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Experimental Topical Drug Shows Promise for Atopic Dermatitis and Plaque Psoriasis
, results from a phase 2a study showed.
PDE4 inhibitors are a promising therapeutic target for inflammatory diseases because “they can increase cyclic adenosine monophosphate levels and subsequently reduce the production of proinflammatory cytokines,” lead study author Lawrence F. Eichenfield, MD, of the dermatology department at the University of California, San Diego, and colleagues wrote. The paper was published online in JAMA Dermatology.
Currently Available Treatments
For plaque psoriasis, the FDA approved the topical PDE4 inhibitor roflumilast in 2022. The oral PDE4 inhibitor apremilast has shown to be effective for plaque psoriasis and is well tolerated, and “it has been associated with gastrointestinal adverse events (AEs) such as nausea and diarrhea,” the researchers wrote.
For AD, crisaborole is the only approved topical PDE4 treatment, and it is associated with application site burning and stinging, they wrote.
An Experimental Alternative
The new study tested a topical PDE4 inhibitor known as PF-07038124, which is being developed by Pfizer. It is designed to be “a potent, oxaborole-based PDE4 inhibitor [that shows] immunomodulatory activity in T-cell–based assays, contributing to inhibition of [interleukin]-4 and IL-13; thus, it could provide therapeutic benefit in the treatment of AD and plaque psoriasis,” the authors wrote.
The phase 2a study was conducted from December 21, 2020, to August 18, 2021. Researchers at 34 sites in four countries randomized 104 patients with mild to moderate AD (70) or plaque psoriasis (34) to receive PF-07038124 as a 0.001% topical ointment or a vehicle only once daily for 6 weeks.
The primary end point was the percent change from baseline in the Eczema Area and Severity Index (EASI) total score among patients with AD and in the Psoriasis Area and Severity Index (PASI) score among patients with plaque psoriasis at week 6. Safety measures of interest included treatment-emergent adverse events.
Overall, the mean age of the 104 patients was 43 years, 52.9%, were women, 3.8% were Asian, 12.5% were Black, and 83.7% were White. Most had moderate disease.
At week 6 in patients with AD, the PF-07038124 group showed statistically significantly greater improvement in the EASI total score, compared with vehicle group (−74.9% vs −35.5% respectively; least squares mean [LSM] difference, −39.4%; 90% CI, −58.8% to−20.1%]; P < .001).
Similarly, at week 6 in patients with plaque psoriasis, the PF-07038124 group demonstrated a significantly greater improvement in the PASI total score, compared with the vehicle group (LSM, −4.8; 90% CI, −6.2 to −3.4] vs 0.1; 90% CI, −1.5 to 1.7), for a difference of −4.9; 90% CI, −7.0 to −2.8; P < .001.
In safety outcomes, treatment-emergent adverse events were reported in 16 people receiving PF-07038124 and 26 people receiving a vehicle. The treatment-related adverse events were reported only in the vehicle groups across all indications, while no patients in the PF-07038124 groups experienced pain or skin reactions at the application sites.
The researchers acknowledged certain limitations of the trial, including its small size and the 6-week treatment period. “Unlike crisaborole, topical PF-07038124 was not associated with application site burning and stinging,” they noted. “To confirm persistence of efficacy and the safety profile of PF-07038124, long-term data should be collected in larger studies.”
Pfizer supported the study. Dr. Eichenfield reported receiving personal fees from Pfizer during the conduct of the study. He also has received grant support from, is consultant to, and/or is a member of the advisory board for many other pharmaceutical companies. Several other study authors reported similar disclosures.
, results from a phase 2a study showed.
PDE4 inhibitors are a promising therapeutic target for inflammatory diseases because “they can increase cyclic adenosine monophosphate levels and subsequently reduce the production of proinflammatory cytokines,” lead study author Lawrence F. Eichenfield, MD, of the dermatology department at the University of California, San Diego, and colleagues wrote. The paper was published online in JAMA Dermatology.
Currently Available Treatments
For plaque psoriasis, the FDA approved the topical PDE4 inhibitor roflumilast in 2022. The oral PDE4 inhibitor apremilast has shown to be effective for plaque psoriasis and is well tolerated, and “it has been associated with gastrointestinal adverse events (AEs) such as nausea and diarrhea,” the researchers wrote.
For AD, crisaborole is the only approved topical PDE4 treatment, and it is associated with application site burning and stinging, they wrote.
An Experimental Alternative
The new study tested a topical PDE4 inhibitor known as PF-07038124, which is being developed by Pfizer. It is designed to be “a potent, oxaborole-based PDE4 inhibitor [that shows] immunomodulatory activity in T-cell–based assays, contributing to inhibition of [interleukin]-4 and IL-13; thus, it could provide therapeutic benefit in the treatment of AD and plaque psoriasis,” the authors wrote.
The phase 2a study was conducted from December 21, 2020, to August 18, 2021. Researchers at 34 sites in four countries randomized 104 patients with mild to moderate AD (70) or plaque psoriasis (34) to receive PF-07038124 as a 0.001% topical ointment or a vehicle only once daily for 6 weeks.
The primary end point was the percent change from baseline in the Eczema Area and Severity Index (EASI) total score among patients with AD and in the Psoriasis Area and Severity Index (PASI) score among patients with plaque psoriasis at week 6. Safety measures of interest included treatment-emergent adverse events.
Overall, the mean age of the 104 patients was 43 years, 52.9%, were women, 3.8% were Asian, 12.5% were Black, and 83.7% were White. Most had moderate disease.
At week 6 in patients with AD, the PF-07038124 group showed statistically significantly greater improvement in the EASI total score, compared with vehicle group (−74.9% vs −35.5% respectively; least squares mean [LSM] difference, −39.4%; 90% CI, −58.8% to−20.1%]; P < .001).
Similarly, at week 6 in patients with plaque psoriasis, the PF-07038124 group demonstrated a significantly greater improvement in the PASI total score, compared with the vehicle group (LSM, −4.8; 90% CI, −6.2 to −3.4] vs 0.1; 90% CI, −1.5 to 1.7), for a difference of −4.9; 90% CI, −7.0 to −2.8; P < .001.
In safety outcomes, treatment-emergent adverse events were reported in 16 people receiving PF-07038124 and 26 people receiving a vehicle. The treatment-related adverse events were reported only in the vehicle groups across all indications, while no patients in the PF-07038124 groups experienced pain or skin reactions at the application sites.
The researchers acknowledged certain limitations of the trial, including its small size and the 6-week treatment period. “Unlike crisaborole, topical PF-07038124 was not associated with application site burning and stinging,” they noted. “To confirm persistence of efficacy and the safety profile of PF-07038124, long-term data should be collected in larger studies.”
Pfizer supported the study. Dr. Eichenfield reported receiving personal fees from Pfizer during the conduct of the study. He also has received grant support from, is consultant to, and/or is a member of the advisory board for many other pharmaceutical companies. Several other study authors reported similar disclosures.
, results from a phase 2a study showed.
PDE4 inhibitors are a promising therapeutic target for inflammatory diseases because “they can increase cyclic adenosine monophosphate levels and subsequently reduce the production of proinflammatory cytokines,” lead study author Lawrence F. Eichenfield, MD, of the dermatology department at the University of California, San Diego, and colleagues wrote. The paper was published online in JAMA Dermatology.
Currently Available Treatments
For plaque psoriasis, the FDA approved the topical PDE4 inhibitor roflumilast in 2022. The oral PDE4 inhibitor apremilast has shown to be effective for plaque psoriasis and is well tolerated, and “it has been associated with gastrointestinal adverse events (AEs) such as nausea and diarrhea,” the researchers wrote.
For AD, crisaborole is the only approved topical PDE4 treatment, and it is associated with application site burning and stinging, they wrote.
An Experimental Alternative
The new study tested a topical PDE4 inhibitor known as PF-07038124, which is being developed by Pfizer. It is designed to be “a potent, oxaborole-based PDE4 inhibitor [that shows] immunomodulatory activity in T-cell–based assays, contributing to inhibition of [interleukin]-4 and IL-13; thus, it could provide therapeutic benefit in the treatment of AD and plaque psoriasis,” the authors wrote.
The phase 2a study was conducted from December 21, 2020, to August 18, 2021. Researchers at 34 sites in four countries randomized 104 patients with mild to moderate AD (70) or plaque psoriasis (34) to receive PF-07038124 as a 0.001% topical ointment or a vehicle only once daily for 6 weeks.
The primary end point was the percent change from baseline in the Eczema Area and Severity Index (EASI) total score among patients with AD and in the Psoriasis Area and Severity Index (PASI) score among patients with plaque psoriasis at week 6. Safety measures of interest included treatment-emergent adverse events.
Overall, the mean age of the 104 patients was 43 years, 52.9%, were women, 3.8% were Asian, 12.5% were Black, and 83.7% were White. Most had moderate disease.
At week 6 in patients with AD, the PF-07038124 group showed statistically significantly greater improvement in the EASI total score, compared with vehicle group (−74.9% vs −35.5% respectively; least squares mean [LSM] difference, −39.4%; 90% CI, −58.8% to−20.1%]; P < .001).
Similarly, at week 6 in patients with plaque psoriasis, the PF-07038124 group demonstrated a significantly greater improvement in the PASI total score, compared with the vehicle group (LSM, −4.8; 90% CI, −6.2 to −3.4] vs 0.1; 90% CI, −1.5 to 1.7), for a difference of −4.9; 90% CI, −7.0 to −2.8; P < .001.
In safety outcomes, treatment-emergent adverse events were reported in 16 people receiving PF-07038124 and 26 people receiving a vehicle. The treatment-related adverse events were reported only in the vehicle groups across all indications, while no patients in the PF-07038124 groups experienced pain or skin reactions at the application sites.
The researchers acknowledged certain limitations of the trial, including its small size and the 6-week treatment period. “Unlike crisaborole, topical PF-07038124 was not associated with application site burning and stinging,” they noted. “To confirm persistence of efficacy and the safety profile of PF-07038124, long-term data should be collected in larger studies.”
Pfizer supported the study. Dr. Eichenfield reported receiving personal fees from Pfizer during the conduct of the study. He also has received grant support from, is consultant to, and/or is a member of the advisory board for many other pharmaceutical companies. Several other study authors reported similar disclosures.
FROM JAMA DERMATOLOGY
Building a Toolkit for the Treatment of Acute Migraine
Selecting a treatment plan to deal with acute migraine attacks can be like putting together a toolkit of possible therapies, individualized for each patient, one expert said.
The toolkit should comprise reliable treatments that patients know are going to work and that act quickly, allowing them to get back to functioning normally in their daily lives, said Jessica Ailani, MD, during a talk at the 17th European Headache Congress held recently in Barcelona, Spain.
“Everyone with migraine needs acute treatment,” Dr. Ailani, who is a clinical professor of neurology at MedStar Georgetown University Hospital and director of the Georgetown Headache Center, Washington, DC, noted. “Sometimes we can reduce acute treatment with preventative agents, but some disability will remain, so we have to focus on good acute treatment, and this becomes more complex if a person has a lot of comorbidities, which is common in older patients.”
In selecting suitable treatments for migraine, consideration has to be given to the patient profile, any other conditions they have, speed of onset of the migraine attack, length of the attack, associated symptoms, and side effects of the medications, she said.
A Complex Case
As an example, Dr. Ailani described the process she used to treat one of her patients who had frequent severe migraines and other issues causing difficult decisions when selecting medications — a woman in her late 60s with several other comorbidities.
“This is the kind of case I see on a daily basis and which keeps me up at night,” she said. “Many times in clinical practice, we see complex cases like this, and through the course of a year, we may try every treatment option we have in a patient like this.”
On the first presentation, the patient had a chronic migraine with severe headaches every day. She had a history of previous cervical discectomy with fusion surgery; uncontrolled hypertension, for which she was taking an angiotensin blocker; high cholesterol, for which she was taking a statin; and diabetes with an A1c of 8. She did not smoke or drink alcohol, exercised moderately, and her body mass index was in a good range.
“Before a patient ever sees a doctor for their migraine, they will have already tried a lot of different things. Most people are already using NSAIDs and acetaminophen, the most commonly used treatments for acute migraine,” Dr. Ailani explains.
Her patient was taking a triptan and the barbiturate, butalbital. Dr. Ailani notes that the triptan is very effective, but in the United States, they are not available over the counter, and the patient is only allowed nine doses per month on her insurance, so she was supplementing with butalbital.
Over the course of a year, Dr. Ailani got her off the butalbital and started her on onabotulinum toxin A for migraine prevention, which reduced her headache days to about 15 per month (8 severe). She then added the anti-calcitonin gene-related peptide (CGRP) monoclonal antibody, galcanezumab, as another preventative, which further reduced the headache days down to 8-10 days per month (all migraine).
The attacks are rapid onset and can last multiple days. They come with photophobia and phonophobia and cause her to be bedridden, she noted.
“I was still worried about this frequency of headache and the fact she was using a triptan for acute treatment when she had uncontrolled hypertension and other cardiovascular risk factors, Dr. Ailani commented.
She explained that triptans are generally not used in individuals aged over 65 years because of a lack of data in this age group. They are also contraindicated in patients with cardiovascular (CV) disease, and caution is advised in patients with CV risk factors. Noting that migraine is an independent risk factor for stroke in healthy individuals, and this patient already had three other major risk factors for stroke, Dr. Ailani said she did not think a triptan was the best option.
When triptans do not work, Dr. Ailani said she thinks about dihydroergotamine, which she describes as “a great drug for long-lasting migraine” as it tends to have a sustained response. But it also has vasoconstrictive effects and can increase blood pressure, so it was not suitable for this patient.
CV risk is also an issue with nonsteroidal anti-inflammatory drugs (NSAIDs), one of the staple treatments for acute migraine.
“NSAIDs are available over the counter, inexpensive, quite effective, and have minimal immediate side effects,” Dr. Ailani said. But long-term adverse events include CV events, particularly in those who already have CV risk factors, and it is now thought that NSAIDs actually carry more CV risk than triptans.
She noted that out of all the NSAIDs, celecoxib carries the lowest CV risk, and in the United States, it is available as a liquid formulation. There is also a study of ketorolac nasal spray showing it to be as effective as sumatriptan nasal spray for acute migraine.
As her patient was still going to the emergency room (ER) quite frequently at this point, Dr. Ailani prescribed ketorolac nasal spray as an emergency rescue medication, which did help to reduce ER visits but did not solve the acute treatment problem.
The next option she tried was the CGRP antagonists or “gepants” because of their good tolerability.
Because her patient had long attacks, Dr. Ailani said her first choice gepant was rimegepant as it has a long half-life.
She noted that in patients who have frequent migraine attacks (> 6 migraine days per month), using rimegepant as needed has been shown to lead to migraine frequency declining over time. “This shows that if we treat acute attacks properly, we can minimize the risk of chronic migraine.”
She pointed out that if a patient has prodrome that is easy to identify or has short attacks, ubrogepant may be a good option, having shown effectiveness in preventing or reducing the onset of the headache in the recently reported PRODROME trial when given the day before migraine starts.
Then there is also zavegepant, which is available as a nasal spray, so it is a good option for patients with nausea and vomiting. Dr. Ailani suggested that zavegepant as a third-generation gepant may be worth trying in patients who have tried the other gepants, as it is a different type of molecule.
