Musculoskeletal Disorders

This transcript has been edited for clarity.

Matthew F. Watto, MD: Welcome to The Curbsiders. I’m here with my great friend and America’s primary care physician, Dr. Paul Nelson Williams. We’re going to be talking about the evaluation of chronic neck pain, which is a really common complaint in primary care. So, Paul, what are the three buckets of neck pain? 

Paul N. Williams, MD: Well, as our listeners probably know, neck pain is extraordinarily common. There are three big buckets. There is mechanical neck pain, which is sort of the bread-and-butter “my neck just hurts” — probably the one you’re going to see most commonly in the office. We’ll get into that in just a second. 

The second bucket is cervical radiculopathy. We see a little bit more neurologic symptoms as part of the presentation. They may have weakness. They may have pain.

The third type of neck pain is cervical myelopathy, which is the one that probably warrants more aggressive follow-up and evaluation, and potentially even management. And that is typically your older patients in nontraumatic cases, who have bony impingement on the central spinal cord, often with upper motor neuron signs, and it can ultimately be very devastating. It’s almost a spectrum of presentations to worry about in terms of severity and outcomes.

We’ll start with the mechanical neck pain. It’s the one that we see the most commonly in the primary care office. We’ve all dealt with this. This is the patient who’s got localized neck pain that doesn’t really radiate anywhere; it kind of sits in the middle of the neck. In fact, if you actually poke back there where the patient says “ouch,” you’re probably in the right ballpark. The etiology and pathophysiology, weirdly, are still not super well-defined, but it’s probably mostly myofascial in etiology. And as such, it often gets better no matter what you do. It will probably get better with time.

You are not going to have neurologic deficits with this type of neck pain. There’s not going to be weakness, or radiation down the arm, or upper motor neuron signs. No one is mentioning the urinary symptoms with this. You can treat it with NSAIDs and physical therapy, which may be necessary if it persists. Massage can sometimes be helpful, but basically you’re just kind of supporting the patients through their own natural healing process. Physical therapy might help with the ergonomics and help make sure that they position themselves and move in a way that does not exacerbate the underlying structures. That is probably the one that we see the most and in some ways is probably the easiest to manage. 

Dr. Watto: This is the one that we generally should be least worried about. But cervical radiculopathy, which is the second bucket, is not as severe as cervical myelopathy, so it’s kind of in between the two. Cervical radiculopathy is basically the patient who has neck pain that’s going down one arm or the other, usually not both arms because that would be weird for them to have symmetric radiculopathy. It’s a nerve being pinched somewhere, usually more on one side than the other. 

The good news for patients is that the natural history is that it’s going to get better over time, almost no matter what we do. I almost think of this akin to sciatica. Usually sciatica and cervical radiculopathy do not have any motor weakness along with them. It’s really just the pain and maybe a little bit of mild sensory symptoms. So, you can reassure the patient that this usually goes away. Our guest said he sometimes gives gabapentin for this. That’s not my practice. I would be more likely to refer to physical therapy or try some NSAIDs if they’re really having trouble functioning or maybe some muscle relaxants. But they aren’t going to need to go to surgery. 

What about cervical myelopathy, Paul? Do those patients need surgery? 

Dr. Williams: Yes. The idea with cervical myelopathy is to keep it from progressing. It typically occurs in older patients. It’s like arthritis — a sort of bony buildup that compresses on the spinal cord itself. These patients will often have neck pain but not always. It’s also associated with impairments in motor function and other neurologic deficits. So, the patients may report that they have difficulty buttoning their buttons or managing fine-motor skills. They may have radicular symptoms down their arms. They may have an abnormal physical examination. They may have weakness on exam, but they’ll have a positive Hoffmann’s test where you flick the middle finger and look for flexion of the first finger and the thumb. They may have abnormal tandem gait, or patellar or Achilles hyperreflexia. Their neuro exam will not be normal much of the time, and in later cases because it’s upper motor neuron disease, they may even report urinary symptoms like urinary hesitancy or just a feeling of general unsteadiness of the gait, even though we’re at the cervical level. If you suspect myelopathy — and the trick is to think about it and recognize it when you see it — then you should send them for an MRI. If it persists or they have rapid regression, you get the MRI and refer them to neurosurgery. It’s not necessarily a neurosurgical emergency, but things should move along fairly briskly once you’ve actually identified it. 

Dr. Watto: Dr. Mikula made the point that if someone comes to you in a wheelchair, they are probably not going to regain the ability to walk. You’re really trying to prevent progression. If they are already severely disabled, they’re probably not going to get totally back to full functioning, even with surgery. You’re just trying to prevent things from getting worse. That’s the main reason to identify this and get the patient to surgery. 

We covered a lot more about neck pain. This was a very superficial review of what we talked about with Dr. Anthony Mikula. Click here to listen to the full podcast.

Matthew F. Watto is clinical assistant professor, Department of Medicine, Perelman School of Medicine at University of Pennsylvania, and internist, Department of Medicine, Hospital Medicine Section, Pennsylvania Hospital, Philadelphia, Pennsylvania. He has disclosed no relevant financial relationships. Paul N. Williams is associate professor of clinical medicine, Department of General Internal Medicine, Lewis Katz School of Medicine, and staff physician, Department of General Internal Medicine, Temple Internal Medicine Associates, Philadelphia, Pennsylvania. He has disclosed the following relevant financial relationships: serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for The Curbsiders; received income in an amount equal to or greater than $250 from The Curbsiders.

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

This transcript has been edited for clarity.

Matthew F. Watto, MD: Welcome to The Curbsiders. I’m here with my great friend and America’s primary care physician, Dr. Paul Nelson Williams. We’re going to be talking about the evaluation of chronic neck pain, which is a really common complaint in primary care. So, Paul, what are the three buckets of neck pain? 

Paul N. Williams, MD: Well, as our listeners probably know, neck pain is extraordinarily common. There are three big buckets. There is mechanical neck pain, which is sort of the bread-and-butter “my neck just hurts” — probably the one you’re going to see most commonly in the office. We’ll get into that in just a second. 

The second bucket is cervical radiculopathy. We see a little bit more neurologic symptoms as part of the presentation. They may have weakness. They may have pain.

The third type of neck pain is cervical myelopathy, which is the one that probably warrants more aggressive follow-up and evaluation, and potentially even management. And that is typically your older patients in nontraumatic cases, who have bony impingement on the central spinal cord, often with upper motor neuron signs, and it can ultimately be very devastating. It’s almost a spectrum of presentations to worry about in terms of severity and outcomes.

We’ll start with the mechanical neck pain. It’s the one that we see the most commonly in the primary care office. We’ve all dealt with this. This is the patient who’s got localized neck pain that doesn’t really radiate anywhere; it kind of sits in the middle of the neck. In fact, if you actually poke back there where the patient says “ouch,” you’re probably in the right ballpark. The etiology and pathophysiology, weirdly, are still not super well-defined, but it’s probably mostly myofascial in etiology. And as such, it often gets better no matter what you do. It will probably get better with time.

You are not going to have neurologic deficits with this type of neck pain. There’s not going to be weakness, or radiation down the arm, or upper motor neuron signs. No one is mentioning the urinary symptoms with this. You can treat it with NSAIDs and physical therapy, which may be necessary if it persists. Massage can sometimes be helpful, but basically you’re just kind of supporting the patients through their own natural healing process. Physical therapy might help with the ergonomics and help make sure that they position themselves and move in a way that does not exacerbate the underlying structures. That is probably the one that we see the most and in some ways is probably the easiest to manage. 

Dr. Watto: This is the one that we generally should be least worried about. But cervical radiculopathy, which is the second bucket, is not as severe as cervical myelopathy, so it’s kind of in between the two. Cervical radiculopathy is basically the patient who has neck pain that’s going down one arm or the other, usually not both arms because that would be weird for them to have symmetric radiculopathy. It’s a nerve being pinched somewhere, usually more on one side than the other. 

The good news for patients is that the natural history is that it’s going to get better over time, almost no matter what we do. I almost think of this akin to sciatica. Usually sciatica and cervical radiculopathy do not have any motor weakness along with them. It’s really just the pain and maybe a little bit of mild sensory symptoms. So, you can reassure the patient that this usually goes away. Our guest said he sometimes gives gabapentin for this. That’s not my practice. I would be more likely to refer to physical therapy or try some NSAIDs if they’re really having trouble functioning or maybe some muscle relaxants. But they aren’t going to need to go to surgery. 

What about cervical myelopathy, Paul? Do those patients need surgery? 

Dr. Williams: Yes. The idea with cervical myelopathy is to keep it from progressing. It typically occurs in older patients. It’s like arthritis — a sort of bony buildup that compresses on the spinal cord itself. These patients will often have neck pain but not always. It’s also associated with impairments in motor function and other neurologic deficits. So, the patients may report that they have difficulty buttoning their buttons or managing fine-motor skills. They may have radicular symptoms down their arms. They may have an abnormal physical examination. They may have weakness on exam, but they’ll have a positive Hoffmann’s test where you flick the middle finger and look for flexion of the first finger and the thumb. They may have abnormal tandem gait, or patellar or Achilles hyperreflexia. Their neuro exam will not be normal much of the time, and in later cases because it’s upper motor neuron disease, they may even report urinary symptoms like urinary hesitancy or just a feeling of general unsteadiness of the gait, even though we’re at the cervical level. If you suspect myelopathy — and the trick is to think about it and recognize it when you see it — then you should send them for an MRI. If it persists or they have rapid regression, you get the MRI and refer them to neurosurgery. It’s not necessarily a neurosurgical emergency, but things should move along fairly briskly once you’ve actually identified it. 

Dr. Watto: Dr. Mikula made the point that if someone comes to you in a wheelchair, they are probably not going to regain the ability to walk. You’re really trying to prevent progression. If they are already severely disabled, they’re probably not going to get totally back to full functioning, even with surgery. You’re just trying to prevent things from getting worse. That’s the main reason to identify this and get the patient to surgery. 

We covered a lot more about neck pain. This was a very superficial review of what we talked about with Dr. Anthony Mikula. Click here to listen to the full podcast.

Matthew F. Watto is clinical assistant professor, Department of Medicine, Perelman School of Medicine at University of Pennsylvania, and internist, Department of Medicine, Hospital Medicine Section, Pennsylvania Hospital, Philadelphia, Pennsylvania. He has disclosed no relevant financial relationships. Paul N. Williams is associate professor of clinical medicine, Department of General Internal Medicine, Lewis Katz School of Medicine, and staff physician, Department of General Internal Medicine, Temple Internal Medicine Associates, Philadelphia, Pennsylvania. He has disclosed the following relevant financial relationships: serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for The Curbsiders; received income in an amount equal to or greater than $250 from The Curbsiders.

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

This transcript has been edited for clarity.

Matthew F. Watto, MD: Welcome to The Curbsiders. I’m here with my great friend and America’s primary care physician, Dr. Paul Nelson Williams. We’re going to be talking about the evaluation of chronic neck pain, which is a really common complaint in primary care. So, Paul, what are the three buckets of neck pain? 

Paul N. Williams, MD: Well, as our listeners probably know, neck pain is extraordinarily common. There are three big buckets. There is mechanical neck pain, which is sort of the bread-and-butter “my neck just hurts” — probably the one you’re going to see most commonly in the office. We’ll get into that in just a second. 

The second bucket is cervical radiculopathy. We see a little bit more neurologic symptoms as part of the presentation. They may have weakness. They may have pain.

The third type of neck pain is cervical myelopathy, which is the one that probably warrants more aggressive follow-up and evaluation, and potentially even management. And that is typically your older patients in nontraumatic cases, who have bony impingement on the central spinal cord, often with upper motor neuron signs, and it can ultimately be very devastating. It’s almost a spectrum of presentations to worry about in terms of severity and outcomes.

We’ll start with the mechanical neck pain. It’s the one that we see the most commonly in the primary care office. We’ve all dealt with this. This is the patient who’s got localized neck pain that doesn’t really radiate anywhere; it kind of sits in the middle of the neck. In fact, if you actually poke back there where the patient says “ouch,” you’re probably in the right ballpark. The etiology and pathophysiology, weirdly, are still not super well-defined, but it’s probably mostly myofascial in etiology. And as such, it often gets better no matter what you do. It will probably get better with time.

You are not going to have neurologic deficits with this type of neck pain. There’s not going to be weakness, or radiation down the arm, or upper motor neuron signs. No one is mentioning the urinary symptoms with this. You can treat it with NSAIDs and physical therapy, which may be necessary if it persists. Massage can sometimes be helpful, but basically you’re just kind of supporting the patients through their own natural healing process. Physical therapy might help with the ergonomics and help make sure that they position themselves and move in a way that does not exacerbate the underlying structures. That is probably the one that we see the most and in some ways is probably the easiest to manage. 

Dr. Watto: This is the one that we generally should be least worried about. But cervical radiculopathy, which is the second bucket, is not as severe as cervical myelopathy, so it’s kind of in between the two. Cervical radiculopathy is basically the patient who has neck pain that’s going down one arm or the other, usually not both arms because that would be weird for them to have symmetric radiculopathy. It’s a nerve being pinched somewhere, usually more on one side than the other. 

The good news for patients is that the natural history is that it’s going to get better over time, almost no matter what we do. I almost think of this akin to sciatica. Usually sciatica and cervical radiculopathy do not have any motor weakness along with them. It’s really just the pain and maybe a little bit of mild sensory symptoms. So, you can reassure the patient that this usually goes away. Our guest said he sometimes gives gabapentin for this. That’s not my practice. I would be more likely to refer to physical therapy or try some NSAIDs if they’re really having trouble functioning or maybe some muscle relaxants. But they aren’t going to need to go to surgery. 

What about cervical myelopathy, Paul? Do those patients need surgery? 

