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FDA OKs First-Line Lazertinib With Amivantamab for NSCLC
This marks the first approval for lazertinib. Amivantamab was initially approved by the FDA in 2021 and carries a few indications for locally advanced or metastatic NSCLC. Both drugs are manufactured by Janssen Biotech Inc.
“Patients will now have the option of a potential new first-line standard of care with significant clinical benefits over osimertinib,” study investigator Alexander Spira, MD, PhD, director, Virginia Cancer Specialists Research Institute, said in a news release from Johnson & Johnson .
Lazertinib is an oral, highly selective, third-generation EGFR tyrosine kinase inhibitor that can penetrate the brain and amivantamab is a bispecific antibody targeting EGFR and MET.
The approval was based on results from the phase 3 MARIPOSA trial, which showed that the combination reduced the risk of disease progression or death by 30% compared with osimertinib.
The MARIPOSA trial randomly allocated 1074 patients with exon 19 deletion or exon 21 L858R substitution mutation-positive locally advanced or metastatic NSCLC and no prior systemic therapy for advanced disease to amivantamab plus lazertinib, osimertinib alone, or lazertinib alone.
Lazertinib plus amivantamab demonstrated a statistically significant improvement in progression-free survival compared with osimertinib (hazard ratio, 0.70; P < .001). Median progression-free survival was 23.7 months with the combination vs 16.6 months osimertinib alone and 18.5 months with lazertinib alone.
The median duration of response was 9 months longer with the combination compared with osimertinib (25.8 months vs 16.7 months).
The most common adverse reactions (≥ 20%) were rash, nail toxicity, infusion-related reactions (amivantamab), musculoskeletal pain, edema, stomatitis, venous thromboembolism, paresthesia, fatigue, diarrhea, constipation, COVID-19, hemorrhage, dry skin, decreased appetite, pruritus, nausea, and ocular toxicity.
“A serious safety signal of venous thromboembolic events was observed with lazertinib in combination with amivantamab and prophylactic anticoagulation should be administered for the first four months of therapy,” the FDA noted in a statement announcing the approval.
Results from MARIPOSA were first presented at the European Society for Medical Oncology 2023 Congress and published in The New England Journal of Medicine in June. Longer-term follow-up data from MARIPOSA will be presented at the International Association for the Study of Lung Cancer 2024 World Congress on Lung Cancer in September.
A version of this article appeared on Medscape.com.
This marks the first approval for lazertinib. Amivantamab was initially approved by the FDA in 2021 and carries a few indications for locally advanced or metastatic NSCLC. Both drugs are manufactured by Janssen Biotech Inc.
“Patients will now have the option of a potential new first-line standard of care with significant clinical benefits over osimertinib,” study investigator Alexander Spira, MD, PhD, director, Virginia Cancer Specialists Research Institute, said in a news release from Johnson & Johnson .
Lazertinib is an oral, highly selective, third-generation EGFR tyrosine kinase inhibitor that can penetrate the brain and amivantamab is a bispecific antibody targeting EGFR and MET.
The approval was based on results from the phase 3 MARIPOSA trial, which showed that the combination reduced the risk of disease progression or death by 30% compared with osimertinib.
The MARIPOSA trial randomly allocated 1074 patients with exon 19 deletion or exon 21 L858R substitution mutation-positive locally advanced or metastatic NSCLC and no prior systemic therapy for advanced disease to amivantamab plus lazertinib, osimertinib alone, or lazertinib alone.
Lazertinib plus amivantamab demonstrated a statistically significant improvement in progression-free survival compared with osimertinib (hazard ratio, 0.70; P < .001). Median progression-free survival was 23.7 months with the combination vs 16.6 months osimertinib alone and 18.5 months with lazertinib alone.
The median duration of response was 9 months longer with the combination compared with osimertinib (25.8 months vs 16.7 months).
The most common adverse reactions (≥ 20%) were rash, nail toxicity, infusion-related reactions (amivantamab), musculoskeletal pain, edema, stomatitis, venous thromboembolism, paresthesia, fatigue, diarrhea, constipation, COVID-19, hemorrhage, dry skin, decreased appetite, pruritus, nausea, and ocular toxicity.
“A serious safety signal of venous thromboembolic events was observed with lazertinib in combination with amivantamab and prophylactic anticoagulation should be administered for the first four months of therapy,” the FDA noted in a statement announcing the approval.
Results from MARIPOSA were first presented at the European Society for Medical Oncology 2023 Congress and published in The New England Journal of Medicine in June. Longer-term follow-up data from MARIPOSA will be presented at the International Association for the Study of Lung Cancer 2024 World Congress on Lung Cancer in September.
A version of this article appeared on Medscape.com.
This marks the first approval for lazertinib. Amivantamab was initially approved by the FDA in 2021 and carries a few indications for locally advanced or metastatic NSCLC. Both drugs are manufactured by Janssen Biotech Inc.
“Patients will now have the option of a potential new first-line standard of care with significant clinical benefits over osimertinib,” study investigator Alexander Spira, MD, PhD, director, Virginia Cancer Specialists Research Institute, said in a news release from Johnson & Johnson .
Lazertinib is an oral, highly selective, third-generation EGFR tyrosine kinase inhibitor that can penetrate the brain and amivantamab is a bispecific antibody targeting EGFR and MET.
The approval was based on results from the phase 3 MARIPOSA trial, which showed that the combination reduced the risk of disease progression or death by 30% compared with osimertinib.
The MARIPOSA trial randomly allocated 1074 patients with exon 19 deletion or exon 21 L858R substitution mutation-positive locally advanced or metastatic NSCLC and no prior systemic therapy for advanced disease to amivantamab plus lazertinib, osimertinib alone, or lazertinib alone.
Lazertinib plus amivantamab demonstrated a statistically significant improvement in progression-free survival compared with osimertinib (hazard ratio, 0.70; P < .001). Median progression-free survival was 23.7 months with the combination vs 16.6 months osimertinib alone and 18.5 months with lazertinib alone.
The median duration of response was 9 months longer with the combination compared with osimertinib (25.8 months vs 16.7 months).
The most common adverse reactions (≥ 20%) were rash, nail toxicity, infusion-related reactions (amivantamab), musculoskeletal pain, edema, stomatitis, venous thromboembolism, paresthesia, fatigue, diarrhea, constipation, COVID-19, hemorrhage, dry skin, decreased appetite, pruritus, nausea, and ocular toxicity.
“A serious safety signal of venous thromboembolic events was observed with lazertinib in combination with amivantamab and prophylactic anticoagulation should be administered for the first four months of therapy,” the FDA noted in a statement announcing the approval.
Results from MARIPOSA were first presented at the European Society for Medical Oncology 2023 Congress and published in The New England Journal of Medicine in June. Longer-term follow-up data from MARIPOSA will be presented at the International Association for the Study of Lung Cancer 2024 World Congress on Lung Cancer in September.
A version of this article appeared on Medscape.com.
‘Gift That Keeps Giving’: The Impact of GLP-1 in Asthma
This transcript has been edited for clarity.
Akshay B. Jain, MD: Welcome back to Medscape at ADA 2024, where Dr. James Kim, primary care physician from Calgary, Alberta, will be joining me in deciphering the key highlights at the ADA conference and bringing our own clinical twist into what the relevance would be for people like you and I to take back to our clinics.
Welcome back, Dr. Kim.
James Kim, MBBCh, PgDip, MScCH: Thank you very much. It’s nice to be back.
Dr. Jain: This was a diabetes conference, so obviously we are very pancreas focused. At this conference, we went outside our general area of territory, going outside of the pancreas and delving into other organ states. What I found fascinating were some data regarding the effects of incretin therapy on the lung, and in particular, some of the restrictive lung disorders.
Dr. Kim, you attended these sessions as well. Can you tell us a little bit more about the results that were discussed?
Dr. Kim: This is an interesting field. The moderator of the session went up and said that there has been no time in any previous ADA sessions where the lung issue was actually discussed. This was the first time ever.
They had some of the world leaders in this field, so it was really awesome to see them. Just to paint a picture of these obese asthmatic patients, they are challenging cases because, as you know, the main therapy for any asthmatic patient is inhaled corticosteroid.
Patients who are obese have quite a bit of a steroid resistance. Therefore, they end up being on many medications that sometimes are off label, and many end up on biologics as well. Therefore, the respiratory world has been seeking therapies for these obese asthmatic patients who are likely to be steroid resistant because these people are also likely to end up on an oral steroid as well.
Dr. Jain, you know the effect of the steroids much better than I do, and it’s like a laundry list. We really don’t want our patients to be on oral steroids.
In the past few years, GLP-1 has been studied quite extensively in the lung, especially in the world of asthma, and also in COPD. What’s really fascinating is that the GLP-1 receptors have been found to be quite abundant in the airway. Some studies show that the highest concentration of GLP-1 lies in the airway, whereas some studies have said that it’s the third most common area to find the GLP-1.
It is not a surprise that GLP-1 is being studied in managing the airway, especially airway inflammation in asthma and COPD patients. The preliminary data have been quite encouraging. They also discussed that there are new medications coming out that seem to be incretin based, so we’ll wait to see what those studies show.
There are two current phase 3 trials being held at the moment. One is using semaglutide 2.4 mg subcutaneous and another one is using metformin to reduce the airway inflammation in these asthmatic patients and also in some COPD patients. We’ll look forward to these results.
Dr. Jain: That’s really important to note because we see that there is a high density of these receptors in the airways, and hitherto we had no idea about the overall effect. Now, we’re looking at, as you mentioned, individuals with obesity who have asthma, so there are both the restrictive and obstructive components in the lung coming into play here.
From an endocrinology perspective, I’m thinking that this could be multiple effects of the GLP-1 receptor agonists, where on one hand you’re managing the obesity and you’re working along that line, and on the other hand, it could have local anti-inflammatory effects in the lung. Hence, there could be potential improvement in the overall pulmonary function of these individuals.
Dr. Kim: We are seeing this in primary care. Ever since I found out this information, I have started numerous patients, who are obese, asthmatic patients who do not have diabetes, on GLP-1 therapies, and their pulmonary function tests have improved significantly.
As a matter of fact, one of my personal friends is a severe asthmatic patient. She ends up being on oral steroids about three times a year. There was even one day when I saw her in one of my classes and she was dyspneic. She was short of breath.
I introduced her to one of my colleagues who’s a respirologist and very much into the impact of the incretins and asthma, and she was started on a GLP-1 receptor agonist. She lost about 30 pounds of weight, but now she is labeled as a mild asthmatic. Her pulmonary function test is completely normal. She hasn’t touched an oral steroid for a couple of years now.
That is a huge success story and I’m seeing that even in my own clinic as well. It’s a huge win for the respiratory world.
Dr. Jain: I think from an endocrinology perspective as well, if we are initiating GLP-1 receptor agonists or medications in that class, where we use it for management of obesity, sooner or later we do hit a stage where people will plateau with their weight loss. They won’t have any additional weight loss.
We tell individuals at that time that the fact that they’re able to maintain the weight loss still means that the medication is working from the obesity perspective. For individuals who also have asthma, it would be a good point to tell them that it could still have potential effects on reducing inflammation ongoing. Hence, even though they may not be losing any additional weight, it would still be helpful to continue on these medications from a pulmonary perspective.
Dr. Kim: Right now these pleiotropic effects of GLP-1 agents are absolutely mind-blowing. I mentioned in one of my respiratory presentations to a bunch of respirologists that diabetes is taking over the world, including the respiratory world. Well, you can imagine what their faces were like. However, they were quite impressed at that, and they were very excited with what these two phase 3 trials will show.
Dr. Jain: I think, based on the ADA 2024 conference, GLP-1 receptor agonists continue to be the gift that keeps giving. We have the effects on diabetes, obesity, kidney function, liver protection, lungs, and Alzheimer’s. We saw some sessions about potential use in people with alcohol misuse disorder or gambling problems. Clearly, there’s a large amount of research that›s being done with these agents.
Perhaps when you and I talk about ADA 2025, we might be able to talk about some more pleiotropic benefits outside the pancreas. Until then, please do check out our other videos from ADA 2024. Thanks for joining us again, Dr. Kim.
Dr. Kim: Thank you very much for having me.
Dr. Jain, clinical instructor, Department of Endocrinology, University of British Columbia, and endocrinologist, TLC Diabetes and Endocrinology, Vancouver, British Columbia, Canada, has disclosed ties with Abbott, Acerus, AstraZeneca, Amgen, Bausch Healthcare, Bayer, Boehringer Ingelheim, Care to Know, CCRN, Connected in Motion, CPD Network, Dexcom, Diabetes Canada, Eli Lilly, GSK, HLS Therapeutics, Janssen, Master Clinician Alliance, MDBriefcase, Merck, Medtronic, Moderna, Novartis, Novo Nordisk, Partners in Progressive Medical Education, Pfizer, Sanofi Aventis, Timed Right, WebMD, Gilead Sciences, Insulet, PocketPills, Roche, and Takeda. Dr. Kim, clinical assistant professor, Department of Family Medicine, University of Calgary, Alberta, has disclosed ties with Abbott, AbbVie, AstraZeneca, Bayer, Boehringer Ingelheim, Eisai, Embecta, Eli Lilly, GSK, Janssen, Linpharma, Novo Nordisk, Miravo, Otsuka, Pfizer, Teva, Takeda, and Sanofi, and Partners in Progressive Medical Education.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Akshay B. Jain, MD: Welcome back to Medscape at ADA 2024, where Dr. James Kim, primary care physician from Calgary, Alberta, will be joining me in deciphering the key highlights at the ADA conference and bringing our own clinical twist into what the relevance would be for people like you and I to take back to our clinics.
Welcome back, Dr. Kim.
James Kim, MBBCh, PgDip, MScCH: Thank you very much. It’s nice to be back.
Dr. Jain: This was a diabetes conference, so obviously we are very pancreas focused. At this conference, we went outside our general area of territory, going outside of the pancreas and delving into other organ states. What I found fascinating were some data regarding the effects of incretin therapy on the lung, and in particular, some of the restrictive lung disorders.
Dr. Kim, you attended these sessions as well. Can you tell us a little bit more about the results that were discussed?
Dr. Kim: This is an interesting field. The moderator of the session went up and said that there has been no time in any previous ADA sessions where the lung issue was actually discussed. This was the first time ever.
