Secondary surgical cytoreduction was feasible but did not extend overall survival among women with platinum-sensitive, recurrent ovarian cancer in a prospective, randomized, phase 3 clinical trial, investigators report.

Women who received platinum-based chemotherapy plus surgery had a median overall survival of about 51 months, compared with 64.7 months for women who received platinum-based chemotherapy and no surgery, according to the results of the Gynecologic Oncology Group (GOG)-0213 study, a multicenter, open-label, randomized, phase 3 trial.

These findings “call into question” the merits of surgical cytoreduction, said the authors, led by Robert L. Coleman, MD, of the department of gynecologic oncology and reproductive medicine at the University of Texas M.D. Anderson Cancer Center, Houston.

Specifically, the shorter overall survival in the surgery group vs. no-surgery group emphasizes the “importance of formally assessing the value of the procedure in clinical care,” said Dr. Coleman and coauthors in the report on GOG-0213. The study was published in the New England Journal of Medicine.

Clinical practice guidelines from the National Comprehensive Cancer Network currently cite secondary cytoreduction as an option for treatment of patients who experience a treatment-free interval of at least 6 months after a complete remission achieved on prior chemotherapy, the GOG-0213 investigators wrote.

Beyond GOG-0213, there are several other randomized trials underway in this setting, including DESKTOP III, a multicenter study comparing the efficacy of chemotherapy alone to chemotherapy plus additional tumor debulking surgery in women with recurrent platinum-sensitive ovarian cancer.

“Maturity of the DESKTOP III trial and other trials will shape the debate on the value or merit of surgery in this patient population,” wrote Dr. Coleman and colleagues.

The GOG-0213 study, conducted in 67 centers, 65 of which were in the United States, had both a chemotherapy objective and a surgical objective in patients with platinum-sensitive recurrent ovarian cancer, investigators said.

Results of the chemotherapy objective, published in 2017 in Lancet Oncology, indicated that bevacizumab added to standard chemotherapy, followed by maintenance bevacizumab until progression, improved median overall survival.

The more recently reported results focused on 485 women of who 245 were randomized to receive chemotherapy alone. While 240 were randomized to receive cytoreduction prior to chemotherapy, 15 declined surgery, leaving 225 eligible patients (94%).

The adjusted hazard ratio for death was 1.29 (95% confidence interval, 0.97-1.72; P = 0.08) for surgery, compared with no surgery, which translated into median overall survival times of 50.6 months in the surgery arm and 64.7 months in the no-surgery arm, Dr. Coleman and coauthors reported.

However, 30-day morbidity and mortality were low, at 9% (20 patients) and 0.4% (1 patient), and just 4% of cases (8 patients) were aborted, they added.

Quality of life significantly declined right after secondary cytoreduction, although after recovery no significant differences were found between groups, according to the investigators.

Taken together, those findings “did not indicate that surgery plus chemotherapy was superior to chemotherapy alone,” investigators concluded.

However, several factors in GOG-0213, including longer-than-expected survival times and substantial platinum sensitivity among women in the trial, could have diluted an independent surgical effect, they said.

Dr. Coleman reported disclosures related to several pharmaceutical companies, including Agenus, AstraZeneca, Clovis, GamaMabs, Genmab, Janssen, Medivation, Merck, Regeneron, Roche/Genentech, OncoQuest, and Tesaro.

SOURCE: Coleman RL et al. N Engl J Med. 2019;381:1929-39.

Secondary surgical cytoreduction was feasible but did not extend overall survival among women with platinum-sensitive, recurrent ovarian cancer in a prospective, randomized, phase 3 clinical trial, investigators report.

Women who received platinum-based chemotherapy plus surgery had a median overall survival of about 51 months, compared with 64.7 months for women who received platinum-based chemotherapy and no surgery, according to the results of the Gynecologic Oncology Group (GOG)-0213 study, a multicenter, open-label, randomized, phase 3 trial.

These findings “call into question” the merits of surgical cytoreduction, said the authors, led by Robert L. Coleman, MD, of the department of gynecologic oncology and reproductive medicine at the University of Texas M.D. Anderson Cancer Center, Houston.

Specifically, the shorter overall survival in the surgery group vs. no-surgery group emphasizes the “importance of formally assessing the value of the procedure in clinical care,” said Dr. Coleman and coauthors in the report on GOG-0213. The study was published in the New England Journal of Medicine.

Clinical practice guidelines from the National Comprehensive Cancer Network currently cite secondary cytoreduction as an option for treatment of patients who experience a treatment-free interval of at least 6 months after a complete remission achieved on prior chemotherapy, the GOG-0213 investigators wrote.

Beyond GOG-0213, there are several other randomized trials underway in this setting, including DESKTOP III, a multicenter study comparing the efficacy of chemotherapy alone to chemotherapy plus additional tumor debulking surgery in women with recurrent platinum-sensitive ovarian cancer.

“Maturity of the DESKTOP III trial and other trials will shape the debate on the value or merit of surgery in this patient population,” wrote Dr. Coleman and colleagues.

The GOG-0213 study, conducted in 67 centers, 65 of which were in the United States, had both a chemotherapy objective and a surgical objective in patients with platinum-sensitive recurrent ovarian cancer, investigators said.

Results of the chemotherapy objective, published in 2017 in Lancet Oncology, indicated that bevacizumab added to standard chemotherapy, followed by maintenance bevacizumab until progression, improved median overall survival.

The more recently reported results focused on 485 women of who 245 were randomized to receive chemotherapy alone. While 240 were randomized to receive cytoreduction prior to chemotherapy, 15 declined surgery, leaving 225 eligible patients (94%).

The adjusted hazard ratio for death was 1.29 (95% confidence interval, 0.97-1.72; P = 0.08) for surgery, compared with no surgery, which translated into median overall survival times of 50.6 months in the surgery arm and 64.7 months in the no-surgery arm, Dr. Coleman and coauthors reported.

However, 30-day morbidity and mortality were low, at 9% (20 patients) and 0.4% (1 patient), and just 4% of cases (8 patients) were aborted, they added.

Quality of life significantly declined right after secondary cytoreduction, although after recovery no significant differences were found between groups, according to the investigators.

Taken together, those findings “did not indicate that surgery plus chemotherapy was superior to chemotherapy alone,” investigators concluded.

However, several factors in GOG-0213, including longer-than-expected survival times and substantial platinum sensitivity among women in the trial, could have diluted an independent surgical effect, they said.

Dr. Coleman reported disclosures related to several pharmaceutical companies, including Agenus, AstraZeneca, Clovis, GamaMabs, Genmab, Janssen, Medivation, Merck, Regeneron, Roche/Genentech, OncoQuest, and Tesaro.

SOURCE: Coleman RL et al. N Engl J Med. 2019;381:1929-39.

Secondary surgical cytoreduction was feasible but did not extend overall survival among women with platinum-sensitive, recurrent ovarian cancer in a prospective, randomized, phase 3 clinical trial, investigators report.

Women who received platinum-based chemotherapy plus surgery had a median overall survival of about 51 months, compared with 64.7 months for women who received platinum-based chemotherapy and no surgery, according to the results of the Gynecologic Oncology Group (GOG)-0213 study, a multicenter, open-label, randomized, phase 3 trial.

These findings “call into question” the merits of surgical cytoreduction, said the authors, led by Robert L. Coleman, MD, of the department of gynecologic oncology and reproductive medicine at the University of Texas M.D. Anderson Cancer Center, Houston.

Specifically, the shorter overall survival in the surgery group vs. no-surgery group emphasizes the “importance of formally assessing the value of the procedure in clinical care,” said Dr. Coleman and coauthors in the report on GOG-0213. The study was published in the New England Journal of Medicine.

Clinical practice guidelines from the National Comprehensive Cancer Network currently cite secondary cytoreduction as an option for treatment of patients who experience a treatment-free interval of at least 6 months after a complete remission achieved on prior chemotherapy, the GOG-0213 investigators wrote.

Beyond GOG-0213, there are several other randomized trials underway in this setting, including DESKTOP III, a multicenter study comparing the efficacy of chemotherapy alone to chemotherapy plus additional tumor debulking surgery in women with recurrent platinum-sensitive ovarian cancer.

“Maturity of the DESKTOP III trial and other trials will shape the debate on the value or merit of surgery in this patient population,” wrote Dr. Coleman and colleagues.

The GOG-0213 study, conducted in 67 centers, 65 of which were in the United States, had both a chemotherapy objective and a surgical objective in patients with platinum-sensitive recurrent ovarian cancer, investigators said.

Results of the chemotherapy objective, published in 2017 in Lancet Oncology, indicated that bevacizumab added to standard chemotherapy, followed by maintenance bevacizumab until progression, improved median overall survival.

The more recently reported results focused on 485 women of who 245 were randomized to receive chemotherapy alone. While 240 were randomized to receive cytoreduction prior to chemotherapy, 15 declined surgery, leaving 225 eligible patients (94%).

The adjusted hazard ratio for death was 1.29 (95% confidence interval, 0.97-1.72; P = 0.08) for surgery, compared with no surgery, which translated into median overall survival times of 50.6 months in the surgery arm and 64.7 months in the no-surgery arm, Dr. Coleman and coauthors reported.

However, 30-day morbidity and mortality were low, at 9% (20 patients) and 0.4% (1 patient), and just 4% of cases (8 patients) were aborted, they added.

Quality of life significantly declined right after secondary cytoreduction, although after recovery no significant differences were found between groups, according to the investigators.

Taken together, those findings “did not indicate that surgery plus chemotherapy was superior to chemotherapy alone,” investigators concluded.

However, several factors in GOG-0213, including longer-than-expected survival times and substantial platinum sensitivity among women in the trial, could have diluted an independent surgical effect, they said.

Dr. Coleman reported disclosures related to several pharmaceutical companies, including Agenus, AstraZeneca, Clovis, GamaMabs, Genmab, Janssen, Medivation, Merck, Regeneron, Roche/Genentech, OncoQuest, and Tesaro.

SOURCE: Coleman RL et al. N Engl J Med. 2019;381:1929-39.

CHARLOTTE, N.C. – Children and adolescents without a history of headache may develop prolonged headaches after sustaining a concussion, according to research presented at the annual meeting of the Child Neurology Society. The headache may be migraine, chronic daily headache, tension-type headache, or a combination of these headaches.

“We strongly recommend that individuals who develop persistent headache after a concussion be evaluated and treated by a neurologist with experience in administering treatment for headache,” said Marcus Barissi, Weller Scholar at the Cleveland Clinic, and colleagues. “Using this approach, we hope that their prolonged headaches will be lessened.”
 