For this patient, neither rimegepant nor ubrogepant worked. “We tried treating in the prodrome, when the pain was starting, adding to other treatments, but she is not a ‘gepant’ responder. We have yet to try zavegepant,” she said.
The next consideration was lasmiditan. “This patient is a triptan responder and lasmiditan is a 5HT1 agonist, so it makes sense to try this. Also, it doesn’t have a vasoconstrictor effect as it doesn’t work on the blood vessels, so it is safe for patients with high blood pressure,” Dr. Ailani noted.
She pointed out, however, that lasmiditan has become a rescue medication in her practice because of side effect issues such as dizziness and sleepiness.
But Dr. Ailani said she has learned how to use the medication to minimize the side effects, by increasing the dose slowly and advising patients to take it later in the day.
“We start with 50 mg for a few doses then increase to 100 mg. This seems to build tolerability.”
Her patient has found good relief from lasmiditan 100 mg, but she can’t take it during the day as it makes her sleepy.
As a last resort, Dr. Ailani went back to metoclopramide, which she described as “a tried and tested old-time drug.”
While this does not make the patient sleepy, it has other adverse effects limiting the frequency of its use, she noted. “I ask her to try to limit it to twice a week, and this has been pretty effective. She can function when she uses it.”
Dr. Ailani also points out that neuromodulation should be in everyone’s tool kit. “So, we added an external combined occipital and trigeminal (eCOT device) neurostimulation device.”
The patient’s tool kit now looks like this:
- Neuromodulation device and meditation at first sign of an attack.
- Add metoclopramide 10 mg and acetaminophen 1000 mg.
- If the attack lasts into the second day, add lasmiditan 100 mg in the evening of the second day (limit 8 days a month).
- If the patient has a sudden onset severe migraine with nausea and vomiting that might make her go to the ER, add in ketorolac nasal spray (not > 5 days per month).
Dr. Ailani noted that other patients will need different toolkits, and in most cases, it is recommended to think about “situational prevention” for times when migraine attacks are predictable, which may include air travel, high-stress times (holidays, etc.), occasions when alcohol will be consumed, and at times of certain weather triggers.
Dr. Ailani disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Selecting a treatment plan to deal with acute migraine attacks can be like putting together a toolkit of possible therapies, individualized for each patient, one expert said.
The toolkit should comprise reliable treatments that patients know are going to work and that act quickly, allowing them to get back to functioning normally in their daily lives, said Jessica Ailani, MD, during a talk at the 17th European Headache Congress held recently in Barcelona, Spain.
“Everyone with migraine needs acute treatment,” Dr. Ailani, who is a clinical professor of neurology at MedStar Georgetown University Hospital and director of the Georgetown Headache Center, Washington, DC, noted. “Sometimes we can reduce acute treatment with preventative agents, but some disability will remain, so we have to focus on good acute treatment, and this becomes more complex if a person has a lot of comorbidities, which is common in older patients.”
In selecting suitable treatments for migraine, consideration has to be given to the patient profile, any other conditions they have, speed of onset of the migraine attack, length of the attack, associated symptoms, and side effects of the medications, she said.
A Complex Case
As an example, Dr. Ailani described the process she used to treat one of her patients who had frequent severe migraines and other issues causing difficult decisions when selecting medications — a woman in her late 60s with several other comorbidities.
“This is the kind of case I see on a daily basis and which keeps me up at night,” she said. “Many times in clinical practice, we see complex cases like this, and through the course of a year, we may try every treatment option we have in a patient like this.”
On the first presentation, the patient had a chronic migraine with severe headaches every day. She had a history of previous cervical discectomy with fusion surgery; uncontrolled hypertension, for which she was taking an angiotensin blocker; high cholesterol, for which she was taking a statin; and diabetes with an A1c of 8. She did not smoke or drink alcohol, exercised moderately, and her body mass index was in a good range.
“Before a patient ever sees a doctor for their migraine, they will have already tried a lot of different things. Most people are already using NSAIDs and acetaminophen, the most commonly used treatments for acute migraine,” Dr. Ailani explains.
Her patient was taking a triptan and the barbiturate, butalbital. Dr. Ailani notes that the triptan is very effective, but in the United States, they are not available over the counter, and the patient is only allowed nine doses per month on her insurance, so she was supplementing with butalbital.
Over the course of a year, Dr. Ailani got her off the butalbital and started her on onabotulinum toxin A for migraine prevention, which reduced her headache days to about 15 per month (8 severe). She then added the anti-calcitonin gene-related peptide (CGRP) monoclonal antibody, galcanezumab, as another preventative, which further reduced the headache days down to 8-10 days per month (all migraine).
The attacks are rapid onset and can last multiple days. They come with photophobia and phonophobia and cause her to be bedridden, she noted.
“I was still worried about this frequency of headache and the fact she was using a triptan for acute treatment when she had uncontrolled hypertension and other cardiovascular risk factors, Dr. Ailani commented.
She explained that triptans are generally not used in individuals aged over 65 years because of a lack of data in this age group. They are also contraindicated in patients with cardiovascular (CV) disease, and caution is advised in patients with CV risk factors. Noting that migraine is an independent risk factor for stroke in healthy individuals, and this patient already had three other major risk factors for stroke, Dr. Ailani said she did not think a triptan was the best option.
When triptans do not work, Dr. Ailani said she thinks about dihydroergotamine, which she describes as “a great drug for long-lasting migraine” as it tends to have a sustained response. But it also has vasoconstrictive effects and can increase blood pressure, so it was not suitable for this patient.
CV risk is also an issue with nonsteroidal anti-inflammatory drugs (NSAIDs), one of the staple treatments for acute migraine.
“NSAIDs are available over the counter, inexpensive, quite effective, and have minimal immediate side effects,” Dr. Ailani said. But long-term adverse events include CV events, particularly in those who already have CV risk factors, and it is now thought that NSAIDs actually carry more CV risk than triptans.
She noted that out of all the NSAIDs, celecoxib carries the lowest CV risk, and in the United States, it is available as a liquid formulation. There is also a study of ketorolac nasal spray showing it to be as effective as sumatriptan nasal spray for acute migraine.
As her patient was still going to the emergency room (ER) quite frequently at this point, Dr. Ailani prescribed ketorolac nasal spray as an emergency rescue medication, which did help to reduce ER visits but did not solve the acute treatment problem.
The next option she tried was the CGRP antagonists or “gepants” because of their good tolerability.
Because her patient had long attacks, Dr. Ailani said her first choice gepant was rimegepant as it has a long half-life.
She noted that in patients who have frequent migraine attacks (> 6 migraine days per month), using rimegepant as needed has been shown to lead to migraine frequency declining over time. “This shows that if we treat acute attacks properly, we can minimize the risk of chronic migraine.”
She pointed out that if a patient has prodrome that is easy to identify or has short attacks, ubrogepant may be a good option, having shown effectiveness in preventing or reducing the onset of the headache in the recently reported PRODROME trial when given the day before migraine starts.
Then there is also zavegepant, which is available as a nasal spray, so it is a good option for patients with nausea and vomiting. Dr. Ailani suggested that zavegepant as a third-generation gepant may be worth trying in patients who have tried the other gepants, as it is a different type of molecule.
For this patient, neither rimegepant nor ubrogepant worked. “We tried treating in the prodrome, when the pain was starting, adding to other treatments, but she is not a ‘gepant’ responder. We have yet to try zavegepant,” she said.
The next consideration was lasmiditan. “This patient is a triptan responder and lasmiditan is a 5HT1 agonist, so it makes sense to try this. Also, it doesn’t have a vasoconstrictor effect as it doesn’t work on the blood vessels, so it is safe for patients with high blood pressure,” Dr. Ailani noted.
She pointed out, however, that lasmiditan has become a rescue medication in her practice because of side effect issues such as dizziness and sleepiness.
But Dr. Ailani said she has learned how to use the medication to minimize the side effects, by increasing the dose slowly and advising patients to take it later in the day.
“We start with 50 mg for a few doses then increase to 100 mg. This seems to build tolerability.”
Her patient has found good relief from lasmiditan 100 mg, but she can’t take it during the day as it makes her sleepy.
As a last resort, Dr. Ailani went back to metoclopramide, which she described as “a tried and tested old-time drug.”
While this does not make the patient sleepy, it has other adverse effects limiting the frequency of its use, she noted. “I ask her to try to limit it to twice a week, and this has been pretty effective. She can function when she uses it.”
Dr. Ailani also points out that neuromodulation should be in everyone’s tool kit. “So, we added an external combined occipital and trigeminal (eCOT device) neurostimulation device.”
The patient’s tool kit now looks like this:
- Neuromodulation device and meditation at first sign of an attack.
- Add metoclopramide 10 mg and acetaminophen 1000 mg.
- If the attack lasts into the second day, add lasmiditan 100 mg in the evening of the second day (limit 8 days a month).
- If the patient has a sudden onset severe migraine with nausea and vomiting that might make her go to the ER, add in ketorolac nasal spray (not > 5 days per month).
Dr. Ailani noted that other patients will need different toolkits, and in most cases, it is recommended to think about “situational prevention” for times when migraine attacks are predictable, which may include air travel, high-stress times (holidays, etc.), occasions when alcohol will be consumed, and at times of certain weather triggers.
Dr. Ailani disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Selecting a treatment plan to deal with acute migraine attacks can be like putting together a toolkit of possible therapies, individualized for each patient, one expert said.
The toolkit should comprise reliable treatments that patients know are going to work and that act quickly, allowing them to get back to functioning normally in their daily lives, said Jessica Ailani, MD, during a talk at the 17th European Headache Congress held recently in Barcelona, Spain.
“Everyone with migraine needs acute treatment,” Dr. Ailani, who is a clinical professor of neurology at MedStar Georgetown University Hospital and director of the Georgetown Headache Center, Washington, DC, noted. “Sometimes we can reduce acute treatment with preventative agents, but some disability will remain, so we have to focus on good acute treatment, and this becomes more complex if a person has a lot of comorbidities, which is common in older patients.”
In selecting suitable treatments for migraine, consideration has to be given to the patient profile, any other conditions they have, speed of onset of the migraine attack, length of the attack, associated symptoms, and side effects of the medications, she said.
A Complex Case
As an example, Dr. Ailani described the process she used to treat one of her patients who had frequent severe migraines and other issues causing difficult decisions when selecting medications — a woman in her late 60s with several other comorbidities.
“This is the kind of case I see on a daily basis and which keeps me up at night,” she said. “Many times in clinical practice, we see complex cases like this, and through the course of a year, we may try every treatment option we have in a patient like this.”
On the first presentation, the patient had a chronic migraine with severe headaches every day. She had a history of previous cervical discectomy with fusion surgery; uncontrolled hypertension, for which she was taking an angiotensin blocker; high cholesterol, for which she was taking a statin; and diabetes with an A1c of 8. She did not smoke or drink alcohol, exercised moderately, and her body mass index was in a good range.
“Before a patient ever sees a doctor for their migraine, they will have already tried a lot of different things. Most people are already using NSAIDs and acetaminophen, the most commonly used treatments for acute migraine,” Dr. Ailani explains.
Her patient was taking a triptan and the barbiturate, butalbital. Dr. Ailani notes that the triptan is very effective, but in the United States, they are not available over the counter, and the patient is only allowed nine doses per month on her insurance, so she was supplementing with butalbital.
Over the course of a year, Dr. Ailani got her off the butalbital and started her on onabotulinum toxin A for migraine prevention, which reduced her headache days to about 15 per month (8 severe). She then added the anti-calcitonin gene-related peptide (CGRP) monoclonal antibody, galcanezumab, as another preventative, which further reduced the headache days down to 8-10 days per month (all migraine).
The attacks are rapid onset and can last multiple days. They come with photophobia and phonophobia and cause her to be bedridden, she noted.
“I was still worried about this frequency of headache and the fact she was using a triptan for acute treatment when she had uncontrolled hypertension and other cardiovascular risk factors, Dr. Ailani commented.
She explained that triptans are generally not used in individuals aged over 65 years because of a lack of data in this age group. They are also contraindicated in patients with cardiovascular (CV) disease, and caution is advised in patients with CV risk factors. Noting that migraine is an independent risk factor for stroke in healthy individuals, and this patient already had three other major risk factors for stroke, Dr. Ailani said she did not think a triptan was the best option.
When triptans do not work, Dr. Ailani said she thinks about dihydroergotamine, which she describes as “a great drug for long-lasting migraine” as it tends to have a sustained response. But it also has vasoconstrictive effects and can increase blood pressure, so it was not suitable for this patient.
CV risk is also an issue with nonsteroidal anti-inflammatory drugs (NSAIDs), one of the staple treatments for acute migraine.
“NSAIDs are available over the counter, inexpensive, quite effective, and have minimal immediate side effects,” Dr. Ailani said. But long-term adverse events include CV events, particularly in those who already have CV risk factors, and it is now thought that NSAIDs actually carry more CV risk than triptans.
She noted that out of all the NSAIDs, celecoxib carries the lowest CV risk, and in the United States, it is available as a liquid formulation. There is also a study of ketorolac nasal spray showing it to be as effective as sumatriptan nasal spray for acute migraine.
As her patient was still going to the emergency room (ER) quite frequently at this point, Dr. Ailani prescribed ketorolac nasal spray as an emergency rescue medication, which did help to reduce ER visits but did not solve the acute treatment problem.
The next option she tried was the CGRP antagonists or “gepants” because of their good tolerability.
Because her patient had long attacks, Dr. Ailani said her first choice gepant was rimegepant as it has a long half-life.
She noted that in patients who have frequent migraine attacks (> 6 migraine days per month), using rimegepant as needed has been shown to lead to migraine frequency declining over time. “This shows that if we treat acute attacks properly, we can minimize the risk of chronic migraine.”
She pointed out that if a patient has prodrome that is easy to identify or has short attacks, ubrogepant may be a good option, having shown effectiveness in preventing or reducing the onset of the headache in the recently reported PRODROME trial when given the day before migraine starts.
Then there is also zavegepant, which is available as a nasal spray, so it is a good option for patients with nausea and vomiting. Dr. Ailani suggested that zavegepant as a third-generation gepant may be worth trying in patients who have tried the other gepants, as it is a different type of molecule.
For this patient, neither rimegepant nor ubrogepant worked. “We tried treating in the prodrome, when the pain was starting, adding to other treatments, but she is not a ‘gepant’ responder. We have yet to try zavegepant,” she said.
The next consideration was lasmiditan. “This patient is a triptan responder and lasmiditan is a 5HT1 agonist, so it makes sense to try this. Also, it doesn’t have a vasoconstrictor effect as it doesn’t work on the blood vessels, so it is safe for patients with high blood pressure,” Dr. Ailani noted.
She pointed out, however, that lasmiditan has become a rescue medication in her practice because of side effect issues such as dizziness and sleepiness.
But Dr. Ailani said she has learned how to use the medication to minimize the side effects, by increasing the dose slowly and advising patients to take it later in the day.
“We start with 50 mg for a few doses then increase to 100 mg. This seems to build tolerability.”
Her patient has found good relief from lasmiditan 100 mg, but she can’t take it during the day as it makes her sleepy.
As a last resort, Dr. Ailani went back to metoclopramide, which she described as “a tried and tested old-time drug.”
While this does not make the patient sleepy, it has other adverse effects limiting the frequency of its use, she noted. “I ask her to try to limit it to twice a week, and this has been pretty effective. She can function when she uses it.”