They had some of the world leaders in this field, so it was really awesome to see them. Just to paint a picture of these obese asthmatic patients, they are challenging cases because, as you know, the main therapy for any asthmatic patient is inhaled corticosteroid.
Patients who are obese have quite a bit of a steroid resistance. Therefore, they end up being on many medications that sometimes are off label, and many end up on biologics as well. Therefore, the respiratory world has been seeking therapies for these obese asthmatic patients who are likely to be steroid resistant because these people are also likely to end up on an oral steroid as well.
Dr. Jain, you know the effect of the steroids much better than I do, and it’s like a laundry list. We really don’t want our patients to be on oral steroids.
In the past few years, GLP-1 has been studied quite extensively in the lung, especially in the world of asthma, and also in COPD. What’s really fascinating is that the GLP-1 receptors have been found to be quite abundant in the airway. Some studies show that the highest concentration of GLP-1 lies in the airway, whereas some studies have said that it’s the third most common area to find the GLP-1.
It is not a surprise that GLP-1 is being studied in managing the airway, especially airway inflammation in asthma and COPD patients. The preliminary data have been quite encouraging. They also discussed that there are new medications coming out that seem to be incretin based, so we’ll wait to see what those studies show.
There are two current phase 3 trials being held at the moment. One is using semaglutide 2.4 mg subcutaneous and another one is using metformin to reduce the airway inflammation in these asthmatic patients and also in some COPD patients. We’ll look forward to these results.
Dr. Jain: That’s really important to note because we see that there is a high density of these receptors in the airways, and hitherto we had no idea about the overall effect. Now, we’re looking at, as you mentioned, individuals with obesity who have asthma, so there are both the restrictive and obstructive components in the lung coming into play here.
From an endocrinology perspective, I’m thinking that this could be multiple effects of the GLP-1 receptor agonists, where on one hand you’re managing the obesity and you’re working along that line, and on the other hand, it could have local anti-inflammatory effects in the lung. Hence, there could be potential improvement in the overall pulmonary function of these individuals.
Dr. Kim: We are seeing this in primary care. Ever since I found out this information, I have started numerous patients, who are obese, asthmatic patients who do not have diabetes, on GLP-1 therapies, and their pulmonary function tests have improved significantly.
As a matter of fact, one of my personal friends is a severe asthmatic patient. She ends up being on oral steroids about three times a year. There was even one day when I saw her in one of my classes and she was dyspneic. She was short of breath.
I introduced her to one of my colleagues who’s a respirologist and very much into the impact of the incretins and asthma, and she was started on a GLP-1 receptor agonist. She lost about 30 pounds of weight, but now she is labeled as a mild asthmatic. Her pulmonary function test is completely normal. She hasn’t touched an oral steroid for a couple of years now.
That is a huge success story and I’m seeing that even in my own clinic as well. It’s a huge win for the respiratory world.
Dr. Jain: I think from an endocrinology perspective as well, if we are initiating GLP-1 receptor agonists or medications in that class, where we use it for management of obesity, sooner or later we do hit a stage where people will plateau with their weight loss. They won’t have any additional weight loss.
We tell individuals at that time that the fact that they’re able to maintain the weight loss still means that the medication is working from the obesity perspective. For individuals who also have asthma, it would be a good point to tell them that it could still have potential effects on reducing inflammation ongoing. Hence, even though they may not be losing any additional weight, it would still be helpful to continue on these medications from a pulmonary perspective.
Dr. Kim: Right now these pleiotropic effects of GLP-1 agents are absolutely mind-blowing. I mentioned in one of my respiratory presentations to a bunch of respirologists that diabetes is taking over the world, including the respiratory world. Well, you can imagine what their faces were like. However, they were quite impressed at that, and they were very excited with what these two phase 3 trials will show.
Dr. Jain: I think, based on the ADA 2024 conference, GLP-1 receptor agonists continue to be the gift that keeps giving. We have the effects on diabetes, obesity, kidney function, liver protection, lungs, and Alzheimer’s. We saw some sessions about potential use in people with alcohol misuse disorder or gambling problems. Clearly, there’s a large amount of research that›s being done with these agents.
Perhaps when you and I talk about ADA 2025, we might be able to talk about some more pleiotropic benefits outside the pancreas. Until then, please do check out our other videos from ADA 2024. Thanks for joining us again, Dr. Kim.
Dr. Kim: Thank you very much for having me.
Dr. Jain, clinical instructor, Department of Endocrinology, University of British Columbia, and endocrinologist, TLC Diabetes and Endocrinology, Vancouver, British Columbia, Canada, has disclosed ties with Abbott, Acerus, AstraZeneca, Amgen, Bausch Healthcare, Bayer, Boehringer Ingelheim, Care to Know, CCRN, Connected in Motion, CPD Network, Dexcom, Diabetes Canada, Eli Lilly, GSK, HLS Therapeutics, Janssen, Master Clinician Alliance, MDBriefcase, Merck, Medtronic, Moderna, Novartis, Novo Nordisk, Partners in Progressive Medical Education, Pfizer, Sanofi Aventis, Timed Right, WebMD, Gilead Sciences, Insulet, PocketPills, Roche, and Takeda. Dr. Kim, clinical assistant professor, Department of Family Medicine, University of Calgary, Alberta, has disclosed ties with Abbott, AbbVie, AstraZeneca, Bayer, Boehringer Ingelheim, Eisai, Embecta, Eli Lilly, GSK, Janssen, Linpharma, Novo Nordisk, Miravo, Otsuka, Pfizer, Teva, Takeda, and Sanofi, and Partners in Progressive Medical Education.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Akshay B. Jain, MD: Welcome back to Medscape at ADA 2024, where Dr. James Kim, primary care physician from Calgary, Alberta, will be joining me in deciphering the key highlights at the ADA conference and bringing our own clinical twist into what the relevance would be for people like you and I to take back to our clinics.
Welcome back, Dr. Kim.
James Kim, MBBCh, PgDip, MScCH: Thank you very much. It’s nice to be back.
Dr. Jain: This was a diabetes conference, so obviously we are very pancreas focused. At this conference, we went outside our general area of territory, going outside of the pancreas and delving into other organ states. What I found fascinating were some data regarding the effects of incretin therapy on the lung, and in particular, some of the restrictive lung disorders.
Dr. Kim, you attended these sessions as well. Can you tell us a little bit more about the results that were discussed?
Dr. Kim: This is an interesting field. The moderator of the session went up and said that there has been no time in any previous ADA sessions where the lung issue was actually discussed. This was the first time ever.
They had some of the world leaders in this field, so it was really awesome to see them. Just to paint a picture of these obese asthmatic patients, they are challenging cases because, as you know, the main therapy for any asthmatic patient is inhaled corticosteroid.
Patients who are obese have quite a bit of a steroid resistance. Therefore, they end up being on many medications that sometimes are off label, and many end up on biologics as well. Therefore, the respiratory world has been seeking therapies for these obese asthmatic patients who are likely to be steroid resistant because these people are also likely to end up on an oral steroid as well.
Dr. Jain, you know the effect of the steroids much better than I do, and it’s like a laundry list. We really don’t want our patients to be on oral steroids.
In the past few years, GLP-1 has been studied quite extensively in the lung, especially in the world of asthma, and also in COPD. What’s really fascinating is that the GLP-1 receptors have been found to be quite abundant in the airway. Some studies show that the highest concentration of GLP-1 lies in the airway, whereas some studies have said that it’s the third most common area to find the GLP-1.
It is not a surprise that GLP-1 is being studied in managing the airway, especially airway inflammation in asthma and COPD patients. The preliminary data have been quite encouraging. They also discussed that there are new medications coming out that seem to be incretin based, so we’ll wait to see what those studies show.
There are two current phase 3 trials being held at the moment. One is using semaglutide 2.4 mg subcutaneous and another one is using metformin to reduce the airway inflammation in these asthmatic patients and also in some COPD patients. We’ll look forward to these results.
Dr. Jain: That’s really important to note because we see that there is a high density of these receptors in the airways, and hitherto we had no idea about the overall effect. Now, we’re looking at, as you mentioned, individuals with obesity who have asthma, so there are both the restrictive and obstructive components in the lung coming into play here.
From an endocrinology perspective, I’m thinking that this could be multiple effects of the GLP-1 receptor agonists, where on one hand you’re managing the obesity and you’re working along that line, and on the other hand, it could have local anti-inflammatory effects in the lung. Hence, there could be potential improvement in the overall pulmonary function of these individuals.
Dr. Kim: We are seeing this in primary care. Ever since I found out this information, I have started numerous patients, who are obese, asthmatic patients who do not have diabetes, on GLP-1 therapies, and their pulmonary function tests have improved significantly.
As a matter of fact, one of my personal friends is a severe asthmatic patient. She ends up being on oral steroids about three times a year. There was even one day when I saw her in one of my classes and she was dyspneic. She was short of breath.
I introduced her to one of my colleagues who’s a respirologist and very much into the impact of the incretins and asthma, and she was started on a GLP-1 receptor agonist. She lost about 30 pounds of weight, but now she is labeled as a mild asthmatic. Her pulmonary function test is completely normal. She hasn’t touched an oral steroid for a couple of years now.
That is a huge success story and I’m seeing that even in my own clinic as well. It’s a huge win for the respiratory world.
Dr. Jain: I think from an endocrinology perspective as well, if we are initiating GLP-1 receptor agonists or medications in that class, where we use it for management of obesity, sooner or later we do hit a stage where people will plateau with their weight loss. They won’t have any additional weight loss.
We tell individuals at that time that the fact that they’re able to maintain the weight loss still means that the medication is working from the obesity perspective. For individuals who also have asthma, it would be a good point to tell them that it could still have potential effects on reducing inflammation ongoing. Hence, even though they may not be losing any additional weight, it would still be helpful to continue on these medications from a pulmonary perspective.
Dr. Kim: Right now these pleiotropic effects of GLP-1 agents are absolutely mind-blowing. I mentioned in one of my respiratory presentations to a bunch of respirologists that diabetes is taking over the world, including the respiratory world. Well, you can imagine what their faces were like. However, they were quite impressed at that, and they were very excited with what these two phase 3 trials will show.
Dr. Jain: I think, based on the ADA 2024 conference, GLP-1 receptor agonists continue to be the gift that keeps giving. We have the effects on diabetes, obesity, kidney function, liver protection, lungs, and Alzheimer’s. We saw some sessions about potential use in people with alcohol misuse disorder or gambling problems. Clearly, there’s a large amount of research that›s being done with these agents.
Perhaps when you and I talk about ADA 2025, we might be able to talk about some more pleiotropic benefits outside the pancreas. Until then, please do check out our other videos from ADA 2024. Thanks for joining us again, Dr. Kim.
Dr. Kim: Thank you very much for having me.
Dr. Jain, clinical instructor, Department of Endocrinology, University of British Columbia, and endocrinologist, TLC Diabetes and Endocrinology, Vancouver, British Columbia, Canada, has disclosed ties with Abbott, Acerus, AstraZeneca, Amgen, Bausch Healthcare, Bayer, Boehringer Ingelheim, Care to Know, CCRN, Connected in Motion, CPD Network, Dexcom, Diabetes Canada, Eli Lilly, GSK, HLS Therapeutics, Janssen, Master Clinician Alliance, MDBriefcase, Merck, Medtronic, Moderna, Novartis, Novo Nordisk, Partners in Progressive Medical Education, Pfizer, Sanofi Aventis, Timed Right, WebMD, Gilead Sciences, Insulet, PocketPills, Roche, and Takeda. Dr. Kim, clinical assistant professor, Department of Family Medicine, University of Calgary, Alberta, has disclosed ties with Abbott, AbbVie, AstraZeneca, Bayer, Boehringer Ingelheim, Eisai, Embecta, Eli Lilly, GSK, Janssen, Linpharma, Novo Nordisk, Miravo, Otsuka, Pfizer, Teva, Takeda, and Sanofi, and Partners in Progressive Medical Education.
A version of this article first appeared on Medscape.com.
Mobile App Shows Promise in Managing Fibromyalgia Symptoms
TOPLINE:
A smartphone app that delivers acceptance and commitment therapy (ACT), a type of cognitive behavioral therapy, improves overall well-being and reduces the severity of pain, fatigue, sleep issues, and depression to a greater extent than daily symptom tracking in patients with fibromyalgia.
METHODOLOGY:
- Researchers conducted the phase 3 PROSPER-FM trial at 25 community sites in the United States to assess the efficacy and safety of digital ACT for patients with fibromyalgia.
- A total of 275 adult patients aged 22-75 years with fibromyalgia were randomly assigned to either the digital ACT group (n = 140) or the active control group (n = 135) for 12 weeks.
- Patients in the digital ACT group received a self-guided, smartphone-delivered program in which they learned and practiced the core ACT skills of acceptance, values, mindfulness, defusion, self as context, and willingness and committed action to build psychological flexibility, while the control group underwent daily symptom tracking and received educational materials.
- The primary endpoint was the response rate on the Patient Global Impression of Change (PGIC) at week 12, which is an indicator of patient well-being.
- The secondary endpoints included changes in the Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score and pain intensity, pain interference, and sleep interference scores.
TAKEAWAY:
- At week 12, 71% of the patients in the digital ACT group responded with a minimally improved or better change in the PGIC response, compared with only 22% of the patients in the control group (P < .0001).
- The digital ACT group showed a significant reduction in the impact of fibromyalgia, with a between-group effect size of d = 0.65 (P < .0001) at week 12. The FIQ-R total score significantly improved within 3 weeks of using the self-guided digital ACT app.
- The use of digital ACT also demonstrated positive effects on the levels of weekly pain intensity (P = .001) and depression (P < .0001), compared with the control group.
- No serious adverse effects related to the app were reported, and both groups demonstrated high rates of adherence, with most (72%) participants in the digital ACT group completing at least 42 sessions.
IN PRACTICE:
“The results found in the study are essential for professionals who care for patients with fibromyalgia as they present a new viable treatment alternative,” Guilherme Torres Vilarino, PhD, Santa Catarina State University, Florianópolis, Brazil, wrote in an accompanying editorial.
SOURCE:
This study was led by R. Michael Gendreau, MD, PhD, Gendreau Consulting, Poway, California. It was published online in The Lancet.
