms improved. But 27 months after stopping maintenance treatments, the facial eruptions reappeared, and the papulopustules were larger than during her original consultation, leading to the diagnosis of PPR. This time, the Dds was high on both cheeks but responded to acaricidal treatment, which indicates that her eruptions were caused Demodex mites.
“All our observations, therefore, highlight the nosological confusion that persists between PPR and rosacea-like demodicosis and the need to update the consensus concerning the definition and classification of rosacea. Moreover, they suggest that PPR and rosacea-like demodicosis may be phenotypes of the same disease,” wrote Dr. Forton and Dr. de Maertelaer. “This concept is supported by our case report, with many features indicating that the second presentation was an evolution of the first.”
They cautioned that their research is not definitive but should provide strong evidence that PPR and rosacea-like demodicosis are the same disease.
“While our observations do not prove a causative role of Demodex in rosacea, they nevertheless support the idea that PPR and rosacea-like demodicosis should no longer be considered as two separate entities but, rather, as two phenotypes of the same disease,” they wrote. “As such, the definition of rosacea subtype II (PPR) should be reconsidered and simplified to include all patients with central face papulopustules – with or without persistent erythema – and thus also patients with ‘rosacea-like demodicosis,’ which is a term that should therefore disappear.”
This study received no external funding. Dr. Forton works for Galderma as a consultant. Dr. de Maertelaer had no conflicts of interest to declare.
SOURCE: Forton F et al. J Eur Acad Dermatol Venereol. 2018 Feb 25. doi: 10.1111/jdv.14885.
according to the authors of a retrospective study.
Currently, there is a lack of consensus among physicians and health care organizations on how Demodex mites affect the development of rosacea. Many experts separate rosacea into two camps: PPR not caused by Demodex and rosacea-like demodicosis caused by Demodex.
During each evaluation session, each patient underwent two consecutive standardized skin surface biopsies (SSSBs), a small 1 square centimeter sample of the horny skin layer and the follicular content, on each cheek. The first sample, SSSB1, was a superficial sample, and SSSB2, the second sample, was a deep sample. The sum of the two samples, SSSB1+2, also was noted.
During the same session, patients had Demodex densities (Dds) measured. To avoid any confounding factors that could affect facial skin symptoms, Dr. Forton and Dr. de Maertelaer evaluated a subgroup of 132 patients who had not been treated in the previous 3 months and had no other facial dermatoses, such as acne vulgaris and seborrheic dermatitis.
The study revealed that, among the 242 patients in the primary analysis group, those with persistent erythema had higher Dds than did those without and the differences were statistically significant when comparing SSSB2 (208 D/cm2 vs. 130 D/cm2; P = 0.031) and SSB1+2 (298 D/cm2 vs. 191 D/cm2; P = 0.025), respectively.
This pattern of greater Dds density among patients with persistent erythema, compared with patients without, also held true among the subgroup of 132 patients who had not received any recent dermatological treatments, but the difference was not statistically significant. Nonetheless, patients with follicular scales did have greater SSSBs than did those without follicular scales.
As part of the study, Dr. Forton and Dr. de Maertelaer analyzed the findings of a case report of a 19-year-old woman who had a facial papulopustular eruption that had been present for 1 year. She had two SSSBs taken on each cheek: the right had follicular scales and papulopustules, and the left was clinically normal. This revealed that she had much higher Dds on the affected cheek than on the clinically normal one (108 and 216 D/cm2 vs. 12 and 20 D/cm2). She was subsequently diagnosed with rosacea-like demodicosis.
After treating the areas with acaricidal ointment, the symptoms improved. But 27 months after stopping maintenance treatments, the facial eruptions reappeared, and the papulopustules were larger than during her original consultation, leading to the diagnosis of PPR. This time, the Dds was high on both cheeks but responded to acaricidal treatment, which indicates that her eruptions were caused Demodex mites.
“All our observations, therefore, highlight the nosological confusion that persists between PPR and rosacea-like demodicosis and the need to update the consensus concerning the definition and classification of rosacea. Moreover, they suggest that PPR and rosacea-like demodicosis may be phenotypes of the same disease,” wrote Dr. Forton and Dr. de Maertelaer. “This concept is supported by our case report, with many features indicating that the second presentation was an evolution of the first.”
They cautioned that their research is not definitive but should provide strong evidence that PPR and rosacea-like demodicosis are the same disease.
“While our observations do not prove a causative role of Demodex in rosacea, they nevertheless support the idea that PPR and rosacea-like demodicosis should no longer be considered as two separate entities but, rather, as two phenotypes of the same disease,” they wrote. “As such, the definition of rosacea subtype II (PPR) should be reconsidered and simplified to include all patients with central face papulopustules – with or without persistent erythema – and thus also patients with ‘rosacea-like demodicosis,’ which is a term that should therefore disappear.”
This study received no external funding. Dr. Forton works for Galderma as a consultant. Dr. de Maertelaer had no conflicts of interest to declare.
SOURCE: Forton F et al. J Eur Acad Dermatol Venereol. 2018 Feb 25. doi: 10.1111/jdv.14885.
