VIENNA — People with spondyloarthritis (SpA) who have low or stable disease activity can effectively and safely be managed using a model of patient-initiated care with or without remote monitoring, suggested the results of two separate trials presented at the European Alliance of Associations for Rheumatology (EULAR) 2024 Annual Meeting. 

In the 18-month, single-center ReMonit study that included 243 people with axial SpA (axSpA), patient-initiated care was found to be noninferior for keeping them in a low-disease activity state, compared with both usual hospital follow-up and remote digital monitoring.

Meanwhile, in the 12-month, multicenter TeleSpA study, which included 200 patients with any type of SpA, the number of hospital visits needed by people who were randomly assigned to receive patient-initiated care together with asynchronous telemonitoring was significantly lower than for the usual-care group, with no detriment to the participants’ overall health outcomes or safety. Moreover, the strategy was deemed cost-effective from a healthcare provision perspective.
 

Time to Rationalize Healthcare Resources?

People with chronic rheumatic diseases such as axSpA require long-term follow-up in specialist healthcare centers, Inger Jorid Berg, MD, PhD, of Diakonhjemmet Hospital in Oslo, Norway, said when she presented the findings of the ReMonit study as a late-breaking abstract.

Sara Freeman/Medscape Medical News

“Traditionally, this has been offered as prescheduled face-to-face consultations at an outpatient clinic, but remote monitoring and patient-initiated care may allow for more targeted and efficient uses of healthcare resources,” Dr. Berg said.

“The end goal of what you’re trying to do is increase the efficiency of outpatient care and provide more patient-tailored care,” Kasper Hermans, MD, said in an interview. He presented the results of the TeleSpA study. 

Dr. Hermans, who is a rheumatology fellow and PhD candidate at Maastricht University, Maastricht, the Netherlands, observed during his presentation at EULAR 2024 that there is an increasing demand for rheumatology services but an expected shortfall in the future workforce. Thus, “sustainable alternative strategies are needed for optimizing the efficiency of care,” he said.

People need to have timely access to care, Dr. Hermans stressed, but perhaps alternatives to the traditional models of care where patients are seen routinely every 6 or 12 months are needed, particularly as prior work had suggested that around one-third of people who were seen by a rheumatologist perhaps did not need to be.

A strategy of patient-initiated care — which is where people are seen by a healthcare provider only if they feel that they need to and request a consultation — is therefore an attractive proposition, particularly if it is backed up with remote monitoring, which is what the TeleSpA study was testing.
 

Two Distinct Studies

ReMonit and TeleSpA were two distinct studies. While both were noninferiority trials and involved patient-initiated care and telemonitoring of outpatients with SpA, that is where the similarities generally end.

Notably, ReMonit included a very specific population of patients — all had a diagnosis of axSpA and were being treated with a tumor necrosis factor (TNF) inhibitor and had been on a stable dose for the last 6 months. For inclusion, they also had to have inactive disease or low disease activity, as indicated by an Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1.

ReMonit’s telemonitoring strategy involved participants completing monthly questionnaires using the Dignio smartphone app. Patients first completed the Patient Global Assessment (PGA) and noted whether they had experienced a flare in their disease. If they had a flare or their PGA score was 3 or higher, then they were asked to also complete the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI). If the BASDAI score was 4 or more, then the patient was called by a study nurse and offered a consultation.

“Patients in all three groups were recommended to take blood samples at the general practitioner’s or at the hospital every third month as a safety procedure when using TNF inhibitors,” Dr. Berg said.

The primary outcome was the proportion of people who remained with low disease activity (ASDAS < 2.1) at 6, 12, and 18 months in each of the three arms of the trial, which were patient-initiated care (n = 81), monthly remote monitoring (n = 80), or usual follow-up in the hospital every 6 months (n = 82).

TeleSpA on the other hand was a “much more pragmatic trial, much closer to actual care,” Dr. Hermans said. “We included axial spondyloarthritis, peripheral spondyloarthritis, or patients who had both axial and peripheral disease, including patients with psoriatic arthritis,” he said, adding that their inclusion was regardless of their baseline ASDAS based on C-reactive protein (ASDAS-CRP).

This means that patients who would otherwise have been classified at baseline as having high disease activity (by ASDAS-CRP or similar disease activity measures) could be included. The main proviso was that both the patient and their rheumatologist had to define the condition as being stable with an acceptable level of symptom control and no immediate plans to change treatment within the next 3 months.

TeleSpA’s remote monitoring strategy involved the use of SpA-Net, which Dr. Hermans and coinvestigators have described previously as “an ongoing, disease-specific, prospective, web-based registry for monitoring SpA in daily practice.” This captures a host of clinical and laboratory test information.

SpA-Net was used in both arms of the study. However, while the 100 participants in the standard-care arm completed questionnaires and had tests before every in-person visit that had been prescheduled with their rheumatologist, the 100 individuals in the patient-initiated care arm had no prescheduled in-person visits except for being seen at the start and end of the study. These patients were reminded via email to complete the necessary SpA-Net registry questionnaires at 6 months.

The primary outcome for TeleSpA was the total number of rheumatology visits, including both physical and telephone or video consultations, within a 1-year period. 
 

ReMonit Results

Berg reported that similar percentages of patients remained in a low disease activity state at 6, 12, and 18 months, regardless of the group that they had been randomized into, and that there was little change seen within the individual groups.

For instance, at 6, 12, and 18 months, 92%, 91%, and 92% of individuals in the patient-initiated arm had an ASDAS of < 2.1. Corresponding percentages for the usual-care arm were 96%, 93%, and 90% and for the remote-monitoring arm were 96%, 96%, and 94%.

Both patient-initiated care and remote monitoring were noninferior to usual care, and patient-initiated care was also noninferior to remote monitoring. There were no differences between the trial arms in terms of disease activity, measured using either ASDAS or BASDAI, at 6, 12, or 18 months.

Dr. Berg stated that “patient satisfaction was high in all three follow-up strategies, and there was the lowest resource use with patient-initiated care.” She concluded that “remote monitoring and patient-initiated care could be implemented in the follow-up of patients with axial spondyloarthritis and low disease activity.”
 

TeleSpA Results

In TeleSpA, people in the patient-initiated care and telemonitoring arm were seen a mean of 1.9 times over the course of the 1-year follow-up vs 2.6 for people in the usual care arm. The reduction was caused in part by the decrease in physical visits (1.4 vs 2.0) as there were the same mean number of telephone visits in each group. Overall, there was a 25.4% reduction in consultations comparing the patient-initiated care and telemonitoring arm with the usual-care arm.

Importantly, the intervention was noninferior regarding all of the predefined health outcomes: ASDAS, BASDAI, pain assessed using a visual analog scale, patient global assessment, and physician global assessment.

And more than 90% of participants in both groups reported having an overall good experience with their care.

Dr. Hermans noted after his presentation that an additional study had been performed where “we actively engaged with patients in the intervention group as well as healthcare providers to ask them what their experiences were with the intervention, how we could possibly improve it, and whether or not they thought that it was a valid approach to follow-up after the end of the study. And results were very, very reassuring.”

In terms of safety, eight serious adverse events were reported, but none were related to the study intervention, Dr. Hermans said. 

Dr. Hermans reported that there was “negligible difference” in the 1-year quality-adjusted life-years (+0.004, in favor of the intervention overall) and that, while healthcare costs were lower at €243/year for the entire intervention period, societal costs were higher, at €513/year vs usual care. The latter was thought to be “due to an unexpected rise in absenteeism that we think was most likely due to a small amount of outliers,” Dr. Hermans said. 

Nonetheless, using at willingness-to-pay threshold of €20,000/ quality-adjusted life year, he reported that the added value of patient-initiated care with remote monitoring yielded a potential net monetary benefit of +€322 from a healthcare perspective for the entire intervention period.

“We believe that these results support the fast-paced adoption of remote care interventions,” Dr. Hermans said. “In the context that I described earlier, of decreasing healthcare personnel and rising costs, we believe that this could be a valuable approach for follow-up for patients with stable axSpA.”

ReMonit was sponsored by Diakonhjemmet Hospital, and TeleSpA was sponsored by Maastricht University Medical Center, with funding from the Dutch Arthritis Society. Dr. Berg and Dr. Hermans had no relevant conflicts of interest to report.

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

Editor’s Note: This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

VIENNA — People with spondyloarthritis (SpA) who have low or stable disease activity can effectively and safely be managed using a model of patient-initiated care with or without remote monitoring, suggested the results of two separate trials presented at the European Alliance of Associations for Rheumatology (EULAR) 2024 Annual Meeting. 

In the 18-month, single-center ReMonit study that included 243 people with axial SpA (axSpA), patient-initiated care was found to be noninferior for keeping them in a low-disease activity state, compared with both usual hospital follow-up and remote digital monitoring.

Meanwhile, in the 12-month, multicenter TeleSpA study, which included 200 patients with any type of SpA, the number of hospital visits needed by people who were randomly assigned to receive patient-initiated care together with asynchronous telemonitoring was significantly lower than for the usual-care group, with no detriment to the participants’ overall health outcomes or safety. Moreover, the strategy was deemed cost-effective from a healthcare provision perspective.
 

Time to Rationalize Healthcare Resources?

People with chronic rheumatic diseases such as axSpA require long-term follow-up in specialist healthcare centers, Inger Jorid Berg, MD, PhD, of Diakonhjemmet Hospital in Oslo, Norway, said when she presented the findings of the ReMonit study as a late-breaking abstract.

Sara Freeman/Medscape Medical News

“Traditionally, this has been offered as prescheduled face-to-face consultations at an outpatient clinic, but remote monitoring and patient-initiated care may allow for more targeted and efficient uses of healthcare resources,” Dr. Berg said.

“The end goal of what you’re trying to do is increase the efficiency of outpatient care and provide more patient-tailored care,” Kasper Hermans, MD, said in an interview. He presented the results of the TeleSpA study. 

Dr. Hermans, who is a rheumatology fellow and PhD candidate at Maastricht University, Maastricht, the Netherlands, observed during his presentation at EULAR 2024 that there is an increasing demand for rheumatology services but an expected shortfall in the future workforce. Thus, “sustainable alternative strategies are needed for optimizing the efficiency of care,” he said.

People need to have timely access to care, Dr. Hermans stressed, but perhaps alternatives to the traditional models of care where patients are seen routinely every 6 or 12 months are needed, particularly as prior work had suggested that around one-third of people who were seen by a rheumatologist perhaps did not need to be.

A strategy of patient-initiated care — which is where people are seen by a healthcare provider only if they feel that they need to and request a consultation — is therefore an attractive proposition, particularly if it is backed up with remote monitoring, which is what the TeleSpA study was testing.
 

Two Distinct Studies

ReMonit and TeleSpA were two distinct studies. While both were noninferiority trials and involved patient-initiated care and telemonitoring of outpatients with SpA, that is where the similarities generally end.

Notably, ReMonit included a very specific population of patients — all had a diagnosis of axSpA and were being treated with a tumor necrosis factor (TNF) inhibitor and had been on a stable dose for the last 6 months. For inclusion, they also had to have inactive disease or low disease activity, as indicated by an Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1.

ReMonit’s telemonitoring strategy involved participants completing monthly questionnaires using the Dignio smartphone app. Patients first completed the Patient Global Assessment (PGA) and noted whether they had experienced a flare in their disease. If they had a flare or their PGA score was 3 or higher, then they were asked to also complete the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI). If the BASDAI score was 4 or more, then the patient was called by a study nurse and offered a consultation.

“Patients in all three groups were recommended to take blood samples at the general practitioner’s or at the hospital every third month as a safety procedure when using TNF inhibitors,” Dr. Berg said.

The primary outcome was the proportion of people who remained with low disease activity (ASDAS < 2.1) at 6, 12, and 18 months in each of the three arms of the trial, which were patient-initiated care (n = 81), monthly remote monitoring (n = 80), or usual follow-up in the hospital every 6 months (n = 82).

TeleSpA on the other hand was a “much more pragmatic trial, much closer to actual care,” Dr. Hermans said. “We included axial spondyloarthritis, peripheral spondyloarthritis, or patients who had both axial and peripheral disease, including patients with psoriatic arthritis,” he said, adding that their inclusion was regardless of their baseline ASDAS based on C-reactive protein (ASDAS-CRP).

This means that patients who would otherwise have been classified at baseline as having high disease activity (by ASDAS-CRP or similar disease activity measures) could be included. The main proviso was that both the patient and their rheumatologist had to define the condition as being stable with an acceptable level of symptom control and no immediate plans to change treatment within the next 3 months.

TeleSpA’s remote monitoring strategy involved the use of SpA-Net, which Dr. Hermans and coinvestigators have described previously as “an ongoing, disease-specific, prospective, web-based registry for monitoring SpA in daily practice.” This captures a host of clinical and laboratory test information.

SpA-Net was used in both arms of the study. However, while the 100 participants in the standard-care arm completed questionnaires and had tests before every in-person visit that had been prescheduled with their rheumatologist, the 100 individuals in the patient-initiated care arm had no prescheduled in-person visits except for being seen at the start and end of the study. These patients were reminded via email to complete the necessary SpA-Net registry questionnaires at 6 months.

The primary outcome for TeleSpA was the total number of rheumatology visits, including both physical and telephone or video consultations, within a 1-year period. 
 

ReMonit Results

Berg reported that similar percentages of patients remained in a low disease activity state at 6, 12, and 18 months, regardless of the group that they had been randomized into, and that there was little change seen within the individual groups.

For instance, at 6, 12, and 18 months, 92%, 91%, and 92% of individuals in the patient-initiated arm had an ASDAS of < 2.1. Corresponding percentages for the usual-care arm were 96%, 93%, and 90% and for the remote-monitoring arm were 96%, 96%, and 94%.

Both patient-initiated care and remote monitoring were noninferior to usual care, and patient-initiated care was also noninferior to remote monitoring. There were no differences between the trial arms in terms of disease activity, measured using either ASDAS or BASDAI, at 6, 12, or 18 months.

Dr. Berg stated that “patient satisfaction was high in all three follow-up strategies, and there was the lowest resource use with patient-initiated care.” She concluded that “remote monitoring and patient-initiated care could be implemented in the follow-up of patients with axial spondyloarthritis and low disease activity.”
 

TeleSpA Results

In TeleSpA, people in the patient-initiated care and telemonitoring arm were seen a mean of 1.9 times over the course of the 1-year follow-up vs 2.6 for people in the usual care arm. The reduction was caused in part by the decrease in physical visits (1.4 vs 2.0) as there were the same mean number of telephone visits in each group. Overall, there was a 25.4% reduction in consultations comparing the patient-initiated care and telemonitoring arm with the usual-care arm.

Importantly, the intervention was noninferior regarding all of the predefined health outcomes: ASDAS, BASDAI, pain assessed using a visual analog scale, patient global assessment, and physician global assessment.

And more than 90% of participants in both groups reported having an overall good experience with their care.

Dr. Hermans noted after his presentation that an additional study had been performed where “we actively engaged with patients in the intervention group as well as healthcare providers to ask them what their experiences were with the intervention, how we could possibly improve it, and whether or not they thought that it was a valid approach to follow-up after the end of the study. And results were very, very reassuring.”

In terms of safety, eight serious adverse events were reported, but none were related to the study intervention, Dr. Hermans said. 

Dr. Hermans reported that there was “negligible difference” in the 1-year quality-adjusted life-years (+0.004, in favor of the intervention overall) and that, while healthcare costs were lower at €243/year for the entire intervention period, societal costs were higher, at €513/year vs usual care. The latter was thought to be “due to an unexpected rise in absenteeism that we think was most likely due to a small amount of outliers,” Dr. Hermans said. 

