Federal Practitioner

Fecal microbiota transplantation (FMT) is safe and highly effective as first-line therapy for patients with first or second Clostridioides difficile infection, according to the first randomized, double-blind, placebo-controlled trial of its kind.

Study enrollment was halted after an interim analysis revealed significantly better outcomes among patients who received vancomycin plus FMT versus vancomycin alone, reported lead author Simon Mark Dahl Baunwall, MD, of Aarhus (Denmark) University Hospital and colleagues in The Lancet Gastroenterology & Hepatology.

gaetan stoffel/gettyimages

The investigators noted that the participants represented a real-world patient population, so the data support FMT “as a necessary, effective first-line option” in routine management of C. difficile infection.

“Previous studies have demonstrated clinical cure rates [with FMT] of up to 92%,” Dr. Baunwall and colleagues wrote. “Early use of FMT for first or second C. difficile infection has therapeutic potential, but no formal randomized trials to support use of the approach as a first-line therapy have been done.”

The present trial, conducted at a university hospital in Denmark, involved 42 adult patients with first or second C. difficile infection. Patients were randomized in a 1:1 ratio to receive either vancomycin alone or vancomycin plus FMT. All patients received 125 mg oral vancomycin four times daily for a minimum of 10 days after diagnosis. On day 1 after completion of vancomycin therapy and again between day 3 and 7, patients received either oral FMT or matching placebo, depending on their group. After completing the protocol, patients were followed for 8 weeks or C. difficile recurrence to evaluate resolution of C. difficile–associated diarrhea.

“In this trial, patients were treated with two sequential FMT procedures on separate days,” the investigators noted. “This practice might have overtreated some patients and differs from previous trials. It remains unknown whether optimal effect is achieved by one or two treatments.”

The trial design called for 84 patients, but enrollment was halted after an interim analysis of the above cohort of 42 patients because of significantly lower rate resolution in the placebo group. At the 2-month mark, 90% (95% confidence interval, 70%-99%) of patients in the FMT group had resolution, compared with only 33% (95% CI, 15%-57%) of patients in the placebo group (P = .0003), constituting a 57% (95% CI, 33%-81%) absolute risk reduction.

Most patients experienced adverse events, including 20 in the FMT group and all 21 in the placebo group, although most were transient and nonserious. The most common adverse events were diarrhea, which occurred more frequently in the FMT group (23 vs. 14 events), followed by abdominal pain(14 vs. 11 events) and nausea (12 vs. 5 events).

One limitation of the study was its single-center design with regional uptake; the authors noted that, despite having high statistical power for the clinical effect, the study’s premature termination and low patient number prevent inferences regarding mortality, time to effect, and cost.

“The results of this trial highlight how the use of fecal microbiota transplantation as a first-line treatment can effectively prevent C. difficile recurrence and suggests that microbiota restoration might be necessary to obtain sustained resolution,” the investigators wrote. “At present, only 10% of patients with multiple, recurrent C. difficile infection and indication for FMT receive it. International initiatives address the unmet need, but logistic and regulatory obstacles remain unsolved.”
 

Encouraging findings, lingering concerns

Nicholas Turner, MD, assistant professor in the division of infectious diseases at Duke University, Durham, N.C., praised the study for “pushing the boundaries for FMT,” and noted that the methodology appeared sound. Results in the placebo group, however, cast doubt on the generalizability of the findings, he said.

“If you look at the group that received vancomycin plus placebo, their failure rate was really astoundingly high,” Dr. Turner said in an interview, referring to the 67% failure rate in the control group; he noted previous studies had reported failure rates closer to 10%. “I think that just calls into question just a little bit what happened with that control group.”

Dr. Turner said his confidence would go “way, way up” if the findings were reproduced in a larger study. Ideally, these future trials would use fidaxomicin, he added, which is becoming the preferred option over vancomycin for treating C. difficile.

John Y. Kao, MD, professor of medicine and codirector of the FMT program at University of Michigan Medicine, Ann Arbor, offered a different perspective, suggesting that the control group findings shouldn’t overshadow the efficacy of FMT.

“I agree that historical data would tell us that the placebo population should see a much higher response,” Dr. Kao said in an interview. “In my mind though, the success rate of FMT over placebo is what I would expect. The message of the study should be upheld: that FMT is an effective therapy whether it’s given early or, as the way we give it now, as a sort of rescue therapy.”

Despite this confidence in FMT as an efficacious first-line option, Dr. Kao said it is unlikely to be routinely used in this way anytime soon, even if a larger trial echoes the present results.

“We don’t know the long-term risks of FMT therapy, although we’ve been doing this now probably close to 20 years,” Dr. Kao said.

Specifically, Dr. Kao was most concerned about the long-term risk of colon cancer, as mouse models suggest that microbiome characteristics may affect risk level, and risk may vary based on host-microbiome relationships. In other words, an organism may pose no risk in the gut of the donor, but the same may not be true for the recipient.

While increased rates of colon cancer or other serious illnesses have not been detected in humans who have undergone FMT over the past 2 decades, Dr. Kao said that these findings cannot be extrapolated over a patient’s entire lifetime, especially for younger individuals.

“In a patient that’s 80, you would say, yeah, let’s go ahead and treat you [with FMT] as first-line therapy, whereas someone who’s 20, and has maybe another 50 or 60 years longevity, you may not want to give FMT as first-line therapy,” Dr. Kao said.

This study was supported by Innovation Fund Denmark. The investigators disclosed no competing interests. Dr. Turner previously performed statistical analyses for a Merck study comparing vancomycin, fidaxomicin, and metronidazole for C. difficile infection. Dr. Kao disclosed no relevant conflicts of interest.

Fecal microbiota transplantation (FMT) is safe and highly effective as first-line therapy for patients with first or second Clostridioides difficile infection, according to the first randomized, double-blind, placebo-controlled trial of its kind.

Study enrollment was halted after an interim analysis revealed significantly better outcomes among patients who received vancomycin plus FMT versus vancomycin alone, reported lead author Simon Mark Dahl Baunwall, MD, of Aarhus (Denmark) University Hospital and colleagues in The Lancet Gastroenterology & Hepatology.

gaetan stoffel/gettyimages

The investigators noted that the participants represented a real-world patient population, so the data support FMT “as a necessary, effective first-line option” in routine management of C. difficile infection.

“Previous studies have demonstrated clinical cure rates [with FMT] of up to 92%,” Dr. Baunwall and colleagues wrote. “Early use of FMT for first or second C. difficile infection has therapeutic potential, but no formal randomized trials to support use of the approach as a first-line therapy have been done.”

The present trial, conducted at a university hospital in Denmark, involved 42 adult patients with first or second C. difficile infection. Patients were randomized in a 1:1 ratio to receive either vancomycin alone or vancomycin plus FMT. All patients received 125 mg oral vancomycin four times daily for a minimum of 10 days after diagnosis. On day 1 after completion of vancomycin therapy and again between day 3 and 7, patients received either oral FMT or matching placebo, depending on their group. After completing the protocol, patients were followed for 8 weeks or C. difficile recurrence to evaluate resolution of C. difficile–associated diarrhea.

“In this trial, patients were treated with two sequential FMT procedures on separate days,” the investigators noted. “This practice might have overtreated some patients and differs from previous trials. It remains unknown whether optimal effect is achieved by one or two treatments.”

The trial design called for 84 patients, but enrollment was halted after an interim analysis of the above cohort of 42 patients because of significantly lower rate resolution in the placebo group. At the 2-month mark, 90% (95% confidence interval, 70%-99%) of patients in the FMT group had resolution, compared with only 33% (95% CI, 15%-57%) of patients in the placebo group (P = .0003), constituting a 57% (95% CI, 33%-81%) absolute risk reduction.

Most patients experienced adverse events, including 20 in the FMT group and all 21 in the placebo group, although most were transient and nonserious. The most common adverse events were diarrhea, which occurred more frequently in the FMT group (23 vs. 14 events), followed by abdominal pain(14 vs. 11 events) and nausea (12 vs. 5 events).

One limitation of the study was its single-center design with regional uptake; the authors noted that, despite having high statistical power for the clinical effect, the study’s premature termination and low patient number prevent inferences regarding mortality, time to effect, and cost.

“The results of this trial highlight how the use of fecal microbiota transplantation as a first-line treatment can effectively prevent C. difficile recurrence and suggests that microbiota restoration might be necessary to obtain sustained resolution,” the investigators wrote. “At present, only 10% of patients with multiple, recurrent C. difficile infection and indication for FMT receive it. International initiatives address the unmet need, but logistic and regulatory obstacles remain unsolved.”
 

Encouraging findings, lingering concerns

Nicholas Turner, MD, assistant professor in the division of infectious diseases at Duke University, Durham, N.C., praised the study for “pushing the boundaries for FMT,” and noted that the methodology appeared sound. Results in the placebo group, however, cast doubt on the generalizability of the findings, he said.

“If you look at the group that received vancomycin plus placebo, their failure rate was really astoundingly high,” Dr. Turner said in an interview, referring to the 67% failure rate in the control group; he noted previous studies had reported failure rates closer to 10%. “I think that just calls into question just a little bit what happened with that control group.”

Dr. Turner said his confidence would go “way, way up” if the findings were reproduced in a larger study. Ideally, these future trials would use fidaxomicin, he added, which is becoming the preferred option over vancomycin for treating C. difficile.

John Y. Kao, MD, professor of medicine and codirector of the FMT program at University of Michigan Medicine, Ann Arbor, offered a different perspective, suggesting that the control group findings shouldn’t overshadow the efficacy of FMT.

“I agree that historical data would tell us that the placebo population should see a much higher response,” Dr. Kao said in an interview. “In my mind though, the success rate of FMT over placebo is what I would expect. The message of the study should be upheld: that FMT is an effective therapy whether it’s given early or, as the way we give it now, as a sort of rescue therapy.”

Despite this confidence in FMT as an efficacious first-line option, Dr. Kao said it is unlikely to be routinely used in this way anytime soon, even if a larger trial echoes the present results.

“We don’t know the long-term risks of FMT therapy, although we’ve been doing this now probably close to 20 years,” Dr. Kao said.

Specifically, Dr. Kao was most concerned about the long-term risk of colon cancer, as mouse models suggest that microbiome characteristics may affect risk level, and risk may vary based on host-microbiome relationships. In other words, an organism may pose no risk in the gut of the donor, but the same may not be true for the recipient.

While increased rates of colon cancer or other serious illnesses have not been detected in humans who have undergone FMT over the past 2 decades, Dr. Kao said that these findings cannot be extrapolated over a patient’s entire lifetime, especially for younger individuals.

“In a patient that’s 80, you would say, yeah, let’s go ahead and treat you [with FMT] as first-line therapy, whereas someone who’s 20, and has maybe another 50 or 60 years longevity, you may not want to give FMT as first-line therapy,” Dr. Kao said.

This study was supported by Innovation Fund Denmark. The investigators disclosed no competing interests. Dr. Turner previously performed statistical analyses for a Merck study comparing vancomycin, fidaxomicin, and metronidazole for C. difficile infection. Dr. Kao disclosed no relevant conflicts of interest.

Fecal microbiota transplantation (FMT) is safe and highly effective as first-line therapy for patients with first or second Clostridioides difficile infection, according to the first randomized, double-blind, placebo-controlled trial of its kind.

Study enrollment was halted after an interim analysis revealed significantly better outcomes among patients who received vancomycin plus FMT versus vancomycin alone, reported lead author Simon Mark Dahl Baunwall, MD, of Aarhus (Denmark) University Hospital and colleagues in The Lancet Gastroenterology & Hepatology.

gaetan stoffel/gettyimages

The investigators noted that the participants represented a real-world patient population, so the data support FMT “as a necessary, effective first-line option” in routine management of C. difficile infection.

“Previous studies have demonstrated clinical cure rates [with FMT] of up to 92%,” Dr. Baunwall and colleagues wrote. “Early use of FMT for first or second C. difficile infection has therapeutic potential, but no formal randomized trials to support use of the approach as a first-line therapy have been done.”

The present trial, conducted at a university hospital in Denmark, involved 42 adult patients with first or second C. difficile infection. Patients were randomized in a 1:1 ratio to receive either vancomycin alone or vancomycin plus FMT. All patients received 125 mg oral vancomycin four times daily for a minimum of 10 days after diagnosis. On day 1 after completion of vancomycin therapy and again between day 3 and 7, patients received either oral FMT or matching placebo, depending on their group. After completing the protocol, patients were followed for 8 weeks or C. difficile recurrence to evaluate resolution of C. difficile–associated diarrhea.

“In this trial, patients were treated with two sequential FMT procedures on separate days,” the investigators noted. “This practice might have overtreated some patients and differs from previous trials. It remains unknown whether optimal effect is achieved by one or two treatments.”

The trial design called for 84 patients, but enrollment was halted after an interim analysis of the above cohort of 42 patients because of significantly lower rate resolution in the placebo group. At the 2-month mark, 90% (95% confidence interval, 70%-99%) of patients in the FMT group had resolution, compared with only 33% (95% CI, 15%-57%) of patients in the placebo group (P = .0003), constituting a 57% (95% CI, 33%-81%) absolute risk reduction.

Most patients experienced adverse events, including 20 in the FMT group and all 21 in the placebo group, although most were transient and nonserious. The most common adverse events were diarrhea, which occurred more frequently in the FMT group (23 vs. 14 events), followed by abdominal pain(14 vs. 11 events) and nausea (12 vs. 5 events).

One limitation of the study was its single-center design with regional uptake; the authors noted that, despite having high statistical power for the clinical effect, the study’s premature termination and low patient number prevent inferences regarding mortality, time to effect, and cost.

“The results of this trial highlight how the use of fecal microbiota transplantation as a first-line treatment can effectively prevent C. difficile recurrence and suggests that microbiota restoration might be necessary to obtain sustained resolution,” the investigators wrote. “At present, only 10% of patients with multiple, recurrent C. difficile infection and indication for FMT receive it. International initiatives address the unmet need, but logistic and regulatory obstacles remain unsolved.”
 

Encouraging findings, lingering concerns

Nicholas Turner, MD, assistant professor in the division of infectious diseases at Duke University, Durham, N.C., praised the study for “pushing the boundaries for FMT,” and noted that the methodology appeared sound. Results in the placebo group, however, cast doubt on the generalizability of the findings, he said.

“If you look at the group that received vancomycin plus placebo, their failure rate was really astoundingly high,” Dr. Turner said in an interview, referring to the 67% failure rate in the control group; he noted previous studies had reported failure rates closer to 10%. “I think that just calls into question just a little bit what happened with that control group.”

Dr. Turner said his confidence would go “way, way up” if the findings were reproduced in a larger study. Ideally, these future trials would use fidaxomicin, he added, which is becoming the preferred option over vancomycin for treating C. difficile.

John Y. Kao, MD, professor of medicine and codirector of the FMT program at University of Michigan Medicine, Ann Arbor, offered a different perspective, suggesting that the control group findings shouldn’t overshadow the efficacy of FMT.

“I agree that historical data would tell us that the placebo population should see a much higher response,” Dr. Kao said in an interview. “In my mind though, the success rate of FMT over placebo is what I would expect. The message of the study should be upheld: that FMT is an effective therapy whether it’s given early or, as the way we give it now, as a sort of rescue therapy.”

Despite this confidence in FMT as an efficacious first-line option, Dr. Kao said it is unlikely to be routinely used in this way anytime soon, even if a larger trial echoes the present results.

“We don’t know the long-term risks of FMT therapy, although we’ve been doing this now probably close to 20 years,” Dr. Kao said.

Specifically, Dr. Kao was most concerned about the long-term risk of colon cancer, as mouse models suggest that microbiome characteristics may affect risk level, and risk may vary based on host-microbiome relationships. In other words, an organism may pose no risk in the gut of the donor, but the same may not be true for the recipient.