Few studies have examined prolonged pediatric postconcussion headache

The Centers for Disease Control and Prevention estimates that between 1.6 million and 3.8 million concussions occur annually during athletic and recreational activities in the United States. About 90% of concussions affect children or adolescents. The symptom most often reported after concussion is headache.

Few studies have focused on new persistent postconcussion headache (NPPCH) in children. Mr. Barissi and colleagues did not find any previous study that had examined prolonged headache following concussion in patients without prior chronic headache. They sought to ascertain the prognosis of patients with NPPCH and no history of prior headache, to describe this clinical entity, and to identify beneficial treatment methods.

The investigators retrospectively reviewed charts for approximately 2,000 patients who presented to the Cleveland Clinic pediatric neurology department between June 2017 and August 2018 for headaches. They identified 259 patients who received a diagnosis of concussion, 69 (27%) of whom had headaches for longer than 2 months after injury.

Mr. Barissi and colleagues emailed these patients, and 33 (48%) of them agreed to complete a questionnaire and participate in a 10-minute phone interview. Thirty-one patients (43%) could not be contacted, and eight (11%) declined to participate. All participants confirmed that they had not had consistent headache before the concussion and that chronic headache had arisen after concussion. To determine participants’ medical outcomes, the researchers compared participants’ initial assessment data with posttreatment data collected during the interview process.
 

Healthy behaviors increased after concussion

Of the 69 eligible participants, 38 (55%) were female. The population’s median age was 17. Twenty-eight (85%) of the 33 patients who completed the questionnaire considered the information and treatment that they had received to be beneficial. Twenty-five (78%) patients continued to have headache after several months, despite treatment.

Participants had withstood a mean of 1.72 concussions, and the mean age at first injury was 12.49 years. The most common cause of injury was a fall for males (36%) and an automobile accident for females (18%).

Forty-eight patients (70%) reported having two types of headache. Fifty-two patients (75%) had migraines, and 65 (94%) had chronic daily headache or tension-type headache. Forty-eight (70%) participants had a family history of headache.

In all, 64 patients (93%) had used a headache medication. The most common headache medications used were amitriptyline, topiramate, and cyproheptadine. Few patients were still taking these medications at several months after evaluation. The most common nonprescription medications used were Migravent (i.e., magnesium, riboflavin, coenzyme Q10, and butterbur), ondansetron, and melatonin. Furthermore, 61 patients (88%) participated in nonmedicinal therapy such as physical therapy, chiropractic therapy, and acupuncture.

After evaluation, patients engaged in several healthy behaviors (e.g., adequate exercise, proper use of over-the-counter medications, and drinking sufficient water) more frequently, but did not get adequate sleep. Sixty-five participants (94%) had undergone CT or MRI imaging, but the results did not improve understanding of headache etiology or treatment. Many patients missed several days of school, but average attendance improved after months of treatment.
 

Long-term outcomes

Thirty-one survey respondents (94%) reported that their emotional, cognitive, sleep, and somatic postconcussion symptoms had resolved. Nevertheless, a majority of participants still had headache. “The persistence of postconcussion symptoms is uncommon, but lasting headache is not,” said the researchers. “If patients are not properly educated, conditions may deteriorate, extending the duration of disability.” A longer study with a larger sample size could provide valuable information, said the researchers. Future work should examine objectively the efficacy of various medications used to treat NPPCH and determine the best methods of treatment for this syndrome, which “can cause prolonged pain, suffering, and lack of function,” they concluded.

The investigators did not report any study funding or disclosures.

[email protected]

SOURCE: Barissi M et al. CNS 2019, Abstract 95.

CHARLOTTE, N.C. – Children and adolescents without a history of headache may develop prolonged headaches after sustaining a concussion, according to research presented at the annual meeting of the Child Neurology Society. The headache may be migraine, chronic daily headache, tension-type headache, or a combination of these headaches.

“We strongly recommend that individuals who develop persistent headache after a concussion be evaluated and treated by a neurologist with experience in administering treatment for headache,” said Marcus Barissi, Weller Scholar at the Cleveland Clinic, and colleagues. “Using this approach, we hope that their prolonged headaches will be lessened.”
 

Few studies have examined prolonged pediatric postconcussion headache

The Centers for Disease Control and Prevention estimates that between 1.6 million and 3.8 million concussions occur annually during athletic and recreational activities in the United States. About 90% of concussions affect children or adolescents. The symptom most often reported after concussion is headache.

Few studies have focused on new persistent postconcussion headache (NPPCH) in children. Mr. Barissi and colleagues did not find any previous study that had examined prolonged headache following concussion in patients without prior chronic headache. They sought to ascertain the prognosis of patients with NPPCH and no history of prior headache, to describe this clinical entity, and to identify beneficial treatment methods.

The investigators retrospectively reviewed charts for approximately 2,000 patients who presented to the Cleveland Clinic pediatric neurology department between June 2017 and August 2018 for headaches. They identified 259 patients who received a diagnosis of concussion, 69 (27%) of whom had headaches for longer than 2 months after injury.

Mr. Barissi and colleagues emailed these patients, and 33 (48%) of them agreed to complete a questionnaire and participate in a 10-minute phone interview. Thirty-one patients (43%) could not be contacted, and eight (11%) declined to participate. All participants confirmed that they had not had consistent headache before the concussion and that chronic headache had arisen after concussion. To determine participants’ medical outcomes, the researchers compared participants’ initial assessment data with posttreatment data collected during the interview process.
 

Healthy behaviors increased after concussion

Of the 69 eligible participants, 38 (55%) were female. The population’s median age was 17. Twenty-eight (85%) of the 33 patients who completed the questionnaire considered the information and treatment that they had received to be beneficial. Twenty-five (78%) patients continued to have headache after several months, despite treatment.

Participants had withstood a mean of 1.72 concussions, and the mean age at first injury was 12.49 years. The most common cause of injury was a fall for males (36%) and an automobile accident for females (18%).

Forty-eight patients (70%) reported having two types of headache. Fifty-two patients (75%) had migraines, and 65 (94%) had chronic daily headache or tension-type headache. Forty-eight (70%) participants had a family history of headache.

In all, 64 patients (93%) had used a headache medication. The most common headache medications used were amitriptyline, topiramate, and cyproheptadine. Few patients were still taking these medications at several months after evaluation. The most common nonprescription medications used were Migravent (i.e., magnesium, riboflavin, coenzyme Q10, and butterbur), ondansetron, and melatonin. Furthermore, 61 patients (88%) participated in nonmedicinal therapy such as physical therapy, chiropractic therapy, and acupuncture.

After evaluation, patients engaged in several healthy behaviors (e.g., adequate exercise, proper use of over-the-counter medications, and drinking sufficient water) more frequently, but did not get adequate sleep. Sixty-five participants (94%) had undergone CT or MRI imaging, but the results did not improve understanding of headache etiology or treatment. Many patients missed several days of school, but average attendance improved after months of treatment.
 

Long-term outcomes

Thirty-one survey respondents (94%) reported that their emotional, cognitive, sleep, and somatic postconcussion symptoms had resolved. Nevertheless, a majority of participants still had headache. “The persistence of postconcussion symptoms is uncommon, but lasting headache is not,” said the researchers. “If patients are not properly educated, conditions may deteriorate, extending the duration of disability.” A longer study with a larger sample size could provide valuable information, said the researchers. Future work should examine objectively the efficacy of various medications used to treat NPPCH and determine the best methods of treatment for this syndrome, which “can cause prolonged pain, suffering, and lack of function,” they concluded.

The investigators did not report any study funding or disclosures.

[email protected]

SOURCE: Barissi M et al. CNS 2019, Abstract 95.

CHARLOTTE, N.C. – Children and adolescents without a history of headache may develop prolonged headaches after sustaining a concussion, according to research presented at the annual meeting of the Child Neurology Society. The headache may be migraine, chronic daily headache, tension-type headache, or a combination of these headaches.

“We strongly recommend that individuals who develop persistent headache after a concussion be evaluated and treated by a neurologist with experience in administering treatment for headache,” said Marcus Barissi, Weller Scholar at the Cleveland Clinic, and colleagues. “Using this approach, we hope that their prolonged headaches will be lessened.”
 

Few studies have examined prolonged pediatric postconcussion headache

The Centers for Disease Control and Prevention estimates that between 1.6 million and 3.8 million concussions occur annually during athletic and recreational activities in the United States. About 90% of concussions affect children or adolescents. The symptom most often reported after concussion is headache.

Few studies have focused on new persistent postconcussion headache (NPPCH) in children. Mr. Barissi and colleagues did not find any previous study that had examined prolonged headache following concussion in patients without prior chronic headache. They sought to ascertain the prognosis of patients with NPPCH and no history of prior headache, to describe this clinical entity, and to identify beneficial treatment methods.

The investigators retrospectively reviewed charts for approximately 2,000 patients who presented to the Cleveland Clinic pediatric neurology department between June 2017 and August 2018 for headaches. They identified 259 patients who received a diagnosis of concussion, 69 (27%) of whom had headaches for longer than 2 months after injury.

Mr. Barissi and colleagues emailed these patients, and 33 (48%) of them agreed to complete a questionnaire and participate in a 10-minute phone interview. Thirty-one patients (43%) could not be contacted, and eight (11%) declined to participate. All participants confirmed that they had not had consistent headache before the concussion and that chronic headache had arisen after concussion. To determine participants’ medical outcomes, the researchers compared participants’ initial assessment data with posttreatment data collected during the interview process.
 

Healthy behaviors increased after concussion

Of the 69 eligible participants, 38 (55%) were female. The population’s median age was 17. Twenty-eight (85%) of the 33 patients who completed the questionnaire considered the information and treatment that they had received to be beneficial. Twenty-five (78%) patients continued to have headache after several months, despite treatment.

Participants had withstood a mean of 1.72 concussions, and the mean age at first injury was 12.49 years. The most common cause of injury was a fall for males (36%) and an automobile accident for females (18%).

Forty-eight patients (70%) reported having two types of headache. Fifty-two patients (75%) had migraines, and 65 (94%) had chronic daily headache or tension-type headache. Forty-eight (70%) participants had a family history of headache.

In all, 64 patients (93%) had used a headache medication. The most common headache medications used were amitriptyline, topiramate, and cyproheptadine. Few patients were still taking these medications at several months after evaluation. The most common nonprescription medications used were Migravent (i.e., magnesium, riboflavin, coenzyme Q10, and butterbur), ondansetron, and melatonin. Furthermore, 61 patients (88%) participated in nonmedicinal therapy such as physical therapy, chiropractic therapy, and acupuncture.