FROM THE JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY
Key clinical point: Demodex densities were greater in patients with persistent erythema than in those without.
Major finding: Deep tissue samples showed higher mite densities in patients with persistent erythema than in those without (SSSB2: 208 D/cm2 and 130 D/cm2; P = 0.031).
Study details: A retrospective, observational, case-control study of 242 patients with central face papulopustules.
Disclosures: This study received no external funding. Dr. Forton works for Galderma as a consultant. Dr. de Maertelaer has no conflicts of interest to declare.
Source: Forton F et al. J Eur Acad Dermatol Venereol. 2018 Feb 25. doi: 10.1111/jdv.14885.
Hormonal contraception boosts breast cancer risk
KAUAI, HAWAII – Current or recent use of hormonal contraception is associated with an increased risk of breast cancer, although in response to the Danish study findings.
“The data looks clear. It’s not a big risk, but it’s clearly a higher risk,” Lawrence F. Eichenfield, MD, said at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
Investigators at the University of Copenhagen conducted a prospective cohort study among all 1.8 million Danish women aged 15-49 years who had not had cancer, venous thromboembolism, or treatment for infertility. Comprehensive nationwide registries were used to follow the women for an average of 10.9 years, which represents 19.6 million person-years of follow-up.
During that time, 11,517 cases of invasive breast cancer occurred in the study population. The relative risk was 1.2-fold greater in current or recent users of hormonal contraception, compared with never users of oral estrogen/progestin contraceptives or progestin-containing intrauterine devices. The risk rose with duration of use: from 1.09-fold with less than 1 year of exposure to 1.38-fold with more than 10 years of hormonal contraception.
From a population standpoint, there were 13 additional breast cancers diagnosed per 100,000 person-years of hormonal contraception use. That worked out to one extra breast cancer for every 7,690 women using hormonal contraception for 1 year (N Engl J Med. 2017 Dec 7;377[23]:2228-39).
Dr. Eichenfield pointed out that among Danish patients who used an oral contraceptive for less than 5 years, the excess risk of breast cancer went away within a year of stopping the medication. If patients used hormonal contraception for more than 5 years, the excess breast cancer risk lasted for 5 years after stopping.
He noted that the antiandrogen spironolactone, widely used off-label to treat adult female acne, has been shown to be free of any increased breast cancer risk.
He reported serving as a consultant to and/or recipient of research grants from more than a dozen pharmaceutical companies.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company..
KAUAI, HAWAII – Current or recent use of hormonal contraception is associated with an increased risk of breast cancer, although in response to the Danish study findings.
“The data looks clear. It’s not a big risk, but it’s clearly a higher risk,” Lawrence F. Eichenfield, MD, said at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
Investigators at the University of Copenhagen conducted a prospective cohort study among all 1.8 million Danish women aged 15-49 years who had not had cancer, venous thromboembolism, or treatment for infertility. Comprehensive nationwide registries were used to follow the women for an average of 10.9 years, which represents 19.6 million person-years of follow-up.
During that time, 11,517 cases of invasive breast cancer occurred in the study population. The relative risk was 1.2-fold greater in current or recent users of hormonal contraception, compared with never users of oral estrogen/progestin contraceptives or progestin-containing intrauterine devices. The risk rose with duration of use: from 1.09-fold with less than 1 year of exposure to 1.38-fold with more than 10 years of hormonal contraception.
From a population standpoint, there were 13 additional breast cancers diagnosed per 100,000 person-years of hormonal contraception use. That worked out to one extra breast cancer for every 7,690 women using hormonal contraception for 1 year (N Engl J Med. 2017 Dec 7;377[23]:2228-39).
Dr. Eichenfield pointed out that among Danish patients who used an oral contraceptive for less than 5 years, the excess risk of breast cancer went away within a year of stopping the medication. If patients used hormonal contraception for more than 5 years, the excess breast cancer risk lasted for 5 years after stopping.
He noted that the antiandrogen spironolactone, widely used off-label to treat adult female acne, has been shown to be free of any increased breast cancer risk.
He reported serving as a consultant to and/or recipient of research grants from more than a dozen pharmaceutical companies.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company..
KAUAI, HAWAII – Current or recent use of hormonal contraception is associated with an increased risk of breast cancer, although in response to the Danish study findings.
“The data looks clear. It’s not a big risk, but it’s clearly a higher risk,” Lawrence F. Eichenfield, MD, said at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
Investigators at the University of Copenhagen conducted a prospective cohort study among all 1.8 million Danish women aged 15-49 years who had not had cancer, venous thromboembolism, or treatment for infertility. Comprehensive nationwide registries were used to follow the women for an average of 10.9 years, which represents 19.6 million person-years of follow-up.
During that time, 11,517 cases of invasive breast cancer occurred in the study population. The relative risk was 1.2-fold greater in current or recent users of hormonal contraception, compared with never users of oral estrogen/progestin contraceptives or progestin-containing intrauterine devices. The risk rose with duration of use: from 1.09-fold with less than 1 year of exposure to 1.38-fold with more than 10 years of hormonal contraception.