While increased rates of colon cancer or other serious illnesses have not been detected in humans who have undergone FMT over the past 2 decades, Dr. Kao said that these findings cannot be extrapolated over a patient’s entire lifetime, especially for younger individuals.

“In a patient that’s 80, you would say, yeah, let’s go ahead and treat you [with FMT] as first-line therapy, whereas someone who’s 20, and has maybe another 50 or 60 years longevity, you may not want to give FMT as first-line therapy,” Dr. Kao said.

This study was supported by Innovation Fund Denmark. The investigators disclosed no competing interests. Dr. Turner previously performed statistical analyses for a Merck study comparing vancomycin, fidaxomicin, and metronidazole for C. difficile infection. Dr. Kao disclosed no relevant conflicts of interest.

PARIS – What do doctors know about their patients’ sexual health? Not a lot. What about oncologists who treat women with breast cancer? Not much more. Yet sexual dysfunction has a significant impact on the quality of life of patients during and after cancer.

To determine the extent of sexual dysfunction among women with breast cancer, Maria Alice Franzoi, MD, an oncologist at Gustave Roussy Hospital, Villejuif, France, analyzed data concerning sexuality from the CANTO cohort study. She showed that sexual dysfunction often predates the cancer diagnosis and doesn’t improve but rather worsens in the following 2 years. She presented her results at the annual meeting of the European Society for Medical Oncology.
 

Present at diagnosis

Dr. Franzoi, whose research projects have focused on patient monitoring post cancer, drew her conclusions from the data provided by CANTO, a longitudinal, prospective cohort study that monitors women being treated for localized breast cancer. Study participants answered the EORTC-QLQ-BR23 quality-of-life questionnaire at the time of diagnosis (T0), 1 year after diagnosis (T1), and 2 years after diagnosis (T2). Four factors were employed to better define women’s sex-related problems: poor body image, poor sexual functioning (activity and desire), lack of sexual pleasure, and a complete lack of sexual activity.

The analysis focused on the responses of 7,895 patients in the CANTO cohort study on sexual activity; 4,523 of those patients answered questions about sexual pleasure. Female respondents who reported engaging in no sexual activity did not have to answer the questions in this second section.

“Seventy-five percent of patients reported at least one of the four concerns during the study,” noted Dr. Franzoi during her presentation. This finding highlights the fact that “sexual problems are already present at the time of diagnosis in a considerable number of patients,” she said. More than a third of participants complained of at least one of the four items.
 

Developments after diagnosis

The proportion of women who reported no arousal or poor sexual function remained stable at around 30% over time, meaning that the sexual problems were reported in similar numbers at T0, T1, and T2. “However, after cancer, more patients are worried about a lack of sexual pleasure (38.7% at T1 and 38.1% at T2, vs. 29.1% at T0) or report having a negative body image (57.8% at T1 and 52.5% at T2, vs. 32.1% at T0),” said Dr. Franzoi.

She identified the following three variables as being associated with sexual dysfunction 2 years after diagnosis: the existence of this problem at the time of diagnosis, the use of adjuvant hormone therapy, and severe depression or a very high stress level after the first year of treatment.
 

Inadequate specific treatment

“Sexual dysfunction is a major unmet need with a significant impact on quality of life,” said Maryam Lustberg, MD, an oncologist at Yale School of Medicine, New Haven, Conn., who was invited to discuss the results at the conference.

Dr. Franzoi observed that most participants with sexual dysfunction that had continued 2 years after diagnosis had not been referred to a doctor for this problem. “In terms of sexual function, it’s better at T2 than at T1, but only 41% of these women have been seen by a gynecologist, and only 15% have received specific treatment,” she reported, emphasizing the need to assess and treat these issues “proactively” at the time of diagnosis and during and after treatment.

“Now we need to work out what the best treatment approach is,” commented Dr. Lustberg. She said that cancers other than breast and gynecologic cancers should also be taken into consideration. She cited the Sexual Health Assessment in Women With Lung Cancer study, which recently revealed that after being diagnosed with lung cancer, female patients experienced a drop in sexual desire (31% vs. 15% before diagnosis) and an increase in vaginal discomfort or dryness (43% vs. 13% before diagnosis). This study, presented in August to the 2022 International Association for the Study of Lung Cancer World Conference on Lung Cancer, also revealed that different parameters affect satisfaction in one’s sex life, including fatigue, sadness, relationship problems with a partner, and even breathing. Dr. Lustberg concluded from this study that a multidisciplinary approach is needed for cancer survivors.

Dr. Franzoi received research funding from Resilience Care. Dr. Lustberg has links with AstraZeneca, Pfizer, Novartis, Sanofi, and Lilly.

This article was translated from the Medscape French edition.

PARIS – What do doctors know about their patients’ sexual health? Not a lot. What about oncologists who treat women with breast cancer? Not much more. Yet sexual dysfunction has a significant impact on the quality of life of patients during and after cancer.

To determine the extent of sexual dysfunction among women with breast cancer, Maria Alice Franzoi, MD, an oncologist at Gustave Roussy Hospital, Villejuif, France, analyzed data concerning sexuality from the CANTO cohort study. She showed that sexual dysfunction often predates the cancer diagnosis and doesn’t improve but rather worsens in the following 2 years. She presented her results at the annual meeting of the European Society for Medical Oncology.
 

Present at diagnosis

Dr. Franzoi, whose research projects have focused on patient monitoring post cancer, drew her conclusions from the data provided by CANTO, a longitudinal, prospective cohort study that monitors women being treated for localized breast cancer. Study participants answered the EORTC-QLQ-BR23 quality-of-life questionnaire at the time of diagnosis (T0), 1 year after diagnosis (T1), and 2 years after diagnosis (T2). Four factors were employed to better define women’s sex-related problems: poor body image, poor sexual functioning (activity and desire), lack of sexual pleasure, and a complete lack of sexual activity.

The analysis focused on the responses of 7,895 patients in the CANTO cohort study on sexual activity; 4,523 of those patients answered questions about sexual pleasure. Female respondents who reported engaging in no sexual activity did not have to answer the questions in this second section.

“Seventy-five percent of patients reported at least one of the four concerns during the study,” noted Dr. Franzoi during her presentation. This finding highlights the fact that “sexual problems are already present at the time of diagnosis in a considerable number of patients,” she said. More than a third of participants complained of at least one of the four items.
 

Developments after diagnosis

The proportion of women who reported no arousal or poor sexual function remained stable at around 30% over time, meaning that the sexual problems were reported in similar numbers at T0, T1, and T2. “However, after cancer, more patients are worried about a lack of sexual pleasure (38.7% at T1 and 38.1% at T2, vs. 29.1% at T0) or report having a negative body image (57.8% at T1 and 52.5% at T2, vs. 32.1% at T0),” said Dr. Franzoi.

She identified the following three variables as being associated with sexual dysfunction 2 years after diagnosis: the existence of this problem at the time of diagnosis, the use of adjuvant hormone therapy, and severe depression or a very high stress level after the first year of treatment.
 

Inadequate specific treatment

“Sexual dysfunction is a major unmet need with a significant impact on quality of life,” said Maryam Lustberg, MD, an oncologist at Yale School of Medicine, New Haven, Conn., who was invited to discuss the results at the conference.

Dr. Franzoi observed that most participants with sexual dysfunction that had continued 2 years after diagnosis had not been referred to a doctor for this problem. “In terms of sexual function, it’s better at T2 than at T1, but only 41% of these women have been seen by a gynecologist, and only 15% have received specific treatment,” she reported, emphasizing the need to assess and treat these issues “proactively” at the time of diagnosis and during and after treatment.

“Now we need to work out what the best treatment approach is,” commented Dr. Lustberg. She said that cancers other than breast and gynecologic cancers should also be taken into consideration. She cited the Sexual Health Assessment in Women With Lung Cancer study, which recently revealed that after being diagnosed with lung cancer, female patients experienced a drop in sexual desire (31% vs. 15% before diagnosis) and an increase in vaginal discomfort or dryness (43% vs. 13% before diagnosis). This study, presented in August to the 2022 International Association for the Study of Lung Cancer World Conference on Lung Cancer, also revealed that different parameters affect satisfaction in one’s sex life, including fatigue, sadness, relationship problems with a partner, and even breathing. Dr. Lustberg concluded from this study that a multidisciplinary approach is needed for cancer survivors.

Dr. Franzoi received research funding from Resilience Care. Dr. Lustberg has links with AstraZeneca, Pfizer, Novartis, Sanofi, and Lilly.

This article was translated from the Medscape French edition.

PARIS – What do doctors know about their patients’ sexual health? Not a lot. What about oncologists who treat women with breast cancer? Not much more. Yet sexual dysfunction has a significant impact on the quality of life of patients during and after cancer.

To determine the extent of sexual dysfunction among women with breast cancer, Maria Alice Franzoi, MD, an oncologist at Gustave Roussy Hospital, Villejuif, France, analyzed data concerning sexuality from the CANTO cohort study. She showed that sexual dysfunction often predates the cancer diagnosis and doesn’t improve but rather worsens in the following 2 years. She presented her results at the annual meeting of the European Society for Medical Oncology.
 

Present at diagnosis

Dr. Franzoi, whose research projects have focused on patient monitoring post cancer, drew her conclusions from the data provided by CANTO, a longitudinal, prospective cohort study that monitors women being treated for localized breast cancer. Study participants answered the EORTC-QLQ-BR23 quality-of-life questionnaire at the time of diagnosis (T0), 1 year after diagnosis (T1), and 2 years after diagnosis (T2). Four factors were employed to better define women’s sex-related problems: poor body image, poor sexual functioning (activity and desire), lack of sexual pleasure, and a complete lack of sexual activity.

The analysis focused on the responses of 7,895 patients in the CANTO cohort study on sexual activity; 4,523 of those patients answered questions about sexual pleasure. Female respondents who reported engaging in no sexual activity did not have to answer the questions in this second section.

“Seventy-five percent of patients reported at least one of the four concerns during the study,” noted Dr. Franzoi during her presentation. This finding highlights the fact that “sexual problems are already present at the time of diagnosis in a considerable number of patients,” she said. More than a third of participants complained of at least one of the four items.
 

Developments after diagnosis

The proportion of women who reported no arousal or poor sexual function remained stable at around 30% over time, meaning that the sexual problems were reported in similar numbers at T0, T1, and T2. “However, after cancer, more patients are worried about a lack of sexual pleasure (38.7% at T1 and 38.1% at T2, vs. 29.1% at T0) or report having a negative body image (57.8% at T1 and 52.5% at T2, vs. 32.1% at T0),” said Dr. Franzoi.

She identified the following three variables as being associated with sexual dysfunction 2 years after diagnosis: the existence of this problem at the time of diagnosis, the use of adjuvant hormone therapy, and severe depression or a very high stress level after the first year of treatment.
 

Inadequate specific treatment

“Sexual dysfunction is a major unmet need with a significant impact on quality of life,” said Maryam Lustberg, MD, an oncologist at Yale School of Medicine, New Haven, Conn., who was invited to discuss the results at the conference.

Dr. Franzoi observed that most participants with sexual dysfunction that had continued 2 years after diagnosis had not been referred to a doctor for this problem. “In terms of sexual function, it’s better at T2 than at T1, but only 41% of these women have been seen by a gynecologist, and only 15% have received specific treatment,” she reported, emphasizing the need to assess and treat these issues “proactively” at the time of diagnosis and during and after treatment.

“Now we need to work out what the best treatment approach is,” commented Dr. Lustberg. She said that cancers other than breast and gynecologic cancers should also be taken into consideration. She cited the Sexual Health Assessment in Women With Lung Cancer study, which recently revealed that after being diagnosed with lung cancer, female patients experienced a drop in sexual desire (31% vs. 15% before diagnosis) and an increase in vaginal discomfort or dryness (43% vs. 13% before diagnosis). This study, presented in August to the 2022 International Association for the Study of Lung Cancer World Conference on Lung Cancer, also revealed that different parameters affect satisfaction in one’s sex life, including fatigue, sadness, relationship problems with a partner, and even breathing. Dr. Lustberg concluded from this study that a multidisciplinary approach is needed for cancer survivors.

Dr. Franzoi received research funding from Resilience Care. Dr. Lustberg has links with AstraZeneca, Pfizer, Novartis, Sanofi, and Lilly.

This article was translated from the Medscape French edition.

Cardiovascular disease (CVD) and mortality risk could be detected by routine retinal scanning, according to a new study using data from the UK Biobank Eye and Vision Consortium and the European Prospective Investigation into Cancer (EPIC)–Norfolk study.

The researchers, from St. George’s University of London, Cambridge University, Kingston University, Moorfields Eye Hospital, and University College London, developed a method of artificial intelligence (AI)–enabled imaging of the retina’s vascular network that could accurately predict CVD and death, without the need for blood tests or blood pressure measurement.

The system “paves the way for a highly effective, noninvasive screening test for people at medium to high risk of circulatory disease that doesn’t have to be done in a clinic,” they said. “In the general population it could be used as a noncontact form of systemic vascular health check, to triage those at medium-high risk of circulatory mortality for further clinical risk assessment and appropriate intervention.” Optometry specialists welcomed the prospect and hailed it as “an exciting development.”
 

Retinal vessels give an accurate early indicator of CVD

The study, published online in the British Journal of Ophthalmology, was based on previous research showing that the width of retinal arterioles and venules seen on retinal imaging may provide an accurate early indicator of CVD, whereas current risk prediction frameworks aren’t always reliable in identifying people who will go on to develop or die of circulatory diseases. 

The researchers developed a fully automated AI-enabled algorithm, called Quantitative Analysis of Retinal vessels Topology and Size (QUARTZ), to assess the potential of retinal vasculature imaging plus known risk factors to predict vascular health and death. They applied QUARTZ to retinal images from 88,052 UK Biobank participants aged 40-69 years, looking specifically at the width, vessel area, and degree of tortuosity of the retinal microvasculature, to develop prediction models for stroke, heart attack, and death from circulatory disease.

They then applied these models to the retinal images of 7,411 participants, aged 48-92 years, in the EPIC-Norfolk study. They then compared the performance of QUARTZ with the widely used Framingham Risk Scores framework.

The participants in the two studies were tracked for an average of 7.7 and 9.1 years, respectively, during which time there were 327 circulatory disease deaths among 64,144 UK Biobank participants (average age, 56.8 years) and 201 circulatory deaths among 5,862 EPIC-Norfolk participants (average age, 67.6 years).
 

Vessel characteristics important predictors of CVD mortality

Results from the QUARTZ models showed that in all participants, arteriolar and venular width, venular tortuosity, and width variation were important predictors of circulatory disease death. In addition, in women, but not in men, arteriolar and venular area were separate factors that contributed to risk prediction.

Overall, the predictive models, based on age, smoking, and medical history (antihypertensive or cholesterol lowering medication, diabetes, and history of stroke or MI) as well as retinal vasculature, captured between half and two-thirds of circulatory disease deaths in those most at risk, the authors said. 

Compared with Framingham Risk Scores (FRS), the retinal vasculature (RV) models captured about 5% more cases of stroke in UK Biobank men, 8% more cases in UK Biobank women, and 3% more cases among EPIC-Norfolk men most at risk, but nearly 2% fewer cases among EPIC-Norfolk women. However, the team said that, while adding RV to FRS resulted in only marginal changes in prediction of stroke or MI, a simpler noninvasive risk score based on age, sex, smoking status, medical history, and RV “yielded comparable performance to FRS, without the need for blood sampling or BP measurement.”
 

Vasculometry low cost, noninvasive and with high street availability

They concluded: “Retinal imaging is established within clinic and hospital eye care and in optometric practices in the U.S. and U.K. AI-enabled vasculometry risk prediction is fully automated, low cost, noninvasive and has the potential for reaching a higher proportion of the population in the community because of “high street” availability and because blood sampling or sphygmomanometry are not needed.