Dr. Williams: Yes. The idea with cervical myelopathy is to keep it from progressing. It typically occurs in older patients. It’s like arthritis — a sort of bony buildup that compresses on the spinal cord itself. These patients will often have neck pain but not always. It’s also associated with impairments in motor function and other neurologic deficits. So, the patients may report that they have difficulty buttoning their buttons or managing fine-motor skills. They may have radicular symptoms down their arms. They may have an abnormal physical examination. They may have weakness on exam, but they’ll have a positive Hoffmann’s test where you flick the middle finger and look for flexion of the first finger and the thumb. They may have abnormal tandem gait, or patellar or Achilles hyperreflexia. Their neuro exam will not be normal much of the time, and in later cases because it’s upper motor neuron disease, they may even report urinary symptoms like urinary hesitancy or just a feeling of general unsteadiness of the gait, even though we’re at the cervical level. If you suspect myelopathy — and the trick is to think about it and recognize it when you see it — then you should send them for an MRI. If it persists or they have rapid regression, you get the MRI and refer them to neurosurgery. It’s not necessarily a neurosurgical emergency, but things should move along fairly briskly once you’ve actually identified it. 

Dr. Watto: Dr. Mikula made the point that if someone comes to you in a wheelchair, they are probably not going to regain the ability to walk. You’re really trying to prevent progression. If they are already severely disabled, they’re probably not going to get totally back to full functioning, even with surgery. You’re just trying to prevent things from getting worse. That’s the main reason to identify this and get the patient to surgery. 

We covered a lot more about neck pain. This was a very superficial review of what we talked about with Dr. Anthony Mikula. Click here to listen to the full podcast.

Matthew F. Watto is clinical assistant professor, Department of Medicine, Perelman School of Medicine at University of Pennsylvania, and internist, Department of Medicine, Hospital Medicine Section, Pennsylvania Hospital, Philadelphia, Pennsylvania. He has disclosed no relevant financial relationships. Paul N. Williams is associate professor of clinical medicine, Department of General Internal Medicine, Lewis Katz School of Medicine, and staff physician, Department of General Internal Medicine, Temple Internal Medicine Associates, Philadelphia, Pennsylvania. He has disclosed the following relevant financial relationships: serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for The Curbsiders; received income in an amount equal to or greater than $250 from The Curbsiders.

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

The Food and Drug Administration has approved ustekinumab-ttwe (Pyzchiva) as a biosimilar to ustekinumab (Stelara) for the treatment of multiple inflammatory conditions.

In addition, the agency “provisionally determined” that the medication would be interchangeable with the reference product but that designation would not take hold until the interchangeability exclusivity period for the first approved biosimilar ustekinumab-auub (Wezlana) expires, according to a press release. This designation would, depending on state law, allow a pharmacist to substitute the biosimilar for the reference product without involving the prescribing clinician. It’s unclear when ustekinumab-auub’s interchangeability exclusivity ends.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Ustekinumab-ttwe, a human interleukin (IL)-12 and IL-23 antagonist, is indicated for the treatment of:

• Moderate to severe plaque psoriasis in adults and pediatric patients aged 6 years or older who are candidates for phototherapy or systemic therapy 
• Active psoriatic arthritis in adults and pediatric patients aged 6 years or older with moderately to severely active Crohn’s disease or ulcerative colitis

It is administered via subcutaneous injection in 45 mg/0.5 mL and 90 mg/mL prefilled syringes or via intravenous infusion in 130 mg/26 mL (5 mg/mL) single-dose vial. 

Developed by Samsung Bioepis, ustekinumab-ttwe will be commercialized by Sandoz in the United States. Besides ustekinumab-auub, the other ustekinumab biosimilar is ustekinumab-aekn (Selarsdi).

Ustekinumab-ttwe is expected to launch in February 2025 “in accordance with the settlement and license agreement with Janssen Biotech,” which manufacturers the reference product, Sandoz said. The other approved ustekinumab biosimilars will launch within a similar time frame.

A version of this article appeared on Medscape.com.

The Food and Drug Administration has approved ustekinumab-ttwe (Pyzchiva) as a biosimilar to ustekinumab (Stelara) for the treatment of multiple inflammatory conditions.

In addition, the agency “provisionally determined” that the medication would be interchangeable with the reference product but that designation would not take hold until the interchangeability exclusivity period for the first approved biosimilar ustekinumab-auub (Wezlana) expires, according to a press release. This designation would, depending on state law, allow a pharmacist to substitute the biosimilar for the reference product without involving the prescribing clinician. It’s unclear when ustekinumab-auub’s interchangeability exclusivity ends.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Ustekinumab-ttwe, a human interleukin (IL)-12 and IL-23 antagonist, is indicated for the treatment of:

• Moderate to severe plaque psoriasis in adults and pediatric patients aged 6 years or older who are candidates for phototherapy or systemic therapy 
• Active psoriatic arthritis in adults and pediatric patients aged 6 years or older with moderately to severely active Crohn’s disease or ulcerative colitis

It is administered via subcutaneous injection in 45 mg/0.5 mL and 90 mg/mL prefilled syringes or via intravenous infusion in 130 mg/26 mL (5 mg/mL) single-dose vial. 

Developed by Samsung Bioepis, ustekinumab-ttwe will be commercialized by Sandoz in the United States. Besides ustekinumab-auub, the other ustekinumab biosimilar is ustekinumab-aekn (Selarsdi).

Ustekinumab-ttwe is expected to launch in February 2025 “in accordance with the settlement and license agreement with Janssen Biotech,” which manufacturers the reference product, Sandoz said. The other approved ustekinumab biosimilars will launch within a similar time frame.

A version of this article appeared on Medscape.com.

The Food and Drug Administration has approved ustekinumab-ttwe (Pyzchiva) as a biosimilar to ustekinumab (Stelara) for the treatment of multiple inflammatory conditions.

In addition, the agency “provisionally determined” that the medication would be interchangeable with the reference product but that designation would not take hold until the interchangeability exclusivity period for the first approved biosimilar ustekinumab-auub (Wezlana) expires, according to a press release. This designation would, depending on state law, allow a pharmacist to substitute the biosimilar for the reference product without involving the prescribing clinician. It’s unclear when ustekinumab-auub’s interchangeability exclusivity ends.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Ustekinumab-ttwe, a human interleukin (IL)-12 and IL-23 antagonist, is indicated for the treatment of:

• Moderate to severe plaque psoriasis in adults and pediatric patients aged 6 years or older who are candidates for phototherapy or systemic therapy 
• Active psoriatic arthritis in adults and pediatric patients aged 6 years or older with moderately to severely active Crohn’s disease or ulcerative colitis

It is administered via subcutaneous injection in 45 mg/0.5 mL and 90 mg/mL prefilled syringes or via intravenous infusion in 130 mg/26 mL (5 mg/mL) single-dose vial. 

Developed by Samsung Bioepis, ustekinumab-ttwe will be commercialized by Sandoz in the United States. Besides ustekinumab-auub, the other ustekinumab biosimilar is ustekinumab-aekn (Selarsdi).

Ustekinumab-ttwe is expected to launch in February 2025 “in accordance with the settlement and license agreement with Janssen Biotech,” which manufacturers the reference product, Sandoz said. The other approved ustekinumab biosimilars will launch within a similar time frame.

A version of this article appeared on Medscape.com.

VIENNA — The interleukin-1 receptor antagonist (IL-1RA) canakinumab provided control of systemic juvenile idiopathic arthritis (sJIA) without the use of glucocorticoids for up to a year in most study participants after three monthly injections.

In this study of 20 patients with newly diagnosed sJIA treated off glucocorticoids, fever was controlled after a single injection in all patients, and 16 patients reached the primary outcome of remission after three injections, said Gerd Horneff, MD, PhD, Asklepios Children’s Hospital, Sankt Augustin, Germany.

Results of this open-label study, called CANAKINUMAB FIRST, were presented as late-breaking findings at the European Alliance of Associations for Rheumatology (EULAR) 2024 Annual Meeting.

“Steroid-free, first-line treatment with canakinumab led to sustained responses in most patients, with a considerable number achieving remission,” said Dr. Horneff, adding that the observation in this group is ongoing.
 

Building on Earlier Data

The efficacy of canakinumab was previously reported in anecdotal experiences and one small patient series published 10 years ago. Dr. Horneff noted that he has offered this drug off label to patients with challenging cases.

The objective was to evaluate canakinumab as a first-line monotherapy administered in the absence of glucocorticoids. The study was open to children aged 2-18 years with active sJIA/juvenile Still disease confirmed with published criteria. All were naive to biologic or nonbiologic disease-modifying antirheumatic drugs as well as steroids.

The median age of the children was 8.4 years. A total of 60% were men. The median disease duration at the time of entry was 1.2 months. Most had fever (95%) and rash (80%) with high levels of inflammatory markers at baseline. The mean number of painful joints was 3.1, and the mean number of systemic manifestations was 2.8. No patient was without any systemic involvement, but four of the patients did not have any painful joints.

At enrollment, patients were scheduled to receive three injections of canakinumab at monthly intervals during an active treatment phase, after which they entered an observation phase lasting 40 weeks. In the event of nonresponse or flares in either phase, they were transitioned to usual care.
 

Symptoms Resolve After Single Injection

After the first injection, active joint disease and all systemic manifestations resolved in 16 (80%) of the 20 patients. Joint activity and systemic manifestations also remained controlled after the second and third injections in 16 of the 20 patients.

One patient in this series achieved inactive disease after a single injection but developed what appeared to be a treatment-related allergic reaction. He received no further treatment and was excluded from the study, although he is being followed separately.

“According to sJADAS [systemic JIA Disease Activity Score] criteria at month 3, 14 had inactive disease, three had minimal disease activity, and one patient had moderate disease activity,” Dr. Horneff said.

At week 24, or 3 months after the last injection, there was still no joint activity in 16 patients. Systemic manifestations remained controlled in 13 patients, but 1 patient by this point had a flare. Another flare occurred after this point, and other patients have not yet completed the 52-week observation period.

“Of the 10 patients who remained in the study and have completed the 52-week observation period, eight have had a drug-free remission,” Dr. Horneff said.
 

MAS Event Observed in One Patient

In addition to the allergic skin reaction, which was considered probably related to the study drug, there were three flares, one of which was a macrophage activation syndrome (MAS) event. The MAS occurred 8 weeks after the last injection, but it was managed successfully.

Of 30 infections that developed during the observation period, 18 involved the upper airway. All were treated successfully. There were also two injection-site reactions and one case of cytopenia.

Among the studies planned for follow-up, investigators will examine genomic and gene activation in relation to disease activity and the effect of canakinumab.

Comoderator of the abstract session and chair of the EULAR 2024 Abstract Selection Committee, Christian Dejaco, MD, PhD, a consultant rheumatologist and associate professor at the Medical University of Graz in Graz, Austria, suggested that these are highly encouraging data for a disease that does not currently have any approved therapies. Clearly, larger studies with a longer follow-up period are needed, but he pointed out that phase 3 trials in a rare disease like sJIA are challenging.

Because of the limited number of cases, “it will be difficult to conduct a placebo-controlled trial,” he pointed out. However, he hopes this study will provide the basis for larger studies and sufficient data to lead to an indication for this therapy.

In the meantime, he also believes that these data are likely to support empirical use in a difficult disease, even in advance of formal regulatory approval.

“We heard that canakinumab is already being used off label in JIA, and these data might encourage more of that,” he said.

Dr. Horneff reported financial relationships with AbbVie, Boehringer Ingelheim, Celgene, Chugai, GlaxoSmithKline, Janssen, Merck Sharpe & Dohme, Novartis, Pfizer, Roche, Sanofi, and Sobe. Dr. Dejaco reported no potential conflicts of interest.

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

VIENNA — The interleukin-1 receptor antagonist (IL-1RA) canakinumab provided control of systemic juvenile idiopathic arthritis (sJIA) without the use of glucocorticoids for up to a year in most study participants after three monthly injections.

In this study of 20 patients with newly diagnosed sJIA treated off glucocorticoids, fever was controlled after a single injection in all patients, and 16 patients reached the primary outcome of remission after three injections, said Gerd Horneff, MD, PhD, Asklepios Children’s Hospital, Sankt Augustin, Germany.

Results of this open-label study, called CANAKINUMAB FIRST, were presented as late-breaking findings at the European Alliance of Associations for Rheumatology (EULAR) 2024 Annual Meeting.

“Steroid-free, first-line treatment with canakinumab led to sustained responses in most patients, with a considerable number achieving remission,” said Dr. Horneff, adding that the observation in this group is ongoing.
 

Building on Earlier Data

The efficacy of canakinumab was previously reported in anecdotal experiences and one small patient series published 10 years ago. Dr. Horneff noted that he has offered this drug off label to patients with challenging cases.

The objective was to evaluate canakinumab as a first-line monotherapy administered in the absence of glucocorticoids. The study was open to children aged 2-18 years with active sJIA/juvenile Still disease confirmed with published criteria. All were naive to biologic or nonbiologic disease-modifying antirheumatic drugs as well as steroids.

The median age of the children was 8.4 years. A total of 60% were men. The median disease duration at the time of entry was 1.2 months. Most had fever (95%) and rash (80%) with high levels of inflammatory markers at baseline. The mean number of painful joints was 3.1, and the mean number of systemic manifestations was 2.8. No patient was without any systemic involvement, but four of the patients did not have any painful joints.

At enrollment, patients were scheduled to receive three injections of canakinumab at monthly intervals during an active treatment phase, after which they entered an observation phase lasting 40 weeks. In the event of nonresponse or flares in either phase, they were transitioned to usual care.
 

Symptoms Resolve After Single Injection

After the first injection, active joint disease and all systemic manifestations resolved in 16 (80%) of the 20 patients. Joint activity and systemic manifestations also remained controlled after the second and third injections in 16 of the 20 patients.

One patient in this series achieved inactive disease after a single injection but developed what appeared to be a treatment-related allergic reaction. He received no further treatment and was excluded from the study, although he is being followed separately.

“According to sJADAS [systemic JIA Disease Activity Score] criteria at month 3, 14 had inactive disease, three had minimal disease activity, and one patient had moderate disease activity,” Dr. Horneff said.

At week 24, or 3 months after the last injection, there was still no joint activity in 16 patients. Systemic manifestations remained controlled in 13 patients, but 1 patient by this point had a flare. Another flare occurred after this point, and other patients have not yet completed the 52-week observation period.

“Of the 10 patients who remained in the study and have completed the 52-week observation period, eight have had a drug-free remission,” Dr. Horneff said.
 

MAS Event Observed in One Patient

In addition to the allergic skin reaction, which was considered probably related to the study drug, there were three flares, one of which was a macrophage activation syndrome (MAS) event. The MAS occurred 8 weeks after the last injection, but it was managed successfully.