LIMITATIONS:
The study population predominantly consisted of women and White individuals, which may limit the generalizability of the findings to more diverse populations. Additionally, the study was conducted in the United States, and the results may thus not be applicable to other countries with different racial, ethnic, educational, and economic characteristics. The study duration was 12 weeks, and the long-term benefits of digital ACT have not yet been shown.
DISCLOSURES:
This study was funded by Swing Therapeutics. Seven authors declared having stock options and/or receiving salary from Swing Therapeutics. Other authors reported having many ties with several sources, including Swing Therapeutics.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
A smartphone app that delivers acceptance and commitment therapy (ACT), a type of cognitive behavioral therapy, improves overall well-being and reduces the severity of pain, fatigue, sleep issues, and depression to a greater extent than daily symptom tracking in patients with fibromyalgia.
METHODOLOGY:
- Researchers conducted the phase 3 PROSPER-FM trial at 25 community sites in the United States to assess the efficacy and safety of digital ACT for patients with fibromyalgia.
- A total of 275 adult patients aged 22-75 years with fibromyalgia were randomly assigned to either the digital ACT group (n = 140) or the active control group (n = 135) for 12 weeks.
- Patients in the digital ACT group received a self-guided, smartphone-delivered program in which they learned and practiced the core ACT skills of acceptance, values, mindfulness, defusion, self as context, and willingness and committed action to build psychological flexibility, while the control group underwent daily symptom tracking and received educational materials.
- The primary endpoint was the response rate on the Patient Global Impression of Change (PGIC) at week 12, which is an indicator of patient well-being.
- The secondary endpoints included changes in the Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score and pain intensity, pain interference, and sleep interference scores.
TAKEAWAY:
- At week 12, 71% of the patients in the digital ACT group responded with a minimally improved or better change in the PGIC response, compared with only 22% of the patients in the control group (P < .0001).
- The digital ACT group showed a significant reduction in the impact of fibromyalgia, with a between-group effect size of d = 0.65 (P < .0001) at week 12. The FIQ-R total score significantly improved within 3 weeks of using the self-guided digital ACT app.
- The use of digital ACT also demonstrated positive effects on the levels of weekly pain intensity (P = .001) and depression (P < .0001), compared with the control group.
- No serious adverse effects related to the app were reported, and both groups demonstrated high rates of adherence, with most (72%) participants in the digital ACT group completing at least 42 sessions.
IN PRACTICE:
“The results found in the study are essential for professionals who care for patients with fibromyalgia as they present a new viable treatment alternative,” Guilherme Torres Vilarino, PhD, Santa Catarina State University, Florianópolis, Brazil, wrote in an accompanying editorial.
SOURCE:
This study was led by R. Michael Gendreau, MD, PhD, Gendreau Consulting, Poway, California. It was published online in The Lancet.
LIMITATIONS:
The study population predominantly consisted of women and White individuals, which may limit the generalizability of the findings to more diverse populations. Additionally, the study was conducted in the United States, and the results may thus not be applicable to other countries with different racial, ethnic, educational, and economic characteristics. The study duration was 12 weeks, and the long-term benefits of digital ACT have not yet been shown.
DISCLOSURES:
This study was funded by Swing Therapeutics. Seven authors declared having stock options and/or receiving salary from Swing Therapeutics. Other authors reported having many ties with several sources, including Swing Therapeutics.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
A smartphone app that delivers acceptance and commitment therapy (ACT), a type of cognitive behavioral therapy, improves overall well-being and reduces the severity of pain, fatigue, sleep issues, and depression to a greater extent than daily symptom tracking in patients with fibromyalgia.
METHODOLOGY:
- Researchers conducted the phase 3 PROSPER-FM trial at 25 community sites in the United States to assess the efficacy and safety of digital ACT for patients with fibromyalgia.
- A total of 275 adult patients aged 22-75 years with fibromyalgia were randomly assigned to either the digital ACT group (n = 140) or the active control group (n = 135) for 12 weeks.
- Patients in the digital ACT group received a self-guided, smartphone-delivered program in which they learned and practiced the core ACT skills of acceptance, values, mindfulness, defusion, self as context, and willingness and committed action to build psychological flexibility, while the control group underwent daily symptom tracking and received educational materials.
- The primary endpoint was the response rate on the Patient Global Impression of Change (PGIC) at week 12, which is an indicator of patient well-being.
- The secondary endpoints included changes in the Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score and pain intensity, pain interference, and sleep interference scores.
TAKEAWAY:
- At week 12, 71% of the patients in the digital ACT group responded with a minimally improved or better change in the PGIC response, compared with only 22% of the patients in the control group (P < .0001).
- The digital ACT group showed a significant reduction in the impact of fibromyalgia, with a between-group effect size of d = 0.65 (P < .0001) at week 12. The FIQ-R total score significantly improved within 3 weeks of using the self-guided digital ACT app.
- The use of digital ACT also demonstrated positive effects on the levels of weekly pain intensity (P = .001) and depression (P < .0001), compared with the control group.
- No serious adverse effects related to the app were reported, and both groups demonstrated high rates of adherence, with most (72%) participants in the digital ACT group completing at least 42 sessions.
IN PRACTICE:
“The results found in the study are essential for professionals who care for patients with fibromyalgia as they present a new viable treatment alternative,” Guilherme Torres Vilarino, PhD, Santa Catarina State University, Florianópolis, Brazil, wrote in an accompanying editorial.
SOURCE:
This study was led by R. Michael Gendreau, MD, PhD, Gendreau Consulting, Poway, California. It was published online in The Lancet.
LIMITATIONS:
The study population predominantly consisted of women and White individuals, which may limit the generalizability of the findings to more diverse populations. Additionally, the study was conducted in the United States, and the results may thus not be applicable to other countries with different racial, ethnic, educational, and economic characteristics. The study duration was 12 weeks, and the long-term benefits of digital ACT have not yet been shown.
DISCLOSURES:
This study was funded by Swing Therapeutics. Seven authors declared having stock options and/or receiving salary from Swing Therapeutics. Other authors reported having many ties with several sources, including Swing Therapeutics.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
AI Matches Expert Interpretation of Routine EEGs
, according to investigators.
These findings suggest that SCORE-AI, the model tested, can reliably interpret common EEGs in real-world practice, supporting its recent FDA approval, reported lead author Daniel Mansilla, MD, a neurologist at Montreal Neurological Institute and Hospital, and colleagues.
“Overinterpretation of clinical EEG is the most common cause of misdiagnosing epilepsy,” the investigators wrote in Epilepsia. “AI tools may be a solution for this challenge, both as an additional resource for confirmation and classification of epilepsy, and as an aid for the interpretation of EEG in critical care medicine.”
To date, however, AI tools have struggled with the variability encountered in real-world neurology practice.“When tested on external data from different centers and diverse patient populations, and using equipment distinct from the initial study, medical AI models frequently exhibit modest performance, and only a few AI tools have successfully transitioned into medical practice,” the investigators wrote.
SCORE-AI Matches Expert Interpretation of Routine EEGs
The present study put SCORE-AI to the test with EEGs from 104 patients between 16 and 91 years. These individuals hailed from “geographically distinct” regions, while recording equipment and conditions also varied widely, according to Dr. Mansilla and colleagues.
To set an external gold-standard for comparison, EEGs were first interpreted by three human expert raters, who were blinded to all case information except the EEGs themselves. The dataset comprised 50% normal and 50% abnormal EEGs. Four major classes of EEG abnormalities were included: focal epileptiform, generalized epileptiform, focal nonepileptiform, and diffuse nonepileptiform.
Comparing SCORE-AI interpretations with the experts’ interpretations revealed no significant difference in any metric or category. The AI tool had an overall accuracy of 92%, compared with 94% for the human experts. Of note, SCORE-AI maintained this level of performance regardless of vigilance state or normal variants.
“SCORE-AI has obtained FDA approval for routine clinical EEGs and is presently being integrated into broadly available EEG software (Natus NeuroWorks),” the investigators wrote.
Further Validation May Be Needed
Wesley T. Kerr, MD, PhD, functional (nonepileptic) seizures clinic lead epileptologist at the University of Pittsburgh Medical Center, and handling associate editor for this study in Epilepsia, said the present findings are important because they show that SCORE-AI can perform in scenarios beyond the one in which it was developed.
Still, it may be premature for broad commercial rollout.
In a written comment, Dr. Kerr called for “much larger studies” to validate SCORE-AI, noting that seizures can be caused by “many rare conditions,” and some patients have multiple EEG abnormalities.
Since SCORE-AI has not yet demonstrated accuracy in those situations, he predicted that the tool will remain exactly that – a tool – before it replaces human experts.
“They have only looked at SCORE-AI by itself,” Dr. Kerr said. “Practically, SCORE-AI is going to be used in combination with a neurologist for a long time before SCORE-AI can operate semi-independently or independently. They need to do studies looking at this combination to see how this tool impacts the clinical practice of EEG interpretation.”
Daniel Friedman, MD, an epileptologist and associate clinical professor of neurology at NYU Langone, pointed out another limitation of the present study: The EEGs were collected at specialty centers.
“The technical standards of data collection were, therefore, pretty high,” Dr. Friedman said in a written comment. “The majority of EEGs performed in the world are not collected by highly skilled EEG technologists and the performance of AI classification algorithms under less-than-ideal technical conditions is unknown.”
AI-Assisted EEG Interpretation Is Here to Stay
When asked about the long-term future of AI-assisted EEG interpretation, Dr. Friedman predicted that it will be “critical” for helping improve the accuracy of epilepsy diagnoses, particularly because most EEGs worldwide are interpreted by non-experts, leading to the known issue with epilepsy misdiagnosis.
“However,” he added, “it is important to note that epilepsy is a clinical diagnosis ... [EEG] is only one piece of evidence in neurologic decision making. History and accurate eyewitness description of the events of concern are extremely critical to the diagnosis and cannot be replaced by AI yet.”
Dr. Kerr offered a similar view, highlighting the potential for SCORE-AI to raise the game of non-epileptologists.
“My anticipation is that neurologists who don’t use SCORE-AI will be replaced by neurologists who use SCORE-AI well,” he said. “Neurologists who use it well will be able to read more EEGs in less time without sacrificing quality. This will allow the neurologist to spend more time talking with the patient about the interpretation of the tests and how that impacts clinical care.”
Then again, that time spent talking with the patient may also one day be delegated to a machine.
“It is certainly imaginable that AI chatbots using large language models to interact with patients and family could be developed to extract consistent epilepsy histories for diagnostic support,” Dr. Wesley said.
This work was supported by a project grant from the Canadian Institutes of Health Research and Duke Neurology start-up funding. The investigators and interviewees reported no relevant conflicts of interest.
, according to investigators.
These findings suggest that SCORE-AI, the model tested, can reliably interpret common EEGs in real-world practice, supporting its recent FDA approval, reported lead author Daniel Mansilla, MD, a neurologist at Montreal Neurological Institute and Hospital, and colleagues.
“Overinterpretation of clinical EEG is the most common cause of misdiagnosing epilepsy,” the investigators wrote in Epilepsia. “AI tools may be a solution for this challenge, both as an additional resource for confirmation and classification of epilepsy, and as an aid for the interpretation of EEG in critical care medicine.”
To date, however, AI tools have struggled with the variability encountered in real-world neurology practice.“When tested on external data from different centers and diverse patient populations, and using equipment distinct from the initial study, medical AI models frequently exhibit modest performance, and only a few AI tools have successfully transitioned into medical practice,” the investigators wrote.
SCORE-AI Matches Expert Interpretation of Routine EEGs
The present study put SCORE-AI to the test with EEGs from 104 patients between 16 and 91 years. These individuals hailed from “geographically distinct” regions, while recording equipment and conditions also varied widely, according to Dr. Mansilla and colleagues.
To set an external gold-standard for comparison, EEGs were first interpreted by three human expert raters, who were blinded to all case information except the EEGs themselves. The dataset comprised 50% normal and 50% abnormal EEGs. Four major classes of EEG abnormalities were included: focal epileptiform, generalized epileptiform, focal nonepileptiform, and diffuse nonepileptiform.
Comparing SCORE-AI interpretations with the experts’ interpretations revealed no significant difference in any metric or category. The AI tool had an overall accuracy of 92%, compared with 94% for the human experts. Of note, SCORE-AI maintained this level of performance regardless of vigilance state or normal variants.
“SCORE-AI has obtained FDA approval for routine clinical EEGs and is presently being integrated into broadly available EEG software (Natus NeuroWorks),” the investigators wrote.
Further Validation May Be Needed
Wesley T. Kerr, MD, PhD, functional (nonepileptic) seizures clinic lead epileptologist at the University of Pittsburgh Medical Center, and handling associate editor for this study in Epilepsia, said the present findings are important because they show that SCORE-AI can perform in scenarios beyond the one in which it was developed.
Still, it may be premature for broad commercial rollout.
In a written comment, Dr. Kerr called for “much larger studies” to validate SCORE-AI, noting that seizures can be caused by “many rare conditions,” and some patients have multiple EEG abnormalities.
Since SCORE-AI has not yet demonstrated accuracy in those situations, he predicted that the tool will remain exactly that – a tool – before it replaces human experts.
“They have only looked at SCORE-AI by itself,” Dr. Kerr said. “Practically, SCORE-AI is going to be used in combination with a neurologist for a long time before SCORE-AI can operate semi-independently or independently. They need to do studies looking at this combination to see how this tool impacts the clinical practice of EEG interpretation.”
Daniel Friedman, MD, an epileptologist and associate clinical professor of neurology at NYU Langone, pointed out another limitation of the present study: The EEGs were collected at specialty centers.
“The technical standards of data collection were, therefore, pretty high,” Dr. Friedman said in a written comment. “The majority of EEGs performed in the world are not collected by highly skilled EEG technologists and the performance of AI classification algorithms under less-than-ideal technical conditions is unknown.”
AI-Assisted EEG Interpretation Is Here to Stay
When asked about the long-term future of AI-assisted EEG interpretation, Dr. Friedman predicted that it will be “critical” for helping improve the accuracy of epilepsy diagnoses, particularly because most EEGs worldwide are interpreted by non-experts, leading to the known issue with epilepsy misdiagnosis.
“However,” he added, “it is important to note that epilepsy is a clinical diagnosis ... [EEG] is only one piece of evidence in neurologic decision making. History and accurate eyewitness description of the events of concern are extremely critical to the diagnosis and cannot be replaced by AI yet.”