After evaluation, patients engaged in several healthy behaviors (e.g., adequate exercise, proper use of over-the-counter medications, and drinking sufficient water) more frequently, but did not get adequate sleep. Sixty-five participants (94%) had undergone CT or MRI imaging, but the results did not improve understanding of headache etiology or treatment. Many patients missed several days of school, but average attendance improved after months of treatment.
 

Long-term outcomes

Thirty-one survey respondents (94%) reported that their emotional, cognitive, sleep, and somatic postconcussion symptoms had resolved. Nevertheless, a majority of participants still had headache. “The persistence of postconcussion symptoms is uncommon, but lasting headache is not,” said the researchers. “If patients are not properly educated, conditions may deteriorate, extending the duration of disability.” A longer study with a larger sample size could provide valuable information, said the researchers. Future work should examine objectively the efficacy of various medications used to treat NPPCH and determine the best methods of treatment for this syndrome, which “can cause prolonged pain, suffering, and lack of function,” they concluded.

The investigators did not report any study funding or disclosures.

[email protected]

SOURCE: Barissi M et al. CNS 2019, Abstract 95.

PHILADELPHIA – Postmenopausal women are at risk of numerous medical conditions after the onset of menopause, but many ob.gyns feel uncomfortable treating those patients, according to a keynote speaker at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

The population of women entering menopause continues to rise, and they are at risk for developing chronic diseases about a decade after the onset of menopause, said Rogerio A. Lobo, MD, professor of obstetrics and gynecology at Columbia University, New York.

“For me, from a primary care perspective, there’s a major opportunity for all of us providers at the onset of menopause to identify risks and initiate preventive strategies,” he said.

These newly menopausal women are at risk for diseases across multiple specialty areas, which include obesity, metabolic syndrome, diabetes, cardiovascular disease, osteoporosis, chronic arthritis, dementia, cognitive decline, depression, and cancer. “My focus along these lines is really longevity, reduction in mortality as well as quality of life,” said Dr. Lobo.

Understanding of the benefits of estrogen therapy for postmenopausal women began with work in two studies in the 1990s. One paper by Meir J. Stampfer, MD, and associates on 15 studies examining the effects of hormone therapy on coronary heart disease (CHD) found that the relative risk of estrogen therapy on the disease was 0.50 (95% confidence interval, 0.43-0.56) after adjusting for only prospective and angiographic studies (Prev Med. 1991;20[1]:47-63).

A second paper by Deborah Grady, MD, MPH, and associates found that hormone therapy with estrogen plus progestin decreased the risk of CHD and hip fracture in women but increased the risk of endometrial and breast cancer, and carried a recommendation for using estrogen plus progestin for women who have received a hysterectomy or who are at high risk for CHD (Ann Intern Med. 1992 Dec 15;117[12]:1016-37).

In the early 2000s, data from the Women’s Health Initiative (WHI) began to show a different story: Therapy with estrogen plus progestin was shown to carry risks of early harm in postmenopausal women, and one study by JoAnn E. Manson, MD, DrPH, and associates had a hazard ratio of 1.24 (nominal 95% confidence interval, 1.00-1.54) for CHD in postmenopausal women aged 50-79 years receiving the combined therapy (N Engl J Med. 2003;349:523-34).

The confidence intervals were later adjusted so the association was not significant, but the results led to conclusions that hormone therapy was harmful to women and increased risk of breast cancer, declining cognition, and dementia, as well as cardiovascular diseases such as coronary disease, stroke and thrombosis.

“That was the dogma for many people to this day, but it was clearly a rush to judgment,” said Dr. Lobo. “More harm than good was done for the field.”

The contradictory findings from the WHI and other studies may be explained by the timing of hormone therapy, Dr. Lobo explained. In the ELITE trial, 643 postmenopausal women, stratified into early-postmenopausal (less than 6 years) and late-postmenopausal (equal to or greater than 10 years) groups, received 1 mg of daily oral 17-beta-estradiol with 45 mg of progesterone vaginal gel or placebo. Researchers found that it was beneficial for preventing the progression of subclinical atherosclerosis when therapy was initiated in early but not in late menopause (N Eng J Med. 2016; 374:1221-31).

Estrogen also has benefits for the brain, and might help improve rates of cognitive decline and Alzheimer’s disease in postmenopausal women, Dr. Lobo said. Of the 1,768 women in the Cache County Study who described their use of hormone therapy after menopause, 176 women developed Alzheimer’s; however, use of hormone therapy within 5 years of menopause was associated with a 30% reduced risk of Alzheimer’s (95% confidence interval, 0.49-0.99) and had better benefits for long-term use up to 10 years. But this effect was not present in women who started hormone therapy 5 years or more after onset of menopause (Neurology. 2012 Oct 30. doi: 10.1212/WNL.0b013e318271f823).

Clinicians also should look at the risk of hormone therapy in terms of absolute real risk rather than relative risk. “In WHI, even though many of these events were not statistically significant, even if they assumed they were, the absolute numbers were 7-8 events per 10,000 women per year,” he said. “Those, according to WHI, are rare events if they’re even true.”

“For breast cancer, which is a big concern a lot of women have, endogenous risk factors are much higher than what hormones do,” he added.

Yet clinicians continue to act on data from the WHI, Dr. Lobo noted. In fact, many ob.gyns. report that they are uncomfortable treating women with symptoms associated with menopause.

“Post WHI, we have lost at least a generation of providers who do not deal with menopause,” he added. “Three out of four women who seek help for symptoms don’t receive it. The practice of menopause has largely disappeared from for many, many practices.”

The American Society for Reproductive Medicine used to have a “menopause day,” but the society no longer offers a track for menopause, Dr. Lobo said. One solution aimed at addressing the absence of training might be a menopause curriculum for ob.gyn. residents to help them initiate prevention strategies for postmenopausal women and have the confidence to manage this patient population. Dr. Lobo cited one study from Johns Hopkins where ob.gyn. residents underwent a 2-year menopause medicine curriculum and scored significantly higher on posttest scores after completing the program (78.7% vs. 57.3%; P less than .05). After the curriculum, 85.7% also reported they were more comfortable treating patients with menopause (Menopause. 2016 Mar. 23[3]:275-9).

Work also needs to be done on the front of understanding which hormone therapies are most effective for postmenopausal women. While there is currently no one hormone therapy to specifically recommend, in the future, pharmacogenetics and genetic or molecular risk analyses will play a role in knowing which products to prescribe. “It can be done, to be able to have a clear path for longevity and improved quality of life,” Dr. Lobo said.

Dr. Lobo reported serving as a consultant to Amgen, Mithra, Sojournix, and TherapeuticsMD. In addition, his institution is receiving support from Bayer and the National Institutes of Health for a clinical trial.

PHILADELPHIA – Postmenopausal women are at risk of numerous medical conditions after the onset of menopause, but many ob.gyns feel uncomfortable treating those patients, according to a keynote speaker at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

The population of women entering menopause continues to rise, and they are at risk for developing chronic diseases about a decade after the onset of menopause, said Rogerio A. Lobo, MD, professor of obstetrics and gynecology at Columbia University, New York.

“For me, from a primary care perspective, there’s a major opportunity for all of us providers at the onset of menopause to identify risks and initiate preventive strategies,” he said.

These newly menopausal women are at risk for diseases across multiple specialty areas, which include obesity, metabolic syndrome, diabetes, cardiovascular disease, osteoporosis, chronic arthritis, dementia, cognitive decline, depression, and cancer. “My focus along these lines is really longevity, reduction in mortality as well as quality of life,” said Dr. Lobo.

Understanding of the benefits of estrogen therapy for postmenopausal women began with work in two studies in the 1990s. One paper by Meir J. Stampfer, MD, and associates on 15 studies examining the effects of hormone therapy on coronary heart disease (CHD) found that the relative risk of estrogen therapy on the disease was 0.50 (95% confidence interval, 0.43-0.56) after adjusting for only prospective and angiographic studies (Prev Med. 1991;20[1]:47-63).

A second paper by Deborah Grady, MD, MPH, and associates found that hormone therapy with estrogen plus progestin decreased the risk of CHD and hip fracture in women but increased the risk of endometrial and breast cancer, and carried a recommendation for using estrogen plus progestin for women who have received a hysterectomy or who are at high risk for CHD (Ann Intern Med. 1992 Dec 15;117[12]:1016-37).

In the early 2000s, data from the Women’s Health Initiative (WHI) began to show a different story: Therapy with estrogen plus progestin was shown to carry risks of early harm in postmenopausal women, and one study by JoAnn E. Manson, MD, DrPH, and associates had a hazard ratio of 1.24 (nominal 95% confidence interval, 1.00-1.54) for CHD in postmenopausal women aged 50-79 years receiving the combined therapy (N Engl J Med. 2003;349:523-34).

The confidence intervals were later adjusted so the association was not significant, but the results led to conclusions that hormone therapy was harmful to women and increased risk of breast cancer, declining cognition, and dementia, as well as cardiovascular diseases such as coronary disease, stroke and thrombosis.

“That was the dogma for many people to this day, but it was clearly a rush to judgment,” said Dr. Lobo. “More harm than good was done for the field.”

The contradictory findings from the WHI and other studies may be explained by the timing of hormone therapy, Dr. Lobo explained. In the ELITE trial, 643 postmenopausal women, stratified into early-postmenopausal (less than 6 years) and late-postmenopausal (equal to or greater than 10 years) groups, received 1 mg of daily oral 17-beta-estradiol with 45 mg of progesterone vaginal gel or placebo. Researchers found that it was beneficial for preventing the progression of subclinical atherosclerosis when therapy was initiated in early but not in late menopause (N Eng J Med. 2016; 374:1221-31).

Estrogen also has benefits for the brain, and might help improve rates of cognitive decline and Alzheimer’s disease in postmenopausal women, Dr. Lobo said. Of the 1,768 women in the Cache County Study who described their use of hormone therapy after menopause, 176 women developed Alzheimer’s; however, use of hormone therapy within 5 years of menopause was associated with a 30% reduced risk of Alzheimer’s (95% confidence interval, 0.49-0.99) and had better benefits for long-term use up to 10 years. But this effect was not present in women who started hormone therapy 5 years or more after onset of menopause (Neurology. 2012 Oct 30. doi: 10.1212/WNL.0b013e318271f823).

Clinicians also should look at the risk of hormone therapy in terms of absolute real risk rather than relative risk. “In WHI, even though many of these events were not statistically significant, even if they assumed they were, the absolute numbers were 7-8 events per 10,000 women per year,” he said. “Those, according to WHI, are rare events if they’re even true.”

“For breast cancer, which is a big concern a lot of women have, endogenous risk factors are much higher than what hormones do,” he added.