From a population standpoint, there were 13 additional breast cancers diagnosed per 100,000 person-years of hormonal contraception use. That worked out to one extra breast cancer for every 7,690 women using hormonal contraception for 1 year (N Engl J Med. 2017 Dec 7;377[23]:2228-39).
Dr. Eichenfield pointed out that among Danish patients who used an oral contraceptive for less than 5 years, the excess risk of breast cancer went away within a year of stopping the medication. If patients used hormonal contraception for more than 5 years, the excess breast cancer risk lasted for 5 years after stopping.
He noted that the antiandrogen spironolactone, widely used off-label to treat adult female acne, has been shown to be free of any increased breast cancer risk.
He reported serving as a consultant to and/or recipient of research grants from more than a dozen pharmaceutical companies.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company..
EXPERT ANALYSIS FROM SDEF HAWAII DERMATOLOGY SEMINAR
Few physicians report adverse events related to body contouring devices
DALLAS – Most physicians do not report adverse events related to noninvasive body contouring devices to the Food and Drug Administration, a database review showed.
“The FDA mandates that manufacturers and device operators disclose medical device reports to monitor suspected injuries and device malfunctions to the Manufacturer and User Facility Device Experience [MAUDE] database,” study author Adam J. Wulkan, MD, said at the annual conference of the American Society for Laser Medicine and Surgery. “Given the rapid growth in the noninvasive fat reduction market, it is essential physicians be aware of associated adverse events.”
“Given that this is the largest database for adverse events, I was surprised how few reports were done by physicians,” Dr. Wulkan said in an interview.
He reported results from 83 of the 98 MDRs. A total of 26 MDRs reported on cryolipolysis and included newly diagnosed or exacerbation of prior umbilical hernias (10), neuropathies (5), paradoxical fat hyperplasias (4), blisters (3), rashes (1), flu-like symptoms (1), gastroenteritis (1), and prolapsed bladder/uterus/rectum (1). Of the 11 MDRs for radio-frequency devices, 10 were burns/blisters and 1 fire.
Dr. Wulkan went on to note that 17 MDRs were reported for 1060-nm laser lipolysis, including burns/blisters (5), nodules (4), pain (3), cellulitis/abscesses (2), excessive swelling (1), neuropathy (1), and vomiting (1). There were four cases of burns on MDRs from focused/pulsed ultrasound procedures. One was on a non–FDA approved body site and another after combination radio-frequency/infrared treatment for cellulite reduction.
There were eight MDRs reported with 1440-nm laser cellulite reduction, including burn (5), unacceptable cosmesis (2), and faulty power supply (1). In addition, there were 12 MDRs reported on high-frequency ultrasound, including burns/blisters (9), subcutaneous nodules (2), and excoriation (1). Finally, vacuum-assisted submission was associated with five MDRs, including festooning/unacceptable cosmesis (2), seroma/hematoma (1), laceration (1), and nodules (1).
Dr. Wulkan acknowledged certain limitations of the study, including the fact that not all MDRs are reported to MAUDE, and that the reliability of patient reporting can be questionable. “We have to figure out if there is a natural causation between the adverse event and the treatment itself,” he said at the meeting. “The number of MDRs for any given device must be correlated to the number of procedures performed before we jump to conclusions about the safety of any given device.”
He reported having no financial disclosures. One study coauthor holds positions on advisory boards of, is a consultant for, and has intellectual property and/or stock options with various industry companies, such as Soliton and Allergan.
SOURCE: Wulkan et. al., ASLMS 2018.
DALLAS – Most physicians do not report adverse events related to noninvasive body contouring devices to the Food and Drug Administration, a database review showed.
“The FDA mandates that manufacturers and device operators disclose medical device reports to monitor suspected injuries and device malfunctions to the Manufacturer and User Facility Device Experience [MAUDE] database,” study author Adam J. Wulkan, MD, said at the annual conference of the American Society for Laser Medicine and Surgery. “Given the rapid growth in the noninvasive fat reduction market, it is essential physicians be aware of associated adverse events.”
“Given that this is the largest database for adverse events, I was surprised how few reports were done by physicians,” Dr. Wulkan said in an interview.
He reported results from 83 of the 98 MDRs. A total of 26 MDRs reported on cryolipolysis and included newly diagnosed or exacerbation of prior umbilical hernias (10), neuropathies (5), paradoxical fat hyperplasias (4), blisters (3), rashes (1), flu-like symptoms (1), gastroenteritis (1), and prolapsed bladder/uterus/rectum (1). Of the 11 MDRs for radio-frequency devices, 10 were burns/blisters and 1 fire.
Dr. Wulkan went on to note that 17 MDRs were reported for 1060-nm laser lipolysis, including burns/blisters (5), nodules (4), pain (3), cellulitis/abscesses (2), excessive swelling (1), neuropathy (1), and vomiting (1). There were four cases of burns on MDRs from focused/pulsed ultrasound procedures. One was on a non–FDA approved body site and another after combination radio-frequency/infrared treatment for cellulite reduction.