Of 30 infections that developed during the observation period, 18 involved the upper airway. All were treated successfully. There were also two injection-site reactions and one case of cytopenia.

Among the studies planned for follow-up, investigators will examine genomic and gene activation in relation to disease activity and the effect of canakinumab.

Comoderator of the abstract session and chair of the EULAR 2024 Abstract Selection Committee, Christian Dejaco, MD, PhD, a consultant rheumatologist and associate professor at the Medical University of Graz in Graz, Austria, suggested that these are highly encouraging data for a disease that does not currently have any approved therapies. Clearly, larger studies with a longer follow-up period are needed, but he pointed out that phase 3 trials in a rare disease like sJIA are challenging.

Because of the limited number of cases, “it will be difficult to conduct a placebo-controlled trial,” he pointed out. However, he hopes this study will provide the basis for larger studies and sufficient data to lead to an indication for this therapy.

In the meantime, he also believes that these data are likely to support empirical use in a difficult disease, even in advance of formal regulatory approval.

“We heard that canakinumab is already being used off label in JIA, and these data might encourage more of that,” he said.

Dr. Horneff reported financial relationships with AbbVie, Boehringer Ingelheim, Celgene, Chugai, GlaxoSmithKline, Janssen, Merck Sharpe & Dohme, Novartis, Pfizer, Roche, Sanofi, and Sobe. Dr. Dejaco reported no potential conflicts of interest.

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

VIENNA — The interleukin-1 receptor antagonist (IL-1RA) canakinumab provided control of systemic juvenile idiopathic arthritis (sJIA) without the use of glucocorticoids for up to a year in most study participants after three monthly injections.

In this study of 20 patients with newly diagnosed sJIA treated off glucocorticoids, fever was controlled after a single injection in all patients, and 16 patients reached the primary outcome of remission after three injections, said Gerd Horneff, MD, PhD, Asklepios Children’s Hospital, Sankt Augustin, Germany.

Results of this open-label study, called CANAKINUMAB FIRST, were presented as late-breaking findings at the European Alliance of Associations for Rheumatology (EULAR) 2024 Annual Meeting.

“Steroid-free, first-line treatment with canakinumab led to sustained responses in most patients, with a considerable number achieving remission,” said Dr. Horneff, adding that the observation in this group is ongoing.
 

Building on Earlier Data

The efficacy of canakinumab was previously reported in anecdotal experiences and one small patient series published 10 years ago. Dr. Horneff noted that he has offered this drug off label to patients with challenging cases.

The objective was to evaluate canakinumab as a first-line monotherapy administered in the absence of glucocorticoids. The study was open to children aged 2-18 years with active sJIA/juvenile Still disease confirmed with published criteria. All were naive to biologic or nonbiologic disease-modifying antirheumatic drugs as well as steroids.

The median age of the children was 8.4 years. A total of 60% were men. The median disease duration at the time of entry was 1.2 months. Most had fever (95%) and rash (80%) with high levels of inflammatory markers at baseline. The mean number of painful joints was 3.1, and the mean number of systemic manifestations was 2.8. No patient was without any systemic involvement, but four of the patients did not have any painful joints.

At enrollment, patients were scheduled to receive three injections of canakinumab at monthly intervals during an active treatment phase, after which they entered an observation phase lasting 40 weeks. In the event of nonresponse or flares in either phase, they were transitioned to usual care.
 

Symptoms Resolve After Single Injection

After the first injection, active joint disease and all systemic manifestations resolved in 16 (80%) of the 20 patients. Joint activity and systemic manifestations also remained controlled after the second and third injections in 16 of the 20 patients.

One patient in this series achieved inactive disease after a single injection but developed what appeared to be a treatment-related allergic reaction. He received no further treatment and was excluded from the study, although he is being followed separately.

“According to sJADAS [systemic JIA Disease Activity Score] criteria at month 3, 14 had inactive disease, three had minimal disease activity, and one patient had moderate disease activity,” Dr. Horneff said.

At week 24, or 3 months after the last injection, there was still no joint activity in 16 patients. Systemic manifestations remained controlled in 13 patients, but 1 patient by this point had a flare. Another flare occurred after this point, and other patients have not yet completed the 52-week observation period.

“Of the 10 patients who remained in the study and have completed the 52-week observation period, eight have had a drug-free remission,” Dr. Horneff said.
 

MAS Event Observed in One Patient

In addition to the allergic skin reaction, which was considered probably related to the study drug, there were three flares, one of which was a macrophage activation syndrome (MAS) event. The MAS occurred 8 weeks after the last injection, but it was managed successfully.

Of 30 infections that developed during the observation period, 18 involved the upper airway. All were treated successfully. There were also two injection-site reactions and one case of cytopenia.

Among the studies planned for follow-up, investigators will examine genomic and gene activation in relation to disease activity and the effect of canakinumab.

Comoderator of the abstract session and chair of the EULAR 2024 Abstract Selection Committee, Christian Dejaco, MD, PhD, a consultant rheumatologist and associate professor at the Medical University of Graz in Graz, Austria, suggested that these are highly encouraging data for a disease that does not currently have any approved therapies. Clearly, larger studies with a longer follow-up period are needed, but he pointed out that phase 3 trials in a rare disease like sJIA are challenging.

Because of the limited number of cases, “it will be difficult to conduct a placebo-controlled trial,” he pointed out. However, he hopes this study will provide the basis for larger studies and sufficient data to lead to an indication for this therapy.

In the meantime, he also believes that these data are likely to support empirical use in a difficult disease, even in advance of formal regulatory approval.

“We heard that canakinumab is already being used off label in JIA, and these data might encourage more of that,” he said.

Dr. Horneff reported financial relationships with AbbVie, Boehringer Ingelheim, Celgene, Chugai, GlaxoSmithKline, Janssen, Merck Sharpe & Dohme, Novartis, Pfizer, Roche, Sanofi, and Sobe. Dr. Dejaco reported no potential conflicts of interest.

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

An intervention combining an individualized walking program and education and significantly reduced low back pain recurrence in adults, compared with controls, based on data from approximately 700 individuals.

Exercise, including walking, is recommended to prevent recurrence of low back pain, but data on the effectiveness and cost-effectiveness of walking as an intervention are lacking, wrote Natasha C. Pocovi, PhD, of Macquarie University, Sydney, Australia, and colleagues.

In a study known as WalkBack, published in the Lancet, the researchers randomized 351 adults aged 18 years and older with a history of more than two prior episodes of low back pain to an intervention and 350 to no intervention.

The intervention consisted of six sessions of education and progressive walking with a physiotherapist over 6 months; both intervention and control groups were followed for a minimum of 12 months and a maximum of 36 months. The mean age of the participants was 54 years, and 81% were female. The primary outcome was the number of days to recurrence of low back pain severe enough to limit activity, based on monthly self-reports.

The intervention was significantly more effective at preventing activity-limiting low back pain recurrence, compared with no intervention (hazard ratio, 0.72; P = .0002), with a median of 208 days and 112 days to recurrence in the intervention and control groups, respectively.

The risk of any low back pain recurrence also was significantly reduced in the intervention group, compared with the controls (HR, 0.80; P = .0066); as was the risk of care-seeking recurrence of low back pain (HR, 0.57; P < .0001).

Overall, the experience of at least one adverse event over 12 months was similar between the intervention and control groups (52% and 54%, respectively), but significantly more adverse events related to lower extremities occurred in the intervention group, compared with the control group (100 vs 54). The intervention also was more likely to be cost effective, compared with a no-treatment control, the researchers wrote.

The findings were limited by several factors including the relatively homogeneous population and that neither the therapists nor participants were masked to group allocation. In addition, the study was conducted during the COVID-19 pandemic, so a telehealth model of video consultations was used instead of in-person meetings, but this protocol change allowed for inclusion of participants from diverse locations including rural and remote areas, the researchers said.

More research is needed to assess the implementation of a walking and exercise intervention as part of a discharge plan after an episode of low back pain and to examine the effectiveness of an intervention involving fewer sessions and a range of healthcare providers, they added. However, the results support the value of the intervention, which has a strong potential for successful implementation because of accessibility and low cost.
 

Preventive Interventions Need More Real-World Research

“Preventive interventions for back pain are an important yet neglected consideration,” Diarmuid Denneny, a doctoral candidate at Brunel University London, and Jackie Walumbe, PhD, of the University of Oxford (England), wrote in an accompanying editorial.

Although recurrence of low back pain is common, guidance on prevention and management is lacking, they said. Strengths of the current study include attention to patient and public preferences in the study design; however, the majority of the participants were of relatively high socioeconomic status and 89% reported post-secondary education.

“Given that pain is known to have a higher impact on marginalized and minoritized groups and those experiencing socioeconomic deprivation, we recommend caution in extrapolating these findings to different contexts,” the editorialists wrote.

They also cautioned that the complex nature of the intervention, which included not only walking but education and physiotherapist appointments, might make it difficult to isolate walking as the key factor in the patients’ improvement. The editorialists also emphasized the need for studies of similar interventions conducted by alternative providers including exercise professionals and digital platforms.

However, the WalkBack trial represents progress toward greater support for individuals with recurrent back pain and may be a foundation for other research involving how other forms of physical activity compare in improving back pain, with attention to the role of publish health in delivering physical activity interventions, they said.

The study was supported by the National Health and Medical Research Council, Australia. Dr. Pocovi disclosed scholarships funded by the National Health and Medical Research Council Low Back Pain Centre of Research Excellence (ANZBACK) and Macquarie University. Mr. Denneny disclosed support from an Economic and Social Research Council fellowship, and disclosed consulting fees from Live Well with Pain and Leva clinic; a grant from the Chartered Society of Physiotherapy. Dr. Walumbe disclosed travel support from the Chartered Society of Physiotherapy Charitable Trust.

An intervention combining an individualized walking program and education and significantly reduced low back pain recurrence in adults, compared with controls, based on data from approximately 700 individuals.

Exercise, including walking, is recommended to prevent recurrence of low back pain, but data on the effectiveness and cost-effectiveness of walking as an intervention are lacking, wrote Natasha C. Pocovi, PhD, of Macquarie University, Sydney, Australia, and colleagues.

In a study known as WalkBack, published in the Lancet, the researchers randomized 351 adults aged 18 years and older with a history of more than two prior episodes of low back pain to an intervention and 350 to no intervention.

The intervention consisted of six sessions of education and progressive walking with a physiotherapist over 6 months; both intervention and control groups were followed for a minimum of 12 months and a maximum of 36 months. The mean age of the participants was 54 years, and 81% were female. The primary outcome was the number of days to recurrence of low back pain severe enough to limit activity, based on monthly self-reports.

The intervention was significantly more effective at preventing activity-limiting low back pain recurrence, compared with no intervention (hazard ratio, 0.72; P = .0002), with a median of 208 days and 112 days to recurrence in the intervention and control groups, respectively.

The risk of any low back pain recurrence also was significantly reduced in the intervention group, compared with the controls (HR, 0.80; P = .0066); as was the risk of care-seeking recurrence of low back pain (HR, 0.57; P < .0001).

Overall, the experience of at least one adverse event over 12 months was similar between the intervention and control groups (52% and 54%, respectively), but significantly more adverse events related to lower extremities occurred in the intervention group, compared with the control group (100 vs 54). The intervention also was more likely to be cost effective, compared with a no-treatment control, the researchers wrote.

The findings were limited by several factors including the relatively homogeneous population and that neither the therapists nor participants were masked to group allocation. In addition, the study was conducted during the COVID-19 pandemic, so a telehealth model of video consultations was used instead of in-person meetings, but this protocol change allowed for inclusion of participants from diverse locations including rural and remote areas, the researchers said.

More research is needed to assess the implementation of a walking and exercise intervention as part of a discharge plan after an episode of low back pain and to examine the effectiveness of an intervention involving fewer sessions and a range of healthcare providers, they added. However, the results support the value of the intervention, which has a strong potential for successful implementation because of accessibility and low cost.
 

Preventive Interventions Need More Real-World Research

“Preventive interventions for back pain are an important yet neglected consideration,” Diarmuid Denneny, a doctoral candidate at Brunel University London, and Jackie Walumbe, PhD, of the University of Oxford (England), wrote in an accompanying editorial.

Although recurrence of low back pain is common, guidance on prevention and management is lacking, they said. Strengths of the current study include attention to patient and public preferences in the study design; however, the majority of the participants were of relatively high socioeconomic status and 89% reported post-secondary education.

“Given that pain is known to have a higher impact on marginalized and minoritized groups and those experiencing socioeconomic deprivation, we recommend caution in extrapolating these findings to different contexts,” the editorialists wrote.

They also cautioned that the complex nature of the intervention, which included not only walking but education and physiotherapist appointments, might make it difficult to isolate walking as the key factor in the patients’ improvement. The editorialists also emphasized the need for studies of similar interventions conducted by alternative providers including exercise professionals and digital platforms.

However, the WalkBack trial represents progress toward greater support for individuals with recurrent back pain and may be a foundation for other research involving how other forms of physical activity compare in improving back pain, with attention to the role of publish health in delivering physical activity interventions, they said.

The study was supported by the National Health and Medical Research Council, Australia. Dr. Pocovi disclosed scholarships funded by the National Health and Medical Research Council Low Back Pain Centre of Research Excellence (ANZBACK) and Macquarie University. Mr. Denneny disclosed support from an Economic and Social Research Council fellowship, and disclosed consulting fees from Live Well with Pain and Leva clinic; a grant from the Chartered Society of Physiotherapy. Dr. Walumbe disclosed travel support from the Chartered Society of Physiotherapy Charitable Trust.

An intervention combining an individualized walking program and education and significantly reduced low back pain recurrence in adults, compared with controls, based on data from approximately 700 individuals.

Exercise, including walking, is recommended to prevent recurrence of low back pain, but data on the effectiveness and cost-effectiveness of walking as an intervention are lacking, wrote Natasha C. Pocovi, PhD, of Macquarie University, Sydney, Australia, and colleagues.

In a study known as WalkBack, published in the Lancet, the researchers randomized 351 adults aged 18 years and older with a history of more than two prior episodes of low back pain to an intervention and 350 to no intervention.

The intervention consisted of six sessions of education and progressive walking with a physiotherapist over 6 months; both intervention and control groups were followed for a minimum of 12 months and a maximum of 36 months. The mean age of the participants was 54 years, and 81% were female. The primary outcome was the number of days to recurrence of low back pain severe enough to limit activity, based on monthly self-reports.