“[Retinal vasculature] is a microvascular marker, hence offers better prediction for circulatory mortality and stroke, compared with MI, which is more macrovascular, except perhaps in women. 

“In the general population it could be used as a noncontact form of systemic vascular health check, to triage those at medium-high risk of circulatory mortality for further clinical risk assessment and appropriate intervention.”

In the United Kingdom, for example, it could be included in the primary care NHS Health Check for those aged 41-74 years, they suggested.  In addition, “high street” retinal scanning could directly feed into primary medical services and help achieve greater screening coverage for older age groups, who are likely to attend an optometric practice for visual correction, especially with the onset of presbyopia. “This would offer a novel approach to identify those at high risk of circulatory mortality, which is not currently screened for,” the team said.
 

Test could help to identify high-risk individuals

In a linked editorial, Ify Mordi, MD, and Emanuele Trucco, MD, of the University of Dundee (Scotland), said that CVD remains a significant cause of mortality and morbidity and the most common cause of death worldwide, accounting for a quarter of all U.K. deaths – and its burden is increasing. “Identification of individuals at high risk is particularly important,” they said, but current clinical risk scores to identify those at risk “are unfortunately not perfect,” so miss some of those who might benefit from preventative therapy.

“The retina is the only location that allows non-invasive direct visualisation of the vasculature, potentially providing a rich source of information.” In the new study, the measurements derived with the software tool, QUARTZ, were significantly associated with CVD, they said, with similar predictive performance to the Framingham clinical risk score.

“The results strengthen the evidence from several similar studies that the retina can be a useful and potentially disruptive source of information for CVD risk in personalised medicine.” However, a number of questions remain about how this knowledge could be integrated into clinical care, including who would conduct such a retinal screening program and who would act on the findings?

The editorial concluded: “What is now needed is for ophthalmologists, cardiologists, primary care physicians, and computer scientists to work together to design studies to determine whether using this information improves clinical outcome, and, if so, to work with regulatory bodies, scientific societies and healthcare systems to optimize clinical work flows and enable practical implementation in routine practice.”
 

‘Exciting development that could improve outcomes’

Asked to comment, Farah Topia, clinical and regulatory adviser at the Association of Optometrists, said: “This is an exciting development that could improve outcomes for many patients by enabling earlier detection of serious health risks. Patients attend optometric practice for a variety of reasons and this interaction could be used to a greater extent to help detect disease earlier. With optometrists available on every High Street, in the heart of communities, it’s an element of primary care that can be accessed quickly and easily, and optometrists are also already trained to have health and lifestyle discussion with patients.”

She added: “Retinal photographs are regularly taken when patients visit an optometrist, so being able to further enhance this process using AI is exciting.

“We look forward to seeing how this area develops and how optometrists can work together with other healthcare sectors to improve patient outcomes and ease the burden the NHS currently faces.” 

The study was funded by the Medical Research Council Population and Systems Medicine Board and the British Heart Foundation.

A version of this article first appeared on Medscape UK.

Cardiovascular disease (CVD) and mortality risk could be detected by routine retinal scanning, according to a new study using data from the UK Biobank Eye and Vision Consortium and the European Prospective Investigation into Cancer (EPIC)–Norfolk study.

The researchers, from St. George’s University of London, Cambridge University, Kingston University, Moorfields Eye Hospital, and University College London, developed a method of artificial intelligence (AI)–enabled imaging of the retina’s vascular network that could accurately predict CVD and death, without the need for blood tests or blood pressure measurement.

The system “paves the way for a highly effective, noninvasive screening test for people at medium to high risk of circulatory disease that doesn’t have to be done in a clinic,” they said. “In the general population it could be used as a noncontact form of systemic vascular health check, to triage those at medium-high risk of circulatory mortality for further clinical risk assessment and appropriate intervention.” Optometry specialists welcomed the prospect and hailed it as “an exciting development.”
 

Retinal vessels give an accurate early indicator of CVD

The study, published online in the British Journal of Ophthalmology, was based on previous research showing that the width of retinal arterioles and venules seen on retinal imaging may provide an accurate early indicator of CVD, whereas current risk prediction frameworks aren’t always reliable in identifying people who will go on to develop or die of circulatory diseases. 

The researchers developed a fully automated AI-enabled algorithm, called Quantitative Analysis of Retinal vessels Topology and Size (QUARTZ), to assess the potential of retinal vasculature imaging plus known risk factors to predict vascular health and death. They applied QUARTZ to retinal images from 88,052 UK Biobank participants aged 40-69 years, looking specifically at the width, vessel area, and degree of tortuosity of the retinal microvasculature, to develop prediction models for stroke, heart attack, and death from circulatory disease.

They then applied these models to the retinal images of 7,411 participants, aged 48-92 years, in the EPIC-Norfolk study. They then compared the performance of QUARTZ with the widely used Framingham Risk Scores framework.

The participants in the two studies were tracked for an average of 7.7 and 9.1 years, respectively, during which time there were 327 circulatory disease deaths among 64,144 UK Biobank participants (average age, 56.8 years) and 201 circulatory deaths among 5,862 EPIC-Norfolk participants (average age, 67.6 years).
 

Vessel characteristics important predictors of CVD mortality

Results from the QUARTZ models showed that in all participants, arteriolar and venular width, venular tortuosity, and width variation were important predictors of circulatory disease death. In addition, in women, but not in men, arteriolar and venular area were separate factors that contributed to risk prediction.

Overall, the predictive models, based on age, smoking, and medical history (antihypertensive or cholesterol lowering medication, diabetes, and history of stroke or MI) as well as retinal vasculature, captured between half and two-thirds of circulatory disease deaths in those most at risk, the authors said. 

Compared with Framingham Risk Scores (FRS), the retinal vasculature (RV) models captured about 5% more cases of stroke in UK Biobank men, 8% more cases in UK Biobank women, and 3% more cases among EPIC-Norfolk men most at risk, but nearly 2% fewer cases among EPIC-Norfolk women. However, the team said that, while adding RV to FRS resulted in only marginal changes in prediction of stroke or MI, a simpler noninvasive risk score based on age, sex, smoking status, medical history, and RV “yielded comparable performance to FRS, without the need for blood sampling or BP measurement.”
 

Vasculometry low cost, noninvasive and with high street availability

They concluded: “Retinal imaging is established within clinic and hospital eye care and in optometric practices in the U.S. and U.K. AI-enabled vasculometry risk prediction is fully automated, low cost, noninvasive and has the potential for reaching a higher proportion of the population in the community because of “high street” availability and because blood sampling or sphygmomanometry are not needed.

“[Retinal vasculature] is a microvascular marker, hence offers better prediction for circulatory mortality and stroke, compared with MI, which is more macrovascular, except perhaps in women. 

“In the general population it could be used as a noncontact form of systemic vascular health check, to triage those at medium-high risk of circulatory mortality for further clinical risk assessment and appropriate intervention.”

In the United Kingdom, for example, it could be included in the primary care NHS Health Check for those aged 41-74 years, they suggested.  In addition, “high street” retinal scanning could directly feed into primary medical services and help achieve greater screening coverage for older age groups, who are likely to attend an optometric practice for visual correction, especially with the onset of presbyopia. “This would offer a novel approach to identify those at high risk of circulatory mortality, which is not currently screened for,” the team said.
 

Test could help to identify high-risk individuals

In a linked editorial, Ify Mordi, MD, and Emanuele Trucco, MD, of the University of Dundee (Scotland), said that CVD remains a significant cause of mortality and morbidity and the most common cause of death worldwide, accounting for a quarter of all U.K. deaths – and its burden is increasing. “Identification of individuals at high risk is particularly important,” they said, but current clinical risk scores to identify those at risk “are unfortunately not perfect,” so miss some of those who might benefit from preventative therapy.

“The retina is the only location that allows non-invasive direct visualisation of the vasculature, potentially providing a rich source of information.” In the new study, the measurements derived with the software tool, QUARTZ, were significantly associated with CVD, they said, with similar predictive performance to the Framingham clinical risk score.

“The results strengthen the evidence from several similar studies that the retina can be a useful and potentially disruptive source of information for CVD risk in personalised medicine.” However, a number of questions remain about how this knowledge could be integrated into clinical care, including who would conduct such a retinal screening program and who would act on the findings?

The editorial concluded: “What is now needed is for ophthalmologists, cardiologists, primary care physicians, and computer scientists to work together to design studies to determine whether using this information improves clinical outcome, and, if so, to work with regulatory bodies, scientific societies and healthcare systems to optimize clinical work flows and enable practical implementation in routine practice.”
 

‘Exciting development that could improve outcomes’

Asked to comment, Farah Topia, clinical and regulatory adviser at the Association of Optometrists, said: “This is an exciting development that could improve outcomes for many patients by enabling earlier detection of serious health risks. Patients attend optometric practice for a variety of reasons and this interaction could be used to a greater extent to help detect disease earlier. With optometrists available on every High Street, in the heart of communities, it’s an element of primary care that can be accessed quickly and easily, and optometrists are also already trained to have health and lifestyle discussion with patients.”

She added: “Retinal photographs are regularly taken when patients visit an optometrist, so being able to further enhance this process using AI is exciting.

“We look forward to seeing how this area develops and how optometrists can work together with other healthcare sectors to improve patient outcomes and ease the burden the NHS currently faces.” 

The study was funded by the Medical Research Council Population and Systems Medicine Board and the British Heart Foundation.

A version of this article first appeared on Medscape UK.

Cardiovascular disease (CVD) and mortality risk could be detected by routine retinal scanning, according to a new study using data from the UK Biobank Eye and Vision Consortium and the European Prospective Investigation into Cancer (EPIC)–Norfolk study.

The researchers, from St. George’s University of London, Cambridge University, Kingston University, Moorfields Eye Hospital, and University College London, developed a method of artificial intelligence (AI)–enabled imaging of the retina’s vascular network that could accurately predict CVD and death, without the need for blood tests or blood pressure measurement.

The system “paves the way for a highly effective, noninvasive screening test for people at medium to high risk of circulatory disease that doesn’t have to be done in a clinic,” they said. “In the general population it could be used as a noncontact form of systemic vascular health check, to triage those at medium-high risk of circulatory mortality for further clinical risk assessment and appropriate intervention.” Optometry specialists welcomed the prospect and hailed it as “an exciting development.”
 

Retinal vessels give an accurate early indicator of CVD

The study, published online in the British Journal of Ophthalmology, was based on previous research showing that the width of retinal arterioles and venules seen on retinal imaging may provide an accurate early indicator of CVD, whereas current risk prediction frameworks aren’t always reliable in identifying people who will go on to develop or die of circulatory diseases. 

The researchers developed a fully automated AI-enabled algorithm, called Quantitative Analysis of Retinal vessels Topology and Size (QUARTZ), to assess the potential of retinal vasculature imaging plus known risk factors to predict vascular health and death. They applied QUARTZ to retinal images from 88,052 UK Biobank participants aged 40-69 years, looking specifically at the width, vessel area, and degree of tortuosity of the retinal microvasculature, to develop prediction models for stroke, heart attack, and death from circulatory disease.

They then applied these models to the retinal images of 7,411 participants, aged 48-92 years, in the EPIC-Norfolk study. They then compared the performance of QUARTZ with the widely used Framingham Risk Scores framework.

The participants in the two studies were tracked for an average of 7.7 and 9.1 years, respectively, during which time there were 327 circulatory disease deaths among 64,144 UK Biobank participants (average age, 56.8 years) and 201 circulatory deaths among 5,862 EPIC-Norfolk participants (average age, 67.6 years).
 

Vessel characteristics important predictors of CVD mortality

Results from the QUARTZ models showed that in all participants, arteriolar and venular width, venular tortuosity, and width variation were important predictors of circulatory disease death. In addition, in women, but not in men, arteriolar and venular area were separate factors that contributed to risk prediction.

Overall, the predictive models, based on age, smoking, and medical history (antihypertensive or cholesterol lowering medication, diabetes, and history of stroke or MI) as well as retinal vasculature, captured between half and two-thirds of circulatory disease deaths in those most at risk, the authors said. 

Compared with Framingham Risk Scores (FRS), the retinal vasculature (RV) models captured about 5% more cases of stroke in UK Biobank men, 8% more cases in UK Biobank women, and 3% more cases among EPIC-Norfolk men most at risk, but nearly 2% fewer cases among EPIC-Norfolk women. However, the team said that, while adding RV to FRS resulted in only marginal changes in prediction of stroke or MI, a simpler noninvasive risk score based on age, sex, smoking status, medical history, and RV “yielded comparable performance to FRS, without the need for blood sampling or BP measurement.”
 

Vasculometry low cost, noninvasive and with high street availability

They concluded: “Retinal imaging is established within clinic and hospital eye care and in optometric practices in the U.S. and U.K. AI-enabled vasculometry risk prediction is fully automated, low cost, noninvasive and has the potential for reaching a higher proportion of the population in the community because of “high street” availability and because blood sampling or sphygmomanometry are not needed.

“[Retinal vasculature] is a microvascular marker, hence offers better prediction for circulatory mortality and stroke, compared with MI, which is more macrovascular, except perhaps in women. 

“In the general population it could be used as a noncontact form of systemic vascular health check, to triage those at medium-high risk of circulatory mortality for further clinical risk assessment and appropriate intervention.”

In the United Kingdom, for example, it could be included in the primary care NHS Health Check for those aged 41-74 years, they suggested.  In addition, “high street” retinal scanning could directly feed into primary medical services and help achieve greater screening coverage for older age groups, who are likely to attend an optometric practice for visual correction, especially with the onset of presbyopia. “This would offer a novel approach to identify those at high risk of circulatory mortality, which is not currently screened for,” the team said.
 

Test could help to identify high-risk individuals

In a linked editorial, Ify Mordi, MD, and Emanuele Trucco, MD, of the University of Dundee (Scotland), said that CVD remains a significant cause of mortality and morbidity and the most common cause of death worldwide, accounting for a quarter of all U.K. deaths – and its burden is increasing. “Identification of individuals at high risk is particularly important,” they said, but current clinical risk scores to identify those at risk “are unfortunately not perfect,” so miss some of those who might benefit from preventative therapy.

“The retina is the only location that allows non-invasive direct visualisation of the vasculature, potentially providing a rich source of information.” In the new study, the measurements derived with the software tool, QUARTZ, were significantly associated with CVD, they said, with similar predictive performance to the Framingham clinical risk score.

“The results strengthen the evidence from several similar studies that the retina can be a useful and potentially disruptive source of information for CVD risk in personalised medicine.” However, a number of questions remain about how this knowledge could be integrated into clinical care, including who would conduct such a retinal screening program and who would act on the findings?

The editorial concluded: “What is now needed is for ophthalmologists, cardiologists, primary care physicians, and computer scientists to work together to design studies to determine whether using this information improves clinical outcome, and, if so, to work with regulatory bodies, scientific societies and healthcare systems to optimize clinical work flows and enable practical implementation in routine practice.”
 

‘Exciting development that could improve outcomes’

Asked to comment, Farah Topia, clinical and regulatory adviser at the Association of Optometrists, said: “This is an exciting development that could improve outcomes for many patients by enabling earlier detection of serious health risks. Patients attend optometric practice for a variety of reasons and this interaction could be used to a greater extent to help detect disease earlier. With optometrists available on every High Street, in the heart of communities, it’s an element of primary care that can be accessed quickly and easily, and optometrists are also already trained to have health and lifestyle discussion with patients.”

She added: “Retinal photographs are regularly taken when patients visit an optometrist, so being able to further enhance this process using AI is exciting.

“We look forward to seeing how this area develops and how optometrists can work together with other healthcare sectors to improve patient outcomes and ease the burden the NHS currently faces.” 