Yet clinicians continue to act on data from the WHI, Dr. Lobo noted. In fact, many ob.gyns. report that they are uncomfortable treating women with symptoms associated with menopause.

“Post WHI, we have lost at least a generation of providers who do not deal with menopause,” he added. “Three out of four women who seek help for symptoms don’t receive it. The practice of menopause has largely disappeared from for many, many practices.”

The American Society for Reproductive Medicine used to have a “menopause day,” but the society no longer offers a track for menopause, Dr. Lobo said. One solution aimed at addressing the absence of training might be a menopause curriculum for ob.gyn. residents to help them initiate prevention strategies for postmenopausal women and have the confidence to manage this patient population. Dr. Lobo cited one study from Johns Hopkins where ob.gyn. residents underwent a 2-year menopause medicine curriculum and scored significantly higher on posttest scores after completing the program (78.7% vs. 57.3%; P less than .05). After the curriculum, 85.7% also reported they were more comfortable treating patients with menopause (Menopause. 2016 Mar. 23[3]:275-9).

Work also needs to be done on the front of understanding which hormone therapies are most effective for postmenopausal women. While there is currently no one hormone therapy to specifically recommend, in the future, pharmacogenetics and genetic or molecular risk analyses will play a role in knowing which products to prescribe. “It can be done, to be able to have a clear path for longevity and improved quality of life,” Dr. Lobo said.

Dr. Lobo reported serving as a consultant to Amgen, Mithra, Sojournix, and TherapeuticsMD. In addition, his institution is receiving support from Bayer and the National Institutes of Health for a clinical trial.

PHILADELPHIA – Postmenopausal women are at risk of numerous medical conditions after the onset of menopause, but many ob.gyns feel uncomfortable treating those patients, according to a keynote speaker at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

The population of women entering menopause continues to rise, and they are at risk for developing chronic diseases about a decade after the onset of menopause, said Rogerio A. Lobo, MD, professor of obstetrics and gynecology at Columbia University, New York.

“For me, from a primary care perspective, there’s a major opportunity for all of us providers at the onset of menopause to identify risks and initiate preventive strategies,” he said.

These newly menopausal women are at risk for diseases across multiple specialty areas, which include obesity, metabolic syndrome, diabetes, cardiovascular disease, osteoporosis, chronic arthritis, dementia, cognitive decline, depression, and cancer. “My focus along these lines is really longevity, reduction in mortality as well as quality of life,” said Dr. Lobo.

Understanding of the benefits of estrogen therapy for postmenopausal women began with work in two studies in the 1990s. One paper by Meir J. Stampfer, MD, and associates on 15 studies examining the effects of hormone therapy on coronary heart disease (CHD) found that the relative risk of estrogen therapy on the disease was 0.50 (95% confidence interval, 0.43-0.56) after adjusting for only prospective and angiographic studies (Prev Med. 1991;20[1]:47-63).

A second paper by Deborah Grady, MD, MPH, and associates found that hormone therapy with estrogen plus progestin decreased the risk of CHD and hip fracture in women but increased the risk of endometrial and breast cancer, and carried a recommendation for using estrogen plus progestin for women who have received a hysterectomy or who are at high risk for CHD (Ann Intern Med. 1992 Dec 15;117[12]:1016-37).

In the early 2000s, data from the Women’s Health Initiative (WHI) began to show a different story: Therapy with estrogen plus progestin was shown to carry risks of early harm in postmenopausal women, and one study by JoAnn E. Manson, MD, DrPH, and associates had a hazard ratio of 1.24 (nominal 95% confidence interval, 1.00-1.54) for CHD in postmenopausal women aged 50-79 years receiving the combined therapy (N Engl J Med. 2003;349:523-34).

The confidence intervals were later adjusted so the association was not significant, but the results led to conclusions that hormone therapy was harmful to women and increased risk of breast cancer, declining cognition, and dementia, as well as cardiovascular diseases such as coronary disease, stroke and thrombosis.

“That was the dogma for many people to this day, but it was clearly a rush to judgment,” said Dr. Lobo. “More harm than good was done for the field.”

The contradictory findings from the WHI and other studies may be explained by the timing of hormone therapy, Dr. Lobo explained. In the ELITE trial, 643 postmenopausal women, stratified into early-postmenopausal (less than 6 years) and late-postmenopausal (equal to or greater than 10 years) groups, received 1 mg of daily oral 17-beta-estradiol with 45 mg of progesterone vaginal gel or placebo. Researchers found that it was beneficial for preventing the progression of subclinical atherosclerosis when therapy was initiated in early but not in late menopause (N Eng J Med. 2016; 374:1221-31).

Estrogen also has benefits for the brain, and might help improve rates of cognitive decline and Alzheimer’s disease in postmenopausal women, Dr. Lobo said. Of the 1,768 women in the Cache County Study who described their use of hormone therapy after menopause, 176 women developed Alzheimer’s; however, use of hormone therapy within 5 years of menopause was associated with a 30% reduced risk of Alzheimer’s (95% confidence interval, 0.49-0.99) and had better benefits for long-term use up to 10 years. But this effect was not present in women who started hormone therapy 5 years or more after onset of menopause (Neurology. 2012 Oct 30. doi: 10.1212/WNL.0b013e318271f823).

Clinicians also should look at the risk of hormone therapy in terms of absolute real risk rather than relative risk. “In WHI, even though many of these events were not statistically significant, even if they assumed they were, the absolute numbers were 7-8 events per 10,000 women per year,” he said. “Those, according to WHI, are rare events if they’re even true.”

“For breast cancer, which is a big concern a lot of women have, endogenous risk factors are much higher than what hormones do,” he added.

Yet clinicians continue to act on data from the WHI, Dr. Lobo noted. In fact, many ob.gyns. report that they are uncomfortable treating women with symptoms associated with menopause.

“Post WHI, we have lost at least a generation of providers who do not deal with menopause,” he added. “Three out of four women who seek help for symptoms don’t receive it. The practice of menopause has largely disappeared from for many, many practices.”

The American Society for Reproductive Medicine used to have a “menopause day,” but the society no longer offers a track for menopause, Dr. Lobo said. One solution aimed at addressing the absence of training might be a menopause curriculum for ob.gyn. residents to help them initiate prevention strategies for postmenopausal women and have the confidence to manage this patient population. Dr. Lobo cited one study from Johns Hopkins where ob.gyn. residents underwent a 2-year menopause medicine curriculum and scored significantly higher on posttest scores after completing the program (78.7% vs. 57.3%; P less than .05). After the curriculum, 85.7% also reported they were more comfortable treating patients with menopause (Menopause. 2016 Mar. 23[3]:275-9).

Work also needs to be done on the front of understanding which hormone therapies are most effective for postmenopausal women. While there is currently no one hormone therapy to specifically recommend, in the future, pharmacogenetics and genetic or molecular risk analyses will play a role in knowing which products to prescribe. “It can be done, to be able to have a clear path for longevity and improved quality of life,” Dr. Lobo said.

Dr. Lobo reported serving as a consultant to Amgen, Mithra, Sojournix, and TherapeuticsMD. In addition, his institution is receiving support from Bayer and the National Institutes of Health for a clinical trial.

The Food and Drug Administration has cleared adalimumab-afzb (Abrilada) as the fifth approved Humira biosimilar and the 25th approved biosimilar drug overall, the agency said in a Nov. 15 announcement.

Olivier Le Moal/Getty Images

According to a press release from Pfizer, approval for Abrilada was based on review of a comprehensive data package demonstrating biosimilarity of the drug to the reference product. This included data from a clinical comparative study, which found no clinically meaningful difference between Abrilada and the reference in terms of efficacy, safety, and immunogenicity in patients with moderate to severe rheumatoid arthritis (RA). In addition to RA, Abrilada is indicated for juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis.

Common adverse events in adalimumab clinical trials included infection, injection-site reactions, headache, and rash.

Pfizer said that it “is working to make Abrilada available to U.S. patients as soon as feasible based on the terms of our agreement with AbbVie [the manufacturer of Humira]. Our current plans are to launch in 2023.”

[email protected]

The Food and Drug Administration has cleared adalimumab-afzb (Abrilada) as the fifth approved Humira biosimilar and the 25th approved biosimilar drug overall, the agency said in a Nov. 15 announcement.

Olivier Le Moal/Getty Images

According to a press release from Pfizer, approval for Abrilada was based on review of a comprehensive data package demonstrating biosimilarity of the drug to the reference product. This included data from a clinical comparative study, which found no clinically meaningful difference between Abrilada and the reference in terms of efficacy, safety, and immunogenicity in patients with moderate to severe rheumatoid arthritis (RA). In addition to RA, Abrilada is indicated for juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis.

Common adverse events in adalimumab clinical trials included infection, injection-site reactions, headache, and rash.

Pfizer said that it “is working to make Abrilada available to U.S. patients as soon as feasible based on the terms of our agreement with AbbVie [the manufacturer of Humira]. Our current plans are to launch in 2023.”

[email protected]

The Food and Drug Administration has cleared adalimumab-afzb (Abrilada) as the fifth approved Humira biosimilar and the 25th approved biosimilar drug overall, the agency said in a Nov. 15 announcement.

Olivier Le Moal/Getty Images

According to a press release from Pfizer, approval for Abrilada was based on review of a comprehensive data package demonstrating biosimilarity of the drug to the reference product. This included data from a clinical comparative study, which found no clinically meaningful difference between Abrilada and the reference in terms of efficacy, safety, and immunogenicity in patients with moderate to severe rheumatoid arthritis (RA). In addition to RA, Abrilada is indicated for juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis.

Common adverse events in adalimumab clinical trials included infection, injection-site reactions, headache, and rash.

Pfizer said that it “is working to make Abrilada available to U.S. patients as soon as feasible based on the terms of our agreement with AbbVie [the manufacturer of Humira]. Our current plans are to launch in 2023.”

[email protected]

The case

CDC/Jennifer Hulsey

A 67-year-old woman with a past medical history significant for diabetes mellitus type 2 and chronic kidney disease stage 3 was recently hospitalized for a community acquired pneumonia and treated for 5 days with moxifloxacin. In the week following this hospitalization, she began to have watery diarrhea and was found to have Clostridioides difficile diarrhea. She was treated with 10 days of oral vancomycin for her C. difficile infection (CDI). Approximately 3 weeks later, she again developed watery diarrhea with some abdominal cramping and has a leukocyte count of 22.4.

Key clinical questions

When is C. difficile considered recurrent?

C. difficile is considered recurrent when a patient experiences symptom onset and has a positive test in the 2-8 week period following the resolution of symptoms from the previous episode that had been confirmed with a positive test.¹

What is the recurrence rate for C. difficile?