Nonetheless, using at willingness-to-pay threshold of €20,000/ quality-adjusted life year, he reported that the added value of patient-initiated care with remote monitoring yielded a potential net monetary benefit of +€322 from a healthcare perspective for the entire intervention period.

“We believe that these results support the fast-paced adoption of remote care interventions,” Dr. Hermans said. “In the context that I described earlier, of decreasing healthcare personnel and rising costs, we believe that this could be a valuable approach for follow-up for patients with stable axSpA.”

ReMonit was sponsored by Diakonhjemmet Hospital, and TeleSpA was sponsored by Maastricht University Medical Center, with funding from the Dutch Arthritis Society. Dr. Berg and Dr. Hermans had no relevant conflicts of interest to report.

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

Editor’s Note: This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

VIENNA — People with spondyloarthritis (SpA) who have low or stable disease activity can effectively and safely be managed using a model of patient-initiated care with or without remote monitoring, suggested the results of two separate trials presented at the European Alliance of Associations for Rheumatology (EULAR) 2024 Annual Meeting. 

In the 18-month, single-center ReMonit study that included 243 people with axial SpA (axSpA), patient-initiated care was found to be noninferior for keeping them in a low-disease activity state, compared with both usual hospital follow-up and remote digital monitoring.

Meanwhile, in the 12-month, multicenter TeleSpA study, which included 200 patients with any type of SpA, the number of hospital visits needed by people who were randomly assigned to receive patient-initiated care together with asynchronous telemonitoring was significantly lower than for the usual-care group, with no detriment to the participants’ overall health outcomes or safety. Moreover, the strategy was deemed cost-effective from a healthcare provision perspective.
 

Time to Rationalize Healthcare Resources?

People with chronic rheumatic diseases such as axSpA require long-term follow-up in specialist healthcare centers, Inger Jorid Berg, MD, PhD, of Diakonhjemmet Hospital in Oslo, Norway, said when she presented the findings of the ReMonit study as a late-breaking abstract.

Sara Freeman/Medscape Medical News

“Traditionally, this has been offered as prescheduled face-to-face consultations at an outpatient clinic, but remote monitoring and patient-initiated care may allow for more targeted and efficient uses of healthcare resources,” Dr. Berg said.

“The end goal of what you’re trying to do is increase the efficiency of outpatient care and provide more patient-tailored care,” Kasper Hermans, MD, said in an interview. He presented the results of the TeleSpA study. 

Dr. Hermans, who is a rheumatology fellow and PhD candidate at Maastricht University, Maastricht, the Netherlands, observed during his presentation at EULAR 2024 that there is an increasing demand for rheumatology services but an expected shortfall in the future workforce. Thus, “sustainable alternative strategies are needed for optimizing the efficiency of care,” he said.

People need to have timely access to care, Dr. Hermans stressed, but perhaps alternatives to the traditional models of care where patients are seen routinely every 6 or 12 months are needed, particularly as prior work had suggested that around one-third of people who were seen by a rheumatologist perhaps did not need to be.

A strategy of patient-initiated care — which is where people are seen by a healthcare provider only if they feel that they need to and request a consultation — is therefore an attractive proposition, particularly if it is backed up with remote monitoring, which is what the TeleSpA study was testing.
 

Two Distinct Studies

ReMonit and TeleSpA were two distinct studies. While both were noninferiority trials and involved patient-initiated care and telemonitoring of outpatients with SpA, that is where the similarities generally end.

Notably, ReMonit included a very specific population of patients — all had a diagnosis of axSpA and were being treated with a tumor necrosis factor (TNF) inhibitor and had been on a stable dose for the last 6 months. For inclusion, they also had to have inactive disease or low disease activity, as indicated by an Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1.

ReMonit’s telemonitoring strategy involved participants completing monthly questionnaires using the Dignio smartphone app. Patients first completed the Patient Global Assessment (PGA) and noted whether they had experienced a flare in their disease. If they had a flare or their PGA score was 3 or higher, then they were asked to also complete the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI). If the BASDAI score was 4 or more, then the patient was called by a study nurse and offered a consultation.

“Patients in all three groups were recommended to take blood samples at the general practitioner’s or at the hospital every third month as a safety procedure when using TNF inhibitors,” Dr. Berg said.

The primary outcome was the proportion of people who remained with low disease activity (ASDAS < 2.1) at 6, 12, and 18 months in each of the three arms of the trial, which were patient-initiated care (n = 81), monthly remote monitoring (n = 80), or usual follow-up in the hospital every 6 months (n = 82).

TeleSpA on the other hand was a “much more pragmatic trial, much closer to actual care,” Dr. Hermans said. “We included axial spondyloarthritis, peripheral spondyloarthritis, or patients who had both axial and peripheral disease, including patients with psoriatic arthritis,” he said, adding that their inclusion was regardless of their baseline ASDAS based on C-reactive protein (ASDAS-CRP).

This means that patients who would otherwise have been classified at baseline as having high disease activity (by ASDAS-CRP or similar disease activity measures) could be included. The main proviso was that both the patient and their rheumatologist had to define the condition as being stable with an acceptable level of symptom control and no immediate plans to change treatment within the next 3 months.

TeleSpA’s remote monitoring strategy involved the use of SpA-Net, which Dr. Hermans and coinvestigators have described previously as “an ongoing, disease-specific, prospective, web-based registry for monitoring SpA in daily practice.” This captures a host of clinical and laboratory test information.

SpA-Net was used in both arms of the study. However, while the 100 participants in the standard-care arm completed questionnaires and had tests before every in-person visit that had been prescheduled with their rheumatologist, the 100 individuals in the patient-initiated care arm had no prescheduled in-person visits except for being seen at the start and end of the study. These patients were reminded via email to complete the necessary SpA-Net registry questionnaires at 6 months.

The primary outcome for TeleSpA was the total number of rheumatology visits, including both physical and telephone or video consultations, within a 1-year period. 
 

ReMonit Results

Berg reported that similar percentages of patients remained in a low disease activity state at 6, 12, and 18 months, regardless of the group that they had been randomized into, and that there was little change seen within the individual groups.

For instance, at 6, 12, and 18 months, 92%, 91%, and 92% of individuals in the patient-initiated arm had an ASDAS of < 2.1. Corresponding percentages for the usual-care arm were 96%, 93%, and 90% and for the remote-monitoring arm were 96%, 96%, and 94%.

Both patient-initiated care and remote monitoring were noninferior to usual care, and patient-initiated care was also noninferior to remote monitoring. There were no differences between the trial arms in terms of disease activity, measured using either ASDAS or BASDAI, at 6, 12, or 18 months.

Dr. Berg stated that “patient satisfaction was high in all three follow-up strategies, and there was the lowest resource use with patient-initiated care.” She concluded that “remote monitoring and patient-initiated care could be implemented in the follow-up of patients with axial spondyloarthritis and low disease activity.”
 

TeleSpA Results

In TeleSpA, people in the patient-initiated care and telemonitoring arm were seen a mean of 1.9 times over the course of the 1-year follow-up vs 2.6 for people in the usual care arm. The reduction was caused in part by the decrease in physical visits (1.4 vs 2.0) as there were the same mean number of telephone visits in each group. Overall, there was a 25.4% reduction in consultations comparing the patient-initiated care and telemonitoring arm with the usual-care arm.

Importantly, the intervention was noninferior regarding all of the predefined health outcomes: ASDAS, BASDAI, pain assessed using a visual analog scale, patient global assessment, and physician global assessment.

And more than 90% of participants in both groups reported having an overall good experience with their care.

Dr. Hermans noted after his presentation that an additional study had been performed where “we actively engaged with patients in the intervention group as well as healthcare providers to ask them what their experiences were with the intervention, how we could possibly improve it, and whether or not they thought that it was a valid approach to follow-up after the end of the study. And results were very, very reassuring.”

In terms of safety, eight serious adverse events were reported, but none were related to the study intervention, Dr. Hermans said. 

Dr. Hermans reported that there was “negligible difference” in the 1-year quality-adjusted life-years (+0.004, in favor of the intervention overall) and that, while healthcare costs were lower at €243/year for the entire intervention period, societal costs were higher, at €513/year vs usual care. The latter was thought to be “due to an unexpected rise in absenteeism that we think was most likely due to a small amount of outliers,” Dr. Hermans said. 

Nonetheless, using at willingness-to-pay threshold of €20,000/ quality-adjusted life year, he reported that the added value of patient-initiated care with remote monitoring yielded a potential net monetary benefit of +€322 from a healthcare perspective for the entire intervention period.

“We believe that these results support the fast-paced adoption of remote care interventions,” Dr. Hermans said. “In the context that I described earlier, of decreasing healthcare personnel and rising costs, we believe that this could be a valuable approach for follow-up for patients with stable axSpA.”

ReMonit was sponsored by Diakonhjemmet Hospital, and TeleSpA was sponsored by Maastricht University Medical Center, with funding from the Dutch Arthritis Society. Dr. Berg and Dr. Hermans had no relevant conflicts of interest to report.

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

Editor’s Note: This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

In this real-life study, Patruno and colleagues found that dupilumab worked well but more slowly in patients with a higher body mass index (BMI). On the basis of these findings, if patients are not in a hurry, the standard dose of dupilumab should eventually work, regardless of BMI. If patients are in a hurry to see improvement, perhaps dose escalation could be considered for patients with a high BMI, or perhaps topical triamcinolone could be used to speed time-to–initial resolution in the high-BMI population.

In the very well-done study by Silverberg and colleagues, tapinarof was effective, well tolerated, and generally safe for atopic dermatitis in adults and children. Great! Topical tapinarof should soon be another good option for our patients with atopic dermatitis. How valuable will it be? We already have topical corticosteroids that are very effective for atopic dermatitis, and we have multiple other nonsteroidal topical agents, including topical calcineurin inhibitors and topical ruxolitinib. 

Perhaps the biggest limitation of all these treatments is poor adherence to topical treatment. I'm not sure how effective even highly effective nonsteroidal topicals will be for patients who did not respond to topical steroids when the primary reason for topical steroid failure is poor treatment adherence. I'd love to see the development of a once-a-week or once-a-month topical therapy that would address the poor-adherence hurdle.

Abrocitinib is an effective treatment for improving atopic dermatitis. Although atopic dermatitis is a chronic condition requiring long-term management, we'd like to minimize exposure to the drug to avoid side effects. Thyssen and colleagues described the effectiveness of two maintenance treatment regimens: continuing 200 mg/d or reducing the dose to 100 mg/d. Both regimens prevented flares more than did placebo. This study also provided information on safety of the maintenance regimens. Rates of herpetic infections were low across all the groups, but unlike the two treatment groups, there were no cases of herpes simplex infection in the patients in the placebo arm.
 

In this real-life study, Patruno and colleagues found that dupilumab worked well but more slowly in patients with a higher body mass index (BMI). On the basis of these findings, if patients are not in a hurry, the standard dose of dupilumab should eventually work, regardless of BMI. If patients are in a hurry to see improvement, perhaps dose escalation could be considered for patients with a high BMI, or perhaps topical triamcinolone could be used to speed time-to–initial resolution in the high-BMI population.

In the very well-done study by Silverberg and colleagues, tapinarof was effective, well tolerated, and generally safe for atopic dermatitis in adults and children. Great! Topical tapinarof should soon be another good option for our patients with atopic dermatitis. How valuable will it be? We already have topical corticosteroids that are very effective for atopic dermatitis, and we have multiple other nonsteroidal topical agents, including topical calcineurin inhibitors and topical ruxolitinib. 

Perhaps the biggest limitation of all these treatments is poor adherence to topical treatment. I'm not sure how effective even highly effective nonsteroidal topicals will be for patients who did not respond to topical steroids when the primary reason for topical steroid failure is poor treatment adherence. I'd love to see the development of a once-a-week or once-a-month topical therapy that would address the poor-adherence hurdle.

Abrocitinib is an effective treatment for improving atopic dermatitis. Although atopic dermatitis is a chronic condition requiring long-term management, we'd like to minimize exposure to the drug to avoid side effects. Thyssen and colleagues described the effectiveness of two maintenance treatment regimens: continuing 200 mg/d or reducing the dose to 100 mg/d. Both regimens prevented flares more than did placebo. This study also provided information on safety of the maintenance regimens. Rates of herpetic infections were low across all the groups, but unlike the two treatment groups, there were no cases of herpes simplex infection in the patients in the placebo arm.
 

In this real-life study, Patruno and colleagues found that dupilumab worked well but more slowly in patients with a higher body mass index (BMI). On the basis of these findings, if patients are not in a hurry, the standard dose of dupilumab should eventually work, regardless of BMI. If patients are in a hurry to see improvement, perhaps dose escalation could be considered for patients with a high BMI, or perhaps topical triamcinolone could be used to speed time-to–initial resolution in the high-BMI population.

In the very well-done study by Silverberg and colleagues, tapinarof was effective, well tolerated, and generally safe for atopic dermatitis in adults and children. Great! Topical tapinarof should soon be another good option for our patients with atopic dermatitis. How valuable will it be? We already have topical corticosteroids that are very effective for atopic dermatitis, and we have multiple other nonsteroidal topical agents, including topical calcineurin inhibitors and topical ruxolitinib. 

Perhaps the biggest limitation of all these treatments is poor adherence to topical treatment. I'm not sure how effective even highly effective nonsteroidal topicals will be for patients who did not respond to topical steroids when the primary reason for topical steroid failure is poor treatment adherence. I'd love to see the development of a once-a-week or once-a-month topical therapy that would address the poor-adherence hurdle.

Abrocitinib is an effective treatment for improving atopic dermatitis. Although atopic dermatitis is a chronic condition requiring long-term management, we'd like to minimize exposure to the drug to avoid side effects. Thyssen and colleagues described the effectiveness of two maintenance treatment regimens: continuing 200 mg/d or reducing the dose to 100 mg/d. Both regimens prevented flares more than did placebo. This study also provided information on safety of the maintenance regimens. Rates of herpetic infections were low across all the groups, but unlike the two treatment groups, there were no cases of herpes simplex infection in the patients in the placebo arm.
 

Certain medications that are used to treat benign prostatic hyperplasia (BPH) are associated with a reduced risk for dementia with Lewy bodies (DLB), the second most common neurodegenerative type of dementia after Alzheimer’s disease.

Investigators found older men taking alpha-1 blockers terazosin, doxazosin, or alfuzosin (Tz/Dz/Az) were 40% less likely to develop DLB than those taking tamsulosin and 37% less likely than men taking the 5-alpha reductase inhibitors (5ARI) finasteride and dutasteride.

“These results are exciting because right now there are no drugs to prevent or treat dementia with Lewy bodies,” study investigator Jacob E. Simmering, PhD, of the University of Iowa in Iowa City, said in a press release. “If we can determine that an existing drug can offer protection against this debilitating disease, that has the potential to greatly reduce its effects.”

The findings were published online in Neurology.
 

Increasing ATP Neuroprotective?

In recent years, investigators have speculated that improving metabolic activity in the brain may reduce the risk for Parkinson’s disease (PD). 

In previous studies, the use of Tz/Dz/Az resulted in the activation of phosphoglycerate kinase-1 (PKG1), which increases the availability of adenosine triphosphate (ATP).