There were eight MDRs reported with 1440-nm laser cellulite reduction, including burn (5), unacceptable cosmesis (2), and faulty power supply (1). In addition, there were 12 MDRs reported on high-frequency ultrasound, including burns/blisters (9), subcutaneous nodules (2), and excoriation (1). Finally, vacuum-assisted submission was associated with five MDRs, including festooning/unacceptable cosmesis (2), seroma/hematoma (1), laceration (1), and nodules (1).
Dr. Wulkan acknowledged certain limitations of the study, including the fact that not all MDRs are reported to MAUDE, and that the reliability of patient reporting can be questionable. “We have to figure out if there is a natural causation between the adverse event and the treatment itself,” he said at the meeting. “The number of MDRs for any given device must be correlated to the number of procedures performed before we jump to conclusions about the safety of any given device.”
He reported having no financial disclosures. One study coauthor holds positions on advisory boards of, is a consultant for, and has intellectual property and/or stock options with various industry companies, such as Soliton and Allergan.
SOURCE: Wulkan et. al., ASLMS 2018.
DALLAS – Most physicians do not report adverse events related to noninvasive body contouring devices to the Food and Drug Administration, a database review showed.
“The FDA mandates that manufacturers and device operators disclose medical device reports to monitor suspected injuries and device malfunctions to the Manufacturer and User Facility Device Experience [MAUDE] database,” study author Adam J. Wulkan, MD, said at the annual conference of the American Society for Laser Medicine and Surgery. “Given the rapid growth in the noninvasive fat reduction market, it is essential physicians be aware of associated adverse events.”
“Given that this is the largest database for adverse events, I was surprised how few reports were done by physicians,” Dr. Wulkan said in an interview.
He reported results from 83 of the 98 MDRs. A total of 26 MDRs reported on cryolipolysis and included newly diagnosed or exacerbation of prior umbilical hernias (10), neuropathies (5), paradoxical fat hyperplasias (4), blisters (3), rashes (1), flu-like symptoms (1), gastroenteritis (1), and prolapsed bladder/uterus/rectum (1). Of the 11 MDRs for radio-frequency devices, 10 were burns/blisters and 1 fire.
Dr. Wulkan went on to note that 17 MDRs were reported for 1060-nm laser lipolysis, including burns/blisters (5), nodules (4), pain (3), cellulitis/abscesses (2), excessive swelling (1), neuropathy (1), and vomiting (1). There were four cases of burns on MDRs from focused/pulsed ultrasound procedures. One was on a non–FDA approved body site and another after combination radio-frequency/infrared treatment for cellulite reduction.
There were eight MDRs reported with 1440-nm laser cellulite reduction, including burn (5), unacceptable cosmesis (2), and faulty power supply (1). In addition, there were 12 MDRs reported on high-frequency ultrasound, including burns/blisters (9), subcutaneous nodules (2), and excoriation (1). Finally, vacuum-assisted submission was associated with five MDRs, including festooning/unacceptable cosmesis (2), seroma/hematoma (1), laceration (1), and nodules (1).
Dr. Wulkan acknowledged certain limitations of the study, including the fact that not all MDRs are reported to MAUDE, and that the reliability of patient reporting can be questionable. “We have to figure out if there is a natural causation between the adverse event and the treatment itself,” he said at the meeting. “The number of MDRs for any given device must be correlated to the number of procedures performed before we jump to conclusions about the safety of any given device.”
He reported having no financial disclosures. One study coauthor holds positions on advisory boards of, is a consultant for, and has intellectual property and/or stock options with various industry companies, such as Soliton and Allergan.
SOURCE: Wulkan et. al., ASLMS 2018.
REPORTING FROM ASLMS 2018
Key clinical point: Most physicians do not report adverse events related to noninvasive body contouring devices to the FDA .
Major finding: Of 83 medical device reports, 26 were related to cryolipolysis.
Study details: An analysis of 83 complications of noninvasive fat reduction and cellulite reduction devices reported to the FDA.
Disclosures: Dr. Wulkan reported having no financial disclosures. One study coauthor holds positions on advisory boards of, is a consultant for, and has intellectual property and/or stock options with various industry companies, such as Soliton and Allergan.
Source: Wulkan et al. ASLMS 2018.
Laser treatment of port wine stains in infancy found safe, effective
DALLAS – Laser treatment of port wine stains in infancy is both safe and effective, with no incidence of scarring or pigmentary changes, according to results from a single-center analysis.
“Early intervention allows for treatment without general anesthesia, with faster and more complete clearance than what has been reported for treatments begun at older ages,” Hana Jeon, MD, said at the annual conference of the American Society for Laser Medicine and Surgery.
A recent Food and Drug Administration Drug Safety Communication warned that “repeated or lengthy used of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains.” Dr. Jeon, a dermatologist in private practice in New York, noted that the FDA warning “places a greater importance on the already controversial topic of when to initiate port wine stain [PWS] treatments in pediatric patients, which requires repeated treatments and are often performed with general anesthesia. Without treatment, these lesions tend to get larger and thicker with time. Starting the treatment during infancy has the potential to limit the use of general anesthesia and to facilitate clearing.”