Of patients who are initially diagnosed with C. difficile, about 20%-35% develop recurrence of their infection, and of those who experience recurrence, roughly 40%-60% will experience a second recurrence.²

What are the risk factors for recurrent C. difficile?

Risk factors for recurrence of C. difficile include older age (older than 65 years), female sex, Caucasian ethnicity, ongoing antibiotic use, concurrent proton pump inhibitor use, and more severe initial disease.

Also, receiving antineoplastic chemotherapy, being an organ transplant recipient, chronic kidney disease, inflammatory bowel disease, hypogammaglobulinemia, or other immunodeficiency, as well as having exposure to infected adult or infant carrier of C. difficile have all been risk factors for recurrent disease. There is still some degree of ongoing controversy over the role of proton pump inhibitors as a risk factor.²

What are the treatment options for initial C. difficile infection?

The recent Infectious Diseases Society of America (IDSA) guidelines recommend treating for an initial CDI with a 10-day course of oral vancomycin or fidaxomicin instead of metronidazole. This change is based on a combined analysis of two large randomized controlled trials that demonstrated better clinical response rates with vancomycin, compared with metronidazole (81.1% vs. 72.7%; P = .002).^1,3

What are the treatment options for first recurrence?

The data is overall limited in treatment of first recurrence of CDI. The IDSA guidelines recommend that a first recurrence of CDI may be treated with oral vancomycin followed by a tapered and pulsed regimen or with a 10-day course of fidaxomicin. If metronidazole was used for the first episode, a 10-day course of vancomycin can be used.¹

What are the treatment options for second and subsequent recurrences?

Second or subsequent CDI recurrences may be treated with oral vancomycin as a tapered and pulsed-dose regimen or with fidaxomicin as described above, but this is based on low quality of evidence.

The IDSA guidelines strongly recommend fecal microbiota transplantation (FMT) for patients who have two or more C. difficile recurrences and in whom standard antibiotic treatment has not been successful. FMT has demonstrated high efficacy rates of 80%-90% for clinical remission of recurrent CDI.

FMT can be administered through various routes. The choice of delivery depends in part on local expertise, patient preference, cost, and risk of the procedure.^1,4,5,6

What new therapies exist for reducing recurrence?

Bezlotoxumab is a humanized monoclonal antibody directed against C. difficile toxin B that was approved by the Food and Drug Administration in 2016 for prevention of recurrent CDI. Randomized placebo-controlled trials demonstrated that a single infusion of bezlotoxumab, given in combination with usual antibiotics for CDI in adults, was effective in reducing CDI recurrence within 12 weeks (rate of recurrent infection in both trials was 16.5% in the bezlotoxumab groups and 26.6% in the placebo groups).

In a post hoc analysis, the highest benefit was in patients with three or more risk factors: older than 65 years, history of CDI, immunocompromised status, or severe CDI. Although the best strategy for prevention of CDI recurrence remains to be determined, bezlotoxumab remains an option.^7,8

Back to the case

The patient had a C. difficile polymerase chain reaction test sent that came back positive for C. difficile. Because she had previously been treated with a 10-day course of oral vancomycin, she was started on a tapered and pulsed-dose regimen of oral vancomycin. Five days later her diarrhea resolved, and her leukocyte count returned to normal.

Dr. Bell is associate clinical professor in the division of hospital medicine at the University of California, San Diego, Medical Center. Dr. Farkhondehpour is a hospitalist and assistant clinical professor at UC San Diego Health.

References

1. McDonald L et al. Clinical practice guidelines for Clostridium difficile infection in adults and children: 2017 update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Clin Infect Dis. 2018 Mar 19;66(7):987-994.

2. Hopkins R and Wilson R. Treatment of recurrent Clostridium difficile colitis: A narrative review. Gastroenterol Rep (Oxf). 2018 Feb;6(1):21-8.

3. Johnson S et al. (2014). Vancomycin, metronidazole, or tolevamer for Clostridium difficile infection: Results from two multinational, randomized, controlled trials. Clin Infect Dis. 2014 Aug 1;59(3):345-54.

4. van Nood E et al. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15.

5. Cammarota G et al. Randomised clinical trial: Faecal microbiota transplantation by colonoscopy vs. vancomycin for the treatment of recurrent Clostridium difficile infection. Aliment Pharmacol Ther. 2015 May;41(9):835-43.

6. Kelly C et al. Effect of fecal microbiota transplantation on recurrence in multiple recurrent Clostridium difficile infection. Ann Intern Med. 2016 Nov 1;165(9):609-16.

7. Gerding DN et al. Bezlotoxumab for prevention of recurrent Clostridium difficile infection in patients at increased risk for recurrence. Clin Infect Dis. 2018 Aug 16;67(5):649-56.

8. Wilcox M et al. Bezlotoxumab for prevention of recurrent Clostridium difficile infection. N Engl J Med. 2017 Jan 26;376(4):305-17.

The case

CDC/Jennifer Hulsey

A 67-year-old woman with a past medical history significant for diabetes mellitus type 2 and chronic kidney disease stage 3 was recently hospitalized for a community acquired pneumonia and treated for 5 days with moxifloxacin. In the week following this hospitalization, she began to have watery diarrhea and was found to have Clostridioides difficile diarrhea. She was treated with 10 days of oral vancomycin for her C. difficile infection (CDI). Approximately 3 weeks later, she again developed watery diarrhea with some abdominal cramping and has a leukocyte count of 22.4.

Key clinical questions

When is C. difficile considered recurrent?

C. difficile is considered recurrent when a patient experiences symptom onset and has a positive test in the 2-8 week period following the resolution of symptoms from the previous episode that had been confirmed with a positive test.¹

What is the recurrence rate for C. difficile?

Of patients who are initially diagnosed with C. difficile, about 20%-35% develop recurrence of their infection, and of those who experience recurrence, roughly 40%-60% will experience a second recurrence.²

What are the risk factors for recurrent C. difficile?

Risk factors for recurrence of C. difficile include older age (older than 65 years), female sex, Caucasian ethnicity, ongoing antibiotic use, concurrent proton pump inhibitor use, and more severe initial disease.

Also, receiving antineoplastic chemotherapy, being an organ transplant recipient, chronic kidney disease, inflammatory bowel disease, hypogammaglobulinemia, or other immunodeficiency, as well as having exposure to infected adult or infant carrier of C. difficile have all been risk factors for recurrent disease. There is still some degree of ongoing controversy over the role of proton pump inhibitors as a risk factor.²

What are the treatment options for initial C. difficile infection?

The recent Infectious Diseases Society of America (IDSA) guidelines recommend treating for an initial CDI with a 10-day course of oral vancomycin or fidaxomicin instead of metronidazole. This change is based on a combined analysis of two large randomized controlled trials that demonstrated better clinical response rates with vancomycin, compared with metronidazole (81.1% vs. 72.7%; P = .002).^1,3

What are the treatment options for first recurrence?

The data is overall limited in treatment of first recurrence of CDI. The IDSA guidelines recommend that a first recurrence of CDI may be treated with oral vancomycin followed by a tapered and pulsed regimen or with a 10-day course of fidaxomicin. If metronidazole was used for the first episode, a 10-day course of vancomycin can be used.¹

What are the treatment options for second and subsequent recurrences?

Second or subsequent CDI recurrences may be treated with oral vancomycin as a tapered and pulsed-dose regimen or with fidaxomicin as described above, but this is based on low quality of evidence.

The IDSA guidelines strongly recommend fecal microbiota transplantation (FMT) for patients who have two or more C. difficile recurrences and in whom standard antibiotic treatment has not been successful. FMT has demonstrated high efficacy rates of 80%-90% for clinical remission of recurrent CDI.

FMT can be administered through various routes. The choice of delivery depends in part on local expertise, patient preference, cost, and risk of the procedure.^1,4,5,6

What new therapies exist for reducing recurrence?

Bezlotoxumab is a humanized monoclonal antibody directed against C. difficile toxin B that was approved by the Food and Drug Administration in 2016 for prevention of recurrent CDI. Randomized placebo-controlled trials demonstrated that a single infusion of bezlotoxumab, given in combination with usual antibiotics for CDI in adults, was effective in reducing CDI recurrence within 12 weeks (rate of recurrent infection in both trials was 16.5% in the bezlotoxumab groups and 26.6% in the placebo groups).

In a post hoc analysis, the highest benefit was in patients with three or more risk factors: older than 65 years, history of CDI, immunocompromised status, or severe CDI. Although the best strategy for prevention of CDI recurrence remains to be determined, bezlotoxumab remains an option.^7,8

Back to the case

The patient had a C. difficile polymerase chain reaction test sent that came back positive for C. difficile. Because she had previously been treated with a 10-day course of oral vancomycin, she was started on a tapered and pulsed-dose regimen of oral vancomycin. Five days later her diarrhea resolved, and her leukocyte count returned to normal.

Dr. Bell is associate clinical professor in the division of hospital medicine at the University of California, San Diego, Medical Center. Dr. Farkhondehpour is a hospitalist and assistant clinical professor at UC San Diego Health.

References

1. McDonald L et al. Clinical practice guidelines for Clostridium difficile infection in adults and children: 2017 update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Clin Infect Dis. 2018 Mar 19;66(7):987-994.

2. Hopkins R and Wilson R. Treatment of recurrent Clostridium difficile colitis: A narrative review. Gastroenterol Rep (Oxf). 2018 Feb;6(1):21-8.

3. Johnson S et al. (2014). Vancomycin, metronidazole, or tolevamer for Clostridium difficile infection: Results from two multinational, randomized, controlled trials. Clin Infect Dis. 2014 Aug 1;59(3):345-54.

4. van Nood E et al. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15.

5. Cammarota G et al. Randomised clinical trial: Faecal microbiota transplantation by colonoscopy vs. vancomycin for the treatment of recurrent Clostridium difficile infection. Aliment Pharmacol Ther. 2015 May;41(9):835-43.

6. Kelly C et al. Effect of fecal microbiota transplantation on recurrence in multiple recurrent Clostridium difficile infection. Ann Intern Med. 2016 Nov 1;165(9):609-16.

7. Gerding DN et al. Bezlotoxumab for prevention of recurrent Clostridium difficile infection in patients at increased risk for recurrence. Clin Infect Dis. 2018 Aug 16;67(5):649-56.

8. Wilcox M et al. Bezlotoxumab for prevention of recurrent Clostridium difficile infection. N Engl J Med. 2017 Jan 26;376(4):305-17.