There have been case reports of PD being linked to mutations affecting PGK1. Researchers speculate that increased ATP availability in neurons resulting from the activation of PKG1 allows cells to better adapt to aging and synuclein aggregation.

To investigate whether glycolysis-enhancing drugs might be neuroprotective in those with DLB, investigators conducted a retrospective cohort study using a commercial health insurance claims database and a Medicare supplemental health claims database to follow a sample of men aged > 40 years taking Tz, Dz, or Az (n = 126,313), tamsulosin (n = 437,035), or a 5ARI (n = 80,158) for BPH.

Tamsulosin and 5ARI medications do not activate PKG1, so investigators used them as comparators to Tz/Dz/Az. Participants were followed from the medication initiation date until the end of enrollment in the claims databases.

After following claimants for an average of 3 years, 195 participants developed DLB who were taking Tz, Dz, or Az, a rate of 5.21 cases per 10,000 people per year.

During the follow-up period, 1286 participants taking tamsulosin developed DLB, a rate of 10.8 per 10,000 people per year, and among those taking 5ARIs, 193 cases of DLB were reported, a rate of 7.8 per 10,000 people per year.

After matching the groups by age and other health conditions that may explain differences in rates of DLB, men taking Tz/Dz/Az had a 60% lower risk than those taking tamsulosin (P < .001) and a 37% lower risk for developing DLB than those taking the 5ARI medications (P = .012).

“This emerging evidence of a protective association across a spectrum of diseases suggests a broad neuroprotective effect for Tz/Dz/Az, consistent with our hypothesized mechanism that activation of PGK1 increases brain ATP and mitigates neurodegeneration,” the authors wrote.

Study limitations include excluding women from the study, so the findings cannot be generalized to women. Claims analyses were limited to administrative data that could have been incorrect, and the analyses did not include medication dosages.

No study funding or author disclosures were reported.

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

Certain medications that are used to treat benign prostatic hyperplasia (BPH) are associated with a reduced risk for dementia with Lewy bodies (DLB), the second most common neurodegenerative type of dementia after Alzheimer’s disease.

Investigators found older men taking alpha-1 blockers terazosin, doxazosin, or alfuzosin (Tz/Dz/Az) were 40% less likely to develop DLB than those taking tamsulosin and 37% less likely than men taking the 5-alpha reductase inhibitors (5ARI) finasteride and dutasteride.

“These results are exciting because right now there are no drugs to prevent or treat dementia with Lewy bodies,” study investigator Jacob E. Simmering, PhD, of the University of Iowa in Iowa City, said in a press release. “If we can determine that an existing drug can offer protection against this debilitating disease, that has the potential to greatly reduce its effects.”

The findings were published online in Neurology.
 

Increasing ATP Neuroprotective?

In recent years, investigators have speculated that improving metabolic activity in the brain may reduce the risk for Parkinson’s disease (PD). 

In previous studies, the use of Tz/Dz/Az resulted in the activation of phosphoglycerate kinase-1 (PKG1), which increases the availability of adenosine triphosphate (ATP).

There have been case reports of PD being linked to mutations affecting PGK1. Researchers speculate that increased ATP availability in neurons resulting from the activation of PKG1 allows cells to better adapt to aging and synuclein aggregation.

To investigate whether glycolysis-enhancing drugs might be neuroprotective in those with DLB, investigators conducted a retrospective cohort study using a commercial health insurance claims database and a Medicare supplemental health claims database to follow a sample of men aged > 40 years taking Tz, Dz, or Az (n = 126,313), tamsulosin (n = 437,035), or a 5ARI (n = 80,158) for BPH.

Tamsulosin and 5ARI medications do not activate PKG1, so investigators used them as comparators to Tz/Dz/Az. Participants were followed from the medication initiation date until the end of enrollment in the claims databases.

After following claimants for an average of 3 years, 195 participants developed DLB who were taking Tz, Dz, or Az, a rate of 5.21 cases per 10,000 people per year.

During the follow-up period, 1286 participants taking tamsulosin developed DLB, a rate of 10.8 per 10,000 people per year, and among those taking 5ARIs, 193 cases of DLB were reported, a rate of 7.8 per 10,000 people per year.

After matching the groups by age and other health conditions that may explain differences in rates of DLB, men taking Tz/Dz/Az had a 60% lower risk than those taking tamsulosin (P < .001) and a 37% lower risk for developing DLB than those taking the 5ARI medications (P = .012).

“This emerging evidence of a protective association across a spectrum of diseases suggests a broad neuroprotective effect for Tz/Dz/Az, consistent with our hypothesized mechanism that activation of PGK1 increases brain ATP and mitigates neurodegeneration,” the authors wrote.

Study limitations include excluding women from the study, so the findings cannot be generalized to women. Claims analyses were limited to administrative data that could have been incorrect, and the analyses did not include medication dosages.

No study funding or author disclosures were reported.

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

Certain medications that are used to treat benign prostatic hyperplasia (BPH) are associated with a reduced risk for dementia with Lewy bodies (DLB), the second most common neurodegenerative type of dementia after Alzheimer’s disease.

Investigators found older men taking alpha-1 blockers terazosin, doxazosin, or alfuzosin (Tz/Dz/Az) were 40% less likely to develop DLB than those taking tamsulosin and 37% less likely than men taking the 5-alpha reductase inhibitors (5ARI) finasteride and dutasteride.

“These results are exciting because right now there are no drugs to prevent or treat dementia with Lewy bodies,” study investigator Jacob E. Simmering, PhD, of the University of Iowa in Iowa City, said in a press release. “If we can determine that an existing drug can offer protection against this debilitating disease, that has the potential to greatly reduce its effects.”

The findings were published online in Neurology.
 

Increasing ATP Neuroprotective?

In recent years, investigators have speculated that improving metabolic activity in the brain may reduce the risk for Parkinson’s disease (PD). 

In previous studies, the use of Tz/Dz/Az resulted in the activation of phosphoglycerate kinase-1 (PKG1), which increases the availability of adenosine triphosphate (ATP).

There have been case reports of PD being linked to mutations affecting PGK1. Researchers speculate that increased ATP availability in neurons resulting from the activation of PKG1 allows cells to better adapt to aging and synuclein aggregation.

To investigate whether glycolysis-enhancing drugs might be neuroprotective in those with DLB, investigators conducted a retrospective cohort study using a commercial health insurance claims database and a Medicare supplemental health claims database to follow a sample of men aged > 40 years taking Tz, Dz, or Az (n = 126,313), tamsulosin (n = 437,035), or a 5ARI (n = 80,158) for BPH.

Tamsulosin and 5ARI medications do not activate PKG1, so investigators used them as comparators to Tz/Dz/Az. Participants were followed from the medication initiation date until the end of enrollment in the claims databases.

After following claimants for an average of 3 years, 195 participants developed DLB who were taking Tz, Dz, or Az, a rate of 5.21 cases per 10,000 people per year.

During the follow-up period, 1286 participants taking tamsulosin developed DLB, a rate of 10.8 per 10,000 people per year, and among those taking 5ARIs, 193 cases of DLB were reported, a rate of 7.8 per 10,000 people per year.

After matching the groups by age and other health conditions that may explain differences in rates of DLB, men taking Tz/Dz/Az had a 60% lower risk than those taking tamsulosin (P < .001) and a 37% lower risk for developing DLB than those taking the 5ARI medications (P = .012).

“This emerging evidence of a protective association across a spectrum of diseases suggests a broad neuroprotective effect for Tz/Dz/Az, consistent with our hypothesized mechanism that activation of PGK1 increases brain ATP and mitigates neurodegeneration,” the authors wrote.

Study limitations include excluding women from the study, so the findings cannot be generalized to women. Claims analyses were limited to administrative data that could have been incorrect, and the analyses did not include medication dosages.

No study funding or author disclosures were reported.

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

Extended-release injectable naltrexone combined with extended-release oral bupropion (NTX + BUPN) for moderate or severe methamphetamine use disorder was associated with a significant decrease in use of the drug, a new study showed.

Investigators leading the randomized clinical trial found a 27% increase in negative methamphetamine urine tests in the treatment group — indicating reduced use — compared with an 11% increase in negative urine tests in control participants.

“These findings have important implications for pharmacological treatment for methamphetamine use disorder. There is no FDA-approved medication for it, yet methamphetamine-involved overdoses have greatly increased over the past decade,” lead author Michael Li, MD, assistant professor-in-residence of family medicine at the David Geffen School of Medicine at UCLA, Los Angeles, said in a news release.

The study was published online in Addiction.

Methamphetamine use has increased worldwide, from 33 million users in 2010 to 34 million in 2020, with overdose deaths rising fivefold in the United States over the past decade, the authors wrote.

A previous open-label study of NTX + BUPN showed efficacy for treating severe methamphetamine use disorder, and NTX and BUPN have each shown efficacy separately for this indication. 

This new study is the second phase of the multicenter ADAPT-2 trial, conducted between 2017 and 2019 in 403 participants with methamphetamine use disorder. In the first stage, 109 people received NTX + BUPN and 294 received placebo.

The treatment group received extended-release NTX (380 mg) or placebo as an intramuscular injection on weeks 1, 4, 7, and 10. Extended-release BUPN or placebo tablets were administered weekly, with BUPN doses starting at 150 mg on day 1 and increasing to 450 mg by day 3. At week 13, participants received a tapering dose for 4 days before discontinuing.

As previously reported by this news organization, the two-drug combo was effective at reducing methamphetamine use at 6 weeks. The current analysis measured change in methamphetamine use during weeks 7-12 of the trial and in posttreatment weeks 13-16.

Participants in the intervention group during stage 1 showed an additional 9.2% increase (P = .038) during stage 2 in their probability of testing negative for methamphetamine. This represented a total increase of 27.1% in negative urine tests across the complete 12 weeks of treatment, compared with a total 11.4% increase in negative tests in the placebo group.

The 12-week increase in methamphetamine-negative urine tests in the intervention group was 15.8% greater (P = .006) than the increase in the placebo group.

There was no significant change in either group at posttreatment follow-up in weeks 13-16.

“Our findings suggest that ongoing NTX + BUPN treatment yields statistically significant reductions in methamphetamine use that continue from weeks 7 to 12,” the authors wrote. The lack of change in methamphetamine use from weeks 13-16 corresponds to the conclusion of treatment in week 12, they added.

It remains to be determined “whether continued use of NTX + BUPN treatment past 12 weeks would yield further reductions in use,” the authors wrote, noting that prior stimulant use disorder trials suggest that change in use is gradual and that sustained abstinence is unlikely in merely 12 weeks of a trial. Rather, it is dependent on treatment duration.

“This warrants future clinical trials to quantify changes in methamphetamine use beyond 12 weeks and to identify the optimal duration of treatment with this medication,” they concluded.

The study was funded by awards from the National Institute on Drug Abuse (NIDA), the US Department of Health and Human Services, the National Institute of Mental Health, and the O’Donnell Clinical Neuroscience Scholar Award from the University of Texas Southwestern Medical Center. Alkermes provided Vivitrol (naltrexone for extended-release injectable suspension) and matched placebo free of charge for use in this trial under a written agreement with NIDA. Dr. Li reports no relevant financial relationships. The other authors’ disclosures are listed on the original paper.

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

Extended-release injectable naltrexone combined with extended-release oral bupropion (NTX + BUPN) for moderate or severe methamphetamine use disorder was associated with a significant decrease in use of the drug, a new study showed.

Investigators leading the randomized clinical trial found a 27% increase in negative methamphetamine urine tests in the treatment group — indicating reduced use — compared with an 11% increase in negative urine tests in control participants.

“These findings have important implications for pharmacological treatment for methamphetamine use disorder. There is no FDA-approved medication for it, yet methamphetamine-involved overdoses have greatly increased over the past decade,” lead author Michael Li, MD, assistant professor-in-residence of family medicine at the David Geffen School of Medicine at UCLA, Los Angeles, said in a news release.

The study was published online in Addiction.

Methamphetamine use has increased worldwide, from 33 million users in 2010 to 34 million in 2020, with overdose deaths rising fivefold in the United States over the past decade, the authors wrote.

A previous open-label study of NTX + BUPN showed efficacy for treating severe methamphetamine use disorder, and NTX and BUPN have each shown efficacy separately for this indication. 

This new study is the second phase of the multicenter ADAPT-2 trial, conducted between 2017 and 2019 in 403 participants with methamphetamine use disorder. In the first stage, 109 people received NTX + BUPN and 294 received placebo.

The treatment group received extended-release NTX (380 mg) or placebo as an intramuscular injection on weeks 1, 4, 7, and 10. Extended-release BUPN or placebo tablets were administered weekly, with BUPN doses starting at 150 mg on day 1 and increasing to 450 mg by day 3. At week 13, participants received a tapering dose for 4 days before discontinuing.

As previously reported by this news organization, the two-drug combo was effective at reducing methamphetamine use at 6 weeks. The current analysis measured change in methamphetamine use during weeks 7-12 of the trial and in posttreatment weeks 13-16.

Participants in the intervention group during stage 1 showed an additional 9.2% increase (P = .038) during stage 2 in their probability of testing negative for methamphetamine. This represented a total increase of 27.1% in negative urine tests across the complete 12 weeks of treatment, compared with a total 11.4% increase in negative tests in the placebo group.

The 12-week increase in methamphetamine-negative urine tests in the intervention group was 15.8% greater (P = .006) than the increase in the placebo group.

There was no significant change in either group at posttreatment follow-up in weeks 13-16.

“Our findings suggest that ongoing NTX + BUPN treatment yields statistically significant reductions in methamphetamine use that continue from weeks 7 to 12,” the authors wrote. The lack of change in methamphetamine use from weeks 13-16 corresponds to the conclusion of treatment in week 12, they added.

It remains to be determined “whether continued use of NTX + BUPN treatment past 12 weeks would yield further reductions in use,” the authors wrote, noting that prior stimulant use disorder trials suggest that change in use is gradual and that sustained abstinence is unlikely in merely 12 weeks of a trial. Rather, it is dependent on treatment duration.

“This warrants future clinical trials to quantify changes in methamphetamine use beyond 12 weeks and to identify the optimal duration of treatment with this medication,” they concluded.

The study was funded by awards from the National Institute on Drug Abuse (NIDA), the US Department of Health and Human Services, the National Institute of Mental Health, and the O’Donnell Clinical Neuroscience Scholar Award from the University of Texas Southwestern Medical Center. Alkermes provided Vivitrol (naltrexone for extended-release injectable suspension) and matched placebo free of charge for use in this trial under a written agreement with NIDA. Dr. Li reports no relevant financial relationships. The other authors’ disclosures are listed on the original paper.

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

Extended-release injectable naltrexone combined with extended-release oral bupropion (NTX + BUPN) for moderate or severe methamphetamine use disorder was associated with a significant decrease in use of the drug, a new study showed.

Investigators leading the randomized clinical trial found a 27% increase in negative methamphetamine urine tests in the treatment group — indicating reduced use — compared with an 11% increase in negative urine tests in control participants.

“These findings have important implications for pharmacological treatment for methamphetamine use disorder. There is no FDA-approved medication for it, yet methamphetamine-involved overdoses have greatly increased over the past decade,” lead author Michael Li, MD, assistant professor-in-residence of family medicine at the David Geffen School of Medicine at UCLA, Los Angeles, said in a news release.

The study was published online in Addiction.

Methamphetamine use has increased worldwide, from 33 million users in 2010 to 34 million in 2020, with overdose deaths rising fivefold in the United States over the past decade, the authors wrote.