Dr. Kerr offered a similar view, highlighting the potential for SCORE-AI to raise the game of non-epileptologists.
“My anticipation is that neurologists who don’t use SCORE-AI will be replaced by neurologists who use SCORE-AI well,” he said. “Neurologists who use it well will be able to read more EEGs in less time without sacrificing quality. This will allow the neurologist to spend more time talking with the patient about the interpretation of the tests and how that impacts clinical care.”
Then again, that time spent talking with the patient may also one day be delegated to a machine.
“It is certainly imaginable that AI chatbots using large language models to interact with patients and family could be developed to extract consistent epilepsy histories for diagnostic support,” Dr. Wesley said.
This work was supported by a project grant from the Canadian Institutes of Health Research and Duke Neurology start-up funding. The investigators and interviewees reported no relevant conflicts of interest.
, according to investigators.
These findings suggest that SCORE-AI, the model tested, can reliably interpret common EEGs in real-world practice, supporting its recent FDA approval, reported lead author Daniel Mansilla, MD, a neurologist at Montreal Neurological Institute and Hospital, and colleagues.
“Overinterpretation of clinical EEG is the most common cause of misdiagnosing epilepsy,” the investigators wrote in Epilepsia. “AI tools may be a solution for this challenge, both as an additional resource for confirmation and classification of epilepsy, and as an aid for the interpretation of EEG in critical care medicine.”
To date, however, AI tools have struggled with the variability encountered in real-world neurology practice.“When tested on external data from different centers and diverse patient populations, and using equipment distinct from the initial study, medical AI models frequently exhibit modest performance, and only a few AI tools have successfully transitioned into medical practice,” the investigators wrote.
SCORE-AI Matches Expert Interpretation of Routine EEGs
The present study put SCORE-AI to the test with EEGs from 104 patients between 16 and 91 years. These individuals hailed from “geographically distinct” regions, while recording equipment and conditions also varied widely, according to Dr. Mansilla and colleagues.
To set an external gold-standard for comparison, EEGs were first interpreted by three human expert raters, who were blinded to all case information except the EEGs themselves. The dataset comprised 50% normal and 50% abnormal EEGs. Four major classes of EEG abnormalities were included: focal epileptiform, generalized epileptiform, focal nonepileptiform, and diffuse nonepileptiform.
Comparing SCORE-AI interpretations with the experts’ interpretations revealed no significant difference in any metric or category. The AI tool had an overall accuracy of 92%, compared with 94% for the human experts. Of note, SCORE-AI maintained this level of performance regardless of vigilance state or normal variants.
“SCORE-AI has obtained FDA approval for routine clinical EEGs and is presently being integrated into broadly available EEG software (Natus NeuroWorks),” the investigators wrote.
Further Validation May Be Needed
Wesley T. Kerr, MD, PhD, functional (nonepileptic) seizures clinic lead epileptologist at the University of Pittsburgh Medical Center, and handling associate editor for this study in Epilepsia, said the present findings are important because they show that SCORE-AI can perform in scenarios beyond the one in which it was developed.
Still, it may be premature for broad commercial rollout.
In a written comment, Dr. Kerr called for “much larger studies” to validate SCORE-AI, noting that seizures can be caused by “many rare conditions,” and some patients have multiple EEG abnormalities.
Since SCORE-AI has not yet demonstrated accuracy in those situations, he predicted that the tool will remain exactly that – a tool – before it replaces human experts.
“They have only looked at SCORE-AI by itself,” Dr. Kerr said. “Practically, SCORE-AI is going to be used in combination with a neurologist for a long time before SCORE-AI can operate semi-independently or independently. They need to do studies looking at this combination to see how this tool impacts the clinical practice of EEG interpretation.”
Daniel Friedman, MD, an epileptologist and associate clinical professor of neurology at NYU Langone, pointed out another limitation of the present study: The EEGs were collected at specialty centers.
“The technical standards of data collection were, therefore, pretty high,” Dr. Friedman said in a written comment. “The majority of EEGs performed in the world are not collected by highly skilled EEG technologists and the performance of AI classification algorithms under less-than-ideal technical conditions is unknown.”
AI-Assisted EEG Interpretation Is Here to Stay
When asked about the long-term future of AI-assisted EEG interpretation, Dr. Friedman predicted that it will be “critical” for helping improve the accuracy of epilepsy diagnoses, particularly because most EEGs worldwide are interpreted by non-experts, leading to the known issue with epilepsy misdiagnosis.
“However,” he added, “it is important to note that epilepsy is a clinical diagnosis ... [EEG] is only one piece of evidence in neurologic decision making. History and accurate eyewitness description of the events of concern are extremely critical to the diagnosis and cannot be replaced by AI yet.”
Dr. Kerr offered a similar view, highlighting the potential for SCORE-AI to raise the game of non-epileptologists.
“My anticipation is that neurologists who don’t use SCORE-AI will be replaced by neurologists who use SCORE-AI well,” he said. “Neurologists who use it well will be able to read more EEGs in less time without sacrificing quality. This will allow the neurologist to spend more time talking with the patient about the interpretation of the tests and how that impacts clinical care.”
Then again, that time spent talking with the patient may also one day be delegated to a machine.
“It is certainly imaginable that AI chatbots using large language models to interact with patients and family could be developed to extract consistent epilepsy histories for diagnostic support,” Dr. Wesley said.
This work was supported by a project grant from the Canadian Institutes of Health Research and Duke Neurology start-up funding. The investigators and interviewees reported no relevant conflicts of interest.
FROM EPILEPSIA
When Childhood Cancer Survivors Face Sexual Challenges
Childhood cancers represent a diverse group of neoplasms, and thanks to advances in treatment, survival rates have improved significantly. Today, more than 80%-85% of children diagnosed with cancer in developed countries survive into adulthood.
This increase in survival has brought new challenges, however. Compared with the general population, childhood cancer survivors (CCS) are at a notably higher risk for early mortality, developing secondary cancers, and experiencing various long-term clinical and psychosocial issues stemming from their disease or its treatment.
Long-term follow-up care for CCS is a complex and evolving field. Despite ongoing efforts to establish global and national guidelines, current evidence indicates that the care and management of these patients remain suboptimal.
The disruptions caused by cancer and its treatment can interfere with normal physiological and psychological development, leading to issues with sexual function. This aspect of health is critical as it influences not just physical well-being but also psychosocial, developmental, and emotional health.
Characteristics and Mechanisms
Sexual functioning encompasses the physiological and psychological aspects of sexual behavior, including desire, arousal, orgasm, sexual pleasure, and overall satisfaction.
As CCS reach adolescence or adulthood, they often face sexual and reproductive issues, particularly as they enter romantic relationships.
Sexual functioning is a complex process that relies on the interaction of various factors, including physiological health, psychosexual development, romantic relationships, body image, and desire.
Despite its importance, the impact of childhood cancer on sexual function is often overlooked, even though cancer and its treatments can have lifelong effects.
Sexual Function in CCS
A recent review aimed to summarize the existing research on sexual function among CCS, highlighting assessment tools, key stages of psychosexual development, common sexual problems, and the prevalence of sexual dysfunction.
The review study included 22 studies published between 2000 and 2022, comprising two qualitative, six cohort, and 14 cross-sectional studies.
Most CCS reached all key stages of psychosexual development at an average age of 29.8 years. Although some milestones were achieved later than is typical, many survivors felt they reached these stages at the appropriate time. Sexual initiation was less common among those who had undergone intensive neurotoxic treatments, such as those diagnosed with brain tumors or leukemia in childhood.
In a cross-sectional study of CCS aged 17-39 years, about one third had never engaged in sexual intercourse, 41.4% reported never experiencing sexual attraction, 44.8% were dissatisfied with their sex lives, and many rarely felt sexually attractive to others. Another study found that common issues among CCS included a lack of interest in sex (30%), difficulty enjoying sex (24%), and difficulty becoming aroused (23%). However, comparing and analyzing these problems was challenging due to the lack of standardized assessment criteria.
The prevalence of sexual dysfunction among CCS ranged from 12.3% to 46.5%. For males, the prevalence ranged from 12.3% to 54.0%, while for females, it ranged from 19.9% to 57.0%.
Factors Influencing Sexual Function
The review identified the following four categories of factors influencing sexual function in CCS: Demographic, treatment-related, psychological, and physiological.
Demographic factors: Gender, age, education level, relationship status, income level, and race all play roles in sexual function.
Female survivors reported more severe sexual dysfunction and poorer sexual health than did male survivors. Age at cancer diagnosis, age at evaluation, and the time since diagnosis were closely linked to sexual experiences. Patients diagnosed with cancer during childhood tended to report better sexual function than those diagnosed during adolescence.
Treatment-related factors: The type of cancer and intensity of treatment, along with surgical history, were significant factors. Surgeries involving the spinal cord or sympathetic nerves, as well as a history of prostate or pelvic surgery, were strongly associated with erectile dysfunction in men. In women, pelvic surgeries and treatments to the pelvic area were commonly linked to sexual dysfunction.
The association between treatment intensity and sexual function was noted across several studies, although the results were not always consistent. For example, testicular radiation above 10 Gy was positively correlated with sexual dysfunction. Women who underwent more intensive treatments were more likely to report issues in multiple areas of sexual function, while men in this group were less likely to have children.
Among female CCS, certain types of cancer, such as germ cell tumors, renal tumors, and leukemia, present a higher risk for sexual dysfunction. Women who had CNS tumors in childhood frequently reported problems like difficulty in sexual arousal, low sexual satisfaction, infrequent sexual activity, and fewer sexual partners, compared with survivors of other cancers. Survivors of acute lymphoblastic leukemia and those who underwent hematopoietic stem cell transplantation (HSCT) also showed varying degrees of impaired sexual function, compared with the general population. The HSCT group showed significant testicular damage, including reduced testicular volumes, low testosterone levels, and low sperm counts.
Psychological factors: These factors, such as emotional distress, play a significant role in sexual dysfunction among CCS. Symptoms like anxiety, nervousness during sexual activity, and depression are commonly reported by those with sexual dysfunction. The connection between body image and sexual function is complex. Many CCS with sexual dysfunction express concern about how others, particularly their partners, perceived their altered body image due to cancer and its treatment.
Physiological factors: In male CCS, low serum testosterone levels and low lean muscle mass are linked to an increased risk for sexual dysfunction. Treatments involving alkylating agents or testicular radiation, and surgery or radiotherapy targeting the genitourinary organs or the hypothalamic-pituitary region, can lead to various physiological and endocrine disorders, contributing to sexual dysfunction. Despite these risks, there is a lack of research evaluating sexual function through the lens of the hypothalamic-pituitary-gonadal axis and neuroendocrine pathways.
This story was translated from Univadis Italy 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.
Childhood cancers represent a diverse group of neoplasms, and thanks to advances in treatment, survival rates have improved significantly. Today, more than 80%-85% of children diagnosed with cancer in developed countries survive into adulthood.
This increase in survival has brought new challenges, however. Compared with the general population, childhood cancer survivors (CCS) are at a notably higher risk for early mortality, developing secondary cancers, and experiencing various long-term clinical and psychosocial issues stemming from their disease or its treatment.
Long-term follow-up care for CCS is a complex and evolving field. Despite ongoing efforts to establish global and national guidelines, current evidence indicates that the care and management of these patients remain suboptimal.
The disruptions caused by cancer and its treatment can interfere with normal physiological and psychological development, leading to issues with sexual function. This aspect of health is critical as it influences not just physical well-being but also psychosocial, developmental, and emotional health.
Characteristics and Mechanisms
Sexual functioning encompasses the physiological and psychological aspects of sexual behavior, including desire, arousal, orgasm, sexual pleasure, and overall satisfaction.
As CCS reach adolescence or adulthood, they often face sexual and reproductive issues, particularly as they enter romantic relationships.
Sexual functioning is a complex process that relies on the interaction of various factors, including physiological health, psychosexual development, romantic relationships, body image, and desire.
Despite its importance, the impact of childhood cancer on sexual function is often overlooked, even though cancer and its treatments can have lifelong effects.
Sexual Function in CCS
A recent review aimed to summarize the existing research on sexual function among CCS, highlighting assessment tools, key stages of psychosexual development, common sexual problems, and the prevalence of sexual dysfunction.
The review study included 22 studies published between 2000 and 2022, comprising two qualitative, six cohort, and 14 cross-sectional studies.
Most CCS reached all key stages of psychosexual development at an average age of 29.8 years. Although some milestones were achieved later than is typical, many survivors felt they reached these stages at the appropriate time. Sexual initiation was less common among those who had undergone intensive neurotoxic treatments, such as those diagnosed with brain tumors or leukemia in childhood.
In a cross-sectional study of CCS aged 17-39 years, about one third had never engaged in sexual intercourse, 41.4% reported never experiencing sexual attraction, 44.8% were dissatisfied with their sex lives, and many rarely felt sexually attractive to others. Another study found that common issues among CCS included a lack of interest in sex (30%), difficulty enjoying sex (24%), and difficulty becoming aroused (23%). However, comparing and analyzing these problems was challenging due to the lack of standardized assessment criteria.
The prevalence of sexual dysfunction among CCS ranged from 12.3% to 46.5%. For males, the prevalence ranged from 12.3% to 54.0%, while for females, it ranged from 19.9% to 57.0%.
Factors Influencing Sexual Function
The review identified the following four categories of factors influencing sexual function in CCS: Demographic, treatment-related, psychological, and physiological.
Demographic factors: Gender, age, education level, relationship status, income level, and race all play roles in sexual function.
Female survivors reported more severe sexual dysfunction and poorer sexual health than did male survivors. Age at cancer diagnosis, age at evaluation, and the time since diagnosis were closely linked to sexual experiences. Patients diagnosed with cancer during childhood tended to report better sexual function than those diagnosed during adolescence.
Treatment-related factors: The type of cancer and intensity of treatment, along with surgical history, were significant factors. Surgeries involving the spinal cord or sympathetic nerves, as well as a history of prostate or pelvic surgery, were strongly associated with erectile dysfunction in men. In women, pelvic surgeries and treatments to the pelvic area were commonly linked to sexual dysfunction.
The association between treatment intensity and sexual function was noted across several studies, although the results were not always consistent. For example, testicular radiation above 10 Gy was positively correlated with sexual dysfunction. Women who underwent more intensive treatments were more likely to report issues in multiple areas of sexual function, while men in this group were less likely to have children.