The case

CDC/Jennifer Hulsey

A 67-year-old woman with a past medical history significant for diabetes mellitus type 2 and chronic kidney disease stage 3 was recently hospitalized for a community acquired pneumonia and treated for 5 days with moxifloxacin. In the week following this hospitalization, she began to have watery diarrhea and was found to have Clostridioides difficile diarrhea. She was treated with 10 days of oral vancomycin for her C. difficile infection (CDI). Approximately 3 weeks later, she again developed watery diarrhea with some abdominal cramping and has a leukocyte count of 22.4.

Key clinical questions

When is C. difficile considered recurrent?

C. difficile is considered recurrent when a patient experiences symptom onset and has a positive test in the 2-8 week period following the resolution of symptoms from the previous episode that had been confirmed with a positive test.¹

What is the recurrence rate for C. difficile?

Of patients who are initially diagnosed with C. difficile, about 20%-35% develop recurrence of their infection, and of those who experience recurrence, roughly 40%-60% will experience a second recurrence.²

What are the risk factors for recurrent C. difficile?

Risk factors for recurrence of C. difficile include older age (older than 65 years), female sex, Caucasian ethnicity, ongoing antibiotic use, concurrent proton pump inhibitor use, and more severe initial disease.

Also, receiving antineoplastic chemotherapy, being an organ transplant recipient, chronic kidney disease, inflammatory bowel disease, hypogammaglobulinemia, or other immunodeficiency, as well as having exposure to infected adult or infant carrier of C. difficile have all been risk factors for recurrent disease. There is still some degree of ongoing controversy over the role of proton pump inhibitors as a risk factor.²

What are the treatment options for initial C. difficile infection?

The recent Infectious Diseases Society of America (IDSA) guidelines recommend treating for an initial CDI with a 10-day course of oral vancomycin or fidaxomicin instead of metronidazole. This change is based on a combined analysis of two large randomized controlled trials that demonstrated better clinical response rates with vancomycin, compared with metronidazole (81.1% vs. 72.7%; P = .002).^1,3

What are the treatment options for first recurrence?

The data is overall limited in treatment of first recurrence of CDI. The IDSA guidelines recommend that a first recurrence of CDI may be treated with oral vancomycin followed by a tapered and pulsed regimen or with a 10-day course of fidaxomicin. If metronidazole was used for the first episode, a 10-day course of vancomycin can be used.¹

What are the treatment options for second and subsequent recurrences?

Second or subsequent CDI recurrences may be treated with oral vancomycin as a tapered and pulsed-dose regimen or with fidaxomicin as described above, but this is based on low quality of evidence.

The IDSA guidelines strongly recommend fecal microbiota transplantation (FMT) for patients who have two or more C. difficile recurrences and in whom standard antibiotic treatment has not been successful. FMT has demonstrated high efficacy rates of 80%-90% for clinical remission of recurrent CDI.

FMT can be administered through various routes. The choice of delivery depends in part on local expertise, patient preference, cost, and risk of the procedure.^1,4,5,6

What new therapies exist for reducing recurrence?

Bezlotoxumab is a humanized monoclonal antibody directed against C. difficile toxin B that was approved by the Food and Drug Administration in 2016 for prevention of recurrent CDI. Randomized placebo-controlled trials demonstrated that a single infusion of bezlotoxumab, given in combination with usual antibiotics for CDI in adults, was effective in reducing CDI recurrence within 12 weeks (rate of recurrent infection in both trials was 16.5% in the bezlotoxumab groups and 26.6% in the placebo groups).

In a post hoc analysis, the highest benefit was in patients with three or more risk factors: older than 65 years, history of CDI, immunocompromised status, or severe CDI. Although the best strategy for prevention of CDI recurrence remains to be determined, bezlotoxumab remains an option.^7,8

Back to the case

The patient had a C. difficile polymerase chain reaction test sent that came back positive for C. difficile. Because she had previously been treated with a 10-day course of oral vancomycin, she was started on a tapered and pulsed-dose regimen of oral vancomycin. Five days later her diarrhea resolved, and her leukocyte count returned to normal.

Dr. Bell is associate clinical professor in the division of hospital medicine at the University of California, San Diego, Medical Center. Dr. Farkhondehpour is a hospitalist and assistant clinical professor at UC San Diego Health.

References

1. McDonald L et al. Clinical practice guidelines for Clostridium difficile infection in adults and children: 2017 update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Clin Infect Dis. 2018 Mar 19;66(7):987-994.

2. Hopkins R and Wilson R. Treatment of recurrent Clostridium difficile colitis: A narrative review. Gastroenterol Rep (Oxf). 2018 Feb;6(1):21-8.

3. Johnson S et al. (2014). Vancomycin, metronidazole, or tolevamer for Clostridium difficile infection: Results from two multinational, randomized, controlled trials. Clin Infect Dis. 2014 Aug 1;59(3):345-54.

4. van Nood E et al. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15.

5. Cammarota G et al. Randomised clinical trial: Faecal microbiota transplantation by colonoscopy vs. vancomycin for the treatment of recurrent Clostridium difficile infection. Aliment Pharmacol Ther. 2015 May;41(9):835-43.

6. Kelly C et al. Effect of fecal microbiota transplantation on recurrence in multiple recurrent Clostridium difficile infection. Ann Intern Med. 2016 Nov 1;165(9):609-16.

7. Gerding DN et al. Bezlotoxumab for prevention of recurrent Clostridium difficile infection in patients at increased risk for recurrence. Clin Infect Dis. 2018 Aug 16;67(5):649-56.

8. Wilcox M et al. Bezlotoxumab for prevention of recurrent Clostridium difficile infection. N Engl J Med. 2017 Jan 26;376(4):305-17.

LAS VEGAS – Biologics are revolutionizing the treatment of atopic dermatitis (AD), but a dermatologist urged colleagues to keep in mind the value of traditional topical and systemic treatments.

Joseph F. Fowler Jr., MD, of the University of Louisville, Ky., offered these tips about AD treatment in a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar:

• Keep the epidermal skin barrier in mind.

The epidermal skin barrier is abnormal in patients with AD, Dr. Fowler said, because of several possible factors: altered levels of natural moisturizing factor (which can be caused by a genetic mutation), imbalances between ceramides and lipids, and reduced aquaporin levels.

Enhancing the skin barrier is crucial in treating AD, he said, and products with these ingredients may help: ceramides, glycerin/glycerol (glucoside), colloidal oatmeal, and components of natural moisturizing factor.

• Expensive products are probably better.

“These products are available over the counter and via prescription,” he said. “Do they make the skin barrier stronger? The answer is they probably they do. But most do tend to be expensive, especially Rx products.”

Not all patients, of course, can afford the most expensive options. “You and your patients have to decide whether it’s better to get something like plain old Vaseline or a very inexpensive cream at Walmart that may be more accessible,” he said. “I tell patients that if the cost is not a big issue, these other products are probably better, and they will make your skin heal better and feel better. But if cost is a problem, use what you can afford.”

• Don’t forget about hypochlorous acid.

While it’s chemically similar to bleach, this product “doesn’t bleach your clothes or smell bleachy,” Dr. Fowler said. “It does have antibiotic and antipruritic effects.”

• For predictability, try methotrexate.

Methotrexate, an old workhorse in dermatology, remains an option, especially for patients who need alternatives to biologics, Dr. Fowler said. “I’ve used it much more in the last 10 years for eczema than for psoriasis and anything else. We’re used to using it, and I find it predictably effective at a dosage that’s similar to that for psoriasis.”

• Mycophenolate mofetil (CellCept) may be helpful.

Dr. Fowler’s research has shown that mycophenolate mofetil is useful in about 50% of chronic AD cases. “The problem with the drug is that you couldn’t tell which ones would get better and which ones wouldn’t.” Still, it can be an alternative to methotrexate and cyclosporine, he said.

• Cyclosporine is a short-term treatment.

“It’s like steroids on steroids,” Dr. Fowler said. “I’ve had to use it sometimes even in the age of biologics, which may not work as fast as we’d like in someone who’s really miserable.” The drug is linked to liver and kidney risks, he cautioned, and “you don’t want to be on it very long.”

• Ultraviolet light therapy can help.

This strategy works well “if they come in and get to the office and do it,” Dr. Fowler said. “We should remember it as an option.”

A patient who’s over 80 years old with bad AD has been getting narrow-band UVB treatments for at least 5 years, he said. “I just look at him every 3-4 months. Every time he says, ‘Can I keep coming and get my light treatments?’ and I say sure. At 80-plus, I’m not too worried about cutaneous malignancy or any other side effects.”

Dr. Fowler reported relationships with the speaker’s bureau of SmartPractice and ties with Asana, Johnson & Johnson, Lilly, Novartis and Pfizer. SDEF and this news organization are owned by the same parent company.

LAS VEGAS – Biologics are revolutionizing the treatment of atopic dermatitis (AD), but a dermatologist urged colleagues to keep in mind the value of traditional topical and systemic treatments.

Joseph F. Fowler Jr., MD, of the University of Louisville, Ky., offered these tips about AD treatment in a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar:

• Keep the epidermal skin barrier in mind.

The epidermal skin barrier is abnormal in patients with AD, Dr. Fowler said, because of several possible factors: altered levels of natural moisturizing factor (which can be caused by a genetic mutation), imbalances between ceramides and lipids, and reduced aquaporin levels.

Enhancing the skin barrier is crucial in treating AD, he said, and products with these ingredients may help: ceramides, glycerin/glycerol (glucoside), colloidal oatmeal, and components of natural moisturizing factor.

• Expensive products are probably better.

“These products are available over the counter and via prescription,” he said. “Do they make the skin barrier stronger? The answer is they probably they do. But most do tend to be expensive, especially Rx products.”

Not all patients, of course, can afford the most expensive options. “You and your patients have to decide whether it’s better to get something like plain old Vaseline or a very inexpensive cream at Walmart that may be more accessible,” he said. “I tell patients that if the cost is not a big issue, these other products are probably better, and they will make your skin heal better and feel better. But if cost is a problem, use what you can afford.”

• Don’t forget about hypochlorous acid.

While it’s chemically similar to bleach, this product “doesn’t bleach your clothes or smell bleachy,” Dr. Fowler said. “It does have antibiotic and antipruritic effects.”

• For predictability, try methotrexate.

Methotrexate, an old workhorse in dermatology, remains an option, especially for patients who need alternatives to biologics, Dr. Fowler said. “I’ve used it much more in the last 10 years for eczema than for psoriasis and anything else. We’re used to using it, and I find it predictably effective at a dosage that’s similar to that for psoriasis.”

• Mycophenolate mofetil (CellCept) may be helpful.