A previous open-label study of NTX + BUPN showed efficacy for treating severe methamphetamine use disorder, and NTX and BUPN have each shown efficacy separately for this indication. 

This new study is the second phase of the multicenter ADAPT-2 trial, conducted between 2017 and 2019 in 403 participants with methamphetamine use disorder. In the first stage, 109 people received NTX + BUPN and 294 received placebo.

The treatment group received extended-release NTX (380 mg) or placebo as an intramuscular injection on weeks 1, 4, 7, and 10. Extended-release BUPN or placebo tablets were administered weekly, with BUPN doses starting at 150 mg on day 1 and increasing to 450 mg by day 3. At week 13, participants received a tapering dose for 4 days before discontinuing.

As previously reported by this news organization, the two-drug combo was effective at reducing methamphetamine use at 6 weeks. The current analysis measured change in methamphetamine use during weeks 7-12 of the trial and in posttreatment weeks 13-16.

Participants in the intervention group during stage 1 showed an additional 9.2% increase (P = .038) during stage 2 in their probability of testing negative for methamphetamine. This represented a total increase of 27.1% in negative urine tests across the complete 12 weeks of treatment, compared with a total 11.4% increase in negative tests in the placebo group.

The 12-week increase in methamphetamine-negative urine tests in the intervention group was 15.8% greater (P = .006) than the increase in the placebo group.

There was no significant change in either group at posttreatment follow-up in weeks 13-16.

“Our findings suggest that ongoing NTX + BUPN treatment yields statistically significant reductions in methamphetamine use that continue from weeks 7 to 12,” the authors wrote. The lack of change in methamphetamine use from weeks 13-16 corresponds to the conclusion of treatment in week 12, they added.

It remains to be determined “whether continued use of NTX + BUPN treatment past 12 weeks would yield further reductions in use,” the authors wrote, noting that prior stimulant use disorder trials suggest that change in use is gradual and that sustained abstinence is unlikely in merely 12 weeks of a trial. Rather, it is dependent on treatment duration.

“This warrants future clinical trials to quantify changes in methamphetamine use beyond 12 weeks and to identify the optimal duration of treatment with this medication,” they concluded.

The study was funded by awards from the National Institute on Drug Abuse (NIDA), the US Department of Health and Human Services, the National Institute of Mental Health, and the O’Donnell Clinical Neuroscience Scholar Award from the University of Texas Southwestern Medical Center. Alkermes provided Vivitrol (naltrexone for extended-release injectable suspension) and matched placebo free of charge for use in this trial under a written agreement with NIDA. Dr. Li reports no relevant financial relationships. The other authors’ disclosures are listed on the original paper.

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

TOPLINE:

In men with type 2 diabetes (T2D), higher serum levels of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) were associated with a lower risk for metabolic dysfunction–associated fatty liver disease (MAFLD), whereas higher progesterone levels were associated with a higher risk. In women with T2D, sex- or thyroid-related hormones were not independently associated with the risk for MAFLD.

METHODOLOGY:

• People with T2D may have FLD, and this study explored the link between sex-related and thyroid-related hormone levels and MAFLD to explore and confirm risk factors.
• The researchers used a 2020 definition of MAFLD, now defined in patients as both hepatic steatosis and the presence of overweight/obesity, T2D, or evidence of metabolic dysfunction in lean individuals.
• This cross-sectional study conducted in one hospital in China included 432 patients hospitalized because of T2D and its complications from January 2018 to April 2020 (median T2D duration, 6 years; mean age, 55.8 years; 247 men and 185 postmenopausal women).
• Researchers measured and later adjusted for potential confounding factors, including weight, height, waist circumference, arterial blood pressure, glycemic parameters, liver function, and lipid profiles.
• They assessed blood levels of sex and thyroid hormones by chemiluminescent immunoassays; MAFLD was diagnosed by either ultrasonography findings of hepatic steatosis or a high liver fat index score (fatty liver index > 60).

TAKEAWAY:

• Overall, 275 (63.7%) patients were diagnosed with MAFLD; after adjusting for potential confounding factors, none of the sex- and thyroid-related hormones were independently associated with the risk for MAFLD in all patients with T2D.
• In men with T2D, higher serum levels of FSH (adjusted odds ratio [aOR], 0.919; P = .019) and LH (aOR, 0.888; P = .022) were associated with a reduced risk for MAFLD.
• Higher serum levels of progesterone were associated with an increased risk for MAFLD in men with T2D (aOR, 8.069; P = .003).
• In women with T2D, sex hormones and thyroid hormones were not significantly linked to the risk of developing MAFLD.

IN PRACTICE:

“Our findings could be used to imply that screening for MAFLD and monitoring sex-related hormones are important for T2D patients, especially in men,” the authors wrote.

SOURCE:

This study was led by Weihong Lu, Xiamen Clinical Research Center for Cancer Therapy, Xiamen, China; Shangjian Li, Zhongshan Hospital (Xiamen), Fudan University, Xiamen, China; and Yuhua Li, China University of Mining & Technology-Beijing, Beijing, and was published online in BMC Endocrine Disorders.

LIMITATIONS:

Temporal sequences of the associations between sex-related and thyroid-related hormones and MAFLD were not evaluated because of the cross-sectional nature of the study. The small sample size from a single institution may have introduced selection bias. Serum levels of sex hormone-binding globulin and free testosterone were not assessed. The postmenopausal status of women in the study may have affected the ability to find sex-hormone related associations. The findings can only be limitedly extrapolated to similar patients with T2D but not the general population.

DISCLOSURES:

The study was supported by the Fujian Province Nature Science Foundations, China, and the Guiding Project on Medicine and Health in Xiamen, China. The authors declared no conflicts of interest.

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

TOPLINE:

In men with type 2 diabetes (T2D), higher serum levels of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) were associated with a lower risk for metabolic dysfunction–associated fatty liver disease (MAFLD), whereas higher progesterone levels were associated with a higher risk. In women with T2D, sex- or thyroid-related hormones were not independently associated with the risk for MAFLD.

METHODOLOGY:

• People with T2D may have FLD, and this study explored the link between sex-related and thyroid-related hormone levels and MAFLD to explore and confirm risk factors.
• The researchers used a 2020 definition of MAFLD, now defined in patients as both hepatic steatosis and the presence of overweight/obesity, T2D, or evidence of metabolic dysfunction in lean individuals.
• This cross-sectional study conducted in one hospital in China included 432 patients hospitalized because of T2D and its complications from January 2018 to April 2020 (median T2D duration, 6 years; mean age, 55.8 years; 247 men and 185 postmenopausal women).
• Researchers measured and later adjusted for potential confounding factors, including weight, height, waist circumference, arterial blood pressure, glycemic parameters, liver function, and lipid profiles.
• They assessed blood levels of sex and thyroid hormones by chemiluminescent immunoassays; MAFLD was diagnosed by either ultrasonography findings of hepatic steatosis or a high liver fat index score (fatty liver index > 60).

TAKEAWAY:

• Overall, 275 (63.7%) patients were diagnosed with MAFLD; after adjusting for potential confounding factors, none of the sex- and thyroid-related hormones were independently associated with the risk for MAFLD in all patients with T2D.
• In men with T2D, higher serum levels of FSH (adjusted odds ratio [aOR], 0.919; P = .019) and LH (aOR, 0.888; P = .022) were associated with a reduced risk for MAFLD.
• Higher serum levels of progesterone were associated with an increased risk for MAFLD in men with T2D (aOR, 8.069; P = .003).
• In women with T2D, sex hormones and thyroid hormones were not significantly linked to the risk of developing MAFLD.

IN PRACTICE:

“Our findings could be used to imply that screening for MAFLD and monitoring sex-related hormones are important for T2D patients, especially in men,” the authors wrote.

SOURCE:

This study was led by Weihong Lu, Xiamen Clinical Research Center for Cancer Therapy, Xiamen, China; Shangjian Li, Zhongshan Hospital (Xiamen), Fudan University, Xiamen, China; and Yuhua Li, China University of Mining & Technology-Beijing, Beijing, and was published online in BMC Endocrine Disorders.

LIMITATIONS:

Temporal sequences of the associations between sex-related and thyroid-related hormones and MAFLD were not evaluated because of the cross-sectional nature of the study. The small sample size from a single institution may have introduced selection bias. Serum levels of sex hormone-binding globulin and free testosterone were not assessed. The postmenopausal status of women in the study may have affected the ability to find sex-hormone related associations. The findings can only be limitedly extrapolated to similar patients with T2D but not the general population.

DISCLOSURES:

The study was supported by the Fujian Province Nature Science Foundations, China, and the Guiding Project on Medicine and Health in Xiamen, China. The authors declared no conflicts of interest.

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

TOPLINE:

In men with type 2 diabetes (T2D), higher serum levels of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) were associated with a lower risk for metabolic dysfunction–associated fatty liver disease (MAFLD), whereas higher progesterone levels were associated with a higher risk. In women with T2D, sex- or thyroid-related hormones were not independently associated with the risk for MAFLD.

METHODOLOGY:

• People with T2D may have FLD, and this study explored the link between sex-related and thyroid-related hormone levels and MAFLD to explore and confirm risk factors.
• The researchers used a 2020 definition of MAFLD, now defined in patients as both hepatic steatosis and the presence of overweight/obesity, T2D, or evidence of metabolic dysfunction in lean individuals.
• This cross-sectional study conducted in one hospital in China included 432 patients hospitalized because of T2D and its complications from January 2018 to April 2020 (median T2D duration, 6 years; mean age, 55.8 years; 247 men and 185 postmenopausal women).
• Researchers measured and later adjusted for potential confounding factors, including weight, height, waist circumference, arterial blood pressure, glycemic parameters, liver function, and lipid profiles.
• They assessed blood levels of sex and thyroid hormones by chemiluminescent immunoassays; MAFLD was diagnosed by either ultrasonography findings of hepatic steatosis or a high liver fat index score (fatty liver index > 60).

TAKEAWAY:

• Overall, 275 (63.7%) patients were diagnosed with MAFLD; after adjusting for potential confounding factors, none of the sex- and thyroid-related hormones were independently associated with the risk for MAFLD in all patients with T2D.
• In men with T2D, higher serum levels of FSH (adjusted odds ratio [aOR], 0.919; P = .019) and LH (aOR, 0.888; P = .022) were associated with a reduced risk for MAFLD.
• Higher serum levels of progesterone were associated with an increased risk for MAFLD in men with T2D (aOR, 8.069; P = .003).
• In women with T2D, sex hormones and thyroid hormones were not significantly linked to the risk of developing MAFLD.

IN PRACTICE:

“Our findings could be used to imply that screening for MAFLD and monitoring sex-related hormones are important for T2D patients, especially in men,” the authors wrote.

SOURCE:

This study was led by Weihong Lu, Xiamen Clinical Research Center for Cancer Therapy, Xiamen, China; Shangjian Li, Zhongshan Hospital (Xiamen), Fudan University, Xiamen, China; and Yuhua Li, China University of Mining & Technology-Beijing, Beijing, and was published online in BMC Endocrine Disorders.

LIMITATIONS:

Temporal sequences of the associations between sex-related and thyroid-related hormones and MAFLD were not evaluated because of the cross-sectional nature of the study. The small sample size from a single institution may have introduced selection bias. Serum levels of sex hormone-binding globulin and free testosterone were not assessed. The postmenopausal status of women in the study may have affected the ability to find sex-hormone related associations. The findings can only be limitedly extrapolated to similar patients with T2D but not the general population.

DISCLOSURES:

The study was supported by the Fujian Province Nature Science Foundations, China, and the Guiding Project on Medicine and Health in Xiamen, China. The authors declared no conflicts of interest.

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

Chicago — The latest findings from the FELIX phase 1b/2 study confirm the efficacy of obecabtagene autoleucel (obe-cel/Auto1, Autolus Therapeutics) and establish the CD19-directed autologous chimeric antigen receptor (CAR) T-cell product as a standard-of-care therapy for adults with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL).

These findings also highlight the favorable impact of CAR T persistence on treatment outcomes, and suggest that consolidative stem cell transplant (SCT) in R/R B-ALL patients treated with obe-cel does not improve outcomes, Elias Jabbour, MD, of the University of Texas MD Anderson Cancer Center, Houston, reported at the American Society of Clinical Oncology (ASCO) annual meeting.

The overall complete remission or complete remission with incomplete count recovery rate was 78% among 127 patients enrolled in the open-label, single-arm study and infused with obe-cel. Among the 99 patients who responded, 18 proceeded to consolidative SCT while in remission, Dr. Jabbour said, noting that all 18 who received SCT were in minimal residual disease (MRD)–negative remission at the time of transplant.

Of those 18 patients, 10 had ongoing CAR T persistence prior to transplant, he said.

At median follow-up of 21.5 months, 40% of responders were in ongoing remission without the need for subsequent consolidation with SCT or other therapy, whereas SCT did not appear to improve outcomes.

The median event-free survival (EFS) after censoring for transplant was 11.9 months, and the 12-month EFS rate was 49.5%. Without censoring for transplant, the EFS and 12-month EFS rate were 9.0 months and 44%, respectively.

“I would like to highlight that the time to transplant was 100 days, and of those 18 patients, all in MRD-negative status ... 80% relapsed or died from transplant-related complications,” Dr. Jabbour said.

Median overall survival (OS) without censoring for transplant was 15.6 months, and the 12-month OS rate was 61.1%. After censoring for transplant, the median OS and 12-month OS rate 23.8 months 63.7%, respectively. The survival curves were fully overlapping, indicating that transplant did not improve OS outcomes.

“Furthermore, when you look at the EFS and [OS], both show a potential plateau for a long-term outcome, and this trend is similar to what was reported in a phase 1 trial with 2 years of follow up and more,” Dr. Jabbour said.

The investigators also assessed the impact of loss of CAR T-cell persistence and loss of B-cell aplasia and found that “both ongoing CAR T-cell persistence and ongoing B-cell aplasia, were correlated with better event-free survival,” he noted, explaining that the risk of relapse was 2.7 times greater in those who lost versus maintained CAR T-cell persistence, and 1.7 times greater in those who lost versus maintained B-cell aplasia.

Among those with ongoing remission at 6 months, median EFS was 15.1 months in those who lost CAR T-cell persistence, whereas the median EFS was not reached in those who maintained CAR T-cell persistence.

Obe-cel is an autologous CAR T-cell product with a fast off-rate CD19 binder designed to mitigate immunotoxicity and improve CAR T-cell expansion and persistence, Dr. Jabbour said, noting that pooled efficacy and safety results from the FELIX phase 1b and 2 trials of heavily pretreated patients have previously been reported.

The findings support the use of obe-cel as a standard treatment in this patient population, and demonstrate that ongoing CAR T-cell persistence and B-cell aplasia are associated with improved EFS — without further consolidation therapy after treatment, he concluded.

This study was funded by Autolus Therapeutics. Dr. Jabbour disclosed ties with Abbvie, Ascentage Pharma, Adaptive Biotechnologies, Amgen, Astellas Pharma, Bristol-Myers Squibb, Genentech, Incyte, Pfizer, and Takeda.

Chicago — The latest findings from the FELIX phase 1b/2 study confirm the efficacy of obecabtagene autoleucel (obe-cel/Auto1, Autolus Therapeutics) and establish the CD19-directed autologous chimeric antigen receptor (CAR) T-cell product as a standard-of-care therapy for adults with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL).