In what she said is the largest retrospective study of its kind to date, Dr. Jeon and her associates evaluated the success and safety of treating PWSs with a pulsed dye laser at the age of 1 year or younger in the office setting without general anesthesia. The patients received their first PWS treatment at their center during 2000-2017. They reviewed the charts of 197 patients to extract relevant data, including demographic information, age at the time of procedure, and treatment dates. The data cutoff was at 1 year following the initial treatment. Four physicians independently reviewed before and after photos and used the visual analogue scale to grade them.
The pulsed dye laser with dynamic cooling spray was used to minimize patient discomfort. No topical, local, or general anesthesia was used. Patients were immobilized by ancillary staff with parents present in most cases. Ocular shields were placed to allow treatment of periocular lesions.
Of the 197 patients, 63% were female, 90.1% had Fitzpatrick skin types I-III, 8.1% had type IV skin, and the rest had type V-VI skin. Most of the lesions were facial (75.6%), and 41.1% had periocular involvement. The average lesion size was 61 cm2.
The treatment settings for the pulsed dye laser were a 10-12 mm spot size delivered at a fluence of 6.5-9 J/cm2 in a pulse duration of 0.45-1.5 milliseconds. The average age at the time of first treatment was 3.4 months (range, 5-355 days), and the average number of treatments was 9.8 (range, 2-23). Most of the patients (116) were aged 0-3 months at the time of first treatment, followed by 51 aged 3-6 months, 19 aged 6-9 months, and 11 aged 9-12 months.
According to the averaged scores on the visual analogue scale assigned by physicians, 27.4% showed a 100% clearance, 39.1% showed 76%-99% improvement, 15.1% showed 51%-75% improvement, 10.7% showed 26%-50% improvement, and 7.7% showed 0%-25% improvement. No scarring or pigmentary changes were observed.
An analysis of dermatomal distribution revealed that the presence of a V1 lesion was a statistically significant predictor of a higher clearance rate, while the presence of a V3 lesion was a statistically significant predictor of a low clearance rate. “Regardless of where the lesion was, all patients did well,” she said.
Given the small proportion of patients who received their first treatment between the ages of 6 and 12 months of age, Dr. Jeon said that “further studies would be needed to elucidate whether earlier intervention helps to achieve better results.”*
Advantages of early treatment, she said, include the ability to “treat lesions before they get larger and thicker, which also decreases the risk of spontaneous bleeding. Thinner skin allows for better penetration of the laser beam, and we can also avoid using general anesthesia. Psychologically, if we’re able to clear these lesions, it can result in improved quality of life and self-esteem; not just for the patient but for the family as well.”
Dr. Jeon acknowledged certain limitations of the study, including its retrospective design, variable follow-up times, and non-standardization of photographs.
She reported having no financial disclosures.
SOURCE: Jeon H et al. ASLMS 2018.
Correction, 4/18/18: An earlier version of this article misstated the age range of the study participants.
DALLAS – Laser treatment of port wine stains in infancy is both safe and effective, with no incidence of scarring or pigmentary changes, according to results from a single-center analysis.
“Early intervention allows for treatment without general anesthesia, with faster and more complete clearance than what has been reported for treatments begun at older ages,” Hana Jeon, MD, said at the annual conference of the American Society for Laser Medicine and Surgery.
A recent Food and Drug Administration Drug Safety Communication warned that “repeated or lengthy used of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains.” Dr. Jeon, a dermatologist in private practice in New York, noted that the FDA warning “places a greater importance on the already controversial topic of when to initiate port wine stain [PWS] treatments in pediatric patients, which requires repeated treatments and are often performed with general anesthesia. Without treatment, these lesions tend to get larger and thicker with time. Starting the treatment during infancy has the potential to limit the use of general anesthesia and to facilitate clearing.”
In what she said is the largest retrospective study of its kind to date, Dr. Jeon and her associates evaluated the success and safety of treating PWSs with a pulsed dye laser at the age of 1 year or younger in the office setting without general anesthesia. The patients received their first PWS treatment at their center during 2000-2017. They reviewed the charts of 197 patients to extract relevant data, including demographic information, age at the time of procedure, and treatment dates. The data cutoff was at 1 year following the initial treatment. Four physicians independently reviewed before and after photos and used the visual analogue scale to grade them.
The pulsed dye laser with dynamic cooling spray was used to minimize patient discomfort. No topical, local, or general anesthesia was used. Patients were immobilized by ancillary staff with parents present in most cases. Ocular shields were placed to allow treatment of periocular lesions.
Of the 197 patients, 63% were female, 90.1% had Fitzpatrick skin types I-III, 8.1% had type IV skin, and the rest had type V-VI skin. Most of the lesions were facial (75.6%), and 41.1% had periocular involvement. The average lesion size was 61 cm2.
The treatment settings for the pulsed dye laser were a 10-12 mm spot size delivered at a fluence of 6.5-9 J/cm2 in a pulse duration of 0.45-1.5 milliseconds. The average age at the time of first treatment was 3.4 months (range, 5-355 days), and the average number of treatments was 9.8 (range, 2-23). Most of the patients (116) were aged 0-3 months at the time of first treatment, followed by 51 aged 3-6 months, 19 aged 6-9 months, and 11 aged 9-12 months.