Dr. Fowler’s research has shown that mycophenolate mofetil is useful in about 50% of chronic AD cases. “The problem with the drug is that you couldn’t tell which ones would get better and which ones wouldn’t.” Still, it can be an alternative to methotrexate and cyclosporine, he said.

• Cyclosporine is a short-term treatment.

“It’s like steroids on steroids,” Dr. Fowler said. “I’ve had to use it sometimes even in the age of biologics, which may not work as fast as we’d like in someone who’s really miserable.” The drug is linked to liver and kidney risks, he cautioned, and “you don’t want to be on it very long.”

• Ultraviolet light therapy can help.

This strategy works well “if they come in and get to the office and do it,” Dr. Fowler said. “We should remember it as an option.”

A patient who’s over 80 years old with bad AD has been getting narrow-band UVB treatments for at least 5 years, he said. “I just look at him every 3-4 months. Every time he says, ‘Can I keep coming and get my light treatments?’ and I say sure. At 80-plus, I’m not too worried about cutaneous malignancy or any other side effects.”

Dr. Fowler reported relationships with the speaker’s bureau of SmartPractice and ties with Asana, Johnson & Johnson, Lilly, Novartis and Pfizer. SDEF and this news organization are owned by the same parent company.

LAS VEGAS – Biologics are revolutionizing the treatment of atopic dermatitis (AD), but a dermatologist urged colleagues to keep in mind the value of traditional topical and systemic treatments.

Joseph F. Fowler Jr., MD, of the University of Louisville, Ky., offered these tips about AD treatment in a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar:

• Keep the epidermal skin barrier in mind.

The epidermal skin barrier is abnormal in patients with AD, Dr. Fowler said, because of several possible factors: altered levels of natural moisturizing factor (which can be caused by a genetic mutation), imbalances between ceramides and lipids, and reduced aquaporin levels.

Enhancing the skin barrier is crucial in treating AD, he said, and products with these ingredients may help: ceramides, glycerin/glycerol (glucoside), colloidal oatmeal, and components of natural moisturizing factor.

• Expensive products are probably better.

“These products are available over the counter and via prescription,” he said. “Do they make the skin barrier stronger? The answer is they probably they do. But most do tend to be expensive, especially Rx products.”

Not all patients, of course, can afford the most expensive options. “You and your patients have to decide whether it’s better to get something like plain old Vaseline or a very inexpensive cream at Walmart that may be more accessible,” he said. “I tell patients that if the cost is not a big issue, these other products are probably better, and they will make your skin heal better and feel better. But if cost is a problem, use what you can afford.”

• Don’t forget about hypochlorous acid.

While it’s chemically similar to bleach, this product “doesn’t bleach your clothes or smell bleachy,” Dr. Fowler said. “It does have antibiotic and antipruritic effects.”

• For predictability, try methotrexate.

Methotrexate, an old workhorse in dermatology, remains an option, especially for patients who need alternatives to biologics, Dr. Fowler said. “I’ve used it much more in the last 10 years for eczema than for psoriasis and anything else. We’re used to using it, and I find it predictably effective at a dosage that’s similar to that for psoriasis.”

• Mycophenolate mofetil (CellCept) may be helpful.

Dr. Fowler’s research has shown that mycophenolate mofetil is useful in about 50% of chronic AD cases. “The problem with the drug is that you couldn’t tell which ones would get better and which ones wouldn’t.” Still, it can be an alternative to methotrexate and cyclosporine, he said.

• Cyclosporine is a short-term treatment.

“It’s like steroids on steroids,” Dr. Fowler said. “I’ve had to use it sometimes even in the age of biologics, which may not work as fast as we’d like in someone who’s really miserable.” The drug is linked to liver and kidney risks, he cautioned, and “you don’t want to be on it very long.”

• Ultraviolet light therapy can help.

This strategy works well “if they come in and get to the office and do it,” Dr. Fowler said. “We should remember it as an option.”

A patient who’s over 80 years old with bad AD has been getting narrow-band UVB treatments for at least 5 years, he said. “I just look at him every 3-4 months. Every time he says, ‘Can I keep coming and get my light treatments?’ and I say sure. At 80-plus, I’m not too worried about cutaneous malignancy or any other side effects.”

Dr. Fowler reported relationships with the speaker’s bureau of SmartPractice and ties with Asana, Johnson & Johnson, Lilly, Novartis and Pfizer. SDEF and this news organization are owned by the same parent company.

Brian Bolwell, MD, chairman of Cleveland Clinic Taussig Cancer Institute in Ohio, has received the 2019 Alfred and Norma Lerner Humanitarian Award.

Dr. Bolwell received the award “in honor of his 32 years of compassionate service as a physician leader and educator, along with his contributions to clinical and translational cancer research throughout the world,” according to a statement from Cleveland Clinic. The award recognizes “Cleveland Clinic physicians whose selfless dedication, boundless compassion, and tireless work have made the most profound and singular contribution to the good of humankind.”

In other Cleveland Clinic news, Halle Moore, MD, has been named director of breast medical oncology and codirector for the comprehensive breast cancer program at the clinic. She will assume this role in January 2020.

Cleveland Clinic has also added four new staff physicians to the department of hematology and medical oncology.

Shilpa Gupta, MD, has joined the clinic’s genitourinary cancer program. Dr. Gupta previously worked in the division of hematology, oncology, and transplantation at the University of Minnesota in Minneapolis, where she led the interdisciplinary solid tumor phase 1 program .

Khaled Hassan, MD, has joined the thoracic cancer program at Cleveland Clinic. Dr. Hassan was previously an assistant professor in the department of internal medicine, division of hematology/oncology at the University of Michigan in Ann Arbor. Suneel Kamath, MD, has joined the gastrointestinal cancer program at the clinic. Dr. Kamath was previously the hematology and medical oncology chief fellow at Northwestern University in Evanston, Ill.

[email protected]

Brian Bolwell, MD, chairman of Cleveland Clinic Taussig Cancer Institute in Ohio, has received the 2019 Alfred and Norma Lerner Humanitarian Award.

Dr. Bolwell received the award “in honor of his 32 years of compassionate service as a physician leader and educator, along with his contributions to clinical and translational cancer research throughout the world,” according to a statement from Cleveland Clinic. The award recognizes “Cleveland Clinic physicians whose selfless dedication, boundless compassion, and tireless work have made the most profound and singular contribution to the good of humankind.”

In other Cleveland Clinic news, Halle Moore, MD, has been named director of breast medical oncology and codirector for the comprehensive breast cancer program at the clinic. She will assume this role in January 2020.

Cleveland Clinic has also added four new staff physicians to the department of hematology and medical oncology.

Shilpa Gupta, MD, has joined the clinic’s genitourinary cancer program. Dr. Gupta previously worked in the division of hematology, oncology, and transplantation at the University of Minnesota in Minneapolis, where she led the interdisciplinary solid tumor phase 1 program .

Khaled Hassan, MD, has joined the thoracic cancer program at Cleveland Clinic. Dr. Hassan was previously an assistant professor in the department of internal medicine, division of hematology/oncology at the University of Michigan in Ann Arbor. Suneel Kamath, MD, has joined the gastrointestinal cancer program at the clinic. Dr. Kamath was previously the hematology and medical oncology chief fellow at Northwestern University in Evanston, Ill.

[email protected]

Brian Bolwell, MD, chairman of Cleveland Clinic Taussig Cancer Institute in Ohio, has received the 2019 Alfred and Norma Lerner Humanitarian Award.

Dr. Bolwell received the award “in honor of his 32 years of compassionate service as a physician leader and educator, along with his contributions to clinical and translational cancer research throughout the world,” according to a statement from Cleveland Clinic. The award recognizes “Cleveland Clinic physicians whose selfless dedication, boundless compassion, and tireless work have made the most profound and singular contribution to the good of humankind.”

In other Cleveland Clinic news, Halle Moore, MD, has been named director of breast medical oncology and codirector for the comprehensive breast cancer program at the clinic. She will assume this role in January 2020.

Cleveland Clinic has also added four new staff physicians to the department of hematology and medical oncology.

Shilpa Gupta, MD, has joined the clinic’s genitourinary cancer program. Dr. Gupta previously worked in the division of hematology, oncology, and transplantation at the University of Minnesota in Minneapolis, where she led the interdisciplinary solid tumor phase 1 program .

Khaled Hassan, MD, has joined the thoracic cancer program at Cleveland Clinic. Dr. Hassan was previously an assistant professor in the department of internal medicine, division of hematology/oncology at the University of Michigan in Ann Arbor. Suneel Kamath, MD, has joined the gastrointestinal cancer program at the clinic. Dr. Kamath was previously the hematology and medical oncology chief fellow at Northwestern University in Evanston, Ill.

[email protected]

The Food and Drug Administration has cleared the Pentax Medical Video ED34-i10T2 model duodenoscope for marketing in the United States, the first approved duodenoscope with a sterile, disposable elevator component.

Previous communication from the FDA has recommended to both health care facilities and duodenoscope manufacturers to transition to duodenoscopes with disposable components. Disposable designs reduce or eliminate the need for reprocessing certain components, a major source of between-patient duodenoscope contamination, the FDA said.

FDA approval for the Pentax device is based on a review through the premarket clearance pathway, and the manufacturer submitted evidence that the device is substantially equivalent to previous devices. Potential risks of using the Pentax duodenoscope include burns, electric shock, perforation, infection, and bleeding.

“Duodenoscopes with a disposable elevator component represent another major step toward lowering the risk of infection among patients who undergo procedures with these devices,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “Improving the safety of duodenoscopes is a top priority for the FDA since such devices remain critical to life-saving care for many patients in the U.S.”

Find the full press release on the FDA website.

[email protected]

The Food and Drug Administration has cleared the Pentax Medical Video ED34-i10T2 model duodenoscope for marketing in the United States, the first approved duodenoscope with a sterile, disposable elevator component.

Previous communication from the FDA has recommended to both health care facilities and duodenoscope manufacturers to transition to duodenoscopes with disposable components. Disposable designs reduce or eliminate the need for reprocessing certain components, a major source of between-patient duodenoscope contamination, the FDA said.

FDA approval for the Pentax device is based on a review through the premarket clearance pathway, and the manufacturer submitted evidence that the device is substantially equivalent to previous devices. Potential risks of using the Pentax duodenoscope include burns, electric shock, perforation, infection, and bleeding.

“Duodenoscopes with a disposable elevator component represent another major step toward lowering the risk of infection among patients who undergo procedures with these devices,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “Improving the safety of duodenoscopes is a top priority for the FDA since such devices remain critical to life-saving care for many patients in the U.S.”

Find the full press release on the FDA website.