These findings also highlight the favorable impact of CAR T persistence on treatment outcomes, and suggest that consolidative stem cell transplant (SCT) in R/R B-ALL patients treated with obe-cel does not improve outcomes, Elias Jabbour, MD, of the University of Texas MD Anderson Cancer Center, Houston, reported at the American Society of Clinical Oncology (ASCO) annual meeting.

The overall complete remission or complete remission with incomplete count recovery rate was 78% among 127 patients enrolled in the open-label, single-arm study and infused with obe-cel. Among the 99 patients who responded, 18 proceeded to consolidative SCT while in remission, Dr. Jabbour said, noting that all 18 who received SCT were in minimal residual disease (MRD)–negative remission at the time of transplant.

Of those 18 patients, 10 had ongoing CAR T persistence prior to transplant, he said.

At median follow-up of 21.5 months, 40% of responders were in ongoing remission without the need for subsequent consolidation with SCT or other therapy, whereas SCT did not appear to improve outcomes.

The median event-free survival (EFS) after censoring for transplant was 11.9 months, and the 12-month EFS rate was 49.5%. Without censoring for transplant, the EFS and 12-month EFS rate were 9.0 months and 44%, respectively.

“I would like to highlight that the time to transplant was 100 days, and of those 18 patients, all in MRD-negative status ... 80% relapsed or died from transplant-related complications,” Dr. Jabbour said.

Median overall survival (OS) without censoring for transplant was 15.6 months, and the 12-month OS rate was 61.1%. After censoring for transplant, the median OS and 12-month OS rate 23.8 months 63.7%, respectively. The survival curves were fully overlapping, indicating that transplant did not improve OS outcomes.

“Furthermore, when you look at the EFS and [OS], both show a potential plateau for a long-term outcome, and this trend is similar to what was reported in a phase 1 trial with 2 years of follow up and more,” Dr. Jabbour said.

The investigators also assessed the impact of loss of CAR T-cell persistence and loss of B-cell aplasia and found that “both ongoing CAR T-cell persistence and ongoing B-cell aplasia, were correlated with better event-free survival,” he noted, explaining that the risk of relapse was 2.7 times greater in those who lost versus maintained CAR T-cell persistence, and 1.7 times greater in those who lost versus maintained B-cell aplasia.

Among those with ongoing remission at 6 months, median EFS was 15.1 months in those who lost CAR T-cell persistence, whereas the median EFS was not reached in those who maintained CAR T-cell persistence.

Obe-cel is an autologous CAR T-cell product with a fast off-rate CD19 binder designed to mitigate immunotoxicity and improve CAR T-cell expansion and persistence, Dr. Jabbour said, noting that pooled efficacy and safety results from the FELIX phase 1b and 2 trials of heavily pretreated patients have previously been reported.

The findings support the use of obe-cel as a standard treatment in this patient population, and demonstrate that ongoing CAR T-cell persistence and B-cell aplasia are associated with improved EFS — without further consolidation therapy after treatment, he concluded.

This study was funded by Autolus Therapeutics. Dr. Jabbour disclosed ties with Abbvie, Ascentage Pharma, Adaptive Biotechnologies, Amgen, Astellas Pharma, Bristol-Myers Squibb, Genentech, Incyte, Pfizer, and Takeda.

Chicago — The latest findings from the FELIX phase 1b/2 study confirm the efficacy of obecabtagene autoleucel (obe-cel/Auto1, Autolus Therapeutics) and establish the CD19-directed autologous chimeric antigen receptor (CAR) T-cell product as a standard-of-care therapy for adults with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL).

These findings also highlight the favorable impact of CAR T persistence on treatment outcomes, and suggest that consolidative stem cell transplant (SCT) in R/R B-ALL patients treated with obe-cel does not improve outcomes, Elias Jabbour, MD, of the University of Texas MD Anderson Cancer Center, Houston, reported at the American Society of Clinical Oncology (ASCO) annual meeting.

The overall complete remission or complete remission with incomplete count recovery rate was 78% among 127 patients enrolled in the open-label, single-arm study and infused with obe-cel. Among the 99 patients who responded, 18 proceeded to consolidative SCT while in remission, Dr. Jabbour said, noting that all 18 who received SCT were in minimal residual disease (MRD)–negative remission at the time of transplant.

Of those 18 patients, 10 had ongoing CAR T persistence prior to transplant, he said.

At median follow-up of 21.5 months, 40% of responders were in ongoing remission without the need for subsequent consolidation with SCT or other therapy, whereas SCT did not appear to improve outcomes.

The median event-free survival (EFS) after censoring for transplant was 11.9 months, and the 12-month EFS rate was 49.5%. Without censoring for transplant, the EFS and 12-month EFS rate were 9.0 months and 44%, respectively.

“I would like to highlight that the time to transplant was 100 days, and of those 18 patients, all in MRD-negative status ... 80% relapsed or died from transplant-related complications,” Dr. Jabbour said.

Median overall survival (OS) without censoring for transplant was 15.6 months, and the 12-month OS rate was 61.1%. After censoring for transplant, the median OS and 12-month OS rate 23.8 months 63.7%, respectively. The survival curves were fully overlapping, indicating that transplant did not improve OS outcomes.

“Furthermore, when you look at the EFS and [OS], both show a potential plateau for a long-term outcome, and this trend is similar to what was reported in a phase 1 trial with 2 years of follow up and more,” Dr. Jabbour said.

The investigators also assessed the impact of loss of CAR T-cell persistence and loss of B-cell aplasia and found that “both ongoing CAR T-cell persistence and ongoing B-cell aplasia, were correlated with better event-free survival,” he noted, explaining that the risk of relapse was 2.7 times greater in those who lost versus maintained CAR T-cell persistence, and 1.7 times greater in those who lost versus maintained B-cell aplasia.

Among those with ongoing remission at 6 months, median EFS was 15.1 months in those who lost CAR T-cell persistence, whereas the median EFS was not reached in those who maintained CAR T-cell persistence.

Obe-cel is an autologous CAR T-cell product with a fast off-rate CD19 binder designed to mitigate immunotoxicity and improve CAR T-cell expansion and persistence, Dr. Jabbour said, noting that pooled efficacy and safety results from the FELIX phase 1b and 2 trials of heavily pretreated patients have previously been reported.

The findings support the use of obe-cel as a standard treatment in this patient population, and demonstrate that ongoing CAR T-cell persistence and B-cell aplasia are associated with improved EFS — without further consolidation therapy after treatment, he concluded.

This study was funded by Autolus Therapeutics. Dr. Jabbour disclosed ties with Abbvie, Ascentage Pharma, Adaptive Biotechnologies, Amgen, Astellas Pharma, Bristol-Myers Squibb, Genentech, Incyte, Pfizer, and Takeda.

Treatment for chronic hypertension in pregnancy with labetalol showed no significant differences in maternal or neonatal outcomes, compared with treatment with nifedipine, new research indicates.

The open-label, multicenter, randomized CHAP (Chronic Hypertension in Pregnancy) trial showed that treating mild chronic hypertension was better than delaying treatment until severe hypertension developed, but still unclear was whether, or to what extent, the choice of first-line treatment affected outcomes.

Researchers, led by Ayodeji A. Sanusi, MD, MPH, with the Division of Maternal and Fetal Medicine at the University of Alabama at Birmingham, conducted a secondary analysis of CHAP to compare the primary treatments. Mild chronic hypertension in the study was defined as blood pressure of 140-159/90-104 mmHg before 20 weeks of gestation.
 

Three Comparisons

Three comparisons were performed in 2292 participants based on medications prescribed at enrollment: 720 (31.4%) received labetalol; 417 (18.2%) initially received nifedipine; and 1155 (50.4%) had standard care. Labetalol was compared with standard care; nifedipine was compared with standard care; and labetalol was compared with nifedipine.

The primary outcome was occurrence of superimposed preeclampsia with severe features; preterm birth before 35 weeks of gestation; placental abruption; or fetal or neonatal death. The key secondary outcome was a small-for-gestational age neonate. Researchers also compared adverse effects between groups.

Among the results were the following:

• The primary outcome occurred in 30.1% in the labetalol group; 31.2% in the nifedipine group; and 37% in the standard care group.
• Risk of the primary outcome was lower among those receiving treatment. For labetalol vs standard care, the adjusted relative risk (RR) was 0.82; 95% confidence interval (CI), 0.72-0.94. For nifedipine vs standard care, the adjusted RR was 0.84; 95% CI, 0.71-0.99. There was no significant difference in risk when labetalol was compared with nifedipine (adjusted RR, 0.98; 95% CI, 0.82-1.18).
• There were no significant differences in numbers of small-for-gestational age neonates or serious adverse events between those who received labetalol and those using nifedipine.

Any adverse events were significantly more common with nifedipine, compared with labetalol (35.7% vs 28.3%, P = .009), and with nifedipine, compared with standard care (35.7% vs 26.3%, P = .0003). Adverse event rates were not significantly higher with labetalol when compared with standard care (28.3% vs 26.3%, P = .34). The most frequently reported adverse events were headache, medication intolerance, dizziness, nausea, dyspepsia, neonatal jaundice, and vomiting.

“Thus, labetalol compared with nifedipine appeared to have fewer adverse events and to be better tolerated,” the authors write. They note that labetalol, a third-generation mixed alpha- and beta-adrenergic antagonist, is contraindicated for those who have obstructive pulmonary disease and nifedipine, a dihydropyridine calcium channel blocker, is contraindicated in people with tachycardia.

The authors write that their results align with other studies that have not found differences between labetalol and nifedipine. “[O]ur findings support the use of either labetalol or nifedipine as initial first-line agents for the management of mild chronic hypertension in pregnancy to reduce the risk of adverse maternal and other perinatal outcomes with no increased risk of fetal harm,” the authors write.

Dr. Sanusi reports no relevant financial relationships. Full coauthor disclosures are available with the full text of the paper.

Treatment for chronic hypertension in pregnancy with labetalol showed no significant differences in maternal or neonatal outcomes, compared with treatment with nifedipine, new research indicates.

The open-label, multicenter, randomized CHAP (Chronic Hypertension in Pregnancy) trial showed that treating mild chronic hypertension was better than delaying treatment until severe hypertension developed, but still unclear was whether, or to what extent, the choice of first-line treatment affected outcomes.

Researchers, led by Ayodeji A. Sanusi, MD, MPH, with the Division of Maternal and Fetal Medicine at the University of Alabama at Birmingham, conducted a secondary analysis of CHAP to compare the primary treatments. Mild chronic hypertension in the study was defined as blood pressure of 140-159/90-104 mmHg before 20 weeks of gestation.
 

Three Comparisons

Three comparisons were performed in 2292 participants based on medications prescribed at enrollment: 720 (31.4%) received labetalol; 417 (18.2%) initially received nifedipine; and 1155 (50.4%) had standard care. Labetalol was compared with standard care; nifedipine was compared with standard care; and labetalol was compared with nifedipine.

The primary outcome was occurrence of superimposed preeclampsia with severe features; preterm birth before 35 weeks of gestation; placental abruption; or fetal or neonatal death. The key secondary outcome was a small-for-gestational age neonate. Researchers also compared adverse effects between groups.

Among the results were the following:

• The primary outcome occurred in 30.1% in the labetalol group; 31.2% in the nifedipine group; and 37% in the standard care group.
• Risk of the primary outcome was lower among those receiving treatment. For labetalol vs standard care, the adjusted relative risk (RR) was 0.82; 95% confidence interval (CI), 0.72-0.94. For nifedipine vs standard care, the adjusted RR was 0.84; 95% CI, 0.71-0.99. There was no significant difference in risk when labetalol was compared with nifedipine (adjusted RR, 0.98; 95% CI, 0.82-1.18).
• There were no significant differences in numbers of small-for-gestational age neonates or serious adverse events between those who received labetalol and those using nifedipine.

Any adverse events were significantly more common with nifedipine, compared with labetalol (35.7% vs 28.3%, P = .009), and with nifedipine, compared with standard care (35.7% vs 26.3%, P = .0003). Adverse event rates were not significantly higher with labetalol when compared with standard care (28.3% vs 26.3%, P = .34). The most frequently reported adverse events were headache, medication intolerance, dizziness, nausea, dyspepsia, neonatal jaundice, and vomiting.

“Thus, labetalol compared with nifedipine appeared to have fewer adverse events and to be better tolerated,” the authors write. They note that labetalol, a third-generation mixed alpha- and beta-adrenergic antagonist, is contraindicated for those who have obstructive pulmonary disease and nifedipine, a dihydropyridine calcium channel blocker, is contraindicated in people with tachycardia.

The authors write that their results align with other studies that have not found differences between labetalol and nifedipine. “[O]ur findings support the use of either labetalol or nifedipine as initial first-line agents for the management of mild chronic hypertension in pregnancy to reduce the risk of adverse maternal and other perinatal outcomes with no increased risk of fetal harm,” the authors write.

Dr. Sanusi reports no relevant financial relationships. Full coauthor disclosures are available with the full text of the paper.

Treatment for chronic hypertension in pregnancy with labetalol showed no significant differences in maternal or neonatal outcomes, compared with treatment with nifedipine, new research indicates.

The open-label, multicenter, randomized CHAP (Chronic Hypertension in Pregnancy) trial showed that treating mild chronic hypertension was better than delaying treatment until severe hypertension developed, but still unclear was whether, or to what extent, the choice of first-line treatment affected outcomes.

Researchers, led by Ayodeji A. Sanusi, MD, MPH, with the Division of Maternal and Fetal Medicine at the University of Alabama at Birmingham, conducted a secondary analysis of CHAP to compare the primary treatments. Mild chronic hypertension in the study was defined as blood pressure of 140-159/90-104 mmHg before 20 weeks of gestation.
 

Three Comparisons

Three comparisons were performed in 2292 participants based on medications prescribed at enrollment: 720 (31.4%) received labetalol; 417 (18.2%) initially received nifedipine; and 1155 (50.4%) had standard care. Labetalol was compared with standard care; nifedipine was compared with standard care; and labetalol was compared with nifedipine.

The primary outcome was occurrence of superimposed preeclampsia with severe features; preterm birth before 35 weeks of gestation; placental abruption; or fetal or neonatal death. The key secondary outcome was a small-for-gestational age neonate. Researchers also compared adverse effects between groups.

Among the results were the following:

• The primary outcome occurred in 30.1% in the labetalol group; 31.2% in the nifedipine group; and 37% in the standard care group.
• Risk of the primary outcome was lower among those receiving treatment. For labetalol vs standard care, the adjusted relative risk (RR) was 0.82; 95% confidence interval (CI), 0.72-0.94. For nifedipine vs standard care, the adjusted RR was 0.84; 95% CI, 0.71-0.99. There was no significant difference in risk when labetalol was compared with nifedipine (adjusted RR, 0.98; 95% CI, 0.82-1.18).
• There were no significant differences in numbers of small-for-gestational age neonates or serious adverse events between those who received labetalol and those using nifedipine.

Any adverse events were significantly more common with nifedipine, compared with labetalol (35.7% vs 28.3%, P = .009), and with nifedipine, compared with standard care (35.7% vs 26.3%, P = .0003). Adverse event rates were not significantly higher with labetalol when compared with standard care (28.3% vs 26.3%, P = .34). The most frequently reported adverse events were headache, medication intolerance, dizziness, nausea, dyspepsia, neonatal jaundice, and vomiting.

“Thus, labetalol compared with nifedipine appeared to have fewer adverse events and to be better tolerated,” the authors write. They note that labetalol, a third-generation mixed alpha- and beta-adrenergic antagonist, is contraindicated for those who have obstructive pulmonary disease and nifedipine, a dihydropyridine calcium channel blocker, is contraindicated in people with tachycardia.