Among female CCS, certain types of cancer, such as germ cell tumors, renal tumors, and leukemia, present a higher risk for sexual dysfunction. Women who had CNS tumors in childhood frequently reported problems like difficulty in sexual arousal, low sexual satisfaction, infrequent sexual activity, and fewer sexual partners, compared with survivors of other cancers. Survivors of acute lymphoblastic leukemia and those who underwent hematopoietic stem cell transplantation (HSCT) also showed varying degrees of impaired sexual function, compared with the general population. The HSCT group showed significant testicular damage, including reduced testicular volumes, low testosterone levels, and low sperm counts.
Psychological factors: These factors, such as emotional distress, play a significant role in sexual dysfunction among CCS. Symptoms like anxiety, nervousness during sexual activity, and depression are commonly reported by those with sexual dysfunction. The connection between body image and sexual function is complex. Many CCS with sexual dysfunction express concern about how others, particularly their partners, perceived their altered body image due to cancer and its treatment.
Physiological factors: In male CCS, low serum testosterone levels and low lean muscle mass are linked to an increased risk for sexual dysfunction. Treatments involving alkylating agents or testicular radiation, and surgery or radiotherapy targeting the genitourinary organs or the hypothalamic-pituitary region, can lead to various physiological and endocrine disorders, contributing to sexual dysfunction. Despite these risks, there is a lack of research evaluating sexual function through the lens of the hypothalamic-pituitary-gonadal axis and neuroendocrine pathways.
This story was translated from Univadis Italy 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.
Childhood cancers represent a diverse group of neoplasms, and thanks to advances in treatment, survival rates have improved significantly. Today, more than 80%-85% of children diagnosed with cancer in developed countries survive into adulthood.
This increase in survival has brought new challenges, however. Compared with the general population, childhood cancer survivors (CCS) are at a notably higher risk for early mortality, developing secondary cancers, and experiencing various long-term clinical and psychosocial issues stemming from their disease or its treatment.
Long-term follow-up care for CCS is a complex and evolving field. Despite ongoing efforts to establish global and national guidelines, current evidence indicates that the care and management of these patients remain suboptimal.
The disruptions caused by cancer and its treatment can interfere with normal physiological and psychological development, leading to issues with sexual function. This aspect of health is critical as it influences not just physical well-being but also psychosocial, developmental, and emotional health.
Characteristics and Mechanisms
Sexual functioning encompasses the physiological and psychological aspects of sexual behavior, including desire, arousal, orgasm, sexual pleasure, and overall satisfaction.
As CCS reach adolescence or adulthood, they often face sexual and reproductive issues, particularly as they enter romantic relationships.
Sexual functioning is a complex process that relies on the interaction of various factors, including physiological health, psychosexual development, romantic relationships, body image, and desire.
Despite its importance, the impact of childhood cancer on sexual function is often overlooked, even though cancer and its treatments can have lifelong effects.
Sexual Function in CCS
A recent review aimed to summarize the existing research on sexual function among CCS, highlighting assessment tools, key stages of psychosexual development, common sexual problems, and the prevalence of sexual dysfunction.
The review study included 22 studies published between 2000 and 2022, comprising two qualitative, six cohort, and 14 cross-sectional studies.
Most CCS reached all key stages of psychosexual development at an average age of 29.8 years. Although some milestones were achieved later than is typical, many survivors felt they reached these stages at the appropriate time. Sexual initiation was less common among those who had undergone intensive neurotoxic treatments, such as those diagnosed with brain tumors or leukemia in childhood.
In a cross-sectional study of CCS aged 17-39 years, about one third had never engaged in sexual intercourse, 41.4% reported never experiencing sexual attraction, 44.8% were dissatisfied with their sex lives, and many rarely felt sexually attractive to others. Another study found that common issues among CCS included a lack of interest in sex (30%), difficulty enjoying sex (24%), and difficulty becoming aroused (23%). However, comparing and analyzing these problems was challenging due to the lack of standardized assessment criteria.
The prevalence of sexual dysfunction among CCS ranged from 12.3% to 46.5%. For males, the prevalence ranged from 12.3% to 54.0%, while for females, it ranged from 19.9% to 57.0%.
Factors Influencing Sexual Function
The review identified the following four categories of factors influencing sexual function in CCS: Demographic, treatment-related, psychological, and physiological.
Demographic factors: Gender, age, education level, relationship status, income level, and race all play roles in sexual function.
Female survivors reported more severe sexual dysfunction and poorer sexual health than did male survivors. Age at cancer diagnosis, age at evaluation, and the time since diagnosis were closely linked to sexual experiences. Patients diagnosed with cancer during childhood tended to report better sexual function than those diagnosed during adolescence.
Treatment-related factors: The type of cancer and intensity of treatment, along with surgical history, were significant factors. Surgeries involving the spinal cord or sympathetic nerves, as well as a history of prostate or pelvic surgery, were strongly associated with erectile dysfunction in men. In women, pelvic surgeries and treatments to the pelvic area were commonly linked to sexual dysfunction.
The association between treatment intensity and sexual function was noted across several studies, although the results were not always consistent. For example, testicular radiation above 10 Gy was positively correlated with sexual dysfunction. Women who underwent more intensive treatments were more likely to report issues in multiple areas of sexual function, while men in this group were less likely to have children.
Among female CCS, certain types of cancer, such as germ cell tumors, renal tumors, and leukemia, present a higher risk for sexual dysfunction. Women who had CNS tumors in childhood frequently reported problems like difficulty in sexual arousal, low sexual satisfaction, infrequent sexual activity, and fewer sexual partners, compared with survivors of other cancers. Survivors of acute lymphoblastic leukemia and those who underwent hematopoietic stem cell transplantation (HSCT) also showed varying degrees of impaired sexual function, compared with the general population. The HSCT group showed significant testicular damage, including reduced testicular volumes, low testosterone levels, and low sperm counts.
Psychological factors: These factors, such as emotional distress, play a significant role in sexual dysfunction among CCS. Symptoms like anxiety, nervousness during sexual activity, and depression are commonly reported by those with sexual dysfunction. The connection between body image and sexual function is complex. Many CCS with sexual dysfunction express concern about how others, particularly their partners, perceived their altered body image due to cancer and its treatment.
Physiological factors: In male CCS, low serum testosterone levels and low lean muscle mass are linked to an increased risk for sexual dysfunction. Treatments involving alkylating agents or testicular radiation, and surgery or radiotherapy targeting the genitourinary organs or the hypothalamic-pituitary region, can lead to various physiological and endocrine disorders, contributing to sexual dysfunction. Despite these risks, there is a lack of research evaluating sexual function through the lens of the hypothalamic-pituitary-gonadal axis and neuroendocrine pathways.
This story was translated from Univadis Italy 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.
Leaving Your Legacy Via Death Bots? Ethicist Shares Concerns
This transcript has been edited for clarity.
I heard recently about a fascinating, important development in artificial intelligence (AI). All kinds of things are happening in AI. Clearly, it’s being used in the background to trace and keep track of medical information inside hospitals.
There are AI bots out there that are starting to talk to patients about, say, mental health issues. Plenty of people are using AI to get information about their medical condition, seeing it supplement search engines, and on and on AI goes.
It has entered into a space where I think patients may raise questions about whether they should use it or seek opinions from doctors and nurses, particularly those involved with seriously ill people. That space is grieving, and what might be called “death bots.”
Here’s what’s going on. There’s a gentleman I read about online, who was dying of end-stage colon cancer. His wife and he were talking, knowing his death was coming, about what it would be like after his death. She said she would really miss being able to ask him questions about a variety of topics that he was expert at and that he knew very well.
He thought about it and decided, well, maybe he could record his voice and then use AI to search information that he would record and have available, which could really address questions that his wife might put to “him” once he was gone.
It turns out that a company was formed shortly thereafter, which is now offering the service both in the US and Europe, and in fact, I think perhaps even worldwide, basically saying we’ll record a dying person’s voice. We will help people grieve by allowing people to interact with the AI version of the departed when they’re gone.
It will be able to, if you will, search not just recorded information but anything they might have online — diaries, things they may have written, earlier videos, and information from earlier parts of their life — to generate plausible answers to questions that might be put to the artificial version of the deceased.
Obviously, this would allow not only spouses but grandchildren and people in future generations to have some way to interact with an ancestor who’s gone. It may allow people to feel comfort when they miss a loved one, to hear their voice, and not just in a prerecorded way but creatively interacting with them.
On the other hand, Is it all right if people wander from the truth in trying to interact with someone who’s died?
There are other ways to leave memories behind. You certainly can record messages so that you can control the content. Many people video themselves and so on. There are obviously people who would say that they have a diary or have written information they can leave behind.
Is there a place in terms of accuracy for a kind of artificial version of ourselves to go on forever? Another interesting issue is who controls that. Can you add to it after your death? Can information be shared about you with third parties who don’t sign up for the service? Maybe the police take an interest in how you died. You can imagine many scenarios where questions might come up about wanting to access these data that the artificial agent is providing.
Some people might say that it’s just not the way to grieve. Maybe the best way to grieve is to accept death and not try to interact with a constructed version of yourself once you’ve passed. That isn’t really accepting death. It’s a form, perhaps, of denial of death, and maybe that isn’t going to be good for the mental health of survivors who really have not come to terms with the fact that someone has passed on.
I’m not against these death bots or AI versions of trying to leave a legacy. There are all kinds of legacies that people might want to leave. While perhaps not 100% accurate, I can see how this technology has a use.
I do think one has to go in with their eyes open. We need consent before anything like this is really purchased by or sold to surviving people. They really have to understand it may not be an accurate version of what the deceased might have said in response to questions, conversations, or interactions.
I think we need to know who controls the information, who can erase it, and who can say, “I’m done with it, and I don’t want my husband’s AI to go on anymore.”
All that said, it’s an interesting development in a world in which I think those who are very ill might start to plan to leave a legacy that is more than just a diary or a video message. It becomes a kind of ongoing, artificial, interactive version of themselves that may provide some people with comfort.
Dr. Caplan, director of the Division of Medical Ethics at New York University Langone Medical Center, New York City, reported conflicts of interest with Johnson & Johnson and Medscape.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
I heard recently about a fascinating, important development in artificial intelligence (AI). All kinds of things are happening in AI. Clearly, it’s being used in the background to trace and keep track of medical information inside hospitals.
There are AI bots out there that are starting to talk to patients about, say, mental health issues. Plenty of people are using AI to get information about their medical condition, seeing it supplement search engines, and on and on AI goes.
It has entered into a space where I think patients may raise questions about whether they should use it or seek opinions from doctors and nurses, particularly those involved with seriously ill people. That space is grieving, and what might be called “death bots.”
Here’s what’s going on. There’s a gentleman I read about online, who was dying of end-stage colon cancer. His wife and he were talking, knowing his death was coming, about what it would be like after his death. She said she would really miss being able to ask him questions about a variety of topics that he was expert at and that he knew very well.
He thought about it and decided, well, maybe he could record his voice and then use AI to search information that he would record and have available, which could really address questions that his wife might put to “him” once he was gone.
It turns out that a company was formed shortly thereafter, which is now offering the service both in the US and Europe, and in fact, I think perhaps even worldwide, basically saying we’ll record a dying person’s voice. We will help people grieve by allowing people to interact with the AI version of the departed when they’re gone.
It will be able to, if you will, search not just recorded information but anything they might have online — diaries, things they may have written, earlier videos, and information from earlier parts of their life — to generate plausible answers to questions that might be put to the artificial version of the deceased.
Obviously, this would allow not only spouses but grandchildren and people in future generations to have some way to interact with an ancestor who’s gone. It may allow people to feel comfort when they miss a loved one, to hear their voice, and not just in a prerecorded way but creatively interacting with them.
On the other hand, Is it all right if people wander from the truth in trying to interact with someone who’s died?
There are other ways to leave memories behind. You certainly can record messages so that you can control the content. Many people video themselves and so on. There are obviously people who would say that they have a diary or have written information they can leave behind.
Is there a place in terms of accuracy for a kind of artificial version of ourselves to go on forever? Another interesting issue is who controls that. Can you add to it after your death? Can information be shared about you with third parties who don’t sign up for the service? Maybe the police take an interest in how you died. You can imagine many scenarios where questions might come up about wanting to access these data that the artificial agent is providing.
Some people might say that it’s just not the way to grieve. Maybe the best way to grieve is to accept death and not try to interact with a constructed version of yourself once you’ve passed. That isn’t really accepting death. It’s a form, perhaps, of denial of death, and maybe that isn’t going to be good for the mental health of survivors who really have not come to terms with the fact that someone has passed on.
I’m not against these death bots or AI versions of trying to leave a legacy. There are all kinds of legacies that people might want to leave. While perhaps not 100% accurate, I can see how this technology has a use.
I do think one has to go in with their eyes open. We need consent before anything like this is really purchased by or sold to surviving people. They really have to understand it may not be an accurate version of what the deceased might have said in response to questions, conversations, or interactions.
I think we need to know who controls the information, who can erase it, and who can say, “I’m done with it, and I don’t want my husband’s AI to go on anymore.”
All that said, it’s an interesting development in a world in which I think those who are very ill might start to plan to leave a legacy that is more than just a diary or a video message. It becomes a kind of ongoing, artificial, interactive version of themselves that may provide some people with comfort.
Dr. Caplan, director of the Division of Medical Ethics at New York University Langone Medical Center, New York City, reported conflicts of interest with Johnson & Johnson and Medscape.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
I heard recently about a fascinating, important development in artificial intelligence (AI). All kinds of things are happening in AI. Clearly, it’s being used in the background to trace and keep track of medical information inside hospitals.
There are AI bots out there that are starting to talk to patients about, say, mental health issues. Plenty of people are using AI to get information about their medical condition, seeing it supplement search engines, and on and on AI goes.
It has entered into a space where I think patients may raise questions about whether they should use it or seek opinions from doctors and nurses, particularly those involved with seriously ill people. That space is grieving, and what might be called “death bots.”
Here’s what’s going on. There’s a gentleman I read about online, who was dying of end-stage colon cancer. His wife and he were talking, knowing his death was coming, about what it would be like after his death. She said she would really miss being able to ask him questions about a variety of topics that he was expert at and that he knew very well.