The study was funded by the Medical Research Council Population and Systems Medicine Board and the British Heart Foundation.

A version of this article first appeared on Medscape UK.

Having a sore throat is becoming a dominant symptom of COVID-19 infection, with fever and loss of smell becoming less common, according to recent reports in the United Kingdom.

The shift could be a cause of concern for the fall. As the main symptoms of the coronavirus change, people could spread the virus without realizing it.

“Many people are still using the government guidelines about symptoms, which are wrong,” Tim Spector, a professor of genetic epidemiology at King’s College London, told the Independent.

Prof. Spector cofounded the COVID ZOE app, which is part of the world’s largest COVID-19 study. Throughout the pandemic, researchers have used data from the app to track changes in symptoms.

“At the moment, COVID starts in two-thirds of people with a sore throat,” he said. “Fever and loss of smell are really rare now, so many old people may not think they’ve got COVID. They’d say it’s a cold and not be tested.”

COVID-19 infections in the United Kingdom increased 14% at the end of September, according to data from the U.K.’s Office for National Statistics. More than 1.1 million people tested positive during the week ending Sept. 20, up from 927,000 cases the week before. The numbers continue to increase in England and Wales, with an uncertain trend in Northern Ireland and Scotland.

The fall wave of infections has likely arrived in the United Kingdom, Prof. Spector told the Independent. Omicron variants continue to evolve and are escaping immunity from previous infection and vaccination, which he expects to continue into the winter.

But with reduced testing and surveillance of new variants, public health experts have voiced concerns about tracking the latest variants and COVID-19 trends.

“We can only detect variants or know what’s coming by doing sequencing from PCR testing, and that’s not going on anywhere near the extent it was a year ago,” Lawrence Young, a professor of virology at the University of Warwick, Coventry, England, told the Independent.

“People are going to get various infections over the winter but won’t know what they are because free tests aren’t available,” he said. “It’s going to be a problem.” 

COVID-19 cases are also increasing across Europe, which could mark the first regional spike since the BA.5 wave, according to the latest data from the European CDC. (In the past, increases in Europe have signaled a trend to come in other regions.)

People aged 65 and older have been hit the hardest, the data shows, with cases rising 9% from the previous week. Hospitalizations remain stable for now, although 14 of 27 countries in the European region have noted an upward trend.

“Changes in population mixing following the summer break are likely to be the main driver of these increases, with no indication of changes in the distribution of circulating variants,” the European CDC said.

For now, most COVID-19 numbers are still falling in the United States, according to a weekly CDC update published Sept. 30. About 47,000 cases are being reported each day, marking a 13% decrease from the week before. Hospitalizations dropped 7%, and deaths dropped 6%.

At the same time, test positivity rose slightly last week, from 9.6% to 9.8%. Wastewater surveillance indicates that 53% of sites in the United States reported a decrease in virus levels, while 41% reported an increase last week.

The CDC encouraged people to get the updated Omicron-targeted booster shot for the fall. About 7.5 million Americans have received the updated vaccine. Half of the eligible population in the United States hasn’t received any booster dose yet.

“Bivalent boosters help restore protection that might have gone down since your last dose – and they also give extra protection for you and those around you against all lineages of the Omicron variant,” the CDC wrote. “The more people who stay up to date on vaccinations, the better chance we have of avoiding a possible surge in COVID-19 illness later this fall and winter.”

A version of this article first appeared on WebMD.com.

Having a sore throat is becoming a dominant symptom of COVID-19 infection, with fever and loss of smell becoming less common, according to recent reports in the United Kingdom.

The shift could be a cause of concern for the fall. As the main symptoms of the coronavirus change, people could spread the virus without realizing it.

“Many people are still using the government guidelines about symptoms, which are wrong,” Tim Spector, a professor of genetic epidemiology at King’s College London, told the Independent.

Prof. Spector cofounded the COVID ZOE app, which is part of the world’s largest COVID-19 study. Throughout the pandemic, researchers have used data from the app to track changes in symptoms.

“At the moment, COVID starts in two-thirds of people with a sore throat,” he said. “Fever and loss of smell are really rare now, so many old people may not think they’ve got COVID. They’d say it’s a cold and not be tested.”

COVID-19 infections in the United Kingdom increased 14% at the end of September, according to data from the U.K.’s Office for National Statistics. More than 1.1 million people tested positive during the week ending Sept. 20, up from 927,000 cases the week before. The numbers continue to increase in England and Wales, with an uncertain trend in Northern Ireland and Scotland.

The fall wave of infections has likely arrived in the United Kingdom, Prof. Spector told the Independent. Omicron variants continue to evolve and are escaping immunity from previous infection and vaccination, which he expects to continue into the winter.

But with reduced testing and surveillance of new variants, public health experts have voiced concerns about tracking the latest variants and COVID-19 trends.

“We can only detect variants or know what’s coming by doing sequencing from PCR testing, and that’s not going on anywhere near the extent it was a year ago,” Lawrence Young, a professor of virology at the University of Warwick, Coventry, England, told the Independent.

“People are going to get various infections over the winter but won’t know what they are because free tests aren’t available,” he said. “It’s going to be a problem.” 

COVID-19 cases are also increasing across Europe, which could mark the first regional spike since the BA.5 wave, according to the latest data from the European CDC. (In the past, increases in Europe have signaled a trend to come in other regions.)

People aged 65 and older have been hit the hardest, the data shows, with cases rising 9% from the previous week. Hospitalizations remain stable for now, although 14 of 27 countries in the European region have noted an upward trend.

“Changes in population mixing following the summer break are likely to be the main driver of these increases, with no indication of changes in the distribution of circulating variants,” the European CDC said.

For now, most COVID-19 numbers are still falling in the United States, according to a weekly CDC update published Sept. 30. About 47,000 cases are being reported each day, marking a 13% decrease from the week before. Hospitalizations dropped 7%, and deaths dropped 6%.

At the same time, test positivity rose slightly last week, from 9.6% to 9.8%. Wastewater surveillance indicates that 53% of sites in the United States reported a decrease in virus levels, while 41% reported an increase last week.

The CDC encouraged people to get the updated Omicron-targeted booster shot for the fall. About 7.5 million Americans have received the updated vaccine. Half of the eligible population in the United States hasn’t received any booster dose yet.

“Bivalent boosters help restore protection that might have gone down since your last dose – and they also give extra protection for you and those around you against all lineages of the Omicron variant,” the CDC wrote. “The more people who stay up to date on vaccinations, the better chance we have of avoiding a possible surge in COVID-19 illness later this fall and winter.”

A version of this article first appeared on WebMD.com.

Having a sore throat is becoming a dominant symptom of COVID-19 infection, with fever and loss of smell becoming less common, according to recent reports in the United Kingdom.

The shift could be a cause of concern for the fall. As the main symptoms of the coronavirus change, people could spread the virus without realizing it.

“Many people are still using the government guidelines about symptoms, which are wrong,” Tim Spector, a professor of genetic epidemiology at King’s College London, told the Independent.

Prof. Spector cofounded the COVID ZOE app, which is part of the world’s largest COVID-19 study. Throughout the pandemic, researchers have used data from the app to track changes in symptoms.

“At the moment, COVID starts in two-thirds of people with a sore throat,” he said. “Fever and loss of smell are really rare now, so many old people may not think they’ve got COVID. They’d say it’s a cold and not be tested.”

COVID-19 infections in the United Kingdom increased 14% at the end of September, according to data from the U.K.’s Office for National Statistics. More than 1.1 million people tested positive during the week ending Sept. 20, up from 927,000 cases the week before. The numbers continue to increase in England and Wales, with an uncertain trend in Northern Ireland and Scotland.

The fall wave of infections has likely arrived in the United Kingdom, Prof. Spector told the Independent. Omicron variants continue to evolve and are escaping immunity from previous infection and vaccination, which he expects to continue into the winter.

But with reduced testing and surveillance of new variants, public health experts have voiced concerns about tracking the latest variants and COVID-19 trends.

“We can only detect variants or know what’s coming by doing sequencing from PCR testing, and that’s not going on anywhere near the extent it was a year ago,” Lawrence Young, a professor of virology at the University of Warwick, Coventry, England, told the Independent.

“People are going to get various infections over the winter but won’t know what they are because free tests aren’t available,” he said. “It’s going to be a problem.” 

COVID-19 cases are also increasing across Europe, which could mark the first regional spike since the BA.5 wave, according to the latest data from the European CDC. (In the past, increases in Europe have signaled a trend to come in other regions.)

People aged 65 and older have been hit the hardest, the data shows, with cases rising 9% from the previous week. Hospitalizations remain stable for now, although 14 of 27 countries in the European region have noted an upward trend.

“Changes in population mixing following the summer break are likely to be the main driver of these increases, with no indication of changes in the distribution of circulating variants,” the European CDC said.

For now, most COVID-19 numbers are still falling in the United States, according to a weekly CDC update published Sept. 30. About 47,000 cases are being reported each day, marking a 13% decrease from the week before. Hospitalizations dropped 7%, and deaths dropped 6%.

At the same time, test positivity rose slightly last week, from 9.6% to 9.8%. Wastewater surveillance indicates that 53% of sites in the United States reported a decrease in virus levels, while 41% reported an increase last week.

The CDC encouraged people to get the updated Omicron-targeted booster shot for the fall. About 7.5 million Americans have received the updated vaccine. Half of the eligible population in the United States hasn’t received any booster dose yet.

“Bivalent boosters help restore protection that might have gone down since your last dose – and they also give extra protection for you and those around you against all lineages of the Omicron variant,” the CDC wrote. “The more people who stay up to date on vaccinations, the better chance we have of avoiding a possible surge in COVID-19 illness later this fall and winter.”

A version of this article first appeared on WebMD.com.

Daniel Freedman, DO, a pediatric neurologist in Austin, Tex., remembers being flabbergasted when a surgeon threw an instrument across the room in medical school.

“I remember thinking, ‘I can’t believe people actually do this, a grown man in his 50s having a temper tantrum,’” Dr. Freedman said in an interview. But it certainly wasn’t the last time he witnessed bad behavior by one of his peers.

The results of Medscape’s recent report, Physicians Behaving Badly: Stress and Hardship Trigger Misconduct, suggest he has plenty of company. More than 4 in 10 respondents (41%) observed inappropriate behavior in the workplace in 2022, an uptick from 35% in 2021, according to the report, which polled more than 1,500 physicians about inappropriate behavior on and off the clock.

Of course, 38% of respondents have not seen any instances of misbehavior; and many of the instances that were seen were mild or infrequent. Additionally, instances of bad behavior have declined significantly over the past 5 years.

Dr. Freedman said he learned a lesson from his mentor and program director during training that has stuck with him throughout his career. “If you couldn’t act that way at any job, whether at McDonald’s or any other possible place, you shouldn’t act that way in medicine.” But he recognizes one limitation of that advice. “A lot of the people that behave badly may not have ever worked in a different environment before,” he said.

“They only perceive that they’re at the top of the food chain, so they can behave badly without repercussions.”

What Dr. Freedman described is formally called disruptive physician behavior, one of several categories of inappropriate behavior in medicine, according to Charles Samenow, MD, MPH, an associate professor of psychiatry and behavioral sciences at George Washington University, Washington, who has studied this phenomenon for years.

“Disruptive physician behavior compromises the safety of the workplace,” Dr. Samenow explained. The behavior can occur at work, outside of work, or on social media. It can hinder operations, threaten patient and staff safety, and affect workplace morale.

“The question is trying to understand where that bad behavior is coming from and the impact of that bad behavior,” Dr. Samenow said in an interview.

One reason is fairly simple: doctors are human, and humans have a wide range of behavior. Plus, as the Medscape survey showed, the tension, stress, dangerous conditions during COVID, burnout, and other problems have made many physicians tired, frustrated, depressed, and more reactive to situations around them.
 

Self-selecting traits become an Achilles heel

“Any human put in a position of power over other humans has the potential to be disruptive, harass, etc, if they have certain personality traits,” said David Gorski, MD, a professor of surgery at Wayne State University, Detroit. That jibes with Dr. Samenow’s research.

Classic disruptive behavior isn’t usually associated with depression, mania, psychosis, or similar characteristics, Dr. Samenow explained. Rather, it tends to be personality driven. “Physicians are not immune to the normal problems every human being faces,” he said.

In the Medscape report, physicians cited personal arrogance as one of the leading reasons physicians engaged in inappropriate behavior (56%), followed closely by personal problems outside of work (52%), a social shift in accepting more casual behavior (50%), and job-related stress (46%). (Respondents could choose more than one answer).

One factor contributing to misbehavior that Dr. Samenow has consistently identified in his research is a history of adverse childhood experiences or family dysfunction: People who grew up in homes with physical or verbal abuse learned anger as a coping skill instead of positive, assertive communication. It’s likely that some physicians, as well as the overall population, learned anger as a coping skill for that reason.
 

How to help avert disruptive behavior in medical settings

Dr. Samenow said that coaching is a “wonderful tool” in teaching the interpersonal skills that medical school often doesn’t address.

In some case, interventions can be very helpful. For example, programs that teach effective communication strategies and teamwork through a combination of culturally sensitive dialectical and cognitive-behavioral therapy and other modalities have been successful, Dr. Samenow said. Although they are more about treating an illness than addressing “misbehavior,” programs for substance use that have been developed by and for doctors are very effective, too.

Fewer resources are available, however, for addressing racism, classism, misogyny, and other forms of bigotry, Dr. Samenow noted. “There’s implicit bias training, but not at the level of what exists for disruptive physicians and those with addiction. “That’s an area we need to work on.” Racist language was the third most commonly observed bad behavior cited in the Medscape survey, behind only bullying of staff and mocking or disparaging of patients. It was reported frequently outside of work as well.

The Medscape report found an increase in observed behavior at work and on social media, although it’s hard to determine prevalence trends over time, Dr. Samenow said. “The tolerance for this behavior has really gone down,” likely leading to more reporting, he said, and more systems for reporting bad behavior exist today than in the past.

However, Dr. Freedman said inadequate regulation, disciplinary action, and follow-through remain a problem.

“There are lots of limitations to our reporting system and to our follow-through with those reports,” including hospitals that, whether for fear of litigation or other reasons, allow physicians to quietly resign and move to another institution, even with positive recommendations, Dr. Freedman said.

Indeed, only a third of observed misbehavior in the Medscape report resulted in disciplinary action. Half the respondents believed a verbal warning was a necessary consequence, followed by a conversation from management and being reported to a supervisor or human resources. Though only 10% thought a report to the medical board was warranted, it likely depends on the offense and its frequency.

“I think going from paternalism to more patient-centered care and having patients involved in those conversations is a nice shift that makes doctors more human and relatable, and hopefully makes the public more forgiving, that we’re going to make mistakes and nobody’s perfect,” Freedman said. But he added that physicians should be held accountable when a mistake or two becomes a pattern.
 

Misinformation is professional misconduct

Sufficient accountability is especially absent, these doctors said, for a subset of professional misconduct: spreading misinformation.

While more “conventional” bad behaviors include fraud, dishonesty, abuse of underlings, and incompetence, bad behavior should also include “selling quackery and antivaccine misinformation, the way some doctors did with various nostrums for COVID-19,” said Dr. Gorski, who frequently blogs about doctors’ spreading misinformation.

Taylor Nichols, MD, an emergency medicine physician based in Sacramento, cites the desire for attention and clout as motivations. “Saying things that are wildly, provably false is professional misconduct,” Nichols said. He distinguished such statements from scientific, academic, or clinical disagreement that is necessary within medicine.

Yet there’s been a “long tradition of looking the other way or letting people with fancy titles get away with saying nonsense just because they’re respected,” Jonathan Howard, MD, an associate professor of psychiatry and neurology at New York University said in an interview.