The authors write that their results align with other studies that have not found differences between labetalol and nifedipine. “[O]ur findings support the use of either labetalol or nifedipine as initial first-line agents for the management of mild chronic hypertension in pregnancy to reduce the risk of adverse maternal and other perinatal outcomes with no increased risk of fetal harm,” the authors write.

Dr. Sanusi reports no relevant financial relationships. Full coauthor disclosures are available with the full text of the paper.

From adolescence onward, the need for sexual health is particularly important. Yet, information and healthcare services are limited, which often leaves patients in distress and subject to misconceptions. What are the specific issues related to sexuality in adolescence, middle age, and beyond? This news organization interviewed Carol Burté, MD, a specialist in sexual medicine from Monaco.

Question: Regarding young individuals, what about sex education in schools?

Dr. Burté: The French law of 2018 specifies that at least three annual sessions must be devoted to sex education in elementary school, middle school, and high school.

In practice, this is not always the case, and interventions are very focused on prevention and rules. Sexuality is almost always absent from the program. Sexuality means: What does it mean to have desire? How does pleasure work? At what age do we have sex? etc. Young people receive prevention advice, but the link with sexuality is not made.

Sexuality remains taboo. You know, like in books: “They got married and had many children ...” End of the story, we don’t know more [laughs].

Question: And outside the school setting, do doctors sufficiently address sexual health issues with adolescents?

Dr. Burté: Rarely. I understand that a general practitioner has little time, but they can still ask the young person if they have any questions. They can refer them to someone or provide reading recommendations. Regarding sex education on the Internet, there are many well-made websites, such as the one by the national education system.

Also, it is important to give young people lifestyle advice to combat overweight, sedentary behavior, etc., by explaining to them that these factors can lead to sexual disorders later as well as infertility.

Another very important point: There is an inequality between boys and girls, but this time, to the disadvantage of boys. We have a sexual health consultation dedicated to young girls for the pill, but no one examines the boys. However, testicular cancer or undescended testicles can occur. I think we really need to change things and establish a clinical examination for boys in adolescence.

Question: More and more young people identify as asexual. What do you think of this?

Dr. Burté: People who identify as asexual represent about 1% of the population. These are individuals who are not attracted to having sexual relationships with someone. This does not prevent them from having a boyfriend, a girlfriend, masturbating, etc. It is sexual intercourse that does not interest them. These young people often say they have done it all. They have seen a lot of images, viewed sexuality as gymnastics with all the positions, tricks. They are jaded. Also, when you are faced with an image that provides a very strong and rapid stimulation, human relationships seem much more difficult because, obviously, you will never reproduce that sensation when you are with your partner with whom you must connect. The relationship is no longer emotional and shared. Yet, sexuality is emotional, relational, intellectual.

I think people go through phases. At a certain point, they feel asexual, but they can change their minds and think differently if they have real encounters, encounters that are increasingly difficult. Today, we are witnessing a loss of confidence. Young people, but also others, want to protect themselves from everything, especially from falling in love, not get back into a relationship because it is constraining. 

Question: Data show that young people are exposed to pornography at an increasingly early age. Is this a problem for their future sexuality?

Dr. Burté: The exposure to pornography at an early age, around 11 years old, has only been a reality for the past decade. It is too early to say how it will impact their sexuality. When examining the literature on this subject, some publications indicate that the consequences can be dramatic for children. Others show that children can distinguish between reality and fantasy.

Whenever I see young people in consultation, I ask them whether they feel pornography has helped or hindered them, whether it is the cause of the issue they are facing. I would say that, other than those who have viewed pornography under duress, which is of the order of violence, pornography does not seem to pose a problem. It can even provide certain knowledge. 

Question: What about sexual violence in children? What are the consequences?

Dr. Burté: In sexual medicine, this is one of the questions we ask systematically because it is very common. It is important to keep in mind that this not only affects girls; boys are also sexually abused. The consequences are dramatic in terms of psychosexual development. Each case is different. 

Question: At the other end of life, is it “normal” to have sexual disorders at a certain age? Should we resign ourselves?

Dr. Burté: When it comes to sexuality, people have many misconceptions and beliefs that are conveyed through media and the Internet. One of them is to believe that because we are aging, we cannot have a proper sexuality. Sexuality slows down with age, as all sensitivities decrease, but desire is something present throughout life. Yet, seniors are rarely questioned about their sexual health by the media.

Note that older people in institutions face an additional obstacle: lack of privacy. Is this normal? Sexuality releases endorphins, oxytocin, it is well-being that costs nothing. It is something that should be prescribed!

Question: Chronic diseases, disabilities with incidence increases with age — are they not inevitable obstacles to a fulfilling sexuality?

Dr. Burté: It is possible to have a sexual life regardless of the disease one has, cancer, diabetes, rheumatic disease — regardless of the disability. 

A collaboration with the National Cancer Institute on the preservation of sexual health after cancer in which I participated shows that people are extremely demanding of care and that this care is still very insufficient, unfortunately, even in the case of prostate cancer, for example, when it should be obvious.

Question: But aging itself brings challenges in terms of sexuality. 

Dr. Burté: Yes, in men, the consequences of low testosterone levels are well known. Therefore, we must stop thinking that men do not have their “menopause.” Men often have a testosterone deficiency after a certain age. This is very annoying because they have many symptoms that are truly unpleasant and yet can be corrected by completely reliable treatments.

Men are very misinformed on this subject. We talk about gender inequality, but in this area, a young woman who has her first period knows very well that one day she will go through menopause, but a boy has no idea that one day he will have hormone problems.

Question: Therefore, is it important to question men past the age of 50 years?

Dr. Burté: Yes. Faced with sexual symptoms or simply fatigue, or among those who are a bit depressed, investigating a testosterone deficiency should be part of the reflexes.

Also, if you ask a man in general, “How is it going from a sexual point of view,” and he answers that everything is going well, this means he has good arteries, good veins, a good nervous system, sufficient hormones, and psychologically, everything is going rather well. Conversely, erectile dysfunction can be one of the first symptoms of cardiovascular pathologies.

After a certain age, there is no test that provides as much information about people’s health as this question about sexual health.

Question: On their side, are women better cared for at menopause?

Dr. Burté: Yes, but women still lack explanations. I work in sexual medicine, and in my consultation, I see women who come simply to get information about menopause.

Women must know that menopause is a turning point in life because they will spend 30%-40% of their lives without hormones.

It is important to explain that indeed, after menopause, without treatment, it is not the same. There are genital and urinary, psychological, sexual, and skin consequences. It is important to provide true data on the influence of hormonal treatments. Today, hormone fear is not over. I think we need to rehabilitate treatments, care for women.

Question: So we must not forget men or women. 

Dr. Burté: Yes. It is also very important to adopt a perspective not only for the individual but also for the couple. If you treat a man with testosterone, after 3 months, he will be in great shape. However, if the couple has long been accustomed to having a limited sexual life, if the woman is not supported on her side, the couple will be unbalanced. The couple is concerned with managing the hormonal changes of both.

Question: Sexual medicine is essential, yet it seems inaccessible. 

Dr. Burté: There are very few specialists in sexual medicine because there is no legal provision for it. These consultations are lengthy but not valued. Who wants to work for that?

If there was reimbursement for sexual medicine consultations at age 15 years, at menopause, and for men around the age of 50 years, it would change mentalities. Sexual medicine must be integrated into medicine. It should also be noted that not all sexologists are physicians.

Some people are very well trained through universities, and others are not. Ideally, someone with a sexual disorder should first have a sexual medicine consultation to understand the situation. Then, the physician can refer the patient to a competent sexologist because we work in a network.

Dr. Burté has no conflicts of interest related to the subject. 

This story was translated from the Medscape French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. 

A version of this article appeared on Medscape.com.

From adolescence onward, the need for sexual health is particularly important. Yet, information and healthcare services are limited, which often leaves patients in distress and subject to misconceptions. What are the specific issues related to sexuality in adolescence, middle age, and beyond? This news organization interviewed Carol Burté, MD, a specialist in sexual medicine from Monaco.

Question: Regarding young individuals, what about sex education in schools?

Dr. Burté: The French law of 2018 specifies that at least three annual sessions must be devoted to sex education in elementary school, middle school, and high school.

In practice, this is not always the case, and interventions are very focused on prevention and rules. Sexuality is almost always absent from the program. Sexuality means: What does it mean to have desire? How does pleasure work? At what age do we have sex? etc. Young people receive prevention advice, but the link with sexuality is not made.

Sexuality remains taboo. You know, like in books: “They got married and had many children ...” End of the story, we don’t know more [laughs].

Question: And outside the school setting, do doctors sufficiently address sexual health issues with adolescents?

Dr. Burté: Rarely. I understand that a general practitioner has little time, but they can still ask the young person if they have any questions. They can refer them to someone or provide reading recommendations. Regarding sex education on the Internet, there are many well-made websites, such as the one by the national education system.

Also, it is important to give young people lifestyle advice to combat overweight, sedentary behavior, etc., by explaining to them that these factors can lead to sexual disorders later as well as infertility.

Another very important point: There is an inequality between boys and girls, but this time, to the disadvantage of boys. We have a sexual health consultation dedicated to young girls for the pill, but no one examines the boys. However, testicular cancer or undescended testicles can occur. I think we really need to change things and establish a clinical examination for boys in adolescence.

Question: More and more young people identify as asexual. What do you think of this?

Dr. Burté: People who identify as asexual represent about 1% of the population. These are individuals who are not attracted to having sexual relationships with someone. This does not prevent them from having a boyfriend, a girlfriend, masturbating, etc. It is sexual intercourse that does not interest them. These young people often say they have done it all. They have seen a lot of images, viewed sexuality as gymnastics with all the positions, tricks. They are jaded. Also, when you are faced with an image that provides a very strong and rapid stimulation, human relationships seem much more difficult because, obviously, you will never reproduce that sensation when you are with your partner with whom you must connect. The relationship is no longer emotional and shared. Yet, sexuality is emotional, relational, intellectual.

I think people go through phases. At a certain point, they feel asexual, but they can change their minds and think differently if they have real encounters, encounters that are increasingly difficult. Today, we are witnessing a loss of confidence. Young people, but also others, want to protect themselves from everything, especially from falling in love, not get back into a relationship because it is constraining. 

Question: Data show that young people are exposed to pornography at an increasingly early age. Is this a problem for their future sexuality?

Dr. Burté: The exposure to pornography at an early age, around 11 years old, has only been a reality for the past decade. It is too early to say how it will impact their sexuality. When examining the literature on this subject, some publications indicate that the consequences can be dramatic for children. Others show that children can distinguish between reality and fantasy.

Whenever I see young people in consultation, I ask them whether they feel pornography has helped or hindered them, whether it is the cause of the issue they are facing. I would say that, other than those who have viewed pornography under duress, which is of the order of violence, pornography does not seem to pose a problem. It can even provide certain knowledge. 

Question: What about sexual violence in children? What are the consequences?

Dr. Burté: In sexual medicine, this is one of the questions we ask systematically because it is very common. It is important to keep in mind that this not only affects girls; boys are also sexually abused. The consequences are dramatic in terms of psychosexual development. Each case is different. 

Question: At the other end of life, is it “normal” to have sexual disorders at a certain age? Should we resign ourselves?

Dr. Burté: When it comes to sexuality, people have many misconceptions and beliefs that are conveyed through media and the Internet. One of them is to believe that because we are aging, we cannot have a proper sexuality. Sexuality slows down with age, as all sensitivities decrease, but desire is something present throughout life. Yet, seniors are rarely questioned about their sexual health by the media.

Note that older people in institutions face an additional obstacle: lack of privacy. Is this normal? Sexuality releases endorphins, oxytocin, it is well-being that costs nothing. It is something that should be prescribed!

Question: Chronic diseases, disabilities with incidence increases with age — are they not inevitable obstacles to a fulfilling sexuality?

Dr. Burté: It is possible to have a sexual life regardless of the disease one has, cancer, diabetes, rheumatic disease — regardless of the disability. 

A collaboration with the National Cancer Institute on the preservation of sexual health after cancer in which I participated shows that people are extremely demanding of care and that this care is still very insufficient, unfortunately, even in the case of prostate cancer, for example, when it should be obvious.

Question: But aging itself brings challenges in terms of sexuality. 

Dr. Burté: Yes, in men, the consequences of low testosterone levels are well known. Therefore, we must stop thinking that men do not have their “menopause.” Men often have a testosterone deficiency after a certain age. This is very annoying because they have many symptoms that are truly unpleasant and yet can be corrected by completely reliable treatments.

Men are very misinformed on this subject. We talk about gender inequality, but in this area, a young woman who has her first period knows very well that one day she will go through menopause, but a boy has no idea that one day he will have hormone problems.

Question: Therefore, is it important to question men past the age of 50 years?

Dr. Burté: Yes. Faced with sexual symptoms or simply fatigue, or among those who are a bit depressed, investigating a testosterone deficiency should be part of the reflexes.

Also, if you ask a man in general, “How is it going from a sexual point of view,” and he answers that everything is going well, this means he has good arteries, good veins, a good nervous system, sufficient hormones, and psychologically, everything is going rather well. Conversely, erectile dysfunction can be one of the first symptoms of cardiovascular pathologies.

After a certain age, there is no test that provides as much information about people’s health as this question about sexual health.

Question: On their side, are women better cared for at menopause?

Dr. Burté: Yes, but women still lack explanations. I work in sexual medicine, and in my consultation, I see women who come simply to get information about menopause.

Women must know that menopause is a turning point in life because they will spend 30%-40% of their lives without hormones.

It is important to explain that indeed, after menopause, without treatment, it is not the same. There are genital and urinary, psychological, sexual, and skin consequences. It is important to provide true data on the influence of hormonal treatments. Today, hormone fear is not over. I think we need to rehabilitate treatments, care for women.

Question: So we must not forget men or women. 

Dr. Burté: Yes. It is also very important to adopt a perspective not only for the individual but also for the couple. If you treat a man with testosterone, after 3 months, he will be in great shape. However, if the couple has long been accustomed to having a limited sexual life, if the woman is not supported on her side, the couple will be unbalanced. The couple is concerned with managing the hormonal changes of both.

Question: Sexual medicine is essential, yet it seems inaccessible. 

Dr. Burté: There are very few specialists in sexual medicine because there is no legal provision for it. These consultations are lengthy but not valued. Who wants to work for that?

If there was reimbursement for sexual medicine consultations at age 15 years, at menopause, and for men around the age of 50 years, it would change mentalities. Sexual medicine must be integrated into medicine. It should also be noted that not all sexologists are physicians.

Some people are very well trained through universities, and others are not. Ideally, someone with a sexual disorder should first have a sexual medicine consultation to understand the situation. Then, the physician can refer the patient to a competent sexologist because we work in a network.

Dr. Burté has no conflicts of interest related to the subject. 

This story was translated from the Medscape French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. 

A version of this article appeared on Medscape.com.

From adolescence onward, the need for sexual health is particularly important. Yet, information and healthcare services are limited, which often leaves patients in distress and subject to misconceptions. What are the specific issues related to sexuality in adolescence, middle age, and beyond? This news organization interviewed Carol Burté, MD, a specialist in sexual medicine from Monaco.

Question: Regarding young individuals, what about sex education in schools?

Dr. Burté: The French law of 2018 specifies that at least three annual sessions must be devoted to sex education in elementary school, middle school, and high school.