[email protected]

The Food and Drug Administration has cleared the Pentax Medical Video ED34-i10T2 model duodenoscope for marketing in the United States, the first approved duodenoscope with a sterile, disposable elevator component.

Previous communication from the FDA has recommended to both health care facilities and duodenoscope manufacturers to transition to duodenoscopes with disposable components. Disposable designs reduce or eliminate the need for reprocessing certain components, a major source of between-patient duodenoscope contamination, the FDA said.

FDA approval for the Pentax device is based on a review through the premarket clearance pathway, and the manufacturer submitted evidence that the device is substantially equivalent to previous devices. Potential risks of using the Pentax duodenoscope include burns, electric shock, perforation, infection, and bleeding.

“Duodenoscopes with a disposable elevator component represent another major step toward lowering the risk of infection among patients who undergo procedures with these devices,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “Improving the safety of duodenoscopes is a top priority for the FDA since such devices remain critical to life-saving care for many patients in the U.S.”

Find the full press release on the FDA website.

[email protected]

ATLANTA – Elderly-onset and young-onset rheumatoid arthritis patients initiating treatment with biologic disease-modifying antirheumatic drugs (bDMARDs) respond similarly with respect to clinical improvement at 48 weeks and adverse events, data from a large registry in Japan suggest.

Sharon Worcester/MDedge News

The findings have important implications – particularly for elderly-onset rheumatoid arthritis (RA) patients, who tend to present with higher disease activity levels and increased disability, but who nevertheless receive biologics less frequently, compared with young-onset RA patients, according to Sadao Jinno, MD, of the department of rheumatology and clinical immunology, Kobe University Graduate School of Medicine, Osaka, Japan, and colleagues.

The findings were presented in a poster at the annual meeting of the American College of Rheumatology.

Of 7,183 participants in the multicenter observational registry, 989 who initiated bDMARDs and who had a DAS28-erythrocyte sedimentation rate score of at least 3.2 at the time of initiation were included in the current analysis. The proportion of elderly-onset RA patients in the registry was 36.8%, and the proportion of elderly-onset RA patients using bDMARDs was significantly lower than that among young-onset RA patients (18.3% vs. 28.0%; P less than .001), Dr. Jinno and colleagues reported.

However, after adjustment for differences in baseline characteristics between the two age groups, no significant difference was seen in Clinical Disease Activity Index (CDAI) score at 48 weeks (odds ratio, 1.01), Dr. Jinno said during a press conference highlighting the findings.

A trend toward lower remission rates was observed in the early-onset patients (OR, 0.52; P = 1.10). The low-disease activity/remission rate was similar in the groups after adjustment for multiple confounders (OR, 0.86; P = 0.77), he said, adding that drug maintenance rates and adverse event–related discontinuation rates also were similar in the groups (hazard ratio, 0.95; P = 0.78 for drug maintenance; HR, 0.78; P = 0.22 for discontinuation).

Patients were enrolled in the multicenter observational registry between September 2009 and December 2017, and those with onset at age 60 years or older were considered to have elderly-onset RA.

“In my daily practice, I see a lot of patients with elderly-onset RA who are treated with biologics very effectively and safely,” he said. “So we wanted to see if there really is any difference [in outcomes] between the elderly-onset patients and the young-onset patients.”

The findings suggest they can be treated as effectively and safely as younger patients, he said.

In a press release, he further stated that clinicians should “choose wisely which patients with elderly-onset RA are safely treated with biologics given that they are still at risk of developing adverse events, especially infections.”

Conversely, it is important to keep in mind that dysfunction in elderly-onset RA patients may worsen without timely biologic treatment, he noted.

Future investigation will focus on whether elderly-onset RA patients respond differently to “various modes of biologics,” he said.

Dr. Jinno and colleagues reported having no relevant disclosures.

[email protected]

SOURCE: Jinno S et al. Arthritis Rheumatol. 2019;71(suppl 10), Abstract 1345.

ATLANTA – Elderly-onset and young-onset rheumatoid arthritis patients initiating treatment with biologic disease-modifying antirheumatic drugs (bDMARDs) respond similarly with respect to clinical improvement at 48 weeks and adverse events, data from a large registry in Japan suggest.

Sharon Worcester/MDedge News

The findings have important implications – particularly for elderly-onset rheumatoid arthritis (RA) patients, who tend to present with higher disease activity levels and increased disability, but who nevertheless receive biologics less frequently, compared with young-onset RA patients, according to Sadao Jinno, MD, of the department of rheumatology and clinical immunology, Kobe University Graduate School of Medicine, Osaka, Japan, and colleagues.

The findings were presented in a poster at the annual meeting of the American College of Rheumatology.

Of 7,183 participants in the multicenter observational registry, 989 who initiated bDMARDs and who had a DAS28-erythrocyte sedimentation rate score of at least 3.2 at the time of initiation were included in the current analysis. The proportion of elderly-onset RA patients in the registry was 36.8%, and the proportion of elderly-onset RA patients using bDMARDs was significantly lower than that among young-onset RA patients (18.3% vs. 28.0%; P less than .001), Dr. Jinno and colleagues reported.

However, after adjustment for differences in baseline characteristics between the two age groups, no significant difference was seen in Clinical Disease Activity Index (CDAI) score at 48 weeks (odds ratio, 1.01), Dr. Jinno said during a press conference highlighting the findings.

A trend toward lower remission rates was observed in the early-onset patients (OR, 0.52; P = 1.10). The low-disease activity/remission rate was similar in the groups after adjustment for multiple confounders (OR, 0.86; P = 0.77), he said, adding that drug maintenance rates and adverse event–related discontinuation rates also were similar in the groups (hazard ratio, 0.95; P = 0.78 for drug maintenance; HR, 0.78; P = 0.22 for discontinuation).

Patients were enrolled in the multicenter observational registry between September 2009 and December 2017, and those with onset at age 60 years or older were considered to have elderly-onset RA.

“In my daily practice, I see a lot of patients with elderly-onset RA who are treated with biologics very effectively and safely,” he said. “So we wanted to see if there really is any difference [in outcomes] between the elderly-onset patients and the young-onset patients.”

The findings suggest they can be treated as effectively and safely as younger patients, he said.

In a press release, he further stated that clinicians should “choose wisely which patients with elderly-onset RA are safely treated with biologics given that they are still at risk of developing adverse events, especially infections.”

Conversely, it is important to keep in mind that dysfunction in elderly-onset RA patients may worsen without timely biologic treatment, he noted.

Future investigation will focus on whether elderly-onset RA patients respond differently to “various modes of biologics,” he said.

Dr. Jinno and colleagues reported having no relevant disclosures.

[email protected]

SOURCE: Jinno S et al. Arthritis Rheumatol. 2019;71(suppl 10), Abstract 1345.

ATLANTA – Elderly-onset and young-onset rheumatoid arthritis patients initiating treatment with biologic disease-modifying antirheumatic drugs (bDMARDs) respond similarly with respect to clinical improvement at 48 weeks and adverse events, data from a large registry in Japan suggest.

Sharon Worcester/MDedge News

The findings have important implications – particularly for elderly-onset rheumatoid arthritis (RA) patients, who tend to present with higher disease activity levels and increased disability, but who nevertheless receive biologics less frequently, compared with young-onset RA patients, according to Sadao Jinno, MD, of the department of rheumatology and clinical immunology, Kobe University Graduate School of Medicine, Osaka, Japan, and colleagues.

The findings were presented in a poster at the annual meeting of the American College of Rheumatology.

Of 7,183 participants in the multicenter observational registry, 989 who initiated bDMARDs and who had a DAS28-erythrocyte sedimentation rate score of at least 3.2 at the time of initiation were included in the current analysis. The proportion of elderly-onset RA patients in the registry was 36.8%, and the proportion of elderly-onset RA patients using bDMARDs was significantly lower than that among young-onset RA patients (18.3% vs. 28.0%; P less than .001), Dr. Jinno and colleagues reported.

However, after adjustment for differences in baseline characteristics between the two age groups, no significant difference was seen in Clinical Disease Activity Index (CDAI) score at 48 weeks (odds ratio, 1.01), Dr. Jinno said during a press conference highlighting the findings.

A trend toward lower remission rates was observed in the early-onset patients (OR, 0.52; P = 1.10). The low-disease activity/remission rate was similar in the groups after adjustment for multiple confounders (OR, 0.86; P = 0.77), he said, adding that drug maintenance rates and adverse event–related discontinuation rates also were similar in the groups (hazard ratio, 0.95; P = 0.78 for drug maintenance; HR, 0.78; P = 0.22 for discontinuation).

Patients were enrolled in the multicenter observational registry between September 2009 and December 2017, and those with onset at age 60 years or older were considered to have elderly-onset RA.

“In my daily practice, I see a lot of patients with elderly-onset RA who are treated with biologics very effectively and safely,” he said. “So we wanted to see if there really is any difference [in outcomes] between the elderly-onset patients and the young-onset patients.”

The findings suggest they can be treated as effectively and safely as younger patients, he said.

In a press release, he further stated that clinicians should “choose wisely which patients with elderly-onset RA are safely treated with biologics given that they are still at risk of developing adverse events, especially infections.”

Conversely, it is important to keep in mind that dysfunction in elderly-onset RA patients may worsen without timely biologic treatment, he noted.

Future investigation will focus on whether elderly-onset RA patients respond differently to “various modes of biologics,” he said.

Dr. Jinno and colleagues reported having no relevant disclosures.

[email protected]

SOURCE: Jinno S et al. Arthritis Rheumatol. 2019;71(suppl 10), Abstract 1345.

November is National Diabetes Month, which gives SVS members the perfect opportunity to further educate their patients and loved ones with the SVS Foundation Patient flier on diabetes and vascular disease. These are available in both English and Spanish and can be downloaded instantly. You may also send patients and referrers to our Diabetes and Vascular Disease page. This holds several resources that might be useful for education purposes. Spread awareness and education using the many resources the SVS has to offer.

November is National Diabetes Month, which gives SVS members the perfect opportunity to further educate their patients and loved ones with the SVS Foundation Patient flier on diabetes and vascular disease. These are available in both English and Spanish and can be downloaded instantly. You may also send patients and referrers to our Diabetes and Vascular Disease page. This holds several resources that might be useful for education purposes. Spread awareness and education using the many resources the SVS has to offer.

November is National Diabetes Month, which gives SVS members the perfect opportunity to further educate their patients and loved ones with the SVS Foundation Patient flier on diabetes and vascular disease. These are available in both English and Spanish and can be downloaded instantly. You may also send patients and referrers to our Diabetes and Vascular Disease page. This holds several resources that might be useful for education purposes. Spread awareness and education using the many resources the SVS has to offer.