Dr. Ailani also points out that neuromodulation should be in everyone’s tool kit. “So, we added an external combined occipital and trigeminal (eCOT device) neurostimulation device.”
The patient’s tool kit now looks like this:
- Neuromodulation device and meditation at first sign of an attack.
- Add metoclopramide 10 mg and acetaminophen 1000 mg.
- If the attack lasts into the second day, add lasmiditan 100 mg in the evening of the second day (limit 8 days a month).
- If the patient has a sudden onset severe migraine with nausea and vomiting that might make her go to the ER, add in ketorolac nasal spray (not > 5 days per month).
Dr. Ailani noted that other patients will need different toolkits, and in most cases, it is recommended to think about “situational prevention” for times when migraine attacks are predictable, which may include air travel, high-stress times (holidays, etc.), occasions when alcohol will be consumed, and at times of certain weather triggers.
Dr. Ailani disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
FROM THE EUROPEAN HEADACHE CONGRESS
For Weight Loss With a Low-Carb Diet, Quality Matters
TOPLINE:
METHODOLOGY:
- Prospective cohort study included 123,332 participants from the Nurses’ Health Studies (NHS, 1986-2010 and 1991-2015) and the Health Professionals Follow-up Study (HPFS, 1986-2018).
- Diets assessed by questionnaires were categorized as: (1) total LCD (TLCD), emphasizing overall lower carbohydrate intake; (2) animal-based LCD (ALCD), emphasizing animal-sourced protein and fat; (3) vegetable-based LCD (VLCD), emphasizing plant-sourced protein and fat; (4) a healthy LCD (HLCD), emphasizing less refined carbohydrates, more plant protein, and healthy fat; and (5) unhealthy LCD (ULCD), emphasizing less healthful carbohydrates, more animal protein, and unhealthy fat.
- The primary outcome was 4-year reported changes in body weight, divided into quintiles, with Q3 = no change, Q1 = largest decrease, and Q5 = largest increase.
TAKEAWAY:
- Participants gained a mean of 1.3 kg over each 4-year interval, with gains of 0.8, 1.8, and 0.5 kg for NHS, NHSII, and HPFS, respectively.
- After adjustment for baseline and concomitant changes in lifestyle and demographic factors, compared with participants with no change in the TLCD score over 4-year intervals, those with the largest increase (Q5) in the TLCD score did not have significant weight change (0.03 kg), while those with the largest decrease (Q1) in the TLCD score had significantly less weight gain (−0.20 kg).
- Similarly, those following a VLCD with Q5 change, compared with those with stable Q3 adherence, experienced 0.21 kg less weight gain, and those with Q1 change experienced 0.17 kg less weight gain, both significant.
- Adhering to an ALCD was associated with more weight gain over time, with each 1 standard deviation (SD) increase in ALCD associated with a significant 0.13 kg more weight gain over 4-year intervals.
- Opposite results were seen for ULCD and HLCD scores, where a 1-SD increase in HLCD and ULCD was associated with a significant 0.36 kg weight loss and 0.39 kg weight gain, respectively, over 4-year intervals.
- The associations were stronger among individuals with baseline body mass index ≥ 30 kg/m2.
IN PRACTICE:
“The findings of this cohort study underscore the importance of diet quality within LCD patterns for weight management… Overall, the study findings argue against the sole focus of macronutrient quantity for weight management and suggest the crucial role of nutrient quality in maintaining a healthy body weight.”
SOURCE:
This study was conducted by Binkai Liu, MS, of the department of nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, and colleagues.
The findings were published online in JAMA Network Open .
LIMITATIONS:
- Self-reported data.
- Observational study, potential for residual confounding.
- No body composition measurement.
- Study population was mainly White health professionals.
DISCLOSURES:
This study was funded by research grants from the National Institutes of Health, and one coauthor is supported by a postdoctoral fellowship award from the Canadian Institutes of Health Research.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Prospective cohort study included 123,332 participants from the Nurses’ Health Studies (NHS, 1986-2010 and 1991-2015) and the Health Professionals Follow-up Study (HPFS, 1986-2018).
- Diets assessed by questionnaires were categorized as: (1) total LCD (TLCD), emphasizing overall lower carbohydrate intake; (2) animal-based LCD (ALCD), emphasizing animal-sourced protein and fat; (3) vegetable-based LCD (VLCD), emphasizing plant-sourced protein and fat; (4) a healthy LCD (HLCD), emphasizing less refined carbohydrates, more plant protein, and healthy fat; and (5) unhealthy LCD (ULCD), emphasizing less healthful carbohydrates, more animal protein, and unhealthy fat.
- The primary outcome was 4-year reported changes in body weight, divided into quintiles, with Q3 = no change, Q1 = largest decrease, and Q5 = largest increase.
TAKEAWAY:
- Participants gained a mean of 1.3 kg over each 4-year interval, with gains of 0.8, 1.8, and 0.5 kg for NHS, NHSII, and HPFS, respectively.
- After adjustment for baseline and concomitant changes in lifestyle and demographic factors, compared with participants with no change in the TLCD score over 4-year intervals, those with the largest increase (Q5) in the TLCD score did not have significant weight change (0.03 kg), while those with the largest decrease (Q1) in the TLCD score had significantly less weight gain (−0.20 kg).
- Similarly, those following a VLCD with Q5 change, compared with those with stable Q3 adherence, experienced 0.21 kg less weight gain, and those with Q1 change experienced 0.17 kg less weight gain, both significant.
- Adhering to an ALCD was associated with more weight gain over time, with each 1 standard deviation (SD) increase in ALCD associated with a significant 0.13 kg more weight gain over 4-year intervals.
- Opposite results were seen for ULCD and HLCD scores, where a 1-SD increase in HLCD and ULCD was associated with a significant 0.36 kg weight loss and 0.39 kg weight gain, respectively, over 4-year intervals.
- The associations were stronger among individuals with baseline body mass index ≥ 30 kg/m2.
IN PRACTICE:
“The findings of this cohort study underscore the importance of diet quality within LCD patterns for weight management… Overall, the study findings argue against the sole focus of macronutrient quantity for weight management and suggest the crucial role of nutrient quality in maintaining a healthy body weight.”
SOURCE:
This study was conducted by Binkai Liu, MS, of the department of nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, and colleagues.
The findings were published online in JAMA Network Open .
LIMITATIONS:
- Self-reported data.
- Observational study, potential for residual confounding.
- No body composition measurement.
- Study population was mainly White health professionals.
DISCLOSURES:
This study was funded by research grants from the National Institutes of Health, and one coauthor is supported by a postdoctoral fellowship award from the Canadian Institutes of Health Research.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Prospective cohort study included 123,332 participants from the Nurses’ Health Studies (NHS, 1986-2010 and 1991-2015) and the Health Professionals Follow-up Study (HPFS, 1986-2018).
- Diets assessed by questionnaires were categorized as: (1) total LCD (TLCD), emphasizing overall lower carbohydrate intake; (2) animal-based LCD (ALCD), emphasizing animal-sourced protein and fat; (3) vegetable-based LCD (VLCD), emphasizing plant-sourced protein and fat; (4) a healthy LCD (HLCD), emphasizing less refined carbohydrates, more plant protein, and healthy fat; and (5) unhealthy LCD (ULCD), emphasizing less healthful carbohydrates, more animal protein, and unhealthy fat.
- The primary outcome was 4-year reported changes in body weight, divided into quintiles, with Q3 = no change, Q1 = largest decrease, and Q5 = largest increase.
TAKEAWAY:
- Participants gained a mean of 1.3 kg over each 4-year interval, with gains of 0.8, 1.8, and 0.5 kg for NHS, NHSII, and HPFS, respectively.
- After adjustment for baseline and concomitant changes in lifestyle and demographic factors, compared with participants with no change in the TLCD score over 4-year intervals, those with the largest increase (Q5) in the TLCD score did not have significant weight change (0.03 kg), while those with the largest decrease (Q1) in the TLCD score had significantly less weight gain (−0.20 kg).
- Similarly, those following a VLCD with Q5 change, compared with those with stable Q3 adherence, experienced 0.21 kg less weight gain, and those with Q1 change experienced 0.17 kg less weight gain, both significant.
- Adhering to an ALCD was associated with more weight gain over time, with each 1 standard deviation (SD) increase in ALCD associated with a significant 0.13 kg more weight gain over 4-year intervals.
- Opposite results were seen for ULCD and HLCD scores, where a 1-SD increase in HLCD and ULCD was associated with a significant 0.36 kg weight loss and 0.39 kg weight gain, respectively, over 4-year intervals.
- The associations were stronger among individuals with baseline body mass index ≥ 30 kg/m2.
IN PRACTICE:
“The findings of this cohort study underscore the importance of diet quality within LCD patterns for weight management… Overall, the study findings argue against the sole focus of macronutrient quantity for weight management and suggest the crucial role of nutrient quality in maintaining a healthy body weight.”
SOURCE:
This study was conducted by Binkai Liu, MS, of the department of nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, and colleagues.
The findings were published online in JAMA Network Open .
LIMITATIONS:
- Self-reported data.
- Observational study, potential for residual confounding.
- No body composition measurement.
- Study population was mainly White health professionals.
DISCLOSURES:
This study was funded by research grants from the National Institutes of Health, and one coauthor is supported by a postdoctoral fellowship award from the Canadian Institutes of Health Research.
A version of this article appeared on Medscape.com.
Doctors in 2 More States May Qualify for Student Loan Forgiveness
, possibly bringing much-needed relief to those with cumbersome debt loads after repayments resumed last month. However, the timing is critical, as some doctors may need to consolidate their loans by December 31 to remain eligible.
Updated guidelines for the Public Service Loan Forgiveness Program (PSLF) took effect in July, expanding the number of potential borrowers who could have their federal student loan balances wiped clean after working full time in a government or nonprofit role and making 120 monthly loan payments.
But loan forgiveness also hinges on having the correct employment type and requires applicants to be a “direct hire” of the organization. State laws in California and Texas prohibit nonprofit hospitals and health care entities from directly hiring physicians — a loophole that has barred doctors in those locations from applying.
Both states’ medical and hospital associations worked with the US Department of Education (DOE) to offer an exception. California and Texas physicians can now satisfy the employment type condition by having a written contract or medical staff privileges with a nonprofit hospital or facility, even if the physician is part of a for-profit sole proprietorship, partnership, or medical group.
Eligible loans cannot be in default and must have been received through the Direct Loan Program, which includes Parent PLUS loans. Doctors with non-qualifying student loans, such as Federal Family Education Loans, can become PSLF-eligible and have past time worked counted toward the requirements if they consolidate into a direct loan by December 31.
The California Medical Association (CMA) has an online guide to help doctors and employers navigate the new rules.
The change comes just in time because California and Texas need to expand their physician workforces by tens of thousands over the next decade. “This program will allow us to retain and recruit new physicians to our states to address our growing physician shortages and access to care challenges for the patients who need us most,” Texas Medical Association president Rick W. Snyder II, MD, said in a statement.
Physicians should use the PSLF Help Tool to complete the forgiveness application, said Ashley Harrington, senior advisor at the DOE. During a free on-demand webinar hosted by CMA, she said the form has been streamlined and will ask applicants to list the nonprofit entity where they provide care, its employer identification number, the length of time worked there, and the average hours worked per week. The employer must sign to certify the physician’s reported hours.
Ideally, physicians should submit a PSLF form annually or each time they change jobs, but they can also wait until the end of the 10 years to submit the form, said Ms. Harrington.
With the average medical education loan debt exceeding $200,000, CMA president Donaldo Hernandez, MD, said the rule will ensure low-income and minority students can consider medical careers.
California family medicine physician Ashley Paydar, DO, said that she has already applied for PSLF and found the process relatively easy. While she awaits final approval, she’s planning for the future. “Loan forgiveness will allow me to do a fellowship and save for my children›s college so they can pursue higher education without the debt,” she said.
Still, employers have no legal obligation to certify physicians’ hours, and many may express hesitation as they try to understand the new guidelines, said Long Do, JD, partner at Athene Law in San Francisco and speaker during the webinar. He urged physicians to have patience when working through the application process.
A version of this article appeared on Medscape.com.
, possibly bringing much-needed relief to those with cumbersome debt loads after repayments resumed last month. However, the timing is critical, as some doctors may need to consolidate their loans by December 31 to remain eligible.
Updated guidelines for the Public Service Loan Forgiveness Program (PSLF) took effect in July, expanding the number of potential borrowers who could have their federal student loan balances wiped clean after working full time in a government or nonprofit role and making 120 monthly loan payments.
But loan forgiveness also hinges on having the correct employment type and requires applicants to be a “direct hire” of the organization. State laws in California and Texas prohibit nonprofit hospitals and health care entities from directly hiring physicians — a loophole that has barred doctors in those locations from applying.
Both states’ medical and hospital associations worked with the US Department of Education (DOE) to offer an exception. California and Texas physicians can now satisfy the employment type condition by having a written contract or medical staff privileges with a nonprofit hospital or facility, even if the physician is part of a for-profit sole proprietorship, partnership, or medical group.
Eligible loans cannot be in default and must have been received through the Direct Loan Program, which includes Parent PLUS loans. Doctors with non-qualifying student loans, such as Federal Family Education Loans, can become PSLF-eligible and have past time worked counted toward the requirements if they consolidate into a direct loan by December 31.
The California Medical Association (CMA) has an online guide to help doctors and employers navigate the new rules.
The change comes just in time because California and Texas need to expand their physician workforces by tens of thousands over the next decade. “This program will allow us to retain and recruit new physicians to our states to address our growing physician shortages and access to care challenges for the patients who need us most,” Texas Medical Association president Rick W. Snyder II, MD, said in a statement.
Physicians should use the PSLF Help Tool to complete the forgiveness application, said Ashley Harrington, senior advisor at the DOE. During a free on-demand webinar hosted by CMA, she said the form has been streamlined and will ask applicants to list the nonprofit entity where they provide care, its employer identification number, the length of time worked there, and the average hours worked per week. The employer must sign to certify the physician’s reported hours.
Ideally, physicians should submit a PSLF form annually or each time they change jobs, but they can also wait until the end of the 10 years to submit the form, said Ms. Harrington.
With the average medical education loan debt exceeding $200,000, CMA president Donaldo Hernandez, MD, said the rule will ensure low-income and minority students can consider medical careers.
California family medicine physician Ashley Paydar, DO, said that she has already applied for PSLF and found the process relatively easy. While she awaits final approval, she’s planning for the future. “Loan forgiveness will allow me to do a fellowship and save for my children›s college so they can pursue higher education without the debt,” she said.
Still, employers have no legal obligation to certify physicians’ hours, and many may express hesitation as they try to understand the new guidelines, said Long Do, JD, partner at Athene Law in San Francisco and speaker during the webinar. He urged physicians to have patience when working through the application process.
A version of this article appeared on Medscape.com.
, possibly bringing much-needed relief to those with cumbersome debt loads after repayments resumed last month. However, the timing is critical, as some doctors may need to consolidate their loans by December 31 to remain eligible.
Updated guidelines for the Public Service Loan Forgiveness Program (PSLF) took effect in July, expanding the number of potential borrowers who could have their federal student loan balances wiped clean after working full time in a government or nonprofit role and making 120 monthly loan payments.