In practice, this is not always the case, and interventions are very focused on prevention and rules. Sexuality is almost always absent from the program. Sexuality means: What does it mean to have desire? How does pleasure work? At what age do we have sex? etc. Young people receive prevention advice, but the link with sexuality is not made.

Sexuality remains taboo. You know, like in books: “They got married and had many children ...” End of the story, we don’t know more [laughs].

Question: And outside the school setting, do doctors sufficiently address sexual health issues with adolescents?

Dr. Burté: Rarely. I understand that a general practitioner has little time, but they can still ask the young person if they have any questions. They can refer them to someone or provide reading recommendations. Regarding sex education on the Internet, there are many well-made websites, such as the one by the national education system.

Also, it is important to give young people lifestyle advice to combat overweight, sedentary behavior, etc., by explaining to them that these factors can lead to sexual disorders later as well as infertility.

Another very important point: There is an inequality between boys and girls, but this time, to the disadvantage of boys. We have a sexual health consultation dedicated to young girls for the pill, but no one examines the boys. However, testicular cancer or undescended testicles can occur. I think we really need to change things and establish a clinical examination for boys in adolescence.

Question: More and more young people identify as asexual. What do you think of this?

Dr. Burté: People who identify as asexual represent about 1% of the population. These are individuals who are not attracted to having sexual relationships with someone. This does not prevent them from having a boyfriend, a girlfriend, masturbating, etc. It is sexual intercourse that does not interest them. These young people often say they have done it all. They have seen a lot of images, viewed sexuality as gymnastics with all the positions, tricks. They are jaded. Also, when you are faced with an image that provides a very strong and rapid stimulation, human relationships seem much more difficult because, obviously, you will never reproduce that sensation when you are with your partner with whom you must connect. The relationship is no longer emotional and shared. Yet, sexuality is emotional, relational, intellectual.

I think people go through phases. At a certain point, they feel asexual, but they can change their minds and think differently if they have real encounters, encounters that are increasingly difficult. Today, we are witnessing a loss of confidence. Young people, but also others, want to protect themselves from everything, especially from falling in love, not get back into a relationship because it is constraining. 

Question: Data show that young people are exposed to pornography at an increasingly early age. Is this a problem for their future sexuality?

Dr. Burté: The exposure to pornography at an early age, around 11 years old, has only been a reality for the past decade. It is too early to say how it will impact their sexuality. When examining the literature on this subject, some publications indicate that the consequences can be dramatic for children. Others show that children can distinguish between reality and fantasy.

Whenever I see young people in consultation, I ask them whether they feel pornography has helped or hindered them, whether it is the cause of the issue they are facing. I would say that, other than those who have viewed pornography under duress, which is of the order of violence, pornography does not seem to pose a problem. It can even provide certain knowledge. 

Question: What about sexual violence in children? What are the consequences?

Dr. Burté: In sexual medicine, this is one of the questions we ask systematically because it is very common. It is important to keep in mind that this not only affects girls; boys are also sexually abused. The consequences are dramatic in terms of psychosexual development. Each case is different. 

Question: At the other end of life, is it “normal” to have sexual disorders at a certain age? Should we resign ourselves?

Dr. Burté: When it comes to sexuality, people have many misconceptions and beliefs that are conveyed through media and the Internet. One of them is to believe that because we are aging, we cannot have a proper sexuality. Sexuality slows down with age, as all sensitivities decrease, but desire is something present throughout life. Yet, seniors are rarely questioned about their sexual health by the media.

Note that older people in institutions face an additional obstacle: lack of privacy. Is this normal? Sexuality releases endorphins, oxytocin, it is well-being that costs nothing. It is something that should be prescribed!

Question: Chronic diseases, disabilities with incidence increases with age — are they not inevitable obstacles to a fulfilling sexuality?

Dr. Burté: It is possible to have a sexual life regardless of the disease one has, cancer, diabetes, rheumatic disease — regardless of the disability. 

A collaboration with the National Cancer Institute on the preservation of sexual health after cancer in which I participated shows that people are extremely demanding of care and that this care is still very insufficient, unfortunately, even in the case of prostate cancer, for example, when it should be obvious.

Question: But aging itself brings challenges in terms of sexuality. 

Dr. Burté: Yes, in men, the consequences of low testosterone levels are well known. Therefore, we must stop thinking that men do not have their “menopause.” Men often have a testosterone deficiency after a certain age. This is very annoying because they have many symptoms that are truly unpleasant and yet can be corrected by completely reliable treatments.

Men are very misinformed on this subject. We talk about gender inequality, but in this area, a young woman who has her first period knows very well that one day she will go through menopause, but a boy has no idea that one day he will have hormone problems.

Question: Therefore, is it important to question men past the age of 50 years?

Dr. Burté: Yes. Faced with sexual symptoms or simply fatigue, or among those who are a bit depressed, investigating a testosterone deficiency should be part of the reflexes.

Also, if you ask a man in general, “How is it going from a sexual point of view,” and he answers that everything is going well, this means he has good arteries, good veins, a good nervous system, sufficient hormones, and psychologically, everything is going rather well. Conversely, erectile dysfunction can be one of the first symptoms of cardiovascular pathologies.

After a certain age, there is no test that provides as much information about people’s health as this question about sexual health.

Question: On their side, are women better cared for at menopause?

Dr. Burté: Yes, but women still lack explanations. I work in sexual medicine, and in my consultation, I see women who come simply to get information about menopause.

Women must know that menopause is a turning point in life because they will spend 30%-40% of their lives without hormones.

It is important to explain that indeed, after menopause, without treatment, it is not the same. There are genital and urinary, psychological, sexual, and skin consequences. It is important to provide true data on the influence of hormonal treatments. Today, hormone fear is not over. I think we need to rehabilitate treatments, care for women.

Question: So we must not forget men or women. 

Dr. Burté: Yes. It is also very important to adopt a perspective not only for the individual but also for the couple. If you treat a man with testosterone, after 3 months, he will be in great shape. However, if the couple has long been accustomed to having a limited sexual life, if the woman is not supported on her side, the couple will be unbalanced. The couple is concerned with managing the hormonal changes of both.

Question: Sexual medicine is essential, yet it seems inaccessible. 

Dr. Burté: There are very few specialists in sexual medicine because there is no legal provision for it. These consultations are lengthy but not valued. Who wants to work for that?

If there was reimbursement for sexual medicine consultations at age 15 years, at menopause, and for men around the age of 50 years, it would change mentalities. Sexual medicine must be integrated into medicine. It should also be noted that not all sexologists are physicians.

Some people are very well trained through universities, and others are not. Ideally, someone with a sexual disorder should first have a sexual medicine consultation to understand the situation. Then, the physician can refer the patient to a competent sexologist because we work in a network.

Dr. Burté has no conflicts of interest related to the subject. 

This story was translated from the Medscape French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab US) for adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

This marks the second indication for the bispecific CD20-directed CD3 T-cell engager. The agent was first approved in 2023 for relapsed or refractory diffuse large B-cell lymphoma in adults.

The current approval was based on the single-arm EPCORE NHL-1 trial in 127 patients with follicular lymphoma who had received at least two lines of systemic therapy.

After a two step-up dosing regimen, the overall response rate was 82%, with 60% of patients achieving a complete response. At a median follow-up of 14.8 months, the median duration of response was not reached. The 12-month duration of response was 68.4%.

Efficacy was similar in the 86 patients who received a three step-up dosing schedule.

Labeling carries a black box warning of cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome. Adverse events in 20% or more of patients included injection site reactions, cytokine release syndrome, COVID-19 infection, fatigue, upper respiratory tract infection, musculoskeletal pain, rash, diarrhea, pyrexia, cough, and headache.

Decreased lymphocyte count, neutrophil count, white blood cell count, and hemoglobin were the most common grade 3/4 laboratory abnormalities.

Three step-up dosing is the recommended regimen, with epcoritamab administered subcutaneously in 28-day cycles until disease progression or unacceptable toxicity. Dosing is increased by steps to the full 48 mg in cycle 1.

The price is $16,282.52 for 48 mg/0.8 mL, according to drugs.com.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab US) for adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

This marks the second indication for the bispecific CD20-directed CD3 T-cell engager. The agent was first approved in 2023 for relapsed or refractory diffuse large B-cell lymphoma in adults.

The current approval was based on the single-arm EPCORE NHL-1 trial in 127 patients with follicular lymphoma who had received at least two lines of systemic therapy.

After a two step-up dosing regimen, the overall response rate was 82%, with 60% of patients achieving a complete response. At a median follow-up of 14.8 months, the median duration of response was not reached. The 12-month duration of response was 68.4%.

Efficacy was similar in the 86 patients who received a three step-up dosing schedule.

Labeling carries a black box warning of cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome. Adverse events in 20% or more of patients included injection site reactions, cytokine release syndrome, COVID-19 infection, fatigue, upper respiratory tract infection, musculoskeletal pain, rash, diarrhea, pyrexia, cough, and headache.

Decreased lymphocyte count, neutrophil count, white blood cell count, and hemoglobin were the most common grade 3/4 laboratory abnormalities.

Three step-up dosing is the recommended regimen, with epcoritamab administered subcutaneously in 28-day cycles until disease progression or unacceptable toxicity. Dosing is increased by steps to the full 48 mg in cycle 1.

The price is $16,282.52 for 48 mg/0.8 mL, according to drugs.com.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab US) for adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

This marks the second indication for the bispecific CD20-directed CD3 T-cell engager. The agent was first approved in 2023 for relapsed or refractory diffuse large B-cell lymphoma in adults.

The current approval was based on the single-arm EPCORE NHL-1 trial in 127 patients with follicular lymphoma who had received at least two lines of systemic therapy.

After a two step-up dosing regimen, the overall response rate was 82%, with 60% of patients achieving a complete response. At a median follow-up of 14.8 months, the median duration of response was not reached. The 12-month duration of response was 68.4%.

Efficacy was similar in the 86 patients who received a three step-up dosing schedule.

Labeling carries a black box warning of cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome. Adverse events in 20% or more of patients included injection site reactions, cytokine release syndrome, COVID-19 infection, fatigue, upper respiratory tract infection, musculoskeletal pain, rash, diarrhea, pyrexia, cough, and headache.

Decreased lymphocyte count, neutrophil count, white blood cell count, and hemoglobin were the most common grade 3/4 laboratory abnormalities.

Three step-up dosing is the recommended regimen, with epcoritamab administered subcutaneously in 28-day cycles until disease progression or unacceptable toxicity. Dosing is increased by steps to the full 48 mg in cycle 1.

The price is $16,282.52 for 48 mg/0.8 mL, according to drugs.com.

A version of this article appeared on Medscape.com.

A few years ago, Kim Lori Sandler, MD, realized many patients newly diagnosed with lung cancer had never been screened for the disease — they received CT scans only because they were symptomatic.

But Dr. Sandler, a radiologist at Vanderbilt University Medical Center in Nashville, Tennessee, could see in medical charts that most of these patients had been eligible for a screening before becoming symptomatic. And for women, most had received decades worth of mammograms. She saw an opportunity and launched a study to find out if an intervention would work.

Low-dose CT and mammography services often are available in the same imaging facility, so women who qualified for a lung cancer screening were offered the scan during their mammography visit. Over a 3-year period, monthly rates of lung scans in women rose by 50% at one facility and 36% at the other.

“What we found is that women are really receptive, if you talk to them about it,” Dr. Sandler said. “I don’t think that lung cancer is thought of as a disease in women.”

Although lung cancer is the leading cause of cancer deaths in the United States, a recent study in JAMA Internal Medicine found only 18% of eligible patients were screened in 2022, a far cry from the rates of 72% for colon cancer — which itself falls short of goals from US medical groups like the American Cancer Society (ACS). Among those eligible, rates of lung screenings were lowest among younger people without comorbid conditions, who did not have health insurance or a usual source of care, and those living in southern states and states that did not expand Medicaid as part of the Affordable Care Act.

But researchers and clinicians, from those working in an urban health center for the homeless to clinics in the poorest counties in the tobacco belt, have used strategies to raise their rates of screening for lung cancer.

Getting patients screened is lifesaving: 27% of people with lung cancer survive 5 years after diagnosis. But the survival rate rises to 63% when cases are diagnosed at an early stage.
 

Increasing Uptake

The formal recommendation to use low-dose chest CT to screen for lung cancer is only a decade old. The approach was first endorsed by the United States Preventive Services Task Force (USPSTF) on the basis of an influential trial that found such testing was linked to a 20% reduction in mortality from the disease. Updated 2021 USPSTF guidelines call for annual screening of people aged 50-80 years who have a 20 pack-year history of smoking and currently smoke or have quit within the past 15 years.

But implementing the recommendation is not always simple. Unlike a colorectal or breast cancer screening, which is recommended primarily on patient age, eligibility for a lung cancer screening requires calculating pack-years of smoking, and, for past smokers, knowledge of when they quit.

The structured fields in most electronic medical records (EMRs) inquire about current or past use of cigarettes and the number of daily packs smoked. But few EMRs can calculate when a patient starts smoking two cigarettes a day but then increases to a pack a day and cuts down again. EMRs also do not track when a patient has stopped smoking permanently. Individual clinicians or health systems must identify patients who are eligible for screening, but the lack of automated calculations makes that job more difficult.

Dr. Sandler and colleagues turned to the informatics team at Vanderbilt to develop a natural language processing approach that extracts smoking data directly from clinician notes instead of using standard variables in their EMR.

The number of patients identified as needing a screening using the algorithm nearly doubled from baseline, from 5887 to 10,231 over a 3-year period, according to results from another study that Dr. Sandler published.

Although the algorithm may occasionally flag someone who does not need screening as eligible, “you can always have a conversation with the patient to determine if they actually meet eligibility criteria,” Dr. Sandler said.
 

Patient Navigators to the Rescue?

About a decade ago, Travis Baggett, MD, MPH, an associate professor of internal medicine at Harvard Medical School, Boston, Massachusetts, received pilot funding from the ACS to study cancer epidemiology among patients at Boston Health Care for the Homeless Program (BHCHP), which serves nearly 10,000 patients at a variety of Boston-area clinics each year.

“We found that both the incidence and mortality rates for lung cancer were more than twofold higher than in the general population,” Dr. Baggett, who is also the director of research at BHCHP, said.

He also discovered that BHCHP patients were diagnosed at significantly later stages than people in the general population for malignancies like breast and colorectal cancer.

Screening for lung cancer was a new recommendation at the time. With additional funding from the ACS, he launched a clinical trial in 2020 that randomized patients who were eligible for lung cancer screening to either work with a patient navigator or receive usual care.

The navigators eased the burden on primary care clinicians: They facilitated shared decision-making visits, helped participants make and attend appointments for low-dose CT, assisted with transportation, and arranged follow-up as needed.

The 3-year study found 43% of patients who received navigation services underwent screening for lung cancer, compared with 9% in the usual-care arm. Participants said the navigators played a critical role in educating them about the importance of screening, coordinating care, and providing emotional support.

“At the root of it all, it was quite clear that one thing that made the navigator successful was their interpersonal qualities and having someone that the patient could trust to help guide them through the process,” Dr. Baggett said.

The navigator program, however, stopped when the funding for the study ended.

But another health system has implemented navigators in a sustainable way through a quality improvement project. Michael Gieske, MD, director of lung cancer screening at St. Elizabeth Healthcare in Edgewood, Kentucky, starts his Friday morning meeting with a multidisciplinary group, including a thoracic surgeon, radiologist, pulmonologist, and several screening nurse navigators. They review the week’s chest CTs, with approximately one-third from patients who underwent lung cancer screening.