The intervention was significantly more effective at preventing activity-limiting low back pain recurrence, compared with no intervention (hazard ratio, 0.72; P = .0002), with a median of 208 days and 112 days to recurrence in the intervention and control groups, respectively.

The risk of any low back pain recurrence also was significantly reduced in the intervention group, compared with the controls (HR, 0.80; P = .0066); as was the risk of care-seeking recurrence of low back pain (HR, 0.57; P < .0001).

Overall, the experience of at least one adverse event over 12 months was similar between the intervention and control groups (52% and 54%, respectively), but significantly more adverse events related to lower extremities occurred in the intervention group, compared with the control group (100 vs 54). The intervention also was more likely to be cost effective, compared with a no-treatment control, the researchers wrote.

The findings were limited by several factors including the relatively homogeneous population and that neither the therapists nor participants were masked to group allocation. In addition, the study was conducted during the COVID-19 pandemic, so a telehealth model of video consultations was used instead of in-person meetings, but this protocol change allowed for inclusion of participants from diverse locations including rural and remote areas, the researchers said.

More research is needed to assess the implementation of a walking and exercise intervention as part of a discharge plan after an episode of low back pain and to examine the effectiveness of an intervention involving fewer sessions and a range of healthcare providers, they added. However, the results support the value of the intervention, which has a strong potential for successful implementation because of accessibility and low cost.
 

Preventive Interventions Need More Real-World Research

“Preventive interventions for back pain are an important yet neglected consideration,” Diarmuid Denneny, a doctoral candidate at Brunel University London, and Jackie Walumbe, PhD, of the University of Oxford (England), wrote in an accompanying editorial.

Although recurrence of low back pain is common, guidance on prevention and management is lacking, they said. Strengths of the current study include attention to patient and public preferences in the study design; however, the majority of the participants were of relatively high socioeconomic status and 89% reported post-secondary education.

“Given that pain is known to have a higher impact on marginalized and minoritized groups and those experiencing socioeconomic deprivation, we recommend caution in extrapolating these findings to different contexts,” the editorialists wrote.

They also cautioned that the complex nature of the intervention, which included not only walking but education and physiotherapist appointments, might make it difficult to isolate walking as the key factor in the patients’ improvement. The editorialists also emphasized the need for studies of similar interventions conducted by alternative providers including exercise professionals and digital platforms.

However, the WalkBack trial represents progress toward greater support for individuals with recurrent back pain and may be a foundation for other research involving how other forms of physical activity compare in improving back pain, with attention to the role of publish health in delivering physical activity interventions, they said.

The study was supported by the National Health and Medical Research Council, Australia. Dr. Pocovi disclosed scholarships funded by the National Health and Medical Research Council Low Back Pain Centre of Research Excellence (ANZBACK) and Macquarie University. Mr. Denneny disclosed support from an Economic and Social Research Council fellowship, and disclosed consulting fees from Live Well with Pain and Leva clinic; a grant from the Chartered Society of Physiotherapy. Dr. Walumbe disclosed travel support from the Chartered Society of Physiotherapy Charitable Trust.

The US Food and Drug Administration (FDA) has approved sarilumab (Kevzara) for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) for patients weighing ≥ 63 kg (139 lb). 

“Polyarticular juvenile idiopathic arthritis (JIA) can be a painful disease for children where multiple joints are impacted by this chronic inflammation,” said George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron in a press release. 

It is estimated that nearly 300,000 children in the United States have JIA, and 1 in 4 of them have pJIA, according to the Arthritis Foundation. 

Wikimedia Commons/FitzColinGerald/Creative Commons License

“Not only are their daily lives impacted, but their futures can be disrupted without adequate treatment,” Dr. Yancopoulos continued. “The approval of Kevzara in polyarticular juvenile idiopathic arthritis provides these vulnerable patients and their families a new FDA-approved treatment option to help navigate this disease.” 

Sarilumab, jointly developed by Sanofi and Regeneron, is an interleukin 6 receptor blocker. It was first approved in 2017 for the treatment of moderate to severely active rheumatoid arthritis (RA) in adults who had inadequate response or intolerance to at least one other disease-modifying antirheumatic drug (DMARD). 

In 2023, the FDA approved sarilumab as the first biologic treatment for polymyalgia rheumatica in adults who had inadequate response to corticosteroids and could not tolerate a corticosteroid taper. 

For pJIA, sarilumab is administered subcutaneously using a 200-mg/1.14-mL prefilled syringe once every 2 weeks. The medication can be used alone or in combination with other conventional DMARDs. 

“Use of KEVZARA in pediatric patients with pJIA is supported by evidence from adequate and well-controlled studies of KEVZARA in adults with RA, pharmacokinetic data from adult patients with RA,” and pharmacokinetic comparability in 101 pediatric patients aged 2-17 years treated with sarilumab, according to the prescribing information. Sarilumab is not approved for pediatric patients < 63 kg “because of a lack of an appropriate dosage form.” 

The most common reported adverse reactions for sarilumab in pJIA are nasopharyngitis, neutropenia, upper respiratory tract infection, and injection site erythema. The pJIA trial recorded no new adverse reactions or safety concerns, compared with patients with RA. 
 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved sarilumab (Kevzara) for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) for patients weighing ≥ 63 kg (139 lb). 

“Polyarticular juvenile idiopathic arthritis (JIA) can be a painful disease for children where multiple joints are impacted by this chronic inflammation,” said George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron in a press release. 

It is estimated that nearly 300,000 children in the United States have JIA, and 1 in 4 of them have pJIA, according to the Arthritis Foundation. 

Wikimedia Commons/FitzColinGerald/Creative Commons License

“Not only are their daily lives impacted, but their futures can be disrupted without adequate treatment,” Dr. Yancopoulos continued. “The approval of Kevzara in polyarticular juvenile idiopathic arthritis provides these vulnerable patients and their families a new FDA-approved treatment option to help navigate this disease.” 

Sarilumab, jointly developed by Sanofi and Regeneron, is an interleukin 6 receptor blocker. It was first approved in 2017 for the treatment of moderate to severely active rheumatoid arthritis (RA) in adults who had inadequate response or intolerance to at least one other disease-modifying antirheumatic drug (DMARD). 

In 2023, the FDA approved sarilumab as the first biologic treatment for polymyalgia rheumatica in adults who had inadequate response to corticosteroids and could not tolerate a corticosteroid taper. 

For pJIA, sarilumab is administered subcutaneously using a 200-mg/1.14-mL prefilled syringe once every 2 weeks. The medication can be used alone or in combination with other conventional DMARDs. 

“Use of KEVZARA in pediatric patients with pJIA is supported by evidence from adequate and well-controlled studies of KEVZARA in adults with RA, pharmacokinetic data from adult patients with RA,” and pharmacokinetic comparability in 101 pediatric patients aged 2-17 years treated with sarilumab, according to the prescribing information. Sarilumab is not approved for pediatric patients < 63 kg “because of a lack of an appropriate dosage form.” 

The most common reported adverse reactions for sarilumab in pJIA are nasopharyngitis, neutropenia, upper respiratory tract infection, and injection site erythema. The pJIA trial recorded no new adverse reactions or safety concerns, compared with patients with RA. 
 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved sarilumab (Kevzara) for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) for patients weighing ≥ 63 kg (139 lb). 

“Polyarticular juvenile idiopathic arthritis (JIA) can be a painful disease for children where multiple joints are impacted by this chronic inflammation,” said George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron in a press release. 

It is estimated that nearly 300,000 children in the United States have JIA, and 1 in 4 of them have pJIA, according to the Arthritis Foundation. 

Wikimedia Commons/FitzColinGerald/Creative Commons License

“Not only are their daily lives impacted, but their futures can be disrupted without adequate treatment,” Dr. Yancopoulos continued. “The approval of Kevzara in polyarticular juvenile idiopathic arthritis provides these vulnerable patients and their families a new FDA-approved treatment option to help navigate this disease.” 

Sarilumab, jointly developed by Sanofi and Regeneron, is an interleukin 6 receptor blocker. It was first approved in 2017 for the treatment of moderate to severely active rheumatoid arthritis (RA) in adults who had inadequate response or intolerance to at least one other disease-modifying antirheumatic drug (DMARD). 

In 2023, the FDA approved sarilumab as the first biologic treatment for polymyalgia rheumatica in adults who had inadequate response to corticosteroids and could not tolerate a corticosteroid taper. 

For pJIA, sarilumab is administered subcutaneously using a 200-mg/1.14-mL prefilled syringe once every 2 weeks. The medication can be used alone or in combination with other conventional DMARDs. 

“Use of KEVZARA in pediatric patients with pJIA is supported by evidence from adequate and well-controlled studies of KEVZARA in adults with RA, pharmacokinetic data from adult patients with RA,” and pharmacokinetic comparability in 101 pediatric patients aged 2-17 years treated with sarilumab, according to the prescribing information. Sarilumab is not approved for pediatric patients < 63 kg “because of a lack of an appropriate dosage form.” 

The most common reported adverse reactions for sarilumab in pJIA are nasopharyngitis, neutropenia, upper respiratory tract infection, and injection site erythema. The pJIA trial recorded no new adverse reactions or safety concerns, compared with patients with RA. 
 

A version of this article appeared on Medscape.com.

Upadacitinib (Rinvoq) is now indicated for patients aged 2 years or older with active polyarticular juvenile idiopathic arthritis (pJIA) and psoriatic arthritis (PsA) who cannot tolerate or achieve adequate disease response with one or more tumor necrosis factor (TNF) blockers, according to a press release from manufacturer AbbVie. 

For the youngest patients, upadacitinib is also available as a weight-based oral solution (Rinvoq LQ) in addition to the previously available tablets, according to the company. JIA, which includes pJIA and juvenile PsA, affects nearly 300,000 children and adolescents in the United States, and alternatives to TNF inhibitor (TNFi) therapy are limited, according to the company. 

“Pediatric patients with pJIA and PsA can be severely limited in their ability to complete daily physical tasks and participate in everyday activities. Understanding their needs today and knowing the likelihood of disease in adulthood underscores the need for additional treatment options,” Aarat Patel, MD, a pediatric rheumatologist at Bon Secours Rheumatology Center, Richmond, Virginia, said in the press release. “Having a treatment option available for patients who do not respond well to a TNFi addresses a need for the healthcare community, patients, and their families,” he said.

Upadacitinib, a Janus kinase (JAK) inhibitor, is being studied for multiple immune-mediated inflammatory diseases. The new indication was supported by data from adults with rheumatoid arthritis (RA) and PsA, 51 pediatric patients with pJIA and active polyarthritis, and safety data from 83 pediatric patients aged 2 years to younger than 18 years with pJIA and active polyarthritis. 

In the studies, the drug’s safety in pediatric patients was similar to the known safety profile in adults, which includes increased risk for serious infections such as tuberculosis, cancer, immune system problems, blood clots, and serious allergic reactions to components of the drug, according to the press release. However, the safety and effectiveness of upadacitinib for pJIA and PsA in patients younger than 2 years are unknown.

“Upadacitinib plasma exposures in pediatric patients with pJIA and PsA at the recommended dosage are predicted to be comparable to those observed in adults with RA and PsA based on population pharmacokinetic modeling and simulation,” according to the press release.

Currently, upadacitinib’s only other pediatric indication is for moderate to severe atopic dermatitis in children aged 12 years or older. Upadacitinib also is indicated for treatment of adults with moderate to severe RA, active PsA, active ankylosing spondylitis, active nonradiographic axial spondyloarthritis, and moderate to severe ulcerative colitis and Crohn’s disease, but safety and efficacy for its use in treatment of these conditions in children and adolescents is unknown.

Upadacitinib also is being studied in phase 3 trials for treatment of conditions including alopecia areata, ankylosing spondylitis, atopic dermatitis, axial spondyloarthritis, Crohn’s disease, giant cell arteritis, hidradenitis suppurativa, psoriatic arthritis, RA, systemic lupus erythematosus, Takayasu arteritis, ulcerative colitis, and vitiligo, according to the press release. 

Full prescribing information and safety data for upadacitinib are available here. 

A version of this article appeared on Medscape.com.

Upadacitinib (Rinvoq) is now indicated for patients aged 2 years or older with active polyarticular juvenile idiopathic arthritis (pJIA) and psoriatic arthritis (PsA) who cannot tolerate or achieve adequate disease response with one or more tumor necrosis factor (TNF) blockers, according to a press release from manufacturer AbbVie. 

For the youngest patients, upadacitinib is also available as a weight-based oral solution (Rinvoq LQ) in addition to the previously available tablets, according to the company. JIA, which includes pJIA and juvenile PsA, affects nearly 300,000 children and adolescents in the United States, and alternatives to TNF inhibitor (TNFi) therapy are limited, according to the company. 

“Pediatric patients with pJIA and PsA can be severely limited in their ability to complete daily physical tasks and participate in everyday activities. Understanding their needs today and knowing the likelihood of disease in adulthood underscores the need for additional treatment options,” Aarat Patel, MD, a pediatric rheumatologist at Bon Secours Rheumatology Center, Richmond, Virginia, said in the press release. “Having a treatment option available for patients who do not respond well to a TNFi addresses a need for the healthcare community, patients, and their families,” he said.

Upadacitinib, a Janus kinase (JAK) inhibitor, is being studied for multiple immune-mediated inflammatory diseases. The new indication was supported by data from adults with rheumatoid arthritis (RA) and PsA, 51 pediatric patients with pJIA and active polyarthritis, and safety data from 83 pediatric patients aged 2 years to younger than 18 years with pJIA and active polyarthritis. 

In the studies, the drug’s safety in pediatric patients was similar to the known safety profile in adults, which includes increased risk for serious infections such as tuberculosis, cancer, immune system problems, blood clots, and serious allergic reactions to components of the drug, according to the press release. However, the safety and effectiveness of upadacitinib for pJIA and PsA in patients younger than 2 years are unknown.

“Upadacitinib plasma exposures in pediatric patients with pJIA and PsA at the recommended dosage are predicted to be comparable to those observed in adults with RA and PsA based on population pharmacokinetic modeling and simulation,” according to the press release.