He thought about it and decided, well, maybe he could record his voice and then use AI to search information that he would record and have available, which could really address questions that his wife might put to “him” once he was gone.
It turns out that a company was formed shortly thereafter, which is now offering the service both in the US and Europe, and in fact, I think perhaps even worldwide, basically saying we’ll record a dying person’s voice. We will help people grieve by allowing people to interact with the AI version of the departed when they’re gone.
It will be able to, if you will, search not just recorded information but anything they might have online — diaries, things they may have written, earlier videos, and information from earlier parts of their life — to generate plausible answers to questions that might be put to the artificial version of the deceased.
Obviously, this would allow not only spouses but grandchildren and people in future generations to have some way to interact with an ancestor who’s gone. It may allow people to feel comfort when they miss a loved one, to hear their voice, and not just in a prerecorded way but creatively interacting with them.
On the other hand, Is it all right if people wander from the truth in trying to interact with someone who’s died?
There are other ways to leave memories behind. You certainly can record messages so that you can control the content. Many people video themselves and so on. There are obviously people who would say that they have a diary or have written information they can leave behind.
Is there a place in terms of accuracy for a kind of artificial version of ourselves to go on forever? Another interesting issue is who controls that. Can you add to it after your death? Can information be shared about you with third parties who don’t sign up for the service? Maybe the police take an interest in how you died. You can imagine many scenarios where questions might come up about wanting to access these data that the artificial agent is providing.
Some people might say that it’s just not the way to grieve. Maybe the best way to grieve is to accept death and not try to interact with a constructed version of yourself once you’ve passed. That isn’t really accepting death. It’s a form, perhaps, of denial of death, and maybe that isn’t going to be good for the mental health of survivors who really have not come to terms with the fact that someone has passed on.
I’m not against these death bots or AI versions of trying to leave a legacy. There are all kinds of legacies that people might want to leave. While perhaps not 100% accurate, I can see how this technology has a use.
I do think one has to go in with their eyes open. We need consent before anything like this is really purchased by or sold to surviving people. They really have to understand it may not be an accurate version of what the deceased might have said in response to questions, conversations, or interactions.
I think we need to know who controls the information, who can erase it, and who can say, “I’m done with it, and I don’t want my husband’s AI to go on anymore.”
All that said, it’s an interesting development in a world in which I think those who are very ill might start to plan to leave a legacy that is more than just a diary or a video message. It becomes a kind of ongoing, artificial, interactive version of themselves that may provide some people with comfort.
Dr. Caplan, director of the Division of Medical Ethics at New York University Langone Medical Center, New York City, reported conflicts of interest with Johnson & Johnson and Medscape.
A version of this article first appeared on Medscape.com.
Will Compounding ‘Best Practices’ Guide Reassure Clinicians?
A new “best practices” guide released by the Alliance for Pharmacy Compounding (APC) aims to educate compounding pharmacists and reassure prescribers about the ethical, legal, and practical considerations that must be addressed to ensure quality standards and protect patients’ health.
Endocrinologists have expressed skepticism about the quality of compounded drugs, particularly the popular glucagon-like peptide 1 (GLP-1) semaglutide. The Food and Drug Administration (FDA) recently issued an alert linking hospitalizations to overdoses of compounded semaglutide.
“This document goes beyond today’s media-grabbing shortages,” APC Board Chair-Elect Gina Besteman, RPh, of Belmar Pharma Solutions told this news organization. “We developed these best practices to apply to all shortage drug compounding, and especially in this moment when so many are compounding GLP-1s. These serve as a reminder about what compliance and care look like.”
Prescribers determine whether a patient needs a compounded medication, not pharmacists, Ms. Besteman noted. “A patient-specific prescription order must be authorized for a compounded medication to be dispensed. Prescribers should ensure pharmacies they work with regularly check the FDA Drug Shortage List, as compounding of ‘essential copies’ of FDA-approved drugs is only allowed when a drug is listed as ‘currently in shortage.’ ”
Framework for Compounding
“With fake and illegal online stores popping up, it’s critical for legitimate, state-licensed compounding pharmacies to maintain the profession’s high standards,” the APC said in a media communication.
Highlights of its best practices, which are directed toward 503A state-licensed compounding pharmacies, include the following, among others:
- Pharmacies should check the FDA drug shortage list prior to preparing a copy of an FDA-approved drug and maintain documentation to demonstrate to regulators that the drug was in shortage at the time it was compounded.
- Pharmacies may only source active pharmaceutical ingredients (APIs) from state-licensed wholesalers who purchase from FDA-registered manufacturers or order directly from FDA-registered manufacturers.
- Verify from the wholesaler that the manufacturer is registered with the FDA and the API meets all the requirements of section 503A, and that both hold the appropriate permits or licenses in their home state and the shipped to state.
- Adhere to USP Chapter <797> testing requirements for sterility, endotoxin, stability, particulate, antimicrobial effectiveness, and container closure integrity studies.
- Counseling must be offered to the patient or the patient’s agent/caregiver. Providing written information that assists in the understanding of how to properly use the compounded medication is advised.
- Instructions should be written in a way that a layperson can understand (especially directions including dosage titrations and conversions between milligrams and milliliters or units).
- Like all medications, compounded drugs can only be prescribed in the presence of a valid patient-practitioner relationship and can only be dispensed by a pharmacy after receipt of a valid patient-specific prescription order.
- When marketing, never make claims of safety or efficacy of the compounded product.
- Advertising that patients will/may save money using compounded medications, compared with manufactured products is not allowed.
“Compounding FDA-approved drugs during shortages is nothing new — pharmacies have been doing it well before GLP-1s came on the scene, and they’ll continue long after this current shortage ends,” Ms. Besteman said. “Prescribers should be aware of APC’s guidelines because they provide a framework for ethically and legally compounding medications during drug shortages.
“To paraphrase The Police,” she concluded, “every move you make, every step you take, they’ll be watching you. Make sure they see those best practices in action.”
‘Reduces the Risks’
Commenting on the best practices guidance, Ivania Rizo, MD, director of Obesity Medicine and Diabetes and clinical colead at Boston Medical Center’s Health Equity Accelerator in Massachusetts, said: “These best practices will hopefully make a difference in the quality of compounded drugs.”
“The emphasis on rigorous testing of APIs and adherence to USP standards is particularly important for maintaining drug quality,” she noted. “This structured approach reduces the risk of variability and ensures that compounded drugs meet high-quality standards, thus enhancing their reliability.”
“Knowing that compounding pharmacies are adhering to rigorous standards for sourcing, testing, and compounding can at least reassure clinicians that specific steps are being taken for the safety and efficacy of these medications,” she said. “The transparency in documenting compliance with FDA guidelines and maintaining high-quality control measures can enhance trust among healthcare providers.”
Although clinicians are likely to have more confidence in compounded drugs when these best practices are followed, she said, “overall, we all hope that the shortages of medications such as tirzepatide are resolved promptly, allowing patients to access FDA-approved drugs without the need for compounding.”
“While the implementation of best practices for compounding during shortages is a positive and necessary step, our ultimate goal remains to address and resolve these shortages in the near future,” she concluded.
Dr. Rizo declared no competing interests.
A version of this article first appeared on Medscape.com.
A new “best practices” guide released by the Alliance for Pharmacy Compounding (APC) aims to educate compounding pharmacists and reassure prescribers about the ethical, legal, and practical considerations that must be addressed to ensure quality standards and protect patients’ health.
Endocrinologists have expressed skepticism about the quality of compounded drugs, particularly the popular glucagon-like peptide 1 (GLP-1) semaglutide. The Food and Drug Administration (FDA) recently issued an alert linking hospitalizations to overdoses of compounded semaglutide.
“This document goes beyond today’s media-grabbing shortages,” APC Board Chair-Elect Gina Besteman, RPh, of Belmar Pharma Solutions told this news organization. “We developed these best practices to apply to all shortage drug compounding, and especially in this moment when so many are compounding GLP-1s. These serve as a reminder about what compliance and care look like.”
Prescribers determine whether a patient needs a compounded medication, not pharmacists, Ms. Besteman noted. “A patient-specific prescription order must be authorized for a compounded medication to be dispensed. Prescribers should ensure pharmacies they work with regularly check the FDA Drug Shortage List, as compounding of ‘essential copies’ of FDA-approved drugs is only allowed when a drug is listed as ‘currently in shortage.’ ”
Framework for Compounding
“With fake and illegal online stores popping up, it’s critical for legitimate, state-licensed compounding pharmacies to maintain the profession’s high standards,” the APC said in a media communication.
Highlights of its best practices, which are directed toward 503A state-licensed compounding pharmacies, include the following, among others:
- Pharmacies should check the FDA drug shortage list prior to preparing a copy of an FDA-approved drug and maintain documentation to demonstrate to regulators that the drug was in shortage at the time it was compounded.
- Pharmacies may only source active pharmaceutical ingredients (APIs) from state-licensed wholesalers who purchase from FDA-registered manufacturers or order directly from FDA-registered manufacturers.
- Verify from the wholesaler that the manufacturer is registered with the FDA and the API meets all the requirements of section 503A, and that both hold the appropriate permits or licenses in their home state and the shipped to state.
- Adhere to USP Chapter <797> testing requirements for sterility, endotoxin, stability, particulate, antimicrobial effectiveness, and container closure integrity studies.
- Counseling must be offered to the patient or the patient’s agent/caregiver. Providing written information that assists in the understanding of how to properly use the compounded medication is advised.
- Instructions should be written in a way that a layperson can understand (especially directions including dosage titrations and conversions between milligrams and milliliters or units).
- Like all medications, compounded drugs can only be prescribed in the presence of a valid patient-practitioner relationship and can only be dispensed by a pharmacy after receipt of a valid patient-specific prescription order.
- When marketing, never make claims of safety or efficacy of the compounded product.
- Advertising that patients will/may save money using compounded medications, compared with manufactured products is not allowed.
“Compounding FDA-approved drugs during shortages is nothing new — pharmacies have been doing it well before GLP-1s came on the scene, and they’ll continue long after this current shortage ends,” Ms. Besteman said. “Prescribers should be aware of APC’s guidelines because they provide a framework for ethically and legally compounding medications during drug shortages.
“To paraphrase The Police,” she concluded, “every move you make, every step you take, they’ll be watching you. Make sure they see those best practices in action.”
‘Reduces the Risks’
Commenting on the best practices guidance, Ivania Rizo, MD, director of Obesity Medicine and Diabetes and clinical colead at Boston Medical Center’s Health Equity Accelerator in Massachusetts, said: “These best practices will hopefully make a difference in the quality of compounded drugs.”
“The emphasis on rigorous testing of APIs and adherence to USP standards is particularly important for maintaining drug quality,” she noted. “This structured approach reduces the risk of variability and ensures that compounded drugs meet high-quality standards, thus enhancing their reliability.”
“Knowing that compounding pharmacies are adhering to rigorous standards for sourcing, testing, and compounding can at least reassure clinicians that specific steps are being taken for the safety and efficacy of these medications,” she said. “The transparency in documenting compliance with FDA guidelines and maintaining high-quality control measures can enhance trust among healthcare providers.”
Although clinicians are likely to have more confidence in compounded drugs when these best practices are followed, she said, “overall, we all hope that the shortages of medications such as tirzepatide are resolved promptly, allowing patients to access FDA-approved drugs without the need for compounding.”
“While the implementation of best practices for compounding during shortages is a positive and necessary step, our ultimate goal remains to address and resolve these shortages in the near future,” she concluded.
Dr. Rizo declared no competing interests.
A version of this article first appeared on Medscape.com.
A new “best practices” guide released by the Alliance for Pharmacy Compounding (APC) aims to educate compounding pharmacists and reassure prescribers about the ethical, legal, and practical considerations that must be addressed to ensure quality standards and protect patients’ health.
Endocrinologists have expressed skepticism about the quality of compounded drugs, particularly the popular glucagon-like peptide 1 (GLP-1) semaglutide. The Food and Drug Administration (FDA) recently issued an alert linking hospitalizations to overdoses of compounded semaglutide.
“This document goes beyond today’s media-grabbing shortages,” APC Board Chair-Elect Gina Besteman, RPh, of Belmar Pharma Solutions told this news organization. “We developed these best practices to apply to all shortage drug compounding, and especially in this moment when so many are compounding GLP-1s. These serve as a reminder about what compliance and care look like.”
Prescribers determine whether a patient needs a compounded medication, not pharmacists, Ms. Besteman noted. “A patient-specific prescription order must be authorized for a compounded medication to be dispensed. Prescribers should ensure pharmacies they work with regularly check the FDA Drug Shortage List, as compounding of ‘essential copies’ of FDA-approved drugs is only allowed when a drug is listed as ‘currently in shortage.’ ”
Framework for Compounding
“With fake and illegal online stores popping up, it’s critical for legitimate, state-licensed compounding pharmacies to maintain the profession’s high standards,” the APC said in a media communication.
Highlights of its best practices, which are directed toward 503A state-licensed compounding pharmacies, include the following, among others:
- Pharmacies should check the FDA drug shortage list prior to preparing a copy of an FDA-approved drug and maintain documentation to demonstrate to regulators that the drug was in shortage at the time it was compounded.
- Pharmacies may only source active pharmaceutical ingredients (APIs) from state-licensed wholesalers who purchase from FDA-registered manufacturers or order directly from FDA-registered manufacturers.
- Verify from the wholesaler that the manufacturer is registered with the FDA and the API meets all the requirements of section 503A, and that both hold the appropriate permits or licenses in their home state and the shipped to state.
- Adhere to USP Chapter <797> testing requirements for sterility, endotoxin, stability, particulate, antimicrobial effectiveness, and container closure integrity studies.
- Counseling must be offered to the patient or the patient’s agent/caregiver. Providing written information that assists in the understanding of how to properly use the compounded medication is advised.
- Instructions should be written in a way that a layperson can understand (especially directions including dosage titrations and conversions between milligrams and milliliters or units).
- Like all medications, compounded drugs can only be prescribed in the presence of a valid patient-practitioner relationship and can only be dispensed by a pharmacy after receipt of a valid patient-specific prescription order.
- When marketing, never make claims of safety or efficacy of the compounded product.
- Advertising that patients will/may save money using compounded medications, compared with manufactured products is not allowed.