“We have a duty to be trusted members of the community,” Dr. Howard said. “People listen when we say things, and we have an obligation to try to be accurate and humble and as honest as possible and admit mistakes when we inevitably make them.”

That extends to social media, which Dr. Nichols said has magnified the problem of promoting quackery and misinformation. He thinks medical boards and professional credentialing bodies should pay attention to what’s happening in the public conversation and understand that our professional responsibility extends beyond the walls of the hospital or clinic. Physicians must represent themselves professionally and uphold the standards that the profession expects.

On the one hand, Medscape respondents agreed: 70% said one doctor’s misbehavior taints the whole profession. Yet, at the same time, 58% of respondents believed physicians should be able to “keep their private lives private” in 2022. But that’s not the reality of the profession when the lines between private life and behavior away from work get blurred, Dr. Samenow said.

“The way a physician behaves in public represents you,” he said. “What happens in Vegas doesn’t always stay in Vegas.”

A version of this article first appeared on Medscape.com.

Daniel Freedman, DO, a pediatric neurologist in Austin, Tex., remembers being flabbergasted when a surgeon threw an instrument across the room in medical school.

“I remember thinking, ‘I can’t believe people actually do this, a grown man in his 50s having a temper tantrum,’” Dr. Freedman said in an interview. But it certainly wasn’t the last time he witnessed bad behavior by one of his peers.

The results of Medscape’s recent report, Physicians Behaving Badly: Stress and Hardship Trigger Misconduct, suggest he has plenty of company. More than 4 in 10 respondents (41%) observed inappropriate behavior in the workplace in 2022, an uptick from 35% in 2021, according to the report, which polled more than 1,500 physicians about inappropriate behavior on and off the clock.

Of course, 38% of respondents have not seen any instances of misbehavior; and many of the instances that were seen were mild or infrequent. Additionally, instances of bad behavior have declined significantly over the past 5 years.

Dr. Freedman said he learned a lesson from his mentor and program director during training that has stuck with him throughout his career. “If you couldn’t act that way at any job, whether at McDonald’s or any other possible place, you shouldn’t act that way in medicine.” But he recognizes one limitation of that advice. “A lot of the people that behave badly may not have ever worked in a different environment before,” he said.

“They only perceive that they’re at the top of the food chain, so they can behave badly without repercussions.”

What Dr. Freedman described is formally called disruptive physician behavior, one of several categories of inappropriate behavior in medicine, according to Charles Samenow, MD, MPH, an associate professor of psychiatry and behavioral sciences at George Washington University, Washington, who has studied this phenomenon for years.

“Disruptive physician behavior compromises the safety of the workplace,” Dr. Samenow explained. The behavior can occur at work, outside of work, or on social media. It can hinder operations, threaten patient and staff safety, and affect workplace morale.

“The question is trying to understand where that bad behavior is coming from and the impact of that bad behavior,” Dr. Samenow said in an interview.

One reason is fairly simple: doctors are human, and humans have a wide range of behavior. Plus, as the Medscape survey showed, the tension, stress, dangerous conditions during COVID, burnout, and other problems have made many physicians tired, frustrated, depressed, and more reactive to situations around them.
 

Self-selecting traits become an Achilles heel

“Any human put in a position of power over other humans has the potential to be disruptive, harass, etc, if they have certain personality traits,” said David Gorski, MD, a professor of surgery at Wayne State University, Detroit. That jibes with Dr. Samenow’s research.

Classic disruptive behavior isn’t usually associated with depression, mania, psychosis, or similar characteristics, Dr. Samenow explained. Rather, it tends to be personality driven. “Physicians are not immune to the normal problems every human being faces,” he said.

In the Medscape report, physicians cited personal arrogance as one of the leading reasons physicians engaged in inappropriate behavior (56%), followed closely by personal problems outside of work (52%), a social shift in accepting more casual behavior (50%), and job-related stress (46%). (Respondents could choose more than one answer).

One factor contributing to misbehavior that Dr. Samenow has consistently identified in his research is a history of adverse childhood experiences or family dysfunction: People who grew up in homes with physical or verbal abuse learned anger as a coping skill instead of positive, assertive communication. It’s likely that some physicians, as well as the overall population, learned anger as a coping skill for that reason.
 

How to help avert disruptive behavior in medical settings

Dr. Samenow said that coaching is a “wonderful tool” in teaching the interpersonal skills that medical school often doesn’t address.

In some case, interventions can be very helpful. For example, programs that teach effective communication strategies and teamwork through a combination of culturally sensitive dialectical and cognitive-behavioral therapy and other modalities have been successful, Dr. Samenow said. Although they are more about treating an illness than addressing “misbehavior,” programs for substance use that have been developed by and for doctors are very effective, too.

Fewer resources are available, however, for addressing racism, classism, misogyny, and other forms of bigotry, Dr. Samenow noted. “There’s implicit bias training, but not at the level of what exists for disruptive physicians and those with addiction. “That’s an area we need to work on.” Racist language was the third most commonly observed bad behavior cited in the Medscape survey, behind only bullying of staff and mocking or disparaging of patients. It was reported frequently outside of work as well.

The Medscape report found an increase in observed behavior at work and on social media, although it’s hard to determine prevalence trends over time, Dr. Samenow said. “The tolerance for this behavior has really gone down,” likely leading to more reporting, he said, and more systems for reporting bad behavior exist today than in the past.

However, Dr. Freedman said inadequate regulation, disciplinary action, and follow-through remain a problem.

“There are lots of limitations to our reporting system and to our follow-through with those reports,” including hospitals that, whether for fear of litigation or other reasons, allow physicians to quietly resign and move to another institution, even with positive recommendations, Dr. Freedman said.

Indeed, only a third of observed misbehavior in the Medscape report resulted in disciplinary action. Half the respondents believed a verbal warning was a necessary consequence, followed by a conversation from management and being reported to a supervisor or human resources. Though only 10% thought a report to the medical board was warranted, it likely depends on the offense and its frequency.

“I think going from paternalism to more patient-centered care and having patients involved in those conversations is a nice shift that makes doctors more human and relatable, and hopefully makes the public more forgiving, that we’re going to make mistakes and nobody’s perfect,” Freedman said. But he added that physicians should be held accountable when a mistake or two becomes a pattern.
 

Misinformation is professional misconduct

Sufficient accountability is especially absent, these doctors said, for a subset of professional misconduct: spreading misinformation.

While more “conventional” bad behaviors include fraud, dishonesty, abuse of underlings, and incompetence, bad behavior should also include “selling quackery and antivaccine misinformation, the way some doctors did with various nostrums for COVID-19,” said Dr. Gorski, who frequently blogs about doctors’ spreading misinformation.

Taylor Nichols, MD, an emergency medicine physician based in Sacramento, cites the desire for attention and clout as motivations. “Saying things that are wildly, provably false is professional misconduct,” Nichols said. He distinguished such statements from scientific, academic, or clinical disagreement that is necessary within medicine.

Yet there’s been a “long tradition of looking the other way or letting people with fancy titles get away with saying nonsense just because they’re respected,” Jonathan Howard, MD, an associate professor of psychiatry and neurology at New York University said in an interview.

“We have a duty to be trusted members of the community,” Dr. Howard said. “People listen when we say things, and we have an obligation to try to be accurate and humble and as honest as possible and admit mistakes when we inevitably make them.”

That extends to social media, which Dr. Nichols said has magnified the problem of promoting quackery and misinformation. He thinks medical boards and professional credentialing bodies should pay attention to what’s happening in the public conversation and understand that our professional responsibility extends beyond the walls of the hospital or clinic. Physicians must represent themselves professionally and uphold the standards that the profession expects.

On the one hand, Medscape respondents agreed: 70% said one doctor’s misbehavior taints the whole profession. Yet, at the same time, 58% of respondents believed physicians should be able to “keep their private lives private” in 2022. But that’s not the reality of the profession when the lines between private life and behavior away from work get blurred, Dr. Samenow said.

“The way a physician behaves in public represents you,” he said. “What happens in Vegas doesn’t always stay in Vegas.”

A version of this article first appeared on Medscape.com.

Daniel Freedman, DO, a pediatric neurologist in Austin, Tex., remembers being flabbergasted when a surgeon threw an instrument across the room in medical school.

“I remember thinking, ‘I can’t believe people actually do this, a grown man in his 50s having a temper tantrum,’” Dr. Freedman said in an interview. But it certainly wasn’t the last time he witnessed bad behavior by one of his peers.

The results of Medscape’s recent report, Physicians Behaving Badly: Stress and Hardship Trigger Misconduct, suggest he has plenty of company. More than 4 in 10 respondents (41%) observed inappropriate behavior in the workplace in 2022, an uptick from 35% in 2021, according to the report, which polled more than 1,500 physicians about inappropriate behavior on and off the clock.

Of course, 38% of respondents have not seen any instances of misbehavior; and many of the instances that were seen were mild or infrequent. Additionally, instances of bad behavior have declined significantly over the past 5 years.

Dr. Freedman said he learned a lesson from his mentor and program director during training that has stuck with him throughout his career. “If you couldn’t act that way at any job, whether at McDonald’s or any other possible place, you shouldn’t act that way in medicine.” But he recognizes one limitation of that advice. “A lot of the people that behave badly may not have ever worked in a different environment before,” he said.

“They only perceive that they’re at the top of the food chain, so they can behave badly without repercussions.”

What Dr. Freedman described is formally called disruptive physician behavior, one of several categories of inappropriate behavior in medicine, according to Charles Samenow, MD, MPH, an associate professor of psychiatry and behavioral sciences at George Washington University, Washington, who has studied this phenomenon for years.

“Disruptive physician behavior compromises the safety of the workplace,” Dr. Samenow explained. The behavior can occur at work, outside of work, or on social media. It can hinder operations, threaten patient and staff safety, and affect workplace morale.

“The question is trying to understand where that bad behavior is coming from and the impact of that bad behavior,” Dr. Samenow said in an interview.

One reason is fairly simple: doctors are human, and humans have a wide range of behavior. Plus, as the Medscape survey showed, the tension, stress, dangerous conditions during COVID, burnout, and other problems have made many physicians tired, frustrated, depressed, and more reactive to situations around them.
 

Self-selecting traits become an Achilles heel

“Any human put in a position of power over other humans has the potential to be disruptive, harass, etc, if they have certain personality traits,” said David Gorski, MD, a professor of surgery at Wayne State University, Detroit. That jibes with Dr. Samenow’s research.

Classic disruptive behavior isn’t usually associated with depression, mania, psychosis, or similar characteristics, Dr. Samenow explained. Rather, it tends to be personality driven. “Physicians are not immune to the normal problems every human being faces,” he said.

In the Medscape report, physicians cited personal arrogance as one of the leading reasons physicians engaged in inappropriate behavior (56%), followed closely by personal problems outside of work (52%), a social shift in accepting more casual behavior (50%), and job-related stress (46%). (Respondents could choose more than one answer).

One factor contributing to misbehavior that Dr. Samenow has consistently identified in his research is a history of adverse childhood experiences or family dysfunction: People who grew up in homes with physical or verbal abuse learned anger as a coping skill instead of positive, assertive communication. It’s likely that some physicians, as well as the overall population, learned anger as a coping skill for that reason.
 

How to help avert disruptive behavior in medical settings

Dr. Samenow said that coaching is a “wonderful tool” in teaching the interpersonal skills that medical school often doesn’t address.

In some case, interventions can be very helpful. For example, programs that teach effective communication strategies and teamwork through a combination of culturally sensitive dialectical and cognitive-behavioral therapy and other modalities have been successful, Dr. Samenow said. Although they are more about treating an illness than addressing “misbehavior,” programs for substance use that have been developed by and for doctors are very effective, too.

Fewer resources are available, however, for addressing racism, classism, misogyny, and other forms of bigotry, Dr. Samenow noted. “There’s implicit bias training, but not at the level of what exists for disruptive physicians and those with addiction. “That’s an area we need to work on.” Racist language was the third most commonly observed bad behavior cited in the Medscape survey, behind only bullying of staff and mocking or disparaging of patients. It was reported frequently outside of work as well.

The Medscape report found an increase in observed behavior at work and on social media, although it’s hard to determine prevalence trends over time, Dr. Samenow said. “The tolerance for this behavior has really gone down,” likely leading to more reporting, he said, and more systems for reporting bad behavior exist today than in the past.

However, Dr. Freedman said inadequate regulation, disciplinary action, and follow-through remain a problem.

“There are lots of limitations to our reporting system and to our follow-through with those reports,” including hospitals that, whether for fear of litigation or other reasons, allow physicians to quietly resign and move to another institution, even with positive recommendations, Dr. Freedman said.

Indeed, only a third of observed misbehavior in the Medscape report resulted in disciplinary action. Half the respondents believed a verbal warning was a necessary consequence, followed by a conversation from management and being reported to a supervisor or human resources. Though only 10% thought a report to the medical board was warranted, it likely depends on the offense and its frequency.

“I think going from paternalism to more patient-centered care and having patients involved in those conversations is a nice shift that makes doctors more human and relatable, and hopefully makes the public more forgiving, that we’re going to make mistakes and nobody’s perfect,” Freedman said. But he added that physicians should be held accountable when a mistake or two becomes a pattern.
 

Misinformation is professional misconduct

Sufficient accountability is especially absent, these doctors said, for a subset of professional misconduct: spreading misinformation.

While more “conventional” bad behaviors include fraud, dishonesty, abuse of underlings, and incompetence, bad behavior should also include “selling quackery and antivaccine misinformation, the way some doctors did with various nostrums for COVID-19,” said Dr. Gorski, who frequently blogs about doctors’ spreading misinformation.

Taylor Nichols, MD, an emergency medicine physician based in Sacramento, cites the desire for attention and clout as motivations. “Saying things that are wildly, provably false is professional misconduct,” Nichols said. He distinguished such statements from scientific, academic, or clinical disagreement that is necessary within medicine.

Yet there’s been a “long tradition of looking the other way or letting people with fancy titles get away with saying nonsense just because they’re respected,” Jonathan Howard, MD, an associate professor of psychiatry and neurology at New York University said in an interview.

“We have a duty to be trusted members of the community,” Dr. Howard said. “People listen when we say things, and we have an obligation to try to be accurate and humble and as honest as possible and admit mistakes when we inevitably make them.”

That extends to social media, which Dr. Nichols said has magnified the problem of promoting quackery and misinformation. He thinks medical boards and professional credentialing bodies should pay attention to what’s happening in the public conversation and understand that our professional responsibility extends beyond the walls of the hospital or clinic. Physicians must represent themselves professionally and uphold the standards that the profession expects.

On the one hand, Medscape respondents agreed: 70% said one doctor’s misbehavior taints the whole profession. Yet, at the same time, 58% of respondents believed physicians should be able to “keep their private lives private” in 2022. But that’s not the reality of the profession when the lines between private life and behavior away from work get blurred, Dr. Samenow said.

“The way a physician behaves in public represents you,” he said. “What happens in Vegas doesn’t always stay in Vegas.”

A version of this article first appeared on Medscape.com.

A growing number of Americans with cardiovascular disease (CVD) have limited or uncertain access to food, results of a new study suggest.

An analysis of data from the National Health and Nutrition Examination Survey (NHANES) representing more than 300 million American adults found that, overall, 38.1% of people with cardiovascular disease were food insecure in 2017-2019.

©Amanda Grandfield/iStockphoto.com

Uphill battle

Johanna Contreras, MD, advanced heart failure and transplant cardiologist at the Mount Sinai Hospital, New York, treats food insecure cardiovascular patients in her practice and tries to educate them about good nutrition. But it is an uphill battle.

“A lot of my patients live in the South Bronx. They have hypertension, hypercholesterolemia, and there are no grocery stores where they can buy fresh vegetables. I talk to them about eating healthy. They tell me it’s impossible. The stores only have pre-packaged foods. So even in the South Bronx, even though it is in New York, it is very hard to get fresh food. And when it is available, it is very expensive,” Dr. Contreras told this news organization.