Currently, upadacitinib’s only other pediatric indication is for moderate to severe atopic dermatitis in children aged 12 years or older. Upadacitinib also is indicated for treatment of adults with moderate to severe RA, active PsA, active ankylosing spondylitis, active nonradiographic axial spondyloarthritis, and moderate to severe ulcerative colitis and Crohn’s disease, but safety and efficacy for its use in treatment of these conditions in children and adolescents is unknown.

Upadacitinib also is being studied in phase 3 trials for treatment of conditions including alopecia areata, ankylosing spondylitis, atopic dermatitis, axial spondyloarthritis, Crohn’s disease, giant cell arteritis, hidradenitis suppurativa, psoriatic arthritis, RA, systemic lupus erythematosus, Takayasu arteritis, ulcerative colitis, and vitiligo, according to the press release. 

Full prescribing information and safety data for upadacitinib are available here. 

A version of this article appeared on Medscape.com.

Upadacitinib (Rinvoq) is now indicated for patients aged 2 years or older with active polyarticular juvenile idiopathic arthritis (pJIA) and psoriatic arthritis (PsA) who cannot tolerate or achieve adequate disease response with one or more tumor necrosis factor (TNF) blockers, according to a press release from manufacturer AbbVie. 

For the youngest patients, upadacitinib is also available as a weight-based oral solution (Rinvoq LQ) in addition to the previously available tablets, according to the company. JIA, which includes pJIA and juvenile PsA, affects nearly 300,000 children and adolescents in the United States, and alternatives to TNF inhibitor (TNFi) therapy are limited, according to the company. 

“Pediatric patients with pJIA and PsA can be severely limited in their ability to complete daily physical tasks and participate in everyday activities. Understanding their needs today and knowing the likelihood of disease in adulthood underscores the need for additional treatment options,” Aarat Patel, MD, a pediatric rheumatologist at Bon Secours Rheumatology Center, Richmond, Virginia, said in the press release. “Having a treatment option available for patients who do not respond well to a TNFi addresses a need for the healthcare community, patients, and their families,” he said.

Upadacitinib, a Janus kinase (JAK) inhibitor, is being studied for multiple immune-mediated inflammatory diseases. The new indication was supported by data from adults with rheumatoid arthritis (RA) and PsA, 51 pediatric patients with pJIA and active polyarthritis, and safety data from 83 pediatric patients aged 2 years to younger than 18 years with pJIA and active polyarthritis. 

In the studies, the drug’s safety in pediatric patients was similar to the known safety profile in adults, which includes increased risk for serious infections such as tuberculosis, cancer, immune system problems, blood clots, and serious allergic reactions to components of the drug, according to the press release. However, the safety and effectiveness of upadacitinib for pJIA and PsA in patients younger than 2 years are unknown.

“Upadacitinib plasma exposures in pediatric patients with pJIA and PsA at the recommended dosage are predicted to be comparable to those observed in adults with RA and PsA based on population pharmacokinetic modeling and simulation,” according to the press release.

Currently, upadacitinib’s only other pediatric indication is for moderate to severe atopic dermatitis in children aged 12 years or older. Upadacitinib also is indicated for treatment of adults with moderate to severe RA, active PsA, active ankylosing spondylitis, active nonradiographic axial spondyloarthritis, and moderate to severe ulcerative colitis and Crohn’s disease, but safety and efficacy for its use in treatment of these conditions in children and adolescents is unknown.

Upadacitinib also is being studied in phase 3 trials for treatment of conditions including alopecia areata, ankylosing spondylitis, atopic dermatitis, axial spondyloarthritis, Crohn’s disease, giant cell arteritis, hidradenitis suppurativa, psoriatic arthritis, RA, systemic lupus erythematosus, Takayasu arteritis, ulcerative colitis, and vitiligo, according to the press release. 

Full prescribing information and safety data for upadacitinib are available here. 

A version of this article appeared on Medscape.com.

BOSTON — Use of over-the-counter arthritis supplements containing undisclosed glucocorticoids can lead to iatrogenic adrenal dysfunction, Cushing syndrome, and/or adrenal insufficiency (AI). 

Patients who have been taking these supplements for prolonged periods must slowly taper off them with corticosteroid replacement, because abruptly stopping the supplement can precipitate AI, Kevin S. Wei, MD, said in a presentation of 12 cases — the largest such series to date of the phenomenon — at the annual meeting of the Endocrine Society.

The specific supplements used were Artri King in eight of the patients, Ardosons in two, and Ajo Rey in one. In April 2022, the US Food and Drug Administration issued a warning that Artri King contains diclofenac and dexamethasone not listed on the product label. In July 2023, the agency issued an expanded warning about that product and others including Ajo Rey.

The supplements are not believed to be sold in the United States, but they are available in Mexico and can be ordered online, said Dr. Wei, a second-year resident at the Keck School of Medicine at the University of California, Los Angeles.

“We found that quite a lot of patients after they’ve been on the Artri King or some other over the counter arthritis supplement, started developing these cushingoid features seen in the physical exam, such as rounded facial features or stretch marks of their abdomen,” he said.

And “when patients are abruptly taken off those supplements … sometimes this can cause them to go into signs or symptoms of adrenal insufficiency. That can occasionally be life-threatening if it’s not addressed in an inpatient setting,” Dr. Wei said.

In an interview, session moderator Sharon L. Wardlaw, MD, professor of medicine at Columbia University Irving Medical Center, New York, explained that when a person takes these drugs containing hidden glucocorticoids, “they won’t be picked up in a cortisol assay, but they’ll suppress the [adrenocorticotropic hormone] and the person’s own cortisol production. They look like they have Cushing, but when you measure their hormone levels, they’re undetectable. And then people wonder what’s going on. Well, their [hypothalamic-pituitary-adrenal] axis is suppressed.”

But if the product is suddenly stopped without cortisol replacement “If they get an infection they can die because they can’t mount a cortisol response.”

The takeaway message, she said, is “always ask patients to show you their supplements and look at them. In many cases, that’s why they work so well for pain relief because they have ingredients that people shouldn’t be taking.”

Twelve Patients Seen During 2022-2023

The 12 patients were seen during 2022-2023 at an endocrinology consult service in an urban safety net hospital. Their median age was 52 years, and one third were women. All had started using the supplements for joint pain, with a median of about 6 months of use prior to cessation.

Presenting symptoms included nausea/vomiting in 42%, fatigue in 42%, abdominal pain in 33%, and dizziness in 17%. Physical exam findings included moon facies in 66%, central adiposity in 66%, abdominal striae in 50%, dorsocervical fat pad in 33%, and bruising in 33%. Three required intensive care admission.

Cortisol testing was performed in 11 of the patients and was normal (≥ 16 mcg/dL) in just one. AI (≤ 3 mcg/dL) was found in three, while the rest had indeterminate results. Of those seven patients, subsequent cosyntropin-stimulation testing suggested AI (cortisol < 16 mcg/dL at 60 minutes post stimulation) in four patients, while the other two showed reduced but normal responses (cortisol 18.2-18.4 mcg/dL).

Ten of the 12 patients were prescribed glucocorticoid tapering replacements to avoid precipitating adrenal crisis, most commonly twice-daily hydrocortisone. Of those ten, eight continued to take the replacement steroids 1-2 years later, Dr. Wei said.

Dr. Wei and Dr. Wardlaw had no disclosures.

A version of this article appeared on Medscape.com.

BOSTON — Use of over-the-counter arthritis supplements containing undisclosed glucocorticoids can lead to iatrogenic adrenal dysfunction, Cushing syndrome, and/or adrenal insufficiency (AI). 

Patients who have been taking these supplements for prolonged periods must slowly taper off them with corticosteroid replacement, because abruptly stopping the supplement can precipitate AI, Kevin S. Wei, MD, said in a presentation of 12 cases — the largest such series to date of the phenomenon — at the annual meeting of the Endocrine Society.

The specific supplements used were Artri King in eight of the patients, Ardosons in two, and Ajo Rey in one. In April 2022, the US Food and Drug Administration issued a warning that Artri King contains diclofenac and dexamethasone not listed on the product label. In July 2023, the agency issued an expanded warning about that product and others including Ajo Rey.

The supplements are not believed to be sold in the United States, but they are available in Mexico and can be ordered online, said Dr. Wei, a second-year resident at the Keck School of Medicine at the University of California, Los Angeles.

“We found that quite a lot of patients after they’ve been on the Artri King or some other over the counter arthritis supplement, started developing these cushingoid features seen in the physical exam, such as rounded facial features or stretch marks of their abdomen,” he said.

And “when patients are abruptly taken off those supplements … sometimes this can cause them to go into signs or symptoms of adrenal insufficiency. That can occasionally be life-threatening if it’s not addressed in an inpatient setting,” Dr. Wei said.

In an interview, session moderator Sharon L. Wardlaw, MD, professor of medicine at Columbia University Irving Medical Center, New York, explained that when a person takes these drugs containing hidden glucocorticoids, “they won’t be picked up in a cortisol assay, but they’ll suppress the [adrenocorticotropic hormone] and the person’s own cortisol production. They look like they have Cushing, but when you measure their hormone levels, they’re undetectable. And then people wonder what’s going on. Well, their [hypothalamic-pituitary-adrenal] axis is suppressed.”

But if the product is suddenly stopped without cortisol replacement “If they get an infection they can die because they can’t mount a cortisol response.”

The takeaway message, she said, is “always ask patients to show you their supplements and look at them. In many cases, that’s why they work so well for pain relief because they have ingredients that people shouldn’t be taking.”

Twelve Patients Seen During 2022-2023

The 12 patients were seen during 2022-2023 at an endocrinology consult service in an urban safety net hospital. Their median age was 52 years, and one third were women. All had started using the supplements for joint pain, with a median of about 6 months of use prior to cessation.

Presenting symptoms included nausea/vomiting in 42%, fatigue in 42%, abdominal pain in 33%, and dizziness in 17%. Physical exam findings included moon facies in 66%, central adiposity in 66%, abdominal striae in 50%, dorsocervical fat pad in 33%, and bruising in 33%. Three required intensive care admission.

Cortisol testing was performed in 11 of the patients and was normal (≥ 16 mcg/dL) in just one. AI (≤ 3 mcg/dL) was found in three, while the rest had indeterminate results. Of those seven patients, subsequent cosyntropin-stimulation testing suggested AI (cortisol < 16 mcg/dL at 60 minutes post stimulation) in four patients, while the other two showed reduced but normal responses (cortisol 18.2-18.4 mcg/dL).

Ten of the 12 patients were prescribed glucocorticoid tapering replacements to avoid precipitating adrenal crisis, most commonly twice-daily hydrocortisone. Of those ten, eight continued to take the replacement steroids 1-2 years later, Dr. Wei said.

Dr. Wei and Dr. Wardlaw had no disclosures.

A version of this article appeared on Medscape.com.

BOSTON — Use of over-the-counter arthritis supplements containing undisclosed glucocorticoids can lead to iatrogenic adrenal dysfunction, Cushing syndrome, and/or adrenal insufficiency (AI). 

Patients who have been taking these supplements for prolonged periods must slowly taper off them with corticosteroid replacement, because abruptly stopping the supplement can precipitate AI, Kevin S. Wei, MD, said in a presentation of 12 cases — the largest such series to date of the phenomenon — at the annual meeting of the Endocrine Society.

The specific supplements used were Artri King in eight of the patients, Ardosons in two, and Ajo Rey in one. In April 2022, the US Food and Drug Administration issued a warning that Artri King contains diclofenac and dexamethasone not listed on the product label. In July 2023, the agency issued an expanded warning about that product and others including Ajo Rey.

The supplements are not believed to be sold in the United States, but they are available in Mexico and can be ordered online, said Dr. Wei, a second-year resident at the Keck School of Medicine at the University of California, Los Angeles.

“We found that quite a lot of patients after they’ve been on the Artri King or some other over the counter arthritis supplement, started developing these cushingoid features seen in the physical exam, such as rounded facial features or stretch marks of their abdomen,” he said.

And “when patients are abruptly taken off those supplements … sometimes this can cause them to go into signs or symptoms of adrenal insufficiency. That can occasionally be life-threatening if it’s not addressed in an inpatient setting,” Dr. Wei said.

In an interview, session moderator Sharon L. Wardlaw, MD, professor of medicine at Columbia University Irving Medical Center, New York, explained that when a person takes these drugs containing hidden glucocorticoids, “they won’t be picked up in a cortisol assay, but they’ll suppress the [adrenocorticotropic hormone] and the person’s own cortisol production. They look like they have Cushing, but when you measure their hormone levels, they’re undetectable. And then people wonder what’s going on. Well, their [hypothalamic-pituitary-adrenal] axis is suppressed.”

But if the product is suddenly stopped without cortisol replacement “If they get an infection they can die because they can’t mount a cortisol response.”

The takeaway message, she said, is “always ask patients to show you their supplements and look at them. In many cases, that’s why they work so well for pain relief because they have ingredients that people shouldn’t be taking.”

Twelve Patients Seen During 2022-2023

The 12 patients were seen during 2022-2023 at an endocrinology consult service in an urban safety net hospital. Their median age was 52 years, and one third were women. All had started using the supplements for joint pain, with a median of about 6 months of use prior to cessation.

Presenting symptoms included nausea/vomiting in 42%, fatigue in 42%, abdominal pain in 33%, and dizziness in 17%. Physical exam findings included moon facies in 66%, central adiposity in 66%, abdominal striae in 50%, dorsocervical fat pad in 33%, and bruising in 33%. Three required intensive care admission.

Cortisol testing was performed in 11 of the patients and was normal (≥ 16 mcg/dL) in just one. AI (≤ 3 mcg/dL) was found in three, while the rest had indeterminate results. Of those seven patients, subsequent cosyntropin-stimulation testing suggested AI (cortisol < 16 mcg/dL at 60 minutes post stimulation) in four patients, while the other two showed reduced but normal responses (cortisol 18.2-18.4 mcg/dL).

Ten of the 12 patients were prescribed glucocorticoid tapering replacements to avoid precipitating adrenal crisis, most commonly twice-daily hydrocortisone. Of those ten, eight continued to take the replacement steroids 1-2 years later, Dr. Wei said.

Dr. Wei and Dr. Wardlaw had no disclosures.

A version of this article appeared on Medscape.com.