“Compounding FDA-approved drugs during shortages is nothing new — pharmacies have been doing it well before GLP-1s came on the scene, and they’ll continue long after this current shortage ends,” Ms. Besteman said. “Prescribers should be aware of APC’s guidelines because they provide a framework for ethically and legally compounding medications during drug shortages.
“To paraphrase The Police,” she concluded, “every move you make, every step you take, they’ll be watching you. Make sure they see those best practices in action.”
‘Reduces the Risks’
Commenting on the best practices guidance, Ivania Rizo, MD, director of Obesity Medicine and Diabetes and clinical colead at Boston Medical Center’s Health Equity Accelerator in Massachusetts, said: “These best practices will hopefully make a difference in the quality of compounded drugs.”
“The emphasis on rigorous testing of APIs and adherence to USP standards is particularly important for maintaining drug quality,” she noted. “This structured approach reduces the risk of variability and ensures that compounded drugs meet high-quality standards, thus enhancing their reliability.”
“Knowing that compounding pharmacies are adhering to rigorous standards for sourcing, testing, and compounding can at least reassure clinicians that specific steps are being taken for the safety and efficacy of these medications,” she said. “The transparency in documenting compliance with FDA guidelines and maintaining high-quality control measures can enhance trust among healthcare providers.”
Although clinicians are likely to have more confidence in compounded drugs when these best practices are followed, she said, “overall, we all hope that the shortages of medications such as tirzepatide are resolved promptly, allowing patients to access FDA-approved drugs without the need for compounding.”
“While the implementation of best practices for compounding during shortages is a positive and necessary step, our ultimate goal remains to address and resolve these shortages in the near future,” she concluded.
Dr. Rizo declared no competing interests.
A version of this article first appeared on Medscape.com.
Commentary: Migraine and Lifestyle Factors, September 2024
Migraine pathophysiology has been shown to be associated with vascular and inflammatory processes. Diet and lifestyle can have an effect on an individual's inflammatory process, and research regarding the steps between these factors and inflammation is vague and nonspecific. The Dietary Inflammation Score (DIS), which is calculated on the basis of a questionnaire, is used to score the inflammatory potential of an individual's diet. The Dietary and Lifestyle Inflammation Score (DLIS) includes the DIS questions, and also incorporates body mass index (BMI), physical activity, smoking, and alcohol consumption. A recent study, based on a secondary analysis of previous data, examined the correlation between migraine and DIS and DLIS among 285 women, 40% of whom had a chronic migraine diagnosis. Results published in Scientific Reports in July 2024 noted that participants with chronic migraine had a significantly higher DIS and DLIS than those who were not diagnosed with chronic migraine. It is important to note that migraine-associated inflammation can also result from genetic factors. A previous study, published in 2023 in Nature Genetics, described a correlation between genetic markers of inflammatory disorders, such as endometriosis, asthma, and migraine.1 These results, consistent with our current understanding of the genetic contribution to migraine risk, emphasize that lifestyle modifications alone are not usually adequate for complete management of migraines.
Patients who experience chronic migraine may be inclined to reduce their time spent exercising and engaging in physical activity, as these activities can exacerbate migraine symptoms. Additionally, after recovering from a migraine, patients often need to catch up on tasks and responsibilities, which can squeeze out time for physical activity and exercise (often considered luxuries that can be done during leisure time). Results of a small cross-sectional retrospective study published in Scientific Reports in 2024 suggested a correlation between daily walking steps and response to calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb). According to the study, which included 22 patients who were diagnosed with migraine and treated with CGRP mAb, patients who experienced an improvement of their migraine symptoms also increased their average daily steps by almost 1000 steps per day. The authors suggested that steps can be used as a marker of treatment response in migraine.
Screen time is often blamed as a cause for a number of different ailments, including obesity, anxiety, depression, insomnia, and migraine. An article published in June 2024 in European Journal of Pain described results of a meta-analysis examining the association between sedentary lifestyle and migraine. The authors noted that time spent watching television could be causally associated with an increased risk for migraine.2Another study, with results published in July 2024 in The Journal of Headache and Pain, examined the relationship between migraine and leisure screen time. The researchers used data from 661,399 European individuals from 53 studies to look at genetically predicted leisure screen time, rather than actual leisure screen time. They reported that genetically predicted leisure screen time was associated with a 27.7% increase in migraine risk. While the results are consistent with what is already widely accepted about screen time and migraine, the inclusion of genetic predisposition to screen time is interesting in suggesting that some underlying drive could be contributing to increased screen time among patients who have migraine.
The results of these studies reemphasize the importance of the link between lifestyle factors and migraine but warn against oversimplifying the correlation. There is a bidirectional relationship between migraine and inflammation. We know that inflammation is mediated by diet as well as physical activity. During a migraine, patients may turn to foods that have a high inflammatory potential. Furthermore, migraine can influence a person's inclination to participate in physical activity, as the pain and discomfort can make it difficult engage in exercise. During a migraine, patients may prefer sedentary activities. Screen time can be appealing or relaxing while recovering from a migraine. Genetic predisposition is an interesting additional contributor to this link. Acknowledging genetic predisposition to inflammation or sedentary activity can be a step in helping patients recognize that it could be challenging to overcome these genetically inherent drives or conditions, while providing encouragement regarding the potential benefits of doing so.
Additional References
1. Rahmioglu N, Mortlock S, Ghiasi M, et al. The genetic basis of endometriosis and comorbidity with other pain and inflammatory conditions. Nat Genet. 2023;55(3):423-436. Doi: 10.1038/s41588-023-01323-z Source
2. Li P, Li J, Zhu H, et al. Causal effects of sedentary behaviours on the risk of migraine: A univariable and multivariable Mendelian randomization study. Eur J Pain. 2024 (Jun 4). Doi: 10.1002/ejp.2296 Source
Migraine pathophysiology has been shown to be associated with vascular and inflammatory processes. Diet and lifestyle can have an effect on an individual's inflammatory process, and research regarding the steps between these factors and inflammation is vague and nonspecific. The Dietary Inflammation Score (DIS), which is calculated on the basis of a questionnaire, is used to score the inflammatory potential of an individual's diet. The Dietary and Lifestyle Inflammation Score (DLIS) includes the DIS questions, and also incorporates body mass index (BMI), physical activity, smoking, and alcohol consumption. A recent study, based on a secondary analysis of previous data, examined the correlation between migraine and DIS and DLIS among 285 women, 40% of whom had a chronic migraine diagnosis. Results published in Scientific Reports in July 2024 noted that participants with chronic migraine had a significantly higher DIS and DLIS than those who were not diagnosed with chronic migraine. It is important to note that migraine-associated inflammation can also result from genetic factors. A previous study, published in 2023 in Nature Genetics, described a correlation between genetic markers of inflammatory disorders, such as endometriosis, asthma, and migraine.1 These results, consistent with our current understanding of the genetic contribution to migraine risk, emphasize that lifestyle modifications alone are not usually adequate for complete management of migraines.
Patients who experience chronic migraine may be inclined to reduce their time spent exercising and engaging in physical activity, as these activities can exacerbate migraine symptoms. Additionally, after recovering from a migraine, patients often need to catch up on tasks and responsibilities, which can squeeze out time for physical activity and exercise (often considered luxuries that can be done during leisure time). Results of a small cross-sectional retrospective study published in Scientific Reports in 2024 suggested a correlation between daily walking steps and response to calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb). According to the study, which included 22 patients who were diagnosed with migraine and treated with CGRP mAb, patients who experienced an improvement of their migraine symptoms also increased their average daily steps by almost 1000 steps per day. The authors suggested that steps can be used as a marker of treatment response in migraine.
Screen time is often blamed as a cause for a number of different ailments, including obesity, anxiety, depression, insomnia, and migraine. An article published in June 2024 in European Journal of Pain described results of a meta-analysis examining the association between sedentary lifestyle and migraine. The authors noted that time spent watching television could be causally associated with an increased risk for migraine.2Another study, with results published in July 2024 in The Journal of Headache and Pain, examined the relationship between migraine and leisure screen time. The researchers used data from 661,399 European individuals from 53 studies to look at genetically predicted leisure screen time, rather than actual leisure screen time. They reported that genetically predicted leisure screen time was associated with a 27.7% increase in migraine risk. While the results are consistent with what is already widely accepted about screen time and migraine, the inclusion of genetic predisposition to screen time is interesting in suggesting that some underlying drive could be contributing to increased screen time among patients who have migraine.
The results of these studies reemphasize the importance of the link between lifestyle factors and migraine but warn against oversimplifying the correlation. There is a bidirectional relationship between migraine and inflammation. We know that inflammation is mediated by diet as well as physical activity. During a migraine, patients may turn to foods that have a high inflammatory potential. Furthermore, migraine can influence a person's inclination to participate in physical activity, as the pain and discomfort can make it difficult engage in exercise. During a migraine, patients may prefer sedentary activities. Screen time can be appealing or relaxing while recovering from a migraine. Genetic predisposition is an interesting additional contributor to this link. Acknowledging genetic predisposition to inflammation or sedentary activity can be a step in helping patients recognize that it could be challenging to overcome these genetically inherent drives or conditions, while providing encouragement regarding the potential benefits of doing so.
Additional References
1. Rahmioglu N, Mortlock S, Ghiasi M, et al. The genetic basis of endometriosis and comorbidity with other pain and inflammatory conditions. Nat Genet. 2023;55(3):423-436. Doi: 10.1038/s41588-023-01323-z Source
2. Li P, Li J, Zhu H, et al. Causal effects of sedentary behaviours on the risk of migraine: A univariable and multivariable Mendelian randomization study. Eur J Pain. 2024 (Jun 4). Doi: 10.1002/ejp.2296 Source
Migraine pathophysiology has been shown to be associated with vascular and inflammatory processes. Diet and lifestyle can have an effect on an individual's inflammatory process, and research regarding the steps between these factors and inflammation is vague and nonspecific. The Dietary Inflammation Score (DIS), which is calculated on the basis of a questionnaire, is used to score the inflammatory potential of an individual's diet. The Dietary and Lifestyle Inflammation Score (DLIS) includes the DIS questions, and also incorporates body mass index (BMI), physical activity, smoking, and alcohol consumption. A recent study, based on a secondary analysis of previous data, examined the correlation between migraine and DIS and DLIS among 285 women, 40% of whom had a chronic migraine diagnosis. Results published in Scientific Reports in July 2024 noted that participants with chronic migraine had a significantly higher DIS and DLIS than those who were not diagnosed with chronic migraine. It is important to note that migraine-associated inflammation can also result from genetic factors. A previous study, published in 2023 in Nature Genetics, described a correlation between genetic markers of inflammatory disorders, such as endometriosis, asthma, and migraine.1 These results, consistent with our current understanding of the genetic contribution to migraine risk, emphasize that lifestyle modifications alone are not usually adequate for complete management of migraines.
Patients who experience chronic migraine may be inclined to reduce their time spent exercising and engaging in physical activity, as these activities can exacerbate migraine symptoms. Additionally, after recovering from a migraine, patients often need to catch up on tasks and responsibilities, which can squeeze out time for physical activity and exercise (often considered luxuries that can be done during leisure time). Results of a small cross-sectional retrospective study published in Scientific Reports in 2024 suggested a correlation between daily walking steps and response to calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb). According to the study, which included 22 patients who were diagnosed with migraine and treated with CGRP mAb, patients who experienced an improvement of their migraine symptoms also increased their average daily steps by almost 1000 steps per day. The authors suggested that steps can be used as a marker of treatment response in migraine.
Screen time is often blamed as a cause for a number of different ailments, including obesity, anxiety, depression, insomnia, and migraine. An article published in June 2024 in European Journal of Pain described results of a meta-analysis examining the association between sedentary lifestyle and migraine. The authors noted that time spent watching television could be causally associated with an increased risk for migraine.2Another study, with results published in July 2024 in The Journal of Headache and Pain, examined the relationship between migraine and leisure screen time. The researchers used data from 661,399 European individuals from 53 studies to look at genetically predicted leisure screen time, rather than actual leisure screen time. They reported that genetically predicted leisure screen time was associated with a 27.7% increase in migraine risk. While the results are consistent with what is already widely accepted about screen time and migraine, the inclusion of genetic predisposition to screen time is interesting in suggesting that some underlying drive could be contributing to increased screen time among patients who have migraine.
The results of these studies reemphasize the importance of the link between lifestyle factors and migraine but warn against oversimplifying the correlation. There is a bidirectional relationship between migraine and inflammation. We know that inflammation is mediated by diet as well as physical activity. During a migraine, patients may turn to foods that have a high inflammatory potential. Furthermore, migraine can influence a person's inclination to participate in physical activity, as the pain and discomfort can make it difficult engage in exercise. During a migraine, patients may prefer sedentary activities. Screen time can be appealing or relaxing while recovering from a migraine. Genetic predisposition is an interesting additional contributor to this link. Acknowledging genetic predisposition to inflammation or sedentary activity can be a step in helping patients recognize that it could be challenging to overcome these genetically inherent drives or conditions, while providing encouragement regarding the potential benefits of doing so.
Additional References
1. Rahmioglu N, Mortlock S, Ghiasi M, et al. The genetic basis of endometriosis and comorbidity with other pain and inflammatory conditions. Nat Genet. 2023;55(3):423-436. Doi: 10.1038/s41588-023-01323-z Source
2. Li P, Li J, Zhu H, et al. Causal effects of sedentary behaviours on the risk of migraine: A univariable and multivariable Mendelian randomization study. Eur J Pain. 2024 (Jun 4). Doi: 10.1002/ejp.2296 Source
Recommended Use of Anticoagulant Reversal in Bleeding Events
The number of patients treated with anticoagulants has significantly increased over the past decade, largely owing to the introduction of direct oral anticoagulants (DOACs). Currently, more than 6 million people nationwide are taking anticoagulants; these include patients receiving care through the Veterans Health Administration.
However, the growing use of oral anticoagulants has been accompanied by a rise in anticoagulant-related bleeding incidents. Dr Geoffrey Barnes from the University of Michigan discusses strategies to assess and manage bleeding events, and he reviews the most current recommendations on the appropriate selection and use of anticoagulation reversal agents.
Dr Barnes also underscores the importance of monitoring for thromboembolic complications in patients treated for life-threatening bleeding to prevent post-bleed thromboembolic events.