“Fresh pineapples can cost $8. A fast-food burger costs $3. So that is what they buy: It’s what they can afford. Even the store managers don’t want to stock fresh produce because it can spoil. They open stores, like Whole Foods, but in the more affluent neighborhoods. They should open one in poor neighborhoods,” she said.

Dr. Contreras says she spends much of her time educating her patients about good nutrition. She asks them to keep a food diary and analyzes the results at each visit.

“I look at what they eat, and I try to see how I can use this information in a good way. I advise them to use frozen foods, and avoid canned, because it is a lot healthier. I am pragmatic, because I know that if I tell my patients to eat salmon, for example, they aren’t going to be able to afford it, if they can even access it.”

She also informs them about relatively healthy fast-food choices.

“I tell them to order 100% fruit juice, water, or milk when they go to McDonalds or other fast-food places. So I think this study is very important. Food insecurity is a very important component of cardiovascular disease, and unfortunately, minority communities are where this occurs.”

Dr. Brandt and Dr. Contreras report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A growing number of Americans with cardiovascular disease (CVD) have limited or uncertain access to food, results of a new study suggest.

An analysis of data from the National Health and Nutrition Examination Survey (NHANES) representing more than 300 million American adults found that, overall, 38.1% of people with cardiovascular disease were food insecure in 2017-2019.

©Amanda Grandfield/iStockphoto.com

Uphill battle

Johanna Contreras, MD, advanced heart failure and transplant cardiologist at the Mount Sinai Hospital, New York, treats food insecure cardiovascular patients in her practice and tries to educate them about good nutrition. But it is an uphill battle.

“A lot of my patients live in the South Bronx. They have hypertension, hypercholesterolemia, and there are no grocery stores where they can buy fresh vegetables. I talk to them about eating healthy. They tell me it’s impossible. The stores only have pre-packaged foods. So even in the South Bronx, even though it is in New York, it is very hard to get fresh food. And when it is available, it is very expensive,” Dr. Contreras told this news organization.

“Fresh pineapples can cost $8. A fast-food burger costs $3. So that is what they buy: It’s what they can afford. Even the store managers don’t want to stock fresh produce because it can spoil. They open stores, like Whole Foods, but in the more affluent neighborhoods. They should open one in poor neighborhoods,” she said.

Dr. Contreras says she spends much of her time educating her patients about good nutrition. She asks them to keep a food diary and analyzes the results at each visit.

“I look at what they eat, and I try to see how I can use this information in a good way. I advise them to use frozen foods, and avoid canned, because it is a lot healthier. I am pragmatic, because I know that if I tell my patients to eat salmon, for example, they aren’t going to be able to afford it, if they can even access it.”

She also informs them about relatively healthy fast-food choices.

“I tell them to order 100% fruit juice, water, or milk when they go to McDonalds or other fast-food places. So I think this study is very important. Food insecurity is a very important component of cardiovascular disease, and unfortunately, minority communities are where this occurs.”

Dr. Brandt and Dr. Contreras report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A growing number of Americans with cardiovascular disease (CVD) have limited or uncertain access to food, results of a new study suggest.

An analysis of data from the National Health and Nutrition Examination Survey (NHANES) representing more than 300 million American adults found that, overall, 38.1% of people with cardiovascular disease were food insecure in 2017-2019.

©Amanda Grandfield/iStockphoto.com

Uphill battle

Johanna Contreras, MD, advanced heart failure and transplant cardiologist at the Mount Sinai Hospital, New York, treats food insecure cardiovascular patients in her practice and tries to educate them about good nutrition. But it is an uphill battle.

“A lot of my patients live in the South Bronx. They have hypertension, hypercholesterolemia, and there are no grocery stores where they can buy fresh vegetables. I talk to them about eating healthy. They tell me it’s impossible. The stores only have pre-packaged foods. So even in the South Bronx, even though it is in New York, it is very hard to get fresh food. And when it is available, it is very expensive,” Dr. Contreras told this news organization.

“Fresh pineapples can cost $8. A fast-food burger costs $3. So that is what they buy: It’s what they can afford. Even the store managers don’t want to stock fresh produce because it can spoil. They open stores, like Whole Foods, but in the more affluent neighborhoods. They should open one in poor neighborhoods,” she said.

Dr. Contreras says she spends much of her time educating her patients about good nutrition. She asks them to keep a food diary and analyzes the results at each visit.

“I look at what they eat, and I try to see how I can use this information in a good way. I advise them to use frozen foods, and avoid canned, because it is a lot healthier. I am pragmatic, because I know that if I tell my patients to eat salmon, for example, they aren’t going to be able to afford it, if they can even access it.”

She also informs them about relatively healthy fast-food choices.

“I tell them to order 100% fruit juice, water, or milk when they go to McDonalds or other fast-food places. So I think this study is very important. Food insecurity is a very important component of cardiovascular disease, and unfortunately, minority communities are where this occurs.”

Dr. Brandt and Dr. Contreras report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Men who have sex with men (MSM) living with HIV, especially those who are young or who’ve had gonorrhea, should get the human papillomavirus (HPV) 9-valent vaccine (Gardasil 9), findings of a newly published study in the Journal of Acquired Immune Deficiency Syndromes suggest.

According to the World Health Organization, only 30% of the target population worldwide has received the HPV vaccine. Despite increased risk for HPV anal infection (an estimated three out of four MSM develop an anal infection from any HPV genotype in their lifetime, epidemiological studies in MSM have been lacking, leaving gaps in data in terms of prevalence rates and prevention.

To help characterize which MSM subgroups benefit the most from early 9-valent HPV vaccination, researchers from Vita-Salute San Raffaele University in Milan determined the prevalence of anal HPV genotypes in MSM who’d been living with HIV for 5 years, and they analyzed the risk factors for HPV anal infection.

Of the 1,352 study participants, 12% were not infected by any HPV genotypes, and the maximum number of genotypes infecting one person (six) was detected in 0.4% (six) people. The prevalence of HR-HPV genotypes or those present in the vaccine remained stable over time.

“Our findings suggest ... that all MSM with HIV would benefit from Gardasil 9 immunization, particularly the youngest and those with a prior gonococcal infection,” wrote Elena Bruzzesi, MD, of Vita-Salute San Raffaele University, and her coauthors.

To determine prevalence of HPV genotypes at anal sites and risk factors, the authors conducted a time-trend, monocentric study on participants who self-identified as MSM who engaged in anal intercourse. The participants underwent one or more anoscopies for HPV genotyping at one academic hospital in Milan between 2015 and 2019.

Swab specimens were collected from the anal canal mucosa, then soaked in thin-layer liquid medium, and sent for molecular analysis.

For detection of HPV phenotypes, the specimens were processed by multiplex real-time polymerase chain reaction.

Findings showed that:

• The overall prevalence of MSM with at least one anal HPV genotype was 88%, with prevalence ranging from 77% to 84%, and no trend difference over the 5-year period.
• Seventy-nine percent of participants were exposed to at least one high-risk (HR)-HPV genotype, and 67.4% by at least one low-risk (LR)-HPV genotype.
• HPV-53, in 27%, was the most prevalent genotype. HPV-6, 11, 16, and 18 prevalence was 22%, 13%, 23%, and 11%, respectively. Of the HR genotypes, HPV-16 and HPV-18 are most often linked with squamous cell cancers and adenocarcinomas, and in the study, prevalence did not change over time.
• Seventy-one percent of participants carried at least one genotype covered by the vaccine, with no change over time.
• On multivariable analysis, the risk of carrying at least one high-risk HPV genotype was linked with younger age (adjusted odds ratio [aOR] for 30 years or younger compared with older than 45 years 2.714; 95% confidence interval [CI], 1.484-4.961), and with having had gonorrhea (aOR, 2.118; 95% CI, 1.100-4.078).
• Also on multivariable analysis, the risk of having one or more genotypes targeted by the 9-valent vaccine was linked with younger age (aOR, 1.868; 95% CI, 1.141-3.060) and with having had gonorrhea (aOR, 1.785; 95% CI, 1.056-3.018).

“We are underutilizing the HPV vaccine in our clinical settings in the United States and globally,” Mehri S. McKellar, MD, an infectious disease specialist at Duke Health in Durham, N.C., told this news organization.

“This powerful study provides important data on HPV genotype prevalence in the MSM HIV+ population, validating that Gardasil 9 will greatly help these individuals,” said Dr. McKellar, who was not involved in the study.

Robert Salata, MD, infectious disease specialist and professor at Case Western Reserve University, Cleveland, also encourages MSM to get the vaccine.

“It is important to understand that the prevalence of anal HPV in men who have sex with men is very high, that the prevalence, including high-risk genotypes, has remained stable, and that the 9-valent vaccine is clearly indicated, especially in younger men and those with known gonorrhea and other STDs,” Dr. Salata (who was also not involved in the study) told this news organization.

“This is an important reminder for us to continue promoting and providing the vaccine to our patients, especially to HIV+ men who have sex with men, who have the highest rates of anal infection with HPV,” Dr. McKellar advised.

The authors, Dr. McKellar, and Dr. Salata report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Men who have sex with men (MSM) living with HIV, especially those who are young or who’ve had gonorrhea, should get the human papillomavirus (HPV) 9-valent vaccine (Gardasil 9), findings of a newly published study in the Journal of Acquired Immune Deficiency Syndromes suggest.

According to the World Health Organization, only 30% of the target population worldwide has received the HPV vaccine. Despite increased risk for HPV anal infection (an estimated three out of four MSM develop an anal infection from any HPV genotype in their lifetime, epidemiological studies in MSM have been lacking, leaving gaps in data in terms of prevalence rates and prevention.

To help characterize which MSM subgroups benefit the most from early 9-valent HPV vaccination, researchers from Vita-Salute San Raffaele University in Milan determined the prevalence of anal HPV genotypes in MSM who’d been living with HIV for 5 years, and they analyzed the risk factors for HPV anal infection.

Of the 1,352 study participants, 12% were not infected by any HPV genotypes, and the maximum number of genotypes infecting one person (six) was detected in 0.4% (six) people. The prevalence of HR-HPV genotypes or those present in the vaccine remained stable over time.

“Our findings suggest ... that all MSM with HIV would benefit from Gardasil 9 immunization, particularly the youngest and those with a prior gonococcal infection,” wrote Elena Bruzzesi, MD, of Vita-Salute San Raffaele University, and her coauthors.

To determine prevalence of HPV genotypes at anal sites and risk factors, the authors conducted a time-trend, monocentric study on participants who self-identified as MSM who engaged in anal intercourse. The participants underwent one or more anoscopies for HPV genotyping at one academic hospital in Milan between 2015 and 2019.

Swab specimens were collected from the anal canal mucosa, then soaked in thin-layer liquid medium, and sent for molecular analysis.

For detection of HPV phenotypes, the specimens were processed by multiplex real-time polymerase chain reaction.

Findings showed that:

• The overall prevalence of MSM with at least one anal HPV genotype was 88%, with prevalence ranging from 77% to 84%, and no trend difference over the 5-year period.
• Seventy-nine percent of participants were exposed to at least one high-risk (HR)-HPV genotype, and 67.4% by at least one low-risk (LR)-HPV genotype.
• HPV-53, in 27%, was the most prevalent genotype. HPV-6, 11, 16, and 18 prevalence was 22%, 13%, 23%, and 11%, respectively. Of the HR genotypes, HPV-16 and HPV-18 are most often linked with squamous cell cancers and adenocarcinomas, and in the study, prevalence did not change over time.
• Seventy-one percent of participants carried at least one genotype covered by the vaccine, with no change over time.
• On multivariable analysis, the risk of carrying at least one high-risk HPV genotype was linked with younger age (adjusted odds ratio [aOR] for 30 years or younger compared with older than 45 years 2.714; 95% confidence interval [CI], 1.484-4.961), and with having had gonorrhea (aOR, 2.118; 95% CI, 1.100-4.078).
• Also on multivariable analysis, the risk of having one or more genotypes targeted by the 9-valent vaccine was linked with younger age (aOR, 1.868; 95% CI, 1.141-3.060) and with having had gonorrhea (aOR, 1.785; 95% CI, 1.056-3.018).

“We are underutilizing the HPV vaccine in our clinical settings in the United States and globally,” Mehri S. McKellar, MD, an infectious disease specialist at Duke Health in Durham, N.C., told this news organization.

“This powerful study provides important data on HPV genotype prevalence in the MSM HIV+ population, validating that Gardasil 9 will greatly help these individuals,” said Dr. McKellar, who was not involved in the study.

Robert Salata, MD, infectious disease specialist and professor at Case Western Reserve University, Cleveland, also encourages MSM to get the vaccine.

“It is important to understand that the prevalence of anal HPV in men who have sex with men is very high, that the prevalence, including high-risk genotypes, has remained stable, and that the 9-valent vaccine is clearly indicated, especially in younger men and those with known gonorrhea and other STDs,” Dr. Salata (who was also not involved in the study) told this news organization.

“This is an important reminder for us to continue promoting and providing the vaccine to our patients, especially to HIV+ men who have sex with men, who have the highest rates of anal infection with HPV,” Dr. McKellar advised.

The authors, Dr. McKellar, and Dr. Salata report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Men who have sex with men (MSM) living with HIV, especially those who are young or who’ve had gonorrhea, should get the human papillomavirus (HPV) 9-valent vaccine (Gardasil 9), findings of a newly published study in the Journal of Acquired Immune Deficiency Syndromes suggest.

According to the World Health Organization, only 30% of the target population worldwide has received the HPV vaccine. Despite increased risk for HPV anal infection (an estimated three out of four MSM develop an anal infection from any HPV genotype in their lifetime, epidemiological studies in MSM have been lacking, leaving gaps in data in terms of prevalence rates and prevention.

To help characterize which MSM subgroups benefit the most from early 9-valent HPV vaccination, researchers from Vita-Salute San Raffaele University in Milan determined the prevalence of anal HPV genotypes in MSM who’d been living with HIV for 5 years, and they analyzed the risk factors for HPV anal infection.

Of the 1,352 study participants, 12% were not infected by any HPV genotypes, and the maximum number of genotypes infecting one person (six) was detected in 0.4% (six) people. The prevalence of HR-HPV genotypes or those present in the vaccine remained stable over time.

“Our findings suggest ... that all MSM with HIV would benefit from Gardasil 9 immunization, particularly the youngest and those with a prior gonococcal infection,” wrote Elena Bruzzesi, MD, of Vita-Salute San Raffaele University, and her coauthors.

To determine prevalence of HPV genotypes at anal sites and risk factors, the authors conducted a time-trend, monocentric study on participants who self-identified as MSM who engaged in anal intercourse. The participants underwent one or more anoscopies for HPV genotyping at one academic hospital in Milan between 2015 and 2019.

Swab specimens were collected from the anal canal mucosa, then soaked in thin-layer liquid medium, and sent for molecular analysis.

For detection of HPV phenotypes, the specimens were processed by multiplex real-time polymerase chain reaction.

Findings showed that:

• The overall prevalence of MSM with at least one anal HPV genotype was 88%, with prevalence ranging from 77% to 84%, and no trend difference over the 5-year period.
• Seventy-nine percent of participants were exposed to at least one high-risk (HR)-HPV genotype, and 67.4% by at least one low-risk (LR)-HPV genotype.
• HPV-53, in 27%, was the most prevalent genotype. HPV-6, 11, 16, and 18 prevalence was 22%, 13%, 23%, and 11%, respectively. Of the HR genotypes, HPV-16 and HPV-18 are most often linked with squamous cell cancers and adenocarcinomas, and in the study, prevalence did not change over time.
• Seventy-one percent of participants carried at least one genotype covered by the vaccine, with no change over time.
• On multivariable analysis, the risk of carrying at least one high-risk HPV genotype was linked with younger age (adjusted odds ratio [aOR] for 30 years or younger compared with older than 45 years 2.714; 95% confidence interval [CI], 1.484-4.961), and with having had gonorrhea (aOR, 2.118; 95% CI, 1.100-4.078).
• Also on multivariable analysis, the risk of having one or more genotypes targeted by the 9-valent vaccine was linked with younger age (aOR, 1.868; 95% CI, 1.141-3.060) and with having had gonorrhea (aOR, 1.785; 95% CI, 1.056-3.018).