According to the averaged scores on the visual analogue scale assigned by physicians, 27.4% showed a 100% clearance, 39.1% showed 76%-99% improvement, 15.1% showed 51%-75% improvement, 10.7% showed 26%-50% improvement, and 7.7% showed 0%-25% improvement. No scarring or pigmentary changes were observed.
An analysis of dermatomal distribution revealed that the presence of a V1 lesion was a statistically significant predictor of a higher clearance rate, while the presence of a V3 lesion was a statistically significant predictor of a low clearance rate. “Regardless of where the lesion was, all patients did well,” she said.
Given the small proportion of patients who received their first treatment between the ages of 6 and 12 months of age, Dr. Jeon said that “further studies would be needed to elucidate whether earlier intervention helps to achieve better results.”*
Advantages of early treatment, she said, include the ability to “treat lesions before they get larger and thicker, which also decreases the risk of spontaneous bleeding. Thinner skin allows for better penetration of the laser beam, and we can also avoid using general anesthesia. Psychologically, if we’re able to clear these lesions, it can result in improved quality of life and self-esteem; not just for the patient but for the family as well.”
Dr. Jeon acknowledged certain limitations of the study, including its retrospective design, variable follow-up times, and non-standardization of photographs.
She reported having no financial disclosures.
SOURCE: Jeon H et al. ASLMS 2018.
Correction, 4/18/18: An earlier version of this article misstated the age range of the study participants.
DALLAS – Laser treatment of port wine stains in infancy is both safe and effective, with no incidence of scarring or pigmentary changes, according to results from a single-center analysis.
“Early intervention allows for treatment without general anesthesia, with faster and more complete clearance than what has been reported for treatments begun at older ages,” Hana Jeon, MD, said at the annual conference of the American Society for Laser Medicine and Surgery.
A recent Food and Drug Administration Drug Safety Communication warned that “repeated or lengthy used of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains.” Dr. Jeon, a dermatologist in private practice in New York, noted that the FDA warning “places a greater importance on the already controversial topic of when to initiate port wine stain [PWS] treatments in pediatric patients, which requires repeated treatments and are often performed with general anesthesia. Without treatment, these lesions tend to get larger and thicker with time. Starting the treatment during infancy has the potential to limit the use of general anesthesia and to facilitate clearing.”
In what she said is the largest retrospective study of its kind to date, Dr. Jeon and her associates evaluated the success and safety of treating PWSs with a pulsed dye laser at the age of 1 year or younger in the office setting without general anesthesia. The patients received their first PWS treatment at their center during 2000-2017. They reviewed the charts of 197 patients to extract relevant data, including demographic information, age at the time of procedure, and treatment dates. The data cutoff was at 1 year following the initial treatment. Four physicians independently reviewed before and after photos and used the visual analogue scale to grade them.
The pulsed dye laser with dynamic cooling spray was used to minimize patient discomfort. No topical, local, or general anesthesia was used. Patients were immobilized by ancillary staff with parents present in most cases. Ocular shields were placed to allow treatment of periocular lesions.
Of the 197 patients, 63% were female, 90.1% had Fitzpatrick skin types I-III, 8.1% had type IV skin, and the rest had type V-VI skin. Most of the lesions were facial (75.6%), and 41.1% had periocular involvement. The average lesion size was 61 cm2.
The treatment settings for the pulsed dye laser were a 10-12 mm spot size delivered at a fluence of 6.5-9 J/cm2 in a pulse duration of 0.45-1.5 milliseconds. The average age at the time of first treatment was 3.4 months (range, 5-355 days), and the average number of treatments was 9.8 (range, 2-23). Most of the patients (116) were aged 0-3 months at the time of first treatment, followed by 51 aged 3-6 months, 19 aged 6-9 months, and 11 aged 9-12 months.
According to the averaged scores on the visual analogue scale assigned by physicians, 27.4% showed a 100% clearance, 39.1% showed 76%-99% improvement, 15.1% showed 51%-75% improvement, 10.7% showed 26%-50% improvement, and 7.7% showed 0%-25% improvement. No scarring or pigmentary changes were observed.
An analysis of dermatomal distribution revealed that the presence of a V1 lesion was a statistically significant predictor of a higher clearance rate, while the presence of a V3 lesion was a statistically significant predictor of a low clearance rate. “Regardless of where the lesion was, all patients did well,” she said.
Given the small proportion of patients who received their first treatment between the ages of 6 and 12 months of age, Dr. Jeon said that “further studies would be needed to elucidate whether earlier intervention helps to achieve better results.”*
Advantages of early treatment, she said, include the ability to “treat lesions before they get larger and thicker, which also decreases the risk of spontaneous bleeding. Thinner skin allows for better penetration of the laser beam, and we can also avoid using general anesthesia. Psychologically, if we’re able to clear these lesions, it can result in improved quality of life and self-esteem; not just for the patient but for the family as well.”
Dr. Jeon acknowledged certain limitations of the study, including its retrospective design, variable follow-up times, and non-standardization of photographs.
She reported having no financial disclosures.