--
Associate Professor, Frankel Cardiovascular Center, University of Michigan, Ann Arbor, Michigan
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Pfizer; Bristol-Myers Squibb; Janssen; Bayer; AstraZeneca; Sanofi; Anthos; Abbott Vascular; Boston Scientific
Received research grant from: Boston Scientific
The number of patients treated with anticoagulants has significantly increased over the past decade, largely owing to the introduction of direct oral anticoagulants (DOACs). Currently, more than 6 million people nationwide are taking anticoagulants; these include patients receiving care through the Veterans Health Administration.
However, the growing use of oral anticoagulants has been accompanied by a rise in anticoagulant-related bleeding incidents. Dr Geoffrey Barnes from the University of Michigan discusses strategies to assess and manage bleeding events, and he reviews the most current recommendations on the appropriate selection and use of anticoagulation reversal agents.
Dr Barnes also underscores the importance of monitoring for thromboembolic complications in patients treated for life-threatening bleeding to prevent post-bleed thromboembolic events.
--
Associate Professor, Frankel Cardiovascular Center, University of Michigan, Ann Arbor, Michigan
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Pfizer; Bristol-Myers Squibb; Janssen; Bayer; AstraZeneca; Sanofi; Anthos; Abbott Vascular; Boston Scientific
Received research grant from: Boston Scientific
The number of patients treated with anticoagulants has significantly increased over the past decade, largely owing to the introduction of direct oral anticoagulants (DOACs). Currently, more than 6 million people nationwide are taking anticoagulants; these include patients receiving care through the Veterans Health Administration.
However, the growing use of oral anticoagulants has been accompanied by a rise in anticoagulant-related bleeding incidents. Dr Geoffrey Barnes from the University of Michigan discusses strategies to assess and manage bleeding events, and he reviews the most current recommendations on the appropriate selection and use of anticoagulation reversal agents.
Dr Barnes also underscores the importance of monitoring for thromboembolic complications in patients treated for life-threatening bleeding to prevent post-bleed thromboembolic events.
--
Associate Professor, Frankel Cardiovascular Center, University of Michigan, Ann Arbor, Michigan
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Pfizer; Bristol-Myers Squibb; Janssen; Bayer; AstraZeneca; Sanofi; Anthos; Abbott Vascular; Boston Scientific
Received research grant from: Boston Scientific
Do You Have Patients With JAKne — JAK Inhibitor–Associated Acne? Here’s What to Know
Since the first Food and Drug Administration approval of a Janus kinase (JAK) inhibitor in 2011, the number of these medications available — and their treatment indications — have continued to grow. Prescribing physicians are familiar with the benefits and risks for these drugs, including higher risk for cardiac events and malignancy; however, one adverse effect may be overlooked, especially by specialties outside of dermatology: acne. Though less serious than some other side effects, JAK inhibitor–associated acne — JAKne, for short — can be a concern for patients.
“Your physical appearance and how you present yourself to the world is an important part of your self-confidence and living life on your own terms,” said Arash Mostaghimi, MD, the director of inpatient dermatology at Brigham and Women’s Hospital in Boston, Massachusetts. “I think letting people know about [JAKne] and then addressing it when it occurs should be a normal part of managing these medications.”
What Is JAKne?
JAKne generally looks like other kinds of acne, explained Janelle Nassim, MD, director of laser and cosmetic dermatology at the Indiana University School of Medicine, Indianapolis. “It can affect the same areas that typical acne affects, including the face, chest, back, neck, and upper shoulders.”
Though it appears like typical forms of acne, it is not clear what drives these skin eruptions in patients taking JAK inhibitors.
“We don’t understand the underlying pathophysiology,” Dr. Mostaghimi said. “It looks like acne, but we don’t know if the exact underlying inflammatory process is the same or if it’s different.”
In a 2023 systematic review of clinical studies, Dr. Mostaghimi and colleagues found that patients on any JAK inhibitor were nearly four times more likely to experience acne than patients who received placebo, but risk varied between medications. Patients taking JAK inhibitors for skin conditions had higher risk for acne than those given the medications for other indications. However, Dr. Mostaghimi thinks this finding is the result of selection bias.
Participants may not mention side effects like acne in trials for rheumatologic or gastrointestinal conditions, he said, unlike in trials for skin conditions. “Clinically, I’ve seen it in patients across every indication.”
Patients with a history of acne seem to be more likely to develop this side effect, though formal studies looking into risk factors are lacking. In Dr. Mostaghimi’s own clinical experience, JAKne is also more common in younger patients, but it can happen to anyone. “I’ve seen 70-year-olds develop acne — patients who’ve never had an issue their whole life — when they’re taking a JAK inhibitor.”
This issue also appears to be more common earlier in treatment, he added, and may improve over time as a patient continues with the medication.
How Do You Treat It?
“I think in other specialties, you will often feel awkward addressing skin conditions or pointing out acne,” Dr. Mostaghimi said. The most important steps are being aware of this potential side effect, and if you see it practice, to bring it up.
“Say: I’m noticing there’s some changes in your skin. Some patients on JAK inhibitors develop more acne. Have you noticed this? And if so, is this bothering you?”
Generally, JAKne is mild to moderate, explained Dr. Nassim, and if non-dermatologists are comfortable, they can prescribe a first-line topical regimen for patients. Dr. Mostaghimi recommends prescribing a clindamycin 1% lotion or gel. In addition, patients can use a benzoyl peroxide wash (4% or 10%) combined with a gentle retinoid, such as adapalene. (Both of these treatments are now available over the counter.)
In patients with scalp or hairline involvement, he often prescribes a ketoconazole 2% shampoo, which patients can use to wash their scalp, face, chest, and back in the shower.
If they aren’t responding to these initial treatments, then refer to a dermatologist for further assessment.
“Ultimately, referring to a dermatologist is the best course of action,” Dr. Nassim said. “I have had patients on JAK inhibitors who improved with topical acne treatments, and some that required more aggressive treatment with oral medications.”
Dr. Mostaghimi reported consulting fees from AbbVie, Concert Pharmaceuticals, Pfizer, and 3Derm Systems; research funding from Incyte, Aclaris Therapeutics, Eli Lilly, and Concert Pharmaceuticals; personal fees from Equillium, ASLAN Pharmaceuticals, ACOM, and Boehringer Ingelheim; and advisory board fees from Fig.1 Beauty, Eli Lilly, Pfizer, and Hims & Hers Health. Dr. Nassim had no relevant disclosures.
A version of this article first appeared on Medscape.com.
Since the first Food and Drug Administration approval of a Janus kinase (JAK) inhibitor in 2011, the number of these medications available — and their treatment indications — have continued to grow. Prescribing physicians are familiar with the benefits and risks for these drugs, including higher risk for cardiac events and malignancy; however, one adverse effect may be overlooked, especially by specialties outside of dermatology: acne. Though less serious than some other side effects, JAK inhibitor–associated acne — JAKne, for short — can be a concern for patients.
“Your physical appearance and how you present yourself to the world is an important part of your self-confidence and living life on your own terms,” said Arash Mostaghimi, MD, the director of inpatient dermatology at Brigham and Women’s Hospital in Boston, Massachusetts. “I think letting people know about [JAKne] and then addressing it when it occurs should be a normal part of managing these medications.”
What Is JAKne?
JAKne generally looks like other kinds of acne, explained Janelle Nassim, MD, director of laser and cosmetic dermatology at the Indiana University School of Medicine, Indianapolis. “It can affect the same areas that typical acne affects, including the face, chest, back, neck, and upper shoulders.”
Though it appears like typical forms of acne, it is not clear what drives these skin eruptions in patients taking JAK inhibitors.
“We don’t understand the underlying pathophysiology,” Dr. Mostaghimi said. “It looks like acne, but we don’t know if the exact underlying inflammatory process is the same or if it’s different.”
In a 2023 systematic review of clinical studies, Dr. Mostaghimi and colleagues found that patients on any JAK inhibitor were nearly four times more likely to experience acne than patients who received placebo, but risk varied between medications. Patients taking JAK inhibitors for skin conditions had higher risk for acne than those given the medications for other indications. However, Dr. Mostaghimi thinks this finding is the result of selection bias.
Participants may not mention side effects like acne in trials for rheumatologic or gastrointestinal conditions, he said, unlike in trials for skin conditions. “Clinically, I’ve seen it in patients across every indication.”
Patients with a history of acne seem to be more likely to develop this side effect, though formal studies looking into risk factors are lacking. In Dr. Mostaghimi’s own clinical experience, JAKne is also more common in younger patients, but it can happen to anyone. “I’ve seen 70-year-olds develop acne — patients who’ve never had an issue their whole life — when they’re taking a JAK inhibitor.”
This issue also appears to be more common earlier in treatment, he added, and may improve over time as a patient continues with the medication.
How Do You Treat It?
“I think in other specialties, you will often feel awkward addressing skin conditions or pointing out acne,” Dr. Mostaghimi said. The most important steps are being aware of this potential side effect, and if you see it practice, to bring it up.
“Say: I’m noticing there’s some changes in your skin. Some patients on JAK inhibitors develop more acne. Have you noticed this? And if so, is this bothering you?”
Generally, JAKne is mild to moderate, explained Dr. Nassim, and if non-dermatologists are comfortable, they can prescribe a first-line topical regimen for patients. Dr. Mostaghimi recommends prescribing a clindamycin 1% lotion or gel. In addition, patients can use a benzoyl peroxide wash (4% or 10%) combined with a gentle retinoid, such as adapalene. (Both of these treatments are now available over the counter.)
In patients with scalp or hairline involvement, he often prescribes a ketoconazole 2% shampoo, which patients can use to wash their scalp, face, chest, and back in the shower.
If they aren’t responding to these initial treatments, then refer to a dermatologist for further assessment.
“Ultimately, referring to a dermatologist is the best course of action,” Dr. Nassim said. “I have had patients on JAK inhibitors who improved with topical acne treatments, and some that required more aggressive treatment with oral medications.”
Dr. Mostaghimi reported consulting fees from AbbVie, Concert Pharmaceuticals, Pfizer, and 3Derm Systems; research funding from Incyte, Aclaris Therapeutics, Eli Lilly, and Concert Pharmaceuticals; personal fees from Equillium, ASLAN Pharmaceuticals, ACOM, and Boehringer Ingelheim; and advisory board fees from Fig.1 Beauty, Eli Lilly, Pfizer, and Hims & Hers Health. Dr. Nassim had no relevant disclosures.
A version of this article first appeared on Medscape.com.
Since the first Food and Drug Administration approval of a Janus kinase (JAK) inhibitor in 2011, the number of these medications available — and their treatment indications — have continued to grow. Prescribing physicians are familiar with the benefits and risks for these drugs, including higher risk for cardiac events and malignancy; however, one adverse effect may be overlooked, especially by specialties outside of dermatology: acne. Though less serious than some other side effects, JAK inhibitor–associated acne — JAKne, for short — can be a concern for patients.
“Your physical appearance and how you present yourself to the world is an important part of your self-confidence and living life on your own terms,” said Arash Mostaghimi, MD, the director of inpatient dermatology at Brigham and Women’s Hospital in Boston, Massachusetts. “I think letting people know about [JAKne] and then addressing it when it occurs should be a normal part of managing these medications.”
What Is JAKne?
JAKne generally looks like other kinds of acne, explained Janelle Nassim, MD, director of laser and cosmetic dermatology at the Indiana University School of Medicine, Indianapolis. “It can affect the same areas that typical acne affects, including the face, chest, back, neck, and upper shoulders.”
Though it appears like typical forms of acne, it is not clear what drives these skin eruptions in patients taking JAK inhibitors.
“We don’t understand the underlying pathophysiology,” Dr. Mostaghimi said. “It looks like acne, but we don’t know if the exact underlying inflammatory process is the same or if it’s different.”
In a 2023 systematic review of clinical studies, Dr. Mostaghimi and colleagues found that patients on any JAK inhibitor were nearly four times more likely to experience acne than patients who received placebo, but risk varied between medications. Patients taking JAK inhibitors for skin conditions had higher risk for acne than those given the medications for other indications. However, Dr. Mostaghimi thinks this finding is the result of selection bias.
Participants may not mention side effects like acne in trials for rheumatologic or gastrointestinal conditions, he said, unlike in trials for skin conditions. “Clinically, I’ve seen it in patients across every indication.”
Patients with a history of acne seem to be more likely to develop this side effect, though formal studies looking into risk factors are lacking. In Dr. Mostaghimi’s own clinical experience, JAKne is also more common in younger patients, but it can happen to anyone. “I’ve seen 70-year-olds develop acne — patients who’ve never had an issue their whole life — when they’re taking a JAK inhibitor.”
This issue also appears to be more common earlier in treatment, he added, and may improve over time as a patient continues with the medication.
How Do You Treat It?
“I think in other specialties, you will often feel awkward addressing skin conditions or pointing out acne,” Dr. Mostaghimi said. The most important steps are being aware of this potential side effect, and if you see it practice, to bring it up.
“Say: I’m noticing there’s some changes in your skin. Some patients on JAK inhibitors develop more acne. Have you noticed this? And if so, is this bothering you?”
Generally, JAKne is mild to moderate, explained Dr. Nassim, and if non-dermatologists are comfortable, they can prescribe a first-line topical regimen for patients. Dr. Mostaghimi recommends prescribing a clindamycin 1% lotion or gel. In addition, patients can use a benzoyl peroxide wash (4% or 10%) combined with a gentle retinoid, such as adapalene. (Both of these treatments are now available over the counter.)
In patients with scalp or hairline involvement, he often prescribes a ketoconazole 2% shampoo, which patients can use to wash their scalp, face, chest, and back in the shower.
If they aren’t responding to these initial treatments, then refer to a dermatologist for further assessment.
“Ultimately, referring to a dermatologist is the best course of action,” Dr. Nassim said. “I have had patients on JAK inhibitors who improved with topical acne treatments, and some that required more aggressive treatment with oral medications.”
Dr. Mostaghimi reported consulting fees from AbbVie, Concert Pharmaceuticals, Pfizer, and 3Derm Systems; research funding from Incyte, Aclaris Therapeutics, Eli Lilly, and Concert Pharmaceuticals; personal fees from Equillium, ASLAN Pharmaceuticals, ACOM, and Boehringer Ingelheim; and advisory board fees from Fig.1 Beauty, Eli Lilly, Pfizer, and Hims & Hers Health. Dr. Nassim had no relevant disclosures.
A version of this article first appeared on Medscape.com.