But loan forgiveness also hinges on having the correct employment type and requires applicants to be a “direct hire” of the organization. State laws in California and Texas prohibit nonprofit hospitals and health care entities from directly hiring physicians — a loophole that has barred doctors in those locations from applying.
Both states’ medical and hospital associations worked with the US Department of Education (DOE) to offer an exception. California and Texas physicians can now satisfy the employment type condition by having a written contract or medical staff privileges with a nonprofit hospital or facility, even if the physician is part of a for-profit sole proprietorship, partnership, or medical group.
Eligible loans cannot be in default and must have been received through the Direct Loan Program, which includes Parent PLUS loans. Doctors with non-qualifying student loans, such as Federal Family Education Loans, can become PSLF-eligible and have past time worked counted toward the requirements if they consolidate into a direct loan by December 31.
The California Medical Association (CMA) has an online guide to help doctors and employers navigate the new rules.
The change comes just in time because California and Texas need to expand their physician workforces by tens of thousands over the next decade. “This program will allow us to retain and recruit new physicians to our states to address our growing physician shortages and access to care challenges for the patients who need us most,” Texas Medical Association president Rick W. Snyder II, MD, said in a statement.
Physicians should use the PSLF Help Tool to complete the forgiveness application, said Ashley Harrington, senior advisor at the DOE. During a free on-demand webinar hosted by CMA, she said the form has been streamlined and will ask applicants to list the nonprofit entity where they provide care, its employer identification number, the length of time worked there, and the average hours worked per week. The employer must sign to certify the physician’s reported hours.
Ideally, physicians should submit a PSLF form annually or each time they change jobs, but they can also wait until the end of the 10 years to submit the form, said Ms. Harrington.
With the average medical education loan debt exceeding $200,000, CMA president Donaldo Hernandez, MD, said the rule will ensure low-income and minority students can consider medical careers.
California family medicine physician Ashley Paydar, DO, said that she has already applied for PSLF and found the process relatively easy. While she awaits final approval, she’s planning for the future. “Loan forgiveness will allow me to do a fellowship and save for my children›s college so they can pursue higher education without the debt,” she said.
Still, employers have no legal obligation to certify physicians’ hours, and many may express hesitation as they try to understand the new guidelines, said Long Do, JD, partner at Athene Law in San Francisco and speaker during the webinar. He urged physicians to have patience when working through the application process.
A version of this article appeared on Medscape.com.
‘Shower’ Me for My Medical Expertise
A recent Reuters article reported that the manufacturer of the leading antiobesity medication semaglutide (Wegovy) “showers money on U.S. obesity doctors.”
Hello. I’d like to be showered.
According to the article, Novo Nordisk, Wegovy/Ozempic manufacturer, paid medical professionals $25.8 million in “fees and expenses” over a decade.
I think all doctors — who spend a decade of their life in training only to emerge with thousands of dollars in debt — would like to be similarly compensated for their expertise.
Yet, many of us forgo lucrative private practices or industry jobs to work at academic medical centers because we wish to pursue our original mission: To provide the best patient care possible.
Fulfilling this mission in today’s “sickcare” system means being more than a clinician. We become researchers, educators, advocates, mentors, consultants, and advisors. We do so because the system compels us to find other ways to provide quality health care, outside of clinic walls. These ways often include:
- Educating the public through media, social media, or community events.
- Training students, residents, and fellows on the latest medical knowledge.
- Advising industry innovators and entrepreneurs who seek our expertise.
Personally, I engaged in these activities because working 8-5 seeing 20 patients a day wasn’t enough. I wanted to help more people, more quickly. When I was faced with these opportunities, I was excited to say “yes” and never thought to ask for compensation because I didn’t want to seem ungrateful.
Eventually, I learned to ask for compensation.
And then I learned to decide my value.
The Reuters article reports that obesity medicine experts Drs. Lee Kaplan, Donna Ryan, Ania Jastreboff, and Jamy Ard were paid thousands of dollars in consulting fees over a decade. This industry-to-physician relationship should be celebrated because:
- Industries should consult experts in the field.
- These leaders have dedicated decades of their lives to understanding and solving the obesity epidemic.
- This collaboration has resulted in a therapeutic option that is changing lives.
If there is anything to criticize, it should be:
- The expectation that medical expertise should be free.Wegovy’s manufacturer is worth $403 billion, and the experts are valued at less than 0.1% of that figure.
- The lack of context.
- Some celebrity doctors can earn $300,000 in just one consult. Other medical or surgical specialties are valued at 100 times more than obesity specialists.
- The false dichotomy.
- Just because money is involved, it doesn’t mean the product is invalid.
Industry and physician relationships have long been examined. Such financial relationships are always disclosed (eg, at conferences, in publications). The Sunshine Act of 2010 and Open Payments provide the necessary transparency for people to decide for themselves whether there were financial incentives or potential conflicts of interest.
We should also take it a step further and ask ourselves: Do conflicts of interest require us to dismiss the end result? In other words, just because the pharmaceutical industry pays these doctors for their time and expertise, does that mean their life’s work is wrong, or that the drug isn’t effective?
In the case of obesity, Wegovy speaks for itself. Remember that the manufacturer stopped advertising. When a disease finally has a treatment, it does not need promoters or salespersons. Just speak to any person with obesity.
Ultimately, I see three main takeaways from Reuters’ reporting:
- The weight loss industry needs more obesity medicine experts.
- We should value ourselves more.
Dr. Tchang received $5525 in 2022 in consulting fees from Novo Nordisk. She plans to ask for more. She also disclosed ties with Gelesis.
A version of this article appeared on Medscape.com.
A recent Reuters article reported that the manufacturer of the leading antiobesity medication semaglutide (Wegovy) “showers money on U.S. obesity doctors.”
Hello. I’d like to be showered.
According to the article, Novo Nordisk, Wegovy/Ozempic manufacturer, paid medical professionals $25.8 million in “fees and expenses” over a decade.
I think all doctors — who spend a decade of their life in training only to emerge with thousands of dollars in debt — would like to be similarly compensated for their expertise.
Yet, many of us forgo lucrative private practices or industry jobs to work at academic medical centers because we wish to pursue our original mission: To provide the best patient care possible.
Fulfilling this mission in today’s “sickcare” system means being more than a clinician. We become researchers, educators, advocates, mentors, consultants, and advisors. We do so because the system compels us to find other ways to provide quality health care, outside of clinic walls. These ways often include:
- Educating the public through media, social media, or community events.
- Training students, residents, and fellows on the latest medical knowledge.
- Advising industry innovators and entrepreneurs who seek our expertise.
Personally, I engaged in these activities because working 8-5 seeing 20 patients a day wasn’t enough. I wanted to help more people, more quickly. When I was faced with these opportunities, I was excited to say “yes” and never thought to ask for compensation because I didn’t want to seem ungrateful.
Eventually, I learned to ask for compensation.
And then I learned to decide my value.
The Reuters article reports that obesity medicine experts Drs. Lee Kaplan, Donna Ryan, Ania Jastreboff, and Jamy Ard were paid thousands of dollars in consulting fees over a decade. This industry-to-physician relationship should be celebrated because:
- Industries should consult experts in the field.
- These leaders have dedicated decades of their lives to understanding and solving the obesity epidemic.
- This collaboration has resulted in a therapeutic option that is changing lives.
If there is anything to criticize, it should be:
- The expectation that medical expertise should be free.Wegovy’s manufacturer is worth $403 billion, and the experts are valued at less than 0.1% of that figure.
- The lack of context.
- Some celebrity doctors can earn $300,000 in just one consult. Other medical or surgical specialties are valued at 100 times more than obesity specialists.
- The false dichotomy.
- Just because money is involved, it doesn’t mean the product is invalid.
Industry and physician relationships have long been examined. Such financial relationships are always disclosed (eg, at conferences, in publications). The Sunshine Act of 2010 and Open Payments provide the necessary transparency for people to decide for themselves whether there were financial incentives or potential conflicts of interest.
We should also take it a step further and ask ourselves: Do conflicts of interest require us to dismiss the end result? In other words, just because the pharmaceutical industry pays these doctors for their time and expertise, does that mean their life’s work is wrong, or that the drug isn’t effective?
In the case of obesity, Wegovy speaks for itself. Remember that the manufacturer stopped advertising. When a disease finally has a treatment, it does not need promoters or salespersons. Just speak to any person with obesity.
Ultimately, I see three main takeaways from Reuters’ reporting:
- The weight loss industry needs more obesity medicine experts.
- We should value ourselves more.
Dr. Tchang received $5525 in 2022 in consulting fees from Novo Nordisk. She plans to ask for more. She also disclosed ties with Gelesis.
A version of this article appeared on Medscape.com.
A recent Reuters article reported that the manufacturer of the leading antiobesity medication semaglutide (Wegovy) “showers money on U.S. obesity doctors.”
Hello. I’d like to be showered.
According to the article, Novo Nordisk, Wegovy/Ozempic manufacturer, paid medical professionals $25.8 million in “fees and expenses” over a decade.
I think all doctors — who spend a decade of their life in training only to emerge with thousands of dollars in debt — would like to be similarly compensated for their expertise.
Yet, many of us forgo lucrative private practices or industry jobs to work at academic medical centers because we wish to pursue our original mission: To provide the best patient care possible.
Fulfilling this mission in today’s “sickcare” system means being more than a clinician. We become researchers, educators, advocates, mentors, consultants, and advisors. We do so because the system compels us to find other ways to provide quality health care, outside of clinic walls. These ways often include:
- Educating the public through media, social media, or community events.
- Training students, residents, and fellows on the latest medical knowledge.
- Advising industry innovators and entrepreneurs who seek our expertise.
Personally, I engaged in these activities because working 8-5 seeing 20 patients a day wasn’t enough. I wanted to help more people, more quickly. When I was faced with these opportunities, I was excited to say “yes” and never thought to ask for compensation because I didn’t want to seem ungrateful.
Eventually, I learned to ask for compensation.
And then I learned to decide my value.
The Reuters article reports that obesity medicine experts Drs. Lee Kaplan, Donna Ryan, Ania Jastreboff, and Jamy Ard were paid thousands of dollars in consulting fees over a decade. This industry-to-physician relationship should be celebrated because:
- Industries should consult experts in the field.
- These leaders have dedicated decades of their lives to understanding and solving the obesity epidemic.
- This collaboration has resulted in a therapeutic option that is changing lives.
If there is anything to criticize, it should be:
- The expectation that medical expertise should be free.Wegovy’s manufacturer is worth $403 billion, and the experts are valued at less than 0.1% of that figure.
- The lack of context.
- Some celebrity doctors can earn $300,000 in just one consult. Other medical or surgical specialties are valued at 100 times more than obesity specialists.
- The false dichotomy.
- Just because money is involved, it doesn’t mean the product is invalid.
Industry and physician relationships have long been examined. Such financial relationships are always disclosed (eg, at conferences, in publications). The Sunshine Act of 2010 and Open Payments provide the necessary transparency for people to decide for themselves whether there were financial incentives or potential conflicts of interest.
We should also take it a step further and ask ourselves: Do conflicts of interest require us to dismiss the end result? In other words, just because the pharmaceutical industry pays these doctors for their time and expertise, does that mean their life’s work is wrong, or that the drug isn’t effective?
In the case of obesity, Wegovy speaks for itself. Remember that the manufacturer stopped advertising. When a disease finally has a treatment, it does not need promoters or salespersons. Just speak to any person with obesity.
Ultimately, I see three main takeaways from Reuters’ reporting:
- The weight loss industry needs more obesity medicine experts.
- We should value ourselves more.
Dr. Tchang received $5525 in 2022 in consulting fees from Novo Nordisk. She plans to ask for more. She also disclosed ties with Gelesis.
A version of this article appeared on Medscape.com.
Olympus provides recall correction for bronchoscopes to reduce fire risk
A series of Olympus bronchofiberscopes and bronchovideoscopes have been recalled by the manufacturer because of a risk for burns and fire, according to a statement from the US Food and Drug Administration (FDA).
However, “this recall is a correction, not a product removal,” according to the FDA.
“While health care providers may choose to continue using the Olympus bronchofiberscopes and bronchovideoscopes, to maximize patient safety and mitigate any potential risk to patient health, the FDA and Olympus advise users not to perform high-frequency cauterization while supplying oxygen, and carefully follow the warnings provided in the Olympus operators manual and highlighted in its October 12, 2023, letter to customers,” an FDA spokesperson said.
The recall affects Olympus bronchofiberscopes and bronchovideoscopes distributed between January 1, 2001, and September 11, 2023. According to the FDA statement, use of these devices may cause serious adverse events to patients and to clinicians. Patients treated with these devices could experience critical burns in the airways or lungs, airway bleeding, breathing difficulty, apnea, loss of consciousness, or death. Healthcare workers using the devices also may be affected in the event of combustion.
On October 12, 2023, Olympus sent an Urgent Medical Device Corrective Action letter. This letter outlined the risks associated with the devices as follows:
“There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.”
To mitigate this risk, Olympus reminds clinicians to heed the warnings found in the device operations manuals, notably these three:
- Do not perform high-frequency cauterization while supplying oxygen.
- Confirm that the electrode section of the electrosurgical device used with the endoscope is at a safe distance from the distal end of the endoscope.
- Only use the Olympus bronchoscopes with compatible high-frequency therapy equipment as described in the operations manual.
The letter also asks facilities that have purchased any of the affected bronchoscopes to ensure that all personnel are “completely knowledgeable and thoroughly aware” of the warnings stated in the operations manual, and it states that users may continue to use the devices according to the current instructions and with attention to the warnings.
Olympus Explains
“Olympus Corporation initiated this Field Corrective Action (FCA) to address complaints of endobronchial combustion occurring when high-frequency-compatible bronchoscopes are used during therapeutic procedures in combination with high-frequency therapy equipment,” a spokeswoman for Olympus said in an interview.
“This corrective action was taken following a thorough assessment of adverse event complaints involving serious patient injury; Olympus takes these complaints very seriously. Patient safety is our top priority,” the spokeswoman said. “The customer notification is intended to remind users of existing warnings not to use oxygen while performing high-frequency cauterization and appropriate distance while using high-frequency therapy equipment.”
The products are not being removed, and no labeling changes are being made at this time, she said.
The bottom line for clinicians: “Users can continue to use Olympus bronchoscopes according to the instructions provided in the operation manual and the customer letter,” the Olympus spokeswoman told this news organization. “This is not a removal action. There are no changes to the existing operation manual regarding compatibility of bronchoscopes with high-frequency therapy equipment,” she said.
“In terms of actions going forward, in addition to the communication provided through this Field Corrective Action, which is intended to remind users of recommendations on oxygen use and clarify the appropriate distance while using high-frequency therapy equipment, the root cause and potential contributing factors are currently under investigation through a formal CAPA (Corrective Action Preventative Action) process. Olympus will take any appropriate enhancement action based on investigation results,” according to the Olympus spokeswoman.
In 2016, this news organization reported that Olympus made medical headlines by recalling its TJF-Q180V duodenoscope in the wake of Congressional investigations after the product was linked to spreading bacterial infections because of design flaws.
United States customers can contact Olympus by phone at 1-800-848-9024 (option 1) with questions about the recall, and healthcare professionals and consumers may report adverse reactions or quality problems associated with the devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program via an online form, regular mail, or fax.
A version of this article first appeared on Medscape.com.