Exercise interventions are recommended to help prevent falls and fall-related morbidity in community-dwelling adults aged 65 years and older who are at increased risk of falls, according to a new recommendation statement from the U.S. Preventive Services Task Force (USPSTF) (JAMA. 2024 Jun 4. doi: 10.1001/jama.2024.8481).

Falls remain the leading cause of injury-related morbidity and mortality among older adults in the United States, with approximately 27% of community-dwelling individuals aged 65 years and older reporting at least one fall in the past year, wrote lead author Wanda K. Nicholson, MD, of George Washington University, Washington, and colleagues.

The task force concluded with moderate certainty that exercise interventions yielded a moderate benefit in fall reduction among older adults at risk (grade B recommendation).

The decision to offer multifactorial fall prevention interventions to older adults at risk for falls should be individualized based on assessment of potential risks and benefits of these interventions, including circumstances of prior falls, presence of comorbid medical conditions, and the patient’s values and preferences (grade C recommendation), the authors wrote.

The exercise intervention could include individual or group activity, although most of the studies in the systematic review involved group exercise, the authors noted.

The recommendation was based on data from a systematic evidence review published in JAMA (2024 Jun 4. doi: 10.1001/jama.2024.4166). The task force reviewed data from 83 randomized trials published between January 1, 2016, and May 8, 2023, deemed fair to good quality that examined six types of fall prevention interventions in a total of 48,839 individuals. Of these, 28 studies involved multifactorial interventions and 27 involved exercise interventions.

Overall, multifactorial interventions and exercise interventions were associated with a significant reduction in falls (incidence rate ratio 0.84 and 0.85, respectively).

Exercise interventions were significantly associated with reduced individual risk of one or more falls and injurious falls, but not with reduced individual risk of injurious falls. However, multifactorial interventions were not significantly associated with reductions in risk of one or more falls, injurious falls, fall-related fractures, individual risk of injurious falls, or individual risk of fall-related fractures.

Although teasing out the specific exercise components that are most effective for fall prevention is challenging, the most commonly studied components associated with reduced risk of falls included gait training, balance training, and functional training, followed by strength and resistance training, the task force noted.

Duration of exercise interventions in the reviewed studies ranged from 2 to 30 months and the most common frequency of sessions was 2 to 3 per week.

Based on these findings, the task force found that exercise had the most consistent benefits for reduced risk across several fall-related outcomes. Although individuals in the studies of multifactorial interventions were at increased risk for falls, the multistep process of interventions to address an individual’s multiple risk factors limited their effectiveness, in part because of logistical challenges and inconsistent adherence, the authors wrote.

The results of the review were limited by several factors, including the focus on studies with a primary or secondary aim of fall prevention, the fact that the recommendation does not apply to many subgroups of older adults, and the lack of data on health outcomes unrelated to falls that were associated with the interventions, the authors noted.

The new recommendation is consistent with and replaces the 2018 USPSTF recommendation on interventions for fall prevention in community-dwelling older adults, but without the recommendation against vitamin D supplementation as a fall prevention intervention. The new recommendation does not address vitamin D use; evidence will be examined in a separate recommendation, the task force wrote.
 

How to Get Older Adults Moving

“The biggest obstacle to exercise is patient inertia and choice to engage in other sedentary activities,” David B. Reuben, MD, and David A. Ganz, MD, both of the University of California, Los Angeles, wrote in an accompanying editorial (JAMA. 2024 Jun 4. doi: 10.1001/jama.2024.9063).

“Given the demonstrated benefits of exercise for cardiovascular disease, cognitive function, and favorable associations with all-cause, cardiovascular, and cancer mortality, specific fall prevention exercise recommendations need to be considered in the context of universal exercise recommendations, including aerobic and muscle strengthening exercise,” the authors wrote. However, maintaining regular exercise is a challenge for many older adults, and more research is needed on factors that drive exercise initiation and adherence in this population, they said.

Multifactorial fall assessments in particular take time, and more fall prevention programs are needed that include multifactorial assessments and interventions, the editorialists said. “Even if primary care clinicians faithfully implement the USPSTF recommendations, a significant reduction in falls and their resulting injuries is still far off,” in part, because of the need for more programs and policies, and the need to improve access to exercise programs and provide insurance coverage for them, they noted.

“Above all, older persons need to be active participants in exercise and reduction of risk factors for falls,” the editorialists concluded.

The research for the recommendation was funded by the Agency for Healthcare Research and Quality (AHRQ). The authors had no financial conflicts to disclose. Dr. Ganz disclosed serving as an author of the 2022 World Guidelines for Falls Prevention and Management for Older Adults.

Exercise interventions are recommended to help prevent falls and fall-related morbidity in community-dwelling adults aged 65 years and older who are at increased risk of falls, according to a new recommendation statement from the U.S. Preventive Services Task Force (USPSTF) (JAMA. 2024 Jun 4. doi: 10.1001/jama.2024.8481).

Falls remain the leading cause of injury-related morbidity and mortality among older adults in the United States, with approximately 27% of community-dwelling individuals aged 65 years and older reporting at least one fall in the past year, wrote lead author Wanda K. Nicholson, MD, of George Washington University, Washington, and colleagues.

The task force concluded with moderate certainty that exercise interventions yielded a moderate benefit in fall reduction among older adults at risk (grade B recommendation).

The decision to offer multifactorial fall prevention interventions to older adults at risk for falls should be individualized based on assessment of potential risks and benefits of these interventions, including circumstances of prior falls, presence of comorbid medical conditions, and the patient’s values and preferences (grade C recommendation), the authors wrote.

The exercise intervention could include individual or group activity, although most of the studies in the systematic review involved group exercise, the authors noted.

The recommendation was based on data from a systematic evidence review published in JAMA (2024 Jun 4. doi: 10.1001/jama.2024.4166). The task force reviewed data from 83 randomized trials published between January 1, 2016, and May 8, 2023, deemed fair to good quality that examined six types of fall prevention interventions in a total of 48,839 individuals. Of these, 28 studies involved multifactorial interventions and 27 involved exercise interventions.

Overall, multifactorial interventions and exercise interventions were associated with a significant reduction in falls (incidence rate ratio 0.84 and 0.85, respectively).

Exercise interventions were significantly associated with reduced individual risk of one or more falls and injurious falls, but not with reduced individual risk of injurious falls. However, multifactorial interventions were not significantly associated with reductions in risk of one or more falls, injurious falls, fall-related fractures, individual risk of injurious falls, or individual risk of fall-related fractures.

Although teasing out the specific exercise components that are most effective for fall prevention is challenging, the most commonly studied components associated with reduced risk of falls included gait training, balance training, and functional training, followed by strength and resistance training, the task force noted.

Duration of exercise interventions in the reviewed studies ranged from 2 to 30 months and the most common frequency of sessions was 2 to 3 per week.

Based on these findings, the task force found that exercise had the most consistent benefits for reduced risk across several fall-related outcomes. Although individuals in the studies of multifactorial interventions were at increased risk for falls, the multistep process of interventions to address an individual’s multiple risk factors limited their effectiveness, in part because of logistical challenges and inconsistent adherence, the authors wrote.

The results of the review were limited by several factors, including the focus on studies with a primary or secondary aim of fall prevention, the fact that the recommendation does not apply to many subgroups of older adults, and the lack of data on health outcomes unrelated to falls that were associated with the interventions, the authors noted.

The new recommendation is consistent with and replaces the 2018 USPSTF recommendation on interventions for fall prevention in community-dwelling older adults, but without the recommendation against vitamin D supplementation as a fall prevention intervention. The new recommendation does not address vitamin D use; evidence will be examined in a separate recommendation, the task force wrote.
 

How to Get Older Adults Moving

“The biggest obstacle to exercise is patient inertia and choice to engage in other sedentary activities,” David B. Reuben, MD, and David A. Ganz, MD, both of the University of California, Los Angeles, wrote in an accompanying editorial (JAMA. 2024 Jun 4. doi: 10.1001/jama.2024.9063).

“Given the demonstrated benefits of exercise for cardiovascular disease, cognitive function, and favorable associations with all-cause, cardiovascular, and cancer mortality, specific fall prevention exercise recommendations need to be considered in the context of universal exercise recommendations, including aerobic and muscle strengthening exercise,” the authors wrote. However, maintaining regular exercise is a challenge for many older adults, and more research is needed on factors that drive exercise initiation and adherence in this population, they said.

Multifactorial fall assessments in particular take time, and more fall prevention programs are needed that include multifactorial assessments and interventions, the editorialists said. “Even if primary care clinicians faithfully implement the USPSTF recommendations, a significant reduction in falls and their resulting injuries is still far off,” in part, because of the need for more programs and policies, and the need to improve access to exercise programs and provide insurance coverage for them, they noted.

“Above all, older persons need to be active participants in exercise and reduction of risk factors for falls,” the editorialists concluded.

The research for the recommendation was funded by the Agency for Healthcare Research and Quality (AHRQ). The authors had no financial conflicts to disclose. Dr. Ganz disclosed serving as an author of the 2022 World Guidelines for Falls Prevention and Management for Older Adults.

Exercise interventions are recommended to help prevent falls and fall-related morbidity in community-dwelling adults aged 65 years and older who are at increased risk of falls, according to a new recommendation statement from the U.S. Preventive Services Task Force (USPSTF) (JAMA. 2024 Jun 4. doi: 10.1001/jama.2024.8481).

Falls remain the leading cause of injury-related morbidity and mortality among older adults in the United States, with approximately 27% of community-dwelling individuals aged 65 years and older reporting at least one fall in the past year, wrote lead author Wanda K. Nicholson, MD, of George Washington University, Washington, and colleagues.

The task force concluded with moderate certainty that exercise interventions yielded a moderate benefit in fall reduction among older adults at risk (grade B recommendation).

The decision to offer multifactorial fall prevention interventions to older adults at risk for falls should be individualized based on assessment of potential risks and benefits of these interventions, including circumstances of prior falls, presence of comorbid medical conditions, and the patient’s values and preferences (grade C recommendation), the authors wrote.

The exercise intervention could include individual or group activity, although most of the studies in the systematic review involved group exercise, the authors noted.

The recommendation was based on data from a systematic evidence review published in JAMA (2024 Jun 4. doi: 10.1001/jama.2024.4166). The task force reviewed data from 83 randomized trials published between January 1, 2016, and May 8, 2023, deemed fair to good quality that examined six types of fall prevention interventions in a total of 48,839 individuals. Of these, 28 studies involved multifactorial interventions and 27 involved exercise interventions.

Overall, multifactorial interventions and exercise interventions were associated with a significant reduction in falls (incidence rate ratio 0.84 and 0.85, respectively).

Exercise interventions were significantly associated with reduced individual risk of one or more falls and injurious falls, but not with reduced individual risk of injurious falls. However, multifactorial interventions were not significantly associated with reductions in risk of one or more falls, injurious falls, fall-related fractures, individual risk of injurious falls, or individual risk of fall-related fractures.

Although teasing out the specific exercise components that are most effective for fall prevention is challenging, the most commonly studied components associated with reduced risk of falls included gait training, balance training, and functional training, followed by strength and resistance training, the task force noted.

Duration of exercise interventions in the reviewed studies ranged from 2 to 30 months and the most common frequency of sessions was 2 to 3 per week.

Based on these findings, the task force found that exercise had the most consistent benefits for reduced risk across several fall-related outcomes. Although individuals in the studies of multifactorial interventions were at increased risk for falls, the multistep process of interventions to address an individual’s multiple risk factors limited their effectiveness, in part because of logistical challenges and inconsistent adherence, the authors wrote.

The results of the review were limited by several factors, including the focus on studies with a primary or secondary aim of fall prevention, the fact that the recommendation does not apply to many subgroups of older adults, and the lack of data on health outcomes unrelated to falls that were associated with the interventions, the authors noted.

The new recommendation is consistent with and replaces the 2018 USPSTF recommendation on interventions for fall prevention in community-dwelling older adults, but without the recommendation against vitamin D supplementation as a fall prevention intervention. The new recommendation does not address vitamin D use; evidence will be examined in a separate recommendation, the task force wrote.
 

How to Get Older Adults Moving

“The biggest obstacle to exercise is patient inertia and choice to engage in other sedentary activities,” David B. Reuben, MD, and David A. Ganz, MD, both of the University of California, Los Angeles, wrote in an accompanying editorial (JAMA. 2024 Jun 4. doi: 10.1001/jama.2024.9063).

“Given the demonstrated benefits of exercise for cardiovascular disease, cognitive function, and favorable associations with all-cause, cardiovascular, and cancer mortality, specific fall prevention exercise recommendations need to be considered in the context of universal exercise recommendations, including aerobic and muscle strengthening exercise,” the authors wrote. However, maintaining regular exercise is a challenge for many older adults, and more research is needed on factors that drive exercise initiation and adherence in this population, they said.

Multifactorial fall assessments in particular take time, and more fall prevention programs are needed that include multifactorial assessments and interventions, the editorialists said. “Even if primary care clinicians faithfully implement the USPSTF recommendations, a significant reduction in falls and their resulting injuries is still far off,” in part, because of the need for more programs and policies, and the need to improve access to exercise programs and provide insurance coverage for them, they noted.

“Above all, older persons need to be active participants in exercise and reduction of risk factors for falls,” the editorialists concluded.

The research for the recommendation was funded by the Agency for Healthcare Research and Quality (AHRQ). The authors had no financial conflicts to disclose. Dr. Ganz disclosed serving as an author of the 2022 World Guidelines for Falls Prevention and Management for Older Adults.

NEW ORLEANS — Postmenopausal women with osteoporosis may not be receiving all the recommended tests to rule out secondary causes of bone loss prior to treatment initiation, new research found.

In a single-center chart review of 150 postmenopausal women who had been diagnosed and treated for osteoporosis, most had received a complete blood cell count, basic metabolic panel, thyroid screening, and vitamin D testing. However, one in four had not been tested for a parathyroid hormone (PTH) level, and in nearly two thirds, a 24-hour urine calcium collection had not been ordered.

Overall, less than a third had received the complete workup for secondary osteoporosis causes as recommended by the American Association of Clinical Endocrinologists (AACE) and the Endocrine Society.

“An appropriate evaluation for secondary causes of osteoporosis is essential because it impacts different treatment options and modalities. We discovered low rates of complete testing for secondary causes of osteoporosis in our patient population prior to treatment initiation,” said Kajol Manglani, MD, an internal medicine resident at Georgetown University/MedStar Washington Hospital Center, Washington, DC, and colleagues, in a poster at the American Association of Clinical Endocrinology (AACE) annual meeting held on May 9-12, 2024.