SOURCE: Jeon H et al. ASLMS 2018.
Correction, 4/18/18: An earlier version of this article misstated the age range of the study participants.
REPORTING FROM ASLMS 2018
Key clinical point:
Major finding: On the visual analogue scale, 27.4% of infants achieved complete clearance of their port wine lesion after treatment.
Study details: An analysis of 197 infants aged 1 year or younger with port wine stains who were treated with a pulsed dye laser during 2000-2017.
Disclosures: Dr. Jeon reported having no financial disclosures.
Source: Jeon H et al. ASLMS 2018.
Enhanced recovery led to fewer complications for major oncologic procedures
CHICAGO – Use of an enhanced recovery protocol for oncology patients has been shown to improve outcomes in colorectal surgery but has been largely unproven in other types of major oncology operations. That prompted researchers at the University of Texas MD Anderson Cancer Center in Houston to investigate They found that the enhanced recovery protocol led to a reduction in complication rates and a decrease in hospital stay with no increase in readmissions, according to an analysis of more than 3,000 oncologic operations presented at the Society of Surgical Oncology Annual Cancer Symposium here.
“Patients treated with enhanced recovery did better,” Rebecca Marcus, MD, said in reporting the results. “There were decreased rates of perioperative transfusions, decreased rates of surgical site infections, decreased rates of complications, including severe complications such as wound dehiscence, pneumonia, renal failure, and unintended returns to the operating room.” She noted that the shorter hospital stays – 4 days for patients on the enhanced recovery protocol versus 5 days for those on the traditional postoperative protocol – did not result in increased readmissions.
The study reviewed 3,256 operations performed during 2011-2016 in the MD Anderson institutional American College of Surgeons National Surgical Quality Improvement Program database. The operations were colorectal (20.4%), gynecologic (19.5%), hepatobiliary (8.9%), thoracic (41.9%) and urologic (9.3%). Most employed the traditional postoperative protocol (53.4%). Colorectal and thoracic/vascular surgery were early adopters of the enhanced recovery protocol at MD Anderson.
Dr. Marcus noted that the overall complication rates were 21.9% for those treated with enhanced recovery–protocol versus 33.9% for those treated with traditional postoperative protocol (P less than .0001). The group treated with enhanced recovery protocol also had lower rates of severe complications: 8.7% vs. 11.7% (P =.0048). The study also noted a trend toward reduced National Surgical Quality Improvement Program 30-day mortality with the enhanced recover protocol (0.4% vs. 0.86%; P = .097). Readmission rates were similar between the two groups: 8.3% for enhanced recovery protocol versus 8.9% for traditional postoperative protocol.
The researchers performed a subanalysis of high-magnitude cases that had a relative value unit of 30 or more and involved operations of greater complexity, which constituted 38% of the study population. “In this group, we still saw the benefit of having treatment with an enhanced recovery protocol with decreased rates of preoperative transfusions, complications, and shorter length of stay without any recent readmission,” Dr. Marcus said. Complication rates in the high-magnitude group were 19% for the enhanced recovery protocol versus 26% for the traditional postoperative protocol in colorectal cases, 21% vs. 40% in gynecology, and 19% vs. 28% in thoracic/vascular.
“The beneficial impact of enhanced recovery appears to be maintained across all specialties and to be independent of case magnitude,” Dr. Marcus said.
She said future research of enhanced recovery in surgical oncology should focus on more long-term outcomes, “such as oncologic benefits of these protocols, especially given the known detrimental effect of the delayed return to adjuvant therapy for this patient population.”
Dr. Marcus and her coauthors reported having no financial disclosures.
SOURCE: Marcus RK et al. SSO 2018, Abstract 21.
CHICAGO – Use of an enhanced recovery protocol for oncology patients has been shown to improve outcomes in colorectal surgery but has been largely unproven in other types of major oncology operations. That prompted researchers at the University of Texas MD Anderson Cancer Center in Houston to investigate They found that the enhanced recovery protocol led to a reduction in complication rates and a decrease in hospital stay with no increase in readmissions, according to an analysis of more than 3,000 oncologic operations presented at the Society of Surgical Oncology Annual Cancer Symposium here.
“Patients treated with enhanced recovery did better,” Rebecca Marcus, MD, said in reporting the results. “There were decreased rates of perioperative transfusions, decreased rates of surgical site infections, decreased rates of complications, including severe complications such as wound dehiscence, pneumonia, renal failure, and unintended returns to the operating room.” She noted that the shorter hospital stays – 4 days for patients on the enhanced recovery protocol versus 5 days for those on the traditional postoperative protocol – did not result in increased readmissions.
The study reviewed 3,256 operations performed during 2011-2016 in the MD Anderson institutional American College of Surgeons National Surgical Quality Improvement Program database. The operations were colorectal (20.4%), gynecologic (19.5%), hepatobiliary (8.9%), thoracic (41.9%) and urologic (9.3%). Most employed the traditional postoperative protocol (53.4%). Colorectal and thoracic/vascular surgery were early adopters of the enhanced recovery protocol at MD Anderson.