A series of Olympus bronchofiberscopes and bronchovideoscopes have been recalled by the manufacturer because of a risk for burns and fire, according to a statement from the US Food and Drug Administration (FDA).
However, “this recall is a correction, not a product removal,” according to the FDA.
“While health care providers may choose to continue using the Olympus bronchofiberscopes and bronchovideoscopes, to maximize patient safety and mitigate any potential risk to patient health, the FDA and Olympus advise users not to perform high-frequency cauterization while supplying oxygen, and carefully follow the warnings provided in the Olympus operators manual and highlighted in its October 12, 2023, letter to customers,” an FDA spokesperson said.
The recall affects Olympus bronchofiberscopes and bronchovideoscopes distributed between January 1, 2001, and September 11, 2023. According to the FDA statement, use of these devices may cause serious adverse events to patients and to clinicians. Patients treated with these devices could experience critical burns in the airways or lungs, airway bleeding, breathing difficulty, apnea, loss of consciousness, or death. Healthcare workers using the devices also may be affected in the event of combustion.
On October 12, 2023, Olympus sent an Urgent Medical Device Corrective Action letter. This letter outlined the risks associated with the devices as follows:
“There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.”
To mitigate this risk, Olympus reminds clinicians to heed the warnings found in the device operations manuals, notably these three:
- Do not perform high-frequency cauterization while supplying oxygen.
- Confirm that the electrode section of the electrosurgical device used with the endoscope is at a safe distance from the distal end of the endoscope.
- Only use the Olympus bronchoscopes with compatible high-frequency therapy equipment as described in the operations manual.
The letter also asks facilities that have purchased any of the affected bronchoscopes to ensure that all personnel are “completely knowledgeable and thoroughly aware” of the warnings stated in the operations manual, and it states that users may continue to use the devices according to the current instructions and with attention to the warnings.
Olympus Explains
“Olympus Corporation initiated this Field Corrective Action (FCA) to address complaints of endobronchial combustion occurring when high-frequency-compatible bronchoscopes are used during therapeutic procedures in combination with high-frequency therapy equipment,” a spokeswoman for Olympus said in an interview.
“This corrective action was taken following a thorough assessment of adverse event complaints involving serious patient injury; Olympus takes these complaints very seriously. Patient safety is our top priority,” the spokeswoman said. “The customer notification is intended to remind users of existing warnings not to use oxygen while performing high-frequency cauterization and appropriate distance while using high-frequency therapy equipment.”
The products are not being removed, and no labeling changes are being made at this time, she said.
The bottom line for clinicians: “Users can continue to use Olympus bronchoscopes according to the instructions provided in the operation manual and the customer letter,” the Olympus spokeswoman told this news organization. “This is not a removal action. There are no changes to the existing operation manual regarding compatibility of bronchoscopes with high-frequency therapy equipment,” she said.
“In terms of actions going forward, in addition to the communication provided through this Field Corrective Action, which is intended to remind users of recommendations on oxygen use and clarify the appropriate distance while using high-frequency therapy equipment, the root cause and potential contributing factors are currently under investigation through a formal CAPA (Corrective Action Preventative Action) process. Olympus will take any appropriate enhancement action based on investigation results,” according to the Olympus spokeswoman.
In 2016, this news organization reported that Olympus made medical headlines by recalling its TJF-Q180V duodenoscope in the wake of Congressional investigations after the product was linked to spreading bacterial infections because of design flaws.
United States customers can contact Olympus by phone at 1-800-848-9024 (option 1) with questions about the recall, and healthcare professionals and consumers may report adverse reactions or quality problems associated with the devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program via an online form, regular mail, or fax.
A version of this article first appeared on Medscape.com.
A series of Olympus bronchofiberscopes and bronchovideoscopes have been recalled by the manufacturer because of a risk for burns and fire, according to a statement from the US Food and Drug Administration (FDA).
However, “this recall is a correction, not a product removal,” according to the FDA.
“While health care providers may choose to continue using the Olympus bronchofiberscopes and bronchovideoscopes, to maximize patient safety and mitigate any potential risk to patient health, the FDA and Olympus advise users not to perform high-frequency cauterization while supplying oxygen, and carefully follow the warnings provided in the Olympus operators manual and highlighted in its October 12, 2023, letter to customers,” an FDA spokesperson said.
The recall affects Olympus bronchofiberscopes and bronchovideoscopes distributed between January 1, 2001, and September 11, 2023. According to the FDA statement, use of these devices may cause serious adverse events to patients and to clinicians. Patients treated with these devices could experience critical burns in the airways or lungs, airway bleeding, breathing difficulty, apnea, loss of consciousness, or death. Healthcare workers using the devices also may be affected in the event of combustion.
On October 12, 2023, Olympus sent an Urgent Medical Device Corrective Action letter. This letter outlined the risks associated with the devices as follows:
“There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.”
To mitigate this risk, Olympus reminds clinicians to heed the warnings found in the device operations manuals, notably these three:
- Do not perform high-frequency cauterization while supplying oxygen.
- Confirm that the electrode section of the electrosurgical device used with the endoscope is at a safe distance from the distal end of the endoscope.
- Only use the Olympus bronchoscopes with compatible high-frequency therapy equipment as described in the operations manual.
The letter also asks facilities that have purchased any of the affected bronchoscopes to ensure that all personnel are “completely knowledgeable and thoroughly aware” of the warnings stated in the operations manual, and it states that users may continue to use the devices according to the current instructions and with attention to the warnings.
Olympus Explains
“Olympus Corporation initiated this Field Corrective Action (FCA) to address complaints of endobronchial combustion occurring when high-frequency-compatible bronchoscopes are used during therapeutic procedures in combination with high-frequency therapy equipment,” a spokeswoman for Olympus said in an interview.
“This corrective action was taken following a thorough assessment of adverse event complaints involving serious patient injury; Olympus takes these complaints very seriously. Patient safety is our top priority,” the spokeswoman said. “The customer notification is intended to remind users of existing warnings not to use oxygen while performing high-frequency cauterization and appropriate distance while using high-frequency therapy equipment.”
The products are not being removed, and no labeling changes are being made at this time, she said.
The bottom line for clinicians: “Users can continue to use Olympus bronchoscopes according to the instructions provided in the operation manual and the customer letter,” the Olympus spokeswoman told this news organization. “This is not a removal action. There are no changes to the existing operation manual regarding compatibility of bronchoscopes with high-frequency therapy equipment,” she said.
“In terms of actions going forward, in addition to the communication provided through this Field Corrective Action, which is intended to remind users of recommendations on oxygen use and clarify the appropriate distance while using high-frequency therapy equipment, the root cause and potential contributing factors are currently under investigation through a formal CAPA (Corrective Action Preventative Action) process. Olympus will take any appropriate enhancement action based on investigation results,” according to the Olympus spokeswoman.
In 2016, this news organization reported that Olympus made medical headlines by recalling its TJF-Q180V duodenoscope in the wake of Congressional investigations after the product was linked to spreading bacterial infections because of design flaws.
United States customers can contact Olympus by phone at 1-800-848-9024 (option 1) with questions about the recall, and healthcare professionals and consumers may report adverse reactions or quality problems associated with the devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program via an online form, regular mail, or fax.
A version of this article first appeared on Medscape.com.
The 2024 Adult Vaccine Schedule Changes Are Here
This transcript has been edited for clarity.
Sandra Fryhofer, MD, highlights .
The biggest change for 2024 is that you don’t need to wait till January 1, 2024, for these schedules go into effect. Both schedules were published and became available in November 2023 and became effective immediately. They include ACIP recommendations approved by the Centers for Disease Control and Prevention (CDC) director through October 23, 2023.
Subsequent recommendations (before publication of the 2025 schedule) will be added to the addendum, a new Step 5, Section 5 in the schedule. The addendum should make Affordable Care Act (ACA)–compliant insurance plans cover ACIP-recommended immunizations sooner.
This year’s schedule includes more vaccines with new recommendations and new color code keys for the schedule’s vaccine tables. The newest vaccine additions to the 2024 schedule include respiratory syncytial virus (RSV) vaccines, the mpox vaccine (Jynneos), a new MenACWY-MenB combo vaccine (Penbraya), and the new 2023-2024 formulation of the updated COVID vaccine (both mRNA and protein-based adjuvanted versions).
These are listed on the cover page (in alphabetical order) by name, abbreviation, and trade name. Vaccine-specific details can be found in the (Step 3) Notes section, also organized alphabetically.
The Tables
Step 1 is Table 1: Vaccinations by Age. Step 2 is Table 2: Vaccinations by Medical Conditions or Other Indications. The table names haven’t changed. However, their color code legends have been adjusted and refined. Also, the legends for the some of the same colors are not the same for both tables.
The order of and conditions covered in the columns on Table 2 have been reorganized.
Even for vaccines whose recommendations have not changed, the color code keys reflecting the recommendations have changed. For this reason, the 2024 version of Table 2 looks very different from the 2023 version. Also, much of the wording on overlays has been removed, which means you have to rely more heavily on the Notes section.
The color brown has been introduced on Table 2 to spotlight groups and conditions that require recurrent revaccination:
- Give Tdap in each and every pregnancy at 27-36 weeks.
- Revaccinate people living with HIV with MenACWY every 5 years.
- Revaccinate those with asplenia and/or complement deficiency with MenACWY every 5 years and MenB every 2-3 years.
- Stem cell transplant recipients need three doses of Hib.
Vaccine order is the same on both tables.
The rows for 2023-2024 formulations of COVID and flu vaccines are at the top of both tables are coded yellow, meaning everyone needs a dose of both vaccines.
Both tables have added a row for RSV vaccines and mpox vaccines.
Notes Section
The notes have been edited for clarity and reveal who needs what and when and include special vaccine-specific sections for special circumstances.
COVID vaccines. The COVID vaccine note embraces the updated 2023-2024 formula. Everyone aged 6 months or older needs a dose of the updated COVID vaccine. Specifics of who needs what (and when) depend on what they have already received, as well as their immune status. Detailed recommendations for both mRNA and protein-based adjuvanted versions are included in the notes.
RSV vaccines. The notes also give vital details about RSV vaccines for pregnant people and for older adults. There are two RSV vaccines. Both are preF RSV vaccines. They’re identified by trade names for clarity. Arexvy contains an adjuvant. Abrysvo does not contain an adjuvant. The RSV vaccine note explains that only Abyrsvo (the vaccine without the adjuvant) can be given to pregnant people, only at 32-36 weeks, and only to those whose baby would be born during RSV season.
ACIP recommends a dose of either vaccine for adults aged 60 or older, under shared clinical decision-making (meaning you and your patients have to discuss and decide). The notes link to additional guidance for making that decision.
Mpox vaccines. For the mpox vaccine, all adults in any age group at increased risk of getting mpox should get a two-dose series of the vaccine. The mpox vaccine notes include a list of mpox risk factors.
Other Features of the 2024 Adult Immunization Schedule
The schedule has useful links to helpful information:
- Vaccine information statements
- Complete ACIP recommendations
- CDC’s General Best Practice Guidelines for Immunizations.
- VAERS (CDC’s Vaccine Adverse Event Reporting System)
A new “Additional Information” section in the Notes links to:
- Travel vaccination requirements
- Best practices guidelines for vaccinating persons with immunodeficiency
- The National Vaccine Injury Compensation program (for resolving any vaccine injury claims)
The cover page has links to:
- CDC’s vaccine app
- QR code to access the schedule online.
With all these tools literally at your fingertips, there’s no reason not to know which vaccines your patients need and when. The challenge now is making it happen: getting those needed vaccines into arms.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Sandra Fryhofer, MD, highlights .
The biggest change for 2024 is that you don’t need to wait till January 1, 2024, for these schedules go into effect. Both schedules were published and became available in November 2023 and became effective immediately. They include ACIP recommendations approved by the Centers for Disease Control and Prevention (CDC) director through October 23, 2023.
Subsequent recommendations (before publication of the 2025 schedule) will be added to the addendum, a new Step 5, Section 5 in the schedule. The addendum should make Affordable Care Act (ACA)–compliant insurance plans cover ACIP-recommended immunizations sooner.
This year’s schedule includes more vaccines with new recommendations and new color code keys for the schedule’s vaccine tables. The newest vaccine additions to the 2024 schedule include respiratory syncytial virus (RSV) vaccines, the mpox vaccine (Jynneos), a new MenACWY-MenB combo vaccine (Penbraya), and the new 2023-2024 formulation of the updated COVID vaccine (both mRNA and protein-based adjuvanted versions).
These are listed on the cover page (in alphabetical order) by name, abbreviation, and trade name. Vaccine-specific details can be found in the (Step 3) Notes section, also organized alphabetically.
The Tables
Step 1 is Table 1: Vaccinations by Age. Step 2 is Table 2: Vaccinations by Medical Conditions or Other Indications. The table names haven’t changed. However, their color code legends have been adjusted and refined. Also, the legends for the some of the same colors are not the same for both tables.
The order of and conditions covered in the columns on Table 2 have been reorganized.
Even for vaccines whose recommendations have not changed, the color code keys reflecting the recommendations have changed. For this reason, the 2024 version of Table 2 looks very different from the 2023 version. Also, much of the wording on overlays has been removed, which means you have to rely more heavily on the Notes section.
The color brown has been introduced on Table 2 to spotlight groups and conditions that require recurrent revaccination:
- Give Tdap in each and every pregnancy at 27-36 weeks.
- Revaccinate people living with HIV with MenACWY every 5 years.
- Revaccinate those with asplenia and/or complement deficiency with MenACWY every 5 years and MenB every 2-3 years.
- Stem cell transplant recipients need three doses of Hib.
Vaccine order is the same on both tables.
The rows for 2023-2024 formulations of COVID and flu vaccines are at the top of both tables are coded yellow, meaning everyone needs a dose of both vaccines.
Both tables have added a row for RSV vaccines and mpox vaccines.
Notes Section
The notes have been edited for clarity and reveal who needs what and when and include special vaccine-specific sections for special circumstances.
COVID vaccines. The COVID vaccine note embraces the updated 2023-2024 formula. Everyone aged 6 months or older needs a dose of the updated COVID vaccine. Specifics of who needs what (and when) depend on what they have already received, as well as their immune status. Detailed recommendations for both mRNA and protein-based adjuvanted versions are included in the notes.
RSV vaccines. The notes also give vital details about RSV vaccines for pregnant people and for older adults. There are two RSV vaccines. Both are preF RSV vaccines. They’re identified by trade names for clarity. Arexvy contains an adjuvant. Abrysvo does not contain an adjuvant. The RSV vaccine note explains that only Abyrsvo (the vaccine without the adjuvant) can be given to pregnant people, only at 32-36 weeks, and only to those whose baby would be born during RSV season.
ACIP recommends a dose of either vaccine for adults aged 60 or older, under shared clinical decision-making (meaning you and your patients have to discuss and decide). The notes link to additional guidance for making that decision.
Mpox vaccines. For the mpox vaccine, all adults in any age group at increased risk of getting mpox should get a two-dose series of the vaccine. The mpox vaccine notes include a list of mpox risk factors.
Other Features of the 2024 Adult Immunization Schedule
The schedule has useful links to helpful information:
- Vaccine information statements
- Complete ACIP recommendations
- CDC’s General Best Practice Guidelines for Immunizations.