“We are underutilizing the HPV vaccine in our clinical settings in the United States and globally,” Mehri S. McKellar, MD, an infectious disease specialist at Duke Health in Durham, N.C., told this news organization.

“This powerful study provides important data on HPV genotype prevalence in the MSM HIV+ population, validating that Gardasil 9 will greatly help these individuals,” said Dr. McKellar, who was not involved in the study.

Robert Salata, MD, infectious disease specialist and professor at Case Western Reserve University, Cleveland, also encourages MSM to get the vaccine.

“It is important to understand that the prevalence of anal HPV in men who have sex with men is very high, that the prevalence, including high-risk genotypes, has remained stable, and that the 9-valent vaccine is clearly indicated, especially in younger men and those with known gonorrhea and other STDs,” Dr. Salata (who was also not involved in the study) told this news organization.

“This is an important reminder for us to continue promoting and providing the vaccine to our patients, especially to HIV+ men who have sex with men, who have the highest rates of anal infection with HPV,” Dr. McKellar advised.

The authors, Dr. McKellar, and Dr. Salata report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Starting treatment for alcohol use disorder (AUD) with extended-release naltrexone injections in the emergency department produced a dramatic reduction in alcohol consumption, according to findings presented at the annual meeting of the American College of Emergency Physicians.

The results show the feasibility of such a program and underscore the importance of the ED in combating AUD, said the researchers, from the University of California, San Francisco.

“According to the National Institute on Alcohol Abuse and Alcoholism, 18% of ED visits had alcohol as a contributing factor – the volume of alcohol-related ED visits has been climbing every year, and it is a significant public health problem,” said Maria Raven, MD, MPH, professor of emergency medicine at UCSF. “Right now, we do very little for people who come to the ED with AUD, so it is a missed opportunity to intervene, especially given the volume of visits we see and that our patient population is one that often has significant barriers to accessing outpatient treatment.”

The findings come from a 12-week, prospective, single-arm study of ED patients who were actively drinking adults with known or suspected AUD and who had positive scores on a screening test. Of 179 patients who were approached, 32 agreed to enroll; the enrollment yield was 18%. Participants were given monthly extended-release naltrexone and case management services.

Of the 32 participants, 25 completed all their study visits and 22 (69%) continued taking naltrexone after the 12 weeks.

The researchers said the results surprised them. The average daily alcohol consumption at baseline was 7.6 drinks a day, and it fell by 7.5 drinks a day – in other words, to almost no consumption.

“The median alcohol consumption when measured over the last 2 weeks of the study was zero,” Dr. Raven said. “This doesn’t mean everyone was at zero, but this was the median and reflects that many participants stopped drinking altogether. We were pleasantly surprised by this. I don’t know that we thought so many people who participated would actually fully abstain.”

On the Kemp Quality of Life Scale – with scores from 1 to 7, with 1 being “life is very distressing,” 4 being “life is so-so,” and 7 being “life is great” – the average baseline score was 3.6. That score rose by 1.2 points by the study’s end.

Dr. Raven said she hoped more would enroll but that “a number of people actually did not want the injection or were not ready to think about stopping.” Still, the 18% enrollment is “a major improvement,” considering that no attempt was made to initiate treatment with naltrexone prior to the study. Oral naltrexone, rather than the injection, could be offered to improve participation, but oral naltrexone has to be taken daily.

She said a larger study is planned at UCSF and that other institutions are interested in starting a similar program.

“When someone is in the ED for an AUD-related issue, it can serve as a turning point for them in some cases,” she said.

Erik S. Anderson, MD, associate research director at Oakland, Calif.–based Alameda Health System, who has studied naltrexone in the ED, said the findings dovetail with what his team has found at his center. He added that psychosocial support is important as well and that his team has found that navigation services are the most important factor in connecting patients with follow-up care – even more so than providing medications.

“In my mind, this is a situation where we have treatment options and approaches that work, and it’s really about implementing these services in a novel care setting,” he said. “ED patients are at higher risk of complications for AUD simply because they are in the ED in the first place – initiating AUD treatment in this setting is the right thing to do.”

Dr. Raven and Dr. Anderson disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Starting treatment for alcohol use disorder (AUD) with extended-release naltrexone injections in the emergency department produced a dramatic reduction in alcohol consumption, according to findings presented at the annual meeting of the American College of Emergency Physicians.

The results show the feasibility of such a program and underscore the importance of the ED in combating AUD, said the researchers, from the University of California, San Francisco.

“According to the National Institute on Alcohol Abuse and Alcoholism, 18% of ED visits had alcohol as a contributing factor – the volume of alcohol-related ED visits has been climbing every year, and it is a significant public health problem,” said Maria Raven, MD, MPH, professor of emergency medicine at UCSF. “Right now, we do very little for people who come to the ED with AUD, so it is a missed opportunity to intervene, especially given the volume of visits we see and that our patient population is one that often has significant barriers to accessing outpatient treatment.”

The findings come from a 12-week, prospective, single-arm study of ED patients who were actively drinking adults with known or suspected AUD and who had positive scores on a screening test. Of 179 patients who were approached, 32 agreed to enroll; the enrollment yield was 18%. Participants were given monthly extended-release naltrexone and case management services.

Of the 32 participants, 25 completed all their study visits and 22 (69%) continued taking naltrexone after the 12 weeks.

The researchers said the results surprised them. The average daily alcohol consumption at baseline was 7.6 drinks a day, and it fell by 7.5 drinks a day – in other words, to almost no consumption.

“The median alcohol consumption when measured over the last 2 weeks of the study was zero,” Dr. Raven said. “This doesn’t mean everyone was at zero, but this was the median and reflects that many participants stopped drinking altogether. We were pleasantly surprised by this. I don’t know that we thought so many people who participated would actually fully abstain.”

On the Kemp Quality of Life Scale – with scores from 1 to 7, with 1 being “life is very distressing,” 4 being “life is so-so,” and 7 being “life is great” – the average baseline score was 3.6. That score rose by 1.2 points by the study’s end.

Dr. Raven said she hoped more would enroll but that “a number of people actually did not want the injection or were not ready to think about stopping.” Still, the 18% enrollment is “a major improvement,” considering that no attempt was made to initiate treatment with naltrexone prior to the study. Oral naltrexone, rather than the injection, could be offered to improve participation, but oral naltrexone has to be taken daily.

She said a larger study is planned at UCSF and that other institutions are interested in starting a similar program.

“When someone is in the ED for an AUD-related issue, it can serve as a turning point for them in some cases,” she said.

Erik S. Anderson, MD, associate research director at Oakland, Calif.–based Alameda Health System, who has studied naltrexone in the ED, said the findings dovetail with what his team has found at his center. He added that psychosocial support is important as well and that his team has found that navigation services are the most important factor in connecting patients with follow-up care – even more so than providing medications.

“In my mind, this is a situation where we have treatment options and approaches that work, and it’s really about implementing these services in a novel care setting,” he said. “ED patients are at higher risk of complications for AUD simply because they are in the ED in the first place – initiating AUD treatment in this setting is the right thing to do.”

Dr. Raven and Dr. Anderson disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Starting treatment for alcohol use disorder (AUD) with extended-release naltrexone injections in the emergency department produced a dramatic reduction in alcohol consumption, according to findings presented at the annual meeting of the American College of Emergency Physicians.

The results show the feasibility of such a program and underscore the importance of the ED in combating AUD, said the researchers, from the University of California, San Francisco.

“According to the National Institute on Alcohol Abuse and Alcoholism, 18% of ED visits had alcohol as a contributing factor – the volume of alcohol-related ED visits has been climbing every year, and it is a significant public health problem,” said Maria Raven, MD, MPH, professor of emergency medicine at UCSF. “Right now, we do very little for people who come to the ED with AUD, so it is a missed opportunity to intervene, especially given the volume of visits we see and that our patient population is one that often has significant barriers to accessing outpatient treatment.”

The findings come from a 12-week, prospective, single-arm study of ED patients who were actively drinking adults with known or suspected AUD and who had positive scores on a screening test. Of 179 patients who were approached, 32 agreed to enroll; the enrollment yield was 18%. Participants were given monthly extended-release naltrexone and case management services.

Of the 32 participants, 25 completed all their study visits and 22 (69%) continued taking naltrexone after the 12 weeks.

The researchers said the results surprised them. The average daily alcohol consumption at baseline was 7.6 drinks a day, and it fell by 7.5 drinks a day – in other words, to almost no consumption.

“The median alcohol consumption when measured over the last 2 weeks of the study was zero,” Dr. Raven said. “This doesn’t mean everyone was at zero, but this was the median and reflects that many participants stopped drinking altogether. We were pleasantly surprised by this. I don’t know that we thought so many people who participated would actually fully abstain.”

On the Kemp Quality of Life Scale – with scores from 1 to 7, with 1 being “life is very distressing,” 4 being “life is so-so,” and 7 being “life is great” – the average baseline score was 3.6. That score rose by 1.2 points by the study’s end.

Dr. Raven said she hoped more would enroll but that “a number of people actually did not want the injection or were not ready to think about stopping.” Still, the 18% enrollment is “a major improvement,” considering that no attempt was made to initiate treatment with naltrexone prior to the study. Oral naltrexone, rather than the injection, could be offered to improve participation, but oral naltrexone has to be taken daily.

She said a larger study is planned at UCSF and that other institutions are interested in starting a similar program.

“When someone is in the ED for an AUD-related issue, it can serve as a turning point for them in some cases,” she said.

Erik S. Anderson, MD, associate research director at Oakland, Calif.–based Alameda Health System, who has studied naltrexone in the ED, said the findings dovetail with what his team has found at his center. He added that psychosocial support is important as well and that his team has found that navigation services are the most important factor in connecting patients with follow-up care – even more so than providing medications.

“In my mind, this is a situation where we have treatment options and approaches that work, and it’s really about implementing these services in a novel care setting,” he said. “ED patients are at higher risk of complications for AUD simply because they are in the ED in the first place – initiating AUD treatment in this setting is the right thing to do.”

Dr. Raven and Dr. Anderson disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Efficacy of the investigational drug lebrikizumab is maintained in patients with moderate to severe atopic dermatitis for at least 1 year, according to new results from the phase 3 ADvocate1 and ADvocate2 trials.

“We’re focused on the responders,” said Andrew Blauvelt, MD, MBA, as he presented the positive findings at the annual congress of the European Academy of Dermatology and Venereology.

Responders were the 291 people whose atopic dermatitis greatly improved after an initial 16 weeks’ treatment with lebrikizumab in both trials and who were then randomly allocated to receive injections every 2 weeks (Q2W, n = 113) or every 4 weeks (Q4W, n = 118), or to receive placebo injections Q2W (n = 60).

“Very interestingly, for me, the Q4W maintenance dosing was just as good as the Q2W maintenance dosing,” said Dr. Blauvelt, president of Oregon Medical Research Center, Portland.

“Another highlight of these data is that the patients who went on to placebo, about 50% of the patients maintained good responses, despite no treatment from week 16 to week 52,” he added.

Most patients did not require topical steroids, and “there were no surprises here” in terms of the safety profile. Lebrikizumab, a monoclonal antibody, binds to soluble interleukin-13 and blocks IL-13 signaling.

“So, the study really shows that specific targeting of IL-13 with lebrikizumab, either Q2W or Q4W, has high maintenance of efficacy and is reasonably tolerated and safe in adolescents and adults with atopic dermatitis,” Dr. Blauvelt concluded.

“We know now that IL-13 is a critical cytokine in AD [atopic dermatitis] pathogenesis. The unique features of this drug I want to highlight is that it has high binding affinity for IL-13,” he said.

“It has a slow dissociation off rate, meaning it binds IL-13 tightly, very potently, and stays blocking and stays hold of IL-13 in a strong manner,” he added. The drug has a half-life of 25 days.

These features could be very important for long-term dosing of the drug, he argued.
 

Lebrikizumab phase 3 trials

ADvocate1 and ADvocate2 are two of several phase 3 trials evaluating the efficacy and safety of lebrikizumab for the treatment of atopic dermatitis.

These include the completed ADhere study, in which lebrikizumab was used in combination with topical steroids and showed positive results in skin improvement and relief of pruritus.

The ADore study, an open-label trial in adolescents, is yet to report. The ongoing ADjoin study, a long-term extension study, is actively recruiting.

ADvocate1 and ADvocate2 are two identically designed – multicenter, randomized, double-blind, placebo-controlled, parallel-group – monotherapy trials that initially pitched two dosing regimens of lebrikizumab (250 mg) against placebo with a double loading dose at baseline and week 2 and then one dose every 2 weeks. The pair of trials enrolled a total of 869 adolescents and adults.

After the 16-week induction period, all patients in the lebrikizumab arm who had responded to treatment were rerandomly assigned to receive lebrikizumab 250 mg Q2W or Q4W, or placebo Q2W during a 36-week long-term maintenance treatment period.

This brought the total treatment time to 52 weeks for those whose atopic dermatitis had initially responded to lebrikizumab, explained Blauvelt.

Responders were those who, at 16 weeks, had an Investigator’s Global Assessment score of 0 or 1 (IGA 0/1) with a 2-point improvement or who had a 75% improvement in the Eczema Area and Severity Index score (EASI 75) without the need for rescue medication, compared with baseline values.
 

Induction and maintenance phase results

At the end of the 16-week induction period, a greater proportion of patients who had been treated with lebrikizumab than placebo met a primary outcome of IGA 0/1 in each trial (43.1% vs. 12.7% in ADvocate1 and 33.2% vs. 10.8% in ADvocate2).

A similar result was seen for another primary outcome, EASI 75 (58.8% vs. 16.2% and 52.1% vs. 18.1%) and for a secondary outcome, improvement in pruritus using a numerical rating scale (45.9% vs. 13.0% and 39.8% vs. 11.5%).

In the maintenance phase, with respect to responders, Dr. Blauvelt reported “very similar results” between the QW2 and Q4W maintenance dosing, “and still a quite high response in [half] the patients who were randomized to placebo at week 16.”

In the ADvocate1 and ADvocate2 trials, respectively, an IGA 0/1 with at least a 2-point improvement was maintained at week 52 in 75.8% and 64.6% of patients treated with the Q2W lebrikizumab dose, 74.2% and 80.6% of those treated with the Q4W dose, and 46.5% and 49.8% of those given placebo.

EASI 75 was maintained at week 52 in a respective 79.2% and 77.4% of patients treated with the Q2W dose, 79.2% and 84.7% with the Q4W dose, and 61.3% and 72.0% with placebo.

As for maintenance of at least a 4-point improvement in pruritus score, results at 52 weeks were 81.2% and 90.3% for the 2-week dose, 80.4% and 88.1% for the 4-week dose, and 65.4% and 67.6% for placebo.

Although topical corticosteroid treatment was allowed during the maintenance phase, only about 15% of patients needed this, Dr. Blauvelt said.
 

Different dosing results questioned

During the discussion period, one delegate highlighted that the twice-weekly maintenance dosing schedule seemed to “do worse a little bit” than the 4-week dosing, with both “close to placebo,” although “the long-term effect is already very impressive.”

Dr. Blauvelt noted that a pooled analysis had been done and that “it’s very clear that being on lebrikizumab works better than not being on lebrikizumab.