Dr. Marcus noted that the overall complication rates were 21.9% for those treated with enhanced recovery–protocol versus 33.9% for those treated with traditional postoperative protocol (P less than .0001). The group treated with enhanced recovery protocol also had lower rates of severe complications: 8.7% vs. 11.7% (P =.0048). The study also noted a trend toward reduced National Surgical Quality Improvement Program 30-day mortality with the enhanced recover protocol (0.4% vs. 0.86%; P = .097). Readmission rates were similar between the two groups: 8.3% for enhanced recovery protocol versus 8.9% for traditional postoperative protocol.
The researchers performed a subanalysis of high-magnitude cases that had a relative value unit of 30 or more and involved operations of greater complexity, which constituted 38% of the study population. “In this group, we still saw the benefit of having treatment with an enhanced recovery protocol with decreased rates of preoperative transfusions, complications, and shorter length of stay without any recent readmission,” Dr. Marcus said. Complication rates in the high-magnitude group were 19% for the enhanced recovery protocol versus 26% for the traditional postoperative protocol in colorectal cases, 21% vs. 40% in gynecology, and 19% vs. 28% in thoracic/vascular.
“The beneficial impact of enhanced recovery appears to be maintained across all specialties and to be independent of case magnitude,” Dr. Marcus said.
She said future research of enhanced recovery in surgical oncology should focus on more long-term outcomes, “such as oncologic benefits of these protocols, especially given the known detrimental effect of the delayed return to adjuvant therapy for this patient population.”
Dr. Marcus and her coauthors reported having no financial disclosures.
SOURCE: Marcus RK et al. SSO 2018, Abstract 21.
CHICAGO – Use of an enhanced recovery protocol for oncology patients has been shown to improve outcomes in colorectal surgery but has been largely unproven in other types of major oncology operations. That prompted researchers at the University of Texas MD Anderson Cancer Center in Houston to investigate They found that the enhanced recovery protocol led to a reduction in complication rates and a decrease in hospital stay with no increase in readmissions, according to an analysis of more than 3,000 oncologic operations presented at the Society of Surgical Oncology Annual Cancer Symposium here.
“Patients treated with enhanced recovery did better,” Rebecca Marcus, MD, said in reporting the results. “There were decreased rates of perioperative transfusions, decreased rates of surgical site infections, decreased rates of complications, including severe complications such as wound dehiscence, pneumonia, renal failure, and unintended returns to the operating room.” She noted that the shorter hospital stays – 4 days for patients on the enhanced recovery protocol versus 5 days for those on the traditional postoperative protocol – did not result in increased readmissions.
The study reviewed 3,256 operations performed during 2011-2016 in the MD Anderson institutional American College of Surgeons National Surgical Quality Improvement Program database. The operations were colorectal (20.4%), gynecologic (19.5%), hepatobiliary (8.9%), thoracic (41.9%) and urologic (9.3%). Most employed the traditional postoperative protocol (53.4%). Colorectal and thoracic/vascular surgery were early adopters of the enhanced recovery protocol at MD Anderson.
Dr. Marcus noted that the overall complication rates were 21.9% for those treated with enhanced recovery–protocol versus 33.9% for those treated with traditional postoperative protocol (P less than .0001). The group treated with enhanced recovery protocol also had lower rates of severe complications: 8.7% vs. 11.7% (P =.0048). The study also noted a trend toward reduced National Surgical Quality Improvement Program 30-day mortality with the enhanced recover protocol (0.4% vs. 0.86%; P = .097). Readmission rates were similar between the two groups: 8.3% for enhanced recovery protocol versus 8.9% for traditional postoperative protocol.
The researchers performed a subanalysis of high-magnitude cases that had a relative value unit of 30 or more and involved operations of greater complexity, which constituted 38% of the study population. “In this group, we still saw the benefit of having treatment with an enhanced recovery protocol with decreased rates of preoperative transfusions, complications, and shorter length of stay without any recent readmission,” Dr. Marcus said. Complication rates in the high-magnitude group were 19% for the enhanced recovery protocol versus 26% for the traditional postoperative protocol in colorectal cases, 21% vs. 40% in gynecology, and 19% vs. 28% in thoracic/vascular.
“The beneficial impact of enhanced recovery appears to be maintained across all specialties and to be independent of case magnitude,” Dr. Marcus said.
She said future research of enhanced recovery in surgical oncology should focus on more long-term outcomes, “such as oncologic benefits of these protocols, especially given the known detrimental effect of the delayed return to adjuvant therapy for this patient population.”
Dr. Marcus and her coauthors reported having no financial disclosures.
SOURCE: Marcus RK et al. SSO 2018, Abstract 21.
REPORTING FROM SSO 2018
Key clinical point: Enhanced recovery protocol implementation is feasible in major oncologic surgery.
Major finding: Complication rates were 21.9% for enhanced recovery protocol versus 33.9% for traditional postoperative protocol.
Study details: Analysis of 3,256 oncology operations in an institutional ACS NSQIP database performed from 2011 to 2016.
Disclosures: Dr. Marcus and her coauthors reported having no financial disclosures.
Source: Marcus RK et al. SSO 2018, Abstract 21