- VAERS (CDC’s Vaccine Adverse Event Reporting System)
A new “Additional Information” section in the Notes links to:
- Travel vaccination requirements
- Best practices guidelines for vaccinating persons with immunodeficiency
- The National Vaccine Injury Compensation program (for resolving any vaccine injury claims)
The cover page has links to:
- CDC’s vaccine app
- QR code to access the schedule online.
With all these tools literally at your fingertips, there’s no reason not to know which vaccines your patients need and when. The challenge now is making it happen: getting those needed vaccines into arms.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Sandra Fryhofer, MD, highlights .
The biggest change for 2024 is that you don’t need to wait till January 1, 2024, for these schedules go into effect. Both schedules were published and became available in November 2023 and became effective immediately. They include ACIP recommendations approved by the Centers for Disease Control and Prevention (CDC) director through October 23, 2023.
Subsequent recommendations (before publication of the 2025 schedule) will be added to the addendum, a new Step 5, Section 5 in the schedule. The addendum should make Affordable Care Act (ACA)–compliant insurance plans cover ACIP-recommended immunizations sooner.
This year’s schedule includes more vaccines with new recommendations and new color code keys for the schedule’s vaccine tables. The newest vaccine additions to the 2024 schedule include respiratory syncytial virus (RSV) vaccines, the mpox vaccine (Jynneos), a new MenACWY-MenB combo vaccine (Penbraya), and the new 2023-2024 formulation of the updated COVID vaccine (both mRNA and protein-based adjuvanted versions).
These are listed on the cover page (in alphabetical order) by name, abbreviation, and trade name. Vaccine-specific details can be found in the (Step 3) Notes section, also organized alphabetically.
The Tables
Step 1 is Table 1: Vaccinations by Age. Step 2 is Table 2: Vaccinations by Medical Conditions or Other Indications. The table names haven’t changed. However, their color code legends have been adjusted and refined. Also, the legends for the some of the same colors are not the same for both tables.
The order of and conditions covered in the columns on Table 2 have been reorganized.
Even for vaccines whose recommendations have not changed, the color code keys reflecting the recommendations have changed. For this reason, the 2024 version of Table 2 looks very different from the 2023 version. Also, much of the wording on overlays has been removed, which means you have to rely more heavily on the Notes section.
The color brown has been introduced on Table 2 to spotlight groups and conditions that require recurrent revaccination:
- Give Tdap in each and every pregnancy at 27-36 weeks.
- Revaccinate people living with HIV with MenACWY every 5 years.
- Revaccinate those with asplenia and/or complement deficiency with MenACWY every 5 years and MenB every 2-3 years.
- Stem cell transplant recipients need three doses of Hib.
Vaccine order is the same on both tables.
The rows for 2023-2024 formulations of COVID and flu vaccines are at the top of both tables are coded yellow, meaning everyone needs a dose of both vaccines.
Both tables have added a row for RSV vaccines and mpox vaccines.
Notes Section
The notes have been edited for clarity and reveal who needs what and when and include special vaccine-specific sections for special circumstances.
COVID vaccines. The COVID vaccine note embraces the updated 2023-2024 formula. Everyone aged 6 months or older needs a dose of the updated COVID vaccine. Specifics of who needs what (and when) depend on what they have already received, as well as their immune status. Detailed recommendations for both mRNA and protein-based adjuvanted versions are included in the notes.
RSV vaccines. The notes also give vital details about RSV vaccines for pregnant people and for older adults. There are two RSV vaccines. Both are preF RSV vaccines. They’re identified by trade names for clarity. Arexvy contains an adjuvant. Abrysvo does not contain an adjuvant. The RSV vaccine note explains that only Abyrsvo (the vaccine without the adjuvant) can be given to pregnant people, only at 32-36 weeks, and only to those whose baby would be born during RSV season.
ACIP recommends a dose of either vaccine for adults aged 60 or older, under shared clinical decision-making (meaning you and your patients have to discuss and decide). The notes link to additional guidance for making that decision.
Mpox vaccines. For the mpox vaccine, all adults in any age group at increased risk of getting mpox should get a two-dose series of the vaccine. The mpox vaccine notes include a list of mpox risk factors.
Other Features of the 2024 Adult Immunization Schedule
The schedule has useful links to helpful information:
- Vaccine information statements
- Complete ACIP recommendations
- CDC’s General Best Practice Guidelines for Immunizations.
- VAERS (CDC’s Vaccine Adverse Event Reporting System)
A new “Additional Information” section in the Notes links to:
- Travel vaccination requirements
- Best practices guidelines for vaccinating persons with immunodeficiency
- The National Vaccine Injury Compensation program (for resolving any vaccine injury claims)
The cover page has links to:
- CDC’s vaccine app
- QR code to access the schedule online.
With all these tools literally at your fingertips, there’s no reason not to know which vaccines your patients need and when. The challenge now is making it happen: getting those needed vaccines into arms.
A version of this article first appeared on Medscape.com.
Commentary: Fertility Concerns and Treatment-Related QOL After Breast Cancer, January 2024
Young women diagnosed with breast cancer have been shown to experience higher rates of symptoms that may adversely affect quality of life (QOL), including depression, weight gain, vasomotor symptoms, and sexual dysfunction; they may also have a harder time managing these issues.3 Chemotherapy-related amenorrhea (CRA) is one of the side effects of breast cancer treatment that can affect premenopausal women, and is associated with both patient- (age, body mass index) and treatment-related (regimen, duration) factors.4 A study analyzing data derived from the prospective, longitudinal Cancer Toxicities Study included 1636 premenopausal women ≤ 50 years of age with stage I-III breast cancer treated with chemotherapy but not receiving ovarian suppression (Kabirian et al). A total of 83.0% of women reported CRA at year 1, 72.5% at year 2, and 66.1% at year 4. A higher likelihood of CRA was observed for women of older age vs those age 18-34 years (adjusted odds ratio [aOR] for 35-39 years 1.84; 40-44 years 5.90; and ≥ 45 years 21.29; P < .001 for all), those who received adjuvant tamoxifen (aOR 1.97; P < .001), and those who had hot flashes at baseline (aOR 1.83; P = .01). In the QOL analysis, 57.1% reported no recovery of menses. Persistent CRA was associated with worse insomnia, more systemic therapy–related adverse effects, and worse sexual functioning. These findings highlight the importance of identifying and discussing CRA with our patients, as this can have both physical and psychological effects in the survivorship setting.
The phase 3 KEYNOTE-522 trial has established immunotherapy plus an anthracycline-based chemotherapy backbone for the treatment of stage II-III triple-negative breast cancer (TNBC), with improvements in pathologic complete response (pCR) rates and survival outcomes.5 This regimen can present tolerance issues in clinical practice, and rare risks for cardiotoxicity and secondary hematologic malignancies are also relevant to consider. Furthermore, some patients may not be candidates for anthracycline-based treatment due to prior receipt of a drug in this class or cardiac comorbidities. De-escalation strategies are desired to lessen toxicity and maintain (or improve) outcomes. An open-label phase 2 trial (NeoPACT) investigated the efficacy of neoadjuvant carboplatin (AUC 6), docetaxel (75 mg/m2), and pembrolizumab (200 mg) every 21 days for six cycles among 115 patients with stage I-III TNBC (Sharma et al). The overall pCR and residual cancer burden (RCB 0+1) rates were 58% (95% CI 48%-67%) and 69% (95% CI 60%-78%), respectively. Estimated 3-year event-free survival was 86% (95% CI 77%-95%) in all patients, 98% in those with a pCR, and 68% in those with residual disease. This study also demonstrated a positive association of immune biomarkers and pathologic response. The most common grade ≥ 3 treatment-related adverse events were diarrhea (4.3%), anemia (3.5%), and peripheral sensory neuropathy (2.6%). The phase 3 SCARLET (Shorter Anthracycline-Free Chemoimmunotherapy Adapted to Pathologic Response in Early TNBC) trial is comparing the NeoPACT regimen with the standard KEYNOTE-522 regimen in early-stage TNBC and will be critical to further defining this treatment space.6 Presently, considering the described efficacy outcomes with the NeoPACT regimen, this regimen would be very reasonable to consider in patients who are not candidates for an anthracycline. Future prospective evaluation of immune biomarkers and additional predictors of response will also be valuable to further individualize treatment for our patients.
Additional References
- Lambertini M, Blondeaux E, Bruzzone M, et al. Pregnancy after breast cancer: A systematic review and meta-analysis. J Clin Oncol. 2021;39:3293-3305. doi: 10.1200/JCO.21.00535
- Partridge AH, Niman SM, Ruggeri M, et al, for the International Breast Cancer Study Group and POSITIVE Trial Collaborators. Interrupting endocrine therapy to attempt pregnancy after breast cancer. N Engl J Med. 2023;388:1645-1656. doi: 10.1056/NEJMoa2212856
- Howard-Anderson J, Ganz PA, Bower JE, Stanton AL. Quality of life, fertility concerns, and behavioral health outcomes in younger breast cancer survivors: A systematic review. J Natl Cancer Inst. 2012;104:386-405. doi: 10.1093/jnci/djr541
- Turnbull AK, Patel S, Martinez-Perez C, et al. Risk of chemotherapy-related amenorrhoea (CRA) in premenopausal women undergoing chemotherapy for early stage breast cancer. Breast Cancer Res Treat. 2021;186:237-245. doi: 10.1007/s10549-020-05951-5
- Schmid P, Cortes J, Dent R, et al; KEYNOTE-522 Investigators. Event-free survival with pembrolizumab in early triple-negative breast cancer. N Engl J Med. 2022;386:556-567. doi: 10.1056/NEJMoa2112651
- US National Cancer Institute, Cancer Therapy Evaluation Program. Shorter anthracycline-free chemoimmunotherapy adapted to pathological response in early TNBC (SCARLET); SWOG S2212. Source
Young women diagnosed with breast cancer have been shown to experience higher rates of symptoms that may adversely affect quality of life (QOL), including depression, weight gain, vasomotor symptoms, and sexual dysfunction; they may also have a harder time managing these issues.3 Chemotherapy-related amenorrhea (CRA) is one of the side effects of breast cancer treatment that can affect premenopausal women, and is associated with both patient- (age, body mass index) and treatment-related (regimen, duration) factors.4 A study analyzing data derived from the prospective, longitudinal Cancer Toxicities Study included 1636 premenopausal women ≤ 50 years of age with stage I-III breast cancer treated with chemotherapy but not receiving ovarian suppression (Kabirian et al). A total of 83.0% of women reported CRA at year 1, 72.5% at year 2, and 66.1% at year 4. A higher likelihood of CRA was observed for women of older age vs those age 18-34 years (adjusted odds ratio [aOR] for 35-39 years 1.84; 40-44 years 5.90; and ≥ 45 years 21.29; P < .001 for all), those who received adjuvant tamoxifen (aOR 1.97; P < .001), and those who had hot flashes at baseline (aOR 1.83; P = .01). In the QOL analysis, 57.1% reported no recovery of menses. Persistent CRA was associated with worse insomnia, more systemic therapy–related adverse effects, and worse sexual functioning. These findings highlight the importance of identifying and discussing CRA with our patients, as this can have both physical and psychological effects in the survivorship setting.
The phase 3 KEYNOTE-522 trial has established immunotherapy plus an anthracycline-based chemotherapy backbone for the treatment of stage II-III triple-negative breast cancer (TNBC), with improvements in pathologic complete response (pCR) rates and survival outcomes.5 This regimen can present tolerance issues in clinical practice, and rare risks for cardiotoxicity and secondary hematologic malignancies are also relevant to consider. Furthermore, some patients may not be candidates for anthracycline-based treatment due to prior receipt of a drug in this class or cardiac comorbidities. De-escalation strategies are desired to lessen toxicity and maintain (or improve) outcomes. An open-label phase 2 trial (NeoPACT) investigated the efficacy of neoadjuvant carboplatin (AUC 6), docetaxel (75 mg/m2), and pembrolizumab (200 mg) every 21 days for six cycles among 115 patients with stage I-III TNBC (Sharma et al). The overall pCR and residual cancer burden (RCB 0+1) rates were 58% (95% CI 48%-67%) and 69% (95% CI 60%-78%), respectively. Estimated 3-year event-free survival was 86% (95% CI 77%-95%) in all patients, 98% in those with a pCR, and 68% in those with residual disease. This study also demonstrated a positive association of immune biomarkers and pathologic response. The most common grade ≥ 3 treatment-related adverse events were diarrhea (4.3%), anemia (3.5%), and peripheral sensory neuropathy (2.6%). The phase 3 SCARLET (Shorter Anthracycline-Free Chemoimmunotherapy Adapted to Pathologic Response in Early TNBC) trial is comparing the NeoPACT regimen with the standard KEYNOTE-522 regimen in early-stage TNBC and will be critical to further defining this treatment space.6 Presently, considering the described efficacy outcomes with the NeoPACT regimen, this regimen would be very reasonable to consider in patients who are not candidates for an anthracycline. Future prospective evaluation of immune biomarkers and additional predictors of response will also be valuable to further individualize treatment for our patients.
Additional References
- Lambertini M, Blondeaux E, Bruzzone M, et al. Pregnancy after breast cancer: A systematic review and meta-analysis. J Clin Oncol. 2021;39:3293-3305. doi: 10.1200/JCO.21.00535
- Partridge AH, Niman SM, Ruggeri M, et al, for the International Breast Cancer Study Group and POSITIVE Trial Collaborators. Interrupting endocrine therapy to attempt pregnancy after breast cancer. N Engl J Med. 2023;388:1645-1656. doi: 10.1056/NEJMoa2212856
- Howard-Anderson J, Ganz PA, Bower JE, Stanton AL. Quality of life, fertility concerns, and behavioral health outcomes in younger breast cancer survivors: A systematic review. J Natl Cancer Inst. 2012;104:386-405. doi: 10.1093/jnci/djr541
- Turnbull AK, Patel S, Martinez-Perez C, et al. Risk of chemotherapy-related amenorrhoea (CRA) in premenopausal women undergoing chemotherapy for early stage breast cancer. Breast Cancer Res Treat. 2021;186:237-245. doi: 10.1007/s10549-020-05951-5
- Schmid P, Cortes J, Dent R, et al; KEYNOTE-522 Investigators. Event-free survival with pembrolizumab in early triple-negative breast cancer. N Engl J Med. 2022;386:556-567. doi: 10.1056/NEJMoa2112651
- US National Cancer Institute, Cancer Therapy Evaluation Program. Shorter anthracycline-free chemoimmunotherapy adapted to pathological response in early TNBC (SCARLET); SWOG S2212. Source
Young women diagnosed with breast cancer have been shown to experience higher rates of symptoms that may adversely affect quality of life (QOL), including depression, weight gain, vasomotor symptoms, and sexual dysfunction; they may also have a harder time managing these issues.3 Chemotherapy-related amenorrhea (CRA) is one of the side effects of breast cancer treatment that can affect premenopausal women, and is associated with both patient- (age, body mass index) and treatment-related (regimen, duration) factors.4 A study analyzing data derived from the prospective, longitudinal Cancer Toxicities Study included 1636 premenopausal women ≤ 50 years of age with stage I-III breast cancer treated with chemotherapy but not receiving ovarian suppression (Kabirian et al). A total of 83.0% of women reported CRA at year 1, 72.5% at year 2, and 66.1% at year 4. A higher likelihood of CRA was observed for women of older age vs those age 18-34 years (adjusted odds ratio [aOR] for 35-39 years 1.84; 40-44 years 5.90; and ≥ 45 years 21.29; P < .001 for all), those who received adjuvant tamoxifen (aOR 1.97; P < .001), and those who had hot flashes at baseline (aOR 1.83; P = .01). In the QOL analysis, 57.1% reported no recovery of menses. Persistent CRA was associated with worse insomnia, more systemic therapy–related adverse effects, and worse sexual functioning. These findings highlight the importance of identifying and discussing CRA with our patients, as this can have both physical and psychological effects in the survivorship setting.