“Now, Q2W versus Q4W. We believe that this may be due to the long half-life of the drug possibly. It could be due to the slow disassociation rate, it’s binding tightly,” he suggested.

“We also could talk about disease modification, right. So, it opens up the concept of hit hard, hit early for 16 weeks, and then maybe you can modify disease over time,” Dr. Blauvelt said.

He added: “That’s highly speculative, of course.”

Short-term safety data

The 52-week safety profile of lebrikizumab is consistent with previously published data at 16 weeks, Dr. Blauvelt said. The most common adverse events during the studies included atopic dermatitis, nasopharyngitis, conjunctivitis, conjunctivitis allergic, headache, and COVID-19.

“This drug has comparable efficacy with dupilumab and tralokinumab,” said Jashin J. Wu, MD, from the Dermatology Research and Education Foundation in Irvine, Calif., in an interview. He was not involved in the study.

“As it does not have any significant advantages with less long-term safety data, I do not see a place for it in my practice,” Dr. Wu said.

Dupilumab (Dupixent) and tralokinumab (Adbry) are monoclonal antibodies that also block IL-13. Both are already licensed for treating atopic dermatitis. Dupilumab was approved by the Food and Drug Administration in 2017, and tralokinumab was approved in 2021.

The study was funded by Dermira, a wholly owned subsidiary of Eli Lilly. Eli Lilly has exclusive rights for the development and commercialization of lebrikizumab in the United States and all countries outside Europe; European rights belong to Almirall for all dermatology indications, including atopic dermatitis. Dr. Blauvelt acts as an investigator and adviser to these companies as well as many other pharmaceutical companies that are involved in developing new dermatologic treatments. Dr. Wu has been an investigator, consultant, or speaker for multiple pharmaceutical companies.

A version of this article first appeared on Medscape.com.

Efficacy of the investigational drug lebrikizumab is maintained in patients with moderate to severe atopic dermatitis for at least 1 year, according to new results from the phase 3 ADvocate1 and ADvocate2 trials.

“We’re focused on the responders,” said Andrew Blauvelt, MD, MBA, as he presented the positive findings at the annual congress of the European Academy of Dermatology and Venereology.

Responders were the 291 people whose atopic dermatitis greatly improved after an initial 16 weeks’ treatment with lebrikizumab in both trials and who were then randomly allocated to receive injections every 2 weeks (Q2W, n = 113) or every 4 weeks (Q4W, n = 118), or to receive placebo injections Q2W (n = 60).

“Very interestingly, for me, the Q4W maintenance dosing was just as good as the Q2W maintenance dosing,” said Dr. Blauvelt, president of Oregon Medical Research Center, Portland.

“Another highlight of these data is that the patients who went on to placebo, about 50% of the patients maintained good responses, despite no treatment from week 16 to week 52,” he added.

Most patients did not require topical steroids, and “there were no surprises here” in terms of the safety profile. Lebrikizumab, a monoclonal antibody, binds to soluble interleukin-13 and blocks IL-13 signaling.

“So, the study really shows that specific targeting of IL-13 with lebrikizumab, either Q2W or Q4W, has high maintenance of efficacy and is reasonably tolerated and safe in adolescents and adults with atopic dermatitis,” Dr. Blauvelt concluded.

“We know now that IL-13 is a critical cytokine in AD [atopic dermatitis] pathogenesis. The unique features of this drug I want to highlight is that it has high binding affinity for IL-13,” he said.

“It has a slow dissociation off rate, meaning it binds IL-13 tightly, very potently, and stays blocking and stays hold of IL-13 in a strong manner,” he added. The drug has a half-life of 25 days.

These features could be very important for long-term dosing of the drug, he argued.
 

Lebrikizumab phase 3 trials

ADvocate1 and ADvocate2 are two of several phase 3 trials evaluating the efficacy and safety of lebrikizumab for the treatment of atopic dermatitis.

These include the completed ADhere study, in which lebrikizumab was used in combination with topical steroids and showed positive results in skin improvement and relief of pruritus.

The ADore study, an open-label trial in adolescents, is yet to report. The ongoing ADjoin study, a long-term extension study, is actively recruiting.

ADvocate1 and ADvocate2 are two identically designed – multicenter, randomized, double-blind, placebo-controlled, parallel-group – monotherapy trials that initially pitched two dosing regimens of lebrikizumab (250 mg) against placebo with a double loading dose at baseline and week 2 and then one dose every 2 weeks. The pair of trials enrolled a total of 869 adolescents and adults.

After the 16-week induction period, all patients in the lebrikizumab arm who had responded to treatment were rerandomly assigned to receive lebrikizumab 250 mg Q2W or Q4W, or placebo Q2W during a 36-week long-term maintenance treatment period.

This brought the total treatment time to 52 weeks for those whose atopic dermatitis had initially responded to lebrikizumab, explained Blauvelt.

Responders were those who, at 16 weeks, had an Investigator’s Global Assessment score of 0 or 1 (IGA 0/1) with a 2-point improvement or who had a 75% improvement in the Eczema Area and Severity Index score (EASI 75) without the need for rescue medication, compared with baseline values.
 

Induction and maintenance phase results

At the end of the 16-week induction period, a greater proportion of patients who had been treated with lebrikizumab than placebo met a primary outcome of IGA 0/1 in each trial (43.1% vs. 12.7% in ADvocate1 and 33.2% vs. 10.8% in ADvocate2).

A similar result was seen for another primary outcome, EASI 75 (58.8% vs. 16.2% and 52.1% vs. 18.1%) and for a secondary outcome, improvement in pruritus using a numerical rating scale (45.9% vs. 13.0% and 39.8% vs. 11.5%).

In the maintenance phase, with respect to responders, Dr. Blauvelt reported “very similar results” between the QW2 and Q4W maintenance dosing, “and still a quite high response in [half] the patients who were randomized to placebo at week 16.”

In the ADvocate1 and ADvocate2 trials, respectively, an IGA 0/1 with at least a 2-point improvement was maintained at week 52 in 75.8% and 64.6% of patients treated with the Q2W lebrikizumab dose, 74.2% and 80.6% of those treated with the Q4W dose, and 46.5% and 49.8% of those given placebo.

EASI 75 was maintained at week 52 in a respective 79.2% and 77.4% of patients treated with the Q2W dose, 79.2% and 84.7% with the Q4W dose, and 61.3% and 72.0% with placebo.

As for maintenance of at least a 4-point improvement in pruritus score, results at 52 weeks were 81.2% and 90.3% for the 2-week dose, 80.4% and 88.1% for the 4-week dose, and 65.4% and 67.6% for placebo.

Although topical corticosteroid treatment was allowed during the maintenance phase, only about 15% of patients needed this, Dr. Blauvelt said.
 

Different dosing results questioned

During the discussion period, one delegate highlighted that the twice-weekly maintenance dosing schedule seemed to “do worse a little bit” than the 4-week dosing, with both “close to placebo,” although “the long-term effect is already very impressive.”

Dr. Blauvelt noted that a pooled analysis had been done and that “it’s very clear that being on lebrikizumab works better than not being on lebrikizumab.

“Now, Q2W versus Q4W. We believe that this may be due to the long half-life of the drug possibly. It could be due to the slow disassociation rate, it’s binding tightly,” he suggested.

“We also could talk about disease modification, right. So, it opens up the concept of hit hard, hit early for 16 weeks, and then maybe you can modify disease over time,” Dr. Blauvelt said.

He added: “That’s highly speculative, of course.”

Short-term safety data

The 52-week safety profile of lebrikizumab is consistent with previously published data at 16 weeks, Dr. Blauvelt said. The most common adverse events during the studies included atopic dermatitis, nasopharyngitis, conjunctivitis, conjunctivitis allergic, headache, and COVID-19.

“This drug has comparable efficacy with dupilumab and tralokinumab,” said Jashin J. Wu, MD, from the Dermatology Research and Education Foundation in Irvine, Calif., in an interview. He was not involved in the study.

“As it does not have any significant advantages with less long-term safety data, I do not see a place for it in my practice,” Dr. Wu said.

Dupilumab (Dupixent) and tralokinumab (Adbry) are monoclonal antibodies that also block IL-13. Both are already licensed for treating atopic dermatitis. Dupilumab was approved by the Food and Drug Administration in 2017, and tralokinumab was approved in 2021.

The study was funded by Dermira, a wholly owned subsidiary of Eli Lilly. Eli Lilly has exclusive rights for the development and commercialization of lebrikizumab in the United States and all countries outside Europe; European rights belong to Almirall for all dermatology indications, including atopic dermatitis. Dr. Blauvelt acts as an investigator and adviser to these companies as well as many other pharmaceutical companies that are involved in developing new dermatologic treatments. Dr. Wu has been an investigator, consultant, or speaker for multiple pharmaceutical companies.

A version of this article first appeared on Medscape.com.

Efficacy of the investigational drug lebrikizumab is maintained in patients with moderate to severe atopic dermatitis for at least 1 year, according to new results from the phase 3 ADvocate1 and ADvocate2 trials.

“We’re focused on the responders,” said Andrew Blauvelt, MD, MBA, as he presented the positive findings at the annual congress of the European Academy of Dermatology and Venereology.

Responders were the 291 people whose atopic dermatitis greatly improved after an initial 16 weeks’ treatment with lebrikizumab in both trials and who were then randomly allocated to receive injections every 2 weeks (Q2W, n = 113) or every 4 weeks (Q4W, n = 118), or to receive placebo injections Q2W (n = 60).

“Very interestingly, for me, the Q4W maintenance dosing was just as good as the Q2W maintenance dosing,” said Dr. Blauvelt, president of Oregon Medical Research Center, Portland.

“Another highlight of these data is that the patients who went on to placebo, about 50% of the patients maintained good responses, despite no treatment from week 16 to week 52,” he added.

Most patients did not require topical steroids, and “there were no surprises here” in terms of the safety profile. Lebrikizumab, a monoclonal antibody, binds to soluble interleukin-13 and blocks IL-13 signaling.

“So, the study really shows that specific targeting of IL-13 with lebrikizumab, either Q2W or Q4W, has high maintenance of efficacy and is reasonably tolerated and safe in adolescents and adults with atopic dermatitis,” Dr. Blauvelt concluded.

“We know now that IL-13 is a critical cytokine in AD [atopic dermatitis] pathogenesis. The unique features of this drug I want to highlight is that it has high binding affinity for IL-13,” he said.

“It has a slow dissociation off rate, meaning it binds IL-13 tightly, very potently, and stays blocking and stays hold of IL-13 in a strong manner,” he added. The drug has a half-life of 25 days.

These features could be very important for long-term dosing of the drug, he argued.
 

Lebrikizumab phase 3 trials

ADvocate1 and ADvocate2 are two of several phase 3 trials evaluating the efficacy and safety of lebrikizumab for the treatment of atopic dermatitis.

These include the completed ADhere study, in which lebrikizumab was used in combination with topical steroids and showed positive results in skin improvement and relief of pruritus.

The ADore study, an open-label trial in adolescents, is yet to report. The ongoing ADjoin study, a long-term extension study, is actively recruiting.

ADvocate1 and ADvocate2 are two identically designed – multicenter, randomized, double-blind, placebo-controlled, parallel-group – monotherapy trials that initially pitched two dosing regimens of lebrikizumab (250 mg) against placebo with a double loading dose at baseline and week 2 and then one dose every 2 weeks. The pair of trials enrolled a total of 869 adolescents and adults.

After the 16-week induction period, all patients in the lebrikizumab arm who had responded to treatment were rerandomly assigned to receive lebrikizumab 250 mg Q2W or Q4W, or placebo Q2W during a 36-week long-term maintenance treatment period.

This brought the total treatment time to 52 weeks for those whose atopic dermatitis had initially responded to lebrikizumab, explained Blauvelt.

Responders were those who, at 16 weeks, had an Investigator’s Global Assessment score of 0 or 1 (IGA 0/1) with a 2-point improvement or who had a 75% improvement in the Eczema Area and Severity Index score (EASI 75) without the need for rescue medication, compared with baseline values.
 

Induction and maintenance phase results

At the end of the 16-week induction period, a greater proportion of patients who had been treated with lebrikizumab than placebo met a primary outcome of IGA 0/1 in each trial (43.1% vs. 12.7% in ADvocate1 and 33.2% vs. 10.8% in ADvocate2).

A similar result was seen for another primary outcome, EASI 75 (58.8% vs. 16.2% and 52.1% vs. 18.1%) and for a secondary outcome, improvement in pruritus using a numerical rating scale (45.9% vs. 13.0% and 39.8% vs. 11.5%).

In the maintenance phase, with respect to responders, Dr. Blauvelt reported “very similar results” between the QW2 and Q4W maintenance dosing, “and still a quite high response in [half] the patients who were randomized to placebo at week 16.”

In the ADvocate1 and ADvocate2 trials, respectively, an IGA 0/1 with at least a 2-point improvement was maintained at week 52 in 75.8% and 64.6% of patients treated with the Q2W lebrikizumab dose, 74.2% and 80.6% of those treated with the Q4W dose, and 46.5% and 49.8% of those given placebo.

EASI 75 was maintained at week 52 in a respective 79.2% and 77.4% of patients treated with the Q2W dose, 79.2% and 84.7% with the Q4W dose, and 61.3% and 72.0% with placebo.

As for maintenance of at least a 4-point improvement in pruritus score, results at 52 weeks were 81.2% and 90.3% for the 2-week dose, 80.4% and 88.1% for the 4-week dose, and 65.4% and 67.6% for placebo.

Although topical corticosteroid treatment was allowed during the maintenance phase, only about 15% of patients needed this, Dr. Blauvelt said.
 

Different dosing results questioned

During the discussion period, one delegate highlighted that the twice-weekly maintenance dosing schedule seemed to “do worse a little bit” than the 4-week dosing, with both “close to placebo,” although “the long-term effect is already very impressive.”

Dr. Blauvelt noted that a pooled analysis had been done and that “it’s very clear that being on lebrikizumab works better than not being on lebrikizumab.

“Now, Q2W versus Q4W. We believe that this may be due to the long half-life of the drug possibly. It could be due to the slow disassociation rate, it’s binding tightly,” he suggested.

“We also could talk about disease modification, right. So, it opens up the concept of hit hard, hit early for 16 weeks, and then maybe you can modify disease over time,” Dr. Blauvelt said.

He added: “That’s highly speculative, of course.”

Short-term safety data

The 52-week safety profile of lebrikizumab is consistent with previously published data at 16 weeks, Dr. Blauvelt said. The most common adverse events during the studies included atopic dermatitis, nasopharyngitis, conjunctivitis, conjunctivitis allergic, headache, and COVID-19.

“This drug has comparable efficacy with dupilumab and tralokinumab,” said Jashin J. Wu, MD, from the Dermatology Research and Education Foundation in Irvine, Calif., in an interview. He was not involved in the study.

“As it does not have any significant advantages with less long-term safety data, I do not see a place for it in my practice,” Dr. Wu said.

Dupilumab (Dupixent) and tralokinumab (Adbry) are monoclonal antibodies that also block IL-13. Both are already licensed for treating atopic dermatitis. Dupilumab was approved by the Food and Drug Administration in 2017, and tralokinumab was approved in 2021.

The study was funded by Dermira, a wholly owned subsidiary of Eli Lilly. Eli Lilly has exclusive rights for the development and commercialization of lebrikizumab in the United States and all countries outside Europe; European rights belong to Almirall for all dermatology indications, including atopic dermatitis. Dr. Blauvelt acts as an investigator and adviser to these companies as well as many other pharmaceutical companies that are involved in developing new dermatologic treatments. Dr. Wu has been an investigator, consultant, or speaker for multiple pharmaceutical companies.

A version of this article first appeared on Medscape.com.