First author Sheetal Bulchandani, MD, said in an interview, “It depends a lot on clinical judgment, but there are certain things that everybody with osteoporosis should be evaluated for. We looked for the things that all the guidelines recommend.”

Studies have suggested that up to 30% of postmenopausal women with osteoporosis have secondary causes, noted Dr. Bulchandani, who conducted the study as a postdoctoral fellow with colleagues at Georgetown University/MedStar Washington Hospital and is now in private endocrine practice in Petersburg, Virginia.

“It’s important not to assume that every woman who walks in with osteoporosis has postmenopausal osteoporosis. I think it would be appropriate to at least discuss with the patients what would warrant certain kinds of clinical workup. … If you don’t figure out if there is an underlying cause, you may end up using an unnecessary medication,” Dr. Bulchandani said.
 

Are You Missing Something Treatable?

For example, she said, if the patient has underlying hyperparathyroidism and is treated with osteoporosis medications, “you might not see the desired or expected outcome in their bone density.”

Asked to comment, Rachel Pessah-Pollack, MD, clinical associate professor at the Holman Division of Endocrinology, Diabetes, and Metabolism at New York University School of Medicine, New York City, told this news organization, “Certainly, if you have patients who have osteoporosis, it’s important to take a good history and consider secondary causes of bone loss because you may find a treatable etiology that actually can improve their bone density without even starting on a medication.”

Dr. Pessah-Pollack, who was an author of the 2020 AACE/American College of Endocrinology 2020 Clinical Practice Guidelines for the Diagnosis and Treatment of Osteoporosis, said a 24-hour urine calcium collection, not a spot calcium check, is “super important because you’re looking to see if there’s any evidence of hypercalciuria or malabsorption that may be associated with higher rates of bone loss. … These may be a little more cumbersome and harder to get patients to do and more logistics to arrange. But clearly, if you pick up hypercalciuria, that is a potentially treatable etiology and can improve bone density as well.”

Another example, Dr. Pessah-Pollack said, is “if they have a low serum calcium level and high PTH, that would be a real reason to look for celiac disease. By not getting that PTH level, you may be missing that potential diagnosis. There is a wide range of additional causes of osteoporosis ranging from common conditions such as hyperthyroidism to rare conditions such as Cushing disease.”
 

Differences in Ordering Found Across Specialties

The 150 postmenopausal women were all receiving treatment with either alendronate, denosumab, or zoledronic acid. Their average age was 64.7 years, and 63% were seeing an endocrinologist.

Complete workups as per AACE and Endocrine Society guidelines had been performed in just 28% of those who saw an endocrinologist and 12.5% of patients seen by a rheumatologist, in contrast to 84% of those who saw the head of the hospital’s fracture prevention program.

Overall, across all specialties, just 28.67% had the complete recommended workup for secondary osteoporosis causes.

The most missed test was a 24-hour urine calcium collection, ordered for just 38% of the patients, while PTH was ordered for 73% and phosphorus for 80%. The rest were more commonly ordered: Thyroid-stimulating hormone level for 92.7%, complete blood cell count for 91.3%, basic metabolic panel for 100%, and vitamin D level for 96%.

The high rate of vitamin D testing is noteworthy, Dr. Pessah-Pollack said. “The fact that 96% of women are having vitamin D levels checked as part of an osteoporosis evaluation means that everybody’s aware about vitamin D deficiency, and people want to know what their vitamin D levels are. … That’s good because we want to identify vitamin D deficiency in our osteoporosis patients.”

But the low rate of complete secondary screening even by endocrinologists is concerning. “I look at this study as an opportunity for education that we can reinforce the importance of a secondary evaluation for our osteoporosis patients and really tailor which additional tests should be ordered for the individual patient,” Dr. Pessah-Pollack said.

In the poster, Dr. Bulchandani and colleagues wrote, “Further intervention will be aimed to ensure physicians undertake adequate evaluation before considering further treatment directions.” Possibilities that have been discussed include electronic health record alerts and educational materials for primary care providers, she told this news organization.

Dr. Manglani and Dr. Bulchandani had no disclosures. Dr. Pessah-Pollack is an advisor for Boehringer Ingelheim and Eli Lilly.

A version of this article appeared on Medscape.com.

NEW ORLEANS — Postmenopausal women with osteoporosis may not be receiving all the recommended tests to rule out secondary causes of bone loss prior to treatment initiation, new research found.

In a single-center chart review of 150 postmenopausal women who had been diagnosed and treated for osteoporosis, most had received a complete blood cell count, basic metabolic panel, thyroid screening, and vitamin D testing. However, one in four had not been tested for a parathyroid hormone (PTH) level, and in nearly two thirds, a 24-hour urine calcium collection had not been ordered.

Overall, less than a third had received the complete workup for secondary osteoporosis causes as recommended by the American Association of Clinical Endocrinologists (AACE) and the Endocrine Society.

“An appropriate evaluation for secondary causes of osteoporosis is essential because it impacts different treatment options and modalities. We discovered low rates of complete testing for secondary causes of osteoporosis in our patient population prior to treatment initiation,” said Kajol Manglani, MD, an internal medicine resident at Georgetown University/MedStar Washington Hospital Center, Washington, DC, and colleagues, in a poster at the American Association of Clinical Endocrinology (AACE) annual meeting held on May 9-12, 2024.

First author Sheetal Bulchandani, MD, said in an interview, “It depends a lot on clinical judgment, but there are certain things that everybody with osteoporosis should be evaluated for. We looked for the things that all the guidelines recommend.”

Studies have suggested that up to 30% of postmenopausal women with osteoporosis have secondary causes, noted Dr. Bulchandani, who conducted the study as a postdoctoral fellow with colleagues at Georgetown University/MedStar Washington Hospital and is now in private endocrine practice in Petersburg, Virginia.

“It’s important not to assume that every woman who walks in with osteoporosis has postmenopausal osteoporosis. I think it would be appropriate to at least discuss with the patients what would warrant certain kinds of clinical workup. … If you don’t figure out if there is an underlying cause, you may end up using an unnecessary medication,” Dr. Bulchandani said.
 

Are You Missing Something Treatable?

For example, she said, if the patient has underlying hyperparathyroidism and is treated with osteoporosis medications, “you might not see the desired or expected outcome in their bone density.”

Asked to comment, Rachel Pessah-Pollack, MD, clinical associate professor at the Holman Division of Endocrinology, Diabetes, and Metabolism at New York University School of Medicine, New York City, told this news organization, “Certainly, if you have patients who have osteoporosis, it’s important to take a good history and consider secondary causes of bone loss because you may find a treatable etiology that actually can improve their bone density without even starting on a medication.”

Dr. Pessah-Pollack, who was an author of the 2020 AACE/American College of Endocrinology 2020 Clinical Practice Guidelines for the Diagnosis and Treatment of Osteoporosis, said a 24-hour urine calcium collection, not a spot calcium check, is “super important because you’re looking to see if there’s any evidence of hypercalciuria or malabsorption that may be associated with higher rates of bone loss. … These may be a little more cumbersome and harder to get patients to do and more logistics to arrange. But clearly, if you pick up hypercalciuria, that is a potentially treatable etiology and can improve bone density as well.”

Another example, Dr. Pessah-Pollack said, is “if they have a low serum calcium level and high PTH, that would be a real reason to look for celiac disease. By not getting that PTH level, you may be missing that potential diagnosis. There is a wide range of additional causes of osteoporosis ranging from common conditions such as hyperthyroidism to rare conditions such as Cushing disease.”
 

Differences in Ordering Found Across Specialties

The 150 postmenopausal women were all receiving treatment with either alendronate, denosumab, or zoledronic acid. Their average age was 64.7 years, and 63% were seeing an endocrinologist.

Complete workups as per AACE and Endocrine Society guidelines had been performed in just 28% of those who saw an endocrinologist and 12.5% of patients seen by a rheumatologist, in contrast to 84% of those who saw the head of the hospital’s fracture prevention program.

Overall, across all specialties, just 28.67% had the complete recommended workup for secondary osteoporosis causes.

The most missed test was a 24-hour urine calcium collection, ordered for just 38% of the patients, while PTH was ordered for 73% and phosphorus for 80%. The rest were more commonly ordered: Thyroid-stimulating hormone level for 92.7%, complete blood cell count for 91.3%, basic metabolic panel for 100%, and vitamin D level for 96%.

The high rate of vitamin D testing is noteworthy, Dr. Pessah-Pollack said. “The fact that 96% of women are having vitamin D levels checked as part of an osteoporosis evaluation means that everybody’s aware about vitamin D deficiency, and people want to know what their vitamin D levels are. … That’s good because we want to identify vitamin D deficiency in our osteoporosis patients.”

But the low rate of complete secondary screening even by endocrinologists is concerning. “I look at this study as an opportunity for education that we can reinforce the importance of a secondary evaluation for our osteoporosis patients and really tailor which additional tests should be ordered for the individual patient,” Dr. Pessah-Pollack said.

In the poster, Dr. Bulchandani and colleagues wrote, “Further intervention will be aimed to ensure physicians undertake adequate evaluation before considering further treatment directions.” Possibilities that have been discussed include electronic health record alerts and educational materials for primary care providers, she told this news organization.

Dr. Manglani and Dr. Bulchandani had no disclosures. Dr. Pessah-Pollack is an advisor for Boehringer Ingelheim and Eli Lilly.

A version of this article appeared on Medscape.com.

NEW ORLEANS — Postmenopausal women with osteoporosis may not be receiving all the recommended tests to rule out secondary causes of bone loss prior to treatment initiation, new research found.

In a single-center chart review of 150 postmenopausal women who had been diagnosed and treated for osteoporosis, most had received a complete blood cell count, basic metabolic panel, thyroid screening, and vitamin D testing. However, one in four had not been tested for a parathyroid hormone (PTH) level, and in nearly two thirds, a 24-hour urine calcium collection had not been ordered.

Overall, less than a third had received the complete workup for secondary osteoporosis causes as recommended by the American Association of Clinical Endocrinologists (AACE) and the Endocrine Society.

“An appropriate evaluation for secondary causes of osteoporosis is essential because it impacts different treatment options and modalities. We discovered low rates of complete testing for secondary causes of osteoporosis in our patient population prior to treatment initiation,” said Kajol Manglani, MD, an internal medicine resident at Georgetown University/MedStar Washington Hospital Center, Washington, DC, and colleagues, in a poster at the American Association of Clinical Endocrinology (AACE) annual meeting held on May 9-12, 2024.

First author Sheetal Bulchandani, MD, said in an interview, “It depends a lot on clinical judgment, but there are certain things that everybody with osteoporosis should be evaluated for. We looked for the things that all the guidelines recommend.”

Studies have suggested that up to 30% of postmenopausal women with osteoporosis have secondary causes, noted Dr. Bulchandani, who conducted the study as a postdoctoral fellow with colleagues at Georgetown University/MedStar Washington Hospital and is now in private endocrine practice in Petersburg, Virginia.

“It’s important not to assume that every woman who walks in with osteoporosis has postmenopausal osteoporosis. I think it would be appropriate to at least discuss with the patients what would warrant certain kinds of clinical workup. … If you don’t figure out if there is an underlying cause, you may end up using an unnecessary medication,” Dr. Bulchandani said.
 

Are You Missing Something Treatable?

For example, she said, if the patient has underlying hyperparathyroidism and is treated with osteoporosis medications, “you might not see the desired or expected outcome in their bone density.”

Asked to comment, Rachel Pessah-Pollack, MD, clinical associate professor at the Holman Division of Endocrinology, Diabetes, and Metabolism at New York University School of Medicine, New York City, told this news organization, “Certainly, if you have patients who have osteoporosis, it’s important to take a good history and consider secondary causes of bone loss because you may find a treatable etiology that actually can improve their bone density without even starting on a medication.”

Dr. Pessah-Pollack, who was an author of the 2020 AACE/American College of Endocrinology 2020 Clinical Practice Guidelines for the Diagnosis and Treatment of Osteoporosis, said a 24-hour urine calcium collection, not a spot calcium check, is “super important because you’re looking to see if there’s any evidence of hypercalciuria or malabsorption that may be associated with higher rates of bone loss. … These may be a little more cumbersome and harder to get patients to do and more logistics to arrange. But clearly, if you pick up hypercalciuria, that is a potentially treatable etiology and can improve bone density as well.”

Another example, Dr. Pessah-Pollack said, is “if they have a low serum calcium level and high PTH, that would be a real reason to look for celiac disease. By not getting that PTH level, you may be missing that potential diagnosis. There is a wide range of additional causes of osteoporosis ranging from common conditions such as hyperthyroidism to rare conditions such as Cushing disease.”
 

Differences in Ordering Found Across Specialties

The 150 postmenopausal women were all receiving treatment with either alendronate, denosumab, or zoledronic acid. Their average age was 64.7 years, and 63% were seeing an endocrinologist.

Complete workups as per AACE and Endocrine Society guidelines had been performed in just 28% of those who saw an endocrinologist and 12.5% of patients seen by a rheumatologist, in contrast to 84% of those who saw the head of the hospital’s fracture prevention program.

Overall, across all specialties, just 28.67% had the complete recommended workup for secondary osteoporosis causes.

The most missed test was a 24-hour urine calcium collection, ordered for just 38% of the patients, while PTH was ordered for 73% and phosphorus for 80%. The rest were more commonly ordered: Thyroid-stimulating hormone level for 92.7%, complete blood cell count for 91.3%, basic metabolic panel for 100%, and vitamin D level for 96%.

The high rate of vitamin D testing is noteworthy, Dr. Pessah-Pollack said. “The fact that 96% of women are having vitamin D levels checked as part of an osteoporosis evaluation means that everybody’s aware about vitamin D deficiency, and people want to know what their vitamin D levels are. … That’s good because we want to identify vitamin D deficiency in our osteoporosis patients.”

But the low rate of complete secondary screening even by endocrinologists is concerning. “I look at this study as an opportunity for education that we can reinforce the importance of a secondary evaluation for our osteoporosis patients and really tailor which additional tests should be ordered for the individual patient,” Dr. Pessah-Pollack said.