The phase 3 KEYNOTE-522 trial has established immunotherapy plus an anthracycline-based chemotherapy backbone for the treatment of stage II-III triple-negative breast cancer (TNBC), with improvements in pathologic complete response (pCR) rates and survival outcomes.5 This regimen can present tolerance issues in clinical practice, and rare risks for cardiotoxicity and secondary hematologic malignancies are also relevant to consider. Furthermore, some patients may not be candidates for anthracycline-based treatment due to prior receipt of a drug in this class or cardiac comorbidities. De-escalation strategies are desired to lessen toxicity and maintain (or improve) outcomes. An open-label phase 2 trial (NeoPACT) investigated the efficacy of neoadjuvant carboplatin (AUC 6), docetaxel (75 mg/m2), and pembrolizumab (200 mg) every 21 days for six cycles among 115 patients with stage I-III TNBC (Sharma et al). The overall pCR and residual cancer burden (RCB 0+1) rates were 58% (95% CI 48%-67%) and 69% (95% CI 60%-78%), respectively. Estimated 3-year event-free survival was 86% (95% CI 77%-95%) in all patients, 98% in those with a pCR, and 68% in those with residual disease. This study also demonstrated a positive association of immune biomarkers and pathologic response. The most common grade ≥ 3 treatment-related adverse events were diarrhea (4.3%), anemia (3.5%), and peripheral sensory neuropathy (2.6%). The phase 3 SCARLET (Shorter Anthracycline-Free Chemoimmunotherapy Adapted to Pathologic Response in Early TNBC) trial is comparing the NeoPACT regimen with the standard KEYNOTE-522 regimen in early-stage TNBC and will be critical to further defining this treatment space.6 Presently, considering the described efficacy outcomes with the NeoPACT regimen, this regimen would be very reasonable to consider in patients who are not candidates for an anthracycline. Future prospective evaluation of immune biomarkers and additional predictors of response will also be valuable to further individualize treatment for our patients.
Additional References
- Lambertini M, Blondeaux E, Bruzzone M, et al. Pregnancy after breast cancer: A systematic review and meta-analysis. J Clin Oncol. 2021;39:3293-3305. doi: 10.1200/JCO.21.00535
- Partridge AH, Niman SM, Ruggeri M, et al, for the International Breast Cancer Study Group and POSITIVE Trial Collaborators. Interrupting endocrine therapy to attempt pregnancy after breast cancer. N Engl J Med. 2023;388:1645-1656. doi: 10.1056/NEJMoa2212856
- Howard-Anderson J, Ganz PA, Bower JE, Stanton AL. Quality of life, fertility concerns, and behavioral health outcomes in younger breast cancer survivors: A systematic review. J Natl Cancer Inst. 2012;104:386-405. doi: 10.1093/jnci/djr541
- Turnbull AK, Patel S, Martinez-Perez C, et al. Risk of chemotherapy-related amenorrhoea (CRA) in premenopausal women undergoing chemotherapy for early stage breast cancer. Breast Cancer Res Treat. 2021;186:237-245. doi: 10.1007/s10549-020-05951-5
- Schmid P, Cortes J, Dent R, et al; KEYNOTE-522 Investigators. Event-free survival with pembrolizumab in early triple-negative breast cancer. N Engl J Med. 2022;386:556-567. doi: 10.1056/NEJMoa2112651
- US National Cancer Institute, Cancer Therapy Evaluation Program. Shorter anthracycline-free chemoimmunotherapy adapted to pathological response in early TNBC (SCARLET); SWOG S2212. Source
Commentary: Variations in DMARD Effectiveness and Enthesitis Treatment in PsA, January 2024
Treatment of enthesitis can be challenging. Head-to-head clinical trials using clinical enthesitis indices have indicated that TNF inhibitors and IL-17 inhibitors have similar efficacy in treating enthesitis. However, clinically determined enthesitis may not be true inflammatory enthesitis. Ultrasonography-confirmed enthesitis probably reflects true enthesitis. Therefore, Elliot and colleagues conducted an observational study that compared the change in MAdrid Sonographic Enthesitis Index (MASEI) at 16 weeks of treatment with either TNF inhibitors or secukinumab. They observed that the mean reduction in MASEI that assesses both active and chronic entheseal disease was not significantly different with TNF inhibitors vs secukinumab treatment. However, TNF inhibitors were significantly more effective than secukinumab when only active entheseal lesions were considered. Thus, TNF inhibitors may be more effective for active enthesitis; randomized trials using ultrasonographic enthesitis indices comparing the two treatments are required.
Serum drug levels have previously been shown to be associated with response to bDMARD therapy, but use of drug-level measurement is not routine in rheumatology practice. Moreover, trough levels are emphasized and may not often be feasible to obtain. Curry and colleagues investigated the relationship between serum non-trough drug levels (SDL) and treatment response at 3 months in patients with PsA who initiated treatment with adalimumab (n = 104) or etanercept (n = 97). They demonstrated that patients with higher etanercept SDL or higher adalimumab SDL were significantly more likely to be responders. A non-trough etanercept SDL of 2.0 µg/mL and adalimumab SDL of 3.6 µg/mL could differentiate between responders and nonresponders with ~50% specificity and > 60% sensitivity. However, the area under the receiver operating characteristic curves were only about 65%; thus, the ability of SDL to discriminate between responders and nonresponders is low.
Treatment of enthesitis can be challenging. Head-to-head clinical trials using clinical enthesitis indices have indicated that TNF inhibitors and IL-17 inhibitors have similar efficacy in treating enthesitis. However, clinically determined enthesitis may not be true inflammatory enthesitis. Ultrasonography-confirmed enthesitis probably reflects true enthesitis. Therefore, Elliot and colleagues conducted an observational study that compared the change in MAdrid Sonographic Enthesitis Index (MASEI) at 16 weeks of treatment with either TNF inhibitors or secukinumab. They observed that the mean reduction in MASEI that assesses both active and chronic entheseal disease was not significantly different with TNF inhibitors vs secukinumab treatment. However, TNF inhibitors were significantly more effective than secukinumab when only active entheseal lesions were considered. Thus, TNF inhibitors may be more effective for active enthesitis; randomized trials using ultrasonographic enthesitis indices comparing the two treatments are required.
Serum drug levels have previously been shown to be associated with response to bDMARD therapy, but use of drug-level measurement is not routine in rheumatology practice. Moreover, trough levels are emphasized and may not often be feasible to obtain. Curry and colleagues investigated the relationship between serum non-trough drug levels (SDL) and treatment response at 3 months in patients with PsA who initiated treatment with adalimumab (n = 104) or etanercept (n = 97). They demonstrated that patients with higher etanercept SDL or higher adalimumab SDL were significantly more likely to be responders. A non-trough etanercept SDL of 2.0 µg/mL and adalimumab SDL of 3.6 µg/mL could differentiate between responders and nonresponders with ~50% specificity and > 60% sensitivity. However, the area under the receiver operating characteristic curves were only about 65%; thus, the ability of SDL to discriminate between responders and nonresponders is low.
Treatment of enthesitis can be challenging. Head-to-head clinical trials using clinical enthesitis indices have indicated that TNF inhibitors and IL-17 inhibitors have similar efficacy in treating enthesitis. However, clinically determined enthesitis may not be true inflammatory enthesitis. Ultrasonography-confirmed enthesitis probably reflects true enthesitis. Therefore, Elliot and colleagues conducted an observational study that compared the change in MAdrid Sonographic Enthesitis Index (MASEI) at 16 weeks of treatment with either TNF inhibitors or secukinumab. They observed that the mean reduction in MASEI that assesses both active and chronic entheseal disease was not significantly different with TNF inhibitors vs secukinumab treatment. However, TNF inhibitors were significantly more effective than secukinumab when only active entheseal lesions were considered. Thus, TNF inhibitors may be more effective for active enthesitis; randomized trials using ultrasonographic enthesitis indices comparing the two treatments are required.
Serum drug levels have previously been shown to be associated with response to bDMARD therapy, but use of drug-level measurement is not routine in rheumatology practice. Moreover, trough levels are emphasized and may not often be feasible to obtain. Curry and colleagues investigated the relationship between serum non-trough drug levels (SDL) and treatment response at 3 months in patients with PsA who initiated treatment with adalimumab (n = 104) or etanercept (n = 97). They demonstrated that patients with higher etanercept SDL or higher adalimumab SDL were significantly more likely to be responders. A non-trough etanercept SDL of 2.0 µg/mL and adalimumab SDL of 3.6 µg/mL could differentiate between responders and nonresponders with ~50% specificity and > 60% sensitivity. However, the area under the receiver operating characteristic curves were only about 65%; thus, the ability of SDL to discriminate between responders and nonresponders is low.
Long COVID: New Info on Who Is Most Likely to Get It
The COVID-19 pandemic may no longer be a global public health emergency, but millions continue to struggle with the aftermath: Long COVID. New research and clinical anecdotes suggest that certain individuals are more likely to be afflicted by the condition, nearly 4 years after the virus emerged.
Many patients with long COVID struggle with debilitating fatigue, brain fog, and cognitive impairment. The condition is also characterized by a catalog of other symptoms that may be difficult to recognize as long COVID, experts said. That’s especially true when patients may not mention seemingly unrelated information, such as underlying health conditions that might make them more vulnerable. This makes screening for certain conditions and investigating every symptom especially important.
The severity of a patient’s initial infection is not the only determining factor for developing long COVID, experts said.
“Don’t judge the person based on how sick they were initially,” said Mark Bayley, MD, medical director of the Toronto Rehabilitation Institute at University Health Network and a professor with the Temerty Faculty of Medicine at the University of Toronto. “You have to evaluate every symptom as best you can to make sure you’re not missing anything else.”
Someone who only had a bad cough or felt really unwell for just a few days and recovered but started feeling rotten again later — “that’s the person that we are seeing for long COVID,” said Dr. Bayley.
While patients who become severely sick and require hospitalization have a higher risk of developing long COVID, this group size is small compared with the much larger number of people infected overall. As a result, despite the lower risk, those who only become mild to moderately sick make up the vast majority of patients in long COVID clinics.
A small Northwestern Medicine study found that 41% of patients with long COVID never tested positive for COVID-19 but were found to have antibodies that indicated exposure to the virus.
Doctors treating patients with long COVID should consider several risk factors, specialists said. They include:
- A history of asthma, eczema, or allergies
- Signs of autonomic nervous system dysfunction
- Preexisting immune system issues
- Chronic infections
- Diabetes
- Being slightly overweight
- A preexisting history of anxiety or depression
- Joint hypermobility ( being “double-jointed” with pain and other symptoms)
Screening for Allergies
Alba Azola, MD, assistant professor of Physical Medicine and Rehabilitation at Johns Hopkins Medicine, said a history of asthma, allergies, and eczema and an onset of new food allergies may be an important factor in long COVID that doctors should consider when evaluating at-risk patients.
It is important to identify this subgroup of patients because they respond to antihistamines and mast cell stabilizers, which not only relieve their allergy symptoms but may also help improve overall fatigue and their tolerance for basic activities like standing, Dr. Azola said.
A recently published systemic review of prospective cohort studies on long COVID also found that patients with preexisting allergic conditions like asthma or rhinitis may be linked to a higher risk of developing long COVID. The authors cautioned, however, that the evidence for the link is uncertain and more rigorous research is needed.
“It stands to reason that if your immune system tends to be a bit hyperactive that triggering it with a virus will make it worse,” said Dr. Bayley.
Signs of Dysautonomia, Joint Hypermobility
Patients should also be screened for signs and symptoms of dysautonomia, or autonomic nervous system disorder, such as postural orthostatic tachycardia syndrome (POTS) or another type of autonomic dysfunction, doctors said.
“There’s a whole list because the autonomic nervous system involves every part of your body, every system,” Dr. Azola said.
Issues with standing, vision, digestion, urination, and bowel movement, for example, appear to be multisystemic problems but may all be linked to autonomic dysfunction, she explained.
Patients who have POTS usually experience a worsening of symptoms after COVID infection, Dr. Azola said, adding that some patients may have even assumed their pre-COVID symptoms of POTS were normal.
She also screens for joint hypermobility or hypermobile Ehlers-Danlos syndrome, which affects connective tissue. Research has long shown a relationship between autonomic dysfunction, mast cell activation syndrome (repeated severe allergy symptoms that affect multiple systems), and the presence of hypermobility, Dr. Azola said. She added that gentle physical therapy can be helpful for patients with hypermobility issues.
Previous studies before and during the pandemic have also found that a substantial subset of patients with myalgic encephalomyelitis/chronic fatigue syndrome, which shares many similarities with long COVID, also have connective tissue/hypermobility disorders.
Depression, Anxiety, and Female Patients
People with a preexisting history of anxiety or depression also appear to be at a higher risk for long COVID, Dr. Bayley said, noting that patients with these conditions appear more vulnerable to brain fog and other difficulties brought on by COVID infection. Earlier research found biochemical evidence of brain inflammation that correlates with symptoms of anxiety in patients with long COVID.
“We know that depression is related to neurotransmitters like adrenaline and serotonin,” Dr. Bayley said. “The chronic inflammation that’s associated with COVID — this will make people feel more depressed because they’re not getting the neurotransmitters in their brain releasing at the right times.”
It may also put patients at a risk for anxiety due to fears of post-exertional malaise (PEM), where symptoms worsen after even very minor physical or mental exertion and can last days or weeks.
“You can see how that leads to a bit of a vicious cycle,” said Dr. Bayley, explaining that the cycle of fear and avoidance makes patients less active and deconditioned. But he added that learning to manage their activity can actually help mitigate PEM due to the anti-inflammatory effects of exercise, its positive impact on mood, and benefits to the immune and cardiovascular systems.
Meanwhile, a number of epidemiologic studies have found a higher prevalence of long COVID among women. Perimenopausal and menopausal women in particular appeared more prone, and at least one study reported that women under 50 years were five times more likely to develop post-COVID symptoms than men.
A recent small UK study that focused on COVID-19 hospitalizations found that women who had lower levels of inflammatory biomarkers at admission were more likely to experience certain long-term symptoms like muscle ache, low mood and anxiety, adding to earlier research linking female patients, long COVID, and neuropsychiatric symptoms.
History of Immune Dysfunction, Diabetes, Elevated Body Mass Index (BMI)
Immune dysfunction, a history of recurrent infections, or chronic sinus infections are also common among patients under Dr. Azola and her team’s care. Those who have arthritis or other autoimmune diseases such as lupus also appear more vulnerable, Dr. Bayley said, along with patients who have diabetes or a little overweight.
Recent research out of the University of Queensland found that being overweight can negatively affect the body’s immune response to the SARS-CoV-2 virus. Blood samples collected 13 months after infection, for example, found that individuals with a higher BMI had lower antibody activity and a reduced percentage of relevant B cells that help build antibodies to fight the virus. Being overweight did not affect the antibody response to the COVID-19 vaccines, however, giving further support for vaccination over infection-induced immunity as an important protective factor, researchers said.