Nurse navigators at St. Elizabeth Healthcare follow up with any patient whose scan is suspicious for lung cancer and guide them through the process of seeing specialists and obtaining additional testing.

“They essentially hold the patient’s hand through this scary time in their life and make sure that everything flows smoothly and efficiently,” said Dr. Gieske, a family medicine physician.

St. Elizabeth’s program also draws on several evidence-based strategies used for other cancer screening programs, such as patient and provider education and quarterly feedback to their 194 primary care clinicians on rates of lung cancer screening among their eligible patients.

Several requirements for reimbursement for a lung cancer screening from the US Centers for Medicare & Medicaid Services can also serve as barriers to getting patients screened: Clinicians must identify who is eligible, provide tobacco cessation counseling, and document the shared decision-making process.

To streamline the steps, St. Elizabeth’s clinicians use an EMR smart set that reminds clinicians to verify smoking history and helps them document the required counseling.

Last year, 47% of eligible patients received their recommended screening, and Dr. Gieske said he expects even more improvement.

“We’re on track this year to complete 60% uptake if things continue,” he said, adding that 76% of the new cases of lung cancer are now diagnosed in stage I, with only 5% diagnosed in stage IV.

Dr. Gieske has shared his experience with many clinics in Appalachia, home to some of the highest rates of mortality from lung cancer in the country. A major part of his role with the Appalachian Community Cancer Alliance is helping educate primary care clinicians in the region about the importance of early detection of lung cancer.

“I think one of the most important things is just to convey a message of hope,” he said. “We’re trying to get the good word out there that if you screen individuals, you’re going to catch it early, when you have an extremely high chance of curing the lung cancer.”

Dr. Baggett reported support from grants from the ACS and the Massachusetts General Hospital Research Scholars Program. Dr. Sandler and Dr. Gieske reported no financial conflicts.

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

A few years ago, Kim Lori Sandler, MD, realized many patients newly diagnosed with lung cancer had never been screened for the disease — they received CT scans only because they were symptomatic.

But Dr. Sandler, a radiologist at Vanderbilt University Medical Center in Nashville, Tennessee, could see in medical charts that most of these patients had been eligible for a screening before becoming symptomatic. And for women, most had received decades worth of mammograms. She saw an opportunity and launched a study to find out if an intervention would work.

Low-dose CT and mammography services often are available in the same imaging facility, so women who qualified for a lung cancer screening were offered the scan during their mammography visit. Over a 3-year period, monthly rates of lung scans in women rose by 50% at one facility and 36% at the other.

“What we found is that women are really receptive, if you talk to them about it,” Dr. Sandler said. “I don’t think that lung cancer is thought of as a disease in women.”

Although lung cancer is the leading cause of cancer deaths in the United States, a recent study in JAMA Internal Medicine found only 18% of eligible patients were screened in 2022, a far cry from the rates of 72% for colon cancer — which itself falls short of goals from US medical groups like the American Cancer Society (ACS). Among those eligible, rates of lung screenings were lowest among younger people without comorbid conditions, who did not have health insurance or a usual source of care, and those living in southern states and states that did not expand Medicaid as part of the Affordable Care Act.

But researchers and clinicians, from those working in an urban health center for the homeless to clinics in the poorest counties in the tobacco belt, have used strategies to raise their rates of screening for lung cancer.

Getting patients screened is lifesaving: 27% of people with lung cancer survive 5 years after diagnosis. But the survival rate rises to 63% when cases are diagnosed at an early stage.
 

Increasing Uptake

The formal recommendation to use low-dose chest CT to screen for lung cancer is only a decade old. The approach was first endorsed by the United States Preventive Services Task Force (USPSTF) on the basis of an influential trial that found such testing was linked to a 20% reduction in mortality from the disease. Updated 2021 USPSTF guidelines call for annual screening of people aged 50-80 years who have a 20 pack-year history of smoking and currently smoke or have quit within the past 15 years.

But implementing the recommendation is not always simple. Unlike a colorectal or breast cancer screening, which is recommended primarily on patient age, eligibility for a lung cancer screening requires calculating pack-years of smoking, and, for past smokers, knowledge of when they quit.

The structured fields in most electronic medical records (EMRs) inquire about current or past use of cigarettes and the number of daily packs smoked. But few EMRs can calculate when a patient starts smoking two cigarettes a day but then increases to a pack a day and cuts down again. EMRs also do not track when a patient has stopped smoking permanently. Individual clinicians or health systems must identify patients who are eligible for screening, but the lack of automated calculations makes that job more difficult.

Dr. Sandler and colleagues turned to the informatics team at Vanderbilt to develop a natural language processing approach that extracts smoking data directly from clinician notes instead of using standard variables in their EMR.

The number of patients identified as needing a screening using the algorithm nearly doubled from baseline, from 5887 to 10,231 over a 3-year period, according to results from another study that Dr. Sandler published.

Although the algorithm may occasionally flag someone who does not need screening as eligible, “you can always have a conversation with the patient to determine if they actually meet eligibility criteria,” Dr. Sandler said.
 

Patient Navigators to the Rescue?

About a decade ago, Travis Baggett, MD, MPH, an associate professor of internal medicine at Harvard Medical School, Boston, Massachusetts, received pilot funding from the ACS to study cancer epidemiology among patients at Boston Health Care for the Homeless Program (BHCHP), which serves nearly 10,000 patients at a variety of Boston-area clinics each year.

“We found that both the incidence and mortality rates for lung cancer were more than twofold higher than in the general population,” Dr. Baggett, who is also the director of research at BHCHP, said.

He also discovered that BHCHP patients were diagnosed at significantly later stages than people in the general population for malignancies like breast and colorectal cancer.

Screening for lung cancer was a new recommendation at the time. With additional funding from the ACS, he launched a clinical trial in 2020 that randomized patients who were eligible for lung cancer screening to either work with a patient navigator or receive usual care.

The navigators eased the burden on primary care clinicians: They facilitated shared decision-making visits, helped participants make and attend appointments for low-dose CT, assisted with transportation, and arranged follow-up as needed.

The 3-year study found 43% of patients who received navigation services underwent screening for lung cancer, compared with 9% in the usual-care arm. Participants said the navigators played a critical role in educating them about the importance of screening, coordinating care, and providing emotional support.

“At the root of it all, it was quite clear that one thing that made the navigator successful was their interpersonal qualities and having someone that the patient could trust to help guide them through the process,” Dr. Baggett said.

The navigator program, however, stopped when the funding for the study ended.

But another health system has implemented navigators in a sustainable way through a quality improvement project. Michael Gieske, MD, director of lung cancer screening at St. Elizabeth Healthcare in Edgewood, Kentucky, starts his Friday morning meeting with a multidisciplinary group, including a thoracic surgeon, radiologist, pulmonologist, and several screening nurse navigators. They review the week’s chest CTs, with approximately one-third from patients who underwent lung cancer screening.

Nurse navigators at St. Elizabeth Healthcare follow up with any patient whose scan is suspicious for lung cancer and guide them through the process of seeing specialists and obtaining additional testing.

“They essentially hold the patient’s hand through this scary time in their life and make sure that everything flows smoothly and efficiently,” said Dr. Gieske, a family medicine physician.

St. Elizabeth’s program also draws on several evidence-based strategies used for other cancer screening programs, such as patient and provider education and quarterly feedback to their 194 primary care clinicians on rates of lung cancer screening among their eligible patients.

Several requirements for reimbursement for a lung cancer screening from the US Centers for Medicare & Medicaid Services can also serve as barriers to getting patients screened: Clinicians must identify who is eligible, provide tobacco cessation counseling, and document the shared decision-making process.

To streamline the steps, St. Elizabeth’s clinicians use an EMR smart set that reminds clinicians to verify smoking history and helps them document the required counseling.

Last year, 47% of eligible patients received their recommended screening, and Dr. Gieske said he expects even more improvement.

“We’re on track this year to complete 60% uptake if things continue,” he said, adding that 76% of the new cases of lung cancer are now diagnosed in stage I, with only 5% diagnosed in stage IV.

Dr. Gieske has shared his experience with many clinics in Appalachia, home to some of the highest rates of mortality from lung cancer in the country. A major part of his role with the Appalachian Community Cancer Alliance is helping educate primary care clinicians in the region about the importance of early detection of lung cancer.

“I think one of the most important things is just to convey a message of hope,” he said. “We’re trying to get the good word out there that if you screen individuals, you’re going to catch it early, when you have an extremely high chance of curing the lung cancer.”

Dr. Baggett reported support from grants from the ACS and the Massachusetts General Hospital Research Scholars Program. Dr. Sandler and Dr. Gieske reported no financial conflicts.

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

A few years ago, Kim Lori Sandler, MD, realized many patients newly diagnosed with lung cancer had never been screened for the disease — they received CT scans only because they were symptomatic.

But Dr. Sandler, a radiologist at Vanderbilt University Medical Center in Nashville, Tennessee, could see in medical charts that most of these patients had been eligible for a screening before becoming symptomatic. And for women, most had received decades worth of mammograms. She saw an opportunity and launched a study to find out if an intervention would work.

Low-dose CT and mammography services often are available in the same imaging facility, so women who qualified for a lung cancer screening were offered the scan during their mammography visit. Over a 3-year period, monthly rates of lung scans in women rose by 50% at one facility and 36% at the other.

“What we found is that women are really receptive, if you talk to them about it,” Dr. Sandler said. “I don’t think that lung cancer is thought of as a disease in women.”

Although lung cancer is the leading cause of cancer deaths in the United States, a recent study in JAMA Internal Medicine found only 18% of eligible patients were screened in 2022, a far cry from the rates of 72% for colon cancer — which itself falls short of goals from US medical groups like the American Cancer Society (ACS). Among those eligible, rates of lung screenings were lowest among younger people without comorbid conditions, who did not have health insurance or a usual source of care, and those living in southern states and states that did not expand Medicaid as part of the Affordable Care Act.

But researchers and clinicians, from those working in an urban health center for the homeless to clinics in the poorest counties in the tobacco belt, have used strategies to raise their rates of screening for lung cancer.

Getting patients screened is lifesaving: 27% of people with lung cancer survive 5 years after diagnosis. But the survival rate rises to 63% when cases are diagnosed at an early stage.
 

Increasing Uptake

The formal recommendation to use low-dose chest CT to screen for lung cancer is only a decade old. The approach was first endorsed by the United States Preventive Services Task Force (USPSTF) on the basis of an influential trial that found such testing was linked to a 20% reduction in mortality from the disease. Updated 2021 USPSTF guidelines call for annual screening of people aged 50-80 years who have a 20 pack-year history of smoking and currently smoke or have quit within the past 15 years.

But implementing the recommendation is not always simple. Unlike a colorectal or breast cancer screening, which is recommended primarily on patient age, eligibility for a lung cancer screening requires calculating pack-years of smoking, and, for past smokers, knowledge of when they quit.

The structured fields in most electronic medical records (EMRs) inquire about current or past use of cigarettes and the number of daily packs smoked. But few EMRs can calculate when a patient starts smoking two cigarettes a day but then increases to a pack a day and cuts down again. EMRs also do not track when a patient has stopped smoking permanently. Individual clinicians or health systems must identify patients who are eligible for screening, but the lack of automated calculations makes that job more difficult.

Dr. Sandler and colleagues turned to the informatics team at Vanderbilt to develop a natural language processing approach that extracts smoking data directly from clinician notes instead of using standard variables in their EMR.

The number of patients identified as needing a screening using the algorithm nearly doubled from baseline, from 5887 to 10,231 over a 3-year period, according to results from another study that Dr. Sandler published.

Although the algorithm may occasionally flag someone who does not need screening as eligible, “you can always have a conversation with the patient to determine if they actually meet eligibility criteria,” Dr. Sandler said.
 

Patient Navigators to the Rescue?

About a decade ago, Travis Baggett, MD, MPH, an associate professor of internal medicine at Harvard Medical School, Boston, Massachusetts, received pilot funding from the ACS to study cancer epidemiology among patients at Boston Health Care for the Homeless Program (BHCHP), which serves nearly 10,000 patients at a variety of Boston-area clinics each year.

“We found that both the incidence and mortality rates for lung cancer were more than twofold higher than in the general population,” Dr. Baggett, who is also the director of research at BHCHP, said.

He also discovered that BHCHP patients were diagnosed at significantly later stages than people in the general population for malignancies like breast and colorectal cancer.

Screening for lung cancer was a new recommendation at the time. With additional funding from the ACS, he launched a clinical trial in 2020 that randomized patients who were eligible for lung cancer screening to either work with a patient navigator or receive usual care.

The navigators eased the burden on primary care clinicians: They facilitated shared decision-making visits, helped participants make and attend appointments for low-dose CT, assisted with transportation, and arranged follow-up as needed.

The 3-year study found 43% of patients who received navigation services underwent screening for lung cancer, compared with 9% in the usual-care arm. Participants said the navigators played a critical role in educating them about the importance of screening, coordinating care, and providing emotional support.

“At the root of it all, it was quite clear that one thing that made the navigator successful was their interpersonal qualities and having someone that the patient could trust to help guide them through the process,” Dr. Baggett said.

The navigator program, however, stopped when the funding for the study ended.

But another health system has implemented navigators in a sustainable way through a quality improvement project. Michael Gieske, MD, director of lung cancer screening at St. Elizabeth Healthcare in Edgewood, Kentucky, starts his Friday morning meeting with a multidisciplinary group, including a thoracic surgeon, radiologist, pulmonologist, and several screening nurse navigators. They review the week’s chest CTs, with approximately one-third from patients who underwent lung cancer screening.

Nurse navigators at St. Elizabeth Healthcare follow up with any patient whose scan is suspicious for lung cancer and guide them through the process of seeing specialists and obtaining additional testing.

“They essentially hold the patient’s hand through this scary time in their life and make sure that everything flows smoothly and efficiently,” said Dr. Gieske, a family medicine physician.

St. Elizabeth’s program also draws on several evidence-based strategies used for other cancer screening programs, such as patient and provider education and quarterly feedback to their 194 primary care clinicians on rates of lung cancer screening among their eligible patients.

Several requirements for reimbursement for a lung cancer screening from the US Centers for Medicare & Medicaid Services can also serve as barriers to getting patients screened: Clinicians must identify who is eligible, provide tobacco cessation counseling, and document the shared decision-making process.

To streamline the steps, St. Elizabeth’s clinicians use an EMR smart set that reminds clinicians to verify smoking history and helps them document the required counseling.

Last year, 47% of eligible patients received their recommended screening, and Dr. Gieske said he expects even more improvement.

“We’re on track this year to complete 60% uptake if things continue,” he said, adding that 76% of the new cases of lung cancer are now diagnosed in stage I, with only 5% diagnosed in stage IV.

Dr. Gieske has shared his experience with many clinics in Appalachia, home to some of the highest rates of mortality from lung cancer in the country. A major part of his role with the Appalachian Community Cancer Alliance is helping educate primary care clinicians in the region about the importance of early detection of lung cancer.

“I think one of the most important things is just to convey a message of hope,” he said. “We’re trying to get the good word out there that if you screen individuals, you’re going to catch it early, when you have an extremely high chance of curing the lung cancer.”

Dr. Baggett reported support from grants from the ACS and the Massachusetts General Hospital Research Scholars Program. Dr. Sandler and Dr. Gieske reported no financial conflicts.

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