In the poster, Dr. Bulchandani and colleagues wrote, “Further intervention will be aimed to ensure physicians undertake adequate evaluation before considering further treatment directions.” Possibilities that have been discussed include electronic health record alerts and educational materials for primary care providers, she told this news organization.

Dr. Manglani and Dr. Bulchandani had no disclosures. Dr. Pessah-Pollack is an advisor for Boehringer Ingelheim and Eli Lilly.

A version of this article appeared on Medscape.com.

CHICAGO — The diabetes/weight loss drug semaglutide is associated with a significantly greater risk for repeat operations in patients with diabetes who require lumbar surgery, a new study suggests.

The risk for additional surgeries was even higher among patients taking the popular weight loss and diabetes drug for longer periods of time.

Investigators say the study provides the first evidence on the impact of semaglutide on spine surgery. 

“The expectation was [that] we would see patients doing better after surgery, less wound complications, and other things, and in our diabetic patients we did not see that and saw increased odds of needing additional surgeries,” investigator Syed I. Khalid, MD, neurosurgery resident at University of Illinois Chicago, told this news organization.

The findings were presented on May 3 at the American Association of Neurological Surgeons (AANS) 2024 Annual Meeting.
 

Additional Surgery at Year 1

The new study used the all-payer Mariner database to identify patients aged 18-74 years with type 2 diabetes who underwent elective one- to three-level transforaminal lumbar interbody fusions (TLIFs) between January 2018 and October 2022. 

Patients were matched in a 3:1 ratio for age, sex, hypertension, obesity, smoking history, chronic kidney disease, osteoporosis, insulin use, and spinal fusion level, resulting in 447 patients with semaglutide use and 1334 with no semaglutide use. More than half (56%) were female, 62% used insulin, and 81% underwent single-level TLIF.

Total medical complications were higher in the semaglutide group, at 13.4%, compared with 7.7% in the no-semaglutide group (odds ratio [OR], 1.85). This was driven by higher rates of urinary tract infection (6.7% vs 2.5%) and acute kidney injury (6.3% vs 3.9%), two complications observed with semaglutide in other studies, Dr. Khalid said.

Total surgical complications, however, were lower in patients taking semaglutide, at 3.8% vs 5.2% in those who did not (OR, 0.73). 

Patients taking semaglutide vs those who were not using semaglutide had fewer wound healing complications (5 vs 31), hematoma (1 vs 9), surgical-site infections (12 vs 44), and cerebrospinal fluid leaks (2 vs 3).

Still, people taking semaglutide were nearly 12 times more likely to have an additional lumbar surgery at 1 year than did those who did not use the drug (27.3% vs 3.1%; OR, 11.79; 95% CI, 8.17-17.33).

Kaplan-Meier plots revealed a striking divergence of these populations when semaglutide exposure for more than or less than 9 months was examined (log-rank P < .0001).

Currently under review for publication, this study provides the first evidence on the impact of semaglutide on spine surgery, Dr. Khalid said. A second follow-up paper, also under review, looked only at patients with patients morbidly obesity without diabetes who had taken semaglutide for weight loss. 

“In nondiabetic, morbidly obese patients undergoing spine surgery, we see a similar trend,” Dr. Khalid said.
 

Sarcopenia the Cause?

The additional surgeries were primarily extensions of constructs, with additional surgery and fusion at more levels, Dr. Khalid noted. 

“The idea is that it could be the fact there is sarcopenia or muscle loss that’s taking place in conjunction with fat loss that’s causing that to happen,” Dr. Khalid said.

The mechanism remains speculative, but evidence from other areas examining frailty states has shown that those patients have weaker bones, sarcopenia, and worse outcomes with spine surgery, he noted. 

The investigators plan to use artificial intelligence to evaluate changes in body composition after semaglutide use in patients who underwent imaging prior to spine surgery or even before back pain occurred. Because these medications are uptitrated over time, follow-up studies will also look at whether this change takes place with a certain dose, Dr. Khalid added. 

On the basis of the current analysis of generic semaglutide alone, it’s not possible to say whether the use of other glucagon-like peptide 1 (GLP-1) receptor agonists will result in similar findings, but “the odds of a class effect are high,” Dr. Khalid said. 

Commenting on the findings, Walavan Sivakumar, MD, director of neurosurgery at Pacific Neuroscience Institute, Los Angeles, noted that the timing of surgery is already an issue for patients taking semaglutide and other GLP-1 receptor agonists following recent guidance from the American Society of Anesthesiologists that suggests stopping GLP-1 receptor agonists prior to elective surgery to reduce the risk for complications associated with anesthesia.

“It’s an incredibly topical point and seems to be something showing up on a daily basis for clinicians all throughout neurosurgery,” Dr. Sivakumar said. “It’s thought-provoking and a great first start.” 

Dr. Sivakumar also observed that frailty is a hot topic in all of neurosurgery. “That’s a major, major point that’s showing an impact on all surgical outcomes and it’s being heavily studied in the neurosurgical subsets right now. So that’s definitely a possible correlating factor.”

Dr. Khalid reported no financial relationships. Dr. Sivakumar reported serving as a consultant for Stryker. 
 

A version of this article appeared on Medscape.com.

CHICAGO — The diabetes/weight loss drug semaglutide is associated with a significantly greater risk for repeat operations in patients with diabetes who require lumbar surgery, a new study suggests.

The risk for additional surgeries was even higher among patients taking the popular weight loss and diabetes drug for longer periods of time.

Investigators say the study provides the first evidence on the impact of semaglutide on spine surgery. 

“The expectation was [that] we would see patients doing better after surgery, less wound complications, and other things, and in our diabetic patients we did not see that and saw increased odds of needing additional surgeries,” investigator Syed I. Khalid, MD, neurosurgery resident at University of Illinois Chicago, told this news organization.

The findings were presented on May 3 at the American Association of Neurological Surgeons (AANS) 2024 Annual Meeting.
 

Additional Surgery at Year 1

The new study used the all-payer Mariner database to identify patients aged 18-74 years with type 2 diabetes who underwent elective one- to three-level transforaminal lumbar interbody fusions (TLIFs) between January 2018 and October 2022. 

Patients were matched in a 3:1 ratio for age, sex, hypertension, obesity, smoking history, chronic kidney disease, osteoporosis, insulin use, and spinal fusion level, resulting in 447 patients with semaglutide use and 1334 with no semaglutide use. More than half (56%) were female, 62% used insulin, and 81% underwent single-level TLIF.

Total medical complications were higher in the semaglutide group, at 13.4%, compared with 7.7% in the no-semaglutide group (odds ratio [OR], 1.85). This was driven by higher rates of urinary tract infection (6.7% vs 2.5%) and acute kidney injury (6.3% vs 3.9%), two complications observed with semaglutide in other studies, Dr. Khalid said.

Total surgical complications, however, were lower in patients taking semaglutide, at 3.8% vs 5.2% in those who did not (OR, 0.73). 

Patients taking semaglutide vs those who were not using semaglutide had fewer wound healing complications (5 vs 31), hematoma (1 vs 9), surgical-site infections (12 vs 44), and cerebrospinal fluid leaks (2 vs 3).

Still, people taking semaglutide were nearly 12 times more likely to have an additional lumbar surgery at 1 year than did those who did not use the drug (27.3% vs 3.1%; OR, 11.79; 95% CI, 8.17-17.33).

Kaplan-Meier plots revealed a striking divergence of these populations when semaglutide exposure for more than or less than 9 months was examined (log-rank P < .0001).

Currently under review for publication, this study provides the first evidence on the impact of semaglutide on spine surgery, Dr. Khalid said. A second follow-up paper, also under review, looked only at patients with patients morbidly obesity without diabetes who had taken semaglutide for weight loss. 

“In nondiabetic, morbidly obese patients undergoing spine surgery, we see a similar trend,” Dr. Khalid said.
 

Sarcopenia the Cause?

The additional surgeries were primarily extensions of constructs, with additional surgery and fusion at more levels, Dr. Khalid noted. 

“The idea is that it could be the fact there is sarcopenia or muscle loss that’s taking place in conjunction with fat loss that’s causing that to happen,” Dr. Khalid said.

The mechanism remains speculative, but evidence from other areas examining frailty states has shown that those patients have weaker bones, sarcopenia, and worse outcomes with spine surgery, he noted. 

The investigators plan to use artificial intelligence to evaluate changes in body composition after semaglutide use in patients who underwent imaging prior to spine surgery or even before back pain occurred. Because these medications are uptitrated over time, follow-up studies will also look at whether this change takes place with a certain dose, Dr. Khalid added. 

On the basis of the current analysis of generic semaglutide alone, it’s not possible to say whether the use of other glucagon-like peptide 1 (GLP-1) receptor agonists will result in similar findings, but “the odds of a class effect are high,” Dr. Khalid said. 

Commenting on the findings, Walavan Sivakumar, MD, director of neurosurgery at Pacific Neuroscience Institute, Los Angeles, noted that the timing of surgery is already an issue for patients taking semaglutide and other GLP-1 receptor agonists following recent guidance from the American Society of Anesthesiologists that suggests stopping GLP-1 receptor agonists prior to elective surgery to reduce the risk for complications associated with anesthesia.

“It’s an incredibly topical point and seems to be something showing up on a daily basis for clinicians all throughout neurosurgery,” Dr. Sivakumar said. “It’s thought-provoking and a great first start.” 

Dr. Sivakumar also observed that frailty is a hot topic in all of neurosurgery. “That’s a major, major point that’s showing an impact on all surgical outcomes and it’s being heavily studied in the neurosurgical subsets right now. So that’s definitely a possible correlating factor.”

Dr. Khalid reported no financial relationships. Dr. Sivakumar reported serving as a consultant for Stryker. 
 

A version of this article appeared on Medscape.com.

CHICAGO — The diabetes/weight loss drug semaglutide is associated with a significantly greater risk for repeat operations in patients with diabetes who require lumbar surgery, a new study suggests.

The risk for additional surgeries was even higher among patients taking the popular weight loss and diabetes drug for longer periods of time.

Investigators say the study provides the first evidence on the impact of semaglutide on spine surgery. 

“The expectation was [that] we would see patients doing better after surgery, less wound complications, and other things, and in our diabetic patients we did not see that and saw increased odds of needing additional surgeries,” investigator Syed I. Khalid, MD, neurosurgery resident at University of Illinois Chicago, told this news organization.

The findings were presented on May 3 at the American Association of Neurological Surgeons (AANS) 2024 Annual Meeting.
 

Additional Surgery at Year 1

The new study used the all-payer Mariner database to identify patients aged 18-74 years with type 2 diabetes who underwent elective one- to three-level transforaminal lumbar interbody fusions (TLIFs) between January 2018 and October 2022. 

Patients were matched in a 3:1 ratio for age, sex, hypertension, obesity, smoking history, chronic kidney disease, osteoporosis, insulin use, and spinal fusion level, resulting in 447 patients with semaglutide use and 1334 with no semaglutide use. More than half (56%) were female, 62% used insulin, and 81% underwent single-level TLIF.

Total medical complications were higher in the semaglutide group, at 13.4%, compared with 7.7% in the no-semaglutide group (odds ratio [OR], 1.85). This was driven by higher rates of urinary tract infection (6.7% vs 2.5%) and acute kidney injury (6.3% vs 3.9%), two complications observed with semaglutide in other studies, Dr. Khalid said.

Total surgical complications, however, were lower in patients taking semaglutide, at 3.8% vs 5.2% in those who did not (OR, 0.73). 

Patients taking semaglutide vs those who were not using semaglutide had fewer wound healing complications (5 vs 31), hematoma (1 vs 9), surgical-site infections (12 vs 44), and cerebrospinal fluid leaks (2 vs 3).

Still, people taking semaglutide were nearly 12 times more likely to have an additional lumbar surgery at 1 year than did those who did not use the drug (27.3% vs 3.1%; OR, 11.79; 95% CI, 8.17-17.33).

Kaplan-Meier plots revealed a striking divergence of these populations when semaglutide exposure for more than or less than 9 months was examined (log-rank P < .0001).

Currently under review for publication, this study provides the first evidence on the impact of semaglutide on spine surgery, Dr. Khalid said. A second follow-up paper, also under review, looked only at patients with patients morbidly obesity without diabetes who had taken semaglutide for weight loss. 

“In nondiabetic, morbidly obese patients undergoing spine surgery, we see a similar trend,” Dr. Khalid said.
 

Sarcopenia the Cause?

The additional surgeries were primarily extensions of constructs, with additional surgery and fusion at more levels, Dr. Khalid noted. 

“The idea is that it could be the fact there is sarcopenia or muscle loss that’s taking place in conjunction with fat loss that’s causing that to happen,” Dr. Khalid said.

The mechanism remains speculative, but evidence from other areas examining frailty states has shown that those patients have weaker bones, sarcopenia, and worse outcomes with spine surgery, he noted. 

The investigators plan to use artificial intelligence to evaluate changes in body composition after semaglutide use in patients who underwent imaging prior to spine surgery or even before back pain occurred. Because these medications are uptitrated over time, follow-up studies will also look at whether this change takes place with a certain dose, Dr. Khalid added. 

On the basis of the current analysis of generic semaglutide alone, it’s not possible to say whether the use of other glucagon-like peptide 1 (GLP-1) receptor agonists will result in similar findings, but “the odds of a class effect are high,” Dr. Khalid said. 

Commenting on the findings, Walavan Sivakumar, MD, director of neurosurgery at Pacific Neuroscience Institute, Los Angeles, noted that the timing of surgery is already an issue for patients taking semaglutide and other GLP-1 receptor agonists following recent guidance from the American Society of Anesthesiologists that suggests stopping GLP-1 receptor agonists prior to elective surgery to reduce the risk for complications associated with anesthesia.

“It’s an incredibly topical point and seems to be something showing up on a daily basis for clinicians all throughout neurosurgery,” Dr. Sivakumar said. “It’s thought-provoking and a great first start.” 

Dr. Sivakumar also observed that frailty is a hot topic in all of neurosurgery. “That’s a major, major point that’s showing an impact on all surgical outcomes and it’s being heavily studied in the neurosurgical subsets right now. So that’s definitely a possible correlating factor.”

Dr. Khalid reported no financial relationships. Dr. Sivakumar reported serving as a consultant for Stryker. 
 

A version of this article appeared on Medscape.com.