Narrowing the Information Gap
The latest Centers for Centers for Disease Control and Prevention’s Household Pulse Survey estimates that 14% of all American adults have had long COVID at some point, with more than 5% of the entire adult population currently experiencing long COVID. With millions of Americans affected, experts and advocates highlight the importance of bridging the knowledge gap with primary care doctors.
Long COVID specialists said understanding these connections helps guide treatment plans and manage symptoms, such as finding the right medications, improving tolerance, optimizing sleep, applying cognitive strategies for brain fog, dietary changes, respiratory exercises to help with shortness of breath, and finding the fine line between what causes PEM and what doesn’t.
“Whenever you see a disease like this one, you always have to ask yourself, is there an alternative way of looking at this that might explain what we’re seeing?” said Dr. Bayley. “It remains to be said that all bets are still open and that we need to continue to be very broad thinking about this.”
A version of this article appeared on Medscape.com.
The COVID-19 pandemic may no longer be a global public health emergency, but millions continue to struggle with the aftermath: Long COVID. New research and clinical anecdotes suggest that certain individuals are more likely to be afflicted by the condition, nearly 4 years after the virus emerged.
Many patients with long COVID struggle with debilitating fatigue, brain fog, and cognitive impairment. The condition is also characterized by a catalog of other symptoms that may be difficult to recognize as long COVID, experts said. That’s especially true when patients may not mention seemingly unrelated information, such as underlying health conditions that might make them more vulnerable. This makes screening for certain conditions and investigating every symptom especially important.
The severity of a patient’s initial infection is not the only determining factor for developing long COVID, experts said.
“Don’t judge the person based on how sick they were initially,” said Mark Bayley, MD, medical director of the Toronto Rehabilitation Institute at University Health Network and a professor with the Temerty Faculty of Medicine at the University of Toronto. “You have to evaluate every symptom as best you can to make sure you’re not missing anything else.”
Someone who only had a bad cough or felt really unwell for just a few days and recovered but started feeling rotten again later — “that’s the person that we are seeing for long COVID,” said Dr. Bayley.
While patients who become severely sick and require hospitalization have a higher risk of developing long COVID, this group size is small compared with the much larger number of people infected overall. As a result, despite the lower risk, those who only become mild to moderately sick make up the vast majority of patients in long COVID clinics.
A small Northwestern Medicine study found that 41% of patients with long COVID never tested positive for COVID-19 but were found to have antibodies that indicated exposure to the virus.
Doctors treating patients with long COVID should consider several risk factors, specialists said. They include:
- A history of asthma, eczema, or allergies
- Signs of autonomic nervous system dysfunction
- Preexisting immune system issues
- Chronic infections
- Diabetes
- Being slightly overweight
- A preexisting history of anxiety or depression
- Joint hypermobility ( being “double-jointed” with pain and other symptoms)
Screening for Allergies
Alba Azola, MD, assistant professor of Physical Medicine and Rehabilitation at Johns Hopkins Medicine, said a history of asthma, allergies, and eczema and an onset of new food allergies may be an important factor in long COVID that doctors should consider when evaluating at-risk patients.
It is important to identify this subgroup of patients because they respond to antihistamines and mast cell stabilizers, which not only relieve their allergy symptoms but may also help improve overall fatigue and their tolerance for basic activities like standing, Dr. Azola said.
A recently published systemic review of prospective cohort studies on long COVID also found that patients with preexisting allergic conditions like asthma or rhinitis may be linked to a higher risk of developing long COVID. The authors cautioned, however, that the evidence for the link is uncertain and more rigorous research is needed.
“It stands to reason that if your immune system tends to be a bit hyperactive that triggering it with a virus will make it worse,” said Dr. Bayley.
Signs of Dysautonomia, Joint Hypermobility
Patients should also be screened for signs and symptoms of dysautonomia, or autonomic nervous system disorder, such as postural orthostatic tachycardia syndrome (POTS) or another type of autonomic dysfunction, doctors said.
“There’s a whole list because the autonomic nervous system involves every part of your body, every system,” Dr. Azola said.
Issues with standing, vision, digestion, urination, and bowel movement, for example, appear to be multisystemic problems but may all be linked to autonomic dysfunction, she explained.
Patients who have POTS usually experience a worsening of symptoms after COVID infection, Dr. Azola said, adding that some patients may have even assumed their pre-COVID symptoms of POTS were normal.
She also screens for joint hypermobility or hypermobile Ehlers-Danlos syndrome, which affects connective tissue. Research has long shown a relationship between autonomic dysfunction, mast cell activation syndrome (repeated severe allergy symptoms that affect multiple systems), and the presence of hypermobility, Dr. Azola said. She added that gentle physical therapy can be helpful for patients with hypermobility issues.
Previous studies before and during the pandemic have also found that a substantial subset of patients with myalgic encephalomyelitis/chronic fatigue syndrome, which shares many similarities with long COVID, also have connective tissue/hypermobility disorders.
Depression, Anxiety, and Female Patients
People with a preexisting history of anxiety or depression also appear to be at a higher risk for long COVID, Dr. Bayley said, noting that patients with these conditions appear more vulnerable to brain fog and other difficulties brought on by COVID infection. Earlier research found biochemical evidence of brain inflammation that correlates with symptoms of anxiety in patients with long COVID.
“We know that depression is related to neurotransmitters like adrenaline and serotonin,” Dr. Bayley said. “The chronic inflammation that’s associated with COVID — this will make people feel more depressed because they’re not getting the neurotransmitters in their brain releasing at the right times.”
It may also put patients at a risk for anxiety due to fears of post-exertional malaise (PEM), where symptoms worsen after even very minor physical or mental exertion and can last days or weeks.
“You can see how that leads to a bit of a vicious cycle,” said Dr. Bayley, explaining that the cycle of fear and avoidance makes patients less active and deconditioned. But he added that learning to manage their activity can actually help mitigate PEM due to the anti-inflammatory effects of exercise, its positive impact on mood, and benefits to the immune and cardiovascular systems.
Meanwhile, a number of epidemiologic studies have found a higher prevalence of long COVID among women. Perimenopausal and menopausal women in particular appeared more prone, and at least one study reported that women under 50 years were five times more likely to develop post-COVID symptoms than men.
A recent small UK study that focused on COVID-19 hospitalizations found that women who had lower levels of inflammatory biomarkers at admission were more likely to experience certain long-term symptoms like muscle ache, low mood and anxiety, adding to earlier research linking female patients, long COVID, and neuropsychiatric symptoms.
History of Immune Dysfunction, Diabetes, Elevated Body Mass Index (BMI)
Immune dysfunction, a history of recurrent infections, or chronic sinus infections are also common among patients under Dr. Azola and her team’s care. Those who have arthritis or other autoimmune diseases such as lupus also appear more vulnerable, Dr. Bayley said, along with patients who have diabetes or a little overweight.
Recent research out of the University of Queensland found that being overweight can negatively affect the body’s immune response to the SARS-CoV-2 virus. Blood samples collected 13 months after infection, for example, found that individuals with a higher BMI had lower antibody activity and a reduced percentage of relevant B cells that help build antibodies to fight the virus. Being overweight did not affect the antibody response to the COVID-19 vaccines, however, giving further support for vaccination over infection-induced immunity as an important protective factor, researchers said.
Narrowing the Information Gap
The latest Centers for Centers for Disease Control and Prevention’s Household Pulse Survey estimates that 14% of all American adults have had long COVID at some point, with more than 5% of the entire adult population currently experiencing long COVID. With millions of Americans affected, experts and advocates highlight the importance of bridging the knowledge gap with primary care doctors.
Long COVID specialists said understanding these connections helps guide treatment plans and manage symptoms, such as finding the right medications, improving tolerance, optimizing sleep, applying cognitive strategies for brain fog, dietary changes, respiratory exercises to help with shortness of breath, and finding the fine line between what causes PEM and what doesn’t.
“Whenever you see a disease like this one, you always have to ask yourself, is there an alternative way of looking at this that might explain what we’re seeing?” said Dr. Bayley. “It remains to be said that all bets are still open and that we need to continue to be very broad thinking about this.”
A version of this article appeared on Medscape.com.
The COVID-19 pandemic may no longer be a global public health emergency, but millions continue to struggle with the aftermath: Long COVID. New research and clinical anecdotes suggest that certain individuals are more likely to be afflicted by the condition, nearly 4 years after the virus emerged.
Many patients with long COVID struggle with debilitating fatigue, brain fog, and cognitive impairment. The condition is also characterized by a catalog of other symptoms that may be difficult to recognize as long COVID, experts said. That’s especially true when patients may not mention seemingly unrelated information, such as underlying health conditions that might make them more vulnerable. This makes screening for certain conditions and investigating every symptom especially important.
The severity of a patient’s initial infection is not the only determining factor for developing long COVID, experts said.
“Don’t judge the person based on how sick they were initially,” said Mark Bayley, MD, medical director of the Toronto Rehabilitation Institute at University Health Network and a professor with the Temerty Faculty of Medicine at the University of Toronto. “You have to evaluate every symptom as best you can to make sure you’re not missing anything else.”
Someone who only had a bad cough or felt really unwell for just a few days and recovered but started feeling rotten again later — “that’s the person that we are seeing for long COVID,” said Dr. Bayley.
While patients who become severely sick and require hospitalization have a higher risk of developing long COVID, this group size is small compared with the much larger number of people infected overall. As a result, despite the lower risk, those who only become mild to moderately sick make up the vast majority of patients in long COVID clinics.
A small Northwestern Medicine study found that 41% of patients with long COVID never tested positive for COVID-19 but were found to have antibodies that indicated exposure to the virus.
Doctors treating patients with long COVID should consider several risk factors, specialists said. They include:
- A history of asthma, eczema, or allergies
- Signs of autonomic nervous system dysfunction
- Preexisting immune system issues
- Chronic infections
- Diabetes
- Being slightly overweight
- A preexisting history of anxiety or depression
- Joint hypermobility ( being “double-jointed” with pain and other symptoms)
Screening for Allergies
Alba Azola, MD, assistant professor of Physical Medicine and Rehabilitation at Johns Hopkins Medicine, said a history of asthma, allergies, and eczema and an onset of new food allergies may be an important factor in long COVID that doctors should consider when evaluating at-risk patients.
It is important to identify this subgroup of patients because they respond to antihistamines and mast cell stabilizers, which not only relieve their allergy symptoms but may also help improve overall fatigue and their tolerance for basic activities like standing, Dr. Azola said.
A recently published systemic review of prospective cohort studies on long COVID also found that patients with preexisting allergic conditions like asthma or rhinitis may be linked to a higher risk of developing long COVID. The authors cautioned, however, that the evidence for the link is uncertain and more rigorous research is needed.
“It stands to reason that if your immune system tends to be a bit hyperactive that triggering it with a virus will make it worse,” said Dr. Bayley.
Signs of Dysautonomia, Joint Hypermobility
Patients should also be screened for signs and symptoms of dysautonomia, or autonomic nervous system disorder, such as postural orthostatic tachycardia syndrome (POTS) or another type of autonomic dysfunction, doctors said.
“There’s a whole list because the autonomic nervous system involves every part of your body, every system,” Dr. Azola said.
Issues with standing, vision, digestion, urination, and bowel movement, for example, appear to be multisystemic problems but may all be linked to autonomic dysfunction, she explained.
Patients who have POTS usually experience a worsening of symptoms after COVID infection, Dr. Azola said, adding that some patients may have even assumed their pre-COVID symptoms of POTS were normal.
She also screens for joint hypermobility or hypermobile Ehlers-Danlos syndrome, which affects connective tissue. Research has long shown a relationship between autonomic dysfunction, mast cell activation syndrome (repeated severe allergy symptoms that affect multiple systems), and the presence of hypermobility, Dr. Azola said. She added that gentle physical therapy can be helpful for patients with hypermobility issues.
Previous studies before and during the pandemic have also found that a substantial subset of patients with myalgic encephalomyelitis/chronic fatigue syndrome, which shares many similarities with long COVID, also have connective tissue/hypermobility disorders.
Depression, Anxiety, and Female Patients
People with a preexisting history of anxiety or depression also appear to be at a higher risk for long COVID, Dr. Bayley said, noting that patients with these conditions appear more vulnerable to brain fog and other difficulties brought on by COVID infection. Earlier research found biochemical evidence of brain inflammation that correlates with symptoms of anxiety in patients with long COVID.
“We know that depression is related to neurotransmitters like adrenaline and serotonin,” Dr. Bayley said. “The chronic inflammation that’s associated with COVID — this will make people feel more depressed because they’re not getting the neurotransmitters in their brain releasing at the right times.”
It may also put patients at a risk for anxiety due to fears of post-exertional malaise (PEM), where symptoms worsen after even very minor physical or mental exertion and can last days or weeks.
“You can see how that leads to a bit of a vicious cycle,” said Dr. Bayley, explaining that the cycle of fear and avoidance makes patients less active and deconditioned. But he added that learning to manage their activity can actually help mitigate PEM due to the anti-inflammatory effects of exercise, its positive impact on mood, and benefits to the immune and cardiovascular systems.
Meanwhile, a number of epidemiologic studies have found a higher prevalence of long COVID among women. Perimenopausal and menopausal women in particular appeared more prone, and at least one study reported that women under 50 years were five times more likely to develop post-COVID symptoms than men.
A recent small UK study that focused on COVID-19 hospitalizations found that women who had lower levels of inflammatory biomarkers at admission were more likely to experience certain long-term symptoms like muscle ache, low mood and anxiety, adding to earlier research linking female patients, long COVID, and neuropsychiatric symptoms.
History of Immune Dysfunction, Diabetes, Elevated Body Mass Index (BMI)
Immune dysfunction, a history of recurrent infections, or chronic sinus infections are also common among patients under Dr. Azola and her team’s care. Those who have arthritis or other autoimmune diseases such as lupus also appear more vulnerable, Dr. Bayley said, along with patients who have diabetes or a little overweight.
Recent research out of the University of Queensland found that being overweight can negatively affect the body’s immune response to the SARS-CoV-2 virus. Blood samples collected 13 months after infection, for example, found that individuals with a higher BMI had lower antibody activity and a reduced percentage of relevant B cells that help build antibodies to fight the virus. Being overweight did not affect the antibody response to the COVID-19 vaccines, however, giving further support for vaccination over infection-induced immunity as an important protective factor, researchers said.
Narrowing the Information Gap
The latest Centers for Centers for Disease Control and Prevention’s Household Pulse Survey estimates that 14% of all American adults have had long COVID at some point, with more than 5% of the entire adult population currently experiencing long COVID. With millions of Americans affected, experts and advocates highlight the importance of bridging the knowledge gap with primary care doctors.
Long COVID specialists said understanding these connections helps guide treatment plans and manage symptoms, such as finding the right medications, improving tolerance, optimizing sleep, applying cognitive strategies for brain fog, dietary changes, respiratory exercises to help with shortness of breath, and finding the fine line between what causes PEM and what doesn’t.
“Whenever you see a disease like this one, you always have to ask yourself, is there an alternative way of looking at this that might explain what we’re seeing?” said Dr. Bayley. “It remains to be said that all bets are still open and that we need to continue to be very broad thinking about this.”
A version of this article appeared on Medscape.com.